Drug and Device Law

Who Are We/What Can We Do?

2012-01-27T12:36:00.001-05:00

We’ve been blogging now, with one lineup or another, since November of 2006 – over five years. As we’ve said on a number of occasions, such as here, our philosophy has always been that a rising tide lifts all boats. It’s the nature of stare decisis (that earlier court decisions are the precedent on which later decisions rest) that defense wins anywhere tend to help other defendants everywhere. We thus strive to keep the pharmaceutical/medical device defense community abreast of new decisions, new arguments, and (when we’re lucky) new strategies that can help win cases.

We’re big firm lawyers. We have big firm clients and big firm resources. Not everybody is or does. But cases not involving big/big/big can be every bit as important as those that do. For instance, the two major product liability cases that established the (we’d say unfortunate) course of strict liability here in Pennsylvania are Azzarello v. Black Brothers Co., 480 Pa. 547, 391 A.2d 1020 (1978), and Berkebile v. Brantly Helicopter Corp., 462 Pa. 83, 337 A.2d 893 (1975). Everyone who’s heard of the Black Brothers Co. or the Brantly Helicopter Corp. other than in connection with these cases raise your hands.

We thought so.

Those cases handled for those clients have screwed up the law in Pennsylvania since before some of us started practicing it. We don’t think Pennsylvania’s unique. The Fortune 500 and the AmLaw 100 aren't anywhere near all that matters.

Thus, as much as we want to reach – and be thought well of by – our big firm colleagues around the country (and globe), we believe it’s probably even more important to reach the folks in the regional firms, and defending the smaller companies, who are involved in prescription medical product liability litigation. Because those folks, and their clients, might not have the resources to do the kind of comprehensive research that we're used to, we try to make what we do on this blog as helpful as possible, and we have even taken research requests on occasion. That’s probably the chief reason we keep our scorecards and cheat sheets. These concern important or current subjects, and provide (we hope) comprehensive and up-to-date legal research that anybody can use and craft to their particular cases.

For these five+ years, we’ve always had a Google Groups subscribe feature on the right hand side of our blog, near the bottom, that allows anybody who wants to receive all of our posts by email. Over those five years, 784 people have signed up (actually, more, but we periodically delete group members whose emails are reported as “bouncing” – meaning invalid). That gives us some data to indicate who the subscribers to this blog, the “we,” are.

We have to discard, at the outset, 229 subscribers whose emails end in “yahoo,” “gmail,” or various other nonspecific domains (that’s what our Google analytics call them, anyway). Anybody who doesn’t want us to know where s/he is affiliated is certainly free to do so. We’re not nosy.

Of the remaining 555 subscribers, 365 of them (one for each day of the year, except this is 2012) are with identifiable defense firms. We have subscribers, who get all of our posts, at 116 different defense firms – from names that anybody would recognize, to names that even we had to check out online to figure out what side of the “v.” they were on. To us, the number of firms is more satisfying than the number of subscribers, because any subscriber can pass any of our posts around internally. The more defense counsel we reach, directly or indirectly, the better we like it.

Some firms, of course, have a lot more subscribers than others. We’d like to give a shout out to our most numerous supporters:

Tucker, Ellis & West – 40 individual subscribers
Shook Hardy & Bacon – 33 individual subscribers
Reed Smith – 20 individual subscribers
Drinker Biddle – 18 individual subscribers
Dechert – 12 individual subscribers (including us)
Sidley & Austin – 10 individual subscribers

We set the cut off at ten. Why? Probably because we have ten fingers.

Another 156 of our subscribers are in house. We’re not going to identify even company names here, but we’re pleased to count among our number practically every well known name in the pharmaceutical and medical device business. We’ve also been invited into many smaller manufacturers, for a total of 66 different recognizable corporate domains.

There are also a handful of subscribers from other manufacturing companies that, as far as we know, don’t make prescription medical products. Some of our interests – class action tolling and removal before service to name a couple – do have impact that extends beyond companies who have to jump when the FDA says so.

We also count 34 plaintiff-side subscribers. Yes, we know who you are (that is, if you sign up from work). No, we’re not going to delete you or anything like that. We don’t work that way. Frankly, we’re rather flattered when those on the other side think we’re saying things that are worth knowing about – even if at times we’re sure we make our opposing colleagues want to pound their keyboards to bits, put their fists through their screens, or throw their PDAs as far as they can.

The remainder of our subscribers come from a variety of related interests and fields. Trade associations – both PhARMA and AdvaMed have subscribers. Folks from both Lexis and Westlaw have signed up. We have subscribers from the FDA and other governmental entities, both federal and state. There are some academics on the list, or at least their email addresses end in “.edu” (they might be law students). We also have various consultants, members of the press (including the medical press), CLE providers, insurance company people, contract researchers, and other health related businesses.

So once you’re here, what can you do? Well, if you’re here to take advantage of our legal research over the years, we put up a post less than a year ago that compiles quite a bit of that in one place (with links). We’ve already mentioned our cheat sheets and scorecards. Briefly, scorecards contain all cases, pro and con. Cheat sheets include only decisions favorable to our (the defense) side.

Each one of these posts is strictly in chronological order and is accessible via a separate link on the right-hand side of the blog, under the category helpfully called “Links.” We’re not known for creativity – except that there are two successive “Links” sections on the blog. Our internal links are in the second of these. The first serves as our blogroll (links to other blogs/websites of interest).

The blog’s basic Google Blogger software (we’re not into pictures and other extraneous stuff here at DDLaw) also provides some tools to help find things.

The blog has an “archive” that includes every post we've ever written – all 1700+ of them. That can be useful, but you first have to know the date or name of the post.

If you don’t know the date or the name (and we, ourselves, are quite forgetful), there’s an internal blog search function in the blog’s extreme upper left-hand corner. It’s not labeled (probably should be) but it has a clickable white space for typing followed by what’s supposed to look like a hand magnifying glass. That search function is good enough for searching relatively unusual terms (such as “conveniens”) or case names (such as “Mensing”), but less useful when trying to accomplish anything more sophisticated. When we require more involved searching, we simply go to Google and search for “druganddevicelaw” along with whatever other terms we want to find.

On the right-hand side, below our “Archive” is a long list of terms called “Topics.” Each one is clickable, and will produce a list of every one of our posts that we’ve decided (in our utterly unreviewable discretion) belongs under that heading. We can use as many headings as we want, and some of our posts are listed in as many as a half-dozen different Topics. The number of posts in a topic range from one (a lot of things) to over 100 (preemption, class actions). While we might have something on the topic of cancer, we won't have anything on the topic of capricorn.

Finally, most people know this already, but in case somebody doesn’t, on just about any internet page, including our blog, you can use “control f” to search for particular words, phrases or sequences of characters that appear on that page.

So thanks to all our loyal subscribers, and to everybody else whom we reach through RSS feed, Twitter, Lexology, and of course those who simply click to our site (over 500 a day according to Google analytics).

The State-of-the-Art Conte Defense

2012-01-27T12:12:00.002-05:00

Because of Dechert's involvement in Reglan litigation, we can't say as much as we'd like to (or used to) about so-called "Conte" liability - that is theories by which plaintiffs who only took generic drugs attempt to impose liability on the manufacturer of a branded bioequivalent that they neither bought nor consumed. As we mentioned previously, that issue is currently pending in the Alabama Supreme Court in Wyeth v. Weeks, its first appearance in a state high court.

We're willing to bet that the defense briefing in Weeks represents the current state of the art in defending/arguing against Conte-style liability. For the benefit of everyone out there who is arguing against Conte, we're therefore providing four publicly filed briefs from the Weeks case: those filed by defendant/appellant Wyeth (be patient, this one takes a while to download), amicus Product Liability Advisory Council, amicus Defense Research Institute, and amicus Pharmaceutical Research & Manufacturers of America.

Thanks to Kevin Newsom at Bradley Arent for the Wyeth brief, to Chilton Varner, at King & Spalding for the PLAC brief, and to Paul Schmidt and Mike Imbroscio at Covington & Burling for the PhRMA brief. We grabbed the DRI brief from its website.

On Performance Standards and Preemption

2012-01-26T16:07:00.000-05:00

As we’ve mentioned before, the supposed “parallel violation claim” exception to medical device preemption has been frustratingly vague. That’s because it originated in a complaint’s vague language that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – decided on a motion to dismiss – speculated might have stated such a claim. A single paragraph of dictum in Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008), seemingly recognizing the exception in the course of explaining that the plaintiffs had waived it, only made things worse.

A new case, Walker v. Medtronic, Inc., No. 10-2219, 2012 WL 206036, slip op. (4th Cir. Jan. 25, 2012), is the first court of appeals case that really takes a close look at what “parallel” claims entail post-Riegel. While we’d prefer that this phantom exception not exist at all, the court’s discussion keeps it tightly constrained and thus gets a thumbs up from us. Perhaps it was fitting that Walker was decided on Bexis’ birthday.

Walker involved what’s essentially a spinal version of a pain pump – designed to infuse a preset amount of specific drugs into the fluid that surrounds the spinal cord. It’s supposed to be accurate within ± (that’s “plus or minus”) fifteen percent of whatever it’s set for, but both the FDA’s approval letter, and the FDA-approved materials that accompany the pump make clear that this fifteen percent is not some kind of absolute guarantee, but only a best estimate, and there are a lot of problems that can lead to a deviation (such deviations being reportable to the FDA as adverse events). Slip op. at 7-8, 14-15.

The pump was “undisputedly a Class III device.” Slip op. at 7. Cf. Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503, at *5 (D. Mass. Jan. 10, 2012) (rejecting argument that based upon claim that not all components of different pump system weren’t all originally PMAed). Thus Riegel preemption applied.

Because Walker is a product liability case, it doesn’t take much to describe what happened. The decedent was taking a bunch of painkilling drugs at the same time and died from “[c]ombined hydromorphone, hydrocodone, diazepam, and venlafaxine intoxication." Slip op. at 9. Only one – hydromorphone – was being infused using the pump, so that’s the one the plaintiff targeted. Plaintiff obtained some sort of "expert" who, through some unexplained process (probably assuming the pump had been filled to the brim when it wasn’t) claimed there had been an overdose. Id.

Whether there was or was not an overdose was not germane to the preemption summary judgment motion. Slip op. at 9-10 n.3. That underscores why preemption is so powerful. It applies irrespective of the merits of the underlying litigation.

Trying to turn the ±15% language in the product literature into a “guarantee of performance,” slip op. at 17, plaintiff argued that she had stated some sort of unpreempted “parallel” violation claim because she had some evidence that the device was outside this range. The court held that no such claim existed.

In so doing, Walker had to decide how broadly to construe the “parallel” claim loophole to preemption. Fortunately it’s construction was relatively restrictive. The FDA has a formal type of specification, called a “performance standard,” under which a manufacturer must guarantee a particular level functioning upon pain of violating the Medical Device Amendments:

The FDA may condition its grant of premarket approval upon certain requirements. Significantly for our purposes, the FDA may require that a device meet certain performance standards if it “determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.” 21 U.S.C. §360d(a)(1).

The establishment of a performance standard is a formal process specifically governed by the MDA. It requires publication of a notice of proposed rulemaking in the Federal Register setting forth justification why the performance standard is necessary, “proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate,” and invitation for comments from interested persons. Id. at §360d(b)(1)(B). . . . When the FDA establishes a performance standard for a Class III device, it does so as a precursor to the grant of premarket approval. 21 C.F.R. §861.1(b)(3).

Walker, slip op. at 5-6 (footnote omitted) (emphasis added).

When a plaintiff, under state law, tries to take some statement, or other device attribute, that hasn’t jumped through the hoops to become a “performance standard,” and through litigation tries to make it into such a mandatory standard is something that's “different from or in addition to” within the meaning of the Act’s preemption clause. Therefore, preemption bars the claim:

Whether the plus or minus 15 percent specification is a formal performance standard is pertinent because only such a performance standard could create the type of binding requirement that would make [plaintiff’s] claims impose requirements parallel to, as opposed to more restrictive than, those imposed by the FDA.

Slip op. at 14 (emphasis added). The court revisits the same point, at greater length, a little later:

[It] is incontrovertible under FDA regulations: the only mechanism for creating a binding, ongoing performance requirement is the creation of a performance standard. And [plaintiff] does not dispute that, here, the plus or minus 15 percent specification is not a performance standard. . . . [I]f we were to treat the flow rate as a requirement, we would be imposing a heightened standard beyond that of the FDA – which is impermissible under Riegel. Moreover, as we have noted, such a holding would upend the carefully calibrated construct Congress created in the MDA, balancing the potential rewards of such devices following the rigorous process of FDA approval against the cost of preempting common law claims based on standards different than those imposed by the FDA.

Id. at 15 (emphasis added). No formal "performance standard" – that's simple, easy to apply, and above all, rare.

The device in question was manufactured sold, etc. in full compliance with everything the FDA required, including those aspects that underlay the expected ±15% flow rate. Plaintiff did not contest that. E.g. slip op. at 16 n.5. But that expectation was not the same as a real FDA requirement that the device could not, for any reason, ever deviate from that rate. For plaintiff to use state law to convert any deviation into a “violation” that did not, in fact, exist was dissimilar from what the FDA required and therefore preempted:

[N]othing in the [device’s] premarket approval application – which was approved in its entirety by the FDA – purported that the device would always dispense medication within the range of the plus or minus 15 percent. . . . To the extent that [plaintiff] interprets the plus or minus 15 percent specification as a guarantee of performance, she seeks to impose a more demanding standard than that of the FDA, rather than a parallel one.

Id. at 17.

As anyone reviewing the cases on our device preemption scorecard can attest, this is one version – and a rather restrictive one – of the elusive “parallel” violation claim that post-Riegel courts have adopted. While not tying the analysis explicitly to “performance specifications,” numerous courts have rejected the theory that underlay the plaintiff’s arguments in Walker, which is that the mere malfunction of a device somehow establishes a non-preempted violation claim. See Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 314 (D.P.R. 2011) (“the failure of a Class III medical device does not establish the existence of a manufacturing defect”); Haynes v. Cyberonics, Inc., 2011 WL 3903238, at *3 (N.D. Ga. Sept. 6, 2011) (“a manufacturer could comply with all FDA regulations, but nevertheless produce a product containing an unintended flaw or abnormal condition”); Timberlake v. Synthes Spine, Inc., 2011 WL 711075, at *9 (S.D. Tex. Feb. 18, 2011), (“plaintiff “must plead and prove the specific way in which Defendants’ manufacturing process differed from that approved by the FDA in order to show that his manufacturing defect claim is truly ‘parallel’”); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011) (“under the federal law governing the PMA process, there is no demand that a product be risk-free, only that its benefits, if manufactured according to specifications, outweigh its risks”; res ipsa loquitur is “refuted by Riegel”); Gelber v. Stryker Corp., 752 F. Supp.2d 328, 334 (S.D.N.Y. 2010) (preemption because plaintiffs “have not pointed to evidence of device-specific violations of federal law”); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010) (“[defendant] received premarket approval”; “that the [device] allegedly failed during normal use does not override the clear language of §360(a) or . . . Riegel”); Banner v. Cyberonics, Inc., 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010) (“FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work”; “if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a [malfunction] does not give rise to liability”); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582, 588 (E.D.N.Y. 2009) (“vague and open-ended . . . regulations . . . cannot serve as the basis for a parallel claim[, s]ince these regulations are open to a particular manufacturer’s interpretation”); Funk v. Stryker Corp., 673 F. Supp.2d 522, 532 (S.D. Tex. 2009) (plaintiff “essentially relies on a circular argument that because he was injured and because the device (allegedly) contained impurities, [it] therefore violated FDA regulations. Such reasoning is contrary to the holding in Riegel”), aff’d, 631 F.3d 777 (5th Cir. 2011); Williams v. Cyberonics, Inc., 654 F. Supp. 2d 301, 306, 308 (E.D. Pa. 2009) ("[t]o avoid federal preemption, a plaintiff must make some showing that the medical device was not manufactured in accordance with FDA standards”; “[w]ithout proof that the [device] did not adhere to the premarket approval, [plaintiffs’] claim must fail”), aff’d, 388 Fed. Appx. 169 (3d Cir. 2010); Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226, 1230 (D. Nev. 2009) (preemption where there is “no evidence to show that the [device] was manufactured out of conformity with the materials or manufacturing specifications approved by the FDA”); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1158 (D. Minn. 2009) (“In the absence of any specific requirement . . . holding [defendant] liable for such a [specific] ‘defect’ would impose requirements ‘different from, or in addition to’ those under federal law”), aff’d, 623 F.3d 1200 (8th Cir. 2010); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (plaintiff “does not specify in what way [device] deviated from the manufacturing process that the FDA approved”; “mere occurrence of an accident” insufficient for preemption); Clark v. Medtronic, Inc., 572 F. Supp. 2d 1090, 1094-95 (D. Minn. 2008) (“[p]laintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe”; his “claims are not based on a breach of the MDA as enforced by the FDA”; “[t]hus plaintiff’s claims are preempted”); In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, 2009 WL 3417867 (Minn. Dist. Oct. 29, 2009) (“that the FDA specifically approved the design and proposed manufacturing processes” requires preemption); Colombini v. Westchester County Health Care Corp., 2009 WL 2170230, at *4 (N.Y. Sup. July 6, 2009) (“plaintiffs cite to no document from the FDA which specifically mandates [the items at issue] as the only solutions to the problems. Plaintiffs therefore have not demonstrated that they have any parallel claims”) (in table at 899 N.Y.S.2d 58).

As the court in Walker observed, “[n]either [plaintiff] nor the dissent point to any case law, nor have we found any, in which a court has reached a contrary conclusion.” Slip op. at 19. We haven't seen any either.

So Walker is the first appellate court explicitly to hold that the mere assertion of a device malfunction is not, at least under anything approaching ordinary circumstances, enough to establish a “parallel” violation claim. The court provides a narrow escape hatch – that a parallel claim would be established if the FDA had adopted a “performance standard” that set a particular characteristic as an absolute floor the non-attainment of which, without more, constitutes a violation. That’s all well and good, but such device-specific “performance standards,” if not quite as rare as hen’s teeth, come close. We’ve only seen one even asserted in any of the post-Riegel device preemption cases we’ve read (and we think we’ve read them all). Burgos v. Satiety, Inc., 2011 WL 1327684, at *5 (E.D.N.Y. Apr. 5, 2011), and even there it wasn’t sufficiently described that we could be sure such a thing actually existed.

Thus, while we’d rather not have a “parallel” requirement exception to preemption at all (they’re disguised attempts at private enforcement of the FDCA, which the statute bans), if we have to have one, the articulation in Walker – requiring the presence of a “performance standard” – is the kind of bright line we can live with.

A Quick Boles Update

2012-01-25T17:27:00.000-05:00

When last we left Boles v Merck, the case had been tried twice and the trial court had certified for appeal its decision denying defendant’s motion for judgment as a matter of law or in the alternative for a new trial. In denying the defense motion, the court saw fit to reduce the verdict, which the plaintiff rejected in favor of seeking a new trial. See posts here and here.

While we are still waiting to see if the Second Circuit will accept that appeal, it did have something to say about plaintiff’s counsel’s attempt to appeal the order imposing minimal sanctions against him for his outrageous conduct in Boles II. Douglas v. Merck & Co., Inc., No. 10-4196-cv, slip op. (2d Cir. Jan 23, 2012) . They quashed it and told Douglas he had to wait until the trial court’s decision to reduce the verdict was before the appellate court – something we hope happens sooner rather than later.

And, while this is really a non-event, what it reminds us is that we needn’t be talking about appeals of remittiturs and sanctions – what we should really be seeing is a new trial. So, since it is a slow news days, we’ll take a minute to stand on our soap box and once again advocate that courts should be more willing to toss out verdicts that are a product of juror passion and prejudice rather than simply remitting them. Just looking at Boles II as an example, in ruling sua sponte on remittitur, the court said that it “believes the $8 million verdict is unreasonably high, but cannot point definitively to anything in the records that caused the surplus.” In re Fosamax Products Liability Litigation, 742 F. Supp. 2d 460, 484 (S.D.N.Y. 2010) If the jury awarded the plaintiff over five times the maximum amount of justifiable compensatory damages, isn’t that sufficient proof that the verdict was tainted? And where there is taint, a new trial should follow.

We understand that new trials based on attorney misconduct and subsequent jury passion are rare because generally courts afford lawyers latitude when representing their clients. But lawyers need to be held accountable when they go too far. There is a limit to what lawyers can do in the courtroom when advocating on behalf of their clients. When plaintiffs’ attorneys – in pursuit of excessive verdicts -- are allowed to vilify defense witnesses, attack defense counsel and distort and mischaracterize the evidence to the jury, the basic tenets of fairness and impartiality in litigation go out the window.

Jurors are people too. As such they, we all know that they are influenced by things like whether they connect to a particular witness, fun demonstratives, and well even if their seats are comfortable. All that aside, juries primarily should be focused on the facts and their verdicts should be supported by the facts in evidence. When they aren’t, new trials are warranted. That should be true if the evidence just isn’t there or if the evidence has been so diluted by attorney misconduct that that misconduct affected the outcome of the trial.

Where an excessive verdict is given under the influence of passion and prejudice (which seems to have been the conclusion of the trial court in Boles II), remittitur isn’t enough. The misconduct should be seen as not simply tainting the amount of the verdict, but indeed the finding of liability itself. Boles itself proves this point considering that without the disingenuous antics of plaintiff’s counsel, the jury in Boles I found in favor of the defendant. While remitting the verdict helps, it doesn’t take away the bad precedent set by a plaintiff verdict in any amount.

Also, Happy Birthday Bexis!

Whether Medical Device or Meat, It’s Preempted

2012-01-24T15:49:00.003-05:00

For this one, we go to the wisdom of Homer:

(Lisa) “I’m going to become a vegetarian”

(Homer) “Are you saying you're never going to eat any animal again? What about bacon?”

(Lisa) “No”

(Homer) “Ham?”

(Lisa) “No.”

(Homer) “Pork Chops?”

(Lisa) “Dad, those all come from the same animal.”

(Homer) “Heh, heh, heh. Ooh, yeah, right, Lisa. A wonderful, magical animal.”

("The Simpsons" Lisa the Vegetarian (1995).) That wonderful, magical animal yesterday helped forge a unanimous preemption decision from the Supreme Court that is, in our view, helpful and comforting with regard to medical device preemption.

The Supreme Court ruled that a California statute that outlawed certain treatment and uses of non-ambulatory (basically, they can’t move) animals by slaughterhouses was preempted. National Meat Assoc. v. Harris, No. 10-224, slip op. (U.S. Jan. 23, 2012). After some nasty undercover video, California enacted the statute, which made it a crime for slaughterhouses to accept non-ambulatory animals. They couldn’t buy them, sell them, handle them, or sell meat or other products made from such animals. Slaughterhouses were required to euthanize in a humane manner any non-ambulatory animals in their possession. This regulation, of course, seems well intentioned.

The problem is that someone else was already doing it – the federal government. Similar journalism, a century ago, inspired the 1906 Federal Meat Inspection Act (FMIA). Read Upton Sinclair’s novel, The Jungle, if you don’t believe us. Congress later expanded FMIA to include humane standards for the treatment and slaughter of animals (while humane slaughter seems like a prickly, almost oxymoronic, concept, that’s an issue for some other blog).

FMIA’s regulation is extensive. The Dep’t of Agriculture’s inspection arm examines animals before they are slaughtered and, for diseases or afflictions – including inability to move – says what can be done with them. Most important, for our purposes, FMIA has an express preemption provision that is almost spot-on to the one contained in the Medical Device Amendments of 1976. Here it is:

Requirements within the scope of this [Act] with respect to premises, facilities and operations of any establishment at which inspection is provided under . . . this [Act] which are in addition to or different than those made under this [Act] may not be imposed by any State.

That’s the same preemption language (“different from or in addition to”) in the Medical Device Amendments. Only the order’s been reversed and “from” changed to “than.”

Seems pretty straightforward, doesn’t it? But like inventive plaintiffs’ lawyers, California and other advocates crafted a number of arguments to try to get around preemption. California’s main argument, which actually won in the Ninth Circuit, was to redefine the reality of what the federal scheme actually regulates, something we’ve seen from plaintiffs’ lawyers in medical device cases. California argued for instance that the FMIA scheme applies only to the group of “animals that are going to be turned into meat,” while the California statute on the other hand simply excludes certain animals from that group. The Ninth Circuit may have bought this one, but it was roadkill in the Supreme Court:

According to the Court of Appeals, “states are free to decide which animals may be turned into meat.” . . . We think not. The FMIA’s scope includes not only “animals that are going to be turned into meat,” but animals on a slaughterhouse’s premises that will never suffer that fate.

That kind of argument by redefinition recalls the plaintiffs’ arguments in cases like Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), over whether tort claims could be “requirements” within the meaning of the statute.

Some of California’s other arguments are also similar to those we’ve seen from medical device plaintiffs’ lawyers, who often lower a microscope to a regulatory scheme and stare only at certain granules of it, hoping to blur any focus on the regulatory scheme as a whole, leaving it unrecognizable and applicable to almost nothing. For instance, California argued that the portion of its statute that prohibits the sale of meat taken from non-ambulatory animals is not preempted because FMIA doesn’t apply to the sale of meat, only its processing. More roadkill for the Court, which rejected California’s offer to look at a single tree and lose focus on the forest of the FMIA’s regulatory scheme. The Court instead determined that the California statute’s sales ban is aimed at prohibitions within the slaughterhouse: “The idea—and the inevitable effect—of the provision is to make sure that slaughterhouses remove non-ambulatory pigs from the production process . . . by criminalizing the sale of their meat.” Accordingly, “the sales ban regulates how slaughterhouses must deal with non-ambulatory pigs on their premises.”

Importantly, the Court rejected California’s argument that its statute is not preempted because it neither prohibits something required by FMIA nor requires something prohibited by FMIA. The Court said that this doesn’t matter. That sounds like impossibility, which as much as we liked it in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has nothing to do with express preemption. Direct conflict is not the issue: “FMIA’s preemption clause covers not just conflicting, but also different and additional state requirements.” As those of us in the business of defending medical device companies know, that is essentially the same language in the preemption clause of the Medical Device Amendments of 1976 (“no State . . . may establish . . . with respect to a device intended for human use any requirement which is different from, or in addition to, any requirement applicable under this chapter to the device and which relates to the safety or effectiveness of the device”)

Homer may or may not be right that a pig is a wonderful, magical animal. But either way the Supreme Court’s decision in Harris is pretty good too. It underscores once again that broad preemptive language like that contained in the Medical Device Amendments of 1976 is not something to be explained away or rendered meaningless by redefinition and strained parsing. It means what it says, and Harris provides further rock-solid Supreme Court precedent that it should be applied that way.

After Further (Careful) Review

2012-01-23T07:00:00.007-05:00

In football the referees will occasionally change bad calls. Maybe it takes a videotape with unambiguous ocular evidence, but errors can get fixed. By contrast, it’s beastly hard to get judges to change their minds. We recall one instance so clearly because it stands out in our experience. When we were clerking on the U.S. Court of Appeals one of our jobs was to review petitions for reconsideration. They seldom detained us very long. The petitions merely rehashed losing arguments and supplied no real reason to revisit the court’s ruling. But one time one of the judges took an interest, convened a conference call of all three judges plus their clerks, and announced that “we’ve blown it.” The court ended up changing its mind. That judge, by the way, is now on the U.S. Supreme Court, and it is more than a little comforting to know that at least one of the Justices is so devoid of ego and dogma and is truly open-minded and conscientious.

That sort of thing is agonizingly rare.

We’ve been keeping a Mensing scorecard, watching what lower courts have done with generic plaintiffs’ efforts to circumvent preemption. One of the early cases we covered was Fisher v. Pelstring, C.A. No. 4:09-cv-00252-TLW (D.S.C. Sept. 30, 2011). The district court declined to dismiss the complaint, holding Mensing preemption inapplicable because the plaintiff argued that the generic defendant did not timely incorporate in its metoclopramide label certain FDA-approved warnings that were added to the brand label. We blogged about Fisher here. Subsequently, the plaintiff filed an amended complaint. Defendant, PLIVA USA, then filed a motion to dismiss the First Amended Complaint and, in the alternative, requested the court to reconsider its September 30, 2011 order. Dear reader, we have some involvement in metoclopramide litigation, so we must confine ourselves to reporting what happened. We will do so with clenched teeth and pounded keyboard. A copy of the Fisher court's new order can be found here.

First, the good news. The court did change its mind on one point and dismissed the claim for manufacturing defect. In its earlier ruling refusing to dismiss that cause of action, the court had “reasoned that the evidence of record supported a finding there was an issue of fact as to whether an error in the manufacturing process caused the 2003 or 2004 changes to the Reglan labeling to not be included on PLIVA’s metoclopramide labels.” Slip op. at 13. That was then and this is now. In its new motion, PLIVA observed that “the plaintiffs’ allegations in the First Amended Complaint focus on the product, not the product labeling. For their manufacturing defect cause of action, the plaintiffs allege that ‘defects in the products were caused by the way the products were manufactured.’” Id. (emphasis in original). That point seems unanswerable. And, indeed, the plaintiffs did not respond to it. Additionally, “the plaintiffs provided no evidence showing that the metoclopramide Mr. Fisher ingested deviated in some way from its design specifications or that it was rendered unsafe by an error in the manufacturing process.” Id. at 14. It is not clear why that was not perfectly obvious back in September. Oh well -- better late than never.

On all the remaining arguments, the Fisher court stood pat. The defendant argued that the claims for breach of implied warranties were preempted by Mensing. Not so, said the court:

After careful consideration, the Court finds that the plaintiffs’ claims
for breach of the implied warranty of merchantability remains viable after Mensing. Unlike an express warranty, the implied warranty of
merchantability is not created by labeling content but rather is implied in a
sales contract, unless excluded or modified, where the seller is a merchant of
goods of the kind sold. See S.C. Code Ann. Section 36-2-313; id. 36-2-314.
Without relying on PLIVA’s labeling content, the plaintiffs could plausibly
demonstrate that long-term use is an ordinary purpose for which metoclopramide
is used or that the metoclopramide PLIVA manufactured is objectionable in the
trade under the contract description.

Slip op. at 5. Did you notice the word "careful"? You'll see it again. And again.

The defendant also sought dismissal of the negligence claims. The court refused on the ground that PLIVA did not incorporate “into its generic metoclopramide labeling certain FDA-approved warnings added to the brand-name labeling for Reglan in 2003 and July 2004.” Slip op. at 6. Those warnings pertained to geriatric patients being “at greater risk for tardive dyskinesia” and that “Therapy should not exceed 12 weeks in duration.” Id. at 6-7. The defendant contended that the negligence cause of action was ineluctably based “on statements in PLIVA’s labeling regarding the risk of developing extrapyramidal symptoms and therefore this claim is preempted.” Id. But the court did “not view the plaintiffs’ pleadings so narrowly” because the First Amended Complaint included allegations that PLIVA “encouraged the long term use of these drugs,” that PLIVA failed to investigate the accuracy of its metoclopramide label,” that PLIVA “concealed the fact that long-term treatment was unsafe, and that “PLIVA breached its “duty to exercise the care of an expert in all aspects of the formulation, manufacture, compounding, testing, inspection, packaging, labeling, distribution, marketing, and sale of Reglan/metoclopramide to insure the safety of its drug and to insure that the consuming public…obtained accurate information and instructions for the safe use or non-use of this drug.” Id. (emphasis in original).

PLIVA asserted that even if the plaintiffs included an allegation that PLIVA failed to conform its generic metoclopramide labeling to the brand-name labeling, the claim would still be preempted because “the FDCA provides that only the federal government may bring an action to enforce the FDCA’s provisions.” Id. at 7. But the court concluded “after careful consideration of the authority cited by PLIVA, a sufficient basis has not been presented for this Court to conclude that a negligence action in which the standard of care is defined by statute is the equivalent of private enforcement of the FDCA.” Id. at 8. PLIVA also argued “that a state law claim must be premised on a duty that would exist in the absence of the FDCA, meaning the plaintiffs must show a state common law duty existed for a generic drug manufacturer to ensure its labeling always conformed to that of the brand-name drug.” Id. at 9. The court was unimpressed, because “PLIVA provides no authority in support of this assertion, and assuming PLIVA’s argument is accurate, this Court does not conclude that the duty which must exist in the absence of the FDCA should be defined as narrowly as PLIVA asserts.” Id.

Our teeth are still clenched and now the keyboard has been pounded to smithereens.

In its September 30, 2011 Order, the court had concluded “that PLIVA may have had avenues available to communicate with physicians about the 2003 and 2004 label changes without seeking FDA approval first.” Id. at 9-10. It seems that it would be hard to square that holding with the Mensing Court’s acceptance of the FDA’s interpretation that generic drug manufacturers may not use “Dear Doctor” letters to send additional warnings to prescribing physicians because such letters are labeling and “must be ‘consistent with and not contrary to [the drug’s] approved…labeling.’” Mensing, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 201.100(d)(1)). Here’s how to do it, according to the Fisher court: “If PLIVA had made alterations to its labeling consistent with the 2003 and 2004 changes to the Reglan labeling, a letter alerting physicians to these changes would arguably not be inconsistent with the drug’s approved labeling. This Court finds that the plaintiffs, in their First Amended Complaint, sufficiently plead a theory of recovery based on an argument PLIVA should have done more when the 2003 and 2004 labeling changes occurred, such as issue a “Dear Doctor” letter. “ Id. at 10. Got that?

The fraud claim also lives to vex another day: “After reviewing the First Amended Complaint in its entirety and particularly paragraph 188, the Court concluded that the plaintiffs sufficiently plead a claim for fraud by concealment based on PLIVA’s alleged non-inclusion of the 2003 and 2004 warnings. Therefore, after careful consideration of this argument and PLIVA’s other arguments in support of dismissing this claim, including its citation to Jimenez v. Daimler Chrysler Corp. 269 F.3d 439 (4th Cir. 2001), PLIVA’s motion to dismiss the plaintiffs’ fraud by concealment claim is DENIED.” Id. at 10.

The court also rejected PLIVA’s arguments that the causes of action for violation of the South Carolina Unfair Trade Practices Act and for intentional infliction of emotional distress claim are preempted under Mensing. Again, failure timely to include the new warnings seems key. According to the court, “That therapy should not exceed twelve weeks is part of the risk the plaintiffs may have wished to measure in deciding whether to continue taking metoclopramide.” Id. at 12. Note the word “plaintiffs.” Note the word “may.”

PLIVA also challenged the claim for punitive damages. After quoting the usual standard of “willful, wanton, or in reckless disregard of the plaintiff’s rights,” the court supplied this helpful analysis: “After careful review of the first Amended Complaint, the Court finds the plaintiffs plead sufficient facts to support an award of punitive damages.” Id. at 14. Okay, then. Similarly, the court rejected a statute of limitation defense “[a]fter careful consideration,” and after listening politely to the defendant’s argument that the plaintiff’s filing was untimely, the court “after a careful re-examination of the evidence cited by the parties and the applicable law … declines to alter its previous ruling.” Id. at 17.

The defendant wheeled out what appears to be a pretty strong warning causation argument. Did the plaintiff meet its burden of showing that the allegedly deficient warning made any difference? The defendant cited case law, which the court distinguished because the “possible alternative warnings in this case – the 2003 and 2004 warnings added to the brand-name Reglan label – are not nearly as ‘apocalyptic’” as in the case cited by PLIVA. Id. at 20. The court also held that “Dr. Pelstring’s knowledge of the risks for which the plaintiffs allege proper warnings were not given does not demonstrate as clear an understanding of those risk as the record” in the cited case. Id. “For example, testimony has not been cited showing Dr. Pelstring knew in 2004 that therapy with metoclopramide should not exceed twelve weeks.” Id. The court’s opinion does not disclose the evidence showing that Dr. Pelsing would have acted any differently had he been warned about the twelve weeks limitation. But the court keeps telling us how "careful" it was, so perhaps that evidence is in there somewhere.

Distribute This!

2012-01-20T11:41:00.001-05:00

Because it applied implied preemption, the decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) is powerful. We’ve previously mentioned how we think Mensing’s principles might be invoked in some claims against non-PMA medical devices, where express preemption is precluded by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We haven’t seen anybody take us up on that idea (yet), but we’re not letting that stop us. We’ve come across a case that’s given us more reason to think about how the implied preemption principle in Mensing may be gainfully employed on behalf of defendants who aren’t generic drug manufacturers.

First of all, the Mensing preemption principle – because it’s important to keep exactly what we’re talking about firmly in mind:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

Mensing, 131 S. Ct. at 1281 (emphasis added).

Because Mensing involved implied preemption, this principle applies outside the specific context of Hatch-Waxman, ANDAs, and generic drugs. Any interposing federal requirement that deprives the defendant of the ability to satisfy state tort duties “independently” should have the same preemptive effect under Mensing.

Now to the case. As our continually updated post-Mensing generic preemption scorecard reflects, there’s already been a favorable generic preemption ruling in the Fosamax MDL. See In re Fosamax Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011) (“Generic Fosamax I”). Well, there’s just been a follow-up. In In re Fosamax Products Liability Litigation, 2012 U.S. Dist. Lexis 5817 (D.N.J. Jan. 17, 2012) (“Generic Fosamax II”), the court had to deal with a generic straggler. All the other generic manufacturers had been dismissed in Generic Fosamax I, but one of them (Watson) was alleged in one case (Welch) to have been more than simply a generic Fosamax manufacturer.

In this Welch case, the plaintiff also alleged:

Defendant Watson was what is known as the authorized distributor of branded Fosamax. Upon information and belief, under the agreement between [the branded manufacturer] and Watson, [it] manufactured and supplied alendronate and Watson marketed and sold the drug under branded name Fosamax.

Generic Fosamax II, 2012 U.S. Dist. Lexis 5817, at *21 (quoting complaint).

On the basis of that one allegation (supported only by “information and belief” pleading), the Fosamax MDL plaintiffs tried to keep one peripheral defendant in one case.

The court said “no,” and that “no” has implications way beyond this one case.

Mensing implied preemption applies even where the defendant is a distributor of the branded product, as alleged in the Welch complaint. Under the Mensing implied preemption principle, a mere distributor is no more able than a generic manufacturer to make unilateral changes in drug labeling:

[E]ven if the Plaintiffs in [other] cases made the allegation found in Welch – that Watson was an authorized distributor of Fosamax – Watson would still be entitled to judgment on the pleadings and dismissal from the MDL. As a distributor of Fosamax, Watson has no power to change Fosamax labeling. That power lies with the applicant who filed the New Drug Application (NDA) seeking approval to market Fosamax. See 21 U.S.C. 355(b); 21 C.F.R. 314.70 (describing the Changes Being Effected or “CBE” regulation, which requires that “the applicant must notify FDA about each change in each condition established in an approved application.”) (emphasis added). In this case, [the branded manufacturer] is the NDA applicant with the corresponding authority to change labeling. Additionally, if FDA had “become aware of new safety information” in connection with Fosamax use that “it believe[d] should be included in the labeling,” FDA must notify the holder of the NDA to initiate the changes. 21 U.S.C. 355(o)(4)(A). Neither of these procedures involves a distributor.

As a result of the scheme set forth by the FDCA, Watson has no authority to initiate a labeling change of Fosamax. That authority lies with the FDA and/or with [the branded manufacturer]. Even taking the allegation in Welch as true, a contractual relationship between Watson and [the branded manufacturer] cannot change the fact that Watson is not the NDA holder. Consequently, Watson has no power to unilaterally change Fosamax labeling. Because Watson could not “independently do under federal law what state law requires of it,” the state law claims brought against it are preempted.

Generic Fosamax II, 2012 U.S. Dist. Lexis 5817, at *27-28 (most emphasis added).

Thus, under Mensing’s implied preemption principle, any distributor of any FDA-regulated prescription drug – branded or generic – has a preemption defense to warning claims based on the simple fact that non-manufacturing distributors aren’t manufacturers and thus aren’t “independently” able to change drug labeling through the CBE (or any other) process. At most, distributors could pass information along to the branded manufacturer – but Mensing also held preempted pass-along claims that “depend[] on the actions of . . . the brand-name manufacturer.” 131 S. Ct. at 2578.

What Generic Fosamax II means is that anybody representing a non-manufacturing distributor of prescription drugs sued as an intermediate seller on a warning-related claim should give a serious look at Mensing impossibility preemption as a defense. Similar arguments might be made on behalf of other non-manufacturing defendants – hospitals, pharmacists, sales reps, component part sellers, the list could be long – as long as their basis for liability is some deficiency in the FDA-approved label, as opposed to conduct specific to that defendant.

Since distributors are often joined as subterfuges to destroy diversity of citizenship, we note (but do not further discuss) the possible effects of the preemption theory in Generic Fosamax II on subject matter jurisdiction issues.

This is what we like to do best on this blog – pass along ideas for defending our clients that our readers might not have considered – so this is a good day for us.

Another Court Throws Generic Plaintiffs a Lifeline

2012-01-18T11:55:00.000-05:00

As evidenced by our generic preemption scorecard the post-Mensing scales have been heavily tipped in favor of the generic manufacturers who have racked up dismissals across the country. But not every court is willing to jump on the “complete dismissal” side of the seesaw. We reported on the Fisher v. Pelstring case from the District of South Carolina back in October and now that court’s neighbor to the north has decided to follow suit – focusing on factual uncertainties regarding timeliness to deny the generic defendants’ motion to dismiss. Couick v. Wyeth, Inc., 2012 U.S. Dist. Lexis 3699 (W.D.N.C. Jan. 11, 2012) (brand manufacturers previously dismissed).

The Couick court divided plaintiffs’ claims into three general categories: product liability claims under the North Carolina Product Liability Act; express and implied warranty claims; and other claims – which in this case were negligent failure to test or surveil and breach of a special duty to abide by FDA requirements. Id. at *5-6. Let’s get rid of the “others” first. North Carolina doesn’t recognize a cause of action for failure to test or surveil. Id. at *20. Claims for private enforcement of FDA requirements are preempted under Buckman. Id. at *21. Both of those claims were dismissed, but as to the rest of plaintiffs’ claims, the court found factual issues existed that challenged whether in fact it was impossible for the generic defendants to comply with both state and federal law.

For instance, on the failure to warn claim, the court found that the defendants had not “provided any proof . . . that their package inserts matched [the brand’s] throughout the period that Plaintiff alleges she took [the drug].” Id. at *9. Because there were conflicting allegations regarding when the plaintiff was prescribed the drug and when defendants adopted certain labeling changes, the court was unwilling to find the claims preempted on the pleadings:

But if Defendants' PIs did not match the brand, there are at least some changes to their PIs that federal law would allow, or even require, Defendants to make. A state law claim for failure to include such warnings would not be preempted by federal law where the FDA would have permitted, or even required, such changes.

Id. at *14.

Similarly on the breach of express warranty claim, defendants argued that the alleged express warranty language was required by federal law to be included in their labeling. Id. at *18. However, “[t]he Court [could not] find impossibility on the record before it. Without proof of what Defendants' and [brand’s] PIs stated, Defendants cannot show that this language was required.” Id. at *17-18. So, on these claims the court decided that it would need to look beyond the four corners of the complaint and examine facts that were not before it on a motion to dismiss.

In denying defendant’s motion on breach of implied warranties, the Couick court found the claims weren’t preempted by Mensing because they “are not dependent on the content of Defendants’ PIs.” Id. at 18.

While Defendant's labeling and warnings may play a role in establishing their products' intended purpose or their customers' reliance, Plaintiff's claim is not that Defendants failed to adequately warn about the risks. These claims are not preempted by federal warning label requirements under Mensing.

Id. at *19. To our knowledge, this is a novel ruling, contrary to the other precedent in our generic preemption scorecard. And, one we hope won’t hold up under further scrutiny.

Motions In Limine In Pa. Case

2012-01-17T10:01:00.000-05:00

Motions in limine were decided (or not) recently in Wolfe v. McNeil-PPC, Inc., 2012 U.S. Dist. Lexis 2160 (E.D. Pa. Jan. 9, 2012). The defendant did pretty well, so here’s a brief listing of the highlights (this isn’t everything, as some were case specific, not decided, moot, or simply boring).

Adverse events – These probably aren’t admissible as they are double hearsay. Some earlier ones might be admissible as to notice, assuming that’s disputed. Experts can rely upon them, but not exclusively, and that doesn’t mean they get to talk about them to the jury (which will be decided at trial). Id. at *6-12.
FDA citizen’s petition – Excluded. The petition was argumentative and didn’t show notice. The defendant also can’t use its outcome to argue that the FDA rejected the requested warnings. Id. at *14-16. A different (older) FDA petition could show notice, assuming that’s disputed. Id. at *17-19.
Voluntary recalls unrelated to the plaintiff’s condition – Excluded as unduly prejudicial. Id. at *19-21.
Foreign labeling – Generally excluded subject to plaintiff making specific arguments that a particular foreign label is somehow relevant, and not hearsay. Id. at *21-22.
Various FDA documents – Generally excluded subject to plaintiff making specific arguments that a particular FDA document is somehow relevant, and not hearsay. Id. at *22.
Marketing material/information not seen by plaintiff (this is an OTC case) – Generally excluded as prejudicial and irrelevant following dismissal of negligent marketing claim. Plaintiff may seek reconsideration as to specific items. Id. at *22-23.
Other lawsuits/claims, etc. – Generally excluded as irrelevant. Plaintiff may argue at trial that specific items are relevant to notice. Id. at *24-25.
Plaintiff continuing to use product after injury – Admissible. That the plaintiff continues to use the product with specific knowledge of its potential risk is relevant to whether any inadequate warning could have been causal. Id. at *31-32.
Other drugs taken in close proximity – Admissible, as tending to prove alternative causes of the claimed injuries. Id. at *34-35.

One general comment on motions in limine. The court in Wolfe criticized both sides on a number of occasions for making overbroad and unsupported arguments. That’s a good thing to keep in mind when drafting or responding to motions in limine. We believe that anything worth doing is worth doing well. If counsel is serious about filing motions in limine, such motions should be both focused and supported with everything a court would need to rule. It’s not only a waste of time to file vague and generic motions in limine/responses, but such filings run the risk of losing credibility with the court.

Rules Matter, Part 2

2012-01-16T07:00:00.007-05:00

Dr. Martin Luther King, Jr. once said, “Justice denied anywhere diminishes justice everywhere.” Maybe simply setting out that quotation, and not-so-simply meditating on it, would constitute an appropriate gesture on this day of service.

But, as usual, we have a few extra words to say before returning to the observances and pleasures of the holiday. Justice is not exactly the same thing as following rules. In fact, Dr. King showed that justice sometimes requires one not to follow the rules. That being said, the concepts of justice and consistent adherence to rules certainly reside in close quarters.

We’ve been thinking about rules while we spent much of the last few days watching contact sports. The National Football League had its best weekend of the year, and Ricky Gervais did his usual, tasteful job of hosting the Golden Globes. Rules played a big role for both. In football we expect enforcement of the rules. The Golden Globes is all about the violation of the rules (mostly by drunken entertainers and journalists whose immigration documents should be carefully checked -- perhaps twice). Nothing makes any sense without rules, even if those rules operate arbitrarily. Coloring outside the lines is cute only because there are lines. But, as lawyers, we're not out for cuteness. (Yes, we know: it shows.) We talk about the rule of law.

Understanding and following the rules is supposed to be a big part of what we do. That being said, it's almost surprising when judges enforce technical rules against plaintiffs who claim serious injuries. Sometimes the enforcement process threatens to become like the National Basketball Association, where referees don't call travelling or carrying if it looks like the player didn't obtain any advantage from the violation. In some courtrooms, the only thing judges ask about is whether there's any prejudice from a violation, not so much whether there was a violation. By contrast, last week we were pleased to report about a judge in the Aredia/Zometa litigation who actually followed the rules and employed them.

Well, the Aredia/Zometa defendants are on a roll. Our friends Joe Hollingsworth and Robert Johnston sent us another example where a fastidious federal judge applied the rules to dismiss a complaint. This happened on January 12, and what the judge specifically did was reject a plaintiff's untimely effort to designate a retained expert witness on specific causation. Harvey v. Novartis Pharms. Corp., No. 2:06-CV-1140-VEH (N.D. Ala. Jan. 12, 2012). The Harvey case was, for a time, part of the Aredia/Zometa MDL in Nashville, for which the appellate court is the Sixth Circuit. Later, the case was remanded to S.D. Alabama. While this case was still part of the MDL, it was subject to the case management order, which controlled the key deadlines. Pursuant to the CMO, the plaintiff in Harvey (originally Ms. Harvey, who suffered from cancer, and subsequently, after she died from cancer, her son) was required to file expert reports by February 21, 2011. The plaintiff (at that point Ms. Harvey's son) complied with the expert designation deadline by naming only the treating oral surgeon to testify about specific causation. That is, the plaintiff declined to designate a retained expert on the issue of specific causation, i.e., whether the drugs caused Ms. Harvey to develop osteonecrosis of the jaw. Op. at 3.

At the time that expert designations were due, the Aredia/Zometa MDL judge had already granted summary judgment in several other MDL cases in which the plaintiffs were represented by the same counsel as Ms. Harvey on the ground that those plaintiffs had not established that their treating physicians were qualified to provide specific causation evidence and had failed to designate any retained experts on that issue. Those summary judgments were later affirmed by the Sixth Circuit. Thomas v. Novartis Pharmaceuticals Corp., Nos. 09-6147, 09-6272, 09-6274, 2011 WL 3701816 (6th Cir. Aug. 23, 2011). We blogged about Thomas here. The Harvey case was remanded to S.D. Alabama on July 26, 2011. Alabama is in the Eleventh Circuit, not the Sixth Circuit.

Following remand, and following the Thomas decision (though not immediately following), the plaintiff moved pursuant to Fed. R. Civ. P. 16(b)(4) to modify the schedule to name a new expert. Op. at 4. Rule 16(b)(4) provides that “[a] schedule may be modified only for good cause and with the judge’s consent.” Under Eleventh Circuit precedent, a schedule should not be modified unless it cannot be met despite the due diligence of the party seeking the extension. So it all comes down to diligence. The plaintiff argued that he had no reason to believe that he needed to retain an expert witness on specific causation until after the Sixth Circuit affirmed the judgment in Thomas and stressed the importance of testimony on specific causation to the viability of his case.

The district court rejected these arguments, concluding that the plaintiff had not shown diligence sufficient to establish "good cause" under the rule. Op. at 8. Instead the court held that at the time expert disclosures had been due in the MDL, the plaintiff's counsel had "firsthand knowledge of potential obstacles pertaining to expert testimony on specific causation" due to his direct involvement in the Thomas cases. Op. at 8. Moreover, the Sixth Circuit decision was an unpublished opinion that was not controlling on the S.D. Alabama and, in any event, it’s not as if it was a bolt from the blue for a court to hold that treating doctors cannot opine on causation unless they are qualified to do so.

The court also observed that several other plaintiffs in the same group of cases had sought additional time to name a retained specific causation experts in the MDL given the Thomas rulings. Op. at 9. The “reactive” nature of the plaintiff’s motion in the wake of Thomas did not support a finding of due diligence. Id. The court stated that "any litigation tactic or strategy, such as waiting on an appellate decision" needed to be made within the time limits imposed by the MDL court. Op. at 10-11. The court also rejected the suggestion that the importance of the testimony to the plaintiff's case could substitute for a diligent effort to comply with the rules Op. at 10. In the end, the court found no evidence of diligence on the part of plaintiff and denied the motion. Op. at 11. Rules are rules.

We also think that justice was done in that case.

Happy Martin Luther King, Jr. Day.

Foreseeability Gets Its Wings Clipped In California

2012-01-13T11:47:00.001-05:00

Late last night we received this message from a correspondent (who will remain anonymous since we lack permission):

Hopefully the groundwork for getting Conte thrown-out has been laid. Only a matter of time. And with any luck we’ll have an opportunity some day soon.

Getting a message like that makes us sit up a little straighter. So we took a look at the attached case, O’Neil v. Crane Co., S177401, slip op. (Cal. Jan. 12, 2011), and we can see what she’s talking about.

As readers may recall from our original rants about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), we think that decision is just flat wrong. The California Supreme Court’s unanimous decision in O’Neil only reinforces that view.

O’Neil involved asbestos. The plaintiff worked on an aircraft carrier. Decades before the plaintiff was aboard ship, one class of defendants made the carrier’s propulsion system. Those defendants supplied products that had no asbestos at all, but were manufactured to specifications that required addition of asbestos insulation from other sources. Slip op. at 2. They were sued because it was “foreseeable” that asbestos would be used in conjunction with their products.

A second group of defendants made the asbestos-containing gaskets that were components of the ship’s engines. These gaskets wore out and were replaced by similar products made by others well before plaintiff was aboard ship. Id. They were sued because it was “foreseeable” that their products would wear out and be replaced by other asbestos-containing products.

In neither case did plaintiff allege that he was exposed to asbestos from any products actually sold by the defendants. Slip op. at 6.

In O’Neil the court unanimously held that “foreseeability” did not trump the other policies animating product liability – and did so for both strict liability and negligence.

As to strict liability the court stated:

We have never held that strict liability extends to harm from entirely distinct products. . . . Instead, we have consistently adhered to the Greenman formulation requiring proof that the plaintiff suffered injury caused by a defect in the defendant’s own product.

Slip op. at 10.

There is no duty to warn in California about defects in another supplier’s product, even though the defendant also failed to warn about similar risks in its own product:

[Defendants] gave no warning about the dangers of asbestos . . . in their products. However, [plaintiff] never encountered these original parts. His exposure to asbestos came from replacement gaskets and packing and external insulation added to defendants’ products long after their installation. . . . There is no dispute that these [other] products were made by other manufacturers. No case law supports the idea that a manufacturer, after selling a completed product to a purchaser, remains under a duty to warn the purchaser of potentially defective additional pieces of equipment that the purchaser may or may not use to complement the product bought from the manufacturer.

Slip op. at 15 (citation, quotation marks, and footnote omitted). Substitute a prescribing physician for the navy in O’Neil and you’ve got Conte.

Imposition of warning duties relating solely to other manufacturers’ products goes “too far”:

An interpretation of [the law] that would require a manufacturer to warn about all potentially hazardous conditions surrounding the use of a product, even when those hazards arise entirely from the product of another manufacturer, reaches too far. There is no precedent in California law for such a broad expansion of a product manufacturer’s duty.

Slip op. at 25-26.

Where the exposure comes solely from subsequent exposure to other manufacturer’s products, there is no warning liability based on “foreseeability.” “California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.” Slip op. at 27. “[T]he foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on the manufacturer of a nondefective product, or one whose arguably defective product does not actually cause harm.” Id. at 28.

We reaffirm that a product manufacturer generally may not be held strictly liable for harm caused by another manufacturer’s product. The only exceptions to this rule arise when the defendant bears some direct responsibility for the harm, either because the defendant’s own product contributed substantially to the harm, or because the defendant participated substantially in creating a harmful combined use of the products.

Id. (citations omitted).

Public policy requires that product liability be limited to the manufacturers of products that actually cause harm.

“[A] manufacturer cannot be expected to exert pressure on other manufacturers to make their products safe.” Slip op. at 30.
Non-manufacturers “will not be able to share the costs of ensuring product safety with these other manufacturers.” Id.
“It is also unfair to require manufacturers of nondefective products to shoulder a burden of liability when they derived no economic benefit from the sale of the products that injured the plaintiff.” Id.
“[I]mpos[ing] on manufacturers the responsibility and costs of becoming experts in other manufacturers’ products . . . would impose an excessive and unrealistic burden.” Id. (citation omitted).

Now, Conte involved a “negligent misrepresentation” claim rather than strict liability, but that won't save it from O'Neil. See 85 Cal. Rptr.3d at 310 (“this is a case involving legal principles of negligent misrepresentation, and not a products liability action”), 310 n.7 (“negligent misrepresentation will subsume intentional fraud”).

O’Neil goes on to reach the same result – holding that there is no equivalent non-manufacturer liability claim in negligence. The California Supreme Court directly addresses “foreseeability” and its limits, applying the public policy factors that Conte refused to address. “[I]n strict liability as in negligence, foreseeability alone is not sufficient to create an independent tort duty.” O'Neil, slip op. at 29 (citation and quotation marks omitted) (emphasis added). “Duty” in negligence “is not an immutable fact of nature but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.” Id. at 30-31.

The plaintiff in O'Neil argued foreseeability uber alles. The court did not agree:

[F]oreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.

Slip op. at 31 (citations and quotation marks omitted). Rather, “when the consequences of a negligent act must be limited to avoid an intolerable burden on society, policy considerations may dictate a cause of action should not be sanctioned no matter how foreseeable the risk. Id. (citation and quotation marks omitted).

These “policy considerations” (the same Rowland v. Christian factors that Conte ignored, 85 Cal. Rptr.3d at 814) mandate no liability where product-related claims are being made against non-manufacturers.

The connection between defendants’ conduct and [plaintiff’s] injury is extremely remote because defendants did not manufacture, sell, or supply any . . . product that may have caused his [injury].” O’Neil, slip op. at 32.
Plaintiff’s injury is “attenuated,” as it occurred decades after the allegedly negligent conduct Id.
“[L]ittle moral blame can attach to a failure to warn about dangerous aspects of other manufacturers’ products.” Id.
“There is no reason to think a product manufacturer will be able to exert any control over the safety of . . . products made by other companies.” Id.
“Manufacturers may also have scant ability to influence their customers’ choices about other products.” Id.
“[R]ecognizing a duty of care would clearly impose a significant burden on defendants and all other companies that could potentially be held liable for injuries caused by products they neither made nor sold.” Id. at 33.
“[R]ecognition of such a duty could lead to an overabundance of potentially conflicting product warnings.” Id.
“[I]t is doubtful that manufacturers could insure against the “unknowable risks and hazards” of other manufacturers’ products used decades later. Id.

For all these reasons, the court in O’Neil unanimously held that, regardless of foreseeability, there should be no negligence liability against the manufacturer of one product for injuries caused by similar products manufactured by other companies:

[E]xpansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiffs no harm. To do so would exceed the boundaries established over decades of product liability law. [S]ocial policy must at some point intervene to delimit liability even for foreseeable injury. The same policy considerations that militate against imposing strict liability in this situation apply with equal force in the context of negligence.

Slip op. at 33 (citations and quotation marks omitted).

We hope, as did our anonymous correspondent, that O’Neil spells the beginning of the end for Conte.

That's A Spicy (Specious?) Footnote!

2012-01-12T16:15:00.000-05:00

We recently read the pain pump decision, Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011). Most of the opinion addresses pretty much mundane disputes on heavily fact-bound questions: (1) whether the risk was scientifically knowable as of the date of this plaintiff’s injury, and (2) whether the prescriber’s treatment would have changed had an “adequate” warning been given. Id. at *4-6. On the facts, the court found triable issues of fact. Id.

But sandwiched in between those arguments in Creech was a brief (2 paragraph) discussion of “strict liability.” The opinion, without much discussion, again concluded that fact issues existed as to warning and design defects. Id. at *5. But then, almost casually, the court drops this footnote:

Despite [defendant’s] argument to the contrary, comment K offers no protection to [it]. In Grundberg v. Upjohn Co., the Utah Supreme Court ruled that comment K to section 402A provided protection to prescription drug manufacturers. Grundberg v. Upjohn Co., 813 P.2d 89, (Utah 1991). The court limited this ruling to design defect claims against prescription drug manufacturers. Id. at 92, 95. Utah law does not preclude strict liability design defect claims against medical product manufacturers.

2012 WL 33360, at *5 n.6.

Say what? Comment k applies to drugs, but not medical devices? Why?

No rationale – other than the Grundberg decision, which factually involved a drug, did not also mention “medical devices.” (A bit of background – in Grundberg the Utah Supreme Court concluded as a matter of law that Restatement (2d) §402A, comment k applied “across the board” and barred assertion of any and all strict liability, design defect claims).

This footnote strikes us as frankly bizarre. There’s practically no authority – and none at all in practically two decades – distinguishing among types of prescription medical products with respect to the applicability of comment k. There’s certainly none under Utah law, and as a federal court, Creech was not supposed to make Erie predictions that expand liability under state law. Taylor v. Phelan, 9 F.3d 882, 887 (10th Cir. 1993) (“[a]s a federal court, we are generally reticent to expand state law without clear guidance from its highest court”); Aclys International v. Equifax, 438 Fed. Appx. 689, 693 (10th Cir. 2011) (Phelan principle “ is especially true when a federal court is asked to make a policy laden choice for the State of Utah”); Northern Natural Gas Co. v. Nash Oil & Gas, Inc., 526 F.3d 626, 631 (10th Cir. 2008) (quoting and applying Phelan); Orr v. Brigham Young University, 108 F.3d 1388 (10th Cir. 1997) (“[a]s a federal court, we are reticent to expand state law in the absence of clear guidance from Utah's highest court, or at least a strong and well-reasoned trend among other courts which Utah might find persuasive, in favor of such expansion”).

So what law is there on whether comment k applies to anything other than the “prescription drugs” mentioned in Grundberg and in the comment itself?

Well, we can start with the comment itself. After explaining that unavoidably unsafe products are “especially common in the field of drugs,” the comment gives an example: “[a]n outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences.”

O-kay.... A vaccine isn’t a drug. Technically it’s a “biologic” – a product consisting of large-molecule derivatives from living tissue, rather than the small molecules used to formulate drugs.

But then, the ALI wrote comment k in the early 1960s (§402A was adopted in 1965), and the concept of a "medical device" wasn't much developed. Congress, for example, didn't give the FDA explicit authority over medical devices until 1976.

For purposes of this post, what’s important is the comment k doesn't address particular categories of products, but enunciates a principle: that a lot of products “in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.” That’s why, for instance, prescription medical products are prescription-only in the first place. They have inherent risks that laypeople aren’t qualified to evaluate. Because of such risks, the FDA forces people to jump through the hoop of visiting a doctor before these products are made available to them.

With that in mind, we next look at Grundberg. Is its rationale somehow limited to drugs, as opposed to devices? Is there something beyond the FDA at work?

Doesn’t seem to be. There’s simply no mention of medical devices at all, one way or the other. As to comment k, the court first endorses and adopts its principles without reference to drugs – or to any other particular product:

Comment k, however, defines a category of “unavoidably unsafe” products that “when properly prepared, and accompanied by proper directions and warning, [are] not defective, nor ... unreasonably dangerous.” (Emphasis in original.) We agree with comment k’s basic proposition-that there are some products that have dangers associated with their use even though they are used as intended. We also agree that the seller of such products, when the products are properly prepared and marketed and distributed with appropriate warnings, should not be held strictly liable for the “unfortunate consequences” attending their use. Thus, we adopt comment k’s basic policy as the law to be applied in this state.

Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991). Then the court goes on to reject making the comment k/unavoidably unsafe determination on a case-by-case basis with respect to the product before it – a prescription drug (Halcion).

“[W]e are troubled by the lack of uniformity and certainty inherent in the case-by-case approach and fear the resulting disincentive for pharmaceutical manufacturers to develop new products.” Id. at 94-95.
“[A] defendant would have an easier time rebutting a plaintiff’s prima facie case of design defect under the traditional standard than meeting the tough burden of “earning” the comment k exemption.” Id. at 95.
“We are persuaded that all prescription drugs should be classified as unavoidably dangerous in design because of their unique nature and value, the elaborate regulatory system overseen by the FDA, the difficulties of relying on individual lawsuits as a forum in which to review a prescription drug’s design, and the significant public policy considerations.” Id.
“[Drugs] will almost always pose some risk of side effects in certain individuals. Despite these risks, new drugs are continually approved by the FDA because of their social benefit in saving lives and alleviating human suffering.” Id.
“The structured follow-up program imposed by law ensures that drugs are not placed on the market without continued monitoring for adverse consequences that would render the FDA’s initial risk/benefit analysis invalid.” Id. at 97.
“The legislature has also acknowledged the important role of governmental standards in Utah Code Ann. section 78-15-6(3) . . . declar[ing] that there is a rebuttable presumption that a product which fully complies with the applicable government standards at the time of marketing is not defective. Id. (footnote omitted).
“[I]f a manufacturer knows or should know of a risk associated with its product, it is directly liable to the patient if it fails to adequately warn the medical profession of that danger.” Id.
“[W]e do not believe that a trial court in the context of a products liability action is the proper forum. . . . Although the FDA may have internal differences of opinion . . ., the individuals making the ultimate judgment will have the benefit of years of experience in reviewing such products, scientific expertise in the area, and access to the volumes of data they can compel manufacturers to produce. Nor is the FDA subject to the inherent limitations of the trial process.” Id. at 98.
“In light of the strong public interest in the availability and affordability of prescription medications, the extensive regulatory system of the FDA, and the avenues of recovery still available to plaintiffs by claiming [non-design-related claims], we conclude that a broad grant of immunity from strict liability claims based on design defects should be extended to FDA-approved prescription drugs in Utah. Id. at *99.

Looking at all these passages from Grundberg, we can’t see that it makes a difference whether the prescription-only product is a drug, a device, or a vaccine. Devices, from pacemakers to pain pumps, save lives and alleviate suffering – even though they have inherent risks and don’t work perfectly all the time. The drawbacks and uncertainties of a scattershot and unpredictable litigation and trial process are the identical, whether the defendant made a drug or a device. The FDA’s expertise and adverse event reporting requirements likewise encompass both drugs and devices. Identically, the statutory presumption for government compliant products applies to both devices and drugs.

Nope, we can’t find in Grundberg a single policy reason that medical devices shouldn’t enjoy the same comment k protections as prescription drugs .

Thus, with respect to determining whether products are unavoidably unsafe under comment k, we don't see any relevant difference between a drug and a device (or a vaccine). If the product is restricted by the FDA to prescription-only status, that’s because it has significant inherent risks, which the Agency requires be stated in the product’s labeling (warning claims explicitly exist under comment k). For that reason, comment k’s exception to design defect claims should apply equally to both prescription drugs and prescription medical devices – whether the jurisdiction chooses to use Grundberg’s across-the board approach, or adopts the competing case-by-case rationale that Grundberg rejected. There’s no meaningful basis for distinguishing, as Creech did, simply between all drugs on one hand and all medical devices on the other.

Looking around, we find that this is indeed overwhelmingly how other courts in other jurisdictions have ruled. Regardless of what comment k is held to mean (that is, across-the board vs. case-by-case), it applies in the same fashion and to the same extent in medical device cases as it does in cases involving prescription drugs.

The Connecticut Supreme Court held that medical devices share the same liability principles with prescription drugs in Hurley v. Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006), having previously in a drug case “adopted comment (k) . . . [and] concluding that the policy considerations set forth therein are persuasive and in accord with this state's product liability jurisprudence.” Id. at 784. The court found no reason to differentiate between drugs and medical devices:

Numerous courts have determined that they are applicable to prescription medical device cases. The parties have not pointed us to any case . . . and we can see no principled reason to distinguish between a prescription implantable medical device like a pacemaker and a prescription drug.

Id. Accord Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 386-88 (Conn. App. 2008) (“[i]n light of existing case law and the language of comment (k) itself, we conclude that the application of comment (k) is not limited to prescription drugs only”); Wegryn v. Smith & Nephew, Inc., 2008 WL 803405, at *2 (Conn. Super. March 5, 2008); Allen v. Mentor Corp., 2006 WL 861007, at *7 (D. Conn. March 31, 2006) (“[m]edical products properly prepared, and accompanied by proper directions and warning [are] not defective, nor . . . unreasonably dangerous” under comment k; breast implant case).

Similarly, the Oklahoma Supreme Court held, in Tansy v. Dacomed Corp.:

While products liability law seeks to protect the public from unreasonably dangerous products, Comment k seeks to protect another facet of the public’s interest-that of having available new products whose benefits are great enough as to justify associated risks. It protects certain manufacturers who develop new products which at the time of manufacture are incapable of being made totally safe, and shields certain products by classifying them as “unavoidably unsafe” rather than as “defective.” Public policy favors the development and marketing of new beneficial drugs and devices because they can save lives, reduce pain and improve the quality of life. . . . Most courts which have considered the question have found that Comment k applies to medical devices, especially those which are implanted in the human body. . . . Following the guidance of our prior case law as well as that of other jurisdictions, we hold that Comment k can apply to medical devices, particularly those which are implanted.

890 P.2d 881, 885-86 (Okla. 1994 (lots of citations omitted). Accord McKee v. Moore, 648 P.2d 21, 23 (Okla. 1982) (comment k applies to IUD; it may be an “unavoidably unsafe” product, and thus not “defective”).

Likewise, the Washington Supreme Court held, in a Dalkon Shield IUD case:

While a sound public policy might indeed dictate that such testing be undertaken before any product to be used on the human body is released in commerce, a decision of that kind rests with the legislative body. The principles stated in comment k do not rest upon a finding or an assumption that all drugs, vaccines or other products obtainable only through a physician have been tested by the Food and Drug Administration. Rather they have their basis in the character of the medical profession and the relationship which exists between the manufacturer, the physician and the patient.

Terhune v. A. H. Robins Co., 577 P.2d 975, 978 (Wash. 1978); see id. at 979 (lower court “quite properly held as a matter of law that the shield was not unreasonably dangerous or defective, as defined in comment k”). Accord Transue v. Aesthetech Corp., 341 F.3d 911, 915 (9th Cir. 2003) (“comment k provides an exemption for medical products generally”) (applying Washington law); Adams v. Synthes Spine Co., 298 F.3d 1114, 1118 (9th Cir. 2002) (“comment k applied (which is to say that strict liability did not apply) to prescription medical products without any separate determination”) (applying Washington law).

The Illinois Supreme Court, in a case involving an x-ray machine, also invoked comment k principles:

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability . . . . [W]e conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.

Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980). Accord Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1041-42 (Ill. App. 2004) (“Comment k . . . provides further support for use of risk-benefit analysis for evaluating the danger of the medical device defendant made”).

In California – another state that, like Utah, applies comment k across the board, any general distinction between drugs and medical devices has been flatly rejected. In Plenger v. Alza Corp., 13 Cal. Rptr.2d 811 (Cal. App. 1992), the court held:

[T]he exemption from strict liability for design defect for prescription drugs is based primarily, if not exclusively on public policy considerations. It is not, as implicitly contended by plaintiffs, based on any inherent distinction between a drug and a device which makes design defect analysis unworkable with respect to prescription drugs. . . . The question, therefore, is not whether the [product] is a prescription drug or a device but rather whether the policy considerations . . . should be applied.

Id. at 817. Similarly, in Hufft v. Horowitz, 5 Cal. Rptr.2d 377 (Cal. App. 1992), the court held:

The differences . . . do not mandate rejection of the comment k standard. . . . [T]he important considerations underlying [comment k] apply with equal force to implanted medical devices, which like prescription drugs, are available only through a physician and can save lives or reduce pain and suffering. Such products are commonly crucial to the well-being of the patient. Some devices are so important that, as is the case with prescription drugs, the patient faces death without them.

Id. at 383. Accord Mitchell v. Acumed LLC, 2011 WL 2433038, at *4 (N.D. Cal. June 13, 2011) (“Plaintiff's argument to be wholly devoid of merit; Plaintiff makes no logical argument that [comment k precedent] should not cover the surgical screw at issue here”).

A similar result was reached here in Pennsylvania, which also applies an across-the board approach:

In applying comment k here . . . no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn [adopting comment k in a drug case]. . . . [Plaintiffs] contend that . . . comment k does not apply to medical devices because the comment text does not mention them. They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply. We find no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.

Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006). Both before and after Creazzo, Pennsylvania courts routinely applied comment k in medical device product liability cases – holding repeatedly that the same considerations applied to all prescription medical products. See Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (comment k principles “extend[] to medical devices”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 & n.4 (E.D. Pa. Oct. 24, 2011) (agreeing with Geesey); Geesey v. Stryker Corp., 2010 WL 3069630, at *4-5 (E.D. Pa. Aug. 4, 2010) (“the Pennsylvania Supreme Court would apply comment k to medical devices”); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (comment k “has been extended to medical devices”) (applying Pennsylvania law); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007) (“predicting . . . that Pennsylvania Supreme Court would extend §402A’s comment k to exclude prescription medical devices from strict liability”); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 746-748 (W.D. Pa. 2004) (“the court agrees . . . that the same considerations exempting prescription drugs from the ambit of §402A equally apply to prescription medical devices”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 441-442 (E.D. Pa. 2004) (“[c]omment k precludes application of Section 402A to prescription medical devices”); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *7 (E.D. Pa. Aug. 23, 1999) (“medical devices present[] the same or very similar risks and benefits” as prescription drugs, so comment k applies); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999) (“the same reasoning underlying comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (comment k applies to medical devices because they present the same “unique set of risks and benefits” as prescription drugs in that “what may be harmful to one patient may be beneficial to another”); Lawrence v. Synthes Inc., 2002 WL 32747667, at *24 n.101 (Pa. C.P. July 25, 2002) (“[p]rescription medical devices must be analyzed similarly”), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004); Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201, 214 (Pa. C.P. Allegheny Co. 1994).

Other cases applying comment k equally to medical devices:

Adams v. G.D. Searle & Co., 576 So.2d 728, 731-33 (Fla. App. 1991) (IUD case; applying comment k on case-by-case basis); Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (heart valve case; comment k is “the standard to be applied in cases involving unavoidably unsafe products”); Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983) (IUD case; “the trial court properly instructed concerning unavoidably unsafe products”); Racer v. Utterman, 629 S.W.2d 387, 395 (Mo. App. 1981) (surgical drape case; Restatement “afford[s] protection to products of this nature whose value is recognized and whose dangers are not only unknown but incapable of determination”); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993) (medical device “may be treated . . . as an unavoidably unsafe product” under comment k cases involving drugs) (applying New York law); Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985) (“If the prerequisites to establish a Comment k defense are met, the defense applies to Dalkon Shield cases”) (applying Oregon law); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230 (4th Cir. 1984) (“products, particularly ethical drugs and medical devices, often cause unwanted side effects despite the fact that they have been carefully designed and properly manufactured. In section 402A terminology, such products are deemed ‘unavoidably unsafe’,”) (applying South Carolina law); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) (“prescription medical devices are unavoidably unsafe products, and where inherent risks are at issue, the only other permissible theory of liability is inadequate warning”); Parks v. Danek Medical, Inc., 1999 WL 1129706, at *6 (N.D. Ind. June 17, 1999) (“comment k has been held to apply to prescription medical devices, as well as to prescription drugs”); Clark v. Danek Medical, Inc., 1999 WL 613316, at *4 (W.D. Ky. March 29, 1999) (the “implant is the sort of desirable but unavoidably unsafe product described by . . . comment k); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (“Several courts have applied Comment k to prescription medical devices. . . . Under Comment k, the manufacturer of an unavoidably unsafe product is not liable for injuries arising from the product, if the manufacturer properly designed and manufactured the drug or device and provided adequate warnings”); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991), aff’d mem., 12 F.3d 194 (11th Cir. 1994); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-1149 (D. Or. 1989) (IUD case, applying comment k).

Thus, in summation: (1) comment k itself does not distinguish between prescription drugs and medical devices; (2) all the policy arguments in Grundberg for adoption of comment k apply analogously to medical devices; and (3) scores of courts across the country recognize that all prescription medical products are equally subject to comment k – regardless of how they interpret the comment itself. There is, in short, no legal basis whatsoever for the peculiar footnote in Creech v. Stryker.

Medical Device Preemption Developments

2012-01-11T10:32:00.000-05:00

Boring title, but accurate. Here’s the latest.

First, Medtronic won another one the other day. Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system. It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body. Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.

The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption. Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004. The insulin delivery system predated the pump, and was PMA approved. By PMA supplement in 2006, the FDA approved incorporation of the pump into the system. The plaintiff was prescribed that system. Duggan, 2012 WL 45503, at *3-4.

Plaintiffs’ primary argument for avoiding preemption was that the components in the system should be parsed, the 2006 PMA supplement ignored, and the pump treated as a “mere” §510k device. They got nowhere. The same argument had been made, and rejected, in other device system litigation (mostly knee implants, if we recall):

Many courts have held that once premarket approval is granted, all claims relating to all components of the device are preempted. This analysis applies even where a component of a PMA-approved device had previously been approved through the § 510(k) process.

Id. at *4 (citations omitted).

Plaintiffs then tried component part argument 2.0, claiming that the data in the defendant’s supplement was insufficient to support PMA approval of the pump. Id. at *5. The opinion doesn’t detail the basis of that argument, but we assume that some malleable FDA “expert” was involved. The court refused to allow PMA preemption turn on a litigant’s after-the-fact deconstruction of the approval submission. What the FDA decided, not what a litigant claimed that the FDA should have decided, controlled:

[T]he sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval. Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review. The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan, 2012 WL 45503, at *5 (citing our old pal, Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)). We view this holding as the most important takeaway from Duggan.

Interestingly, plaintiffs also tried to intervene with the FDA itself, attempting to depose Agency personnel and filing an FDA citizen’s petition challenging the scope of the PMA. 2012 WL 45503, at *3. Both moves backfired. It’s really difficult to depose government personnel when the government doesn’t want it. E.g., United States ex rel. Touhy v. Regan, 340 U.S. 462 (1951). That goes double for the FDA in the First Circuit. See Giza v. Secretary of HEW, 628 F.2d 748 (1st Cir. 1980). Oops. Duggan, 2012 WL 45503, at *5 (plaintiffs forced to drop subpoena). On top of that, the FDA denied the petition, reaffirming that the PMA covered the entire system. Really oops. Id. (“[t]o the extent there was any ambiguity about the scope of the approval letter, this rejection of the Citizen Petition is the cherry on the icing”). Observing that plaintiffs had thusly shot themselves in the foot, the court granted summary judgment. Id.

Second, Boston Scientific won a preemption motion in a rather unusual case in Erickson v. Boston Scientific Corp., No. SACV 10-698 AG (ANx), slip op. (C.D. Cal. Dec. 12, 2011). We’re only just finding out about it, though. The unusual nature of the case is the general attack on the life expectancy of several of the defendant’s products (pacemakers powered by batteries). The plaintiff claimed that he had been told that four different pacemakers “would last ten years” but that none of them (except the last, which hadn't been implanted very long) came close to that lifespan. Slip op. at 2.

Erickson was dismissed via judgment on the pleadings. So, initially, it is a valuable judicial notice decision, as the court took judicial notice of the FDA approvals of all four pacemakers (six total FDA documents) – a PMA, two PMA supplements, and several supplemental product development protocols (“PDPs”). Slip op. at 3-4. Judicial notice, of course, allows for dismissal on the pleadings, thereby saving considerable discovery expense and reducing the nuisance value of plainly preempted litigation.

Erickson held that both of these regulatory avenues – the PMA supplements and supplemental PDPs – were equivalent to pre-market approval, and thus preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), barred the action. Slip op. at 7. The decision discussed supplemental PDPs at some length:

Some of Defendants’ pacemakers were not subject to the FDA’s PMA process, but were instead approved through the FDA’s supplemental Product Development Protocol (“PDP”). In Reigel, the Supreme Court stated that an application for supplemental premarket approval is “evaluated under largely the same criteria as an initial application.” Riegel v. Medtronic, Inc., 552 U.S. 312, 319. Courts have interpreted Reigel to mean that preemption applies equally to both the PMA and PDP processes.

Slip op. at 8 (other citations omitted). We’ve seen supplemental PMA and PDP preemption decisions before (see our device preemption scorecard for details), but Erickson is the first case we can recall specifically discussing a supplement to a PDP in the context of preemption. That’s probably the most important takeaway from Erickson.

In Erickson the plaintiff also trotted out the “parallel violation” exception. Slip op. at 9-10. The defendant made mincemeat of it – aided significantly by the plaintiff's failure to plead anything resembling an adequate parallel claim. Plaintiff did not allege what was violated or how that related to his claim. Id. at 9-10. That didn’t cut it:

[A] plaintiff cannot simply incant the magic words “[defendant] violated FDA regulations” in order to avoid preemption. Rather, a plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue, or identify specific PMA requirements that have been violated.

Slip op. at 9 (citations and quotation marks omitted).

The only thing specific that the plaintiff in Erickson alleged was that some of the pacemakers had been recalled. A bare allegation of a recall, however, wasn’t nearly enough. First, “[m]any courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.” Slip op. at 10 (citations omitted). Second, recalls do not amount to withdrawal of approval. Id. Third, the recall wasn't even relevant, since there was no allegation “that the recall was prompted by defects relating to the pacemakers’ longevity.” Id.

The treatment of the recall is a second very usable takeaway from Erickson. Finally, for the record, Erickson also dismissed fraud claims as insufficiently pleaded, slip op. at 10-11, and throws out several of the claims (the older pacemakers) under the statute of limitations. Id. at 13-15.

Mensing and TwIqbal Team Up To Deliver a Knockout

2012-01-10T10:58:00.000-05:00

We know sports-courtroom analogies are overused, hackneyed, timeworn, trite (you get the idea). But, nevertheless they can be useful and provide a little color to what might otherwise be viewed by some (of course, not us) as dull legal goings on. For instance, we could simply report that the District of Maryland tossed out another case against a generic prescription drug manufacturer. Grinage v. Mylan Pharmaceuticals, Inc., 2011 U.S. Dist. Lexis 149667 (D. Md. Dec. 30, 2011). Or we could say –

A four-round hard glove fight took place in at 101 W. Lombard Street, Baltimore in the final days of 2011. The fight pitted local Beatrice “the Plaintiff” Grinage against West Virginia’s own Mylan “the Defendant” Pharmaceuticals. Catherine C. Blake, United States District Judge acted as referee. The stakes were Grinage’s claim for the wrongful death of her husband allegedly caused by his ingestion of generic Allopurinal. From the minute the bell rang, it was evident that the Defendant, with the law on its side, had the reach advantage. In the first round, the Defendant had Grinage reeling from a right uppercut. In the second, the Defendant’s left jab, right cross combination almost finished the Plaintiff off. The Plaintiff hung in for two more rounds, but the devastating blows from the prior rounds had taken the wind from the Plaintiff’s sails. With one last hook, the Plaintiff went down; the bell rang and Mylan emerged victorious. And the crowd went crazy!!

OK, back to reality. The punches were really Mensing and TwIqbal and they were as effective as any roundhouse and equally impervious to all plaintiff’s bobbing and weaving.

Round One – Failure to Warn: Plaintiff tried to dodge Mensing by arguing efficacy over substance. If claims regarding the substance of the generic drug warning are preempted, plaintiff claimed that generic drug manufacturers should have tried to harder to provide the warning they were allowed to give. Grinage, 2011 U.S. Dist. Lexis 149667, *10. Plaintiff argued that the defendant should have “employed more effective communication to healthcare providers and consumers” through things like Dear Doctor letters, training programs and public notifications. Id. To be clear, plaintiff’s contention was that the defendant could have met its duty to warn by using these methods of communication “without including substantial new warning information.” Id. at *12. However, even if Mensing leaves open for consideration a claim for “effective communication,” you still have to plead causation:

Here, there is no allegation that [plaintiff] and his doctor did not see the labeling as it was approved and take into consideration the information included therein . . . . Nor has [plaintiff] alleged any other facts sufficient to support a reasonable inference that further communications consistent with the approved label would have affected the choices made by [plaintiff] or his doctor.

Id. at *13. Down goes failure to warn.

Round Two – Defective Design: This is where Mensing and TwIqbal work a really effective combo. Maryland state courts are divided over whether the proper test for determining if a prescription drug is defectively designed is risk-utility or consumer expectation. The latter fails under Mensing:

An ordinary consumer forms her expectations regarding the safety of drugs from her doctor or from the drug's label. Thus, if [a drug] is dangerous beyond the expectations of the ordinary consumer, that can only be a symptom of [the manufacturer’s] failure to update its label or communicate effectively with doctors. For reasons articulated above, any state law defective design claim predicated on this theory is pre-empted by FDA labeling regulations.

Id. at *18. But plaintiff’s design defect claim couldn’t be helped by application of the risk-utility test because she failed to plead any facts regarding the utility of the drug or the availability of less dangerous alternatives. In steps TwIqbal. “Here, no factual allegations are included that raise the right to relief on a risk-utility design defect theory above the speculative level.” Id. at *19. Down goes design defect.

Round Three – Breach of Implied Warranty: With the plaintiff on the ropes, the breach of warranty claims topple over with very little resistance. First, a breach of warranty of merchantability requires proof of the existence of a defect. Id. at *20-21. See rounds one and two. Second, a breach of warranty of fitness for a particular purpose requires an allegation of a particular purpose “as distinguished from the ordinary or general use to which the goods would be put by the ordinary buyer.” Id. at *21. No such allegation means no such claim. Down goes breach of warranty.

Round Four – Fraud: Plaintiff is staggering and it doesn’t take much to secure the knockout. Fraudulent representations allegedly made to the plaintiff or his doctor – preempted under Mensing. Id. at *22-23. Fraudulent representations allegedly made to the FDA – insufficiently pled to meet the heightened requirements of Rule 9(b):

The complaint contains no reference to any specific communication to the FDA that constituted a misrepresentation, or to any specific studies or other information improperly omitted from filings or other communications with the FDA.

Id. at *23-24. And, we would argue this fraud claim is also preempted by Buckman, but we’ll settle for a Rule 9 dismissal. Down goes fraud.

Another bout goes in the books in favor of generic drug manufacturers. Thanks to Adam S. Ennis at
Jackson Kelly PLLC for passing this one along.

Shameless Plug - Free Webinar on Duty to Warn in the Digital Era

2012-01-09T10:27:00.001-05:00

On January 25, 2012 (Bexis’ birthday), between 12:00-1:00 p.m. (EST), our friends who publish the Physicians Desk Reference are putting on a free webinar entitled "‘Duty-To-Warn’ in the Digital Era: Emerging Issues." You can register for it online here.

And did we mention, it's free?

Here’s a brief description of the subject matter:

Manufacturers have a legal responsibility to communicate the known risks associated with their medications and ‘duty-to-warn’ responsibilities have traditionally been fulfilled by publishing labeling information online or in reference texts.

However, as physician workflow consolidates around electronic health record systems, manufacturers may increasingly find themselves under scrutiny regarding their ‘duty-to-warn’ efforts – how and where they provide safety messaging will make the difference.

Hear industry experts share the latest developments in:
‘Duty-to-warn’ relating to medical malpractice litigation and product liability management, including an update on the Supreme Court’s recent cases and the impact on generics.
The increasing role of technology in the evolution of ‘duty-to-warn’ benchmarking.
The growing responsibility on regulatory and marketing operations regarding ‘duty-to-warn’ in healthcare IT systems.
The importance of labeling information in the physician’s electronic workflow.

Why do we care?

Well, Steve McConnell of our blog (the guy who mostly writes the funny Monday posts) is one of the panelists, and he’s going to be presenting much of the legal framework for the webinar. Other panelists include Christopher L. Gaenzle, Assistant General Counsel for litigation at Pfizer; Richard E. Hinson, and former senior marketing executive at Roche; Jay H. Stone, M.D., an interventional cardiologist at the Shore Cardiac Institute in Toms River, N.J. The moderator is Brian McDonough, .M.D., a syndicated medical correspondent.

So if you’d like to interact with Steve, and learn something about the interface between technology and defending litigation involving prescription drugs and medical devices, drop in on this webinar. For additional information, contact Jason Willett at (415) 644-3926 or by email at jason.willett@pdr.net.

Rules Matter

2012-01-09T07:00:00.003-05:00

A long time ago, when we were just starting out as defense hacks, a mentor told us to beware of the double-standard that lawyers representing big corporations face: we are expected to be virtually perfect in our compliance with every possible rule (even rules whose existence and/or application are doubtful) while plaintiff lawyers can blow every deadline, botch every filing, bobble every rule, and get away with it because they are, pretend to be, or claim to represent, the little guy. For years we thought that double-standard applied. In front of some judges, we still fear the double standard. But we also have lots of friends among the plaintiffs' bar and we have heard them complain of a double-standard that they face. Maybe everybody in our business labors under the impression that they are uniquely oppressed. Maybe we want to portray ourselves as heroes confronting long odds.

Most judges try to enforce the rules but also try to inject a little bit of flexibility into the system. They will cut litigants some slack, until it becomes clear that the litigant is a serial offender. Indeed, as brutal as the combat can be between plaintiffs and defendants, more often than not we usually find ways to cut each other some slack. There is a bit of 'there but for the grace of God go I' in these extensions of merciful courtesies. Nevertheless, if it becomes clear that the rule violations form a pattern of indifference or sloppiness, and if the noncompliance is truly disruptive or prejudicial (and our clients have more than a little input in this sort of calculation) it becomes appropriate to ask the court for enforcement of the rules and implementation of the correct sanction or remedy.

In mass tort litigation, there are two areas where we almost always run into at least some plaintiffs (and their attorneys) who fail to cross the t's and dot the i's where it matters: (1) plaintiffs who declared bankruptcy but did not include their tort claims as an asset in bankruptcy, and (2) plaintiffs who died and were not appropriately substututed for per the relevant state procedure. Our friend Joe Hollingsworth called our attention to an example of the latter in the Aredia/Zometa MDL, which has already been so prolific in producing grist for our bloggy mill.

The United States District Court for the Western District of Arkansas granted Novartis Pharmaceuticals Corporation’s motion to dismiss in McDaniel v. Novartis Pharmaceuticals Corporation, Case No. 2:08-CV-02088 (W.D. Ark. Jan. 6, 2012), because a deceased plaintiff had not been properly substituted for, despite representations to the court that the substitution would be accomplished. The case was originally filed in the United States District Court for the Middle District of Tennessee and was centralized in the Aredia and Zometa MDL. The case was ultimately remanded to the Western District of Arkansas, where the plaintiff's family resided and was set for a February 2012 trial. At the time of trial, the putative plaintiff was the son of the allegedly injured party, who had died as a result of multiple myeloma.

But a lot had happened, or failed to happen, before February 2012. A Suggestion of Death had been filed, and the decedent's husband was provisionally substituted in as personal representative. But the husband never changed his status from provisional personal representative to personal representative by submitting to the MDL court an order of appointment, as was required by the court's case management order. Then the husband became incompetent to serve as personal representative. In early 2010, the son took over as provisional representative. But he never made application to be appointed administrator of his mother's estate and never changed his status from provisional personal representative to personal representative by submitting to the MDL court an order of appointment. No estate had ever been opened for the decedent, and no petition had ever been filed to appoint someone (husband or son) as personal representative. After the passage of substantial time (nearly four years), and on the eve of trial, the plaintiff filed a Motion to Amend Order of Substitution, while the defense filed a Motion to Dismiss the Case.

The plaintiff's motion was denied, and the defense motion was granted. The court was clearly reluctant to dismiss a case on what seems to be technical grounds, but was just as clearly constrained by the rules and the procedural posture of the case. The court found itself "in the unfortumate situation where, on the eve of trial, Plaintiff requests that this Court travel back in time and cure the procedural missteps done in the course of this litigation," which "the Court cannot and will not do." The husband's and son's failure to substitute in as personal representative violated three levels of rules: (1) they "failed to follow the terms of the MDL court’s case management order in substituting a proper party in interest within the time period specified by the order and prior to remand of the case" for trial; (2) they "failed to meet F.R.C.P. 25’s requirements for proper substitution of a deceased party"; and (3) they "failed to properly revive the claim according to A.C.A. § 16-62-108 [the Arkansas revivial statute] within a year of Mrs. McDaniel’s death." The court stated, "[t]he simple fact is that Plaintiff’s counsel had plenty of time to correct the procedural deficiency created by the death of Mrs. McDaniel." Moreover, the "procedural deficiency" is not merely technical. The court lacks jurisdiction over the matter because the husband and son had failed to revive the claim.

Because the rule at issue really mattered, and because the plaintiffs had no viable excuse for ignoring the rule over such a long period of time, the court had no choice. For some rules, there simply is no double standard.

Breaking News - The New One-Two

2012-01-06T16:25:00.000-05:00

We just received from defense counsel Matt Wender at Pietragallo Gordon a copy of Moore v. Mylan, Inc., No. 11:1-CV-03037-MHS, slip op. (N.D. Ga. Jan. 5, 2012). It's another post-Mensing case holding: (1) that the plaintiff can only sue a maker of the drug s/he took (whatever that might turn out to be in this case), and (2) dismissing the generic on the basis of preemption.

As to product identification, Moore, applies well-settled Georgia law:

Moreover, the plaintiff needs to establish that the product that allegedly caused the injury was in fact manufactured or supplied by the defendant. Plaintiffs allegations in her complaint fail to state a claim for strict liability under Georgia law . . . Third, setting aside the lack of specific factual information regarding [defect claims], plaintiff has not even alleged that a phenytoin product designed or manufactured by [one or the other of the defendants] proximately caused plaintiffs injuries. It is unclear from plaintiffs complaint whether [the branded or generic defendant] manufactured, distributed, supplied, or sold the product that the decedent ingested.

Moore, slip op. at 12-14 (citations omitted); accord id. at 32 (additional causes of action). Plaintiff's complaint was so poorly pleaded that that product identification was wholly lacking as to any defendant. Other branded related rulings are: (1) all warning claims other than as to the plaintiff's physician are barred by the learned intermediary rule, id. at 9-10; and (2) fraud claims were not pleaded with particularity, id. at 29-30.

As to preemption, the court held that the fact that the defendant generic was also a reference listed drug ("RLD") did not preclude preemption. As far as we know, Moore is the first decision thoroughly discussing RLD issues. The court holds: (1) that being the RLD for one strength of a generic product does not give the generic manufacturer the ability to change the label unilaterally on another strength of drug. "Thus, because 100-mg and 300-mg are two different products, plaintiff has not shown any authority that would have required [defendant] to change the label of 100-mg to conform to the 300-mg label." Slip op. at 21-22. (2) The RLD for the strength that the plaintiff used continued to be a branded product, therefore the Mensing rationale for preemption fully applied. Id. at 22. (3) There's no authority that becoming an RLD gives a generic manufacturer rights to change the label unilaterally:

[P]laintiff has not shown how [defendant] acquired all of the same rights as a brand name drug manufacturer simply by manufacturing one drug that was an RLD. Plaintiff has not shown that [defendant's] manufacture of one RLD converted [defendant] into brand name drug manufacturer with the right to use the CBE process to change the label of any of its drugs.

Id. at 21-22.

Another notable generic preemption ruling in Moore is that any claim that the defendant should simply have stopped selling its product is preempted. Id. at 34 n.14.

Plaintiff was given leave to file an "amended complaint [that] should address the concerns in this order." Id. at 37.

We'll be adding Moore to both our generic preemption and branded/generic scorecards.

Ear Candle Suit Snuffed

2012-01-06T11:07:00.000-05:00

Not quite a year ago we had a little fun commenting on the Daubert dismissal of a suit involving something called an “ear candle.” As we said back then:

[W]e never thought about lighting a candle in our ear. That seems a little strange. Maybe even a little risky. We can’t think of a good reason to plant a candle in an ear, and we can think of a pretty good reason not to: hot wax. That might hurt.

Apparently the FDA had similar qualms. We’ve just learned from reading Holistic Candlers & Consumers Ass’n v. FDA, ___ F.3d ___, 2012 WL 5831 (D.C. Cir. Jan. 3, 2012), that: (1) those who make candles for people to shove in their ears (at least 15 different entities) and set on fire actually have their own lobbying group (that’s scary – are UFO believers next?); (2) some people actually believe shoving a lit candle in your ear is a healthy thing to do (that’s scarier); and (3) the FDA is on the case (that’s probably good, although one might wonder about the Agency’s enforcement priorities).

So why do we care about people who stick lit candles in their ears?

Because – aside from keeping a straight face – the Court of Appeals makes a point about FDA warning letters that needs to be kept in mind whenever such things surface in product liability litigation. Such letters, including the 15 issued in this case, don’t mean squat as supposed statements of FDA regulatory positions:

FDA’s warning letters . . . neither mark the consummation of the agency’s decisionmaking process nor determine the appellants’ legal rights or obligations. The letters plainly do not mark the consummation of FDA's decisionmaking. . . . FDA warning letters . . . giv[e] firms an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action. . . . Nor do the letters represent a decision determining rights or obligations, or one from which legal consequences flow. . . . [A] Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the [FDCA]. Although a warning letter communicates the agency’s position on a matter, it is only informal and advisory and does not commit FDA to taking enforcement action. . . . In short, an FDA warning letter compels action by neither the recipient nor the agency.

Holistic Candlers, 2012 WL 5831, at *2-3 (citation to the FDA’s regulatory procedures manual and quotation marks omitted).

This discussion of FDA warning letters was important in Holistic Candlers because, due to their preliminary nature, “FDA warning letters do not represent final agency action subject to judicial review.” Id. at *4. Thus, the litigation was snuffed.

To us it’s important because FDA warning letters don’t even rise to the level of a criminal indictment, let alone a conviction. An indictment is at least the “initiation of an enforcement action,” whereas an FDA warning letter isn’t even that. It might even be less than a DOJ target letter (we say "might" because we're not criminal lawyers, and don't claim to know all the implications of a target letter). If mere criminal charges not leading to conviction are not admissible evidence, then a fortiori an FDA warning letter should not be admissible in similar circumstances. This isn’t the first time we’ve made this point about FDA warning letters, but it’s a point that bears repeating.

Just What The Doctor Ordered

2012-01-04T12:01:00.000-05:00

Ringing in the New Year’s been a might slow. Not too much shaking loose in the Drug/Device law area it seems. There were some pretty hideous Daubert rulings in Yazmin/Yaz, but not all that much reasoning to support them. It seems to be a judicial settlement pressure tactic - aimed at defendants - since we read this morning that, immediately after issuing all these bad rulings, the court cancelled the bellwether trial that had prompted the motions in the first place, and required mediation instead. Anyway, we noted the worst of the bunch in our bottom ten post a week ago, so we’ll leave them at that.

One new case we’ve seen is Roberts v. Albertson’s LLC, ___ Fed. Appx. ___, 2011 WL 6807608 (9th Cir. Dec. 28, 2011) (non-precedential), where the combination of a corner-cutting lawyer and his not-so-bright client resulted in a nice defense win. Roberts involved a medical device, a blood pressure monitor. The plaintiff claimed it didn’t work right and gave deceptively low readings. Allegedly that caused, or was a substantial factor in, the plaintiff having a stroke.

We say allegedly because – well, we’re defense lawyers – but more because plaintiff didn’t have any expert to explain why that was. Usually that kind of thing happens where: (1) causation is pretty darn obvious, or (2) the plaintiff has lost the product and has no other choice. That doesn’t seem to be the case in Roberts. How a mere monitoring device can cause a stroke is anything but obvious, and there’s no mention of a lost product in the case, so we chalk the absence of any plaintiff experts up to the other side not willing to invest anything in the case.

So much the better for us.

So to the client. Plaintiff was prescribed blood pressure medication after the one time he had his blood pressure tested by a doctor, it was elevated. He also bought the home BP monitor that was at issue in the case. It gave him consistently normal readings – plaintiff claims improperly. Supposedly, due to those readings, the plaintiff decided, contrary to doctor’s orders to stop taking his medication and to use a “homeopathic” regimen of his own concoction (fish oil and something called “Co-Q 10”) instead. After abandoning real drugs for that garbage, he had a stroke.

And he didn’t have any experts.

The district court granted summary judgment, and now the Ninth Circuit affirmed, albeit on somewhat different grounds, those being:

• Although there was a discrepancy between the home readings and the one doctor’s reading, “that single discrepancy does not establish that the monitor gave inaccurately low readings.” 2011 WL 6807608, at *2. The directions warned that readings could vary, and any comparison to a single in-office reading wasn’t valid without some kind of expert proof.

• There was no “substantial factor” causation because nothing in the monitor’s directions made it any more, or less, likely – in the absence of any affirmative evidence – that the plaintiff would have stopped taking his prescribed drugs, contrary to doctor’s orders. Id.

• There was no proximate cause. Plaintiff had no evidence that it was “foreseeable” that a malfunction in a home monitor would cause a reasonable man to stop taking prescribed drugs, contrary to doctor’s orders, and go homeopathic. Id. at *2-3

The court didn’t say it in quite this fashion, but we will – product liability is not free insurance against a plaintiff’s own stupid behavior involving drugs or medical devices. A would-be plaintiff who simply stops taking his/her prescribed drugs on his/her own volition has only him/herself to blame.

New Year's Job(s) Resolutions

2012-01-02T11:46:00.003-05:00

It's a National Holiday, and we do not expect to do a heckuva lot of work today. There's a decent college bowl game tonight and our Flyers will be taking on the Hated Rangers in the Winter Classic outdoor hockey game. There's a bottle of champagne in the fridge that somehow evaded last night's jackals-masquerading-as-friends. And it's time to start working on those New Year's resolutions.

Experts tell us that New Year's resolutions are doomed to fail unless the list is short and limited to the important and attainable. We're going to plug in the treadmill and stop falling for the "If you order dessert I'll help you finish it" gambit. We also are thinking through some resolutions inspired by one of our Christmas presents, Walter Isaacson's biography of Steve Jobs:
　
1. As much as we focus on technical areas (e.g., legal procedures , doctrines such as preemption, etc.), we must keep our eye on the basic human aspirations of our consumers (clients, courts, and juries). If there's one Big Theme in the Jobs bio, it's that Jobs was a miraculous combination of the technical and the spiritual. Jobs talked about the iPad (and, indeed, the company) residing at the intersection of liberal arts and technology. Jobs cared as much about consumer emotions as he did about computer code. Some science geeks can come up with devices that are intricate, brilliant -- and ugly and user-hateful. Jobs arrived at a brilliant synthesis that embraced creativity and technology to produce tools for living. What we as lawyers do isn't rocket, or even computer, science. But sometimes we focus unduly on technical issues and forget about how real human beings will receive and use what we say.

2. Binary thinking can be a good thing. Jobs invariably called ideas or products "amazing" or dreck (he used a much tougher word). People were either "heroes" or "bozos." Sure, that viewpoint discards nuance. But it also facilitates action. Jobs had high standards and was decisive. He wasn't always right, but he certainly made "a dent in the universe." Groupthink can introduce too much compromise and muddle. We were at a presentation where a consultant said that while most consumer product organizations are promiscuous in their use of focus groups and surveys, Apple's approach was a bit leaner. Then the consultant put up a photograph of Jobs: that's how Apple made important decisions. We've been in cases where sometimes it seemed that one strong-willed plaintiff lawyer had certain advantages over a defense side frazzled by way too many diverging opinions.

3. Simplicity is the purest form of sophistication. Look at an iMac. It's simple, uncluttered, beautiful, and invites interaction. By contrast, this post is being typed on something that looks like it was designed by an Uzbekistani death squad. It takes a lot of work to make something complicated seem simple and inevitable, but that effort is worth it, whether it's with a device, legal brief, graphical presentation, or argument.
　
4. Relentless, even crazy, perfectionism, can be inspiring. Jobs was notorious for insisting that even the inside of Apple products -- parts that nobody would ever likely see -- had to be beautiful, with straight lines and the right colors. It seems like a maniacal, wasteful approach, but somehow that kind of craftsmanship does manifest itself it to the consumer. It's a tough standard to meet, but what's the point of pledging to easy New Year's resolutions?

5. In the end, the product is the key. When Jobs returned to Apple after his exile, he gave a speech to the troops. He asked: Why is the company in trouble? His answer was blunt: "The products suck." Jobs wasn't in the businesses he chose (think also of Pixar) to make money, though he did pretty well in that regard. He wanted to make great products. Of course, one should lead to the other. If you have smart people, sound processes, and all the great intentions in the world, none of it matters if the products aren't great. It reminds us of something ex-Cubs and Phillies reliever Mitch Williams says about pitching: hitters don't see how you feel, they see what you throw. Now, you might say two things: (1) this point is perfectly obvious, and (2) how does this notion apply to legal services? Lawyers don't actually act as if it's the product that matters. We talk a lot about how smart and insightful and eloquent we are. But what are we actually delivering to the client (and courts and juries)? Where is the actual, ocular proof that what we are doing is helping our consumers? We think we can do better. We have some ideas. At a minimum, those are questions we need to ask ourselves everyday in 2012 and beyond.
　
Happy New Year.

FDA, Off-Label Uses and the Internet – Something New for 2012 (Well sort of)

2011-12-30T10:24:00.001-05:00

It is the end of the year – a time to look back and reflect and a time to look forward and ponder. We’ve already looked back and posted about the best and worst prescription pharmaceutical and medical device cases of the year. So, on this the last posting-day of 2011, we’d thought we’d look at something aimed toward the future – FDA’s Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. As this is just a draft guidance right now, we don’t really know what the future holds, but we thought this looked a bit like an FDA New Year’s Resolution – FDA resolves to admit the internet exists and to figure out what to do about it. We just aren’t sure they are going about it the right way. Sort of like resolving to lose weight, but going about it by cutting back to only 2 doughnuts per day – it’s really not going to get the job done.

Off-label promotion – just the words leave our clients shivering. Pharmaceutical and medical device manufacturers walk a fine line between providing current, relevant, and accurate medical information to their clients (health care professionals) and being accused of violating FDA regulations against off-label promotion. Even the FDA admits that:

FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.

Draft Guidance at 6. How to accomplish that scientific communication without running afoul of FDA regulations is the tricky part. And, the FDA is now admitting, technology has made it a bit trickier.

The FDA hasn’t said much about internet promotion in any context, so this guidance is interesting just for admitting the internet exists. Even more interesting is the recognition that there is a lot of information floating around on the internet and not all of it is good. For instance, a consumer recently prescribed a drug for an off-label indication can post a question on Yahoo! Answers and it can be answered by anyone – no medical degree, no pharmaceutical experience, no scientific background required. So, we were encouraged by the FDA’s admission that maybe the drug and device manufacturers might offer better answers than Aunt Millie or anonymousknowitall@server.com:

Furthermore, as these firms are regulated by FDA and have robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.

Draft Guidance at 3.

But, the FDA is still trying to hide the off-label ball; trying to force anything substantive to be non-public. Drug and device manufacturers have long been aware of the FDA’s rules regarding how it should respond to non-public requests (phone calls, direct emails, one-on-one communications) for off-label information about their products and those rules really haven’t changed – the response has be specifically tailored, truthful, non-misleading, accurate, balanced, and scientific. But what about those internet questions – those posted on product websites, chat rooms, discussion boards, etc. When Aunt Millie responds to those public questions, her response – no matter how inaccurate – is out there for the whole world to see. So, shouldn’t the specifically tailored, truthful, non-misleading, accurate, balanced, and scientific response by the manufacturer get equal all-access status. Not according to the FDA:

[B]ecause product information posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).

Draft Guidance at 10. So, anonymousknowitall’s response can linger forever to be discovered years later by someone searching at random for information about a product, but a drug manufacturer’s informed medical response has to be hidden under a rock. Essentially, the manufacturer can respond to a public request for off-label information only by providing contact information where the requester can make a non-public request. Draft Guidance at 11.

Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum.

Id.

This is simply weird. The FDA admits that the information itself, properly vetted and hemmed in by mandatory disclosures and fair balance (not the Fox News kind, either) requirements is not misleading if done privately. How could it possibly be misleading when it’s public? Especially when the alternative is so easy. If the FDA is worried about the information somehow going stale, the posting companies could be made to keep track of where they post and update the information accordingly. That’s not hard. We do it all the time on our own scorecards.

The public/private distinction is just silly – the FDA is making a mockery of free speech yet again for its bureaucratic reasons. Equally silly is the FDA’s solicited/unsolicited distinction. The same information that the FDA admits is truthful and beneficial in one context becomes illegal in another, for reasons having nothing to do with the content of the speech and everything to do with the FDA’s seeming death wish to continue banning truthful off-label promotion. Well we have seen the future and it is Sorrell – we fervently hope.

Still, we guess it is better than nothing. Some people will get beneficial information for some of their medical problems. We can only hope that when someone requesting information about a drug gets a response from anonymousknowitall claiming to “know it all” and a response from the drug’s manufacturer saying “please call us,” they do the latter.

But doesn’t the FDA know that it’s impossible to censor the Internet? We trust it will find out the hard way like every other would-be Savanorola or Breen Master of the Web before them. Before the Civil War, the Post Office censored the mail to remove abolitionist literature. May the FDA’s attempt meet with the same historical fate.

In hopes of hastening that eventuality we’d like to point out – to any of you entrepreneurs out there – that the FDA’s Draft Guidance creates the possibility for a wonderful online business opportunity. The partial censorship that the FDA is proposing practically cries out for some industrious on-line aggregator to defeat it, and make a buck doing it. Here’s how:

(1) There are lots of authoritative sources listing accepted off-label uses. There’s a list in the Physicians Desk Reference. There are the three compendia that Medicare uses in determining whether to reimburse off label uses. See 42U.S.C. §1396r-8(g)(1)(B)(i) (listing the American Hospital Formulary Service Drug Information, the United States Pharmacopeia-Drug Information, and the DRUGDEX Information System).

(2) Some enterprising soul – unaffiliated with any FDA regulated entity, of course – could send non-public emails, compliant with the Draft Guidance, to companies requesting information about all the off-label uses contained in these lists. We’d recommend a separate email for each off-label use. There’s no business reason for the recipient companies not to respond with compliant replies, since sales are sales.

(3) Collect all of the non-public responses and create a website – like “offlabeluse.com” or something similar; then post all the responses for the cyber world to see. Google’s spidering capabilities take care of the rest. The world gets useful information, the aggregator’s website charges for it in one way or another, money is made, and censorship is defeated. Win-win.

And, if you run with this idea and it makes you rich, don’t forget your friends at the Drug and Device Law Blog (a modest finder’s fee would not be looked upon negatively!)

Happy New Year!

Top Ten Best Prescription Drug/Medical Device Decisions Of 2011

2011-12-29T09:53:00.000-05:00

Happy Christmas/Hanukkah/solstice and Merry New Year to all our readers. May your 2012 be filled with winning arguments, TwIqbal dismissals, and summary judgments. There’s not much of 2011 left now, although we’d be overjoyed for one or more last-minute decisions to come down and warrant a change to the list that follows.

What list is that?

Why our list of our favorite drug/medical device judicial decisions of 2011, of course. And what a list it is. Between three United States Supreme Court decisions, four (maybe five, depending on how we count) court of appeals decisions, and two more by state supreme courts, only one federal trial court opinion was able to make this year’s cut.

We’ve even heard tell that some firms (we won’t name names) have actually advertised their involvement with cases on our past top ten list. We should be flattered at that – we suppose. But such considerations don’t enter into our rankings, which are purely subjective opinions. Anyway, without further ado, here are our best of 2011 – the decisions that made us rush to our computers to blog about, and cases that we hope will help our (and your) clients in the coming year.

1. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). It’s such a big win for preemption that it has to be number one, even though generic manufacturers are the only immediate beneficiaries. Not only was it a win, but after Wyeth v. Levine, 555 U.S. 555 (2009), a lot of commentators had written generic preemption off – but not us, as we pointed out here almost a month before Mensing was decided. Mensing also reveals a Court that is about as evenly split as it is possible to be on the presumption against preemption, with four justices saying no, four saying yes, and Justice Kennedy (who else on this Court?) supporting preemption without feeling the need to address that issue. What shoots Mensing into the top spot is it being an implied preemption case. This means that its principles are not limited to generic drugs. So keep in mind Mensing’s test for impossibility preemption: “whether the private party could independently do under federal law what state law requires of it.” Id. at 2579. It’s usable elsewhere. Consider how that test might play in the context of, say, black box warnings, design defect claims (both drugs and non-PMA devices), Dear Doctor letters, and any other situation where our clients are required to get the FDA’s (or some other federal agency’s) sign off before doing this or that. Also supporting the #1 ranking is that the reservations we have about some aspects of Mensing have not materialized (see #9 below). We blogged about Mensing here and here.

2. Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011). We’re #2! We’re #2! This blog has been following Bruesewitz since it was in the district court. Vaccine defendants effectively ran the table in Bruesewitz. The main holding is that Congress totally preempted design defect claims as part of the Vaccine Act (the statute creating the current federal administrative compensation scheme for vaccine-related injuries). As in Mensing, the purported presumption against preemption goes on walkabout. Bruesewitz also rejected each and every of the plaintiff’s hair-splitting arguments. After Bruesewitz, there shouldn’t be much left of common-law vaccine litigation, with both warning (assuming the vaccine carries FDA-approved warnings – not a hard thing to do) and design claims preempted. Bruesewitz also makes a number of useful statements concerning common law issues that, while not binding, we are pleased to add to our defense armamentarium. The only reason Bruesewitz doesn’t rank higher is because vaccines are a narrower category of litigation than drugs or medical devices. We listed our favorite bits of Bruesewitz here.

3. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011). The best third-party payer/economic loss decision of the year. “Third-party” and “three” go together well, we think. A defense hat trick, with Rule 12 (no expensive discovery) dismissals affirmed against RICO, consumer fraud, and common-law claims under the law of – get this – 46 different states. That’s just about every theory plaintiffs advance in this kind of case. As to each, the basic rationale is pretty much the same, simply paying a theoretically higher price for a safe and effective drug isn’t the kind of loss any of these causes of action is designed to prevent. Third party payers are by definition insurers, so they can simply raise their premiums. To be actionable, the drug itself must be either unsafe or ineffective. But safety/effectiveness claims necessarily vary from patient to patient (and thus from prescriber to prescriber), so third party payer plaintiffs must prove any claims one by one (which, of course, they have no intention of doing). ILU68 also rules that pharmaceutical companies owe no duty of disclosure to third party payers, thus this decision has to rank very high on our list. We celebrated it here.

4. Williams v. Mast Biosurgery USA, Inc., 644 F.3d 1312 (11th Cir. 2011). We absolutely hate (see 2011 bottom ten #1) decisions that relax proof standards where plaintiffs have for whatever reason disposed of the product. Such decisions only create incentives for plaintiffs to do just that – arrange for the products at issue to become unavailable. Conversely we really like decisions that reinforce the requirement that there must always be a definable defect in a purportedly defective product. We especially like decisions that reject use of res ipsa loquitur as an end run around the defect (and sometimes causation) requirement of product liability. Williams is just such a case, and these issues are treated at some length. An added bonus to Williams is the careful discussion of the difference between lay and expert testimony in the case of treating physicians. We blogged about it here.

5. Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011). Yup, the United States Supreme Court decided two cases on our top ten list on the same day. Sorrell is not a product liability case, but rather a 6-3 constitutional decision that declares, “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” 131 S. Ct. at 2259. Boom. Such speech cannot be “silence[d] . . . by censoring its content.” Id. at 2264. Double boom. Our complete description of Sorrell is here. As we pointed out in that post, and as the dissent pointed stated in the decision, id. at 2678, Sorrell is of particular interest because it puts very distinct handwriting very on the wall implicating the constitutionality of the FDA’s prohibition against truthful promotion of off-label use. Still, that’s in the future – hopefully in a top ten list yet to come. But for its great potential (and for being a Supreme Court case), we award Sorrell the #5 spot on our list.

6. Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011). Everybody knows how much we like TwIqbal. Courts of appeals follow about four different TwIqbal standards in drug/device cases. The standard articulated in W-G is the best of the bunch. Parallel violation claims must be “specifically stated.” Plaintiffs must allege the “particular” statutory section/regulation supposedly violated. “Specific” facts must establish the nature of the violation. Crucial allegations must be supported by “factual detail.” Seems almost self-evident, but trust us, it hasn’t been. Not only that, but W-G is also good on PMA device preemption. A two-fer, and because the court enunciates the toughest TwIqbal standard, we rate it the highest. We blogged about W-G here .

7. Garza v. Merck & Co., 347 S.W.3d 256 (Tex. 2010). How often does the best Daubert decision of the year come from a state court? In Garza the Texas Supreme Court took a hard look at the epidemiological “proof” that the plaintiffs offered in support of a multi-million dollar verdict – and wiped that verdict from the face of the earth. The studies involved dissimilar populations (as is almost always the case, the plaintiff took less of the drug for less time than the studied population) and didn’t show a statistically significant doubling of the relative risk. Not only that, under Texas law, there must be two qualifying studies to guard against aberrant, fluky results. Without those studies, there was no legally sufficient proof of causation in Garza. Judgment n.o.v. city. If only federal Daubert decisions stood as tall as Texans. We gave Garza the old hook-em ’Horns salute here.

8. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011). A gutsy judge making a gutsy call in the post-Levine world. We’ve always argued that the SSRI (“selective serotonin reuptake inhibitor”) suicide cases – especially the adult ones – presented the best factual basis for implied conflict preemption in the prescription drug context. The FDA record, rejecting such warnings over and over again as scientifically unsubstantiated, is just awesome, which is why the Agency intervened in these cases as amicus curiae. But unfortunately, the Supreme Court screwed up the law in Levine before it had a chance to review an SSRI case. After bad decisions all last year (e.g., 2010 bottom ten #3) along comes Dobbs to hold that the SSRI record constitutes the kind of “clear evidence” of FDA rejection that Levine says is needed to support preemption. Maybe there’s hope yet. We blogged about Dobbs here.

9. Smith v. Wyeth, Inc., 657 F.3d. 420 (6th Cir. 2011), and Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011). Virtually unanimous state law before Mensing absolutely required that the plaintiff have used the defendant’s product for any product-related cause of action to exist. The Supreme Court’s Mensing decision speaks only to preemption and has nothing to do with substantive state law. Thus, state law after Mensing absolutely requires that the plaintiff have used the defendant’s product for any product-related cause of action to exist. There’s not a lot of reasoning in either decision – otherwise they’d rank higher – but the bottom line message is crystal clear. We blogged about Smith here.
10. Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011) (they take a long time to publish in Arkansas). Kowalski is a ringing reaffirmation of the learned intermediary rule by the Arkansas Supreme Court, combined with extension of the rule to pharmacists and an ultimately pro-defense outcome. The court adopts the majority position that the rule precludes any general duty to warn from being imposed on pharmacists, and affirms entry of summary judgment. Best learned intermediary case of the year. Our post on the case is here.

That’s the top ten, but our Christmas tree still isn’t bare. Judicial Claus has left us a bunch of smaller, but still nice, judicial presents over the past year. We like defense wins, so here are the next ten in summary form:

Honorable mentions: (11) Astra USA, Inc. v. Santa Clara County, 131 S. Ct. 1342 (2011), not a products case, but quite citable as precedent for rejecting private tort actions in the teeth of an exclusive federal enforcement provision similar to the FDCA’s 21 U.S.C. §337(a) (our post here); (12) Walton v. Bayer Corp., 643 F.3d 994 (7th Cir. 2011), putting a decisive an end to fraudulently joined non-diverse pharmacists precluding removal – a commonly used dodge – that’s kept cases trapped in southern Illinois hellholes (our post here); (13) Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011), another good appellate TwIqbal decision, just not quite as good as W-G, due in large part to the plaintiff’s procedural errors (our post here); (14) Degelmann v. Advanced Medical Optics, Inc., 659 F.3d 835 (9th Cir. 2011), Preemption? In a Class-II device case? It can happen if the moon and stars align (our post here); (15) Kinetic Co. v. Medtronic, Inc., 2011 WL 1485601 (D. Minn. April 19, 2011), good on preemption, TwIqbal, parallel claims, discovery, and express warranty, all in one opinion (our post here); (16) Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701 (D. Minn. Sept. 27, 2011), a trailblazing decision involving reprocessed medical devices; well-reasoned and mostly favorable to the defense (our post here); (17) In re Digitek Products Liability Litigation, ___ F. Supp.2d ___, 2011 WL 5282595 (S.D.W. Va. Nov. 3, 2011), its excellent discussion of why “adulteration” has nothing to do with product defect will be cited again and again; would rank higher but for its shooting-fish-in-a-barrel aspect (our post here); (18) Gazal v. Boehringer Ingelheim Pharmaceuticals, 647 F.3d 833 (8th Cir. 2011), we don’t usually rank statute of limitations decisions, but this one stands for the general proposition that absence of scientific proof capable of surviving Daubert does not toll the statute of limitations (our post here); (19) In re Prempro Products Liability Litigation, 765 F. Supp.2d 1113 (W.D. Ark. 2011), excellent Daubert decision rejecting a type of claim – product use of less duration/amount than implicated in published studies – that recurs in multiple mass torts (our post here); (20) Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467 (E.D.N.Y. Apr. 24, 2011), an antidote to Y/Y (see 2011 bottom ten #3), excluding Dr. Parisian altogether on Daubert and other grounds (our post here). A half-dozen others – literally – just missed the cut.

Breaking out the old crystal ball, we note, in looking ahead to next year, that two of 2010’s bottom ten (Hamilton #4 (DTC exception to learned intermediary rule and Lance #6 (negligent design in prescription drug cases)), both from intermediate state appellate courts, have been accepted for further review by their states’ respective highest courts. A third 2010 stinkeroo (Bartlett #8 (strict liability design defect without an alternative design requirement)) is in the First Circuit Court of Appeals in a much changed, and hopefully improved, post-Mensing environment. No results in any of these yet, but we’re hopeful of having at least some good news to report in the coming year. In one way or another, Bexis has managed to involve himself in all three of these further appeals, so we expect prompt – if not necessarily fulsome (client concerns control, after all) – reporting. More truncated coverage is possible in Daniel (#8 of this year’s bottom ten (punitive damages despite FDA compliance)), as it is also a Dechert matter accepted for further appeal.

Beyond prior listings, this U.S. Supreme Court term (at least so far) doesn’t have nearly as many cases with interesting potential impact on the drug/medical device product liability arena. One that might is Kiobel v. Royal Dutch Petroleum (our post here), which could nullify a horrible Alien Tort Statute decision, Abdullahi v. Pfizer, 562 F.3d 163 (2d Cir. 2009) (#2 on our worst list for 2009). The issue before the Court in Kiobel is very broad and rather remote – whether that statute has any applicability at all to corporations – so it’s not specifically drug/device related.

Other notable pending appeals we’re aware of: In Weeks v. Wyeth, the Alabama Supreme Court will become the first state high court to consider Conte branded/generic issues. We blogged about that, here and here. The Second Circuit will almost surely decide the Caronia case (our posts here and here), where the constitutionality of the FDA’s prohibition against truthful off-label promotion is squarely at issue. It’s the same circuit that, last year, favorably decided the First Amendment Sorrell decision (see 2010 top ten best #8) that the Supreme Court turned into our #5 above. Finally, the Virginia Supreme Court has before it the question of cross-jurisdictional class action tolling, as we mentioned here. Again, we hope to have more good news to report.

Happy new year to all.

A Tale Of Two – No, Three – Drugs

2011-12-28T16:13:00.000-05:00

It was the best of times, it was … no, check that, it was the best of times. In the recent decision, Wendell v. Johnson & Johnson, 2011 WL 6291792 (N.D. Cal. Dec. 15, 2011), the moving defendants all received summary judgment, so it was just the best of times.

Wendell itself is something of a three ringed circus, insofar as the facts involve three drugs – mercaptopurine (also known, for reasons unknown to us, as "6-MP," which has the advantage of being shorter), Remicaid, and Humira – and the interaction between their respective warnings. The only simple thing about the facts is there is only one prescribing physician.

Here goes.

In 1998, the plaintiff’s decedent was diagnosed with inflammatory bowl disease (“IBD”), a nasty autoimmune condition. Prescriber, who didn’t ordinarily review drug labeling – but did just enough to preclude summary judgment on that basis – began drug treatment. Initially, the treatment featured Prednisone. Unfortunately Prednisone is well-know among those who prescribe and use it (such as Bexis’ daughter, for a while) for causing adverse reactions approximately 100% of the time.

The decedent didn’t like the reactions, and Prednisone isn’t a very good long-term treatment for a chronic condition anyway. Thus, by 1999, the prescriber went with 6-MP to try to get the decedent off Prednisone. 6-MP isn’t without its own risks, either. “At the time [the prescriber] prescribed 6–MP he was aware of a paper reporting the occurrence of lymphoma [that’s a kind of cancer] in adults taking the drug.” The prescriber warned the decedent about this, although he might have said “malignancy” rather than the precise type.

Apparently, the attempted substitution didn’t work all that well, because almost three years later the poor man is still taking both Prednisone and 6-MP. All this (and a lot of what follows) is from the “Background” section of Wendell, 2011 WL 6291792, at *1-5, by the way.

Still trying to get the decedent off Prednisone, the prescriber, now in mid-2002, discusses adding Remicade to the mix. Remicade is an “anti-tumor necrosis factor” drug – an “TNF inhibitor.” The tumor necrosis factor in the body causes inflammation, and inflammation is a major problem in a whole host of autoimmune conditions, including IBD. Unfortunately, “tumor necrosis” means exactly what it sounds like – tumor death. Tumor necrosis factor also kills tumors. Inhibit TNF, as this type of drug does, and one of the body’s defenses against cancer goes away.

Thus, Remicade (and probably all TNF inhibitors) is also associated with increased risks of malignancies. It’s a trade-off: almost a certainty of less inflammation for an increased risk of possible cancer.

The prescriber knew this, too. And “virtually always” informed his patients of an increased risk of tumors and malignancies.

In 2005 and 2006, more information became available about a possible synergistic effect between 6-MP and Remicade, involving a particularly dangerous form of lymphoma. This development culminated in 2006 with an FDA black box warning about using these drugs in combination.

The prescriber was contemporaneously aware of all of this. Fortunately, the stuff also worked. By mid 2006, the decedent’s IBD was in remission. He was taken off Remicade.

One problem with autoimmune conditions is that once they’re beat, they don’t always stay beat. Half a year later, in November, the decedent had a relapse. Instead of Remicade and 6-MP, the prescriber prescribed Humira and 6-MP. When asked why he had switched from one TNF inhibitor to another, the prescriber stated:

So in November ′06, we had been aware for some time of complication of hepatosplenic T-cell lymphoma, so that would have been part of my discussion with the family. Ease of therapy is always a discussion with Humira versus Remicade.

Wendell, 2011 WL 6291792, at *4.

However, it was also true that, at that time Remicade bore the aforementioned black box warning about cancer risk, while Humira did not. The prescriber said, essentially, that the black box didn't make much difference to him, since he already was aware of the risk and discussed it with his patients. In addition to being easier to administer, Humir, also had (the prescriber said, we have no independent idea) a "superior" safety profile for other reasons, primarily being 100% human (as opposed to being produced from genetically modified mice) in its origin.

Wendell is a product liability suit, so necessarily the worst happened. After using this second TNF inhibiter for seven months, the decedent got the nasty lymphoma warned about in the Remicade black box and died.

On this record the makers of Humira and 6-MP moved for summary judgment under the learned intermediary rule. The maker of Remicade did not (also for reasons unknown to us).

The court granted the motions.

Here’s why.

The prescriber knew full well about the risks involved when he prescribed those drugs. It didn’t matter that the black box warning was only on Remicade, because he saw it on that drug before prescribing the other one.

California law is quite good, going back even before Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004), on there being no duty – or no causation – where plaintiffs demand that physicians be warned about things they already know:

[The prescriber] knew of the risk of malignancies associated with 6–MP and Humira, but still prescribed the medication. Thus, there is insufficient evidence to create a material dispute of fact as to whether the warnings that Plaintiffs contend should have been given would have changed [the decedent’s] treatment.

Wendell, 2011 WL 6291792, at *6. Indeed, the prescriber had known about the risk of 6-MP since day one – and probably warned the plaintiff about it way back then. Id.

Then it gets really interesting. Plaintiffs love to claim than any post-injury change in prescribing habits means that the same change could have been induced earlier had only there been adequate warnings. But rarely is there any real proof of this. In Wendell the court required some supporting evidence, and when none was forthcoming, pitched the claim:

Nor is there evidence that a warning specific to pediatric patients or specific to treatments combining 6-MP with TNF-blockers would have led [the prescriber] to stop prescribing 6-MP alone or in combination. . . . Contrary to [plaintiffs’] contention, evidence that [he] ceased prescribing TNF-blockers in combination with 6–MP after [the decedent’s injury] does not prove that he would have changed his prescription practices based on the warning they suggest. A warning about rare occurrences . . . associated with therapy combining 6-MP and Remicade is bound to have less persuasive power than an instance of the disease affecting a doctor's own patient follow[ing] that therapy.

Id. at *7 (emphasis added). In the end, the issue (at least as to 6-MP) boiled down to prescription despite prior knowledge, “[T]he undisputed fact is that [the prescriber] was already aware of the risk of lymphomas associated with 6-MP, but still chose to prescribe the drug.” Id.

Touché.

As to Humira, given the timing of the first prescription, the causation fight was won for these reasons:

As with 6-MP, a mere subsequent change in prescribing habits, with no additional affirmative evidence, did not mean that it would have happened earlier had there been different warnings. Id.
The “better safety profile” wasn’t linked to black box warnings, or to cancer risk at all, but to a 100% human origin product having fewer allergenic risks – a major concern with an autoimmune patient. Id. at *8.
With the prescriber already knowing about the risk, there’s no evidence that the different state of warnings (black box versus no black box) played any part in the prescription decisions. Id.
Since the prescriber had prescribed other drugs with cancer risks, whether or not the prescriber believed that Humira had that risk was not by itself causal. Id.
The plaintiff parents’ self-serving statements that they would never have allowed the treatment had they been warned, was immaterial, since the decedent was an adult and made his own treatment decisions. Id.

In states like California, where the basic law concerning learned intermediary causation is well established, collecting analogous fact patterns where causation is defeated as a matter of law is the name of the game. Wendell has some good ones.

Many Happy Returns

2011-12-26T15:37:00.003-05:00

Today is Boxing Day, when we, along with millions of other Americans, scamper off to the Mall to return those Christmas presents that just didn't quite fit (physically or spiritually or aesthetically) our needs. So buh-bye jelly-of-the-month club (we're diabetic), Hello Kitty lounge pants (wrong size), Three Stooges talking bottle-opener (we love hearing "nyuck, nyuck, nyuck" whilst popping the top off a Yuengling, and that's why we already have one), and the boxed DVD set of all the episodes of Punky Brewster (like we said, we're diabetic).

We wish we could take back some of the crummier cases we saw this year, and exchange them for something better. Luckily, something like that happened with one of the cases that made it onto last week's Ten Worst list. We bemoaned Lefaivre v. KY Pharmaceuticals Co., 636 F.3d 935 (8th Cir. 2011), for permitting an improper private FDCA violation claim to go forward. More recently, a subsequent iteration from that litigation suggests the claims won't go very far forward, because there is no ascertainable loss. In Polk v. KV Pharmaceuticals Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011), the same basic claim was dismissed pursuant to Fed. R. Civ. P. 12(b)(6). The plaintiffs filed a putative class action, alleging that they had used Metoprolol Succinate tablets, and had gotten less than they expected because the FDA found that the defendants were not in compliance with current good manufacturing practices. That FDA finding means that the tablets were "adulterated" within the meaning of 21 U.S.C. section 351(a)(2)(B).

The plaintiffs tried to rely on the Consent Decree entered into between the defendants and the FDA. But in the Consent Decree preamble the parties disclaimed liability, The plaintiffs argued that the disclaimer was "inconsequential" and that the findings in the Consent Decree provided evidence of liability. The court disagreed and concluded that the Consent Decree contained "only allegations that were neither admitted nor denied by Defendants as well as the express denial of liability by the Defendants." 2011 WL 6257466 at *4. Therefore, the Consent Decree was evidence of nothing except that a settlement was reached between the defendants and the FDA. So far so good.

And it's about to get better. The plaintiffs' central claim is that the medication was worth less than what they paid for it, in light of the adulteration. But there was no evidence that the tablets posed any health risk to consumers. The court then followed the reasoning of Myers-Armstrong v. Actavis Totowa, LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009), a case we applauded here. Noncompliance with good manufacturing practices is insufficient in the face of no actual "manifestation of a defect that results in some injury or rational fear of injury" to state a cognizable claim. 2011 WL 6257466, quoting Myers-Armstrong. Put simply, there's no evidence that "adulteration" equals ascertainable loss. Therefore, the claims under both the Missouri consumer protection statute and breach of warranty fail.

The Polk case is like finding another present under the tree after you thought you were all done. Or it's like taking back that weird "The Scream" inflatable and exchanging it for something serviceable and solid, like a Yellow Submarine ice cube tray, or a nice, pro-defense ruling.

Removal News

2011-12-23T14:15:00.001-05:00

There hasn’t been a lot of talk about this, but Congress just passed, and the President signed, something called the" Federal Courts Jurisdiction and Venue Clarification Act of 2011," H. R. 394, P.L 112-63, copy here. As far as we’re concerned, this new act (we’ll call it, creatively, “the Act”) is as significant for what it didn’t do as for what it did.

The Act completely rewrote 28 U.S.C. §1441(b). Why’s that important? Because the literal language of §1441(b) – “removable only if none of the parties in interest properly joined and served is a citizen of the State in which such action is brought” – is what allows removal prior to service to trump the so-called “forum defendant” loophole. As we’ve pointed out in many posts (most of which you can access from here), the “and served” qualifier to the forum defendant loophole means that, if an otherwise diverse action is removed before an in-state defendant is served, then that defendant’s citizenship, according to the statute, must be ignored and the action is properly in federal court.

That’s the express language of the statute. The plaintiffs have responded with a mushy, result-oriented counter-argument that surely Congress didn’t mean what it said; that result would be absurd. As we’ve mentioned, some benighted courts have bought that rationale.

Well, that argument just went out the window. Why? Because in the Act (the 2011 one mentioned above), Congress had the opportunity to change §1441(b) if it was uncomfortable with the result dictated by that section's express terms. It didn’t. Quite the contrary, while Congress completely rewrote §1441(b) in the Act, it retained (and arguably improved, see this law review article, pp. 162-63) the “properly filed and served” language verbatim in the new version. After the Act, here’s how §1441(b) now reads:

(b) REMOVAL BASED ON DIVERSITY OF CITIZENSHIP. – (1) In determining whether a civil action is removable on the basis of the jurisdiction under section 1332(a) of this title, the citizenship of defendants sued under fictitious names shall be disregarded.

(2) A civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.

Act §103(a)(3) (emphasis added).

Thus Congress reenacted the identical language of the statute that plaintiffs claim creates an “absurd” result. When amending statutes, Congress is presumed to appreciate how the existging language is being interpreted in the courts. E.g., Forest Grove School Dist. v. T.A., 129 S.Ct. 2484, 2492 (2009) (“Congress is presumed to be aware of a[] . . . judicial interpretation of a statute and to adopt that interpretation when it re-enacts a statute without change”) (citation and quotation marks omitted) (there are lots of similar cases). Obviously, in the case of removal before service, Congress didn’t consider elimination of the forum defendant rule to be “absurd” in the least. Rather, the forum defendant rule is itself an anachronism of earlier times when local prejudice against “foreigners” – that is, those from other states – was much greater than in the extremely mobile society of the Twenty-First Century.

So we think that the Act, by re-enacting verbatim the “and served” caveat to the forum defendant rule, has effectively ratified the validity of pre-service removal as a means of escaping hellhole jurisdictions where diversity is otherwise present.

What else is there in the Act?

Probably of most import to practicing litigators, Congress cleaned up the controversy about whether the 30-day removal period began to run with the first, or with the last, defendant to be served, where (as is usually the case these days) more than one defendant is sued. Congress adopted the majority (but hardly unanimous) rule measuring time from the date of the last service – the so-called “last served defendant” rule. See Act §103(b)(3)(B) (creating a new 28 U.S.C. §1446(b)(2)(B) specifically addressing this issue). Earlier served defendants, even if they independently blew the 30-day removal period, may nevertheless consent to a timely petition filed by a later-served defendant. Id. (creating a new 28 U.S.C. §1446(b)(2)(C) specifically addressing this issue).

Also, Congress has codified the formerly judge-made (but extremely long-standing) gloss on §1446, and now formally requires that all defendants (except those otherwise statutorily excluded) join in a diversity-based removal petition. See Act §103(b)(3)(B) (creating a new 28 U.S.C. §1446(b)(2)(A) specifically addressing this issue).

Plaintiffs like to play hide-the-ball with the amount in controversy ("AiC") (currently $75,000 - that hasn't changed) in potentially removable cases. The Act addresses this problem, as well, by providing that, where the AiC is not plainly stated in the complaint, any later filing (such as discovery) that yields AiC information establishing a demand above the limit required for diversity-based removal is treated as “another paper” that creates a new window for removal of the case. See Act §103(b)(3)(C) (creating a new 28 U.S.C. §1446(c)(3)(A) specifically addressing this issue).

Also regarding the jurisdictional AiC, any dispute over what the plaintiff is actually demanding is to be resolved by the court on a “preponderance of the evidence” basis (some courts had imposed more restrictive proof standards). Id. (creating a new 28 U.S.C. §1446(c)(2)(B) specifically addressing this issue). Note, this section of the Act consistently refers to "§1332(a)," meaning that it doesn't apply to AiC disputes under the Class Action Fairness Act, which is codified elsewhere, at 28 U.S.C. §1332(d).

There’s now a catch-all escape valve from the one-year limit (from time of suit commencement) for removing a diverse action. If the court finds that the plaintiff acted in “bad faith” in any way to prevent removal, the one-year limit doesn’t apply. See Act §103(b)(3)(C) (creating a new 28 U.S.C. §1446(c)(1) specifically addressing this issue). This “bad faith” exception also applies to AiC issues. Id. (creating a new 28 U.S.C. §1446(c)(3)(B) specifically addressing this issue).

Another change involves cases in which there are mixed removable (usually federal question) and non-removable (usually non-diverse tort claims) parts of a complaint. Under the Act, the entire action can be removed (as at present) but once in federal court it’s now mandatory to sever the non-removable parts of the litigation and remand them to state court. Conversely, defendants not affected by the removable parts, need not consent to removal. See Act §103(a)(4) (amending §1441(c)).

Given the date that the Act was enacted, it will become effective on January 6, 2012. From that day forward, it applies to all commenced in state (for removal purposes) or federal court.

NOTE: The Act also contains amendments affecting jurisdiction and venue, but that’s beyond the scope of this post. Here are a couple of write ups of the Act that cover those aspects.

The Dregs - The Ten Worst Drug/Medical Device Decisions of 2011

2011-12-22T14:59:00.000-05:00

Here we go again. At the end of every year, we look back over the past twelve months – the highs and the lows – the thrill of victory and the agony of defeat. We always start with the agony, however, and this year’s no exception. Despite our best efforts, our side didn’t win everything everywhere. So as we’ve done for the past four years, we’re handing out lumps of coal right before Christmas, specifically the ten worst prescription medical product liability decisions of 2011. These noxious weeds seem to pop up all over. We have federal cases and state cases. We’ve been burned, of course, by hellhole jurisdictions, but also at least as much (if not necessarily as frequently) in jurisdictions that, until now, hadn’t earned that sobriquet.

Like last year, there’s still a week and a half left for courts to continue plumbing the depths. There could be a new number one before the end of the year. But, frankly, we want to get this over with before that vulture over there keels over and falls off its dung heap. The last week of the year we reserve for the fun stuff, that is to say our top ten best decisions.

So let’s take the plunge – holding our noses all the way. Here are our ten levels of hellhole, our bottom ten worst judicial drug and device decisions of 2011.

1. DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. 2011). The worst drug/device product liability decision of 2011 earned its dubious distinction by encouraging plaintiffs to lose the product that allegedly caused their injuries.  DiCosolo involved a pain killing patch used by a drug addicted (8 different drugs in the bloodstream) decedent whose death was initially ruled a suicide (before the plaintiff's lawyer prevailed on the coroner to alter his findings). The plaintiff had used recalled patches, but the patch found on the decedent's body was tested and unequivocally did not exhibit any sign of the defective condition that prompted the recall. No worries, held DiCosolo, the plaintiff can sue over the patch before that – the so-called "penultimate patch – that conveniently had been thrown away and was unavailable for similar testing. A suspiciously timed affidavit (after a long period of silence) by the financially interested plaintiff just happened to remember seeing the problem that prompted the recall present in the discarded patch. Thus the plaintiff was allowed to bring in the recall to the jury's attention, even though only a minute fraction of the recalled product had the defect. That fraction included the only patch that could be tested (all others having since gone missing), but despite that test result, DiCosolo let the plaintiff proceed under res ipsa loquitur, even though a drug overdose is not a visible malfunction. Nor did DiCosolo trouble itself overly with alternative causes, even though the plaintiff's deficient list had induced the coroner not to test the decedent’s blood for overdoses of several other drugs. Goes to the weight, the court held, wrongly, since circumstantial proof only holds together in the absence of such causes. Season this mess with some incompetent fraud on the FDA testimony , and an $18 million verdict was the result. What’s the message of this terrible decision? Plaintiffs – throw away your products! You have nothing (in Illinois) to lose but your cases. We made our best Calvin and Hobbes face at this unappetising decision here.

2. Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011). Hughes allowed an improper private FDCA-violation claim – the defendant’s “algorithm” for reporting adverse events allegedly violating some obscure regulation – to masquerade as a tort suit. Why did plaintiff even bother with such a bizarre claim? Because the product was a PMA device and all the usual claims were preempted. This duty-to-report based claim wasn’t even plausibly “parallel” to any tort cause of action ever recognized in Mississippi, so Hughes simply “assumed” that the Mississippi Supreme Court (hotbed of judicial liberalism that it is) would recognize the claim.  Hughes called it “negligence per se” even though Mississippi doesn’t recognize negligence per se where an allegedly-violated statute bars private causes of action. What about Buckman? Hughes bobbled that, too, holding that Riegel (unlike Buckman, an express preemption case) “unequivocally held” that there was an exception for parallel claims (actually, Riegel held only that the plaintiffs waived the whole subject). In one decision Hughes messed up Mississippi common law, express preemption, and implied preemption – a trifecta that warrants a #2 ranking. We vented our frustration at Hughes here.

3. In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 6302287 (S.D. Ill. Dec. 16, 2011). What happens when one plops a federal MDL in the vicinity of Madison County (yeah, we know, us Philadelphians should talk)? Whatever it is, it’s not looking very pretty at the moment, having just yielded the #3 worst decision, and the lowest by a trial court. Before Y/Y, even the worst MDL Daubert decisions at least clipped the wings of the other side’s Through-the-Looking-Glass coterie of purported “FDA experts.” Not this time. In a spectacular abdication of judicial gatekeeping authority, the Red Queen, the Mad Hatter and the rest get to testify unrestrained – even about purported FDA-related fraud and foreign regulations.  Y/Y will overdose the jury with FDA-related fantasy until the supposed “law” bears only passing resemblance to what the FDA actually enforces. All this in a state – Illinois – where the highest court forbids FDCA-based common-law causes of action (see Martin v. Ortho, 661 N.E.2d 352 356-57 (Ill. 1996)) – something that supposedly matters under Lexecon. We haven’t blogged before about this lump of coal in our stockings because it just happened.

4. Forman v. Novartis Pharmaceuticals Corp., 793 F. Supp.2d 598 (E.D.N.Y. 2011). Judicial hubris is bad. Judicial hubris that ignores Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), is worse. Combining the two moves Forman into the #4 slot of our list, ahead of a number of bad appellate cases. As step one, Forman held that New Jersey appellate courts didn’t know what they were doing when those courts applied Buckman preemption to the fraud-on-the-FDA exception of New Jersey’s punitive damages statute. As step two, Forman held that predicating punitive damages on a finding of fraud on the FDA was okay, despite the unanimous Buckman holding that this was a no-no and the likelihood that punitive damages can exceed compensatory damages, and thus raise even more acutely the adverse consequences that underscored the Buckman result. We kvetched about Forman here.

5. Smith v. Bayer, 131 S. Ct. 2368 (2011). The Supreme Court overturned one of our sentimental favorites, In re Bridgestone/Firestone, Inc. Tires Products Liability Litigation, 333 F. 3d 763 (7th Cir. 2003) (Bexis played a part), and held that, because state class action rules (even if verbatim identical to federal Rule 23) might be interpreted differently, federal denial of class certification wasn’t preclusive against the same plaintiff’s lawyers seeking to certify an identical class action in some state court. While we don’t like plaintiffs being allowed a second bite of the apple – and it’s a Supreme Court decision – we only rank Smith #5 because, frankly, the whole problem’s become a bit anachronistic. Smith involved a class action that had lain dormant, hiding in the weeds for many years. In the interim, Congress did a rare intelligent thing and passed the Class Action Fairness Act, which moved most of the class actions we care about into federal court. After CAFA uniform (and tougher) class certification standards make the two-bites-at-the-apple issue much less salient than it had been back in the days of Bridgestone/Firestone. We regretted Smith here.

6. Lefaivre v. KV Pharmaceutical Co., 636 F.3d 935 (8th Cir. 2011).   Lefaivre allowed what amounted to an improper private FDCA-violation claim to survive as a “breach of implied warranty” action. Supposedly, Levine somehow limits Buckman even though not even Levine itself claimed to do that. How Lefaivre could give precedence to a two-justice concurrence (about already adjudicated violations) over the 7-justice Buckman majority, which recognized no such exception, is also mystifying. Topping everything off is blatant confusion (if not outright wrong-headedness) – a unique statement that Buckman was somehow a “field preemption” case. All this is worthy of our #6 spot. It certainly didn’t help matters that the defendant had entered into a consent decree containing damaging statements. Bad facts (if they even qualify as "facts") clearly helped make bad law. We rolled our eyes at Lefaivre here. At least there’s a silver lining, since the case has once again been tossed, this time on compensable loss grounds. See Polk v. KV Pharmaceutical Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011). Redemption anyone?

7. Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa. Super. 2011), is an unfortunate punitive damages (aren’t they all?) decision by an appellate court in a large state. Thus it weighs in (and us down) at #7.  Daniel allowed punitive damages even though the FDA indisputably had never charged the defendant with any relevant regulatory violation. The basis for punitive damages was apparently failure to test – which doesn’t even rate as an independent cause of action in Pennsylvania. Not only that, the plaintiff in Daniel got away with playing “hide the expert,” resulting in the jury hearing the recorded opinion of an expert that the expert later testified he had recanted. Beneath all this was a moot footnote (choice of law not being disputed) that the law of the defendant’s principal place of business (Pennsylvania has no tort reform whatever concerning punitive damages) should control for punitive damages purposes over the law of the plaintiff's state of residence, a distinct minority position. But in the silver lining department, the Pennsylvania Supreme Court has accepted an appeal concerning the punitive damages aspect of the case. See 2011 WL 6034401 (Pa. Dec. 5, 2011). We blogged about Daniel here and here.

8. Murthy v. Abbott Laboratories, 2011 WL 5416333 (S.D. Tex. Nov. 8, 2011). Without citing any law – and contrary to a lot of law it didn’t cite – Murthy announced what amounts to a per se rule that any doctor receiving compensation for participating in a clinical trial involving an investigational drug can’t qualify as a learned intermediary under Texas law (although, of course, both side's experts can be paid much more). Since physician compensation in this situation is routine, Murthy amounts to a blanket exception to the learned intermediary rule for all investigational drug cases. Murthy also stretches – á la Hamilton (2010 bottom ten #4) – to carve out a second exception, for DTC advertised drugs, even though there wasn't any DTC advertising, since the prescriber okayed the information at issue. Except, Hamilton at least was a state court with ostensible authority to change state law. Murthy was a diversity case, without any such pretense, so its adventurous rulings exceeded that court’s power under our federal system, not to mention disregarded contrary Fifth Circuit authority. Sigh. At least this decision goes bye-bye if the Texas Supreme Court reverses Hamilton. We called out Murthy's abuse of judicial power here.

9. Slater v. Hoffmann-LaRoche Inc., 771 F. Supp.2d 524 (E.D. Pa. 2011). One of the things that made Madison County such a notorious hellhole back in the day was how the local federal courts collaborated (probably as much for docket control as anything else) in trapping defendants in state court. We’re starting to see something similar between the Eastern District of Pennsylvania and the current #1 hellhole, Philadelphia (where we happen to be based). To prevent removal of a case from – guess where – Slater held that a publisher could conceivably be sued for the “inadequate” contents of warnings that it printed. The First Amendment implications are obvious, which is why Pennsylvania courts have rejected similar (non-drug/device) claims against book publishers. But Slater ignores Pennsylvania law and holds, on the basis of one distinguishable (brought against a pharmacy, not a publisher) Massachusetts case that maybe, somehow, Pennsylvania law might impose liability on publishers for substantive errors in what they publish. We published our own views on Slater here.

10. Brewer v. SmithKline Beacham Corp., 774 F. Supp.2d 720 (E.D. Pa., Mar. 24, 2011), Patton v. SmithKline Beecham Corp., 2011 WL 6210724 (E.D. Pa. Dec. 14, 2011), and Maldonado v. SmithKline Beecham Corp., 2011 U.S. Dist. Lexis 142578 (E.D. Pa. Dec. 12, 2011). Maybe we’re being too parochial, but here’s another example of a federal court bending (or worse) the law to trap defendants in the Philadelphia hellhole. These three decisions run roughshod over several provisions of Delaware corporate law (supported by the Third Circuit's interpretation) and admittedly deviate from the terms of the Supreme Court’s “nerve center” jurisdictional test – all because "form" supposedly shouldn’t triumph over "substance." Hey, this is corporate law, which is all about form, since corporations are legal fictions to begin with. The result in Brewer, et al., deprives companies with a significant Philly presence of otherwise perfectly legal means of changing residence for purposes of diversity jurisdiction, in effect creating sort of a “product line exception” to corporate law generally.  They also create an incentive for companies to up and leave Pennsylvania altogether. We excoriated Brewer here.

Before we take our much-deserved long, hot shower, for the record we need to mention a couple of truly awful decisions that otherwise would fall through the cracks. Both Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010) (covered here) and Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (covered here and here), were decided in that ten-day window between our 2010 worst decisions post and the end of 2010. Thus, this terrible twosome isn’t really eligible for discredit in 2011, but was timed to avoid censure in 2010. Stevens was adverse in several ways, most notably on the questions of cross-jurisdictional class action tolling and creating a duty to warn treaters not even in the same field as those who prescribed the drug. Bausch – that’s easy – it’s quite simply the worst TwIqbal decision ever, at least from an appellate court. We couldn’t let those two stinkers slouch away unscathed.

We also had to cut a few other candidates: Wright v. Aventis Pastreur, Inc., 14 A.3d 850 (Pa. Super. 2011), was a tour de farce concerning preemption of vaccine design defect claims. Wright added insult to injury, being rushed out while Bruesewitz (see, here) was pending in the United States Supreme Court. Now, with Bruesewitz thoroughly trumping Wright, the latter just wasn’t important enough for the top ten. Ditto for Gaeta v. Perrigo Pharmaceuticals Co., 630 F.3d 1225 (9th Cir. 2011), a bad appellate generic preemption case rendered irrelevant by Mensing. See L. Perrigo Co. v. Gaeta, 132 S. Ct. 497 (2011) (summarily vacating bad decision). And just missing the cut (maybe not if we weren’t from Philly) is Winter v. Novartis Pharmaceuticals Corp., 2011 WL 5008008 (W.D. Mo. Oct. 20, 2011), which allowed a plaintiff to escape what should have been fatal “I didn’t read the warning” prescriber testimony with a Magical Mystery Tour-like argument involving a Dear Doctor letter exquisitely timed to arrive at just the right moment to make some sort of causal difference with the plaintiff's utterly indifferent prescriber.

And thus the torture endeth. Now, only the fun stuff is left. Tune again next week when we celebrate the top ten best drug/device decisions of 2011.

A Short PSA on Knowledge

2011-12-20T16:02:00.000-05:00

Before Cartoon Network, Nickelodeon and the Disney Channel, cartoons were reserved for Saturday mornings. And, if you were a pre-teen boy in the mid-1980s (or are now married to someone who was), you are probably familiar with the G.I. Joe cartoon series. If so, you also probably know that each episode ended with a public service announcement in which Joe quipped: “Now you know and knowing is half the battle.” From that same generation (and still enjoyed by kids today) is Schoolhouse Rock’s “Knowledge is Power.” Or, while not cartoon-based but just to get a little more current, there is NBC’s series of PSA’s entitled “The More You Know” All of these are certainly true in the case of a pharmaceutical failure to warn claim – the prescriber’s knowledge is crucial and if the prescriber knew about the risks, there is no failure to warn.

That’s what a court said last week in Wendell v. Johnson & Johnson, 2011 WL 6291792 (N.D. Cal. Dec. 15, 2011). At issue was the treatment of inflammatory bowel disease with combination therapy of two prescription drugs – one an immunosuppressive drug and the other a TNF inhibitor (anti-tumor necrosis factor drug). Studies had reported incidences of lymphomas in patients being treated with this type of combination therapy. Id. at *2. In addition, a different TNF inhibitor carried a black box warning regarding the development of lymphomas with concomitant use of the two classes of drugs. Id. at *3. Unfortunately, plaintiff was diagnosed with lymphoma and passed away. Id. at *5.

Putting aside the adequacy of the defendants’ warnings, the court focused on causation – did the absence of a warning cause the plaintiff’s injury? Id. at *6. Here it is all about the doctor’s knowledge. 1) Where did he get his knowledge? And, 2) what did he know?

Question 1: The prescriber testified that

[h]e received information on medications from multiple sources, including meetings, other professionals in the field, articles and occasional meetings with drug representatives.

Id. at *1. He also testified “that it was not his regular practice to look at drug labeling.” Id. He looked at labels more often for new drugs or drugs less familiar to him. Id. It was also clear that he relied on medical literature as he was aware of studies regarding the development of lymphomas. Id. at *2. Since this isn’t a case where the causal link was broken because the doctor never read the label or never relied on information from the manufacturer, the court moved onto question 2.

Question 2: The answer was clear – “[The prescriber] knew of the risk of malignancies associated with [combination therapy], but still prescribed the medication.” Id. at *6. In fact, the prescriber in this case, based on his knowledge of the risks, warned his patients of a “nonzero increased risk of serious infections and malignancies related to immunosuppressives and anti-tumor necrosis factor drugs.” Id. at 2.

Giving the benefit of the doubt to plaintiff and assuming that the prescriber read the labeling, the court still granted summary judgment to the defendants because “the physician knew of the risk for which the plaintiff sought a warning” and “no harm could have been caused by failure to warn of a risk already known.” Id. at *6. Given that the doctor’s own knowledge of the risk did not “persuade[] him to cease recommending or prescribing the drug,” the court found there was insufficient evidence that any additional warning suggested by plaintiffs would have altered the physician’s course of treatment. Id.

Finally, it is also worth mentioning the court’s discussion of the prescribing physician’s prescription habits after the incident at issue – a favorite topic of plaintiffs:

Contrary to [plaintiff’s] contention, evidence that [the prescriber] ceased prescribing TNF-blockers in combination with [the immunosuppressive] after [plaintiff] was diagnosed with hepatosplenic lymphoma does not prove that he would have changed his prescription practices based on the warning they suggest. A warning about rare occurrences of hepatosplenic lymphoma associated with therapy combining [these drugs] is bound to have less persuasive power than an instance of the disease affecting a doctor's own patient followed that therapy.

Id. at *7. A good point to keep in mind if plaintiffs try to argue the persuasiveness of the doctor’s post-incident prescribing habits.

So what did we learn from today’s episode? It’s what you know, not where you learned it that counts! Don’t forget to tune into our next episode where Josie and the Pussycats explain why, like TwIqbal, facts do matter.

TV and DDL Guide

2011-12-19T07:30:00.015-05:00

This is the time of the year when critics and pundits come out with their top (and, sometimes, bottom) ten lists. Bexis will soon recite his most and least favorite court decisions of the year, with his usual withering wit and disproportionate enthusiasm. Some writers have already entered the fray on the mass culture front. Our favorite television critic, Alan Sepinwall, made a pretty good case for the best ten television shows of the year. We found ourselves nodding at almost all of Sepinwall’s selections. We also found ourselves thinking of some of the DDL cases we ran across this year. What does that mean? Clearly, we don’t get out enough.

Here are our tv favorites of 2011, along with our sometimes-logical-sometimes-puerile associations with legal rulings we encountered over the past twelve months.

Game of Thrones – HBO gave us a Tolkien-esque fantasy where dynamic leaders formed shifting alliances to topple one another. The character with whom the audience most identified was beheaded near the end of the season, throwing us (at least those of us who hadn’t read George R.R. Martin’s books) for a loop. Peter Dinklage rightly got some Emmy love as a supporting actor. We can’t wait for the next season to begin. There is already a teaser trailer online here. Season One contained plenty of strategy, sex (including yucky incest), and lots of blood. Naturally, when we think of battles in high places, we think of the Supreme Court’s opinion in Mensing, and how it squared with, or was inconsistent with, Levine. We’d like to think that the presumption against preemption, at least in implied preemption cases, is now as dead as King Robert Baratheon, Khal Drogo, and (sob) Ned Stark.

Boss- Kelsey Grammer played the same character, Frasier Crane, for many years across two sitcoms, Cheers and Frasier. In fact, he tied James Arness (Gunsmoke) for longevity. Grammer has also supplied the voice to our favorite Simpsons villain, Sideshow Bob (12 times and counting). Now Grammer goes dramatic, inhabiting the role of Mayor of Chicago, lording over the City of Big Shoulders like a mighty Colossus. Actually, make that a crazy Colossus, because Hizzonor is starting to lose his faculties. The Mayor has been diagnosed with Lewy body dementia. No doubt some enterprising Chicago plaintiff lawyer will take the case and allege that off-label use of some blockbuster drug caused this malady. Boss gives us another reason to tune to the Starz channel, besides seeing ConAir for the fortieth time. Grammer’s character is crazy, brilliant, colorful, and brutal. For some reason, we began thinking of our favorite Chicago judge, who most definitely is not crazy, but certainly is brilliant, colorful, and, yes, sometimes brutal when the level of advocacy is sufficiently execrable.

Community – This offbeat comedy is set in a community college full of crazy doings. The show is endlessly creative, full of meta-humor, and it pretty much never goes where you think it will go. Consequently, it has abysmal ratings and NBC has placed it on hiatus. (This is the same network that revived Fear Factor.) We cannot think of too many cases involving higher (or not-so-high) education, but we did blog about a case loaded up with perfectly ridiculous allegations against a university hospital. In Milton v. Robinson, 131 Conn. App. 760 (Conn. App. 2011), the plaintiff claimed an adverse reaction from her involvement in a clinical trial. The injury was a rash, and the plaintiff appears to have taken the placebo, not the active drug. The plaintiff proffered her husband as an expert witness. And there’s lots more silliness in that case. We have little difficulty imagining Joel McHale, Chevy Chase, Danny Pudi, and the rest of the cast having a sport with that story.

Parks & Recreation – This mockumentary at first looked like a weak sister to The Office, but it’s now the most consistently fine sitcom on the air. Amy Poehler heads up tv’s best ensemble cast about a municipal department dedicated to creating nice places for its citizens to play. We read somewhere that its take on local politics was somehow inspired by The Wire (only the greatest drama in the history of television). That is so hard to believe that we think it simply has to be a joke. But the show offers a lot of texture. All of the characters are vivid. Aziz Ansari barely reels-in his frantic stand-up persona – which is fine by us. Rob Lowe brings his incredible energy and brings the funny. (We have a theory that guest-hosting on Saturday Night Live is a finely calibrated test for real talent. It turns out that Alec Baldwin, Justin Timberlake, and Rob Lowe are vibrant, open performers. The less said about January Jones, the better.) Adam Scott was already a favorite from his appearances on the Doug Loves Movies podcast, and he plays a splendidly sincere and awkward romantic interest in P&R. How does this show remind us of DDL litigation? Here we must stretch. (Okay, this whole post is a self-indulgent stretcharama.) Playing games or sports in the park can lead to painful injuries. What’s better for pain than a nice pain pump? And what’s better for our defense-oriented selves than a pain pump case where the court soundly rejected plaintiff motions in limine? In Musgrave v. Breg, Inc., 2011 U.S. Dist. LEXIS 113661 (S.D. Ohio Oct. 3, 2011), the court issued a series of pretty good rulings on warning, causation, and Daubert. You can revisit our scintillating coverage of that case, complete with wildly inapposite analogies to George Harrison songs, here.

Breaking Bad – For a couple of years we felt outrage that Bryan Cranston (who played the father in Malcolm in the Middle and an overly-sensitive dentist in five episodes of Seinfeld) prevailed over Jon Hamm (Mad Men) for the best actor Emmy. But that was before we started watching Breaking Bad. (By the way, we still think Hamm should have won an Emmy for his remarkable monologue in “The Wheel” episode at the end of Mad Men season One. We dare you to watch this and disagree.) The folks at AMC have a pretty good thing going where they always have the best drama on the air – either Mad Men or Breaking Bad. Last season’s Breaking Bad was transcendent. Gus Fring (played by Giancarlo Esposito) was the best villain on tv. Unless, you want to call Walter White a villain -- and how could you not? After all, this one-time high school teacher has now become a meth dealer, a child poisoner, and “the one who knocks.” We thought of the Synthes criminal sentencing of executives under the Park doctrine, a story that is sad beyond our poor powers of expression.

Boardwalk Empire – It’s a close call whether this HBO drama belongs on the list. The last couple of episodes of Season Two redeemed what had been a so-so string. We admire Steve Buscemi (Reservoir Dogs, The Big Lebowski, and Ghost World), but aren’t sure he’s a lead, or at least the right lead for this show. The character he’s based on really did run Atlantic City in the 20’s, but he was a tall hulking guy whereas Buscemi is diminutive. Still, the show has terrific production values and some wonderful actors. Plus, it’s always great to see Omar from The Wire back in business, even if he’s wearing spats. The show has two weird parallels to the other HBO drama listed here, Game of Thrones: (1) one of the main characters was killed off, reminding us of what an uncertain universe we dwell in, and (2) the penultimate episode had an incest scene that was beautifully filmed, but it made us squirm. Know what else makes us squirm? Litigation in Atlantic City, both this year and in the past. Nuff said.

Homeland – This Showtime drama is the opposite of Boardwalk Empire insofar as the first four or so episodes were tense and unsettling, but it started to become too conventional. A tale of terrorism and turncoats edged into more standard cop procedural territory. We’ve always adored Claire Danes. Mandy Patinkin cuts back on his usual scenery mastication and is an arresting presence. The third main character is played by Damian Lewis, yet another British actor who plays an American so well that it can be a shocker when you hear him speak in his native voice. (Think of Hugh Laurie in House or Dominic West in The Wire.) Lewis was the lead in Band of Brothers, playing the late, great Richard Winters (who, by the way, deserves a Congressional Medal of Honor. Too bad it’ll be posthumous if it comes.) Homeland oozes with paranoia about the bad intentions of certain foreigners, even though some of the prime threats are domestically-grown. We are reminded of the Heparin case where a plaintiff’s lawyer attempted to exploit anti-foreigner animus by proffering an “expert” on Chinese culture.

Modern Family – This is the only one of our top ten shows that might actually reside in the top ten for ratings. We’ve come a long way from I Love Lucy and Leave it to Beaver. We mentioned this show after Ty Burrell uttered our single favorite line of the year about his fists being England Dan and John Ford Coley. The point of the show is that “Modern” does not necessarily mean dysfunctional, at least not where it really matters. Of course, most of us think of our own families as utterly dysfunctional. How many of us geezers reluctantly signed up for Facebook, only to see five wall postings per day from some nephew whom we remember as a sweet little boy, but who now festoons the internet with the most gross, vulgar twaddle? Yikes. Anyway, there have been interesting developments on the discoverability of social media, such as Facebook. We wrote about it here. And, no, it’s none of your business what our “status” is, and we don’t want to help you win Farmville.

Curb Your Enthusiasm – By every right, Larry David’s comedy should have grown stale and tired in its eighth season. (There’s an interesting intersection of this show and legal affairs. Back in 2003, an outtake from Curb showed that a murder suspect was in Dodger Stadium at the time of the killing. Larry David has gone on record that supplying an alibi to an innocent man might be the one swell thing he has done in his life. Not true: putting JB Smoove on tv also counts as a good deed.) This season’s “Palestinian Chicken” episode is on the Mt. Rushmore of comedy. Someone calls out Larry for being a “social assassin” because he has a genius for saying hurtful things that nobody else will dare say, and he seems to get away with it. It’s kind of like the DiCosolo case, which we wrote about here, where the plaintiff’s lawyer somehow got away with a closing argument accusing the defendant of “killing” the decedent out of “corporate greed run amok,” and of mounting a ”frivolous defense.” We found this argument to be, unlike Curb, not the least bit funny.

Louis – Louis CK constantly walks the line between painful revelation and gut-busting comedy. For a couple of years, Louis CK has been called the “comedians’ comedian.” We’re not sure what that means, though we’d love to be called “the defense hacks’ defense hack.” Louis wrote for other comedians, including Chris Rock. Louis wrote and directed Pootie Tang. (What we wouldn’t do to get that credit into our Martindale-Hubbell listing.) (By the way, JB Smoove was in Pootie Tang. Be honest: what other ABA top 100 blawg brings you the inside dope on Pootie Tang?) Louis now seems to be creeping into the wider public consciousness. He guested on an arc on Parks and Recreation a couple of years ago. On his new show on FX (he earlier did Lucky Louie on HBO) Louis plays somebody very like himself, a comedian battling between commerce and principle, raising two cute daughters who are actually raising him. There were great scripts on entertaining troops in Afghanistan and dealing with a suicidal friend. (Louie’s argument against suicide is one of the best we’ve ever heard.) Here is Louie on relationships: "It's hard to really, like, look at somebody and go, hey, maybe something nice will happen.... Or you'll meet the perfect person, who you love infinitely, and you even argue well, and you grow together, and you have children, and then you get old together, and then she's going to die. That's the best-case scenario." There’s so much wisdom in the show, we’d like to share it with our kids. But a key part of Louie’s comedy is the incessant foul language. To be sure, there have been some cases this year about foul language, but they either haven’t been in our area or they haven’t been that interesting. So we’ll instead mention a case of fowl language. In Gonzalez-Servin v. Ford Motor Co., 2011 WL 5924441 (7th Cir. Nov. 23, 2011), the issue was forum non conveniens. The appellant lawyer failed to address controlling case law. Judge Posner likened that lawyer to an ostrich sticking its head in the sand, even supplying helpful photographs. That’s about as close as the F.3d will ever get to slapstick comedy.

We think it was a great year for television. The proliferation of channels has induced the production of shows that are less broad and more nuanced. It’s fine that lots of people like The Big Bang Theory or Two and a Half Men. But it’s better that somewhere in the 500 channel universe there’s room for Louis and Breaking Bad. If you don’t like what you’re watching, you can change the channel.

Would that we could do that with some of the opinions we read this year.

First Amendment Smorgasbord

2011-12-16T13:33:00.000-05:00

While we’re all waiting for the Second Circuit to decide the Caronia case – and, we hope, hold that the FDA’s prohibiting the truthful promotion of off-label use violates the First Amendment – we’d like to pass along some light reading. The current issue of Health Matrix, published by the Case Western Reserve Law School, is mostly a symposium on commercial speech and public health. It contains six articles that provide a variety of viewpoints on the First Amendment and health-related communications generally, and off-label use in particular.

Here are some brief descriptions to whet your appetite:

Beales, “Health Related Claims, the Market for Information, & the First Amendment,” 21 Health Matrix 7 (2011). A former FTC consumer regulator, argues for surprising limited regulation of commercial speech. More information is better than less, and regulation should be viewed skeptically lest it backfire.
Noah, “Truth or Consequences?: Commercial Free Speech vs. Public Health Promotion (at the FDA),” 21 Health Matrix 31 (2011). We could read Lars Noah all day on any number of topics (his recent article on Conte liability is a gem). Well, here’s sixty more pages. He thinks the FDA’s on the path to perdition, and that regulation of off-label promotion needs to be a lot more nuanced than the Agency’s current meat axe approach.
Gilhooley, “Commercial Speech, Drugs, Promotion & A Tailored Advertisement Moratorium,” 21 Health Matrix 97 (2011). She doesn’t like DTC advertising, so she would be happy to see Congress shut it down. Back-handedly, she seems to admit that she has a lousy legal hand at the moment, so she wants the Court to back away from its decision in Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
Masoudi & Pruitt, “The Food & Drug Administration v. The First Amendment: A Survey of Recent FDA Enforcement,” 21 Health Matrix 111 (2011). Masoudi worked in the belly of the beast, but seems to have thought better of it. The article posits that the FDA’s enforcement posture is both substantively unconstitutional and chills free speech. It takes one to know one.
Conko, “Hidden Truth: The Perils and Protection of Off-Label Drug & Medical Device Promotion,” 21 Health Matrix 149 (2011). This one’s probably closest to our views, since it: (a) recognizes the health benefits of off-label use and (b) emphasizes less restrictive alternatives to the FDA’s flat ban.
Yosifon, “Discourse Norms as Default Rules: Structuring Corporate Speech to Multiple Stakeholders,” 21 Health Matrix 189 (2011). The other side will like this, since he views corporate speech as a “problem,” and somehow consumers become “stakeholders” just by existing. This view can’t really be reconciled with the last 30 years of First Amendment jurisprudence, so Yosifon doesn’t much bother to try.

Enjoy.

New Stuff #3

2011-12-15T15:28:00.000-05:00

We can’t say much about it because we’re involved in the metoclopramide litigation, but those of you involved in product liability suits involving generic drugs will want to review Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011), for the following propositions:

(1) Warning-related claims involving generic drugs are preempted under Mensing, no matter what a plaintiff calls them. Fullington, 2011 WL 6153608, at *4-5.

(2) Manufacturing defect claims can’t be pleaded under TwIqbal without pleading either an act of manufacturing or defect. Id. at *5.

(3) Design defect claims can’t be pleaded under TwIqbal without pleading either an act of designing or defect. Id. at *5.

(4) Plaintiffs may not escape preemption by arguing that a generic drug should have been removed from the market altogether. Id. at *6.

(5) Nothing in Mensing did (or could) change state law that product-related claims only lie against the manufacturer of the product that the plaintiff actually used. Id. at *6.

Thanks to Kurt Karst at the FDA Law Blog for passing this decision along.

New Stuff #2

2011-12-15T13:17:00.000-05:00

Our continuing interest in removal/remand strategies for extricating our clients from state-court hellholes comes as no surprise to anyone who’s been following our blog for any length of time. In particular, we’ve advocated and (we flatter ourselves) helped to popularize the technique of pre-service removal – see our most recent prior post here.

Basically, pre-service removal eliminates a loophole in the federal removal statute that allows plaintiffs to keep cases in which diversity of citizenship indisputably exists in state court through the device of suing an in-state defendant - if that defendant has been "properly joined and served." Pre-service removal eliminates this “forum defendant” loophole by removing the action to federal court before the plaintiff has sued the in-state defendant (or, indeed, has served anybody at all).

We’re pleased to pass along a new win on this issue in New Jersey, which is pretty much the pre-service removal “ground zero,” given the number of pharmaceutical manufacturers with the misfortune of being headquartered in this notoriously pro-plaintiff jurisdiction. The case is Poznanovich v. AstraZeneca Pharmaceuticals LP, No. 3:11-cv-04001-JAP-TJB, slip op. (D.N.J. Dec. 12, 2011).

Poznanovich is a Nexium case where the plaintiff – an Illinois resident attracted by New Jersey’s pro-plaintiff reputation – chose to sue in New Jersey state court. Two named defendants, AstraZeneca LP and KBI Sub Inc., were allegedly New Jersey citizens, but the other defendants managed to remove the case before either of those defendants was served with process.

The recurring question on remand (before the Honorable Joel Pisano) was the usual – does the court follow the express language of the removal statute, 28 U.S.C. §1441(b), which predicates the forum defendant loophole on that defendant being “properly joined and served”? Go with the plain meaning of the statutory text and the removal is proper. Make up some speculation that the plain text leads to some “absurd” result (why isn’t the forum defendant rule itself “absurd” in the 21st Century?) and a court can find a way to remand.

Poznanovich fortunately was willing to give Congress credit for meaning what it said. Finding (quite properly) that precedent on this issue was “split” (without any binding appellate authority), slip op. at 3, the court chose to adopt the majority view of the New Jersey federal courts and denied remand.

[T]he Court concludes that the weight of the authority and better reasoning supports denial of Plaintiff’s motion to remand. The Court finds that the language of the statute is plain, and, thus, adherence to the plain language is required. . . . Here, Congress expressly used the phrase “properly joined and served,” and this Court should not adopt an interpretation of the statute which renders the “and served” language superfluous. Under the unambiguous language of the statute, the presence of an unserved forum defendant does not prohibit removal by a non-forum defendant in cases where complete diversity exists.

Slip op. at 8.

The court also disposed of some subsidiary red herring arguments. The first – whether the forum defendant itself could remove before service – went by the boards because the moving party wasn’t, in fact, a forum defendant. A partnership’s citizenship is determined solely by the citizenship of that partnership’s members, and is not affected by anyone with whom the partnership may later decide to form other partnerships. Poznanovich, slip op. at 3-4. Here, the plaintiff’s overpleading, suing a bunch of unnecessary peripheral entities, came back to bite him, since one of those peripheral entities was able to remove as a non-forum defendant.

Second, the plaintiff argued that removal simply could not occur in the absence of formal service. The court correctly perceived that argument as garbage. Need not does not equal must not. Supreme Court precedent (Murphy Brothers, Inc. v. Michetti Pipe Stringing, Inc., 526 U.S. 344 (1999)), that defendants need not respond to unserved complaints, does not disable defendants from responding if they so choose:

That decision [Murphy], however, did not hold that formal service is a prerequisite for removal. Indeed, a party is free to waive service of process. . . . [C]ourts appear to routinely hold that formal service is not a prerequisite to removal.

Poznanovich, slip op. at 9-10 (citations omitted).

Third, plaintiff’s invoking the unanimity requirement was a smoke screen, because unserved defendants need not consent to removal. Id. at 10.

Last and least, the subject matter jurisdiction of the court was not dependent upon prior service of process. Since the state court had jurisdiction over the action from its inception, removal conferred the same jurisdiction on the federal court. Id. at 10-11.

Anyway, Poznanovich confirms what we already thought – that the “plain meaning” approach has by far the better side of the argument. The “absurdity” approach is just judicial nullification, pure and simple. There’s no constitutional issue here, so if Congress thinks the law is being misapplied, it can always change the statute. As Poznanovich points out, the majority rule commands majority support for good reason.

Congrats to Amy Fisher at Ice Miller for emerging victorious, and further thanks for passing the decision along to us.

New Stuff #1

2011-12-15T12:28:00.000-05:00

An anonymous friend of the blog recently passed along an unusual MDL order, along with the question had we ever seen anything like it? The order (copy here) denies an uncontested motion to designate 34 cases as tagalongs in the Aredia/Zometa MDL. As the order reflects, the 34 plaintiffs had sought tagalong status, and the defendant joined in the motion.

Nonetheless the J.P.M.D.L. (Judicial Panel on Multidistrict Litigation, for those of you unfamiliar with the nomenclature) denied transfer. The Panel found that transfer was “not necessary to achieve the just and efficient conduct of the litigation.” A/Z Order at para. 2. Apparently the Panel had had some discussions and determined not to approve anymore tagalongs. Id. (“[e]arlier this year the Panel determined that conditionally transferring actions to MDL No. 1760 would not serve the purposes of [MDL transfer]”). These discussions must have been internal and without notice to anyone, because neither the plaintiffs nor the defendants evidently knew about this prior determination. We suspect (and hope), however, that the Panel consulted with Judge Campbell, the MDL judge for Aredia/Zometa.

Here are the reasons for denial of transfer, as stated by the panel:

Common discovery has been completed in the centralized proceedings, and the transferee court has issued rulings on general causation. The remaining issues in the cases in the transferee court appear to be case-specific, and the transferee court has been suggesting remand of waves of individual cases once briefing on motions has been completed. . . . The parties also have not addressed why they cannot avail themselves of the documents and depositions accumulated [in] MDL No. 1760 while the cases move forward in their respective courts.

A/Z Order at paras. 2-4.

The closest thing we’ve seen to what happened in Aredia/Zometa occurred in our Seroquel MDL. In Seroquel, the plaintiffs successfully opposed a tagalong motion that we filed, getting an earlier order vacated. They argued that everything was on the verge of being remanded anyway. The Panel agreed:

Multidistrict litigation is not static. . . . Over the course of time, the relative merits of transferring additional cases can change as the transferee court completes its primary tasks. The point of diminishing benefit in tag-along transfers is never absolutely clear. After a certain point, however, the benefits of transfer should not be assumed to continue. This is a concern which, in close consultation with transferee judges, we intend to give closer attention.

Seroquel Order at paras. 2-3.

Maybe Aredia/Zometa is an example of this “closer attention.” Still, neither we, nor even our blogger emeritus Mark Herrmann (to whom the minutiæ of MDL practice is almost a hobby) had ever seen an MDL order cutting off tagalongs sua sponte while the MDL is still in litigation. In Bone Screw, for example, Judge Bechtle continued to accept tagalongs right up until the eventual settlement, even after literally hundreds of cases were remanded.

We wonder whether these orders reflects some sort of emerging view by the Panel as to what is the proper scope of an MDL proceeding. Is it merely for so-called “common discovery” – disproportionately burdening defendants – and “general causation” rulings? We hope not. Otherwise MDLs degenerate into exercises in using one-sided discovery expense as a weapon to force settlement.

In Bone Screw Judge Bechtle chose to conduct a fair amount of what the Panel might view as “individual case discovery” – especially: (1) requiring a case-specific general causation expert in each case, and (2) deposing all plaintiffs’ treating physicians. We found that kind of centralization made for significant efficiencies – for example, with well over 500 prescribers to depose, attorneys on the defense side (and we assume on the other side as well) got pretty well versed in the specific issues those depositions raised.

Other judges of course do things differently. There aren’t many judges as “hands on” as Judge Bechtle was in his MDLs. We’d like to think that the Panel is not strait-jacketing the MDL transferree judges into any particular vision of what is, and what isn’t, appropriate for MDL practice. That’s why we hope that what was going on behind the scenes in Aredia/Zometa was nothing more than “close consultation” – Judge Campbell letting the Panel know that “I’m remanding cases, please don’t send me any more.”

OTC Drug Plaintiff Fit To Be Fryed In New York

2011-12-14T12:26:00.000-05:00

Just when we’re disgruntledly packing away our “Fry Mumia” buttons for the last time (guilty as sin, that one was), we get word from New York that the plaintiff in one of Dechert’s Tylenol cases lost a Frye-based appeal. Unfortunately, because Ratner v. McNeil-PPC, Inc., ___ N.Y.S.2d ___, 2011 WL 5865657 (N.Y.A.D. Nov. 22, 2011), is one of our cases, we can’t supersize this post. But we can give you an outline of what happened.

First, Ratner is an example of the philosophy behind this blog – that a defense win anywhere helps defendants everywhere. A few years ago we (well, Bexis) participated in an amicus brief filed by the Product Liability Advisory Council, Inc. (“PLAC”) in a case called Parker v. Mobil Oil. That appeal turned out well, producing an excellent Frye-based expert opinion – Parker v Mobil Oil Corp., 857 N.E.2d 1114 (N.Y. 2006). Parker, in turn became the foundation for the recent win in Ratner.

So what happened?

Ratner involved a drug containing acetaminophen. Massive overdoses of this drug can cause liver failure, which is not disputed. Ratner, however, did not involve any sort of overdose – plaintiff claimed only routine, therapeutic doses of the drug, significantly expanding the scope of liability, if allowed . Fortunately, the trial court found no valid scientific basis for the claim and granted summary judgment. In Ratner, the Appellate Division affirmed, holding that none of the plaintiffs’ four experts had scientifically valid causation opinions.

The key issue in Ratner was not any particular test or technique used by the plaintiffs’ experts, but rather whether those tests could even be applied, given a fundamental lack of underlying scientific evidence. The court recognized this hurdle as a “separate inquiry” not tied to novelty:

[W]here there is no novel or innovative science involved, or where the tendered scientific deduction has been deemed generally accepted as reliable, there remains a separate inquiry applied to all evidence. This inquiry is “whether there is a proper foundation – to determine whether the accepted methods were appropriately employed in a particular case.”

Ratner, 2011 WL 5865657, at *7 (quoting Parker). The plaintiff’s “novel theory of cauastion” – “that therapeutic acetaminophen use caused the plaintiff's liver cirrhosis” – not any particular methodology, was at issue. Id. at *8

The plaintiff’s experts claimed to be relying on “extrapolation” from the known hepatic risks of the drug in overdose situations. Id. The court held that there was nothing from which to extrapolate. Absent adequate underlying data, the claimed “extrapolation” was simply an expert’s “ipse dixit.” Ratner, 2011 WL 5865657, at *9. All the plaintiff really offered was a pair of widely separated case reports of people who, after taking the drug in therapeutic quantities, later suffered liver trouble. That was not enough:

[O]bservational studies or case reports are not generally accepted in the scientific community on questions of causation. . . . [T]he two aforementioned case studies relied upon by the plaintiff constitute merely observational data which are of a lesser caliber than controlled clinical studies from which results can be reviewed and verified.

Id. at *10.

Not only were case studies inherently insufficient, but these (even for case studies) were pretty weak. For one thing, their authors did not reach causation conclusions. “The two studies merely hypothesized that the liver injuries sustained by the patients therein were related to ingestion of therapeutic doses of acetaminophen and that further study was warranted.” Id. Or, as another author:

state[d] that the clinical importance . . . was unclear, and the authors of the study did not interpret the finding . . . to be indicative of serious liver injury.

Id. at *10. Thus, the plaintiff’s experts were attempting to draw conclusions from purported bases of their opinions that went well beyond what those initial authors felt was justified.

And more. Because acetaminophen had been around for a long time, there were plenty of (and much better) contrary data – “thousands of journal articles” – that “acetaminophen is safe in therapeutic doses, even for individuals suffering from liver disease." Ratner, 2011 WL 5865657, at *10.

Since the plaintiffs’ experts’ opinions were: (1) based upon minimal and comparatively weak data, (2) that was contradicted by large amounts of more powerful data, and (3) went beyond the conclusions that even the reporters of that weak data felt was justified, those opinions were “fundamentally speculative.” Id. at *11. Thus, the trial court had properly excluded those opinions and entered summary judgment:

[W]hen an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community. Here, the plaintiff failed to meet that burden.

Id.

New Important Appeal Grant in Pennsylvania

2011-12-13T10:49:00.000-05:00

We can't discuss the substance, because Dechert's involved, but recently, the Pennsylvania Supreme Court accepted an appeal in a prescription drug product liability case, Daniel M. v. Wyeth Pharmaceuticals, Inc., (order here) to decide the following issue:

Whether the Superior Court erred in reversing the trial court’s grant of JNOV for [defendant] on [Respondents’] punitive damages claim under Pennsylvania law, where (a) the FDA extensively reviewed and approved the prescription drug at issue, the sufficiency of the testing for that drug, and the drug’s label warnings of the risk of breast cancer, (b) there was no evidence that [defendant] concealed information from or misled the FDA or knew that the risk of breast cancer was greater than disclosed in its warnings, and (c) the drug was extensively tested and studied by [defendant] and independent researchers?

Throw Enough Mud at the Wall and Some of it Will Stick

2011-12-13T10:32:00.000-05:00

We could have gone with “if at first you don’t succeed, try, try again.” Or, Dory’s famous “Just keep swimming” from Disney’s Finding Nemo. But, when talking about plaintiffs, slinging mud just feels more appropriate (to us). And, I guess somewhere in here is a backhanded compliment about being persistent, but really we would describe our children as “persistent” when they ask for the 20^th time to go see the latest Disney movie – and it wouldn’t be a compliment. In fact, under our breath you’d probably catch a few words we wouldn’t want our children to hear. Since our message here isn’t for impressionable children but rather hardened plaintiffs’ counsel – we’ll shout it right out: YOU CAN’T BRING A *&$%#%& CLAIM FOR FRAUD ON THE FDA. Phew, that felt good.

In a much more diplomatic and reserved fashion, that is what the court said in Pontious v. Medtronic, 2011 U.S. Dist. Lexis 140717 (D. Kan. Dec. 7, 2011). Plaintiff attempted to bring her fraud-on-the-FDA claim as a consumer fraud action alleging that “[d]efendants violated the KCPA . . . when they willfully failed and refused to timely report information . . . as required by 21 C.F.R. § 805.50(a).” Id. at *5-6. The court quickly concluded that

Here, as in Buckman, the federal regulation is critical to plaintiff's state-law claim. . . . Claims that a defendant failed to make a report to the FDA as required by the [MDA] are among those that are preempted and cannot give rise to a state law cause of action.

Id. at *6-7 (citations omitted). Like putting lipstick on a pig, it doesn’t matter if you dress it up as strict liability, negligence, misrepresentation, or consumer fraud – state law claims for alleged failure to provide information to the FDA are preempted under Buckman. End of story.

Well, it wasn’t quite the end of this story. Having not succeeded and wanting to keep swimming, plaintiff decided to throw a little mud. While the court granted defendant’s motion to dismiss, it also granted plaintiff’s motion to amend her complaint. Plaintiff’s new consumer fraud claim alleges “that defendants designed, manufactured, marketed, distributed, and/or sold a defective product; and . . .that defendants violated the KCPA by willfully marketing and/or selling that defective product.” Id. at *10. Because the claim now focuses on alleged misrepresentations to consumers rather than to the FDA, the court found the new claim not preempted under Buckman. Id. Although not willing to toss out the amended complaint, the court did recognize that it was “short on facts” supporting plaintiff’s consumer fraud claim and acknowledged that the claim might still be preempted “to the extent that any misrepresentation was based on a failure to comply with the FDA’s regulatory standards.” Id. at *11. The court just wasn’t quite ready to go there yet.

So, while it is clear to us that the fat lady has sung on fraud-on-the-FDA claims, this plaintiff, at least, has lived to fight another day.

A View from the Bench on MDLs

2011-12-12T08:18:00.003-05:00

Last week we attended ACI’s Annual Drug and Medical Device Litigation Conference. As always, it was nice to be in New York City during the holiday season (though the persistent drizzle was less than festive) and even nicer to see so many friends.

The presentations were quite good and up-to-date. The Mensing discussion was especially enlightening. As usual, we were most eager for the judicial panel, and it did not disappoint. In fact, it was so good, we’re calling it an early Christmas gift.

The topic for the judges was recent MDL litigation. Judges Cogen, Cote, Herndon, Montgomery, and Waxse were all engaging and thoughtful. Here are a few of the highlights:

• The judges realize that there is virtually no agreement as to how much a transferee judge must accomplish prior to remand. (Well, maybe we already knew that).

• There are also a variety of approaches to selecting bellwether trials. Permitting the parties to select their strongest cases, even with vetoes, does not ensure trials of representative cases. And if they’re not representative, where’s the value for settlement? One judge tells each party to proffer cases along with arguments for why they are truly representative. He then chooses the most representative case. Like baseball arbitration, it builds in an incentive for each party to be reasonable.

• As that old Barbie doll said, “Math is hard.” So is science. But all the judges believe that Daubert forces judges to act as real gatekeepers. Consequently, judges – with plenty of help from the parties, lawyers, and experts – must do the homework to keep junk science away from the jury. It was pretty clear that all of the judges on the panel were hard workers and quick studies, and that they would not be the least bit shy to police expert evidence.

• It’s no surprise that all the judges dislike discovery disputes. What is a surprise is the array of creative techniques the judges use to resolve or curtail these disputes. Our favorite? Ordering the parties to videotape a follow-up meet-and-confer session. If the dispute isn’t resolved, the parties must send the tape to the judge. Guess what? Not a single tape has yet arrived.

• Fed.R.Civ.P. 26 has a couple of subsections that lawyers might want to read again (or, maybe, read for the first time). Here is what Rule 26(b)(2)(C) provides:

On motion or on its own, the court must limit the frequency or extent of discovery otherwise allowed by these rules or by local rule if it determines that:

(i) the discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive;
(ii) the party seeking discovery has had ample opportunity to obtain the information by discovery in the action; or
(iii) the burden or expense of the proposed discovery outweighs its likely benefit, considering the needs of the case, the amount in controversy, the parties’ resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues.

Thus, either in considering a party’s motion, or on its own, a court must limit discovery that isn’t worth the effort or expense. Proportionality matters. Wow. That’s an issue with most of the discovery we see. And here’s the kicker: Rule 26(g)(1)(B) requires lawyers to sign discovery requests and responses certifying that either they are complying with the discovery rules (including 26(b)(2)(C), and that what they are doing is

(iii) neither unreasonable nor unduly burdensome or expensive, considering the needs of the case, prior discovery in the case, the amount in controversy, and the importance of the issues at stake in the action.

If a certification violates Rule 26, the court “must impose an appropriate sanction on the signer, the party on whose behalf the signer was acting, or both.” Fed.R.Civ.P. 26(g)(3). It’s like a Rule 11 for discovery. One judge said that pretty much every discovery request and response he’s seen violates 26(b)(2)(C) and could conceivably warrant sanctions.

Take a look at the Notes to these provisions. Maybe courts seldom invoke these provisions, halt disproportionate discovery, and impose sanctions, but it’s clear that active judicial involvement was contemplated. For our part, we’re happy to have a judge engage in that proportionality analysis. We’re even happier when it’s done by judges who are smart, fair, and conscientious. Based on what we saw last week, we’re optimistic.

• We’re not sure this last point is the most significant in terms of jurisprudence, but it produced the single most lasting image from the conference. One judge said that looking through the activities in an MDL can be like going through the refrigerator, opening up Tupperware containers, and gaping in puzzlement and/or horror at the goodies within. Yeah – we’ve been there, both actually and metaphorically.

Latest Generic Preemption Decision

2011-12-09T15:18:00.000-05:00

Those of you who check our post-Mensing generic preemption scorecard regularly are aware that a preemption massacre has been going on in Louisiana federal court. By our count, just since October there have been eight preemption-related dismissals down in pelican country (don’t blame us, y’all put it on your license plate). Most of them have been pretty cut and dried, but the recent decision in Whitener, v. PLIVA, Inc., 2011 WL 6056546 (E.D. La. Dec. 6, 2011), warrants special mention.

In Whitener the plaintiffs made three arguments against preemption. The court rejected two and told plaintiffs to replead if they wanted to pursue the third. The first argument played off a footnote in Mensing, 131 S.Ct. at 2574 n.1, that the Court “express[ed] no view on the impact of the 2007 [FDAAA].” Plaintiffs claimed that, since their use of the drug was after FDAAA was passed, Mensing didn’t apply. Okay, but so what? The plaintiff couldn't say. It was a distinction without a difference. The court found absolutely nothing FDAAA that altered the Food, Drug and Cosmetic Act (“FDCA”) in any relevant way:

Plaintiffs have not articulated, and the Court cannot find, any changes in the FDAAA to a generic drug manufacturer's ability to alter the FDA-approved brand-name label for a drug.

Whitener, 2011 WL 6056546, at *3. Because the FDAAA didn’t change anything, Mensing preemption didn’t change either. “ In the absence of any such change . . . , compliance with both state and federal requirements remains impossible.” Id.

Plaintiffs next tried to argue that, because their use of the drug had been off-label, that somehow allowed them to demand different warnings. The court found the argument peculiar because regardless of the nature of the actual use, the label was the label:

There was an FDA-approved label without which Defendants could not have sold [the drug]. Defendants had no choice but to use that label and could not say more in warning, just as the generic manufacturers in Mensing could not. Thus, the fact that a doctor prescribed [the drug off-label] does not distinguish this case from Mensing. Defendants were bound by federal law to use the FDA-approved label and could not provide the additional warnings Plaintiffs allege should have been given. Plaintiffs' failure-to-warn claims are preempted.

Whitener, 2011 WL 6056546, at *4.

Beyond that plaintiffs in Whitener muttered darkly about “illegal” off-label promotion. The court told them that, if they wanted to make any argument on that ground, plaintiffs had better state explicitly who made what statements to whom, and how they were purportedly illegal under the FDCA. Id. at *5.

Thus the court did not pass on the legal viability of a supposed parallel violation claim in the Mensing implied preemption context. In that vein we simply note that the concept of “parallel” violations arose as an exception to the “different from, or in addition to” express preemption language in the Medical Device Amendments. It really should have nothing to do with the implied preemption analysis of Mensing, which deals with conflict, and not with comparing federal and state legal duties. See Guarino v. Wyeth LLC, ___ F. Supp.2d ___, 2011 WL 5358709, at *3 (M.D. Fla. Nov. 7, 2011).

Thanks to Kurt Karst at the FDA law blog for the tip.

On Self Promotion

2011-12-08T13:22:00.003-05:00

Yesterday we blogged about co-promotion, an obscure topic if ever there was one. Today we’re blogging about promotion that's considerably less obscure – self promotion. We’re not all that much into self-promotion here on the Drug And Device Law Blog, and before you start throwing things and telling us we’re a pack of blogging liars, try this. Go look for a link to our law firm’s (that would be Dechert LLP) website on this page. You won’t find it. It’s not there. We provide you with our personal pages (so you know who we are, or at least who we want you to think we are) and professional emails (so you can contact us), but that’s it. So it’s not like we’re being total hypocrites here.

We continue this blog for the same reason we started it. That’s to provide up-to-date information and commentary useful to those who, like us, defend pharmaceutical and medical device companies (also vaccines) in product liability litigation, either in law firms or in-house legal departments. We have strong views on practically all aspects of this subject – we’ve written books and articles – and our big-firm platform allows us the relative luxury of keeping current on a plethora of legal issues, from preemption to ediscovery. We firmly believe that a rising tide lifts all boats, that is, that defense wins anywhere help other defendants (like our clients) win everywhere.

That’s why we blog, so the defense lawyer on the front line in Augusta, Georgia or Spokane, Washington can get real-time access to new decisions (and what they mean) and tactical innovations (such as removal techniques) being pursued by us white-shoes up in our air conditioned skyscrapers. All we ask in return is that you folks in the field let us know when you’ve won something so we can report it (with full attribution, of course) to everybody else. Our soapbox is, and always has been, pointed squarely towards our colleagues in the defense bar and the in-house people who supervise us.

So to that extent we’re self-promoters. We believe we have something to say that others who do what we do will find worthwhile. Big deal. We share that view with everybody else who’s ever blogged.

But that’s it. It goes no further. You won’t find bells and whistles, ads, or any sort of fancy graphics here – only content; we try to post something every business day. We didn’t start blogging with the expectation that we were going to be quoted in the press, or in law review articles, or that we would be requested to give speeches and the like. That’s all happened, but from day one we’ve said that the availability of such opportunities is what has most surprised us as a consequence of creating a successful blog.

And something else goes along with successful blogging.

Badges.

The more blogs there are, and the more legal blogs (“blawgs”), the more other folks out there want to take advantage of the new media’s popularity for their own purposes. One way these non-bloggers do that is to “rank” us bloggers. Technorati’s been doing that sort of thing for years, although their rankings are so opaque we’ve never really understood them. But who mentions that? Technorati needs to start handing out badges.

In the last couple of weeks we’ve been informed, first, that according to Lexis-Nexis, this blog is one of the top 25 tort law blogs in the country. It’s an honor we share with some other blogs we link to, such as Abnormal Use, FDA Law Blog, Mass Tort Defense, Pharmalot, and Tort Talk. We also find some of our favorite advocates from the other side on the list: Litigation and Trial and the NY Personal Injury Law Blog.

About a week later, we’re also informed that the legal gods of the ABA have anointed our blog as one of the best 100 law blogs in the whole country. Wow! We share that list with some true heavyweights, like AboveTheLaw, SCOTUS Blog, and The Volokh Conspiracy. We look at those puppies, and we figure there’s a little more going on than a few guys commenting on cases when they have a spare moment. Some (lucky?) folks must do legal blogging full time. Seriously, though, we are flattered; it’s the fourth consecutive year we’ve been on the ABA’s list.

However, there’s more to these awards than the pretty badges (we’re sure our tech guys will figure out how to get the ABA’s latest up). We’re supposed to get you – our faithful readers – to vote for us for this or that. For the ABA, it’s vote for the number one blawg in twelve different categories. For Lexis/Nexis it’s name the best tort blog of all.

Anyway, if you want to vote for us, we thank you. We've just given you the links.

Bexis voted, and since he refuses to vote for himself, he went with SCOTUS blog (among others) on the ABA site, and the FDA Law Blog on Lexis/Nexis. Then again, Bexis is an old stick-in-the-mud about this sort of thing. He doesn’t even like fan voting for the all star game (only one such game warrants the article “the”). Remember what happened in 1957.

So if you don’t want to vote, that’s fine, too. It’s all a bunch of log rolling. Indeed, some of our friends on the plaintiff side, more accustomed to pejorative language, would probably call it a Google-ranking scam or at least blatant cyber-hucksterism. Essentially, in return for the privilege of festooning our site with badges, we’re supposed to write posts like these to drive traffic (you guys, our readers) to their sites. Lexis/Nexis is even worse – in order to vote, you have to register for its “communities” – and they ask us to link to them.

You’ll find that link right next to the link to our firm’s webpage, folks.

We’re not terribly comfortable with unpaid shilling for anybody, so this implicit – and sometimes explicit – quid pro quo arrangement leaves us feeling a little queasy. Not to mention, the expectation of mutual back scratching takes some of the fun out of winning this sort of recognition.

Anyway, we don’t want to take up more of your valuable time on a subject that, at the end of the day, is neither here nor there when it comes to what this blog is trying to accomplish. On this subject (and probably only this subject) we’re content to let the other side of the “v.” have the last word. Bloggers Max Kennerly and Eric Turkewitz have more choice things to say about badges for law bloggers, if you’re interested.

Co-Promoter Liability

2011-12-07T14:32:00.000-05:00

“Co-promotion,” for those not familiar with the term, is a contractual arrangement between two drug companies. The details will differ, but basically one company has a drug but not enough sales people. The second company – the co-promoter – has a larger (or in some other way better situated) sales force, and no competing drug. By signing a co-promotion agreement, the second company (for compensation, of course) puts its sales force to work stirring up interest in - that is, promoting - the other company’s drug.

Such arrangements are fairly frequent in the pharmaceutical business (less so with devices), so we thought we’d take a look at co-promoter liability – that is, whether there’s any support for the independent liability of the non-manufacturing co-promoter. We’re not looking at the other party’s (the manufacturer’s) liability, since that would be determined primarily by the law of agency as applied in a standard product liability case.

We’re interested in the liability of the non-manufacturing co-promoter precisely because that entity isn’t going to be a “manufacturer” or a “seller” of the product for purposes of black letter product liability law. Co-promoters typically do not manufacture, sell, or supply the drugs they promote. They likewise don’t usually have design, clinical research, or FDA regulatory roles with respect to the product. See Steadfast Insurance Co. v. Purdue Frederick Co., 2004 WL 2166258, at *5 (Conn. Super. Sept. 1, 2004) (describing role of pharmaceutical co-promoter).

We wanted to see what sort of claims had succeeded against co-promoters. We thought it would make a good post. We’ve been disappointed. We searched high and low, and we couldn’t find a single case where any claim, under any theory, had succeeded against any defendant sued as a co-promoter of a drug.

None.

But that’s not for want of trying.

We’ve found that, because they’re not product manufacturers or sellers, the usual product liability claims don’t lie against co-promoters. Lopienski v. Centocor, Inc., 2008 WL 2565065, at *4 (D.N.J. June 25, 2008) (no claim under New Jersey product liability statute); Yurcic v. Purdue Pharma, L.P., 343 F. Supp.2d 386, 397 (M.D. Pa. 2004) (warranty claims fail). We can't say we're surprised at that; it's why we started writing this post in the first place.

Also, while it seems sort of obvious, in order to make any kind of claim at all against an alleged co-promoter, there needs to be evidence that the defendant actually entered into such an agreement. See In re Diet Drugs, 2004 WL 1824357, at *6 (E.D. Pa. Aug. 12, 2004) (not even a “colorable” claim where plaintiff’s only evidence was an unsigned “draft” contract) (applying Florida law).

And a third thing’s pretty clear. Since promotional activity is a co-promoter’s only tie to a plaintiff, where there wasn’t any promotion directed towards the plaintiff’s prescribing doctor(s), there’s no claim. Koenig v. Purdue Pharma Co., 435 F. Supp.2d 551, 554 (N.D. Tex. 2006) (promotion only after the prescriptions in question); Timmons v. Purdue Pharma Co., 2006 WL 263602, at *5 & n.9 (M.D. Fla. Feb. 2, 2006) (no promotion); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 709 (E.D. Ky. 2003) (promotion only after the prescriptions in question); Ewing v. Purdue Pharma, L.P., 2003 WL 1883475, at *2 (W.D. Va. April 10, 2003) (no promotion); Allen v. Purdue Pharma, L.P., 2002 WL 32726841, at *1 (W. Va. Cir. June 26, 2002) (same). For some reason, it was the Oxy-C cases that litigated this.

That’s all we know. We wish it were more, but we haven’t seen any co-promoter cases that have gotten past these obstacles. If anyone has anything to add, we’re all ears.

The Number of the Beast

2011-12-07T09:48:00.000-05:00

We recently noticed that there are finally official United States Reports page numbers for Wyeth v. Levine. That means that the days of citing the Supreme Court reporter for Levine are now over. Thus, the Levine decision may now be cited like any other Supreme Court case:

Wyeth v. Levine, 555 U.S. 555 (2009).

Two New PMA Preemption Cases

2011-12-06T16:59:00.000-05:00

You all know we love preemption. So, when two favorable medical device preemption decisions are entered on the same day, well that’s a two-fer we can’t wait to blog about. In both cases, plaintiffs tried to plead and argue their way around PMA preemption – unsuccessfully. Here is the spin plaintiffs tried and why it didn’t work.

Bentzley v. Medtronic, Inc., 2011 U.S. Dist. Lexis 136570 (E.D. Pa. Nov. 28, 2011): This one involves an insulin and glucose monitoring system. The system includes a sensor/transmitter and a pump that work together to monitor the patient’s glucose levels and administer insulin automatically and continuously. Id. at *2. Plaintiff alleged that his system malfunctioned and failed to administer the correct dosage of insulin and the reason for the malfunction was that it was exposed to high-strength electromagnetic fields during his employment. Id. at *7-8. This is a known risk with this particular system and one that prompted a Class 2 Recall a year before the system was implanted in plaintiff, including the addition of warning information in the systems shipped to new customers. Id.

The system received pre-market approval and therefore, plaintiff was faced with trying to get around Riegel v. Medtronic, Inc., 522 U.S. 312 (2008). His argument was that to consider the preemption issue, the court needed to break down the “system” into its component parts. Wrong. Plaintiff argued that the pump “is separate and apart from the insulin infusion system and did not gain approval through the PMA process.” Bentzley, 2011 U.S. Dist Lexis 136570, at *16. He tried to suggest that the pump had received approval through the §510(k) process and therefore fit under the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) rationale.

The court found that plaintiff had neither the requisite factual nor legal support for his argument. In fact, the court cited to the FDA’s recent rejection of a Citizen Petition requesting that the FDA clarify that their PMA letter for the system did not extend to the pump itself. Bentzley, at *15. The FDA’s response was that the system was the entire system – the sensor and the pump. The pump had been modified and combined with the sensor to create the system.

Accordingly, FDA approved the PMA supplement for the . . . System, including both the . . . pump and the . . . sensor, on April 7, 2006. . . . [T]he approval letter, as issued, applies to the . . . System as a whole.

Id. at *17 (quotation marks omitted). Seems clear enough to us. The court thought so too.

As for lacking legal support, the court includes a nice string of citations to the cases (involving knee implants) that have rejected the component-part argument. See id. at *18-19. So, the court went on to grant summary judgment to defendant on plaintiff’s strict liability and negligence design defect claims (manufacturing and design defect claims “are state requirements that are preempted by MDA because of their potential conflict with FDA labeling, design, and manufacturing requirements, id. at *22) and breach of implied warranty claims (“[i]mplied warranties in Pennsylvania are centered around the accepted standards of design and manufacture” which differ from the “federal requirements relating to design and manufacture, id. at *25-26) as preempted. See id. at *21-26.

The concordance of Bentzley with the knee implant cases is a lesson that we never tire of pointing out – the success of one manufacturer with one product will redound to the benefit of other defendants with other products. That’s what this blog is all about.

The Bentzley court gave the plaintiff something of a pass on his manufacturing defect and failure to warn claims supposing that plaintiff intended to allege non-preempted parallel claims premised on violations of FDA manufacturing and warning requirements. Id. at *24. But that Annie Oakley didn’t get the plaintiff very far, because he had no evidence to raise a genuine issue of material fact that the system departed from FDA manufacturing standards, id. at *30, or that the system was not accompanied by the FDA-required warnings. Id. at *42-43. So, both those claims were likewise dismissed. To be complete, the court ruled plaintiff’s express warranty claim was not preempted because express warranties “do not independently arise by operation of state law” and therefore “[do] not involve a state requirement and [are] not preempted by MDA.” Id. at *26-27. Defendant’s summary judgment motion, however, did not address the merits of plaintiff’s express warranty claims beyond preemption – so whether they are viable remains to be seen.

Bush v. Thoratec Corporation, 2011 U.S. Dist. Lexis 136838 (E.D. La. Nov. 28, 2011). This one involves a heart pump that allegedly stopped working and supposedly caused plaintiff’s cardiac arrest and subsequent death. Id. at *2. The heart pump is also a Class III medical device that received premarket approval and is therefore subject to Riegel preemption. Id. at *6. For purposes of plaintiff’s arguments, it is important to note that the heart pump at question was subject to a voluntary recall.

Plaintiff argued that one of her claims was not preempted – that defendant failed to notify her of issues with the heart pump – a/k/a fraudulent concealment. Id. at *12. Louisiana law, however, does not recognize a claim for fraudulent concealment against a product manufacturer. So, plaintiff spun her claim accordingly.

[Defendant] did not completely notify the FDA of the nature of [heart pump] malfunctions, pursuant to FDA regulations. . . Plaintiff theorizes that if [defendant] had fully informed the FDA, the FDA would have issued a Class I recall rather than a Class II recall and had the FDA classified [the] recall as Class 1, it would have likely imposed more stringent notice requirements, and expanded the class of recipients of the notice, including end users like [plaintiff].

Id. at *13 (quotation marks and citations omitted). That’s a lot of ifs and maybes. Plaintiff asserts two legal arguments why this claim is not preempted. One is a well-worn legal theory – fraud-on-the-FDA – and one more novel approach – a recall exception.

We’ll start with the purported recall exception. We’ve known about that little savings clause in 21 U.S.C. §360h(d) since Bone Screw days. It didn’t help the plaintiffs then, and it isn’t helping them now. In Bush, the plaintiff argued that her claims weren’t preempted because §360h(d) “permits state court remedies for claims relating to compliance with recall notifications issued by the Secretary of Health and Human Services.” Id. at *9. The court’s response: “Plaintiff has not cited any authority for the proposition that § 360h(d) giveth back what § 360k taketh away.” Id. at *11 (also citing Riegel, 552 U.S. at 325 n.4 (§360h(d) “could not possibly mean that all state-law claims are not pre-empted, since that would deprive the MDA pre-emption clause of all content.”)).

In addition to no legal support, plaintiff had no factual support for her theory either because the recall at issue was voluntary and did not involve an order issued pursuant to §360h(d) – the only context to which the savings clause may apply. Id. To top it all off the court called the plaintiff to task for misrepresenting §360h(d) as applying to the entire Act, instead of merely recalls under that section. Id.

With no recall exception, plaintiff tried fraud-on-the-FDA. We won’t re-hash the whole fraud-on-the-FDA argument but rather point you to our prior posts on the subject and specifically our prior discussion of Hughes v. Boston Scientific Corp., 631 F.3d 762, 768 (5th Cir. 2011). Plaintiff here apparently attempted to use Hughes to by-pass Buckman preemption by arguing that her claim was a “viable parallel state-law claim predicated on violation of FDA regulations.” Id. at *12. The court didn’t buy it:

Plaintiff's claim of fraudulent concealment depend[s] on speculation that the FDA would have taken any particular regulatory action in response to violation of the regulations at issue, as in Buckman. . . .Moreover, Plaintiff is arguing that [defendant] breached disclosure duties owed to the FDA, not that [defendant] breached a disclosure duty owed to Plaintiff by failing to comply with FDA regulations. Under Buckman, such a claim is preempted.

Bush, 2011 U.S. Dist. Lexis 136838, at *15-16. The court, however, was inclined to give the plaintiff a chance to amend her complaint to state a claim more like Hughes (a state law duty to warn based on the manufacturer’s alleged breach of applicable federal regulations) and less like Buckman. So, this plaintiff may take another stab at trying to dodge preemption, but for now we put these two cases in the win column.

There'll Always Be Posner: Double-header

2011-12-05T07:00:00.001-05:00

A great Chicagoan, Ernie Banks, was famous for saying “Let’s play two” – an expression of pure joy about the game of baseball. Another great Chicagoan, Judge Richard Posner, recently came out with a pair of opinions that brought us some joy and reminded us of what good legal reasoning and writing looks like. In both decisions, Judge Posner was on a panel with Chief Judge Easterbrook, so the intellectual lineup behind the opinions was as strong and fearsome as Billy Williams batting after Banks.

Let’s start with United States v. Muoghalu, 2011 WL 5866568 (7th Cir. Nov. 21, 2011), where a pharmacy director appealed from his conviction for extracting kickbacks from a pharmacy company. The basis for the appeal was the government’s failure to produce Brady (exculpatory) material until after trial. The pharmacy company paid Muoghalu $32,000 for 16 speeches he never gave. Muoghalu admitted he had never given such speeches, but claimed they were informal talks. Sadly, he had no documentation or corroboration of any sort. He was the only defense witness at trial. Posner makes it clear that this appeal is going nowhere: “[Muoghalu’s] guilt is so plain that we might stop here; none of the alleged trial errors could have affected the result of the trial, assuming, as courts do when assessing trial error, that the jury was reasonable (no one could predict what an unreasonable jury would do). But we’ll trudge on.” 2011 WL 5865658 at *1.

Posner says “trudge” but it’s really more of a glide. What was the alleged Brady material? The Department of Health and Human Services had prepared a memo summarizing an investigation of the pharmacy company for paying kickbacks. The prosecutor did not have the memo until after sentencing, so it did not withhold it. Moreover, the memo is not exculpatory. The memo fingered Muoghalu, among others. How is that exculpatory? The memo connected a pharmacy company employee – the recipient of the kickbacks – with off-label promotion that resulted in patient deaths. How is that exculpatory? According to Muoghalu, the memo frightened the pharmacy employee with the prospect of a homicide prosecution, so that employee had a strong incentive to cooperate and testify against Muoghalu. But if the pharmacy employee was connected to the deaths, so was Muoghalu.

It’s hard to believe that any sane defense lawyer would place the connection in front of the jury, just to secure whatever slight incremental impeachment value suggested by the memo. As Posner says, “Had Muoghalu’s lawyer told the judge and jury about the risk that his client had endangered lives, Muoghalu would now be arguing for a new trial on the ground of ineffective assistance of counsel.” Id. At *3. To assess whether evidence really falls within Brady – i.re., whether it would likely have increased the chance of acquittal – “the court has to determine the likely net impact of the evidence, with realistic awareness of prejudice as well as probativeness.” Id. at *4 (emphasis in original). The defense lawyer can make all sorts of creative, imaginative arguments on appeal about how a certain piece of evidence might have changed the outcome, but the court does not have to ignore reality. Here, reality resulted in an affirmance of the conviction.

The opinion in Gonzalez-Servin v. Ford Motor Co., 2011 WL 5924441 (7th Cir. Nov. 23, 2011), is about a lawyer who ignored reality – or, to be more specific, ignored controlling precedent. The opinion has gotten really famous really quick, so we’ll try to be quick in covering it. The issue is forum non conveniens in multidistrict litigation. The appeal is really two appeals: one from an order transferring to Mexico claims that tires installed on Ford vehicles in Latin America had caused vehicular accidents, the other from an order transferring to Israel claims that hemophiliacs in Israel were injured by blood products contaminated with HIV. After the appellants’ briefs were filed a couple of Seventh Circuit decisions came down – Abad v. Bayer Corp., 563 F.3d 663 (7th Cir. 2009), and Chang v. Baxter Healthcare Corp., 599 F.3d 728 (7th Cir. 2010) – that ordered FNC transfer under circumstances virtually identical to the case at issue. Understandably, the appellees discussed those cases in detail. Not so understandably, the appellants’ reply briefs completely ignored Chang and mentioned Abad in passing – and incorrectly, at that.

This is no way to impress Judge Posner, the Seventh Circuit, or any judge, for that matter. Needless to say, the transfers are affirmed and the appellants lose. But they do not merely lose; they are ridiculed. Judge Posner tells the appellants that their “advocacy is unacceptable” and that the “’ostrich-like tactic of pretending that potentially dispositive authority against a litigant’s contention does not exist is as unprofessional as it is pointless’” (quoting a case quoting another case). And then Posner administers the coup de grace: he attaches pictures of both an ostrich sticking its head in the ground (though Posner emphasizes that the “noble animal” does not really do that), along with a picture of a man sticking his head in the ground. It is a beat-down with visual aids.

Posner is having fun, and what’s wrong with that? Granted, the losing lawyer took little delight in this exercise, and has even gone so far as to suggest that it is Posner who is the ostrich. (Er, good luck on your next visit to the Seventh Circuit.) Another blogger has pointed out that this is not the first time that Posner has taken pains to point out that no ostrich really buries its head in the ground. This is also certainly not the first time that Posner has turned bad lawyering into a source of judicial mirth.

And we’re also sure it’s not the last time.

Tallying TwIqbal

2011-12-02T17:00:00.003-05:00

It’s been a while since we’ve taken a comprehensive look at how TwIqbal’s been affecting prescription medical product liability pleading. We’ve done lots of posts about this or that case, but we haven’t synthesized anything lately - like in a year. So today we thought we’d take a look at exactly what’s been held insufficiently pleaded and why. For convenience, we took our research back a year (a little longer on some issues)

Of course, TwIqbal applies generally to bar complaints that plead nothing but legal conclusions. Salvio v. Amgen, Inc., ___ F. Supp.2d ___, 2011 WL 3651314, at *6-7 (W.D. Pa. Aug. 18, 2011); Tillman v. Taro Pharmaceutical Industries Ltd., 2011 WL 3704762, at *4-6 (N.D. Ill. Aug. 17, 2011); Rollins v. Wackenhut Services Inc., ___ F. Supp.2d ___, 2011 WL 3489442, at *11-12 (D.D.C. Aug. 10, 2011); Henderson v. Sun Pharmaceuticals Industries, Ltd., 2011 WL 4024656, at *8 (N.D. Ga. June 9, 2011); Nimtz v. Cepin, 2011 WL 831182, at *4 (S.D. Cal. Mar. 3, 2011), dismissed with prejudice, 2011 WL 2160181 (S.D. Cal. June 1, 2011); Llado-Carreno v. Guidant Corp., 2011 WL 705403, at *3 (S.D. Fla. Feb. 22, 2011). But TwIqbal extends to a variety of particular, recurrent pleading flaws.

A very beneficial effect of TwIqbal has been its use to require plaintiffs to sort out their claims against different defendants – a particular, persistent problem permeating pathetically pleaded Pain Pump cases (8 "P's" in a row, not bad). Simply alleging that “defendants” did this or that, especially when the defendants aren’t similarly situated, is no longer allowed (if it ever was). Currier v. Stryker Corp., 2011 WL 4898501, at *4 (E.D. Cal. Oct. 13, 2011); In re McNeil Consumer Healthcare Marketing & Sales Practices Litigation, 2011 WL 2802854, at *18 (E.D. Pa. July 15, 2011); McFarland v. APP Pharmaceuticals, LLC, 2011 WL 2413797, at *2-3 (W.D. Wash. June 13, 2011); Johnson v. Moog, Inc., 2011 WL 719600, at *2-3 (E.D. Tex. Feb. 22, 2011); Timmons v. Linvatec Corp., 263 F.R.D. 582, 584-85 (C.D. Cal. 2010); Peterson v. Breg, Inc., 2010 WL 2044248, at *2 (D. Ariz. April 29, 2010); Adams v. I-Flow Corp., 2010 WL 1339948, at *3 (C.D. Cal. March 30, 2010). Yeah - we went back a little further than a year on this one because it's important.

A particular application of this rule requires that the plaintiff plead product identification – to identify specifically who made what that they claimed injured them. Patterson v. Novartis Pharmaceuticals Corp., ___ Fed. Appx. ___, 2011 WL 3701884, at *2 (6th Cir. Aug. 23, 2011); Hammonds v. Boston Scientific, Inc., 2011 WL 4978369, at *2 (W.D. Okla. Oct. 19, 2011); Henderson v. Sun Pharmaceuticals Industries, Ltd., ___ F. Supp.2d ___, 2011 WL 4015658, at *4 (N.D. Ga. Aug. 22, 2011); Singleton v. Eli Lilly Co., 2011 WL 2621067, at *3 (E.D. Cal. June 29, 2011); McFarland, 2011 WL 2413797, at *2; Bloom v. Depuy Orthopaedics, Inc., 2011 WL 1135753, at *1-2 (D. Md. March 25, 2011); Johnson, 2011 WL 719600, at *2-3; Rojas v. Qualitest Pharmaceuticals Inc., 2011 WL 334671, at *3 (E.D. La. Jan. 28, 2011); Timmons, 263 F.R.D. at 584-85; Peterson, 2010 WL 2044248, at *2; Adams, 2010 WL 1339948, at *3.
The converse has also happened, although not as often. TwIqbal has been employed against a complaint that alleged no facts about the plaintiffs beyond where they lived and that they used the product. Cardenas v. Abbott Laboratories, 2011 WL 4808166, at *4 (N.D. Ill. Oct. 7, 2011); Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, at *1-2 (D. Ariz., Aug. 11, 2011). It has also been employed where the complaint is so vague as not to identify what the product at issue really was. Baldwin v. Zimmer, Inc., 2011 WL 3652411, at *2 (S.D. Ohio Aug. 19, 2011). That's pretty bad.

We also like those TwIqbal cases that require plaintiffs to plead facts that plausibly establish causation – that the product the complaint describes could actually cause the harm alleged. This has been particularly useful in medical device cases covered by Riegel preemption, as it requires a nexus between a claimed FDCA violation and the device that the plaintiff actually used. Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011); In re Fosamax Products Liability Litigation, 2011 WL 5903623, at *7 (D.N.J. Nov. 21, 2011); Henderson, 2011 WL 4015658, at *4-5; O’Brien v. Intuitive Surgical, Inc., 2011 WL 3040479, at *2 (N.D. Ill. July 25, 2011); King v. Pfizer Pharmaceutical Co., 2011 WL 3157305, at *3 (D. Md. July 25, 2011); Rhynes v. Stryker Corp., 2011 WL 2149095, at *2-3 (N.D. Cal. May 31, 2011); White v. Stryker Corp., ___ F. Supp.2d ___, 2011 WL 1131496, at *7-8 (W.D. Ky. March 25, 2011); Llado-Carreno, 2011 WL 705403, at *3; Cohen v. Guidant Corp., 2011 WL 637472, at *1-2 (C.D. Cal. Feb. 15, 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328, 334-35; Maness v. Boston Scientific, 751 F. Supp.2d 962, 970-72 (E.D. Tenn. 2010).

Another aspect of causation we’ve seen TwIqballed (but not as often) is warning causation – requiring facts to be pleaded suggesting that a better warning would have changed the prescriber’s conduct. Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850, at *3 (D. Ariz. Oct. 7, 2011); Mills, 2011 WL 3566131, at *2; Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3 (W.D. Tex. June 23, 2011).

It’s also useful that TwIqbal requires plaintiffs to specify the nature of the alleged product defect with some specificity. In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1206 (8th Cir. 2010); Fosamax, 2011 WL 5903623, at *5; Wamsley v. LifeNet Transplant Services Inc., 2011 WL 5520245, at *6 (S.D.W. Va. Nov. 10, 2011); Currier v. Stryker Corp., 2011 WL 4898501, at *2-3 (E.D. Cal. Oct. 13, 2011) (manufacturing defect); Younker v. Ohio State University Medical Center, 2011 WL 4558922, at *2 (S.D. Ohio Sept. 29, 2011); Leonard v. Medtronic, Inc., 2011 WL 3652311, at *2-3 (N.D. Ga. Aug. 19, 2011); Baldwin, 2011 WL 3652411, at *2; Mills, 2011 WL 3566131, at *2-3; Rollins, 2011 WL 3489442, at *11; McNeil Consumer, 2011 WL 2802854, at *10; Woodhouse, 2011 WL 3666595, at *3-4; Henderson, 2011 WL 4024656, at *5; Llado-Carreno, 2011 WL 705403, at *4; Maness, 751 F. Supp.2d at 969-70; Adams v. Stryker Pain Pump Corp., 2010 WL 4909564, at *2 (D. Minn. Dec. 1, 2010); Forslund v. Stryker Corp., 2010 WL 3905854, at *3-4 (D. Minn. Sept. 30, 2010). Thus, in a failure to warn case:

a complaint should at least identify which danger was not warned against, that the danger was substantial, that the danger was not readily recognizable to an ordinary consumer, that the manufacturer knew or should have reasonably known of the danger, and causation.

Nimtz, 2011 WL 831182, at *2. The defect point has probably generated more TwIqbal law than any other in the product liability sphere.

Perhaps our personal favorite, however, is that TwIqbal requires more than a bare pleading of “defendant violated the law." Rather, the complaint must specify what statute, regulation, etc. was violated. Sprint Fidelis, 623 F.3d at 1206; Desabio v. Howmedica Osteonics Corp., ___ F. Supp.2d ___, 2011 WL 4074391, at *6 (W.D.N.Y. Sept. 13, 2011); Leonard, 2011 WL 3652311, at *2; White, 2011 WL 1131496, at *7-8; Gelber, 752 F. Supp.2d at 334; Bishoff v. Medtronic, Inc., 2010 WL 4852650, at *2 (N.D.W. Va. Nov. 22, 2010); Bass v. Stryker Corp., 2010 WL 3431637, at *4-5 (N.D. Tex. Aug. 31, 2010).

Other generally beneficial effects of TwIqbal are challenges to the vague use of “and/or,” Patterson, 2011 WL 3701884, at *2, and a sharp limitation upon employment of “information and belief” pleading. Mills, 2011 WL 4708850, at *2.

On occasion, punitive damages claims have been TwIqballed for failure to plead facts establishing the heightened elements (such as scienter) required for such damages. Rhynes, 2011 WL 2149095, at *4-5.

Finally, it happened quite a bit even before TwIqbal, but express warranty claims must plead what the warranty is and how it became part of the basis of the bargain (that is to say, reliance). Fisher v. APP Pharmaceuticals, LLC, 783 F. Supp.2d 424, 431-32 (S.D.N.Y. 2011); Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *4 (W.D. Pa. Nov. 10, 2011); Tillman, 2011 WL 3704762, at *8; Mills, 2011 WL 3566131, at *3 n.3; McCauley v. Hospira, Inc., 2011 WL 3439145, at *6 (M.D.N.C. Aug. 5, 2011); Llado-Carreno, 2011 WL 705403, at *4; Gelber, 752 F. Supp.2d at 335; Quatela v. Stryker Corp., ___ F. Supp.2d ___, 2010 WL 7801786, at *3 (N.D. Cal. Dec. 17, 2010); Stanger v. APP Pharmaceuticals LLC, 2010 WL 4941451, at *4 (D.N.J. Nov. 30, 2010); Baker v. APP Pharmaceuticals LLC, 2010 WL 4941454, at *4 (D.N.J. Nov. 30, 2010); Bishoff, 2010 WL 4852650, at *3.

Don't forget that we have more on our TwIqbal cheat sheet.

So there you go. Forearmed is ... well, forearmed. Now you have the precedent to try to force the other side to plead what they should have been pleading all along.

Guest Post - A Tale of Two Books

2011-12-01T12:39:00.000-05:00

The following post is by our blogger emeritus, Mark Herrmann, now moved on to greener cyber-pastures. He gets all the credit and/or blame for what follows. He also suffers from some misconceptions (what else is new) which we'll correct:

(1) Vale, not Bexis, is responsible for the MDL section of our competing work, so don't blame Bexis.

(2) We'd have done more with the trial practice section, except our trial lawyers are too busy trying cases to sit down with us - but maybe Herrmann will give us some ideas.

(3) Bexis would have been happy to collaborate with Herrmann on a treatise, except that his firm at the time (not Dechert) wanted to keep the publishing opportunity for itself. Blogging? Nobody knew what to make of that at the time.

Now on with the guest post

*****************

I’m back from the dead.

You may remember me from 2006 through the end of 2009, when I co-hosted this blog along with Bexis. As a result of that blogging, Oxford University Press solicited Bexis and me to write a treatise about defending drug and device cases. Bexis declined, because he’d already written a definitive work on that subject: James M. Beck & Anthony Vale, Drug and Medical Device Product Liability Deskbook, available here (publisher) and here (Amazon) (Law Journal Press 2011). But I accepted, and promptly left the private practice of law (and the defense of drug and device cases) eight months later to go in-house. The book project nonetheless carried on, and the finished result was just released: Mark Herrmann & David B. Alden, Drug And Device Product Liability Litigation Strategy, available here (Oxford Univ. Press 2012).

So Bexis and I were head-to-head competitors for clients while we co-hosted this blog, and we’re about to become head-to-head competitors for book sales. (What can I say? We’re odd ducks.) But I’m an honest guy: Here’s why you should buy Bexis’s book and why you should buy mine.

Him first.

Bexis’s book has more encyclopedic footnotes than mine does. (Bexis has a harder butt than I do. He’s always been able to hammer away at a subject for longer than I could.) If you want footnotes that provide comprehensive citations about a subject, buy Bexis’s book, not mine.

Bexis’s book does a better job on negligence per se claims. This has always been a pet issue for Bexis, and it would be impossible to outdo his thunder on that issue. Bexis devotes 17 pages to negligence per se claims. I noted the issues in two pages and did none of the heavy lifting. I figure there’s no reason to try to compete with stuff that’s been done before.

Bexis is pretty darn good on some other subjects, too. He has a chapter devoted to non-manufacturer defendants (pharmacists, physicians, brand name in generic cases, and the like) in drug and device litigation. And he analyzes some topics that cut across all types of litigation -- for example, removal and punitive damages. You won’t find those topics in my book, and Bexis has written some good material (I’m sadly forced to admit).

Yeah, his book’s okay. But mine isn’t bad, either.

If you want MDL strategy and tactics (a pet issue of mine), come to me, not what’s-his-name. My MDL chapter looks at every drug or device case decided by the MDL Panel from the Panel’s creation through the end of 2010, and tells you how often (and under what circumstances) the Panel has granted those motions. We break down the analysis by time, so you can see the Panel’s recent (slight) trend toward granting motions to centralize. Need to predict for a client whether the MDL Panel will grant a motion to centralize? Come to me, not Bexis.

And there’s more! My MDL chapter gives you the inside scoop on the use of master complaints and direct filing provisions in multidistrict litigation. Parties often stipulate to those provisions unthinkingly, and the parties may thus unwittingly alter the choice of law applicable to a lawsuit or the reach of the MDL transferee court’s personal jurisdiction. I always liked the nuances of MDL procedure more than Bexis did, and it shows here (if I do say so myself).

What about picking juries? Bexis basically blows this off, but my book devotes an entire chapter - 100 pages - to the subject. Not bad.

There are other differences between the two books, of course. (These puppies are both hundreds of pages in length.) But I’ll stop there.

With all due modesty, Bexis and I (and our respective co-authors) have probably now written the two leading treatises on the defense of drug and device products cases. As always, however, we’ve played to our respective strengths and preferences, and the books reflect those choices. Each book fills a slightly different niche. In fact, if you took both books and combined them into one, you’d have one heck of a treatise.

Actually, that’s not a bad idea: Bexis, why didn’t you and I ever think of combining forces and undertaking some joint endeavor?

Class Action Smackdown

2011-11-30T10:59:00.000-05:00

Class action plaintiff lawyers have been known to do some pretty sleazy things. Don’t just take our word for it. Check out the ALI’s recently adopted Principles of the Law of Aggregate Litigation §§1.05, 3.08 (2010), and especially the cases and articles cited in the Reporter’s Notes. Class action plaintiff lawyers also have to satisfy the “adequacy of representation” prong of Rule 23(a) in order to get a class certified. When can the former preclude the latter?

That was the question in the recent decision by the Seventh Circuit in Creative Montessori Learning Centers v. Ashford Gear LLC, No. 11-8020, slip op. (7th Cir. Nov. 22, 2011). Creative Montesori isn’t a drug/device case – far from it – but it’s a useful reminder about another way to defend against class actions. Moreover, we recommend that defense counsel read it with an eye towards the type of discovery that would be appropriate to prove the sorts of representation issues that the Seventh Circuit has declared relevant (and potentially dispositive) to class certification.

You’ve probably heard of “patent trolls” – entities that produce nothing of value, only litigation over questionable patents. Well, Creative Montessori involves what could be called “fax trolls” – a law firm that specializes in bringing suits under a federal statute (the so-called “Telephone Consumer Protection Act”) that imposes “draconian” penalties for sending unsolicited faxes. Slip op. at 2. The firm apparently scraped the bottom of the barrel rather thoroughly to dig up the purported plaintiffs for the suit in question, engaging in two types of conduct that the appellate court took issue with:

First, they "obtain[ed] material from [a fax broadcaster’s] files on the basis of a promise of confidentiality that concealed the purpose of obtaining the material, a purpose inconsistent with maintaining confidentiality and likely to destroy [the broadcaster’s] business.” Creative Montessori, slip op. at 6. This case was not the only such breach of confidence. According to the opinion, the same firm brought “more than 50 similar class action suits based on information” from the same source. Id. at 6.
Second, once the firm identified the fax recipients, it solicited their participation in the class action suit by “implying in the letter to [the would-be plaintiff] that there already was a certified class to which the [plaintiff] belonged.” This “would constitute misconduct . . . because the communication was misleading.” Id. at 6-7.

The district court ignored these incidents in deciding to certify the class, holding that the alleged misconduct was properly the province of “bar authorities.” Creative Montessori, slip op. at 7. The lower court went on to hold that “only the most egregious misconduct” by would-be class counsel “could ever arguably justify denial of class status.” Id. at 2. The Seventh Circuit, in a unanimous decision by Judge Posner, vehemently disagreed. Any serious allegation of misconduct by class counsel undercuts the adequacy of their representation:

Misconduct by class counsel that creates a serious doubt that counsel will represent the class loyally requires denial of class certification. . . . A serious or, equivalently, a “major” ethical violation, should place on class counsel a heavy burden of showing that they are adequate representatives of the class.

Id. at 10-11 (citations omitted). A lesser standard, without the burden being on class counsel to justify their adequacy in such circumstances, is merely an invitation to class action lawyers to profit from their own ethical misdeeds:

To rule that only the most egregious misconduct “could ever arguably justify denial of class status,” as the court went on to hold, would if taken literally condone, and by condoning invite, unethical conduct.

Id. at 10 (emphasis original).

The court therefore vacated class certification and remanded – with the explicit instruction to “re-evaluate the gravity of class counsel’s misconduct and its implications for the likelihood that class counsel will adequately represent the class.” Creative Montessori, slip op. at 11.

There’s even more to Creative Montessori than we’ve discussed (such as that the would-be class representative probably never even received a fax), so it’s worth a read by anyone defending class actions of any sort. The opinion is a ringing reiteration of the principle that “actions have consequences,” something that lawyers, as well as children, should bear in mind. Moreover, by expressly linking ethical lapses – not limited in any way to the solicitation of clients – the opinion underscores the need for properly targeted discovery, at the class certification stage, into potential misconduct by class counsel.

Nevada Formally Adopts The Learned Intermediary Rule

2011-11-29T16:52:00.000-05:00

When you add together the plurality (p. 958 n.16) and one of the dissents (p. 969) in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), there's a majority in favor of the learned intermediary rule. Thus, we've included Nevada in our post that lists all of the states adopting the rule, Still, when we have to mix and match like that, there's a little doubt in the back of our minds that we're not on as sound ground as we might have liked.

No longer. In Klasch v. Walgreen Co., ___ P.3d ___, 2011 WL 5878054 (Nev. Nov. 23, 2011), we got a little Black Friday gift from the Nevada Supreme Court. Without even mentioning Allison, the court formally adopted the rule - this time unanimously - and, in the same case, extended it to pharmacists:

Traditionally, the learned-intermediary doctrine has been used to insulate drug manufacturers from liability in products-liability lawsuits. Under the learned-intermediary doctrine, a drug manufacturer is immune from liability to a patient taking the manufacturer's drug so long as the manufacturer has provided the patient's doctor with all relevant safety information for that drug. It is then up to the patient's doctor—who has the benefit of knowing the patient's specific situation—to convey to the patient any information that the doctor deems relevant.

Jurisdictions adopting the learned-intermediary doctrine in the context of pharmacist/customer tort litigation have put forth a similar rationale: that between the doctor and the pharmacist, the doctor is in the best position to warn the customer of a given medication's generalized risks. Or, viewed more pragmatically, the doctrine prevents pharmacists from constantly second-guessing a prescribing doctor's judgment simply in order to avoid his or her own liability to the customer. In this sense, the learned-intermediary doctrine preserves the pharmacist's role as a conduit for dispensing much-needed prescription medications.

Because we believe that these public-policy considerations are sound, we adopt the learned-intermediary doctrine in the context of pharmacist/customer tort litigation. Accordingly, Nevada pharmacists have no duty to warn their customers of the generalized risks inherent in the prescriptions they fill.

2011 WL 5878054, at *3 (footnotes to out-of-state learned intermediary cases omitted).

All is not sweetness and light, however, in Klasch - at least not for pharmacies. The court holds that pharmacies having actual knowledge of a "customer-specific risk" can be liable for not notifying either the doctor or the customer of that risk. Id. at *5. Although the facts look pretty bad for the plaintiff (the doctor prescribed with knowledge of the alleged risk, id. at *1), that wasn't the basis of the pharmacy's summary judgment motion, so the court reversed while practically inviting the defendant to try again on a fuller record. Id. at *5-6.

Two Post-Mensing Firsts

2011-11-29T13:49:00.000-05:00

In a post-Mensing world, plaintiffs -- faced with almost certain dismissal of any claim based on labeling, promotion or warnings -- are scrambling to re-define their claims against generic drug manufacturers. They are most certainly looking for their port in a storm. As our faithful readers know, we are keeping track of post-Mensing generic drug preemption decisions here -- an ever growing list of dismissals of failure to warn claims.

Today, however, our focus is on how Mensing is being applied to some of plaintiffs’ “alternate” theories of liability. So we bring you two cases -- Gross v. Pfizer, Inc., ___ F. Supp.2d ___, 2011 WL 5865267 (D. Md. Nov. 22, 2011) (metoclopramide) and In re Fosamax Litigation, 2011 U.S. Dist. Lexis 135006 (D.N.J. Nov. 21, 2011) (alendronate sodium) (thanks to Anita Hotchkiss at Goldberg Segalla for forwarding this one). A quick note of interest for brand-defendants – in Gross, the court had dismissed plaintiff’s claims against the brand defendants because she had not ingested the brand-name drug. Gross, 2011 WL 5865267, *1. Post-Mensing, the court denied plaintiff’s motion to reconsider its judgment in favor of the brand defendants. Id.

Now back to generics. In both cases, generic defendants moved to dismiss all of plaintiffs’ state law claims as preempted. First, both courts quickly and easily dismissed plaintiffs’ failure to warn claims. Id. at *3 (plaintiff conceded her inadequate labeling claims were preempted); In re Fosamax, 2011 U.S. Dist. Lexis 135006, *34 (“Plaintiffs’ claims of failure to warn are squarely preempted by Mensing). In In re Fosamax, the court also went on to find that nothing in the 2007 Food and Drug Administration Amendments Act (“FDAAA”) changes the generic preemption analysis

Accordingly, the Mensing analysis is not affected by FDAAA because the Generic Manufacturers are still unable to unilaterally change drug labeling without special permission and assistance, which is dependent on the exercise of judgment by a federal agency.

Id. at *37-38 (citation and quotation marks omitted).

Next, the courts explained that plaintiffs’ omission of the words “failure to warn” in certain claims, doesn’t make them any less failure to warn claims. In Gross, for instance, plaintiff unsuccessfully argued that her negligence claim for concealing important safety information survived Mensing. Gross, 2011 WL 5865267 at *4. Really? Concealing safety information isn’t a failure to warn claim? Likewise, the Fosamax court made short shrift of plaintiffs’ breach of express warranty, fraud, misrepresentation, failure to conform to representation, negligent misrepresentation and violation of consumer protection statutes “because the gravamen of these allegations is the insufficiency of [the] labeling.” In re Fosamax, 2011 U.S. Dist. Lexis 135006 at *43.

After doing away with all of the labeling-based claims, these courts examined two additional claims designed to circumvent Mensing – negligent continued selling and design defect. In Gross, plaintiff brought negligence claims alleging the generic manufacturer had a duty to cease selling metoclopramide. The court acknowledged that that very argument had been adopted by the Eighth Circuit and therefore rejected by the Supreme Court in Mensing. Gross, at *3. In holding the “stop selling” claims preempted, the court stated that it

is aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce. Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.

Id. The Fosamax court also didn’t buy the “stop selling” argument. In re Fosamax, at *36, n.5 (“To accept Plaintiffs' argument that Generic Defendants could have simply stopped marketing alendronate sodium, this Court would have to directly contravene binding law;” “it is essentially a re-argument of Mensing.”).

The Fosamax court also dismissed plaintiffs’ design defect claims on the identical sameness rationale used in warning cases. In Mensing, the Supreme Court

found that generic manufacturers have a federal duty of "sameness" to, at all times, insure that the label for the generic drug is identical to the label adorning the corresponding reference-listed drug.

Id. at *28. As with the label, federal law requires that the “active ingredient of the [generic] drug is the same as that of the listed drug.” Id. at *33 (citation omitted).

Hence, the "duty of sameness" also applies in the context of generic drug design. Mensing stands for the principle that a federal duty of sameness arising out of FDA's regulatory requirements preempts any conflicting tort duty arising under state law.

Id. Because federal law requires generic Fosamax to have the same active ingredient as brand-name Fosamax, the generic defendants could not have changed the design of the drug and therefore, plaintiffs’ design defect claims are preempted. Id. at *34.

So, at least in these two courts, plaintiffs have yet to find a safe harbor in which to dock and remain adrift in the swirling seas of Mensing.

The Difficulty of Quantifying the Effect of TwIqbal

2011-11-28T07:00:00.003-05:00

When we took stock of things to be thankful for last week, we focused on family, friends, and health. Amidst the turkey, sweet potatoes, and cranberries (the real ones, not the canned stuff), there was little room for professional considerations (or, as our Texan friends call it, bidness). You see, despite our nerdiness, we actually do possess a sense of perspective. If we did make a list of legal-reasons-to-be-thankful, we'd include, along with the Washington Legal Foundation and Judge Posner, our old buddies Twombly and Iqbal.

But have those cases really made a difference? A couple of weeks ago we linked to an article by Professor Hubbard that concluded, after the requisite quantitative analysis, that Twombly might not have had much concrete effect. Color us surprised and somewhat disillusioned. We thought we were getting served up with stuffing and gravy, and instead someone passed us the turnips.

We got a peak at a forthcoming (volume 121) Yale Law Journal article, "Locking the Doors to Discovery? Conceptual Challenges in and Empirical Results for Assessing the Effects of Twombly and Iqbal on Access to Discovery." It's a fine article, well worth a read. We don't want to steal Mr. Gelbach's thunder, so we'll merely summarize a couple of the key ideas.

As a preliminary matter, pardon us for an aw-shucks moment as we note that the article refers to the debate in Pennumbra between some of our bloggers and Penn Professor Stephen Burbank over the merits of TwIqbal. But the focus of the new article isn't whether TwIqbal is good or bad, it's whether those cases have changed anything. Those cases have certainly caught the attention of the judiciary; as of July 2011, Twombly has been cited by courts over 45,000 times, and Iqbal over 25,000 times. The question is whether all of that is only lip service.

Gelbach canvasses the existing literature, which goes both ways. Gelbach's fundamental insight is that party reactions to the new doctrine - selection effects -- must be considered. Simply comparing before and after rates of dismissals can be misleading. If plaintiffs file fewer or different cases, or if defendants file more motions to dismiss, or if parties alter settlement strategies, the dataset against which motions to dismiss are measured is altered.

The dataset Gelbach mines is from the Federal Judicial Center, which seems to be the gold standard and which underlies most of the analytical literature. The Yale article then sprinkles a bunch of equations across the pages, producing an effect on us not unlike tryptophan. To his credit, the author bemoans "tedious algebra." But the result is far from tedious. TwIqbal appears to have had a profound influence. True, the percentage of dismissals has hardly budged, but it looks like defendants are filing more motions to dismiss. The bottom line, according to Gelbach, is that "at least 18 percent of all cases facing MTDs in the post-Iqbal period failed to reach discovery because of the switch to heightened pleading." Further, contrary to concerns expressed by some, TwIqbal seems to have had less, not more, effect on employment and civil rights cases. That is because there is less of a defendant selection effect for those cases, as defendants already usually filed motions to dismiss against them.

The article alludes to the issue of whether TwIqbal has increased social costs (more motions) or reduced them (sifting out meritless cases). Guess which way we vote? There is also a recommendation for further research: "If Twombly and Iqbal have culled mostly low-merit cases, then there should have been a noticeable drop in the number of cases where plaintiffs lose at defense summary judgment." We're not so sure about that. Sad to say, merit or lack thereof does not always animate the decisions of some judges. Specious notions of docket management, or deep-rooted hostility to dispositive motions, where judges think the whole game is about compelling settlement whether the cases have merit or not, taint the dataset. Meritless cases settle. Is that good or is that a pity?

In any event, Gelbach's article is undeniably interesting, and it restores our affection for TwIqbal. We might even put them back on our Holiday gift list.

.

Aredia/Zometa – One Step Forward, One Step Back

2011-11-25T08:00:00.001-05:00

On November 18, 2011, the defense scored a victory in the New Jersey Zometa/Aredia mass tort program, when the court granted a motion to apply New Jersey punitive damages law. The plaintiff was a Virginia litigation tourist who brought suit in New Jersey state court despite his treatment having nothing to do with the state. See Irby v. Novartis Pharmaceuticals Corp., 2011 WL 5835414, slip op. (N.J. Super. Nov. 18, 2011). Both sides had agreed on Virginia substantive law governing the plaintiff’s causes of action, but they scuffled over choice of law in punitive damages.

Why? This isn’t the first time we’ve considered choice of law in punitive damages. New Jersey has a statute that precludes punitive damages against FDA approved drugs. N.J.S.A. 2A:58C-5(c). Not only that, but the New Jersey appellate courts have held that the only significant statutory loophole – fraud on the FDA – is preempted. See McDarby v. Merck & Co., 949 A.2d 223, 272 (N.J. Super. A.D. 2008). So, where a product is FDA approved, application of New Jersey law is tantamount to a dismissal of the punitive damages claim.

The defense even had to overcome a presumption that the law of the place of injury (Virginia, in Irby) governs. The court considered the various factors laid out by Restatement (Second) of Torts §145 (1965), to find that the presumption was defeated. The court held that New Jersey had a more significant relationship than Virginia to the issue of punitive damages. The location of plaintiff’s injury was “‘fortuitous’ because the place of injury bears little relation to [defendant’s] alleged punitive conduct,” given that it “is headquartered in New Jersey,” that the drug (Zometa) “was widely distributed throughout the United States,” and “nothing in NPC’s sales, marketing, or distribution practices suggests that the alleged injury was more likely to occur in Virginia than in any other state.” Slip op. at 7.

The court also held that the next §145 factor, location of the allegedly injurious conduct, favored New Jersey because conduct at issue for punitive damages would have occurred in the defendant’s New Jersey corporate headquarters. Id. at 8-9. The plaintiff failed to prove that the conduct occurred in the company’s international Swiss headquarters. Id. at 9 & n.4. Irby also held that the relationship between plaintiff and defendant was centered on New Jersey because plaintiff’s punitive damages claims “stem from [defendant’s] New Jersey business activities.” Id. at 10.

A serious comity issue also popped up, since “punitive damages are generally intended to regulate conduct within the bounds of an interested state” and, based on the finding that the alleged misconduct occurred in New Jersey, “interstate comity would be least offended by the application of New Jersey law to the issue of punitive damages.” Id. at 12. That's a bit of a bootstrap, but it worked. More importantly, New Jersey has decided to limit punitive damages by statute when FDA-approved drugs are involved, and plaintiff, having chosen to come to New Jersey when she could have filed suit in Virginia, was not really in a position to assert comity. Id. at 15-16. Finally, the court held that prior law was basically split concerning the punitive choice of law question. Id. at 17.

Thanks to Joe Hollingsworth, of Hollingsworth LLP, both for winning the motion and passing it along.

Why there’s such a fierce fight over choice of law in punitive damages in the Aredia/Zometa litigation is demonstrated by another recent decision that’s not so favorable to our side. In Fussman v. Novartis Pharmaceuticals Corp., 2011 WL 5836928 (M.D.N.C. Nov. 21, 2011), the court denied post-trial motions – most of them – in a case that had produced a verdict of $287,000 in compensatory damages, and $12,600,000 in punitive damages. Id. at *1. When you’ve got runaway juries awarding blatantly unconstitutional punitives that run almost 44 times compensatories, there’s good reason to fight such claims tooth and nail.

Fortunately, North Carolina has a statute (N.C.G.S. §1D-25) that limits punitives to three times the compensatory award, so that post-trial motion, at least, was granted in Fussman. Id.

The other motions were denied. As to the motions for judgment, it’s hard to say exactly why, except that the court was not about to reverse the jury’s verdict. Fussman, 2011 WL 5836928, at *3-4. Where's the beef?

There’s not much more meat to the discussion of punitive damages in Fussman. The court finds those claims unpreempted in light of Wyeth v. Levine, but doesn’t really explain itself. Fussman, 2011 WL 5836928, at *4 (still where's the beef). But we did find an interesting footnote about fraud on the FDA, which states, in pertinent part:

[T]he claim presented in the present case was not based on alleged fraud on the FDA or alleged violation of any federal laws or regulations. . . . Thus, while it is undisputed that “fraud on the FDA” claims are preempted by federal law, the present case does not involve “fraud on the FDA” claims. Instead, the willful and wanton conduct alleged . . . involved . . . investigating side effects and communicating with medical professionals.

Id. at *4 n.6. On one hand, Fussman sheds some light on Irby – since it doesn’t look like the plaintiffs could muster a case under the New Jersey fraud on the FDA exception, even if it wasn’t preempted under McDarby. On the other hand, since plaintiff was not claiming a violation in Fussman, we’re a bit surprised not to see anything about N.C.G.S. §99B-6(b)(4), which specifically requires consideration of “[t]he extent to which the labeling for a prescription . . . drug approved by the United States Food and Drug Administration conformed to any applicable government . . . standard that was in effect when the product left the control of its manufacturer.” We’ve already posted on the effect of governmental compliance on punitive damages.

In another interesting, and more disturbing, footnote, Fussman essentially nullifies the “reasonable likelihood” statutory (N.C.G.S. §1D-35) standard for risk of harm in punitive damages claims out of existence. 2011 WL 5836928, at *7. The court holds that no particular percentage likelihood is required for a prima facie case of punitive damages to exist, only that there be an unspecified “connection.” That seems pretty shaky to us, since it would theoretically allow an increased risk from one in a bazillion to two in a bazillion to support a punitive award, notwithstanding the inclusion of a “likelihood” of harm element in the statute. Nor is the cited precedent particularly persuasive. Everhart v. O’Charley's Inc., 683 S.E.2d 728, 738 (N.C. App. 2009), discussed an entirely different statute – “related to” as used in N.C.G.S. §1D–15 – and so is not at all on point. Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1389 (4th Cir. 1995), was decided under Virginia common law, and thus has no conceivable relevance to the interpretation of a North Carolina statute.

It’s hard to say, given the vagueness of other parts of the Fussman opinion, but the likelihood point looks like a good appellate issue to us. Maybe we’ll look into it in some future post

The evidentiary rulings in Fussman are more of "where's the beef?" If the defendant actually did open the door to subsequent remedial measures by asserting them affirmatively, then we can’t fault that ruling. See 2011 WL 5836928, at *7.

We can’t be as charitable to the court’s hearsay ruling, though. The facts aren’t particularly important, but we don’t see how use of hearsay “to establish what information [defendant’s] employees had received from [its] consultants, and the actions [those] officials took in response,” id., can possibly be anything other than relying upon such evidence for “the truth” of what it states. Id. Unless the information is considered to be true, then it’s not capable of proving any of those things.

The decision on admission of “national sales figures” to prove anything “related to” the plaintiff doesn’t make any sense. How national sales could be relevant to one individual is beyond us. Id. at *8. We’ve heard of this kind of thing being admitted in punitive damages cases on various reprehensibility grounds, but never on the rationale offered in Fussman.

So within three days of one another, each side won one in Aredia/Zometa. That dance seems unlikely to end anytime soon.

They Can't Do It To Us; We Can't Do It To Them

2011-11-23T12:42:00.000-05:00

This just in. In an important case concerning discoverability of expert materials in Pennsylvania, the en banc Superior Court has overturned a prior panel decision that allowed discovery of correspondence between expert witnesses and the lawyers who retained them. Here's the opinion: Barrick v. Holy Spirit Hospital, 2011 Pa. Super. 251, slip op. (Pa. Super. Nov. 23, 2011). Both sides are limited to the expert discovery provided in the rules, that being "the substance of the facts and a summary of the grounds for each opinion." Slip op. at 18. Thus, Pennsylvania will not become home to the sort of expert discovery that the federal rules were recently amended to preclude.