Friday, October 29, 2010

Four By Four

The Drug and Device Law Blog is four years old.  Our first post – our once lampooned but more recently copied “Disclaimers and Terms of Use,” went up four years ago yesterday.  Our first substantive post…. Well, that took a little longer.  We've survived four years now.

We celebrated our first birthday here – full of vim and vigor.

We contemplated our second birthday here, a bit more philosophically.

We staggered through our third birthday here, feeling old.

Four years of age is ancient for a legal blog whose contributors are attorneys in private practice.  Not having time for a comprehensive survey, we simply checked out the blogs on our blog roll.  Only Cal Biz Lit, which came online a couple of months after ours, is anywhere near as old – at least in terms of continuous blogging.  Of the rest on our list, only the FDA Law Blog (Hyman Phelps), the Life Sciences Legal Update (Reed Smith) and Mass Tort Defense (Dechert partner Sean Wajert) are significantly more than half our geriatric lifespan – in terms of continuous operation.

There are older legal blogs.  Overlawyered comes immediately to mind.  But most of those aren't written by lawyers who still (privately) practice what they preach.  Sort of reminds of the saying about "old pilots" and "bold pilots."   There are times when, feeding the blog's insatiable appetite, we do feel like old, bold pilots.

We don’t take sabbaticals here at Drug and Device Law.  Litigation doesn’t stop and neither do we.

In a lot of ways, we’re the same as we are when we started four years ago.  We address substantive legal issues concerning drug and device (and occasionally vaccine) product liability litigation, we hope in a readable, accessible fashion.  But we don’t do pictures or fancy graphics – only content.  Not that there’s anything wrong with pictures. We’re great fans, for example, of the comic book cover posts over at Abnormal Use. By the way, thank y’all for the shout out, guys.  We appreciate it.

We’re conservative (a lot of defense lawyers are) so, after 1359 posts, we’re still using the same clunky (defiantly so) layout that comes with Google’s free blogger software/website.  We’ve thought about changing, but our bare-bones, substance-only layout is part of what we are and what we do, so we think we’ll keep it.  Besides, the orange and green format reminds Bexis of some of the license plates from his home state of Georgia (only they called orange, “peach”) back when he was growing up.

Another thing we don’t do is much legal marketing.  We figure the best self/firm promotion we can do is by doing what we've been good at doing, and that’s to provide others who defend drug/device manufacturers with information that’s of use in winning cases for their clients with problems similar to our own.  A rising tide, after all, lifts all boats.  As long as we provide useful legal analysis and (sometimes) news, we figure our readers will think we’re good lawyers that they might want to hire or collaborate with in appropriate cases.  That's enough.  We learned long ago – before we started blogging – that, whatever the subject, it’s better to show an audience than to tell them.  So as long as we do this, that’s how we’ll go about it.

As regular readers know, however, there have been also some changes here at the Drug And Device Law Blog.  By far the biggest was the retirement of one of the two founding bloggers, Mark Herrmann, at the end of 2009.  Mark used to be a partner at Jones Day, and the compromises necessary to maintain a blog where the contributors were members of different firms both competing for the same client base were in large part responsible for our “just the facts, ma’am” style that’s served us so well.

Herrmann’s now in house Aon, the big insurance broker, as his swan song post mentioned.  Bexis had dinner with him the other day, and he’s happy – and a lot more relaxed – these days.  As a litigator for many years, Herrmann mainlined adrenalin with the best of them.  He’d kicked that habit successfully, and settled nicely into the in-house role.  He still has the same wicked sense of humor, so anybody pitching Aon for business better watch out.  He also might start blogging again (look out), about in-house counsel issues, but he'll announce that when/if he's good and ready.

As we told our readers when Herrmann hung up his keyboard, Dechert was more than happy to lend a hand to keep the blog running.  Hence our current line-up of regular contributors:  Bexis, the sole surviving son of the original blog, Steve McConnell, Will Sachse, and Dave Walk (anybody can access our bios in the right-hand margin).  In an increasingly competitive blogging environment – plaintiff-side blogs are getting better – our new line up isn’t afraid to mix it up with the other side.

Our current line up is the second “four” in the title of this post, if anyone needed the hint.

Another new thing we’ve done over the past year is to create issue “cheat sheets” to go along with our previous “scorecards.” Our scorecards are for issues where our side is winning, because they include both favorable and unfavorable decisions.  But we don’t want to do the plaintiffs’ research for them, so we needed something more versatile.  So we created the cheat sheets, which address issues that have had more mixed results.  We’d prefer more scorecards, because we prefer winning more issues, but we think our cheat sheets are better than nothing.

You, our readers, have continued to support us through all our changes.  We’ve added well over an additional hundred subscribers to our Google group over the last year.  The group is now up to over 620 (and that’s with culling emails that bounce, which we do) members.  Anybody who wants to join can type his/her e-mail address in the blank that’s in the right-hand column towards the bottom.  Our RSS feed subscribers (the blank next to the orangey ripple button on the right hand side) now number slightly more than our Google Group.  And our Twitterers – or is it “Twitterees” – who get only the post headlines, now check in at more than 450.

So we have nearly 1700 subscribers to each of our posts who don’t even have to come to the blog itself to know what we’re saying.

On top of all that, we continue to get between (roughly) 20,000 and 30,000 pageviews each month from the rest of the Internet, mostly from non-subscribers who drop by for whatever reason to check us out.

Not bad for a niche blog.   There are only so many people out there interested in drug and medical device product liability.  We hope that those who are listen to us.

Beyond our viewers, we’re especially grateful to those of you – and you know who you are – who get in touch with us off-line and let us know about new opinions, new litigation strategies, new law review articles, and other new stuff that keeps us informed about what’s going on in the various corners of our sandbox.  We’re more than happy to give credit where credit is due, or to keep our contributors’ identities confidential, depending on individual circumstances.

We’ll keep typing as long as you keep reading – deal?

We thank all those who continue to visit us, and you all can have some cybercake courtesy of the Drug and Device Law Blog.

Thursday, October 28, 2010

More on Bryant v. Medtronic

Shortly after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) was decided, we put up a post, “Riegel at (Almost) Six Months,” where we surveyed the immediate aftermath of the Supreme Court’s preemption decision.  Then we did another at “Riegel” at 1 ½” post in July of last year.

The recent decision in Bryant v. Medtronic, Inc., 2010 WL 4026802 (8th Cir. Oct 15, 2010), offers us the first post-Riegel appellate guidance on preemption and PMA devices.  We did a quickie post on it before, but the decision’s important enough that it deserves a closer look.  Since Bryant effectively affirmed the dismissal of an entire multi-district litigation on the basis of preemption, one thing that's a given is that the plaintiffs were most thorough and assiduous in making the arguments that they thought would best hold up against preemption.  That none of them did is a sign of the strength of the preemption doctrine in the medical device field.

First, the plaintiffs tried an argument that had prevailed in Wyeth v. Levine, 129 S. Ct. 1187 (2009) – that because of a defendant’s asserted ability to change FDA-approved warnings prior to FDA approval (the so-called “changes being effected” or “CBE” process) there wasn’t any preemption.  That might work against an implied preemption argument, but Riegel was an express preemption case.  Whether or not voluntary from the standpoint of the FDA, any obligation to change FDA-approved warnings would still be “in addition to” whatever the FDA had approved.  And so the court in Bryant held:

Even if federal law allowed [defendant] to provide additional warnings, as Plaintiffs alleged, any state law imposing an additional requirement is preempted by § 360k.  Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.  Plaintiffs’ reliance on [Levine] for a contrary rule is unavailing.  [Levine] turned on implied conflict preemption, not express preemption, because Congress did not extend the express preemption for medical devices in §360k to prescription drugs.
Bryant, 2010 WL 4026802, at *3.  So much for CBE in the express preemption context.

Second to bite the dust was the argument that, because a defendant gets an improved device modification approved by the FDA, every prior version is “defective” because it isn’t as good.  Nope.  As long as a device’s design remains FDA approved, then to impose liability because some other design exists is preempted.  “[A]s the FDA did not prohibit [defendant] from continuing to sell the unmodified [device], a state requirement to that effect would be “different from or in addition to” the federal requirement and preempted.”  Id.

Third, a claim that the defendant engaged in fraud on the FDA – “failed to provide the FDA with sufficient information” or “not timely fil[ing] adverse event reports” – failed because that claim was preempted by Buckman.  Id.

Fourth, plaintiffs argued “that [defendant] lost its federal preemption defense when the [devices] were recalled.”  2010 WL 4026802, at *2 n.4.  That one didn’t even warrant treatment in the text.  In a footnote the court rejected the contention “for the reasons stated by the district court.”  Id.  Those reasons were – just so everything’s in the same place:

(1) Recalls don’t invalidate preemption.

[T]he argument is predicated on the faulty assumption that the recall invalidated the [devices’] PMA. Plaintiffs have cited no authority for that proposition, and . . . the PMA process is governed by a completely separate statutory and regulatory regime than that governing withdrawal of a PMA-a process to which the [devices] have never been subjected.
In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1155 (D. Minn. 2009), aff’d, 2010 WL 4026802 (8th Cir. Oct. 15, 2010).

(2) FDA regulatory status is determined as of the time a device is used.

Plaintiffs’ argument ignores that PMA for the [devices] was in place at the time [they] were implanted.  This is what matters, because liability under Plaintiffs' various legal theories hinges upon whether the leads were defective at that time.
Id. at 1156.

(3) Juries aren’t allowed to second guess FDA device approvals.

[These] claims threaten[] to interfere with the PMA process because allowing them to proceed would, in essence, result in retroactive second-guessing of the FDA’s decision-making. . . .  [I]f a PMA were invalidated or withdrawn . . . a jury confronting such a situation would be required to retroactively question the FDA’s initial decision to approve the medical device at issue.  Doing so would interfere with the PMA process ipso facto.

Those are only the initial skirmishes. The real battle involved “parallel violation” claims.  The most important aspect of Bryant, from our perspective, is that it adopted the view that “violation” claims are subject to both express and implied preemption.  We consider that self-evident, but there’s always a bit of bated breath involved until an appellate court has agreed.  The express preemption part is easy – that’s Riegel and 21 U.S.C. §360k(a).  Bryant pointed out, Riegel “noted” (that’s correct, Riegel did not so hold, because of the plaintiff’s waiver) “§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations.”  2010 WL 4026802, at *2.

The recognition that Buckman implied preemption narrowed the scope of parallel violation claims was agreed to by the entire panel.  Specifically, the court held:

The MDA also provides that all actions to enforce FDA requirements “shall be by and in the name of the United States,” 21 U.S.C. § 337(a).  In Buckman . . ., the Court construed §337(a) as barring suits by private litigants “for noncompliance with the medical device provisions.” Read together Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.  The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by §360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).  The contours of the parallel claim exception were not addressed in Riegel and are as-yet ill-defined.
2010 WL 4026802, at *2 (various other citations omitted).  We think that’s precisely correct.  In order for there to be parallelism, there must first be two lines: one common-law and the other the FDCA violation. I f there’s no equivalent common-law claim, then there’s nothing to parallel, and all that’s left is a Buckman-barred claim for violation of the FDCA.

The court held that you couldn’t get by with rote recitations that the defendant did whatever it did in a way that violated the statutes.  Plaintiffs’ design defect claims went to defeat in that fashion.  Plaintiffs got plenty of chances to allege something specific, but couldn’t.  “Absent concrete allegations that the product sold by Medtronic was not the product design approved in the PMA Supplement, these are not parallel claims.”  2010 WL 4026802, at *3.  Simply claiming design “violations” without identifying them were roundabout “attacks on the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device.”  Id.

Plaintiffs manufacturing defect claims at least didn’t suffer from a lack of specificity.  Plaintiffs were quite clear that they were based upon use of “direct resistance spot welding,” which they claimed was “unreliable.”  Plaintiffs’ problem was that this kind of welding was precisely what the FDA’s approval allowed.  “Plaintiffs conceded that the PMA Supplement doubtless authorized the use of spot welding.”  2010 WL 4026802, at *4.  That's the kind of concession that sends someone packing.

Plaintiffs whined that they hadn’t had discovery, and that without any, the TwIqbal standards were impossible.  The Bryant court allowed that plaintiffs might have had a point if they hadn’t “specifically disclaimed the need for discovery in opposing [defendant’s] motion to dismiss.”  Id.  So plaintiffs were hoist by their own petard.  The dissent in part dissented on this part, saying that in light of TwIqbal, the court should have cut the plaintiffs a break:

I would hold the specificity requirements of Twombly must be applied in a practical manner that recognizes the parties’ relative access to information necessary to articulate claims with specificity.  Here, as described by the majority and determined by the district court, the parallel state claim that may escape preclusion under §360k requires the plaintiffs to prove [defendant] failed to manufacture the [device] in compliance with the requirements set forth in the confidential PMA and supplemental PMAs.  To apply Twombly rigidly without permitting discovery as to these documents effectively creates an impossible-to-achieve specificity requirement.  I do not believe the Court intended Twombly to create this type of insurmountable hurdle.
Bryant, 2010 WL 4026802, at *7 (dissent in part).

We don’t agree with these sentiments. We think that a nearly “insurmountable hurdle” is precisely what should be erected in this circumstance.  The problem is not TwIqbal, rather the reason is Congress itself.  Congress did two things:  (1) it enacted a broad express preemption clause in the Medical Device Amendments, and (2) it expressly prohibited anybody other than the government from seeking to enforce the FDCA.  Both of those congressional actions counsel against cutting plaintiffs any breaks when they purport to bring parallel violation claims.  Such claims are in derogation of not one, but two, express indications of congressional intent.  If plaintiffs can’t easily plead a parallel violation claim – that’s exactly what Congress wanted.  In light of these two provisions in the FDCA/MDLs, the courts should not be authorizing discovery “fishing expeditions” into whether manufacturers of PMA devices violated the FDCA.

Unless the FDA has already concluded that the defendant violated the terms of its PMA – something that would already be public information in the hands of the plaintiffs – and that violation affected a device in such a way that injured the plaintiffs, then state common law has no business opening the courthouse doors.  Between preemption and lack of standing, Congress has spoken twice that it does not want to see claims of this sort.  Sometimes there’s a reason for having a pleading standard that’s “insurmountable” in certain circumstances.  This is one of them.

But we digress from our main point, which is to detail what’s important in the Bryant decision.  There’s not much more.  Plaintiffs’ last card, on the merits of preemption, was express warranty.  There’s been some uncertainty about express warranty and preemption, because early case law, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 525 (1992), took the view that express warranties were freely entered into and thus weren’t related to agency “requirements.”  But not all express warranty claims are of this sort – and where something as intensively regulated as PMA medical devices are concerned, most aren’t.  There was no claim in Bryant that the defendant had actually made any express warranty of the sort anticipated under the UCC.  As with the design claims, the plaintiffs' express warranty claims were merely allegations without any specific facts or language to back them up, a supposed warranty of safety.  Thus the court (back to being unanimous, the only disagreement was over pleading) held:

To succeed on the express warranty claim asserted in this case, Plaintiffs must persuade a jury that [devices] were not safe and effective, a finding that would be contrary to the FDA’s approval of the PMA Supplement. . . .  The MDA in §360k expressly prohibits States from imposing requirements “in addition to” federal requirements.  The district court correctly concluded that this express warranty claim interferes with the FDA’s regulation of Class III medical devices and is therefore conflict preempted.
Bryant, 2010 WL 4026802, at *5 (citations omitted)

We don’t have to tell anyone doing device preemption work that Bryant now goes right underneath Riegel any briefing on this subject.  Aside from a little namby-pambyness on pleading, it makes all the major points we want, on parallel violations, recalls, warranty claims and more.

And we don’t expect an appeal, given the unfortunately timed settlement.

Wednesday, October 27, 2010

Interesting Supreme Court Tidbit

From out of left (well, really, right) field.  The lack of FDA approval, by itself, doesn't mean anything.

Five justices of the Supreme Court conclude, in the context of a death penalty appeal, that the fact that the state got a drug to be used in the execution from an overseas source that was not FDA-approved, doesn't - by itself - establish that there's likely to be anything wrong with the drug:
There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe.  The district court granted the restraining order because it was left to speculate as to the risk of harm.  But speculation cannot substitute for evidence that the use of the drug is sure or very likely to cause serious illness and needless suffering.  There was no showing that the drug was unlawfully obtained.
Brewer v. Landrigan, No. 10-416, 562 U.S. ___ (U.S. Oct. 26, 2010) (citations omitted) (per curiam).

A Jurisdictional Idea To Ponder

We confess that we read McAdams v. Medtronic, Inc., 2010 WL 3909958 (S.D. Tex. Sept. 29, 2010), a while ago, but we weren’t sure what to make of it.  On the one hand, there’s an interesting idea in there.  On the other hand, it didn’t win in McAdams. We still don’t know if it will win or not, but after thinking about it, we think it's worthy of our readers' consideration.

McAdams is another shot at one of defense counsel’s holy grails:  to use the presence of an issue implicating federal law – but something less than a federal cause of action – as a basis of obtaining subject matter jurisdiction in federal court.  The general principle is stated in Grable & Sons Metal Products, Inc. v. Darue Engineering. & Manufacturing, 545 U.S. 308 (2005).  Removal is appropriate where a state court claim “necessarily raise[s] a stated federal issue [that is] actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities.”  Id. at 312.

Satisfying all of the requirements is hard – and it’s intended to be, since one of the factors is that no defendant’s bright idea should be able to upset the federal-state balance by moving lots of cases into federal court.  Empire Healthchoice Assurance, Inc. v. McVeigh, 547 U.S. 677, 699-700 (2006) (Grable only allows removal of a “small and special” set of cases).

What went on in McAdams has to do with the impact of medical device preemption after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Basically, most courts have preempted just about everything except “parallel” claims that, in effect, allege violations of the Medical Device Amendments.  Thus, one effect of Riegel is to place FDA compliance/violation issues front and center in any case involving a PMA medical device.

The defense syllogism:  FDA compliance = embedded federal issue under Grable.

The first part of the test is does the plaintiff’s “right to relief necessarily depends on resolution of a substantial question of federal law”?  Well, if there’s nothing else that survives preemption, the “necessarily depends on” part of the test is satisfied pretty easily.  As the court in McAdams observed, “it appears that plaintiffs cannot prove their claims absent establishing that [the defendant] failed to meet FDA standards.”  2010 WL 3909958, at *3.

That’s right. The only way a violation claim survives preemption under Riegel is where it’s neither “different from” nor “in addition to” the FDA standard.

How about the “substantial question”?  Here, the court stated that “[w]hether [defendant] complied with federal standards with respect to its [device] is important to [defendant] (and to plaintiffs), but there is no broader issue of federal law implicated.” Why? The main reason the court gave is that “the MDA has specifically been interpreted to permit parallel state court claims,” which the court viewed as “indication that the federal interest in this matter is not substantial.”  McAdams, 2010 WL 3909958, at *4 (citing Riegel).

That argument, we think, is fixable.  First of all, it’s not exactly accurate.  Riegel didn’t hold anything about parallel violation claims.  All such claims in Riegel had been waived by the plaintiff’s failure to preserve.  The Court made an observation based upon such claims surviving in Lohr.  552 U.S. at 330 (“Although [plaintiff’s] now argue that their lawsuit raises parallel claims, they made no such contention in . . . the Second Circuit. . . . We decline to address that argument in the first instance here.”).

Two, four, six, eight ... time to re-substantiate.  (Apologies to Tom Lehrer).

So maybe next time we take the position that the plaintiffs can’t in fact bring parallel claims because they are nothing more than a prohibited private right of action under the MDAs/FDCA.  Buckman pretty much says that.  Do we actually win that argument?  At this point probably not short of the Supreme Court - but at the removal stage that’s not the point.  The point is we’re no longer just arguing about this plaintiff or this device. We’re arguing that federal law, 21 U.S.C. §337(a), doesn’t allow these claims at all.

That argument, win or lose, is considerably more “substantial” under the Grable test.  It might work to keep a case in federal court.  Whether a court agrees with us or not about the dictum in Riegel, the issue is significant to more than the parties.

On to the last Grable prong.

Will allowing removal upset the federal/state balance?  The McAdams decision says it would:

The Supreme Court has already declined to open the federal courts up to medical torts in the context of Merrell Dow [Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804 (1986)], and this case is not distinguishable on any relevant basis.  Indeed, allowing every state law tort claim that involves a medical device to be removed to federal court would result in precisely the type of “potentially enormous shift” of cases from the state to federal courts that the Supreme Court refused to permit in Merrell Dow.
McAdams, 2010 WL 3909958, at *5.

Either the court didn’t understand, or didn’t want to understand, the narrow scope of a post-Riegel parallel violation claim.

“[E]very state law tort claim that involves a medical device”?

We wish.

Our side lost that issue in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Riegel is quite clear that the only type of device entitled to preemption is one that’s pre-market approved by the FDA.  552 U.S. at 317-20.  Most devices aren’t PMA-approved.  Rather, they’re cleared as “substantially equivalent” under the process held not preemptive in Lohr.  The Second Circuit addressed that point in Riegel:  “In other words . . . approximately ninety-nine percent of such devices went through the § 510(k) process and only one percent went through the PMA process."  Riegel v. Medtronic, Inc., 451 F.3d 104, 112 (2d Cir. 2006), aff’d, 552 U.S. 312 (2008).

We aren’t talking about “every” device here – not even close.

The vast majority of even Class III devices aren’t PMA.

Moreover, not every PMA device products case can raise a plausible parallel violation claim.  There has to be a real violation, not just some vague allegation that the defendant might have violated something.  Lots of decisions in our medical device preemption scorecard hold that the claimed violation must be:  (1) of a particular, pleaded regulation, (2) that is causally related to the device that allegedly injured the plaintiff.  In practice that means that, if the FDA hasn’t already taken enforcement action, there’s no such animal.  Even most violation claims don’t make it past TwIqbal.

So McAdams way overstates the effect of a holding that a post-Riegel parallel violation claims is an embedded federal question that supports subject-matter jurisdiction under Grable.  This isn’t anywhere near what the Supreme Court had in front of it in Thompson.  The defendant's argument in Thompson could have put virtually every drug product liability case in federal court.  The number of PMA devices is infinitesimally smaller, and the number of cases where there’s a viable parallel violation claim is smaller still.  A sympathetic judge could easily distinguish what the court in McAdams chose not to.

Does that mean that the centrality of parallel violation claims in post-Riegel PMA device cases puts them on a fast track to federal court?

We wouldn’t say that, but we think that tying Grable to “parallel violation” claims, where such claims are effectively the only thing that a plaintiff has left after Riegel, is an intriguing idea.  The proposition didn’t win in McAdams, but we don’t see anything in that decision’s reasoning that looks like an insurmountable obstacle.

Monday, October 25, 2010

Confidentiality: We're Telling You for the Last Time

Here's how a typical mass tort oral argument goes. No matter whose motion it is, the plaintiffs' lawyers beat us to the lectern and deliver a Faulknerian riff about how awful our clients are (kicking dogs, blowing up the old folks home, lurking on the grassy knoll in Dallas in 1963, etc). If the plaintiffs' lawyers momentarily allude to the matter at hand, it comes as a genuine surprise. It's sort of like when the great American playwright George S. Kaufman would sit backstage while the Marx Brothers were performing in one of his plays, and Kaufman would be heard sporadically to mumble, "Wait - that last line is actually in the script."

Eventually we get a chance to slip in a few words about the pertinent cases, policy, and facts. And then we sit down. What happens next? Before the judge can offer a homily about how the parties should work things out and spare the court the need to, you know, decide something, other plaintiff lawyers march to the microphone to emphasize again how horrible the defense side (both clients and lawyers) is. Think back to the scene early in Blazing Saddles, where genuine Western gibberish is followed by a chorus of a bunch of guys harumphing that "Johnson is right!"

That's how it felt to us after we penned a little ditty criticizing a motion by Aredia/Zometa plaintiffs to undo a protective order. We didn't much care for the plaintiffs' maneuvering to get broad-based discovery after agreeing to a protective order, then griping about alleged overdesignation of confidential documents attached to motions, and then asking for elimination of confidentiality protections for all documents, not just those attached to the motions. Along the way, we offered a few bromides about how plaintiff lawyers abuse the whole confidentiality process, ramping up expenses and seeking to use the confidential documents as extra-legal leverage. Pretty tame stuff. Who could disagree?

Believe it or not there are a couple of plaintiff blogs out there every bit as brilliant and charming and poetic as this one. And they pummelled us. First, Ronald Miller at the Drug Recall Lawyer Blog said it was a case of the "Pot Calling the Kettle Black," and that it was really defense lawyers who abuse the confidentiality process and seek to run up expenses.

We gave that contention a good deal of thought and whipped off a retort that cited all the leading authoriities -- the Third Circuit, Judge Weinstein, Jersey Shore, and Argentinian folk sayings. Unanswerable, right?

And then Justinian Lane at the Dangerous Drugs blog lobbed in his "Two Cents." He criticized our facts. He criticized our law. He criticized our policy arguments. He didn't say anything about our taste in clothes, but if he had we're betting it would've been critical. (And he'd be right.) By the way, what gives with the argumentative blog titles like "Drug Recall" or "Dangerous Drugs"? Should we retitle ours "Medicines and Devices that Help People" or "Nice, Job-Creating Products"? Anyway, we thought we had already said our piece so that substantively, if not chronologically, we had the Last Word. And then last week the Drug Recall blog blasted us again. Listen: when we said "Come at Me, Bro" we didn't really mean for you guys to come at us! Why, that's as silly as asking Al Quaeda to "bring 'em on."

Because Ron Miller and Justinian Lane are smart plaintiff lawyers, their blog posts are clever, insightful, and well-crafted. Because Ron Miller and Justinian Lane are plaintiff lawyers, their bottom line is bereft of merit. So here we go again. To quote Jerry Seinfeld, we're telling you for the last time. Just among us, it's hard to say more on confidentiality without repeating ourselves. It's like the Die Hard franchise. (True story: At a Hollywood pitch meeting a couple of years ago, someone proposed a new Die Hard film. It would be "Die Hard in a building." Um, does anyone remember what the first Die Hard was about?) So let's just get in and get out, hitting the key points. And unlike Ryan Howard, if we're going to strike out, at least we're going down swinging.

Here are the main issues raised by the Bad Guys -- okay, Mistaken Guys -- along with our helpful explanations of why they are Mistaken.

Doesn't the hourly billing system give defense lawyers an incentive to create useless work? No. Unlike mass tort plaintiff lawyers, defense lawyers have clients who control litigation strategies and tactics, all the while eyeing the bottom line. As we've said before, the old scorched earth mentality is the exception, not the norm. In-house lawyers don't like it, their bosses don't like it, and their insurers don't like it. Guess what? Courts don't like it either. For that matter, outside lawyers don't like it. Generating make-work isn't satisfying, even assuming one could get away with it. Better to spend more time on other matters. Oh, and have you heard of fixed-fee arrangements or caps? This might be one of those topics where plaintiff lawyers are going to continue to believe whatever they believe, unhindered by reality and warped by years of suspicion. No doubt there are misperceptions like this going the other way. Maybe we're wrong to think that mass tort plaintiff lawyers drink martinis flavored with panda tears and that they're pulling off a massive wealth redistribution scam that kills off American jobs. Maybe.

Defense lawyers are resentful, greedy chuckle-heads. Both the Dangerous Drugs and Drug Recall blogs veer off into digressions on the difference between plaintiff and defense lawyers. One says that defense lawyers are probably smarter, but are infuriated by the success of plaintiff lawyers who make up with daring what they lack in Shephardizing skills. "How can people who never read Proust outsmart me on preemption?" Or something like that. The other says that defense lawyers have been brainwashed by "golden handcuffs" to be conservative on tort issues even if they are correct and liberal about everything else. We don't buy it. And what's the point? Its like Marxists or Freudians who argue that their opponents aren't just wrong but are plagued by false consciousness. And now Marx and Freud occupy the dust-bin of history. So there. Look, we know plenty of plaintiff lawyers who are brilliant brief writers. We don't think we're brain-washed. We get along pretty well with our opponents. The stereotypes are hooey -- except that plaintiff lawyers sometimes can be a little too quick to conjure up a phony morality play.

Expense-exschmense. Isn't e-discovery cheap? Are you kidding? The Dangerous Drugs blog talks about how cheap it is to copy a dvd. Sure. But that leaves out everything that takes place before that. It costs an enormous amount of money to look for documents, collect them, and review them for responsiveness, privileges, trade secrets, and confidentiality. It costs a lot of money to produce those materials. If the plaintiff lawyers insist on reviewing backup tapes (they usually do) that's another mountain of expense. Hosting fees are higher than high. Almost none of this involves moneys paid to your friendly neighborhood defense lawyer. It goes to vendors and contract lawyers. And it's not as if any of these expenses are avoidable. Discovery of electronically stored information (ESI) is grotesquely expensive. Plaintiff lawyers typically insist that they are entitled to every document, email, database item, etc that mentions Drug X. But let's assume the plaintiff lawyers content themselves with an ESI search for only 25 company employees. So let's leave out thornier issues of databases, shared drives, legacy media, and EU privacy issues. Let's further assume that each employee has 10 gb of active data. (There would be much more if there is an email archive in play.) Vendors typically charge $500 per gb to process ESI. Hosting fees average around $25 per gb per month. And we're not talking at all about the massive costs of boots on the ground to collect, review, and process this stuff. A corporate defendant will spend millions of dollars on discovery, without having been found liable for anything. Check out Ralph Losey's e-Discovery Team blog on the costs of e-discovery. These costs are going up, not down. Nobody disputes this, except maybe plaintiff lawyers whose clients have no data and don't have to worry about such costs. And the fact is that a vanishingly small percentage of this discovery ever gets used, or even looked at, by plaintiffs. It's a pressure point, pure and simple.

Doesn't the public have a right to, and wouldn't it benefit from, publicizing all discovery materials? No and no. The U.S. Supreme Court in Seattle Times Co. v. Rhinehart, 467 U.S. 20 (1984) made it clear that the press and public have no constitutional right of access to materials exchanged as part of the discovery process. Confidentiality orders "are not a restriction on a traditionally public source of information." Id. at 32. Of course it is true that under the usual day-to-day operation of the Federal Rules of Civil Procedure, the parties are free to disseminate discovery materials. That's because it usually doesn't matter. There's no confidential material and nobody cares. But Rule 26(c) provides that if there is "good cause" then the court will enter an order protecting a party from "annoyance, embarrassment, oppression, or undue burden or expense." Rule 26(c) contains a nonexhaustive list of eight orders a court might fashion. Number 7 provides that a court may order "a trade secret or other confidential research, development, or commercial information not be revealed or be revealed only in a designated way." In the sorts of cases we're talking about, the millions of documents produced in discovery will invariably contain material for which there is good cause to limit dissemination. For example, scientifc research and development and marketing documents contain trade secrets. And it's not only trade secrets that warrant protection. Consequently, courts often issue "umbrella" protective orders. Remember, in the case that got this whole debate started, the plaintiffs were seeking to undo the entire protective order. Neither the Drug Recall nor Dangerous Drugs blog try to support that. Instead, they say that the public benefits from release of certain types of information. Interestingly, Dangerous Drugs uses exactly the same example we did. Assume all the data has been provided to the FDA. Assume that various scientists at the company set about interpreting the data. One scientist initially interprets the data to disclose a risk. But a whole slew of other scientists analyze the data more carefully and show that the data is not, in fact, suggestive of such a risk. They even manage to persuade the errant scientist. Should that one scientist's interpretation be publicized? It certainly would make for a punchy item in the plaintiff lawyer's press conference. But it's not reflective of reality. It is, in a word, misleading. But the company probably cannot or will not issue a corrective press release (e.g., "here are the other 20 documents that show the proper context") because anything like that would be, in itself, lawsuit-bait. Plaintiff-securities lawyers can push a button and spit out a complaint as soon as the stock price burps. But of course the company faces no such issue during the trial, where the whole truth can be brought out fairly and with all appropriate context. Why not allow the actual right of press and public access to play out at trial on a balanced record? Is it because what's afoot here isn't informing the public but, rather, prejudicing the jury pool and exerting leverage?

We'd like to put this Point-Counterpoint gig to rest. Maybe we can end with a really cool quote. Hamlet's last words come to mind: "The rest is silence." Or the Talking Heads: "Say something once, why say it again?" Whatever. Who decides who gets the Last Word?

Remember what got this whole thing started? That plaintiff motion in Aredia-Zometa seeking to undo the protective order? The court recently issued its decision, saw the plaintiffs' motion for the overbroad, disingenuous mess it was, and ruled against the plaintiffs. For now, we're calling that the Last Word.

Interesting Third Circuit Discussion of Levine

The Third Circuit issued a whopper of a preemption opinion on Friday in Farina v. Nokia, Inc., ___ F.3d ___, 2010 WL 4138502 (3d Cir. Oct. 22, 2010), unanimously holding that state-law claims that cellphones emitted harmful radiation were preempted.  We’re not going to delve into Farina very much because:  (1) cell phones are not medical devices or drugs (though they can be addicting); and (2) Dechert is involved in that litigation, so we have to keep our mouths, if not shut then carefully regulated.

However, one interesting legal point in Farina deserves attention – its discussion of one of the (numerous) problems with the Supreme Court’s reasoning in Wyeth v. Levine, 129 S. Ct. 1187 (2009).  That discussion occurs on pages *22-24 of the Farina opinion (Westlaw version).  One of Levine’s grounds for not finding any implied preemption was the absence of any express preemption clause in the FDCA.  Specifically, the Court stated:

If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history. But despite its 1976 enactment of an express pre-emption provision for medical devices, Congress has not enacted such a provision for prescription drugs. Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.
129 S. Ct. at 1200 (citations removed). We commented at the time – literally the same afternoon that Levine came down – that this analysis was problematic:

[T]he majority allows implied preemption to be driven by express preemption (or, more properly, the lack of it) more than it has in previous cases.
We were being kind.  Before Levine, quite a few cases – we can think of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), Geier v. American Honda Motor Co., 529 U.S. 861 (2000), and Freightliner Corp. v. Myrick, 514 U.S. 280 (1995), off the top of our heads – had held that express and implied preemption operated independently.  That is, these decisions had held that the presence or absence of an express preemption clause didn’t affect, one way or the other, whether a particular claim was impliedly preempted due to conflict with federal law.

Levine not only didn't overrule these prior decisions – it didn’t even mention them (not for this proposition, anyway).

Well, the plaintiffs threw this aspect of Levine into the hopper in opposing preemption in Farina. The Third Circuit wasn’t buying.

[T]he lack of an express preemption provision covering claims like [plaintiff’s] does not necessarily mean Congress intended to preserve conflicting state law.  We do not read [Levine’s] reference to Congress’s decision not to enact an express preemption provision, as standing for the proposition that conflict preemption should not be found absent an express preemption provision.  Such a reading would come too close to subsuming conflict preemption into express preemption analysis, and is inconsistent with the axiom that an express preemption provision does not “bar the ordinary working of conflict pre-emption principles,” Geier, 529 U.S. at 869.
Farina, 2010 WL 4138502, at *22 (various other citations omitted) (emphasis added).

Farina is one of the first decisions we’ve seen that has addressed directly Levine’s unspoken divergence from prior law on whether express preemption (or the lack of same) can have negative implications for implied preemption.  We doubt it will be the last.

Friday, October 22, 2010

Still Rolling....

A tip of the cypercap to Dave Gossett at Mayer Brown, who has just forwarded to us the latest Medtronic preemption win.  It's Cenac v. Hubble, C.A. No. No. 09-3686, slip op. (E.D. La. Oct. 21, 2010).  After letting the plaintiffs amend their complaint to add "parallel" claims, the court in Cenac grants the motion to dismiss in its entirety.  This was not one of those cases where the plaintiff didn't try very hard, either.  The plaintiff put considerable time and effort into the amendment.

To no ultimate avail.

The plaintiff's basic claim was that Medtronic's pump (this is not a shoulder pain pump case) administered a lethal dose of some sort of medication, allegedly due to some sort of "missing propellant."

The parallel claims failed for substantive reasons, not just because of TwIqbal.

(1) The plaintiff alleged violations of several sections of the FDA's Good Manufacturing Practices ("GMPs") and the reg that required the manufacturer to follow its PMA.  These, however, were all found too generic to support a parallel violation claim.  They essentially told the manufacturer what it had to do, but left it to the manufacturer's discretion how to do it.  The plaintiff's allegations claimed that the defendant should have done those things in a different way.  That was a preempted no-no, since by going beyond what the regulations required and demanding specific methods, the plaintiff was asserting "different" and "additional" claims.  Slip op. at 7-9.

(2) The plaintiff alleged violations of reporting requirements.  Sorry, but this sort of post-PMA allegation of fraud on the FDA is preempted.  Slip op. at 9.

(3)  The plaintiff alleged "that [defendant] failed to provide and update information with respect to the device after FDA approved the device."  Sorry, but warning claims, pre or post, are preempted.  Slip op. at 9-10.

(4) Express and implied warranty claims are preempted.  Slip op. at 10.

(5) The Louisiana statutory (LPLA) claims are all preempted.  Slip op. at 10-12.

Finally, we'd like to point out the footnote, slip op. at 3 n.6, taking judicial notice of FDA approval documents.  Dave Gossett, who sent us the Cenac case, also figured out how to create permanent links to the FDA's website documents that establish the regulatory history of medical devices.  That's an issue because the most straightforward way of finding such documents produces links that go away in a couple of weeks max - not a good thing when litigating motions takes longer than that.  If you need to know how to get online FDA documents before the court (with links that don't disappear), go to this post and read the last part of it.

Thursday, October 21, 2010

Another One Bites The Dust

We can't say much, because Dechert's involved in the litigation, but the Ninth Circuit has just affirmed (unpublished - but a win is a win is a win), the Rule 12 of the Amgen third-party payer action over alleged off-label promotion of Arasnep and Epogen.  The grounds:

(1) Failure to plead RICO and UCL (California's notorious consumer protection statute) with particularity.

(2) Failure to plead proximate cause.  The plaintiff's theory was too "attenuated" as a matter of law.

Personal Jurisdiction - A Primer

We mentioned late last month, back when everybody was still high on the Phillies, that the Supreme Court had granted certiorari in several interesting opinions.  Two of those decisions, Brown v. Meter, 681 S.E.2d 382 (N.C. App. 2009), appeal denied, 695 S.E.2d 756 (N.C. 2010), and Nicastro v. McIntyre Machinery America, Ltd., 987 A.2d 575 (N.J. 2010), deal with personal jurisdiction in product liability matters brought in state court.  Here, copied from our earlier post, are the questions that the Supreme Court agreed to hear:


Whether a foreign corporation is subject to general personal jurisdiction, on causes of action not arising out of or related to any contacts between it and the forum state, merely because other entities distribute in the forum state products placed in the stream of commerce by the defendant.

Whether, consistent with the Due Process Clause and pursuant to the stream-of-commerce theory, a state may exercise in personam jurisdiction over a foreign manufacturer when the manufacturer targets the U.S. market for the sale of its product and that product is purchased by a forum state consumer.
We can hear the yawns already.  “Who the [word uttered when Uribe hit 9th inning sacrifice fly] cares.”   Well, product liability defendants and their lawyers should care.  We’ll try to explain what’s going on – which is easier than to explain Oswalt was pitching rather than Lidge last night.

“Personal jurisdiction” is the phrase given to the collection of questions that arise when a party asks, “What the heck am I doing before this court?  I’ve never had anything to do with [fill in state].”  We’re only dealing with defendants today, since that’s what both Brown and Nicastro deal with, but it’s not unknown for plaintiffs to ask the same question – particularly when nationwide class actions are brought in state court.

In personal jurisdiction cases, particularly in product liability, we’re dealing with the tension between:  (1) our federal system, in which states remain independent sovereigns in their exercise of the powers (such as trying tort cases) assigned or reserved to them under the Constitution, and (2) the nationalization – and, indeed, internationalization – of commerce epitomized by the Interstate Commerce Clause.

Way back when, personal jurisdiction was strictly limited by territorial boundary, in that (to overgeneralize) the defendant had either to be a resident of the state or the object (usually real property, back then), known as a “res,” was within the state.  The paradigmatic case for that view was called Pennoyer v. Neff, 95 U.S. 714 (1878), but it’s so old and out of date we’re not going to discuss it further.

The current rule, articulated by two ironically named cases, International Shoe Co. v. Washington, 326 U.S. 310 (1945) (where the defendant wasn’t very “international”), and World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286 (1980) (where the defendant was anything but “world-wide”), is that there must be “minimum contacts” between the defendant and the forum State such that the defendant has a relationship with said state sufficient that “he should reasonably anticipate being haled into court there.”  World-Wide Volkswagen, 444 U.S. at 297.

The purposes of requiring “minimum contacts” for personal jurisdiction in our federal system are two-fold:

It protects the defendant against the burdens of litigating in a distant or inconvenient forum.  And it acts to ensure that the States through their courts, do not reach out beyond the limits imposed on them by their status as coequal sovereigns in a federal system.
World-Wide Volkswagen, 444 U.S. at 292.

There’s another personal jurisdiction concept that comes into play – the distinction between “general” and “specific” jurisdiction.  “General” personal jurisdiction means that the defendant has enough contact with a state that it can be sued there about anything, even if the subject matter of the suit has nothing to do with that state.  That kind of jurisdiction requires "substantial" contact, and is usually limited to the residence of an individual or state of incorporation or principal place of business of a corporation.  “General” jurisdiction is why a drug manufacturer based in say, New Jersey, can be sued in New Jersey by a plaintiff from Montana who was prescribed the defendant’s drug by a Montana physician, and who has never set foot in New Jersey.

“Specific” jurisdiction is where the facts of a particular case have enough to do with a state that the defendant can be sued there in that case, even if it couldn’t for something not involving that state.  That’s why our hypothetical Montana plaintiff could sue our not-so-hypothetical New Jersey drug company in Montana, as well, when the defendant detailed the prescriber and sent the drugs to him/her in Montana.  An Missouri plaintiff, on the other hand, with no Montana contacts, could not sue the New Jersey company in Montana (assuming no general jurisdiction there), because the Missouri plaintiff would have no case-specific contacts with Montana.  The Missouri plaintiff, however, could sue either in New Jersey (under “general” personal jurisdiction) or in Missouri (under “specific” personal jurisdiction).

That’s all well and good as a general matter, and not really in dispute.  But things get complicated in product liability cases – including, but hardly limited to, cases involving prescription drugs.  What if a California (or a Japanese) manufacturer sold its products to a  middlemen (or to two or three) and had no idea or control over where its products ended up?  Plaintiff in state X is injured by the product.  Is there personal jurisdiction over the manufacturer in state X for that reason alone?  To put it another way, is the “invisible hand” of commerce – foreseeability that the product could end up essentially anywhere in the country, if not the world – a sufficient “minimum contact”?  It’s hardy an uncommon situation, and it’s from that kind of fact pattern that the “stream of commerce” theory of personal jurisdiction mentioned in the Brown and Nicastro cert. grants comes from.

The stream of commerce theory made it to the Supreme Court more than 20 years ago in Asahi Metal Industries Co. v. Superior Court, 480 U.S. 102 (1987), which any lawyer familiar with case names knows must have been from California.  The Supreme Court considered opposing arguments that:  (1) there must be more than bare foreseeability to have minimum contacts, so a defendant must have some kind of purposeful interaction with a state, or conversely (2) modern commerce in products is typically conducted through independent, impersonal middlemen and through long chains of distribution, so the mere presence of a product in a jurisdiction should be a sufficient contact to support jurisdiction.

The Court split 4-4 on the issue – but since facts peculiar to Asahi (we'll get to them later) meant that personal jurisdiction failed even under stream of commerce, a published opinion rather than a Kent-style summary affirmance, resulted.  Justice O’Connor, speaking for four justices, believed that the random yet foreseeable presence of a product (in Asahi, a valve for a motorcycle tire) in a jurisdiction was not enough to support personal jurisdiction, and that some "purposeful" conduct by the defendant affiliating itself with the state was required:

The substantial connection, between the defendant and the forum State necessary for a finding of minimum contacts must come about by an action of the defendant purposefully directed toward the forum State.  The placement of a product into the stream of commerce, without more, is not an act of the defendant purposefully directed toward the forum State.  Additional conduct of the defendant may indicate an intent or purpose to serve the market in the forum State. . . .  But a defendant’s awareness that the stream of commerce may or will sweep the product into the forum State does not convert the mere act of placing the product into the stream into an act purposefully directed toward the forum State.
480 U.S. 112 (all citations and quotation marks removed).

Justice Brennan, speaking for another coterie of four justices, took the opposite view:

The stream of commerce refers not to unpredictable currents or eddies, but to the regular and anticipated flow of products from manufacture to distribution to retail sale.  As long as a participant in this process is aware that the final product is being marketed in the forum State, the possibility of a lawsuit there cannot come as a surprise.  Nor will the litigation present a burden for which there is no corresponding benefit.  A defendant who has placed goods in the stream of commerce benefits economically from the retail sale of the final product in the forum State, and indirectly benefits from the State’s laws that regulate and facilitate commercial activity.  These benefits accrue regardless of whether that participant directly conducts business in the forum State, or engages in additional conduct directed toward that State.
480 U.S. at 117.

However, the claim actually at issue in Asahi wasn’t the injured California consumer’s claim.  Rather, it was a third-party claim between a Taiwanese tire manufacturer plaintiff and a Japanese valve manufacturer defendant for indemnity “on the basis of a sale made in Taiwan and a shipment of goods from Japan to Taiwan.”  Id. at 115.  The court held that, entirely apart from stream of commerce, Due Process did not allow that claim to be dragged into a California court.  Id. at 116 (“Considering the international context, the heavy burden on the alien defendant, and the slight interests of the plaintiff and the forum State, the exercise of personal jurisdiction by a California court over Asahi in this instance would be unreasonable and unfair”).

After Asahi, the states went their merry ways for more than twenty years – an object lesson to anyone who thinks that, after Kent, surely fraud on the FDA will soon find its way back to the Court.  Some states applied the O’Connor view and some the Brennan view.  Obviously, neither Nicastro nor Brown followed O’Connor.

Both cases are peculiar in their own way.  We’ll start with Nicastro.  In that case, the New Jersey Supreme Court took stream of commerce to its perhaps logical futuristic extreme.  Citing modern times, the court effectively abolished federalism, as is evident from these quotes:

The increasingly fast-paced globalization of the world economy has removed national borders as barriers to trade. . . .  Due process permits this State to provide a judicial forum for its citizens who are injured by dangerous and defective products placed in the stream of commerce by a foreign manufacturer that has targeted a geographical market that includes New Jersey.
987 A.2d at 577 (emphasis added).

We do not find that [defendant] had a presence or minimum contacts in this State – in any jurisprudential sense-that would justify a New Jersey court to exercise jurisdiction in this case.  Plaintiff's claim that [defendant] may be sued in this State must sink or swim with the stream-of-commerce theory of jurisdiction.
Id. at 582 (emphasis added).

[A] foreign manufacturer that places a defective product in the stream of commerce through a distribution scheme that targets a national market, which includes New Jersey, may be subject to the in personam jurisdiction of a New Jersey court in a product-liability action.
Id. at 589 (emphasis added).

Essentially in Nicastro the New Jersey Supreme Court ignored the state borders of New Jersey and every other state insofar as it applies to personal jurisdiction.  Nicastro doesn't look to a defendant’s contacts with New Jersey at all, but rather to contacts with the United States as a whole.  Stream of commerce fully and finally trumps any federalistic limits on the exercise of state power.  The state’s “policy reasons” – “a strong interest in protecting its citizens from defective products” and its “paramount interest in ensuring a forum for its injured citizens,” 987 A.2d at 590 – triumph over the supposedly archaic, 230-year-old concepts that at least some members of the United States Supreme Court have found in the Constitution.  The New Jersey Supreme Court thus becomes a rather shrill advocate of the notion that "today's world" changes constitutional notions of Due Process, at least as to personal jurisdiction:

In today’s world, foreign manufacturers, plying overseas markets, should be covered by insurance, accounting for the risks of doing business and providing a fund for consumers who may be injured by their products.  Defending a suit in one of the United States, moreover, is not as burdensome as it once might have been, given that air transport can bring the principals of a business here within hours and instantaneous communication allows an ongoing dialogue with counsel in this country. . . .  Although we cannot control manufacturing plants leaving this country or control a foreign manufacturer’s employment policy, working conditions, or the quality of its operations, we can ensure that a manufacturer that targets its defective products at a wide geographic market that includes New Jersey will not be immune from suit in our State’s courts.
987 A.2d at 591. We’ve never seen left-liberal “living constitution” philosophy combined with Tea Party know-nothingism in quite the same way before.  Take that you nasty foreigners!  Look how you took the all jobs from my home town!  At least we'll make you come to our courts!

We think Federalists on the Court are going to have a field day with Nicastro, since (as mentioned above) one of the "purposes" of limits on personal jurisdiction is precisely to "ensure" that states stay within "the limits imposed on them by their status as coequal sovereigns in a federal system."  World-Wide Volkswagen, supra.

Limits?  Joisey don't need no stinkin' limits!

Brown, rather than taking stream of commerce doctrine to its logical(?) extreme, applied it to an entirely different issue – general, as opposed to, specific – jurisdiction.  In both Asahi and Nicastro, at least the accident had taken place in the forum state.  In Brown it did not.  The plaintiffs (decedents, technically) in Brown were a couple of tourists from North Carolina who went to France.  No French (or other foreign) product came to North Carolina.  While in France they took a bus and were killed in an accident.  Their lawyer blamed the French accident on the French/Luxembourgian/Turkish tires (it’s Europe, so maybe the word should be “tyres”) that the French bus company installed on the French bus.

Of course, suit was brought in North Carolina.

Well, because the accident and everything pertaining to it occurred overseas, there was no basis for asserting “specific” personal jurisdiction over the any of the European companies that sold their tires to Europeans in Europe.  None of the “case specific” facts helped the North Carolina plaintiffs.  “The present dispute is not related to, nor did it arise from, Defendants' contacts with North Carolina.  As a result, the issue raised in this case involves general rather than specific jurisdiction.”  Brown, 681 S.E.2d at 388. So in a novel approach, the court applied stream of commerce theory to general jurisdiction:

[W]e conclude that the appropriate question that must be answered in order to determine whether Defendants are subject to the jurisdiction of the courts of this state is whether Defendants have purposefully injected their product into the stream of commerce without any indication that they desired to limit the area of distribution of their] product so as to exclude North Carolina. . . .
Id. at 391 (as usual, all internal cites and quotes removed).  Brown found stream of commerce general jurisdiction based upon the defendant’s combined sales over a three year period of 44,384 tires that – through the hands of middlemen – found their way to North Carolina.  Id. at 393-94.

Now that’s 44,384 tires out of what?  Brown doesn’t say.  Like the lamentable Wyeth v. Levine opinion the court provides only a numerator (the 20 adverse events in Levine) but no denominator.  We had to look at the Brown defendants’ certiorari petition to find the answer.  During the same period these defendants produced “more than 90 million tires.”  Cert. petition at 4.  We did the math.  The court in Brown based its finding of general personal jurisdiction on the passive delivery (through middlemen the did not control) of one-two-thousandth (0.0005) of the defendant’s output.

This is general jurisdiction, we’re talking about.

A finding of general jurisdiction means that literally anybody – not just dead North Carolina tourists – can sue these Turkish, Luxembourgian, and French defendants in North Carolina.  North Carolina can be a venue for, say, an Istanbul intellectual property action, a dispute over contract signed in Chonqing with a Chinese company, or a tort claim arising from a Nigerian clinical trial.

And the same would be true of any other state whose courts reached a similar conclusion.  Chillingly, there’s nothing in Brown’s discussion of the 44,000 tires that suggests a belief that it is treading anywhere near a Due Process line.  Rather, one-twentieth of one per cent of total product sales was “substantial”:

[T]he distribution chain through which tires manufactured by Defendants were shipped into the United States and, eventually, into North Carolina, was a continuous and systematic process. . . .  [T]hrough a regular process employed within the [defendants’] organization, a substantial number of tires manufactured by the Defendants were imported into the United States and distributed to various entities in North Carolina.
681 S.E.2d at 394.  North Carolina today; North Dakota tomorrow.  Who’s to say that a court up there won’t think that forty Firestones to Fargo isn’t also “substantial.”  According to Brown, “the sole act of a manufacturer’s intentional injection of his product into the stream of commerce provides sufficient grounds for a forum state's exercise of personal jurisdiction.”  Id. at 391.

So that’s what the Supreme Court has to deal with in Nicastro and Brown. In Nicastro a state court employed stream of commerce theory to abolish state boundaries altogether for personal jurisdiction – truly a tour de force for a court of just one of the fifty states.  In Brown stream of commerce theory is used to expand general personal jurisdiction in order to misconstrue de minimis product sales as “substantial” and to find “purposeful injection” of products into a state where there plainly was none.  If Brown stands, then potentially any product manufacturer could be sued anywhere over anything.

Those are the stakes, and these implications are why we’re following these cases.  If you defend product liability cases, you should likewise pay attention.  If plaintiffs have their way, it could be a Brave New World. What stream of commerce has joined, is federalism powerless to put asunder?

Wednesday, October 20, 2010

Post-Levine Drug/Vaccine Preemption Cheat Sheet

It's no secret that non-medical device preemption arguments haven't been as successful after Wyeth v. Levine as they were before.  Here at the Drug and Device Law Blog, we like to provide information, but we also follow a defense Hippocratic Oath not to do harm by doing the other side's research for them.  Our "scorecards" cover all decisions on both sides of an issue - but for us to keep a scorecard, the good guys (our clients) have to be doing well enough that we're not in effect helping the other side.  That's why we also have "cheat sheets" that include only those cases where our side wins.

Levine changed the landscape.  Thus after thinking long and hard about it, we've decided to "demote" non-device preemption from a scorecard to a cheat sheet.  So here's our Post/Levine drug/vaccine cheat sheet.  Maybe, if we prevail in Bruesewitz, the landscape changes again and we'll separate out vaccines.  Fingers crossed.

  1. Smith v. Wyeth, 2009 WL 736208 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4697002, reconsideration denied, 2009 WL 425032) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5460) is pending in the Sixth Circuit.
  2. Morris v. Wyeth, 2009 WL 736200 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (582 F.Supp.2d 861, reconsideration denied, 642 F. Supp.2d 677) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5509) is pending in the Sixth Circuit
  3. Wilson v. Wyeth, Inc., 2009 WL 736198 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4696995, reconsideration denied, 2009 WL 425027) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5466) is pending in the Sixth Circuit
  4. In re Aredia & Zometa Products Liability Litigation, 2009 WL 2497229 (M.D. Tenn. Aug. 13, 2009), finding preemption of fraud-on-the-FDA allegation made in opposition to Michigan tort reform statute presumption of non-defectiveness from regulatory compliance.
  5. In re: Aredia & Zometa Products Liability Litigation, 352 Fed. Appx. 994 (6th Cir. Nov. 24, 2009), affirming preemption (see pre-Levine scorecard) of fraud-on-the-FDA exception to Michigan tort reform statute. Preemption applies to all claims alleging fraud on the FDA, including post-approval fraud and fraud asserted against an affirmative defense.
  6. LeFaivre v. KV Pharmaceutical Co., 2010 WL 59125 (E.D. Mo. Jan. 5, 2010), finding preemption under Buckman of economic-loss-only claim alleging that Metoprolol Succinate ER was "adulterated" and therefore unmerchantable under a state consumer protection statute. The adulteration claim was a disguised FDCA private right of action barred under Buckman. Levine involved a traditional state-law claim and did not affect the inability of state-law plaintiffs to sue over FDCA violations having no parallel in state law.
  7. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 678 (N.D. Tex. Jan. 27, 2010), dictum stating that "clear evidence" supporting preemption would exist if plaintiffs were claiming only that two technical disease terms should have been used in OTC labeling, in light of regulatory history rejecting these terms.  Finding, however, that plaintiff's claims were broader than that.  Reconsideration denied, 2010 WL 2484505 (N.D. Tex. June 17, 2010).  Affirmed on other grounds, 672 F.3d 372 (5th Cir. 2012).
  8. Murphy v. Mylan, Inc., 2010 WL 2008797 (Utah Dist. Iron Co. May 10, 2010), finding Buckman preemption in case (specific drug not stated) involving statutory fraud-on-the-FDA exception to Utah statute barring punitive damages against manufacturers of FDA-approved drugs.
  9. Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. Aug. 11, 2010), finding failure to warn claim in in OTC Motrin case preempted with respect to failure to warn of SJS/TEN because the FDA rejected that warning in response to a petition. The FDA's rejection was "clear evidence" under Levine that would not permit the warning plaintiff advocated. Possible preemption of claim that OTC drug should have been sold by prescription only.
  10. Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011), finding consumer fraud claims preempted in Botox case where the allegations of illegal off-label promotion were nothing more than a private attempt to enforce the FDCA.
  11. Bruesewitz v. Wyeth LLC, 131 S.Ct. 1068 (U.S. Feb. 22, 2011), Vaccine Act expressly preempts all design defect claims against vaccine manufacturers.  Any other reading would render "unavoidable" as used in the Act meaningless.  No mention of any presumption against preemption.  Affirming 561 F.3d 233 (3d Cir. March 27, 2009).
  12. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. June 13, 2011), regulatory history of Effexor was "clear evidence" that, had the defendant submitted a stronger warning about adult suicide to the FDA, the FDA would have rejected it.  Plaintiff's failure to warn claim was preempted.
  13. Emerson v. Novartis Pharmaceuticals Corp., 446 Fed. Appx. 733 (6th Cir. Aug. 23, 2011), fraud on the FDA claims, made in pursuant to a statutory presumption of non-defectiveness by reason of FDA compliance, were preempted.
  14. In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411(D.N.J. Jan. 17, 2012).  An authorized distributor of an innovator drug does not hold that drug’s New Drug Application and has no power to change that drug’s labeling.  Warning claims are preempted against those having no power to change the labeling unilaterally.
  15. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. Feb. 22, 2012), fraud on the FDA claims, made in pursuant to a statutory presumption (Texas) of non-defectiveness by reason of FDA compliance, were preempted.  Garcia's reasoning is more persuasive than DesianoAffirming 682 F. Supp.2d 662  (N.D.Tex. Jan. 27, 2010).
  16. Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. Sept. 6, 2012).  Reaffirming Garcia that Buckman preemption applies to fraud on the FDA statutory immunity exceptions and all other claims that attack the sufficiency of information submitted to the FDA.  "Compliance" refers to the aspects of the drug specified in the statute and not to fraud on the FDA-related non-compliance.  If "compliance" were broadly interpreted, then it would be preempted by Buckman for the same reasons as Garcia.  While Levine would preclude preemption of ordinary warning claims, the statute abolished those claims as a matter of state law.
  17. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 1831632, slip op. (E.D. Ky. Oct. 10, 2012).  Mensing preemption bars warning-related claims in a branded drug case where the defendant had sold its NDA, and thus lost the ability to change warnings through the CBE process, before the plaintiff used its drug.manufacture the product that the plaintiff ingested.  Affirmed, see below.
  18. In re Fosamax Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. June 27, 2013).  The FDA's rejection of a supplement submitted for pre-approval two days after the plaintiff suffered the injury that was the subject of the supplement was "clear evidence" that the FDA would have rejected a CBE submission concerning the same drug risk.  The substantive scientific standard for a warning was the same for both types of regulatory submissions.  The FDA had more information from more sources than any one manufacturer, and there was no evidence that any information was withheld.  Therefore, the plaintiff's warning claim was impliedly preempted under Levine.
  19. Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. Jan. 28, 2014).  Any change in the dosage of a drug is a "major change" requiring prior FDA approval.  Therefore, plaintiffs' class action consumer fraud claims based on "overfilling" are preempted because the dose in which the drug was marketed was approved by the FDA and was impossible to change immediately to comply with the plaintiffs' claimed state-law obligation.
  20. In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994 (D.N.J. March 26, 2014).  The previous implied preemption "clear evidence" ruling in Fosamax (see above) is extended to other, similarly situated cases in the Fosamax MDL.
  21. Amos v. Biogen Idec Inc., 28 F. Supp.3d 164 (W.D.N.Y. June 25, 2014).  Design defect claims against all prescription drugs are preempted as impossible under Bartlett.  Drug manufacturers cannot simultaneously comply with FDA requirements mandating the specific design of an approved drug and state law requirements mandating that the design be altered.
  22. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. June 27, 2014).  Mensing preemption bars warning-related claims in a branded drug case after the defendant divested its NDA.  After divestiture a branded company has no power to change warnings and is no different than a generic manufacturer in that respect
  23. Booker v. Johnson & Johnson, 54 F. Supp.3d 868 (N.D. Ohio Oct. 10, 2014).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-genericl drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Where state law demands an alternative design to avoid liability, that would require changing the composition of the drug, which is prohibited by federal law.  Therefore, the state-law claim is preempted.
  24. Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680 (N.D. Ohio Jan. 5, 2015).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-genericl drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Following BookerAffirmed 808 F.3d 281 (see below).
  25. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. Feb. 20, 2015).  A California consumer protection class action alleging misleading statements about the efficacy of an innovator/branded drug is entirely preempted under Levine/Mensing.  None of the efficacy-related label changes plaintiffs sought involved "new" information that the FDA had not already considered in its approval of the challenged indication, so they could have been accomplished through a CBE supplement.  Nor was the type of label change plaintiffs sought allowable through the CBE process.  The CBE process involves new safety-related information, and is not a way to second-guess FDA approval.  Because the CBE process is inapplicable, the label changes plaintiffs seek must be have FDA pre-approval, and are therefore preempted as impossible under Mensing.
  26. Kaleta v. Abbott Laboratories, Inc., 87 F. Supp.3d 916 (S.D. Ill. Feb. 20, 2105).  The defendant presented clear evidence that the FDA would not have included a developmental delay warning for Depakote at any time relevant to the plaintiff's case.  Twice, after plaintiff's use of the drug, the FDA refused attempts by the defendant to add such a warning, on the basis that the scientific support was insufficient.
  27. Shah v. Forest Laboratories, Inc., 2015 WL 3396813 (N.D. Ill. May 26, 2015).  Under Bartlett, state-law design defect claims against all prescription drugs are preempted.
  28. Rheinfrank v. Abbott Laboratories, Inc., 111 F. Supp.3d 749 (S.D. Ohio Aug. 10, 2015).  The defendant presented clear evidence that the FDA would not have included a developmental delay warning for Depakote at any time relevant to the plaintiff's case.  Twice, after plaintiff's use of the drug, the FDA refused attempts by the defendant to add such a warning, on the basis that the scientific support was insufficient.  Because fraud on the FDA claims are preempted, plaintiff cannot try to undercut this evidence with fraud on the FDA claims.  Buckman preempts statutory fraud on the FDA punitive damages exception.
  29. Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 5836973, slip op. (S.D. Ohio Oct. 2, 2015).  Under Bartlett, state-law design defect claims against all prescription drugs are preempted.
  30. In re Incretin-Based Therapies Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 6912689, slip op. (S.D. Cal. Nov. 9, 2015).  Because the FDA specifically considered pancreatic cancer risk, publicly confirmed the adequacy of the challenged labeling, and has maintained its position that scientific evidence of a causal association between the drugs in question and the risk is indeterminate, there is clear evidence under Levine that the FDA would have rejected the warnings that plaintiffs demand.  Timing does not suggest gaps in the FDA's consideration.  Actual submission and FDA rejection of a warning are not required.  All warning claims are preempted.  Buckman preempts attempts at claiming misreporting and underreporting to the FDA.  What the FDA chooses to consider in its evaluation cannot be second-guessed by litigants.
  31. In re Byetta Cases, 2015 WL 7184655slip op. (Cal. Super. Nov. 13, 2015).  Plaintiffs cannot oppose preemption by alleging fraud on the FDA, which is itself preempted.  Plaintiffs warning claims are preempted because of clear evidcnce that the FDA has concluded that there is insufficient scientific evidence to warrant a warning that incretin mimetics cause pancreatic cancer.  The FDA took account of the ADEs plaintiffs relied on.  Preemption is a legal, not a factual, question, which is inherently a judicial function.
  32. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. Dec. 11, 2015).  Impossibility preemption under Bartlett applies where the alleged defect would have been a "major" change under FDA regulations, requiring FDA preapproval.  "Pre-approval" design claims are too speculative, since they require another design to have been approved, to have been used, and to have prevented injury.  Prior FDA approval of would have been necessary in any event.  A claim that a defendant should never have started selling its FDA-approved drug is preempted for the same reasons that stop-selling claims were preempted in BartlettAffirming 76 F. Supp.3d 680.
  33. Batoh v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2016 WL 922779 (D. Conn. March 10, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving OTC drug.  The change in composition that plaintiff claims is required would be a "major change" requiring FDA preapproval.
  34. Cerveny v. Aventis, Inc., ___ F. Supp.3d ___, 2016 WL 1065826 (D. Utah March 16, 2016).  FDA rejection, after plaintiff's alleged injury, of citizen's petition alleging same injury, was clear evidence that FDA would not allow the label change plaintiff demanded.  Further, the FDA continued to approve similar products with the labeling plaintiff challenged.  Pregnancy X label involving different risk was irrelevant.  Nonsensical to argue that any possible label strengthening, even if irrelevant to plaintiff's case, precludes preemption.
  35. Barcal v. EMD Serono, Inc., 2016 WL 1086028 (N.D. Ala. March 21, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving branded drug.  The design of any FDA approved drug cannot be changed without prior FDA approval, rendering compliance with both state and federal law impossible.

Kester Out On The Old Keister (Again)

A nifty new decision, Kester v. Zimmer Holdings, Inc., 2010 U.S. Dist. Lexis 110403 (W.D. Pa. Oct. 18, 2010), popped up on one of our automatic searches this morning.  It's a sequel to the even niftier Kester v. Zimmer Holdings, Inc., 2010 WL 2696467 (W.D. Pa. June 16, 2010), that we reported on earlier.  In that post we mentioned that the plaintiff had been given leave to amend, and we wondered what would happen.

Now we know.

In Kester I the court quite rightly got all over the plaintiffs for simply pleading "defendants" this and "defendants" that where the plaintiff had sued several quite dissimilarly situated defendants - it's a pain pump case, and for one thing, the plaintiff sued both makers of the pump and makers of the drug used in the pump.

Turns out, right off the bat, it was a good thing for defendants to make that motion.  It turns out that the plaintiff was either really lazy or had a really bad case against most of those she sued.  Her response was to drop every defendant, except one, and simply replace "defendants" with the name of the unfortunate one that remained.  "The Amended Complaint names Zimmer as the sole defendant. . . . [and] simply replaces the word 'defendants' with 'Zimmer.'"   2010 U.S. Dist. Lexis 110403, at *3, *8.

We've wondered before if there's something about these pain pump cases that attracts either really lousy or really lazy pleaders, and given what just happened in Kester we're scratching our heads again.  That plaintiff would simply drop five defendants rather than bother to plead a proper case against any of them has us yearning for the good old days when Rule 11 really had teeth.

But we digress.

The last remaining defendant - you guessed it, Zimmer - filed a second Rule 12 motion and got the court to bounce every claim in the amended complaint that it moved against.  Those were breach of implied warranty and fraudulent concealment.  Fraud fell under Rule 9(b) this time rather than (to be technical about it) Twiqbal.  That's hardly surprising, because any allegation broad enough to encompass "defendants" generally is very likely to be too vague to meet 9(b)'s "particularity" requirement when any given defendant's name was rotely substituted and no other amendment made.

And so it was.

(1) Plaintiff can't cheat by alleging misrepresentations in the alternative.  That is alleging a misrepresentation "to Plaintiff and/or Plaintiff's healthcare providers, and/or the FDA" doesn't cut it.  "Alleged misrepresentations made to other individuals cannot take the place of allegations in the Amended Complaint that constitute fraud against Plaintiff."  Kester II, 2010 U.S. Dist. Lexis 110403, at *11 (emphasis original).  We really like that one.  "And/or"s are another pet pleading peeve of ours.

(2) Plaintiff can't cheat by throwing up a laundry list of "misrepresentations" without alleging when they were made or by whom.  Such "averments are deficient of any specific facts and are conclusory in nature" in that they "neither identif[y] any particular person who made the alleged misrepresentations nor specif[y] the time or place such misrepresentations or omissions were allegedly made."  Id. at *10.

Not only that, the same allegations also failed as a matter of law.  In Pennsylvania, a plaintiff can't bring fraud or implied warranty claims bases on allegations that the manufacturer didn't say what it should have.
[P]laintiffs are barred from asserting a non-negligence cause of action against the manufacturer of a pharmaceutical device. . . .  The Pennsylvania Supreme Court has determined that negligence is the sole theory upon which a plaintiff may recover against a prescription drug manufacturer in a suit based upon the manufacturer's failure to warn.
Id. at *12 (citing the usual cases).  The court properly observes that this reasoning extends as well to medical devices.  Id. at *12-13 (ditto).

Motion granted.