Thursday, November 27, 2008
The product: a total knee replacement device called the "natural knee II." It's a class III pre-market approved device (naturally). It had to be replaced after four 1/2 years in plaintiff's body. The FDA considered the PMA for three years before finally approving it.
Plaintiff claims it caused "further osteolysis" (a progressive condition), and because it used materials "prone to wear" (tell us when you find something that isn't).
To the surprise of absolutely nobody the court applies Riegel and finds there is preemption. Slip op. at 5-
To the more interesting issues - any discussion of alleged loopholes?
Non-compliance. Zimmer established its ongoing compliance with the FDA's conditions of approval. Slip op. at 8-9. How? You'll have to take a look at the filing, because plaintiff's counsel couldn't follow the rules.
Fraud on the FDA. Plaintiff argued that the defendant "did not fully and honestly disclose all informationrelevant to the safety of the [device] to the FDA." Slip op. at 9. After noting plaintiff had no proof of the allegation, the court held that, in any event, "any allegations that [defendant] committed a fraud upon the FDA are also preempted." Id. (citing Buckman).
Post-approval. Plaintiff claimed that Riegel doesn't apply because that alleged defects only "came to light after [the device] received premarket approval." Slip op. at 9-10. Since the FDA isn't going to approve a device it knows is defective, this is an argument that Riegel doesn't apply to anything. The court found there was no evidence, and in any event the argument failed because it was based on the lone dissent in Riegel.
Congressional intent. Plaintiff urged the court to ignore the Supreme Court because Congress didn't mean what it said in the express preemption provision and might change it. Slip op. at 10. The court (being nice) followed Riegel's observation that the text of the statute is the best indicator of congressional intent.
No loopholes in Riegel.
Tuesday, November 25, 2008
We can almost hear you scoffing. Surely, in over two years of “all preemption, all the time” blogging, that’s the one topic we haven't missed. Wouldn’t that be like Court TV discovering something new about the OJ trial?
Well, we’re not saying that we know anything new about OJ, but there actually is an aspect of preemption we’ve ignored until now.
Over-the-counter (“OTC”) drugs (which, in our jargon-filled field, are also referred to as “monograph” drugs) are governed by a limited form of express preemption provided by 21 U.S.C. §379r. The general preemption language protecting OTC drugs is similar to, but even stronger than, the language that the Supreme Court held broadly preemptive in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008):
Except as provided in subsection . . . (e) . . . of this section, no State or political subdivision of a State may establish or continue in effect any requirement – that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title [that means an OTC drug]; and that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter . . . .21 U.S.C. §379r(a). In Riegel, “different from or in addition to” was enough to preempt a whole lot of things. The express preemption clause for OTC drugs has all that, and more – “otherwise not identical with.” So the preemption protection provided to OTC drug manufacturers is very, very deep, indeed.
It’s just not very broad.
There are various exceptions, but only one’s of interest to us product liability litigators. That’s subsection (e), which provides:
(e) No effect on product liability lawThis preemption exception is (like the UCC) recognized by every state in the union except Louisiana. Green v. BDI Pharmaceuticals, 803 So.2d 68, 74-75 (La. App. 2001) (preempting product liability claim notwithstanding exception). We don’t often say it, but Green is a pro-defense result that we think was just wrong.
Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.
So now we’ve drilled all the way down to §378r(e) – subsection e of part r of section 378. Jeez, the FDCA is getting as complicated as the Internal Revenue Code these days.
That means we’ve got really comprehensive preemption, except that it doesn’t apply to “the product liability law of any state.”
But we’re lawyers. We can nitpick anything if it’s likely to help our clients.
And we have.
The question becomes what is “product liability”?
Well, under both the second and third Restatements, liability for product defects requires physical injury to person or property. This requirement was stated in the “physical harm” language of Restatement (Second) of Torts §402A (1965), and in section 21 of the Restatement (Third) of Torts, Products Liability, which allows recovery of “economic loss” only in connection with personal injury or property damage.
Thus, the proposition that OTC drug manufacturers advance is that suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not “product liability” actions saved from preemption by §379r(e).
And we’ve been winning.
It all started, as much product liability law has, in California. For a long time the Golden State had a consumer protection statute that was really bizarre – like you-didn’t-even-have-to-use-the-product-to-sue type bizarre. A few years back, the voters of California cut that statute back to just ordinarily bizarre, something we alluded to here. The upshot of California’s bizarrely expansive consumer protection statute has been that there were lots of economic-loss only class actions filed in the state targeting almost everything, including OTC drugs.
OTC manufacturers subject to these suits responded by first developing the preemption defense. The big win for the good guys (the defense, of course) was Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72 (Cal. App. 2002), involving head lice treatments. Supposedly these products were ineffective because those nasty little buggers had developed resistance to the active ingredient. In other words, the evolution of the organism had overcome the original intelligent design of the product. The defendants argued, and the court agreed, that the claim for purely economic loss, brought (inevitably) as a class action, was preempted because it wasn’t “product liability”:
The savings clause states plainly and unambiguously that the preemption provisions of the section do not affect “the product liability law of any State.” Under the product liability law of California, injury to the plaintiff from a defective product is an essential element of a cause of action. Liability may be imposed either for personal injury or for physical damage to property, but if the damage consists solely of economic losses, recovery on a products liability theory is unavailable.
Plaintiffs acknowledge that their complaint does not allege any personal injury or injury to property as a result of using defendants’ products. They argue, however, that Congress intended “product liability law” within the meaning of section 379r(e) to have a broader meaning, encompassing an expansive category of state common law and statutory actions imposing liability on commercial sellers of products. The argument is inconsistent with the fundamental principle that a savings clause should not be interpreted in such a way as to undercut or dilute an express preemption clause. . . .
[L]egislative history. . .confirms its plain meaning. Commenting on the scope of the savings clause, the Senate committee report. . .states, “Finally, the legislation explicitly provides that it shall not be construed to modify or otherwise affect the traditional product liability law of any State. Tort liability rules and requirements would remain unchanged and unaffected.” Plaintiffs have not alleged a cause of action under the traditional product liability law of this state, and the savings clause does not exempt their claims from preemption.
122 Cal. Rptr.2d at 80-81 (various citations omitted).
The California Supreme Court got its hands on the same question a few years later in Dowhal v. SmithKline Beecham Consumer Healthcare, 88 P.3d 1 (Cal. 2004), involving OTC nicotine gum used to stop smoking. The court acknowledged the extraordinary depth of OTC preemption. A state requirement “may be ‘different from, in addition to, or ... not identical’ to an FDA requirement, without actually conflicting with the federal requirement.” Id. at 7 (statutory citation omitted). The court found the claim preempted:
Although there is reason to believe that nicotine can cause reproductive harm, plaintiff has offered no qualitative assessment of this risk. The mere existence of the risk, however, is not necessarily enough to justify a warning; the risk of harm may be so remote that it is outweighed by the greater risk that a warning will scare consumers into foregoing use of a product that in most cases will be to their benefit. The FDA has so determined in this case, and we find no basis to question the FDA's expert determination.Id. at 14. Since then, federal courts have also joined the party in California. Carter v. Novartis Consumer Health, Inc., ___ F. Supp.2d ___, 2008 WL 4694585, at *9-10 (C.D. Cal. Aug. 5, 2008) (adopting Riegel preemption in light of similarity of preemption language; consumer fraud claims against manufacturers of OTC cough/cold medicines preempted; although safety issue was alleged, only economic loss was sought); cf. Gaeta v. Perrigo Pharmaceuticals Co., 562 F. Supp.2d 1091, 1095 (N.D. Cal. 2008) (noting issue in personal injury case; finding claims preempted on other grounds).
But it’s not just California anymore – especially after Riegel. In Mills v. Warner-Lambert Co., ___ F. Supp.2d ___, 2008 WL 4488308 (E.D. Tex. Sep. 30, 2008), the same head lice claims that Kanter held preempted resurfaced in Texas. Citing Kanter extensively, the court in Mills held that the claims (again, for purely economic loss) were preempted. First, under Riegel and Kanter there were broadly preemptive federal “requirements”:
The similarities between the approval process for medical devices [in Riegel] and the approval process for drugs make the reasoning of those cases relevant here. Based on that reasoning, the NDA approval process establishes a federal requirement for drug labeling under Section 379r. As the California Court of Appeals wrote in Kanter, “[t]he parallels between the premarket approval process for medical devices and the new drug application process with respect to product labeling are striking.”2008 WL 4488308. at *11.
Second, state law potentially imposed additional requirements:
[A]part from Riegel, the text of Section 379r also indicates that the term “requirements” includes State law claims. Section 379r(e), the statute’s “saving clause,” exempts “any action. . .under the product liability law of any State.” There would be no reason to exempt only product liability actions, unless Congress intended to encompass State law claims within the term “requirement,” in Section 379r(a). . . . [B]y excluding only product liability actions, Congress made clear that the term “requirement” includes all other State law claims.2008 WL 4488308. at *14.
Third, the standards were different. Plaintiffs took a position concerning the safety and effectiveness of the product that was “diametrically opposed” to that of the FDA:
[T]he FDA specifically reviewed the safety and effectiveness of [the first product] during the NDA process. The FDA determined that [it] was “effective” for the [indicated use in question]; and, required that such language appear on the [product’s] label. Similarly, during monograph process, the FDA tested the active ingredients in [the other products] and determined that they were “safe and effective” for the [indicated use]. The FDA then issued a final monograph for [this type of product], specifying the terms upon which they may be sold without being misbranded. If Defendants sell [their products] without the FDA-required language on the drug’s label, they are subject to regulatory action. However, if they sell the drugs with the FDA-required label (and Plaintiffs prevail in this suit), Defendants will be subject to liability. The two requirements are clearly different.2008 WL 4488308. at *15.
Fourth, and finally, plaintiffs’ action for purely economic loss was not a “product liability” action saved from preemption by §379r(e):
[This provision] indicates that Congress did not intend to attribute any particular meaning to “product liability law.” Rather, the statute’s language reflects an intent to defer to each State’s interpretation of “product liability,” and thereby avoid interfering with the State’s product liability regime. Despite Plaintiffs' attempt to frame the issue differently, the relevant question for this Court is whether Texas considers Plaintiffs' claims to be product liability actions. . . .2008 WL 4488308. at *16. Since claims for purely economic loss were not “product liability” claims as defined under state law, they were not saved from preemption, and the court granted summary judgment. Id. at *19.
It is beyond dispute that Plaintiffs’ claims in this lawsuit do not “aris[e] out of personal injury, death, or property damage.” Their claims seek only recovery of the purchase price for the [products]. As such, they are not products liability actions, as defined by [Texas statutory law].
There are a few other cases construing §379r(e). In Warner-Lambert Co. v. Mills, 117 S.W.3d 488, 494 (Tex. App. 2003), the court found economic loss claims so thoroughly preempted by §379r(a) – and not saved by subsection e – that there wasn't even state court jurisdiction to hear them. The Texas Supreme Court reversed that latter aspect of Mills, holding “[e]ven if the defendants are correct that the FDCA preempts this state-law claim, however, it does not mean that the trial court lacked jurisdiction over the claim.” Mills v. Warner Lambert Co., 157 S.W.3d 424, 427 (Tex. 2005). In Tesauro v. Quigley Corp., 2006 WL 4401695 (Pa. C.P. Philadelphia Co. Nov. 8, 2006), a state trial court, citing Kanter, held that economic loss claims (breach of warranty and unjust enrichment) involving a cold medicine were preempted. In Berenguer v. Warner-Lambert Co., 2003 WL 24299241, at *4 (Fla. Cir. Hillsborough Co. July 31, 2003), another head lice case was held preempted.
We haven’t handled many OTC cases in our careers (we surely would have touched upon this topic sooner, if we had). So we have to fess up to a little jealousy here, that manufacturers of products for which the FDA doesn’t even require a prescription have a nice, clean preemption defense to purely economic loss class actions – something we consider strike suits – whereas our clients’ more heavily regulated products don’t. But then, we’re talking about express preemption, and nobody said Congress has to act rationally in everything it does.
But if we ever do get one of these OTC purely economic loss cases, we certainly won’t question our good fortune, or §379r.
Monday, November 24, 2008
When people suffer an actual physical injury as a result of an allegedly defective product, they can usually find a lawyer willing to take their case on a contingent fee. The lawyer files a lawsuit on behalf of that one plaintiff seeking to recover money damages.
When no one has been injured by the product, it's trickier to gin up a lawsuit that will convince a defendant to pay money to resolve the claim. Thus, in the "no-injury" cases, plaintiffs' counsel rope all of the non-injured people into a supposed "class" of plaintiffs and file a lawsuit on behalf of the entire class. (We don't make this stuff up. For a collection of "no-injury" cases in the context of drugs and devices alone, click on the "No Injury Scorecard" over on the righthand side of this blog, or just click here for a quick view.)
If a court certifies a class of thousands or millions of people, the defendant is facing a serious risk at trial, even if none of the plaintiffs has been injured. If it works, this game can be worth real money to plaintiffs' counsel.
Sometimes it's hard for plaintiffs' counsel to find a legal theory to support claims being brought by people who weren't hurt. But state consumer protection laws occasionally do the trick. In some states, the elements of statutory consumer protection claims are amorphous, so allegations that wouldn't support any traditional claim may (wrongly, in our view) state a consumer protection claim.
We thus see a fair number of putative class actions brought under state consumer protection laws.
In February 2008, the Tennessee Supreme Court put an end to this for claims brought under Tennessee law. Walker v. Sunrise Pontiac involved a claim that a car dealership misrepresented the nature of "dealer incurred costs" that it passed on to people who bought cars from it. Walker sued on behalf of a putative class of people who had supposedly been misled into paying these charges.
The trial court certified the class.
The Tennessee Supreme Court reversed. The court held (as most courts do) that the individualized nature of any misrepresentations made to customers precluded certifying a class of fraud or misrepresentation claims.
And, on the issue dearer to our hearts, the court also held that plaintiffs cannot, under any circumstances, bring class action claims under the Tennessee Consumer Protection Act. Tennessee Code Annotated section 47-18-109(a)(1) provides that "[a]ny person . . . may bring an action individually to recover actual damages." The word "individual" refers to a single person, as opposed to a class or group. Thus, by its plain language, the Tennessee Consumer Protection Act does not allow class action lawsuits.
If protection of a class of people were necessary, the Act gives the state Attorney General and the Division of Consumer Affairs of the Tennessee Department of Commerce and Insurance the power to investigate and prosecute violations of the law. Thus, the Act protects the public without the need for private class actions.
This decision will help defendants in three ways. First, Tennessee residents cannot bring class actions under the TCPA. Second, when plaintiffs bring class actions on behalf of the citizens of all fifty states, courts will have to recognize that at least some of the plaintiffs -- those who live in Tennessee -- are not permitted to proceed on a classwide basis. That legal wrinkle will provide extra ammunition to defendants trying to avoid certification of a nationwide class. Finally, when plaintiffs bring cases against corporations that reside in Tennessee and insist (improperly, in our view) that Tennessee law should apply to everyone, that Tennessee law will not permit the case to proceed on a classwide basis.
This isn't a drug or device case in particular, but it's a decision that will affect putative class action lawsuits brought against many product manufacturers, including those who inhabit our little sandbox. All lawyers who defend class actions should be aware of this case.
Thursday, November 20, 2008
The other half has been there and done that. In the spirit of “there but for the grace of God, go I,” he has expressed empathetic frustration. So today we’re going to discuss some dos – and some don’ts – of drafting motions in limine, with an emphasis (duh!) on mass pharmaceutical/medical device torts.
Select – We don’t presume to tell anybody all the motions in limine to file in any particular mass tort. Obviously, that varies with the litigation. It seems, though, that every company has a couple of people who don’t quite grasp that snarky things put in emails, or making off-the-wall marketing proposals – even if nothing comes of them – can come back to bite the company itself in litigation. Because the range of some people’s obtusity (is that even a word?) is seemingly endless, every mass tort will present at least some new or different motion in limine possibilities.
But the key to selecting motions in limine is the same as much of the rest of the process – on the whole, motion in limine practice isn’t plowing new ground. Chances are, if you haven’t done this before, somebody else at your firm has. “Don’t re-invent the wheel” is the first principle here. Save the client’s money, for chrissake. So, step one, which seems obvious, but can’t be overstated, from the partner in charge of the whole shebang to the junior associate drafting the most mundane of motions, is to review the motions in limine that your firm’s already filed in similar litigation.
Next (or if you’re truly new to the game, first), go to Westlaw and Lexis. The services have been bulking up on filed briefs and motions for a number of years now. Most, if not all, of the opinions in the major pharma/device mass torts – you know, the ones that read “In re [fill in the blank] Products Liability Litigation” – have links to scores (sometimes hundreds) of pretrial filings, including lots and lots of filed motions in limine. Reviewing what’s been filed in two or three mass torts involving similar products/issues (e.g., drug vs. medical device; on- vs. off-label use; recall vs. no recall) should provide a pretty good sample of what’s out there. Add to that some common sense, and a careful review of the litigation’s particular “bad documents” and expert reports and presto! A list of motions in limine emerges.
Standardize: Only “foolish” consistency is the “hobgoblin of small minds.” If there are going to be two dozen different motions in limine (and, sadly, that’s a conservative number in many mass torts), they should look pretty much alike. To some extent, it’s simply a matter of the particular law firm’s style – how the footnotes will look, whether the text is justified or not, that kind of thing. Some stylistic decisions are driven by rules of court – whether letter-brief format required, whether footnotes be in a smaller typeface. Gotta get these right. The first thing actually to draft is thus a standard form for all motions in limine. We emphasize first. It’s far easier to get the right caption, headings, paragraph/footnote styles, signature blocks, etc. done once than to reverse engineer two dozen (or more) individual draft template motions, or worse, a hundred motions in limine after they’ve been cloned for filing in individual cases.
So start with a standard form, and distribute it to everyone who will be preparing drafts.
Templatize: Mass torts are repetitive. Most of the legal issues covered by motions in limine will recur in, if not all of the plaintiff’s cases, then in a significant subset. Some motions in limine, making a purely legal point, will be identical for all cases – at least at first. In others, facts unique to individual cases will have to be added to a legal argument that’s essentially the same.
For ease of use, and for ease of updating, it’s usually best to prepare motions in limine in template form, complete with fill in the blanks and alternative paragraphs for recurring fact patterns. The templates can then be distributed to the various case teams, or to local counsel, for adding case-specific facts.
Preparing a template motion means something else, too. The template needs to be absolutely the highest quality work product. We know, everything is supposed to be the best we can do, but the reason why it’s called a “template” is because it’s going to get filed over and over again. A lot of other lawyers are going to see it, use it, and revise it. It’s not a good idea – for you or for your firm – if these other lawyers feel compelled to re-do parts of it that you’ve written, and that aren’t supposed to need revising.
Once templates are prepared and approved, they need to be kept in one place, presumably a file in the litigation’s computer work space. Preferably one person should then be charged with updating all the templates once they are actively being used in litigation. Some changes will, of course, be adaptations to address opposing arguments, or developments in the jurisdiction’s case law. Another set of updates will be to include favorable rulings on the motion when presented in individual cases – especially if multiple judges are trying cases.
This last point is really important. It’s the reason for filing essentially the same motion over and over again. The point is to file a motion in limine and win. That makes the next motion easier – if our next version isn’t just a refiling of the original motion. Rather, we update the original template motion to tell all subsequent courts that this precise issue has already been litigated, and our client won. The whole point is to build your own favorable – and indistinguishable – precedents. Don’t let them go to waste.
Often there will be a set of exhibits to be filed with a template motion. It’s a good idea to collect all the exhibits together, attach them all to something like an email and archive the set of template exhibits together with the template motion itself. That way nobody ends up scrounging around (inevitably at the last minute) for exhibits ever again.
Organize: Document naming conventions are an oft-overlooked aspect of keeping track of motions in limine. After the trial phase gets well underway, there are going to be dozens of similar looking documents in your firm's document database. Since the templates are being constantly updated, it's crucial not only to know what's what, but when a particular motion was filed. The document names for all motions in limine should provide the necessary information without having to individually open up and review the document itself. All Templates should be designated as such. The names of motions filed in individual cases should include both the name of the case and the date (month and year are fine) of that case's motion deadline. Making sure this is done in advance saves a lot of time later on.
Plagiarize: Now we’re talking to the (probably) associate assigned to draft specific motions. The "don’t reinvent the wheel" principle applies here, too. By now most (we would like to say all) firms have full-text searching capability for their own documents. Know how to do this and use it. It saves you time and the client money.
But don’t stop there. Many, probably most, motions in limine have been filed before in other litigation. Lots of those motions are on Westlaw or Lexis. There’s a reason why it takes so darn long for a Vioxx or Rezulin or fen-phen opinion to open up when you click on it while doing computer research. That reason is all the links supplied at the end of the opinion to all the briefs filed in these big mass torts. Use them, too.
Customize: This is the flip side of the plagiarize principle. If all it took to prepare a motion in limine was copying a prior brief and putting a new caption on it, that task wouldn’t have been assigned to a lawyer. For one thing, the jurisdiction is likely to be different. That means that the citations for the boilerplate propositions – like who bears the burden of proof – need to be watched.
If the motion is being filed in, say the Eastern District of Arkansas, then we’ll want to see Eighth Circuit precedent for such routine propositions. A Third Circuit case, left over from some other brief, not only looks odd, but it will make the court (and us) question whether the relevant appellate court (judges don't like being reversed) actually adheres to the principle we’re relying on.
“Proper law” also means, where there are lots and lots of cases for the same proposition, citing one that: (1) comes to the “right” result (exclusion or admission, depending on which side the motion is arguing), (2) is in a civil, rather than a criminal case – ideally in another product liability case, and (3) best of all has something else to do with the motion (recognizing that this last point is not always possible).
Simply picking the first case that shows up for the proposition in a long list of computer generated citations is not a good idea.
Customizing also means plagiarizing from more than one earlier brief. The first one you find might not be very good. That’s a fact of life. There are a lot of bad briefs in the Lexis and Westlaw databases – and presumably in law firm internal databases (present company excepted, of course). A way that often works quickly is to click on the “citing references” link for a key case, such as the Rezulin case for excluding corporate intent evidence or the Norplant case for excluding marketing materials that the prescribing physician never saw. Cases like that will be cited in just about every motion in limine available online (and you wouldn’t want to read motions that miss the most important case, anyway). Read through enough motions in limine on the same topic, and it’s pretty easy to synthesize an argument that’s actually better than any single brief that you’ve read.
Finally, there are a bunch of pickier details that, if we’re reviewing a draft, we don’t think it should be our responsibility to fix. Is it one plaintiff or more than one? Make sure the cloned motion uses the correct number (singular or plural) of plaintiffs. Is the plaintiff male or female? Make sure the pronouns are for the right sex. Is the jurisdiction a “state” or a “commonwealth”? Things like that. Those kind of picayune things should be handled at the initial cloning stage. They shouldn’t be the responsibility of the more senior people who are editing these briefs for substance.
Write For The Judge: Is the motion in limine a letter brief to be filed in state court, or a global motion that will decide the point for a bellwether trial in a federal MDL? The answer to that question will have a lot to do with how motion will look. A state trial judge with limited help from clerks isn’t going to read a ten-page argument citing every case anywhere that excluded adverse drug experience reports as unreliable. But that might well be precisely what an MDL motion, particularly in a bellwether situation, is supposed to argue. Know the situation and write the motion accordingly.
When in doubt, though, put it in. If we're reviewing the motion, it’s better to have and not need an argument than to need it but not have it.
Write For The Facts: “Bad documents” come in an almost infinite variety of forms and topics. Every mass tort we’ve ever been in generates quite a few “that’s irrelevant” (Fed. R. Evid. 401-02) or “probative value outweighed by undue prejudice” (Fed. R. Evid. 403) motions in limine. These motions present special challenges.
There’s plenty of precedent – an overwhelming amount, actually – about Rules 401-03. What we want to see cited as precedent are those cases with similar fact patterns, such as: (1) It was a dumb marketing idea, but it never saw the light of day, so it’s irrelevant. (2) That proposal might well have violated the FDCA, but we didn’t use it, or if we did, only in some state halfway across the country, and you shouldn’t let plaintiffs tell the jury that the client a criminal over something that remote. (3) That involved a dose three times what the plaintiff ever took. We’ll have to introduce in a whole new set of studies to address it.
No 1: Irrelevant. No. 2: Undue prejudice. No. 3: Collateral and a waste of time.
So how do you find the needle in the haystack?
We’re assuming there’s nothing out there in terms of other briefing. Also easy sources – drug-related headnotes, Bexis’ book, ALR articles – have been reviewed without success. So don't blame us (well, maybe Bexis, for leaving it out of his book) for your predicament.
At this point more general keynumbered headnotes are unlikely to be of much use, because evidentiary rulings tend to get grouped by substantive subject (criminal law, contract law, ladders, etc.). We’re beyond that at this point. So now what?
The one place online where all (well, most, but a very high percentage) of the potentially relevant cases are found in one place are in the annotations to the relevant evidentiary rules. Once that window is open, then it’s possible to focus the search, either by some term (“off-label” perhaps, or even “different”), or by jurisdiction. Narrowing the search in that way lets the searcher click through all headnotes under the rule that are in the targeted jurisdiction (say, the Seventh Circuit and the Southern District of Illinois), or all cases ruling on when off-label promotion is too prejudicial to be admissible.
If that doesn’t work – and sometimes it won’t – you’re back to the general libraries. At that point, you’re just going to have to read a lot of cases. Get over it. Life isn’t fair.
A Special Note About State Motions: State motions in limine are a lot like federal ones, except that the number of relevant cases is likely to be less – not if you’re comparing the Northern District of Iowa with the whole state of California – but in general. It’s possible to find state-court motions in limine in some jurisdictions, particularly where there are state-law equivalents to federal MDLs (one of Herrmann’s favorite topics).
But there might also be actual state trial court rulings on some of these topics. So, how do you make sure you get them? Now it doesn’t seem to be much of a problem on Lexis, but on Westlaw they’ve gone and created a whole new set of libraries just for state trial court opinions (“trialorders”). A good thing? You would think, but you have to be careful.
The problem is, on Westlaw, the trialorders databases are kept separate. If you search in the state-specific database for what’s supposedly “all” the cases in the state, you don’t really get “all” the cases.
What? You tell me that, if I search “all,” I don’t get “all.” What do I get?
Less than all, that’s what. You only get all the appellate cases – and in some states trial court opinions that are actually published in some sort of reporting service.
We know. We know. We’ve had this discussion with Westlaw ourselves.
On Westlaw, it’s necessary to search the trialorders databases (and there aren’t ones for every state) separately. Now, Westlaw has its reasons for doing things this way (we disagree, but it’s their business), but for us lawyers – especially junior lawyers drafting this sort of motion – it can be a trap for the unwary. So when putting together a state-court motion in limine, if you’re using Westlaw, remember to check separately for relevant state trial-level decisions.
Do all these things, and chances are you’ll end up involved with a lot of motions in limine. Hey, ditch the queasy feeling. Like having another birthday, it may well beat the alternative – at least until you’re senior enough to be giving, rather than receiving, this kind of advice.
Tuesday, November 18, 2008
Professor Epstein favors preemption, but he thinks that Wyeth's position does not go far enough: Wyeth seeks preemption only because of a conflict between the warnings that the FDA required and the warnings that Levine insisted were necessary. Epstein prefers "field preemption," in which FDA regulation would displace state law whether or not the FDA-mandated warnings conflict with those sought by a plaintiff, because the FDA alone should control drug labeling.
Epstein suggests that Congress should pass a law guaranteeing preemption, if necessary: "Congress should cut through the legal tangle by explicitly preventing tort plaintiffs from doing an end run around FDA-approved warnings. "
Hat tip to Overlawyered.
In 2006, the California legislature passed a law that included something called the California Environmental Contaminant Biomonitoring Program. Cal. Health Safety Code § 105440-105459 (2008). That program “shall utilize biological specimens, as appropriate, to identify designated chemicals that are present in the bodies of Californians.” Participation in the program is completely voluntary, but, once a person agrees to be in the program, he or she will be evaluated for the presence of “designated chemicals” (defined as “chemicals known to, or strongly suspected of, adversely impacting human health or development. . . .”). The individuals will be given the results of their tests (presumably blood, urine or saliva), if they ask, and “when either physiological or chemical data obtained from a participant indicate a significant known health risk (undefined by the statute), program staff experienced in communicating biomonitoring results shall consult with the individual and recommend follow-up steps, as appropriate.”
The “Scientific Guidance Panel” designated by the legislature has not yet made its recommendations on the “design and implementation of the program, including specific recommendations for chemicals that are priorities for biomonitoring in California,” but, when that program is up and running, some people will be receiving information about biomarkers of exposure. What might they do with that information?
One possibility is filing a lawsuit. Two recent cases have discussed how courts might handle biomarker of exposure evidence.
In Cleary v. Wallace Oil Company, 2008 WL 4682615 (N.Y. A.D. 2 Dept.), the Second Department of New York’s Appellate Division considered what evidence of harm was necessary in a case for negligent infliction of emotional distress. In that case, the defendant had accidentally pumped 900 gallons of home heating oil directly into the plaintiff’s basement. No one was home at the time.
The appellate court affirmed the grant of judgment as a matter of law in favor of the heating oil company. The court said that the law in New York is that “a breach of a duty of care ‘resulting directly in emotional harm is compensable even though no physical injury occurred.’” However, to prevent frivolous claims, a requirement exists that the claim “possesses some guarantee of genuineness.” That “guarantee of genuineness,” in New York, is “clinical evidence of some physical manifestation of contamination,” or evidentiary proof of “some other indication of a toxin induced disease.”
In the Cleary case, the court held that the plaintiffs put in no evidence that they were exposed to the admittedly “toxic environment” when they went into the house after the spill, nor did they present “clinical evidence of some physical manifestation of contamination,” or proof of “some other indication of a toxin-induced disease.” Though, in that case, the ability to detect hydrocarbons from heating oil in the bodies of the plaintiffs would have been very difficult, especially after some time had elapsed, in another type of case, biomarkers might be able to supply that proof.
In fact, New York decisions have held that the “clinically demonstrable presence of a toxin in the plaintiff’s body” satisfies the evidentiary requirement. See Prato v. Vizliatta, 253 A.2d of 46 (1998); Abusco v. Consolidated Edison Co., 238 A.D. 2d 454 (1997) (PCBs). That “clinically demonstrable presence,” for example, can be satisfied by the “clinical presence of asbestos fibers in the lung.” Rittenhouse v. St. Regis Hotel Joint Venture, et al., 149 Misc.2d 452 (1990). The court there pointed out that New York and federal courts had upheld jury verdicts that awarded damages for fear of cancer when the plaintiff had scarring in the lungs [fibrosis] or of the pleura [pleural plaques or thickening].
In Rittenhouse itself, though, there was no objective, physical evidence of an asbestos-related condition. Therefore, there was no rational basis for fear of disease. “In view of the fact that asbestos was widely used and asbestos removal [is] now common, fear of cancer without a physical indication of disease is not reasonable.” The Appellate Court upheld that aspect of the lower court’s determination (though it reversed an award of attorney’s fees), saying “since we find that all objective testing of plaintiff’s person and possessions had demonstrated no physical manifestation of asbestos contamination, we agree with the . . . determination granting defendant’s motion for summary judgment.” Rittenhouse v. St. Regis Hotel Joint Venture, et al., 180 A.D.2d, 523 (1992).
However, a recent decision by the Ohio Supreme Court (in the context of deciding whether certain revisions to state laws governing asbestos litigation were retroactive) weighed in on the extent to which pleural plaques could be used to support an injury claim. In that case, Ackison v. Anchor Packing Company, et al., 2008 WL 4601676 (Ohio), the court held that the provisions were retroactive. However, in so ruling, it also commented on an Ohio Appellate Court decision, Verbryke v. Owens Corning Fiberglass Corp., 84 Ohio App.3d 388, 616, N.E.2d 1162 (1992), which had held that pleural thickening or “plaques” were sufficient to constitute an injury, for purposes of stating a personal injury cause of action under Ohio law. The Ohio Supreme Court said that, contrary to the plaintiff’s assertion, that case did not establish the substantive rule that pleural thickening was sufficient, in Ohio, to “establish a compensable injury for asbestos exposure.” In fact, said the court, the biomarker of pleural thickening, or pleural plaques, is not sufficient, alone, to establish “asbestos-related illness or impairment,” necessary for personal injury tort recovery in Ohio.
These decisions are obviously not inconsistent, because the New York case just allows evidence of the toxin in the body (the biomarker) to be used to prove an emotional distress cause of action, and the Ohio case just refuses to allow evidence of the biomarker to be used to prove “bodily harm” in a personal injury cause of action. However, both cases illustrate that biomarkers have taken on increasing significance in litigation, and the California approach may well lead to yet more litigation.
Monday, November 17, 2008
Without Supreme Court guidance, the issue will continue to percolate in the lower courts.
And percolate it has.
The most recent decision came down on Halloween. See Grange v. Mylan Laboratories, No. 1:07-CV-107 TC, 2008 WL 4813311 (D. Utah Oct. 31, 2008).
Physicians prescribed Mylan Labs' Fentanyl Transdermal System to relieve Ronald Grange Sr.'s pain. The fentanyl patch allegedly malfunctioned, delivering a fatal overdose of fentanyl. Grange's estate and two of his children filed suit in Utah.
We're going to note in passing a couple of preliminary issues that might matter in particular cases but that are not the thrust of our post today. First, Grange used the fentanyl patch in Utah, but Mylan manufactured the patch in Vermont. The federal trial court held that Utah, not Vermont, law applied to plaintiffs' claims.
Second, the court dismissed plaintiffs' strict liability design defect claim, because that claim is not viable under Utah Supreme Court precedent.
And the court then addressed the issue that we're thinking about today -- the one that the Supreme Court didn't resolve in Warner-Lambert v. Kent.
A Utah statute says that plaintiffs cannot recover punitive damages in a case involving a drug that was approved by the FDA. Utah Code Ann. Sec. 78B-8-203(1). That immunity does not apply, however, if "the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration." Id. Sec. 78B-8-203(2).
As readers of this blog well know, the Supreme Court case of Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341 (2000), holds that state law fraud-on-the-FDA claims are impliedly preempted by federal law. So what happens when a statute gives a drug manufacturer some type of immunity, but the statute then creates an exception to the immunity if the manufacturer defrauded the FDA? Is the exception preempted by Buckman? If so, does the immunity still stand? We posted here on a similar issue that arose under Texas law in the Vioxx litigation last year.
Judge Tena Campbell, of the federal court in Utah, came down on the side that we prefer. If plaintiffs were allowed to present evidence of fraud on the FDA, then "state courts are essentially second-guessing the FDA and drug companies, nervous about state litigation, will have an incentive to flood the FDA with information." Grange, 2008 WL at *7. The fraud-on-the-FDA exception is thus preempted under Buckman, leaving only the immunity from liability for punitive damages intact.
The court noted that preemption would not apply "in cases where the FDA itself has found that there was fraud in the application process." Id.
As we've noted previously, many states have laws that give drug manufacturers some type of immunity if their products are FDA-approved, but then create fraud-on-the-FDA exceptions to that immunity.
Utah courts will not be alone as they grapple with this issue in the future.
Friday, November 14, 2008
No, we're not changing our defiantly clunky appearance. Our readers come for the substance, not to look at pretty pictures and fancy fonts.
But we are under construction.
A lot of our links are broken. You don't have to tell us, we know. We're trying to fix them, but it's one more thing to do whenever we can get around to us.
The site (File Den) that hosted our uploads, and thus our links to things like FDA amicus briefs, suddenly closed our account, with neither notice nor explanation. We have no idea why, but that closure broke all of our links.
We'd demand our money back, except the service was free.
We know, we know ... you get what you pay for.
Anyway, we're trying to fix these links, but sometimes we have to go out and try to find things all over again. We've got most of them since August working but before that ... well, we're under construction.
Thursday, November 13, 2008
We said that we thought the case was very important – and very wrong – for separating liability for product warnings from the manufacture or sale of the product. Probably because we were first on the web with Conte, our little post drew a lot of attention, from the FDA Law Blog (who saw “potentially vast” implications), the Tort Professors (who called the decision “stunning”), Pharmalot, The Recorder (a major California legal newspaper), Law and More (which called it a “legal game changer”) and Overlawyered. That’s a lot of attention for a little post in a little blog like ours.
But then the Conte case warrants a lot of attention. So we’ve thought about it some more. The more we think about it, the worse it gets. At bottom Conte is based on two fallacies. The first of these we’ll call the "Lipstick On A Pig" fallacy. That fallacy is, if you put lipstick on a pig it will somehow be something other than a pig. The Conte decision fell for this, snout, line, and mascara.
California's where they basically invented modern product liability, well before Restatement (Second) of Torts §402A (1965). The seminal case, Greenman v. Yuba Power Products, Inc., explained the rationale for what it called “strict liability”:
We need not recanvass the reasons for imposing strict liability on the manufacturer. The purpose of such liability is to insure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves.377 P.2d 897, 901 (Cal. 1963).
And that’s been the bedrock rationale for product liability ever since – that manufacturers should bear the costs of injuries when they make defective products. The only really serious breach of that standard was market share liability in Sindell v. Abbott Laboratories, 607 P.2d 924, (Cal. 1980). The Sindell court, after recognizing “the proposition that, as a general rule, the imposition of liability depends upon a showing by the plaintiff that his or her injuries were caused by the act of the defendant or by an instrumentality under the defendant's control,” id. at 928, created a narrow exception where: (1) the manufacturer was unknown, because (2) there were a bunch of interchangeable chemically identical products made by different companies, and (3) the plaintiff was not at fault for not knowing the manufacturer (in Sindell a drug caused injuries that did not manifest themselves for decades, after pharmacy records were typically destroyed). Even then Sindell recognized the gravity of the limited exception it was creating:
In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs. . . . [W]e acknowledge that some adaptation of the rules of causation and liability may be appropriate in these recurring circumstances.Id. at 936. The Sindell court thus reiterated the overall policy that a “manufacturer is in the best position to discover and guard against defects in its products and to warn of harmful effects; thus, holding it liable for defects and failure to warn of harmful effects will provide an incentive to product safety.” Id.
So what happened in Conte? Fifty-five years of California product liability policy goes out the window. None of the Sindell factors for easing the manufacturer-liability link are present. The manufacturer of the drug is identified, who made what product is not in doubt, since there are only two defendants, and there’s no long-delayed injury (Reglan allegedly causes tardive dyskinesia, a condition that quickly becomes all-too-apparent).
The Conte court gets to this result by putting lipstick on the product liability pig and calling it “fraud” or “negligent misrepresentation.”
[W]e reject [defendant’s] syllogism premised upon product liability doctrine that. . .this is merely a products liability lawsuit disguised as an action for fraud and misrepresentation. . . . The conclusion would be sound were [plaintiff] in fact pursuing a cause of action against [defendant] for strict products liability. But she is not. The complaint alleges that [defendant] made intentional and/or negligent misrepresentations about the safety of [the drug].2008 WL 4823066, at *5. Form over substance. Over and over again, the court focuses on the lipstick rather than the pig. Id. at *6 (“this is a case involving legal principles of negligent misrepresentation, and not a products liability action”), at *8 n. 9 (refusing to apply principle that “a manufacturer owes no duty to consumers injured by a competitor’s product” because “we do not find this principle determinative in a suit based on allegedly actionable misrepresentations”), at *11 n.16 (rejecting public policy arguments as product liability-related); at *12 (rejecting all relevant prior precedent as rellying on product liability-related criteria).
Sorry, but we ain’t buying that pig in a poke. The alleged misrepresentations are limited solely to statements made in the labeling that accompanied the product. While at one place Conte asserts that the case is about “a defendant who authors and disseminates information about a product manufactured and sold by another,” 2008 WL 4823066, at *6, that’s simply wrong. The claims at issue “are premised on misrepresentations in [the drug’s] labeling” and “in a monograph [the defendant] provided for the Physician’s Desk Reference (PDR).” Id. at *4. The PDR compiles FDA-approved drug labeling, id. at *4 n.4 - the same sort of routine product warnings that have been the bread and butter of product liability liability litigation for decades. We think that the labeling-related claims in Conte are product liability claims no matter how much legal lipstick anybody puts on that pig. The outcome of a case should not depend on the caption by which the plaintiff chooses to call the cause of action.
In this sense, “intentional/negligent misrepresentation” is simply the latest in a long line of putative theories – trespass, negligent marketing, public nuisance, and market share liability itself – that plaintiffs have advanced in search of their promised land: industry-wide liability for non-defective products.
After wandering in the wilderness for 55 years, have plaintiffs found their promised land in California? We hope not.
The second fallacy the Conte court falls prey to we’ll call “omniforeseeability.” That’s just a made-up word for the truism that “anything is foreseeable in hindsight.” There are a number of terms in the law – “reasonableness,” “duty,” “foreseeability,” and “proximate cause” chief among them – that courts ordinarily invoke as a way of setting limits on liability. Before Conte, courts had (uniformly, we think) taken the position that foreseeability was limited, when liability for product-related attributes was involved, to the actions of the product manufacturer.
Hamilton v. Beretta USA Corp. is a good example of this limitation, rejecting pure foreseeability in the context of a negligent marketing claim alleged against all handgun manufacturers because “a duty and the corresponding liability it imposes do not rise from mere foreseeability of the harm.” 750 N.E.2d 1055, 1062 (N.Y. 2001).
Another, more recent, example of limited foreseeability is Gourdine v. Crews, 955 A.2d 769 (Md. 2008), which we discussed here. Gourdine held that it wasn’t legally foreseeable that a drug company’s supposedly inadequate warning would cause injury to anybody who the patient collided with while under the influence of the drug - thus preventing potential liability to the entire human race. We’re sure there are many other similar examples of legal foreseeability limiting factual foreseeability, because if there weren’t, Conte wouldn’t be such a big deal.
Hamilton and Gourdine are two cases holding that legal foreseeability is not the same, and is more limited than, factual foreseeability.
Conte goes all the way in the opposite direction. It rejects what it calls “heightened foreseeability.” 2008 WL 4823066, at *6 n.9.
Conte falls to the omniforeseeability fallacy, when it holds – using hindsight, of course – that it’s “foreseeable” that a doctor wouldn’t rely upon the labeling of the generic drug he just prescribed, but rather on similar labeling for the pioneer drug that he read years earlier (here, during the doctor’s residency):
[O]ur duty analysis must look primarily to the foreseeability of physical harm. . . . It is. . .highly likely that a prescription for [the pioneer drug] written in reliance on [its manufacturer’s] product information will be filled with generic [drug]. And, because by law the generic and name-brand versions of drugs are biologically equivalent, it is also eminently foreseeable that a physician might prescribe generic [drug] in reliance on [the pioneer manufacturer’s] representations about [its drug].2008 WL 4823066, at *8 (citations omitted). Thus foreseeability is used to trump both time and space – another manufacturer’s warnings from much longer ago, read anywhere, trumps nonreliance on the warnings that came with the product that the doctor actually prescribed.
Wow. You heard that right. Defendant's "duty of care in disseminating product information extends to those patients who are injured by generic metoclopramide as a result of prescriptions written in reliance on [defendant's] product information for Reglan." 2008 WL 4823066, at *9.
If “negligent/intentional misrepresentation” is what makes the product identification requirement vanish, pharmaceutical product liability isn’t the half of it. Try this hypothetical:
Plaintiff New Dad gives plaintiff New Mom his old SUV, manufactured by Gasguzzlers ‘R Us, so she has something big and safe to drive New Baby around. To replace it, he buys a hybrid made by Minigas, Inc. to drive to work. Wife puts New Baby’s carseat in the front seat, and plows into a telephone pole (or something else, it really doesn't matter). The airbag kills New Baby. Gasguzzlers ‘R Us didn’t get its federal bailout and goes bankrupt. But since both of the family cars had identical government-mandated (allegedly) inadequate warnings about not putting an infant car seat next to an airbag, who gets sued, Minigas – even though it’s car had nothing to do with the accident.
Farfetched? We wish. Isn’t it foreseeable that New Mom and Dad would have relied on the warnings in the brand new owner’s manual they just saw when buying their brand new hybrid, instead of the older manual in the SUV, which they haven’t looked at in years (assuming they still have the old manual at all)? Under Conte’s omniforeseeability analysis, why not?
So the hybrid maker ends up paying for injuries caused by an accident involving a different – and bankrupt – manufacturer’s SUV. We’ve seen plaintiffs come up with lots of creative theories when the usual suspect is broke. Think “asbestos.” We have no doubt they’d try something like this, and try it 100,000 times over.
So let’s try an asbestos hypothetical. We’ll keep it simple:
Landowner hires contractors, who hire subcontractors, who hire subs of their own, to install or remove asbestos products from Blackacre. The owner doesn’t tell anybody any more about asbestos risks than did the manufacturers, which is to say nothing. Half a century later, all the asbestos manufacturers are bankrupt, so the employees of all the various entities sue Landowner.
Why bother with all the ins and outs of premises liability? Just call the tort “negligent/intentional misrepresentation,” and under Conte all privity-related limitations upon premises liability evaporate. If Landowner could have known, everything else is “foreseeable.”
Finally, let’s try a hypo closer to home:
Careful Drug Co. gets word from the field that its drug, “X”, might cure high blood pressure when a doctor comes to it with a case series. Careful takes a look at its data and concludes that the doctor might just be right. It encourages the doctor to publish the data, and, because this would otherwise be an off-label use, immediately begins a clinical trial. Rival manufacturer, Flybynight, upon reading the published article, immediately promotes its competing drug, “Almost X,” off label for curing high blood pressure, and gets a huge market share because Almost X is much cheaper. Careful’s expensive clinical trial reveals that, when X is used long term it causes cancer. Everybody sues Almost X, and it declares bankruptcy/settles cheap/whatever. Everybody then sues Careful.
Under Conte omniforeseeability, is there liability against Careful where the article being used by Flybynight in its off-label promotion discussed Careful’s similar drug? Of course! Isn’t it foreseeable that the doctors would draw the analogy between the two closely related products (especially since that’s precisely what Flybynight’s reps were saying)? And to that, we can add that the relevant warnings for X and Almost X were identical because they were in same class. And isn’t it foreseeable that doctors would rely more on Careful, given it’s much better reputation, than Flybynight? How about if preliminary, short-term, results of Careful’s clinical trial were favorable and were published?
Because prescriber reliance is “foreseeable,” the responsible manufacturer (Careful) gets hit with liability for the sloppiness/illegal actions of a competitor (Flybynight). There’s nothing it can do about it, since it has no control over the competitor – short of closing its eyes to a potentially breakthrough new use for its product.
As these hypotheticals demonstrate, once the fundamental limitation of product liability that only the manufacturer can be liable for defects in its product goes bye-bye, a huge free rider problem develops. Liability for older products made by less successful manufacturers gets shifted to more successful manufacturers and their newer products. These newer products may well be safer. Or, as in the second hypothetical, liability arising from one manufacturer’s corner-cutting ends up being imposed upon a more reputable manufacturer that followed the rules.
And in the prescription medical product area it gets worse. Conte-style liability can only drive up the cost of new drugs – all of them. Generic drugs are cheaper precisely because their manufacturers did not incur the cost of drug development – costs which run into the hundreds of millions of dollars for each successful FDA approval. Because they are cheap, generics typically drive the pioneer manufacturer’s drug off the market (or into a very small market share) within a few years, if not sooner. Generic drugs will stay cheap under Conte. But imposing liability in perpetuity upon pioneer manufacturers for products they no longer sell or get any profit from means that the pioneer manufacturers (being for-profit entities) have to recoup that liability expense somewhere. There’s only one place it can come from. That’s as an add-on to the costs of new drugs that still enjoy patent protection.
Conte-style liability also is a disincentive to innovation - probably a dramatic one. That’s because imposing liability based upon labels/warnings that doctors once read years earlier when they were first introduced to a drug – or class of drugs – will inevitably hit the innovator the hardest. Remember penicillin? Of course. People won the Nobel Prize for that. Remember the second drug in the same class as penicillin?
Didn’t think so.
Well, that’s the way it is in medicine as just about everywhere. The innovator – the inventor of the first drug or device in its class – will get the most publicity and the most prestigious position. Its drug/device is going to be the one discussed the most in medical schools and in lectures to practicing physicians. The labeling for the first-of-its-class product is going to be what doctors read most and remember most vividly when they encounter it for the first time.
First impressions are important.
Now, back to Conte. Why was Wyeth’s liability at issue at all? Because the plaintiff had no warning causation case against the generic manufacturer (actually more than one, but that’s irrelevant) under well-established learned intermediary rule principles. The doctor testified that he hadn’t read and didn’t rely upon the generic manufacturer’s labeling. 2008 WL 4823066 at *13-15. That's summary judgment city for lack of warning causation (the unread, unrelied upon warning couldn't possibly have caused any injury). But the doctor also testified that he probably read the pioneer drug’s warnings, at least back when he first encountered the drug, years ago. Id. at *4 (prescriber testified that “he ‘probably’ read” the pioneer warnings “during his residency training” and that he “generally refers” to the Physician’s Desk reference (which contained the pioneer warnings) “in his clinical practice”).
So Conte transfers liability from the generic company that produced the drug and made a profit from it to the company that invented it – innovated – years ago.
But why should only generic drug-using plaintiffs get a free shot at a second defendant?
Nothing in Conte’s omniforeseeability reasoning is unique to generic drugs. Lots of drugs have what the FDA calls “class labeling.” You can search for them on the FDA’s website. Lots more in the same class undoubtedly have essentially identical labeling even if not formally mandated as class labeling. Statin drugs would be one example. There are certainly a bunch of those. SSRIs are another class of drugs that have experienced a lot of litigation lately. Think about birth control pills, bone screws (our sentimental favorites) or implantable defibrillators. The list goes on and on.
So anytime a plaintiff, as in Conte, has trouble proving warning causation against the actual manufacturer of a drug, what’s the potential target? The plaintiff will look to any manufacturer of the same class of drug whose labeling the prescribing doctor remembers – even vaguely, as in Conte – first learning about. And in virtually every case, that target is going to be the innovative manufacturer that first entered the field. Why? Because that’s the one that the doctor is going to remember.
First impressions are, after Conte, going to be expensive.
And what does Conte have to say about this sort of jurisprudential policy considerations? Essentially nothing. The decision chooses to ignore what isn’t in the record:
While there is much that could and will be said in various fora about the burdens, societal consequences, cost, and insurance implications of [defendant’s] potential liability, the limited record on summary judgment does not provide the information necessary to inform such a debate. These broader consequences of the duty we identify today cannot be considered on the limited facts in the record.
2008 WL 4823066, at *9. Well, of course not. Why would the defendant have any reason to anticipate that a wide-ranging theory of liability that even the court concedes is contrary to every precedent cited to it? Id. at *10-11 (refusing to follow all prior precedent from other jurisdictions); cf. id. at *5 (admitting issue is “one of first impression in California”).
"See no evil; hear no evil; speak no evil," doesn't mean there's no evil.
Conte is the very definition of “unprecedented.” And along with other precedent, the court refuses to consider policy either. What’s left is a very thin reed, indeed.
Whatever happened to the proposition “we may not as judges ignore what we know as men”? E.g., United States v. Maze, 414 U.S. 395, 403 n.7 (1974). We’re just a couple of bloggers and even we can think these things through without Brandeis briefs.
So the more we look at Conte, the worse it gets. It violates our sense of personal responsibility, shared by courts for 55 years, that manufacturers should be liable for defects in their own products – and only for defects in their own products. Conte will expand liability to deep pocket defendants, while letting free riders – whose conduct probably should subject them to liability – off the hook.
Unless, of course, the defendants sue each other as "concurrent torfeasors." 2008 WL 4823066, at * 11.
And the policy implications are truly awful. Conte holds manufacturers liable for competing products they can’t do anything about, on the basis of supposed “misrepresentations” they can’t change because they no longer control them, if they ever did. The liability is without end – as long as anybody makes the product. And in the drug/device area, Conte-style liability will inevitably serve as a lead weight around the ankles of the companies that invented the most significant breakthrough products.
Conte is bad law and worse policy.
We certainly hope Wyeth succeeds in getting it reversed.
Needless to say, that site draws a lot of traffic.
But yesterday, Above the Law amazed us.
This blog receives about 1000 pageviews on a typical weekday.
Yesterday, we received 3554.
And a full 2415 of those views were the result of Above the Law linking to a couple of our recent posts (here and here).
That's an astonishing number. By way of contrast, Point of Law, a popular legal blog for which we have an awful lot of respect, linked to us yesterday and sent us 30 pageviews. The Wall Street Journal's "onespot" law page linked to a couple of our stories yesterday, and it sent us 23 pageviews.
Hats off to you Above the Law. We're not sure what you're doing right, but you're a remarkable force in the legal blogosphere.
Wednesday, November 12, 2008
So here are three items from today's news that may entertain you.
First, here's speculation that David Frederick, who argued on behalf of Diana Levine in Wyeth v. Levine, is a possible choice for Solicitor General under President Obama. (Please don't automatically take that comment as criticism. We don't know much about Frederick, and we'd be among the last to fault lawyers for positions they defended while in private practice. So long as nominees are smart, compassionate, and diligent, we're happy with people holding a very wide range of views serving on the bench or in government. We're not taking any position here on Frederick.)
Second, the Ninth Circuit set a compensatory-to-punitive damages ratio of 3 to 1 in Southern Union v. Irvin. Hat tip to, and more coverage at, Life Sciences Legal Update.
Finally, Michael Hausfeld apparently learned of his expulsion from Cohen Milstein by reading a note left on his chair. As to that item, we have nothing to add.
Now, look: We're old guys; we're not even sure what that last sentence means.
But the titles of our new posts (and links to them) will now be distributed through updates on Twitter. If you'd like to follow our blog that way, please click on the "Follow us on Twitter" icon over there in the righthand column of this blog, under the "Archives."
We never thought we'd write these words:
This is beneath even us: Tweet.
Tuesday, November 11, 2008
Predictably, the class action complaints arrived. The MDL Panel dutifully coordinated the cases. And just eight months later, in September 2007, the parties proposed a settlement agreement. On July 15, 2008, the court gave final approval to the settlement.
All of this was uneventful. But last week, on November 3, Judge William G. Young of the District of Massachusetts entered his order awarding attorneys' fees relating to the settlement. And that's where things got interesting. See In re TJX Companies Retail Security Breach Litig., No. 07-10162-WGY, slip op. (D. Mass. Nov. 3, 2008) (here's a link).
Class counsel asserted that the settlement provided over $200 million in theoretical benefits to the class. Judge Young was concerned, however, that the class members might not actually claim anything approaching that $200 million mark. "As of October 30, 2008, . . . class members had claimed just over $6,100,000 in benefits, a figure unlikely significantly to increase." Id. at 10. Why, then should class counsel be awarded the requested $6,500,000 in fees?
Judge Young analyzed the cases saying that attorneys' fees should be based on the "basket of benefits" that counsel create for the class, rather than the benefits that the class members actually claim. Id. at 11. He reasoned that those cases involved the defendant contributing actual funds, rather than a process by which the defendant agrees to "pay claims on an as-made basis." Id. at 12.
In that second situation, "only a fraction of any given class is likely to claim the benefits provided for in a settlement." Id. at 16. Moreover, "attorneys for each side bargain knowing that this is true. Thus, class counsel can -- and likely often do -- push defendants for higher payout caps or fund amounts in order to expand the basis for their fee petition without any real expectation that those additional funds will be claimed by the class." Id. at 17. Judge Young therefore announced that, in the future, he will be "tying the award of attorneys' fees to claims made by class members." Id. at 20.
This will encourage class counsel to design notice plans that actually communicate with class members and to offer settlement benefits that class members are inclined to apply for. Class counsel should not merely lead the horse to water, but should go further, "verifying the horse can see the water, choosing clear, fresh, and cold water, . . . and making sure there are no obstacles in the horse's path." Id. at 28.
We like that approach; it can only improve the workings of class action settlements.
Indeed, we have only one (petty) quibble with this opinion: footnote 16 at page 18. Judge Young writes: "[A]s Professor Samuel Issacharoff, Visiting Professor of Law at Harvard Law School, tells his students with succinct brilliance, 'Multi-district litigation is like the old Roach Motel ad: 'Roaches [the cases transferred by the MDL Panel] check in -- but they don't check out.''"
No, no, no.
We have a somewhat earlier cite for that "succinct brilliance" -- and it's one we have a personal stake in: "[A] cynic might ask: 'What's the similarity between an MDL and a Roach Motel?' The punch line, of course: 'Cases check in, but they never check out.'" Mark Herrmann, "To MDL or Not to MDL? A Defense Perspective," Litigation 43, 47 (1998).
But that's quibbling around the edges of what is otherwise a thoughtful opinion that may well improve the law of class action settlements.
Monday, November 10, 2008
In a recent decision, Bridge v. Phoenix Bond & Indemnity Co., 128 S.Ct. 2131 (U.S. June 9, 2008), held "that a plaintiff asserting a RICO claim predicated on mail fraud need not show, either as an element of its claim or as a prerequisite to establishing proximate causation, that it relied on the defendant's alleged misrepresentations." We predicted that, after Bridge, third-party payers (and other economic loss plaintiffs) would now make non-reliance RICO claims one of their theories of choice, since "no reliance" translates into "class action" in the minds of most plaintiff's counsel.
That happened. But now the Seroquel MDL court says "not so fast." Drug cases, unlike Bridge, involve learned intermediaries. That makes a difference.
First of all, Bridge did not completely eliminate reliance in every circumstance. "[T]he complete lack of reliance may prevent the plaintiff from establishing proximate cause." 128 S.Ct. at 2144.
Thus, in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP, the court held that the complexity of having to prove the extent to which there actually was prescribing physician reliance - or none at all - or something in between - required dismissal of a third-party payer suit under Holmes v. Securities Investor Protection Corp., 503 U.S. 258 (1992), the case that established a remoteness test for proximate cause under RICO. Slip op. at 6.
In relation to the first Holmes factor [directness of injury], this case raises serious concerns regarding the ascertainment of damages caused by Defendants' alleged fraudulent conduct, as opposed to damages caused by other, independent factors. The key independent factor in this case stems from the fact that consumers may only obtain Seroquel through a prescription from a physician. Presumably, these physicians use their independent medical judgment to decide whether Seroquel is the best treatment for a given patient. This independent judgment can be influenced by a number of things, only one of which may be representations by a manufacturer.... Thus, in the context of this case, establishing that Plaintiffs' injuries were caused by Defendants' misconduct would require an inquiry into the specifics of each doctor-patient relationship implicated by the lawsuit. In other words, each physician who prescribed Seroquel to an individual ... would have to be questioned as to whether his or her independent medical judgment was influenced by Defendants' misrepresentations, and to what extent. Furthermore ..., this individualized inquiry would likely have to be conducted with regard to each consumer purchase transaction or third-party reimbursement payment made over the last approximately ten years. This is precisely the type of "intricate, uncertain inquir[y]" the Holmes court sought to prevent.
Slip op. at 7 (emphasis added).
There's lots more where this comes from, but we're busy today, so you can read the opinion for yourselves.
The key takeaway: under this decision, Bridges-style non-reliance RICO liability is not available to third-party payers seeking to impose liability upon prescription drug manufacturers. Even if RICO doesn't have a reliance element, such cases are defensible on the basis of Holmes remoteness, given the intervening presence of independent prescribing physicians.
Plaintiff, Joseph Landrieu, is an 80-year-old Louisiana resident. His medical history includes coronary artery disease, hypertension, cervical spondylosis, lumbar disc syndrome, back surgery, kidney cancer, and Parkinson's disease. Slip op. at 10. He took Baycol and later had a heart attack and suffered from "physical weakness." Id. at 10-11. Landrieu then filed a putative class action complaint on behalf of all Louisiana residents who "have taken Baycol, and who have suffered injury, may suffer injury in the future or who fear a risk of future injury." Id. at 6.
Note to professors teaching complex litigation: This puppy would make a pretty nice exam question, wouldn't it? Just give the students those three sentences, and then ask: "Why isn't this case suitable for class certification?" (Make sure it's a three-hour exam, to give students enough time to write the complete answer.)
But we digress.
Bayer filed a motion to deny class certification and for summary judgment of Landrieu's claim. Id. at 2.
Landrieu's lawyers tried to invoke the age-old adage, "He who fights and runs away lives to fight another day." Instead of opposing Bayer's motion, they filed a motion to dissolve the MDL proceeding and have the MDL judge remand Landrieu's case to the federal court in which it had been filed. (The opinion doesn't tell us which court that was, but we'd bet it's the Eastern District of Louisiana.)
That tactic makes sense: If you know you're gonna lose in Minneapolis, catch the next train out of Dodge. (Well, okay: Catching the next train out of Minneapolis would make more sense, but that doesn't sound nearly as folksy.)
Judge Davis would have none of it.
He trotted through the precedents discussing when MDL transferor courts should remand cases. Judge Davis then concluded that "based upon the long-term duration of the Baycol MDL, and the extensive background, expertise, and knowledge acquired by this Court over the course of this litigation, in conjunction with the fact that this Plaintiff will still benefit from participation in the MDL, Plaintiff's motion to dissolve this MDL and to suggest remand is denied." Id. at 6.
Ain't no train leaving Dodge today.
That left Landrieu in Minneapolis -- and he who fights but stays nearby is surely destined soon to cry. (Lodge your complaints in the "comments" section. We're having fun today.)
Judge Davis had previously denied class certification of the Baycol injury cases because "individual issues of fact and law disqualify actions, such as this, for class certification." Id. at 7. That ruling applied equally to Landrieu's putative class.
The court then granted summary judgment on Landrieu's individual claims.
Landrieu claimed "that Baycol caused his heart attack, permanently damaged his kidneys and muscles, and [caused his] physical weakness." Id. at 11. All three of his treating physicians, however, begged to differ. In the words of one of the three, it "'seems unlikely' that a statin was causing Plaintiff's problems [and] that it was more likely his 'documented osteoarthritis and the cervical disk disease and arthritis and the other Parkinson's things and stuff.'" Id. (Don't worry, doc: We don't insist on proper grammar when you're giving us testimony like that.)
Remarkably, even Landrieu's case-specific expert didn't offer the opinion that was needed to get this case to a jury. During his deposition, Landrieu's expert "conceded that it was improbable that Baycol caused Plaintiff to have a heart attack," and that "it was more likely than not that he did not suffer muscle damage as a result of taking Baycol." Id. at 12. With testimony like that, we'd be hopping a train out of town, too, if we represented the plaintiff. (Yo, Bexis: Are we permitted to type those words on this blog, even in the subjunctive: "if we represented the plaintiff"? We'll have to make a policy decision on that.)
And so it ended. Judge Davis denied the motion to dissolve the MDL and remand Landrieu's case, granted the motion to deny class certification, and granted summary judgment on Landrieu's individual claims.
The next fight will be on another day, and with a different plaintiff.
Friday, November 07, 2008
The prescribing doctor denied reading any of the generic manufacturer's warnings but was wishy-washy about whether he might have read the pioneer manufacturer's labeling at some point in the more distant past.
Well, since the dawn of product liability, we thought we knew the answer to that question. You can only sue the manufacturer of the product that injured you. Only the manufacturer made a profit from selling the product, and only the manufacturer controls the safety of the product it makes, so only the manufacturer can be liable.
Black letter law (and sound public policy), right?
Not in California.
Utilizing a "negligent misrepresentation" theory as an end run around decades of product liability precedent, the Conte court holds that, as long as it's "foreseeable" that somebody might rely on its negligently incorrect information, there can be liability - with no limitation as to time or "special relationship" or anything else - owed to essentially anybody in the world (or at least in California).
If it stands, the implications of the Conte decision could be worse than Sindell market share liabilty (another ill-considered California legal "innovation"), because there's no effective limitation on the scope of the theory, only "foreseeability," which amounts to no limitation at all. It's also a terrible place to put liability as a matter of jurisprudence, because it created a huge "free rider" problem in that pioneer manufacturers are stuck with liability for generic products that, not only do they not get any profit from, but whose sales are detrimentally affected by the generic product.
Look for misrepresentation claims to skyrocket in California. Look for contribution/indemnity claims brought by pioneer manufacturers against generics to proliferate as well.
It's the Hatfields versus the McCoys all over again.
What's really going on is the preemption argument which this rationale allowed the court to dodge. Whatever the merits of preemption in the context of generic drugs, we've thought for some time that, as a practical matter, if the generic manufacturers' preemption argument wins, that necessarily puts more pressure on the product identification requirement that protects pioneer manufacturers from liability in such cases. Judges, being human beings, don't like putting large numbers of plaintiffs entirely out of court.
Well that pressure just sprung a big leak in California.
We see the "key word" searches that bring visitors to our site, and we anticipated that folks would be searching on-line this week for (1) predictions about the effect of Obama's election on appointments at the FDA, and (2) analyses of the likely effect of Obama's election on the Supreme Court generally, and the doctrine of preemption in particular.
We were right; in the last couple of days, we've seen a lot of traffic from people searching on-line for that information.
For new visitors to the blog, please don't overlook our earlier posts on those subjects: Obama's likely effect on the FDA, and Obama's effect on the Supreme Court and the preemption doctrine.
Also, we can't resist noting that we predicted two weeks before Election Day -- on October 21 -- that Obama would win the presidency and the Democrats would capture 58 seats in the Senate. Obama's now clinched it, and the Democrats have 57 seats in the Senate, with three races still too close to call or headed for recounts.
We'd like to correct only one thing from our October 21 post. We inadvertently wrote on October 21 that our projection of 58 Democratic Senate seats was the result of basically "picking a random number . . . between 51 and 60."
We meant to write that we've developed a complex, multifactorial algorithm that projects with perfect accuracy the result of any upcoming election. It took years of effort to develop that algorithm, but we'd be ready to sell it -- for a price. If either the Democratic or Republican National Committee would like to make us an offer, please contact us off-line.
Thursday, November 06, 2008
As for the first proposition, we base our belief that the Supreme Court will establish preemption in drug product liability on the basis of exchanges like this:
JUSTICE ALITO: Well, suppose the record showed that the FDA clearly considered whether IV push should be contraindicated and concluded it should not be and prescribed the label that now appears on the drug; and then. . .the very day after the FDA made that ruling, Ms. Levine was injured. Would you still -- would she still have a claim in your view, a non-pre-empted claim?Transcript at 32-33 (all emphasis is ours throughout); accord 39-40 (responses to questions by Justice Souter).
MR. FREDERICK: That [sic, would] be pre-empted. And the reason it would be pre-empted is because the FDA would have considered and rejected on the basis of the same information or similar information the very duty that underlies the State claim.
Bingo. The other side actually conceded the existential preemption point. If there’s no new information for the FDA to consider with respect to the risk in question, and the Agency has rejected a plaintiff’s position concerning that risk – even the plaintiff side in Levine concedes there is preemption. Arguments that tort preemption cannot exist at all, already on life support after Geier and Buckman and Riegel, just got thrown under the bus.
From now on, the argument is only going to be about how much conflict preemption there is, and under what circumstances, not whether it exists at all. Like in the old joke, all we’re doing now is “haggling about the price.”
But wait, there’s more along the same lines.
JUSTICE STEVENS: Mr. Frederick,. . .I understood you to agree with Justice Alito that there is a hypothetical case in which there would be pre-emption, and would you tell me what particular fact distinguishes your case from his hypothetical?
MR. FREDERICK: The fact is there was no consideration and rejection of a stronger IV push warning. There was no consideration by the FDA of IV push as a means of administration distinct from other intravenous forms that would lead to a different kind of risk-benefit balancing. So with the – in the case where there would be pre-emption, FDA would be asked, we – we want to put a stronger warning as against this – FDA says: We don't think there is scientific evidence. Do not put that warning on the label.
Transcript at 39-40.
Good stuff! We recognize that fact pattern as being SSRI/suicide preemption. After reaffirming the general concession that conflict preemption exists for prescription drugs, plaintiff’s counsel goes on to give up SSRI suicide claims, which involve the FDA rejecting warnings as scientifically unfounded (see, e.g., our prior discussion, here, at point 7). We hope that, in crafting its opinion the Court will review the amicus brief filed by DRI, as well as that part of the government’s argument, Transcript at 16-17, both of which address which address preemption of SSRI claims involving suicide risks.
Given the other side’s concessions, we think that it’s quite likely that the Court in Levine will recognize that there are situations in which FDA labeling decisions preempt state-law product liability claims that seek to overturn those decisions.
The $64,000 question is how broadly? That gets us to our second proposition. Early on in the oral argument, Wyeth tried to interest the Court in its broader preemption positions. In response to the very first question (from Justice Kennedy) Wyeth’s counsel stated the defendant’s broad preemption position, “could they use. . .the precise label that in approving the application in 1998 the FDA required Wyeth to use, and also use the label that the Vermont jury determined should be used[?]” Transcript at 4.
Wyeth articulated its broader preemption position twice more. Transcript at 5 (“The [preemption] question is what did the labeling say and upon what information was the labeling decision made.”); 13 (describing “two positions” – a narrow position based upon “the absence of new information,” and a broader position a jury cannot re-evaluate “the same information that the labeling that the FDA had approved” and reach a different safety/efficacy result). The Court, however, seemed more interested in narrowing its focus to the facts of the case.
Thus, Wyeth also addressed what it did not come within its view of the scope of preemption:
[W]e are not seeking here a rule of field preemption. We are not seeking to preclude tort remedies for conduct that violates Federal law.Transcript at 11. The government made similar statements as amicus arguing in support of Wyeth. See Transcript at 15 (“we are not arguing. . .that tort remedies. . .are pre-empted as a general matter”), 16 “if the State standard was the same as the Federal standard, there wouldn’t be any conflict”), 16 (“if you failed to provide it [new information to the FDA] altogether, there would not be. . .a pre-emption defense”), 18 (“we are not arguing that there is preemption in a situation where there is new information that is not brought to FDA’s attention”).
Thus it’s quite apparent that neither side went to court in Levine looking for the sort of broad, sweeping preemption ruling that both sides – but especially plaintiff-oriented folks – have publicly suggested might be the result. If neither side asks for a result from the United States Supreme Court, the chances are good that the Court isn’t going to reach that result.
And at this point, a narrow ruling in favor of preemption is probably something that our side should be satisfied with, given the current political situation. We don't want to overreach. As we’ve discussed before, Congress could only eliminate implied preemption by getting rid of the underlying substantive conflict between FDA control of labeling and state tort litigation. To do that Congress would have to gut the FDA’s control over labeling and give final say to state-law juries. There are lots of public health reasons – why the FDA was created in the first place – not to go that route. But a really broad preemption ruling might prompt a pro-plaintiff Congress to expend the political capital necessary to upset the FDA applecart. Conversely, a narrow ruling probably wouldn’t prompt such drastic action. A narrow win in Levine lets our side go to work broadening our beachhead in the lower courts, and by the time the issue percolates back up to the Supreme Court, well, perhaps the political situation will be more auspicious.
So is that kind of ruling in the cards?
We’d say yes, based on the argument.
The Court heard a lot about the particular facts of the Levine case. Indeed, we believe that Wyeth’s counsel set the direction for the argument early on with a very precise and powerful presentation of four ways in which the record demonstrated that the FDA had specifically considered the risk of IV push in connection with its approval of the drug’s labeling:
JUSTICE GINSBURG: . . . [A]s I understand this, the FDA was aware of the IV use and a certain risk. But did it ever, ever discreetly consider IV push versus IV administered the usual way by a drip bag?Transcript at 5-6. See id. at 22-23 (government agreeing with Wyeth on facts in response to question from Justice Kennedy).
MR. WAXMAN: Yes it did, Justice Ginsburg. . . . [T]here are. . .four separate references that, as we explained in footnote 11 of our reply brief, only apply to IV push. There is a reference to the use of the Tubex system. That is a direct IV push system. There is a reference to rigid plungers and small-bore needles. Again nothing to do with drip. There is a reference to a maximum rate of administration. Drip is gravity. The testimony in the case was that an instruction that a particular rate of administration not be exceeded only referred to IV push. And finally, there are cautions on the label about how the ordinary aspiration of blood to see if its bright or dark, which is only done in the context of a needle that is being used to push something into a vein.
How did the FDA address the risk in Levine? Let Wyeth count the ways.
In our opinion Wyeth’s four points were key. After that, plaintiff could not argue credibly that the FDA had not considered IV push in making its labeling decisions. The case became one about the “heartland” of preemption. Transcript at 11.
If the FDA looked at a specific risk and ordered specific labeling, can a state court overturn that? In light of what was in the label, Chief Justice Roberts did not seem to think so. Transcript at 25-26. Even Justice Ginsburg, whose votes suggest that she is the most anti-preemption member of the Court, was troubled by Wyeth’s four points and asked plaintiff’s counsel to address them. Transcript at 42. He had a hard time:
I will acknowledge that the references in some instances suggest IV push. There is no doubt that the FDA knew that IV push was a method of intravenous administration, but our point is a starker one, and that is that the FDA never was put to the test of deciding comparative risks and benefits of IV push versus IV drip.Id. Ouch! He had to cut the salami pretty thin to wiggle around that one.
Indeed, plaintiff’s counsel was doing a great deal of salami-slicing in Levine, given the problematic facts. He offered two arguments. First, as we just quoted, he claimed that the FDA didn’t conduct a risk-benefit analysis specifically between IV push and IV drip – another form of intravenous administration. See also Transcript at 25 (in response to a question from Justice Scalia); 41 (in response to a question from Justice Stevens). Somehow, we think the Court might not be inclined to let plaintiff cut the salami that fine:
So, as I understood your answer to be, all we have to do is simply look at the record, and if we think the FDA considered specifically IV push risks as opposed to general arterial exposure, then you lose, and if we determine that they did not, then they lose.
Transcript at 41 (Roberts, C.J.).
Second, plaintiff argued (we’d say tautologically) that the FDA couldn’t have conducted a risk/benefit analysis at all, because no “reasonable” analysis would have kept IV push on the label. Transcript at 26 (in response to a question from Chief Justice Roberts). Justice Scalia, at least, didn’t think much of that point, seeing it as a direct attack on the reasonableness of the FDA’s determination:
JUSTICE SCALIA: Well, you’re just contradicting the label. The fact is they could not have approved that label unless they made that determination.
Now, if you’re telling me the FDA acted. . .irresponsibly, then sue the FDA.
Id. Neither did Justice Souter, Transcript at 43 (asking plaintiff’s counsel what evidence he had of FDA non-consideration “[a]part from” this argument), or (again) Justice Scalia, Transcript at 44 (pointing out that the label discusses IV push separately from IV drip).
Another way in which Wyeth’s four-points evidence influenced the oral argument involves novelty. As its counsel forcefully argued, plaintiff had no evidence that Wyeth withheld anything from the FDA:
That is what is so wrong. That is why he [plaintiff’s counsel] stood up and said [during closing argument at trial] the FDA doesn't decide this question. You decide this question. And there was never, ever a suggestion in the record in this case, nor could there have been, that Wyeth ever failed to bring every single adverse-event report to the FDA's attention, every analysis that it did to the FDA's attention.
Transcript at 52.
The lack of any “new” information that plaintiff could point to highlighted the regulatory paradox in the plaintiff’s position. If one argues (as plaintiff tried to do, e.g., Transcript at 35-36) that new information was not a prerequisite to state-law claims that defendants must “strengthen” their labels, that means that “FDA approval. . .doesn’t give you any protection at all” (Transcript at 36 (Scalia, J.)). Plaintiff’s position amounts to an argument that a common-law duty to supplement can arises the moment after FDA approval of drug labeling:
It would be fundamentally inconsistent with a prior approval system to have a regime in which the very next day State law could require the manufacturer to change the very labeling that FDA has struck a balance.
Transcript at 22 (government argument in response to question from Justice Breyer). Not surprisingly, this “next day” issue was what prompted Justice Alitio’s question that we quoted at the very beginning of this post – which in turn led plaintiff to concede that preemption does occur under certain facts.
Without novelty, the CBE (“changes being effected”) argument that defendants have the power to change their labels without FDA pre-approval is simply illogical. Even very skilled counsel couldn’t pull that off in Levine.
Now, all the Court has to do to find preemption is resolve the “new” information question in favor of Wyeth on the facts of Levine.
So novelty – specifically how much novelty the CBE regulation requires – dominated large portions of the Levine oral argument. The government also took a strong position on novelty, “[n]ew information means new information about a risk that is greater in severity or frequency,” which it cast as a “long-standing interpretation.” Transcript at 18-19 (responding to a question from Justice Breyer), accord id. at 24 (same, in response to a question from Justice Scalia). Since we put our finger on this critical preemption issue early in our blogging experience, we were gratified (but not surprised) to see it become so central in the Levine oral argument.
Several of the justices indicated that, in the absence of novel information, they are likely to find that the FDA’s consideration of a risk and subsequent approval of risk-specific labeling gives rise to preemption. See Transcript at 25, 28, 37 (Scalia, J.), 30 (Roberts, C.J.), 32, 36-37 (Souter, J.), 34 (Alito, J.), 44-45 (Kennedy, J.). That’s five right there – the magic number.
Even Justice Stevens, a usually reliable “no” vote on preemption, seemed to accept novelty as the proper framework; his response was to try to get plaintiff’s counsel (who seemed surprisingly balky) to fit his facts into a “new information” context. Transcript at 44-47.
There’s a wild card in all this – Justice Breyer. At several points, he pursued questioning that strongly suggested he thought the novelty issue had been waived. See, e.g., Transcript at 20 (“nobody brought up this new information point” in the lower courts), 50 (“nobody said anything about the FDA’s claim that the information necessary to just go ahead and change the label had to be new”). At the very end of his rebuttal, Wyeth’s counsel explained that, with preemption removed from the case through summary judgment early on, there hadn’t been any opportunity to develop the “new information” point at trial. Transcript at 53. Who knows if that’ll be enough to sway Justice Breyer?
Justice Breyer’s position, raises the possibility of a Lohr-type situation where he authors a lone opinion (none of the other justices seemed impressed by the waiver point, especially Justice Kennedy (see Transcript at 22, 48)), that is abstractly favorable to preemption but avoids the issue in the context of the case. We certainly hope not, given the mess that Lohr produced.
And we don’t think it will.
As we’ve already stated, we count at least five justices (Roberts, Scalia, Souter, Alito, and Kennedy) inclined towards the novelty requirement even without Justice Breyer. Given the facts – and plaintiff’s concessions that implied preemption exists in the FDCA arena – a relatively narrow opinion, based upon explicit FDA review of gangrene/IV push and the lack of any novel information not brought to the FDA’s attention, should be enough to garner the support of a majority. And that’s without considering Justice Thomas, who (as is his practice) asked no questions during the Levine oral argument. All we can say about Justice Thomas is that he supported preemption in Lohr and (with qualifications) in Buckman, but was probably, like Justice Souter, a vote against preemption in Kent.
Hence our prediction, based upon a close reading of the transcript, is that there will be a narrow decision supporting preemption of plaintiff’s failure-to-contraindicate claim on the basis of drug-specific facts. The vote? Now we’re really going out on a limb. How about 6-1-2, but with everyone (except maybe Justice Ginsburg) agreeing that, upon a sufficiently strong set of facts, FDA-approved labeling can create implied preemption of prescription drug product liability claims.
Another prediction: If we’re right about Levine, look for lots of preemption litigation involving “new” analyses of “old” information. It won’t be hard for plaintiffs to find experts ready to reanalyze anything that any given defendant submitted to the FDA and then to opine, based upon that after-the-fact reanalysis, that the defendant should have unearthed and disclosed – surprise! – something more about the risk that injured the plaintiff.
So we don’t think we’ll be seeing prescription drug litigation vanishing from the face of the earth any time soon.
But we’ll keep trying.