Tuesday, March 31, 2009

Ebel - Affirmed

A little more than a year ago, we blogged about Ebel v. Eli Lilly & Co., 536 F. Supp.2d 767 (S.D. Tex. 2008), which granted summary judgment in a suicide case involving off-label use of Zyprexa, primarily on warning causation grounds - but as we posted then, the plaintiff had seven strikes against him.

Well, yesterday the Fifth Circuit affirmed. With so many strikes against the plaintiff, the affirmance was not for publication, but if you're preparing for a treater deposition and want to see what really good "I already knew" non-causation testimony looks like - and can do - this opinion is worth a gander. Ebel's discussion of the burden of proof is also worth noting, because the court rejects the contention that the learned intermediary rule is an affirmative defense as to which the defendant, rather than the plaintiff, had the obligation to prove. Slip op. at 11-12. The court also rejects the "read and heed" presumption under Texas law. Id. at 12 n.5, 14.

Reading Ebel, we have to shake our heads over what some plaintiffs are willing to argue these days. That the plaintiff (seeking to take the defendant's money, and thus change the status quo) has to prove the elements of his/her cause of action is a proposition as old as tort law itself. But Ebel argued that requiring her to prove causation was “completely inimical to Texas products liability law.” Slip op. at 12. Needless to say, the court rejected that position, id., ("indeed, it is required by Texas law"), but one wonders what a litigant has to argue before a court concludes "frivolous" and imposes sanctions.

The court also gives a slightly different twist to causation. In Ebel it was readily apparent that the decedent needed some kind of treatment for his condition (severe headaches). He had gone through dozens of other drugs without success, and off-label Zyprexa was sort of a last resort. In those circumstances, it was not a viable argument simply to say that the doctor, or the patient, might not have prescribed/used this drug had there been an "adequate" warning. Rather, the plaintiff had to show that there was some sort of alternative available:
[Plaintiff] presented no evidence to suggest that [the prescriber] would have changed either his decision to prescribe Zyprexa or his risk–benefit analysis had he received some alternative warning concerning Zyprexa. Indeed, the record indicates that Zyprexa was perceived to be the last remaining treatment option available to [the decedent] after he had tried upwards of forty-five other medications to no avail.... [Plaintiff] has produced no evidence demonstrating that [the prescriber] would have prescribed anything other than Zyprexa at that time. For these reasons, [plaintiff] has failed to show that a genuine issue of material fact exists as to whether [defendant's] warning was the producing cause of [the decedent's] death.

Slip op. at 14. There aren't many cases out there that explore the need for the plaintiff to establish an available alternative therapy as part of the burden of proving causation, so even though Ebel is (regrettably) unpublished, we recommend it particularly on this point.

Another Look At Some Recent Scholarship

We see all these fascinating law review articles appear in print, and we plan to read the articles and react intelligently to them.

Then life gets in the way.

Instead of actually reading the things, we pile a bunch of 'em up on our desks and then give up. Instead of publishing an intelligent blog post, we simply alert the world that the new stuff is out there.

So that's our confession, and that's what we're doing here, again:

We liked the abstract of "The Quasi-Class Action Method of Managing Multidistrict Litigations: Problems and a Proposal," posted at SSRN by Charles Silver and Geoffrey Miller. Here's a link to the abstract (and, in turn, the entire article), and here's the entire text of the abstract:

"This article uses three recent multi-district litigations (MDLs) that produced massive settlements - Guidant ($240 million), Vioxx ($4.85 billion), and Zyprexa ($700 million) - to study the emerging quasi-class action approach to MDL management. The approach has four components: (1) judicial selection of lead attorneys; (2) judicial control of lead attorneys' compensation; (3) forced fee transfers from non-lead lawyers to cover lead attorneys' fees; and (4) judicial reduction of non-lead lawyers' fees to save claimants money. These widely used procedures have serious downsides. They make lawyers financially dependent on judges and, therefore, loyal to judges rather than clients. They compromise judges' independence by involving them heavily on the plaintiffs' side and making them responsible for plaintiffs' success. They allocate monies in ways that likely over-compensate some attorneys and under-pay others, with predictable impacts on service levels. They also lack needed grounding in substantive law because the common fund doctrine, which supports fee awards in class actions, does not apply in MDLs. Academics have not previously noted these shortcomings; this is the first scholarly assessment of the quasi-class action approach.

"This article also proposes an alternative method of MDL management. It recommends the creation a plaintiffs' management committee (PMC) composed of the attorney or attorney-group with the most valuable client inventory, as determined objectively by the trial judge. The PMC, which would have a large interest in the success of an MDL, would then select and retain other lawyers to perform common benefit work (CBW) for all claimants and monitor the lawyers' performance. The new approach would thus use micro-incentives to organize the production of CBW in MDLs rather than judicial control and oversight. The court would stand back from the process, exercising only a limited backup authority to prevent abuses. If enacted as a statute, the proposal would restore judges' independence, preserve lawyers' loyalties, provide the requisite legal foundation for fee awards, and encourage the fairer, more efficient, and more appropriate representation of claimants in MDLs."

We also like the sound of Richard Nagareda's recent piece, "Aggregate Litigation Across the Atlantic and the Future of American Exceptionalism." Again, here's a link to the abstract (which will take you to the full text of the article in the January 2009 issue of the Vanderbilt Law Review), and here's what the abstract tells us:

"This article analyzes the emerging phenomenon of trans-Atlantic civil litigation on an aggregate basis - chiefly, though not exclusively, by way of class actions. European systems have shown a growing receptiveness for aggregate litigation, but treatments of this development have consisted largely of description. This article offers an analytical framework with which to anticipate the structural dynamics of transnational aggregate litigation in the twenty-first century.

"Simply put, these structural dynamics will tend to recreate the difficulties seen in the context of nationwide class action litigation within the United States. The nationalization of US commerce led to aggregate litigation of a commensurately national scope. The result, however, was regulatory mismatch - for the scope of aggregation to expand to match the scope of the disputed nationwide activity, rather than the jurisdictional sovereignty of the forum. The globalization of commerce, coupled with the very multiplicity of approaches to aggregate litigation seen today, has a considerable tendency to replicate these mismatches - now, with international proportions. The recent Vivendi securities class action in the United States and the pathbreaking Royal Dutch Shell settlement under the 2005 Dutch collective settlement act confirm this trend.

"The article then analyzes the vehicles by which to address regulatory mismatches. Here, too, the US experience is instructive, underscoring both the centrality and the limitations of the two vehicles by which to achieve a kind of de facto, informal governance: the principles for transnational claim preclusion and the latitude available for private contracts to shift disputes from litigation to arbitration."

Finally, we're mighty tempted by Thomas Colby's forthcoming piece in the Yale Law Journal, "Clearing the Smoke From Philip Morris v. Williams: The Past, Present, and Future of Punitive Damages." Here's the link to SSRN, and here's what the abstract tells us:

"In Philip Morris v. Williams, the Supreme Court held that the Constitution does not permit the imposition of punitive damages to punish a defendant for harm caused to third parties. This Article critiques the reasoning, but seeks ultimately to vindicate the result, of this landmark decision. It argues that, although the Court's procedural due process analysis does not stand up to scrutiny, punitive damages as punishment for third-party harm do indeed violate procedural due process, but for reasons far more profound than those offered by the Court. To reach that conclusion, the Article confronts the most basic and fundamental questions about punitive damages - questions that the Supreme Court has studiously avoided for more than a century: what, exactly, is the purpose of punitive damages, and how is it constitutional to impose them as a form of punishment in a judicial proceeding without affording the defendant the protection of the Constitution's criminal procedural safeguards?

"The Article argues that punitive damages are properly conceived of a form of punishment for private wrongs: judicially sanctioned private revenge. As such, the Article explains, it makes both theoretical and doctrinal sense to impose them without affording the defendant criminal procedural protections, which are necessitated only for the punishment of public wrongs on behalf of society. When, however, courts employ punitive damages as a form of punishment for public wrongs, they become a substitute for the criminal law and thus make an intolerable end run around the Bill of Rights. For that reason, Williams was ultimately correct that punitive damages must be limited to punishment for the harm done to the individual plaintiff, not the harm done to the general public.

"The Article concludes by considering the future of punitive damages in light of the Williams decision. It concludes that, contrary to the emerging conventional wisdom, Williams does not stand in the way of the imposition of substantial extra-compensatory damages of the type favored by law and economics scholars as a means of forcing the defendant to internalize the costs of its behavior in order to achieve optimal deterrence. It is the fact that punitive damages punish, and that they do so in order to vindicate the interests of the state, that precludes their use to address third-party harms. Once the element of punishment is eliminated from the remedy, the constitutional infirmity at issue in Williams is ameliorated."

As we said, this all sound like good stuff.

And we'll read these puppies in their entirety any day now; perhaps starting on the days we retire.

Monday, March 30, 2009

Tuna That Tastes Good: Tri-Union Seafoods

We don't do food; we do drugs.

(Does that sound bad?)

We veered off into food to read The People ex rel. Edmund G. Brown, Jr. v. Tri-Union Seafoods, LLC, No. A116792, 2009 Cal. App. LEXIS 309 (Cal. App. Mar. 11, 2009), a California Proposition 65 case. Tri-Union involved a lawsuit brought by the State of California to require producers of canned tuna to warn pregnant women that they are exposed to methylmercury when they consume canned tuna.

After a six-week bench trial, the court said, "Sorry, Charlie," ruling that the State was not entitled to any of the relief it requested. The trial court rested its decision on three separate grounds: (1) Prop 65, as it applied to the tuna companies, was preempted by federal law, (2) the amount of methylmercury in canned tuna doesn't rise to the threshold level that would trigger a warning requirement, and (3) virtually all methylmercury is "naturally occurring," and thus doesn't count toward the threshold exposure.

We were hoping for a decision on the preemption issue, but the court disappointed us. The First District Court of Appeal affirmed the trial court judgment solely on the ground that there was substantial evidence to support the decision that virtually all methylmercury is naturally occurring. Given that holding, the appellate court didn't have to reach the other issues.

We overcame our disappointment about not reading a preemption case when we reached the following language, suggesting that courts consider appointing expert panels to help resolve complex scientific questions:

"It bears contemplating, however, whether the truth about complex, threshold scientific issues encompassed within Proposition 65 -- such as whether methylmercury in fish is naturally occurring -- is best derived by application of the substantial evidence rule to the testimony and opinions of dueling experts serving under partisan commitments. . . . More than a century ago our Supreme Court proposed that rather than relying on expert witnesses called by the parties, the trial courts should summon a disinterested body or board of experts to give their opinion and reasons therefore to the court and jury regardless of the consequences to either litigant. . .. Our Evidence Code now provides for a similar remedy, authorizing courts to appoint experts to investigate and render a report on the matter in question, subject to cross-examination by the parties. . . . Resort to such a procedure could reduce the risk of a decision based on anything but the most valid scientific investigation and assessment."

Id. at *45-46.

In appropriate circumstances, we're all in favor of convening expert panels to help guide factfinders. We'll tuck this precedent in a file, and we'll use it when the right time comes.

We hope you will, too.

Friday, March 27, 2009

Vaccine Act Preemption Affirmed in Bruesewitz

The Third Circuit has just affirmed summary judgment on grounds of express preemption under the Vaccine Act in Bruesewitz v. Wyeth, No. 07-3794, slip op. (3d Cir. March 27, 2009). Interpreting the statute's legislative history as demonstrating congressional intent to preempt sufficient to overcome any presumption against preemption, the court creates a split of authority by specifically disagreeing with the analysis of the Georgia Supreme Court in American Home Products Corp v. Ferrari, 668 S.E.2d 236 (Ga. 2008). Slip op. at 28, 29 ("We do not consider the Ferrari Court’s reading to be compelling"; "we think the Ferrari Court’s construction is contrary to the structure of the Act") (the 669 in the opinion's Ferrari cite is a typo).

With Ferrari currently before the Supreme Court on certiorari, the after-created direct split between the federal court of appeals and a state's highest court on a question of federal preemption raises the prospect of yet another High Court preemption battle regarding an FDA-approved product. That is, if the Court is willing to revisit preemption in the FDA context so soon after deciding three cases in a year.

Bruesewitz addresses and distinguishes Wyeth v. Levine as follows:

In Wyeth v. Levine, S. Ct. 8 , No. 06-1249, 2009 WL529172, at *1 (2009), the Supreme Court examined whether federal law preempted state tort claims alleging that a drug manufacturer failed to adequately warn of the dangers associated with a drug. Id. at *1. Though we recognize that the Supreme Court concluded that state tort law claims were not preempted in that case, id. at 13, Levine is readily distinguishable on several grounds. First, the Court explicitly noted the absence of an express preemption provision and found Congress’s silence, “coupled with its certain awareness of the prevalence of state tort litigation, [] powerful evidence.” Id. at 10. In this case, however, Congress included an express preemption provision that was prompted, as evidenced by the Committee Report, by the prevalence of state tort litigation. Second, it recognized that, under federal law, a drug manufacturer could strengthen a drug's label without preapproval from the FDA. Id. at 7. This stands in contrast to the FDA’s far-more extensive control and oversight of the approval of a drug’s design and alteration.

Slip op. at 30-31 n.8.

The court, examining the history of Vaccine Act, concluded that Congress intended to apply Restatement (Second) of Torts §402A, comment k (1965) across the board to bar all design defect claims, whether sounding in negligence or strict liability, against vaccines covered by the Act. Slip op. at 33-35. An attempt by a committee of a later congress to undercut preemption was rejected. Slip op. at 36-40.

For additional information on Vaccine Act preemption, the Washington Legal Foundation, recently released an interesting "Legal Backgrounder."

"Fun" Friday: Academic Earth

We're veering way off topic here.

And we recognize that you have to share our perverse concept of "fun" to appreciate the website that we're about to recommend. (Remember: In an odd way, we've thought it was "fun" to publish these 834 blog posts over the course of the last 2 1/2 years.)

But Academic Earth is a great, fun website. It contains "thousands of video lectures from the world's top scholars." Care to hear Professor Alan Blinder of Princeton on the "Origins of the Financial Mess"? It's there. Professor Mahran Sahami of Stanford on "The History of Computing"? It's there. And so are many, many others.

So that's what's there.

If, on the other hand, you're ready to settle for Beck and Herrmann on Drug and Device Law . . . well, you know where to find that, too.

Back to that subject shortly.

Wednesday, March 25, 2009

Colacicco Briefing Slightly Postponed

The Third Circuit entered this order today in Colacicco v. Apotex:

"The foregoing motion by Appellee Beth Ann McNellis and unopposed request by Appellant Colacicco for a 15-day extension of time to file memoranda until April 16, 2009 is granted. Opposing counsel may file their responses on or before April 30, 2009."

The plaintiffs-side briefs will thus be filed and served on April 16, rather than April 1, as originally ordered.

Tuesday, March 24, 2009

Calabresi On Preemption

Judge (and former Yale Law School Dean) Guido Calabresi gave the keynote speech last month at NYU Law School's symposium on "Tort Law in the Shadow of Agency Preemption."

We don't want to steal his thunder. We assume (but don't know) that Calabresi's talk may be published in next year's symposium issue of the Annual Survey of American Law.

But we thought the speech was pretty interesting, so we're going to share a couple of ideas from it here.

The two of us typically think about preemption from deep in the trenches. We have a drug company client; the plaintiff claims a certain injury; we're working with a specific package insert, administrative history of interactions with the FDA, and a governing body of case law. Is there an argument that the plaintiff's claim is preempted?

End of thinking.

Judge Calabresi steps way back from the trenches. (Maybe that's why Calabresi's a judge and former dean, while your humble scribes are just . . . well, humble scribes.)

Anyway, Calabresi noted several choices that are implicit in any discussion of preemption as a policy issue. (Most of what follows are Calabresi's ideas. But we were jotting down our own reactions as we listened to the talk, and now we can't separate the two, so there may be a few of our ideas mixed in with Calabresi's in the following discussion. Needless to say, whatever's correct is probably what Calabresi said; we surely came up with the errors on our own.)

1. Who should bear the cost of error in the drug regulatory process? For example: Should the user harmed by a prematurely approved drug bear the cost, or should the non-user harmed by an improperly delayed drug? The user of a drug that contained too few warnings, or the non-user of a drug that contained too many?

Whatever choice society makes, there are distributional consequences, because different people will bear the costs.

2. The choice between "national" and "local" regulation is not necessarily a choice between the national Food and Drug Administration and juries applying varying state laws. Society could, if it cared to, have mini-FDA's (at the state or local level) that regulated drugs or, on the other hand, a single national body of product liability law.

3. The choice between "expert" and "lay" regulation is also not necessarily a choice between the FDA and lay juries. Society could, if it cared to, create regulatory agencies run by laymen or, more likely, empanel blue ribbon juries consisting entirely of experts in a field.

4. What institution should set minimum and maximum regulatory standards? If government sets the maximum standard ("no warnings beyond these may be given;" "no treatment beyond X may be provided"), then the government is deciding who lives and who dies -- what can be done to save a life. Perhaps it's dangerous for federal agencies to assign values to human lives. Or perhaps it's unseemly to require juries to assign values to human lives. Either way, this is a policy choice.

5. Should regulations be set before the fact (ex ante) or after the fact (ex post)? Regulatory agencies set standards in advance that companies must then follow. Tort law regulates from an after-the-fact perspective (no matter what the substantive tort rules are). The choice between ex ante and ex post regulation is a policy choice.

Calabresi had a bunch of other ideas, too. But, as we said, we really don't want to steal his thunder. (First, that would be wrong. And, second, we're not in the business of ticking off Second Circuit judges.)

So ponder the few thoughts that we've shared above, but be sure to look at the symposium issue of the Annual Survey of American Law next year to read Calabresi's own words on this subject.

Monday, March 23, 2009

Colacicco Update - briefs due 4/1

Entry on Third Circuit's docket, dated 3/18:

CLERK'S LETTER to counsel written at the direction of the Court. You are undoubtedly aware that the United States Supreme Court has remanded the above matter to this Court for further consideration in light of its opinion in Wyeth v. Levine, 555U.S.___(2009). The Court requests counsel to file contemporaneous memoranda with respect to the effect of the decision in Wyeth on the Court's decision in the above matters. An original and three copies of this memorandum should be filed in the Clerk's Office on or before April 1, 2009 and should not exceed fifteen pages double-spaced.

Riegel Redux: Delaney v. Stryker Finds PMA Preemption

Sometimes, we try to be encyclopedic in our blog posts. Sometimes, we try to be funny. (Yeah, yeah: "Try" is the operative word.) Today, we're just being descriptive.

In Delaney v. Stryker Orthopedics, No. 08-03210 (DMC), 2009 U.S. Dist. LEXIS 16865 (D.N.J. Mar. 5, 2009), Delaney underwent hip replacement surgery with a hip prosthesis manufactured by the predecessor to Stryker. The ceramic femoral ball component later shattered and was replaced. The hip prosthesis had been approved through the premarket approval process.

Stryker moved to dismiss, and the trial court granted the motion in large part. As for claims of failure to warn, design defect, negligence and recklessness, and implied warranties, the court applied Riegel without hesitation. ""[T]he FDA imposed the same requirements regarding safety and effectiveness as were imposed on the Riegel device. As in Riegel, these claims are expressly preempted . . . . " Id. at *10.

The express warranty claim was a different matter. "Riegel did not specifically address preemption with regard to a claim for breach of an express warranty." Id. at *14. "[T]he absence of Supreme Court guidance means that the [earlier Third Circuit opinion in] Michael v. Shiley" controls. Id. Under Shiley, "express warranty claims based on FDA approved product packaging are not preempted by the'" Medical Device Amendments. Id. at *15. According to the court, it's thus theoretically possible for an express warranty claim to survive preemption in the Third Circuit.

Delaney had not, however, specified exactly what words constituted the purported warranty. Citing Bell Atlantic v. Twombley, the court required Delaney to replead his express warranty claim with more specificity. Id.

Delaney also pleaded manufacturing defect claims, but he didn't identify "a defect or a deviation from the FDA-reviewed . . . manufacturing specifications regarding the [device] implanted in him." The court thus dismissed the manufacturing defect claim. Id. at *19.

Finally, as the New Jersey Supreme Court held in Sinclair v. Merck, any claim under the New Jersey Consumer Fraud Act was subsumed under the New Jersey Products Liability Act. Id. at 20.

All of the counts were thus dismissed with prejudice, except for the express warranty claim, which Delaney can replead. (But he won't. We don't know anything about those hip implants or that package insert, but we'll bet the mortgage that there's no express warranty tucked in there.)

Although this post was purely descriptive, it's another nice arrow in the quiver of folks defending medical devices. Please put Delaney to good use.

Sunday, March 22, 2009

Preemption Still Be-Longs After Levine

A little more than a year ago we posted about Longs v. Wyeth, 536 F. Supp.2d 843 (N.D. Ohio 2008), a fen-phen decision that, among other things, held preempted a claim that the drug in question was so dangerous that there was no adequate warning that could make it "safe" enough for state tort law. As we reported then:
It’s one thing to say that the warning was inadequate. . . . But it’s quite another thing to say that there isn’t any warning on the face of the earth that could make an FDA-approved drug “safe” under state law. That’s the same thing as saying that, as far as state law is concerned, notwithstanding the FDA’s approval, the defendant should never have sold the product.And for a state to tell the FDA that its approval should
never have happened – well, that’s preempted.

Well we're happy to report that last Friday, the same judge on reconsideration after Wyeth v. Levine, held that nothing had changed. Even after Levine, a claim (analogous to the failure-to-contraindicate claim that we thought Levine was about) is still preempted. It could hardly be otherwise if the FDA is to retain any real authority at all. In Longs v. Wyeth, No.: 1:03 CV 2042 (N.D. Ohio March 20, 2009), the court drew a distinction between "pre-approval" and "post-approval" tort claims and observed that Levine dealt with "the postmarketing phase [when] new risks emerge. Slip. op. at 5 (quoting Levine, 2009 WL 529172, at *12). The court accordingly held that the plaintiffs too-dangerous-for-warnings claim was still preempted:
The instant case is distinguishable from Wyeth as this case does not involve a failure to warn claim, which served as the basis for the Supreme Court’s determination. Furthermore, the court, in holding that a failure to warn claim is not preempted, focused on the fact that the claim arises out of the actions of the manufacturer post-FDA approval. The Court found that after the FDA approves a product for the market, manufacturers maintain a duty to update warning labels because of their superior knowledge of new risks concerning their products. This post-FDA approval duty is distinguishable from a manufacturer’s duty prior to approval by the FDA, a circumstance that the Court does not explicitly address. While Wyeth may stand for the proposition that post-FDA approval claims are [sic not?] preempted, it does not purport to hold that the same is true for pre-FDA approval claims. Thus, Plaintiff fails to demonstrate that this court erred in its holding that Plaintiff’s pre-FDA approval claims are preempted.

Slip op. at 7.

That distinction makes sense to us, particularly in light of what the Supreme Court did not decide in Levine, which was the failure-to-contraindicate claim. A claim that a drug cannot be made reasonably safe by warnings is a direct challenge to the power of the FDA to approve drugs in first place. The same thing goes for indications vs. contraindications. Since any new indication requires FDA approval (that's what the off-label use debate is all about), then a failure to contraindicate claim is the same thing - a direct challenge to the FDA's power to approve uses of drugs.

We think that the plaintiffs in Longs overreached even the broadest possible scope of the common law in Levine - we doubt they will be the last to do so.

Friday, March 20, 2009

The State-Of-The-Art Defense In Drug/Device Cases After Levine

A linchpin of the preemption analysis in Wyeth v. Levine, 2009 WL 529172 (U.S. March 4, 2009), was the Court’s discussion of the “changes being effected” regulation, id. at *7-8, which in turn depended on the existence of either “newly acquired information” or “new analyses of previously submitted data.” Id. at *7. Factually, there wasn’t much of a record, so the Court held, essentially, that the defendant hadn’t proven the negative – that an analysis of twenty “incidents” (we’d guess adverse drug experience reports, but the opinion doesn’t specify) wouldn’t have yielded “new” information upon which a CBE submission could have been based. Id. at *8 (“[defendant] could have analyzed the accumulating data and added a stronger warning”).

To us, all this emphasis on “newness” suggests the likelihood that state-of-the-art issues will see increased play in prescription drug product liability litigation after Levine. Since we’ve been blogging, the state-of-the-art defense in prescription drug litigation hasn’t been all that hot of a topic. In terms of recent cases, there’s been the Maryland high court decision in Gourdine v. Crews, 955 A.2d 769, 781 (Md. 2008), which discussed state-of-the-art issues as a reason for deciding that negligence and strict liability weren’t all that different, and the trial court decision in Totterdale v. Lederle Laboratories, 2008 WL 972657 (W. Va. Cir. March 19, 2008), which rejected some sort of weird duty to develop a safer design more quickly than the state of the art actually advanced. In short, not a whole lot on the subject recently.

That’s likely to change, so we thought we’d stay ahead of the curve and provide our readers with the lay of the land. The state-of-the-art defense isn’t a hard one to understand. It’s the rather self-evident proposition that a defendant shouldn’t be liable for not warning about something (usually, but not necessarily, a product risk) that hasn’t been discovered or invented yet. That’s straightforward enough, and as long as product liability cases were brought under the “reasonable man” standard of negligence, there wasn’t any significant dispute over this requirement. It wasn’t “reasonable” to expect a defendant to know the unknowable.

With the advent of strict liability, things changed, and there was a good deal of agitation – at least on the academic front – that strict liability wasn’t really “strict” if defendants could escape liability because science hadn’t yet discovered the causal link that the plaintiff was asserting. Some courts bought the argument in some circumstances, most frequently in asbestos cases. Where such rulings were broad enough, they tended to create legislative backlash, as happened in New Jersey. See N.J.S.A. 2A:58C-3a(1) (“state of the art” a complete defense).

Drugs have always been treated more carefully by the law than things that go clank, and courts have been very leery of tinkering with the state-of-the-art defense in a field so dependent upon advances in scientific knowledge as prescription drugs. State of the art was the issue that prompted the California Supreme Court essentially to exempt prescription drugs from strict liability in Brown v. Superior Court, 751 P.2d 470 (1988):

Thus far the courts have tended to hold the manufacturer to a high standard of care in preparing and testing drugs of unknown potentiality and in giving warning; but in the absence of evidence that this standard has not been met, they have refused to hold the maker liable for unforeseeable harm.
Id. at 479 (reaffirming state-of-the-art defense in design defect context).

For these same reasons of policy, we reject plaintiff’s assertion that a drug manufacturer should be held strictly liable for failure to warn of risks inherent in a drug even though it neither knew nor could have known by the application of scientific knowledge available at the time of distribution that the drug could produce the undesirable side effects suffered by the plaintiff.

Id. at 480.

There are lots of rationales for why drug companies (and device and vaccine makers, too) shouldn’t be liable for not warning about scientifically unknown risks or not using some design that hasn’t been invented yet. The Illinois Supreme Court, years ago, summed them up well: to “hold the manufacturer liable for failure to warn of a danger of which it would be impossible to know based on the present state of human knowledge would make the manufacturer the virtual insurer of the product.” Woodill v. Parke Davis & Co., 402 N.E.2d 194, 199 (Ill. 1980). A manufacturer is not required to be “clairvoyant,” but rather, its judgments are evaluated “as of the time the product is distributed to the plaintiff.” Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987).

The thin judicial support for a hindsight approach to the duty to warn is easily explained. The goal of the law is to induce conduct that is capable of being performed. This goal is not advanced by imposing liability for failure to warn of risks that were not capable of being known.

Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909, 922-23 (Mass. 1998).

For all of these reasons, we believe that the state-of-the-art defense dovetails with the Supreme Court’s evaluation of the prerequisites for a CBE submission in Levine. If, at the relevant time, the warning in question would not have supported common-law liability under the state-of-the-art defense, then there’s no factual basis for a CBE submission under the relevant FDA regulation. Where a CBE submission is not possible under the facts, then that’s one route to the “clear evidence that the FDA would not have approved a [label] change” that Levine, 2009 WL 529172, at *9, stated would support preemption. The state of the art defense cases thus provide a well-established body of law, and a reasonably numerous collection of factual analogies for dealing with the knotty question of whether there was insufficient “new” information for the FDA to allow a CBE submission, and thus for the application of preemption.

Here are the state-of-the-art cases that we’re familiar with in our limited field of drug and medical device product liability litigation:

Alaska: Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); Polley v. Ciba-Geigy Corp., 658 F.Supp. 420, 421 (D. Alaska 1987).

Arizona: Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978).

Arkansas: DeLuryea v. Winthrop Laboratories, 697 F.2d 222, 229 (8th Cir. 1983).

California: Carlin v. Superior Court, 920 P.2d 1347, 1350-51 (Cal. 1996); Brown v. Superior Court, 751 P.2d 470, 480-81 (Cal. 1988); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 263 (Cal. App. 1999); Rosburg v. Minnesota Mining & Manufacturing Co., 226 Cal. Rptr. 299, 305-06 (Cal. App. 1986); Fogo v. Cutter Laboratories, Inc., 137 Cal. Rptr. 417, 422-23 (Cal. App. 1977); Carmichael v. Reitz, 95 Cal. Rptr. 381, 404 (Cal. App. 1971); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 2023569, at *2 (D. Minn. July 6, 2007).

Colorado: Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118, 123 (Colo. 1983).

Connecticut: Vitanza v. Upjohn Co., 778 A.2d 829, 836 (Conn. 2001); Tomer v. America Home Products Corp., 368 A.2d 35, 38 (Conn. 1976); LaMontagne v. E.I. Du Pont De Nemours & Co., 41 F.3d 846, 859 (2d Cir. 1994); Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969).

District of Columbia: McNeil Pharmaceutical v. Hawkins, 686 A.2d 567, 578 (D.C. 1996).

Florida: E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 828 (Fla. 1997); Bailey v. Janssen Pharmaceutica, Inc., 2006 WL 3665417, at *4 (S.D. Fla. Nov. 14. 2006).

Hawaii: Ontai v. Straub Clinic & Hospital, Inc., 659 P.2d 734, 743 (Haw. 1983).

Idaho: Toner v. Lederle Laboratories, 732 P.2d 297, 306-07 (Idaho 1987).

Illinois: Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 354 (Ill. 1996); Woodill v. Parke Davis & Co., 402 N.E.2d 194, 198-99 (Ill. 1980); Needham v. White Laboratories, Inc., 847 F.2d 355, 357-58 (7th Cir. 1988); McMahon v. Eli Lilly & Co., 774 F.2d 830, 835 (7th Cir. 1985); Martinkovic v. Wyeth Laboratories, Inc., 669 F.Supp. 212, 215 (N.D. Ill. 1987).

Indiana: Ortho Pharmaceutical Corporation v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 305-06 (7th Cir. 1987).

Iowa: Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986); Brazzell v. United States, 880 F.2d 84, 86-87 (8th Cir. 1989).

Kansas: Savina v. Sterling Drug, Inc., 795 P.2d 915, 926-27 (Kan. 1990); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1227 (Kan. 1987); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057, 1062-64 (Kan. 1984).

Louisiana: La.Rev. Stat. Ann. §9:2800.59(B); Cauvin v. Sisters of Mercy Health System, Inc., 818 So.2d 833, 835 (La. App. 2002); Kinney v. Hutchinson, 468 So.2d 714, 718 (La. App. 1985); Miller v. Upjohn Co., 465 So.2d 42, 45 (La. App. 1985); Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 272 n.11 (5th Cir. 2002); Williams v. Ciba-Geigy Corp., 686 F.Supp. 573, 575 (W.D. La. 1988), aff’d, 864 F.2d 789 (5th Cir. 1988).

Maine: Porter v. Pfizer Hospital Products Group, Inc., 783 F.Supp. 1466, 1475 (D. Me. 1992).

Maryland: Gourdine v. Crews, 955 A.2d 769, 781 (Md. 2008); Miles Laboratories, Inc. v. Doe, 556 A.2d 1107, 1121-22 (Md. 1989); Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191-93 (4th Cir.1991); Chambers v. G.D. Searle & Co., 441 F.Supp. 377, 381-82 (D. Md. 1975), aff’d, 567 F.2d 269 (4th Cir. 1977).

Massachusetts: Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909, 923-24 (Mass. 1998); Kelly v. Wyeth, 2007 WL 1302589, at *7 (Mass. Super. April 12, 2007); Haidak v. Pfizer, Inc., 2002 WL 126680, at *2 (S.D.N.Y. Jan. 31, 2002).

Michigan: Muilenberg v. Upjohn Co., 426 N.W.2d 767, 773 (Mich. App. 1988); May v. Parke, Davis & Co., 370 N.W.2d 371, 376 (Mich. App. 1985); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 580 (Mich. App. 1983).

Minnesota: O’Hare v. Merck & Co., 381 F.2d 286, 291 (8th Cir. 1967).

Missouri: Bine v. Sterling Drug, Inc., 422 S.W.2d 623, 627-28 (Mo. 1968); Meyer v. Astrazeneca Pharmaceuticals, L.P., 224 S.W.3d 106, 108 (Mo. App. 2007); Johnston v. Upjohn Co., 442 S.W.2d 93, 97 (Mo. App. 1969); Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 84 (8th Cir. 1966); Stanger v. Smith & Nephew, Inc., 401 F.Supp.2d 974, 980-81 (E.D. Mo. 2005).

Montana: Hill v. Squibb & Sons, 592 P.2d 1383, 1388 (Mont. 1979); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968).

New Hampshire: Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 657-58 (1st Cir. 1981).

New Jersey: N.J.S.A. 2A:58C-3a(1); Feldman v. Lederle Laboratories, 479 A.2d 374, 386-87 (N.J. 1984); Ferrigno v. Eli Lilly & Co., 420 A.2d 1305, 1321 (N.J. Super. Law Div. 1980).

New Mexico: Richards v. Upjohn Co., 625 P.2d 1192, 1195-96 (N.M. App. 1980).

New York: Mulhall v. Hannafin, 841 N.Y.S.2d 282, 285-86 (N.Y.A.D. 2007); Donigi v. American Cyanamid Co., 394 N.Y.S.2d 422, 422-23 (N.Y.A.D. 1977), aff’d mem., 374 N.E.2d 1245 (N.Y. 1978); Friedman v. Medtronic, Inc., 345 N.Y.S.2d 637, 642 (N.Y.A.D. 1973); Garfinkel v. Bayer Corp., 2003 WL 25668274 (N.Y. Sup. Oct. 30, 2003); Tenuto v. Lederle Laboratories, 695 N.Y.S.2d 259, 263 (N.Y. Sup. 1999), aff’d, 714 N.Y.S.2d 448 (N.Y.A.D. 2000).

North Dakota: Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *3 n.2 (D.N.D. Sept. 5, 2000).

Ohio: White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753 (Ohio 1988); see Ohio Rev. Code §2307.76(A0(1)(a).

Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 303 (Okla. 1997).

Oregon: McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528-29 (Or. 1974); Cochran v. Brooke, 409 P.2d 904, 907 (Or. 1966).

Pennsylvania: Hahn v. Richter, 628 A.2d 860, 867-68 (Pa. Super. 1993), aff’d, 673 A.2d 860 (Pa. 1996); Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 458 (Pa. Super. 1973); Mazur v. Merck & Co., 964 F.2d 1348, 1366-67 (3d Cir. 1992); In re Zyprexa Products Liability Litigation, 489 F.Supp.2d 230, 268 (E.D.N.Y. 2007).

Puerto Rico: Muniz-Nunez v. American Home Products Corp., 582 F.Supp. 459, 462 (D.P.R. 1984).

Rhode Island: Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775, 782 (R.I. 1988); Castrignano v. E.R. Squibb & Sons, Inc., 900 F.2d 455, 459-60 (1st Cir. 1990).

South Dakota: McElhaney v. Eli Lilly & Co., 575 F.Supp. 228, 231-32 (D.S.D. 1983), aff’d, 739 F.2d 340 (8th Cir. 1984).

Tennessee: Witherspoon v. Ciba-Geigy Corp., 1986 WL 2138, at *3 (Tenn. App. Feb. 12, 1986).

Texas: Bristol-Myers Co. v. Gonzales, 561 S.W.2d 801, 804 (Tex. 1978); Crocker v. Winthrop Laboratories, 514 S.W.2d 429, 433 (Tex. 1974); Gerber v. Hoffmann-La Roche Inc., 392 F.Supp.2d 907, 915 (S.D. Tex. 2005).

Utah: Grundberg v. Upjohn Co., 813 P.2d 89, 98 (Utah 1991).

Virginia: Stanback v. Parke, Davis & Co., 502 F.Supp. 767, 770 (W.D. Va. 1980).

Washington: Laisure-Radke v. Par Pharmaceutical, Inc., 426 F.Supp.2d 1163, 1172-73 (W.D. Wash. 2006).

West Virginia: Totterdale v. Lederle Laboratories, 2008 WL 972657 (W. Va. Cir. March 19, 2008).

Wisconsin: Stupak v. Hoffman-La Roche, Inc., 2007 WL 4218982, at *2 (M.D. Fla. Nov. 29, 2007).

Wyoming: Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 854-55 (10th Cir. 2003); Jacobs v. Dista Products Co., 693 F.Supp. 1029, 1033-34 (D. Wyo. 1988)

We’ll be greatly interested to see how the state-of-the-art defense evolves in prescription drug product liability litigation, now that the Supreme Court has invoked knowability/unknowability principles as a limitation on preemption.

Wednesday, March 18, 2009

NJ Vioxx Class Certification Denial

We can't say much, because Herrmann's on the road and Bexis is involved in the litigation, but a trial court in New Jersey just denied certification of an individual consumer economic loss class action, both nationwide and limited to New Jersey. The bases of the decision:

There is no predominance. "The causal nexis between the loss sustained by each member of the class and the consumer fraud. . .creates an insurmountable barrier to a class action." Slip op. at 12. Consumers made "individualized decisions" to use the drug. Id. at 13.

Unjust enrichment is not a valid theory of liability in a case involving allegations of improper warnings/marketing of a product. Id. at 15.

There is no typicality because each class menber "received a different benefit from the drug." Id. at 16.

There is no superiority because "it would be unfair to [defendant] to certify a class and allow a jury to reach one uniform determination of liability where results [as shown by past outcomes] could vary from plaintiff to plaintiff." Id. at 17.

The court did not reach choice of law. Id. at 18

Class Action Articles Posted To SSRN

This is not really new news.

Herrmann (and co-authors) published "The Class Action Fairness Act: An Ill-Conceived Approach to Class Settlements" a couple of years ago in the Tulane Law Review and "Making Class Actions Work: The Untapped Potential of the Internet" more recently in the University of Pittsburgh Law Review.

The new news is that one of Herrmann's co-authors has figured out how to upload documents to the Social Sciences Research Network, so there are now SSRN links for each of these articles. For the Tulane piece, please click here. And for Pittsburgh, click here.

Tuesday, March 17, 2009

Generic Drugs Meet Levine

One silver lining from the severe pruning that prescription drug preemption took in Wyeth v. Levine, is that there may now be less incentive to expand the common-law liabilty of pioneer manufacturers in generic drug cases - something we've discussed in posts that readers can find under the "product identification" "generic drug" and "Conte" labels in the right-hand margin of the blog.

In Schrock v. Wyeth, slip op., 2009 WL 635415 (W.D. Okla. Mar. 11, 2009), the court basically gave the preemption arguments made by generic drug manufacturers the back of its hand, holding:
Defendants in this case have proffered similar, if not identical, arguments concerning the obstruction of the purposes and objectives of federal drug labeling regulation. As in Wyeth, however, this Court finds that there is a longstanding coexistence of state and federal law in the regulatory history and background relevant to this case. Therefore, the Court finds that this state-law action does not obstruct the purposes and objectives of Congress. . . . As to any remaining basis which defendants have presented in the instant matter, the United States Supreme Court has clearly concluded that Congress did not intend the preempt state-law failure-to-warn actions.

Slip op., 2009 WL 635415, at *3. After Levine we're not particularly surprised at this result.

What's of greater interest to us (since we don't represent generic drug manufacturers) is the court's grant of summary judgment to the pioneer manufacturer - on the entirely reasonable ground that the plaintiff never took its drug. The court cites the usual state-law proposition that manufacturers aren't liable for defects in products they didn't make. Slip op., 2009 WL 635415, at *4-5. It also follows the federalist principle we've advocated previoiusly (see "Erie doctrine" label): "As a federal court, we are generally reticent to expand state law without clear guidance from its highest court." Slip op., 2009 WL 635415, at *4. We love all that, but what follows may be even more significant in the long run:
Finally, plaintiffs opine that they would be denied of any remedy if the generic manufacturers are not responsible due to federal preemption, and the brand name manufacturers are similarly not responsible. The Court finds, however, that this is no longer an issue in light of the earlier finding that plaintiffs are not preempted by federal law from pursuing their state law claims.

Slip op., 2009 WL 635415, at *4 (emphasis added). We've long been of the opinion that the source of most of the pressure in generic drug cases on traditional tort principles that limit manufacturer liability to their own products has been the strength of the generics' preemption arguments, and corresponding judicial reluctance to throw generic-using plaintiffs out of court entirely.

If, however, the preemption arguments of the generic manufacturers don't fare any better after Levine than they did in Schrock, the urge that some courts have felt to distort well-settled tort principles to sock it to pioneer (non-)manufacturers may well abate.

It's certainly an unintended consequence, but to this extent Wyeth v. Levine may prove to be of at least some benefit to defendants.

A Riegel Wrinkle: "Adjunct Clinical Trial" Preemption

As you know, we watch the medical device preemption cases.

And we've discussed a case after Riegel finding preemption in the context of a device used in a clinical trial under an Investigational Device Exemption.

But here's a Riegel wrinkle. (In fact, we like this case so much that we might call it a regal Riegel wrinkle. In fact, . . . well, never mind.)

Anyway, it's Dorsey v. Allergan, No. 3:08-0731, slip op. (M.D. Tenn. Mar. 11, 2009) (here's the obligatory link). After the breast implant brouhaha in the very early '90s, McGhan Medical Corporation obtained FDA approval to conduct a clinical trial studying the use of breast implants in breast augmentation patients. That was the "core" study and was approved by the FDA in 1998. Id. at 2-3.

On a separate track, the FDA also approved McGhan's proposal to study breast implants used in breast reconstruction patients. That was the "adjunct" study, also approved in 1998. Id. at 2.

Plaintiff Susan Dorsey received Style 20 implants on November 9, 2005, as part of the adjunct study. Her consent form "indicated that the use of the implants was investigational and not FDA approved." Id. at 3. Dorsey allegedly began to experience pain and fatigue immediately after the surgery, and her implants were removed on September 29, 2006. The Style 20 implants received premarket approval from the FDA two months later, on November 17, 2006.

Dorsey pleaded one count of strict liability against Allergan, which manufactured the implants.

Allergan moved for summary judgment on the basis of preemption, citing, among other cases, Riegel v. Medtronic, 128 S. Ct. 999 (2008). Dorsey tried to distinguish Riegel on the grounds that (1) the Style 20 implants had not received premarket approval at the time of her surgery, and (2) her surgery was performed under the adjunct clinical trial, rather than the core one. Id. at 8.

The court rejected both arguments. First, the FDA ultimately granted premarket approval to the Style 20 implants. The FDA thus concluded that the devices were safe and effective. That finding undercut any claim that the devices were "unreasonably dangerous" for purposes of strict liability under Tennessee law. "[T]he subsequent approval by the FDA is a bar to Plaintiff's strict liability claim because the FDA has determined that the implants at issue are reasonably safe for consumers and there is no suggestion that the implants she received were somehow different than those ultimately approved by the FDA." Id. at 9.

Second, the use of the implants in an adjunct study, rather than a core one, was a distinction without a difference. "[W]hether the Style 20 implant was a part of the core or adjunct study, the FDA has approved its use and therefore Plaintiff's claim is preempted." Id. at 11.

"[R]egardless of how it was characterized (as a clinical or adjunct study), the record suggests that the information given to the FDA was consistent with the IDE protocol in the core study and Plaintiff has provided absolutely no evidence which would suggest otherwise." Id.

After Riegel, preemption should be available as a defense in PMA and IDE cases (and, depending on the facts, perhaps in others, too). There's no reason to distinguish between core and adjunct clinical trials, so we're pleased to see that argument laid to rest.

Monday, March 16, 2009

Your Humble Scribes On Levine In BNA Product Safety Reporter

Blogging makes you psycho. (Frankly, we didn't have that far to go even before we started blogging.)

Not only do you want to break stories on the web, you want to be among the first to comment in the print media, too.

The two of us thus teamed up to write a piece for today's BNA's Product Safety & Liability Reporter analyzing the implications of Wyeth v. Levine. Here's a link to the article. (Since BNA is a subscription publication, you may not be able to open this unless your firm subscribes. Sorry about that.)

Friday, March 13, 2009

Accutane: McCarrell Remanded For New Trial

We know that headline is boring: "Accutane: McCarrell Remanded For New Trial."

But give us a break.

Levine comes down. We're duty-bound to blog about it. The press calls for reactions to it. We're writing about the case in print media. We're being asked to speak about the case.

And then there's our real jobs: Our long-dormant drug cases bust loose because all those stays pending Levine are now lifted.

And that same week -- that same week -- the !**@!! New Jersey Appellate Division hands down a 113-page appellate decision in McCarrell v. Hoffman-LaRoche, No. A-3280-07T1 (N.J. App. Div. Mar. 12, 2009) (link here). What's a blogger to do?

Here's what we'll do: We'll give you the shortest little description of McCarrell, tell you very briefly why it matters, and then call it quits. We apologize for giving you the bum's rush, but life's pretty hectic here.

Andrew McCarell took Accutane for acne and then developed inflammatory bowel disease, which led to, among other things, surgical removal of his colon. He sued Hoffman-LaRoche, the manufacturer of the drug, in New Jersey state court for product liability and consumer fraud. After a 15-day trial, the jury returned a verdict (of $119,000 for past medical expenses and $2.5 million in compensatory damages) in favor of McCarrell on the product liability claim, and a verdict in favor of Roche on the consumer fraud claim.

The first issue on appeal was the admissibility of plaintiff's expert testimony purportedly linking Accutane to IBD. (The federal MDL judge excluded similar expert testimony under Daubert, in a decision that was upheld by the Eleventh Circuit.) The New Jersey Appellate Division trotted through (at a length that's really not acceptable when we're this busy) the scientific evidence supporting plaintiff's expert's opinion. The court then concluded that (1) different experts testified in the MDL and in New Jersey state court, (2) the standards for admissibility are different in federal court and New Jersey state court, and (3) the evidentiary record in New Jersey was more developed, because it followed a trial. The court thus affirmed the decision to admit the expert's testimony on causation. Id. at 82.

The second issue on appeal was whether the trial court erred by letting plaintiff's witness refer to the number of adverse incidents reported about Accutane while excluding Roche's testimony about the large number of people who had ingested the drug and "the comparative significance of those figures." Id. at 92. The appellate division held "that the trial court erred in unduly restricting Roche's effort to provide relevant background statistics and other related proofs about Accutane usage to the jury." Id. at 104.

That's a holding that matters. Judge Higbee made similar evidentiary rulings in other Accutane cases that have been tried before her, so it's quite likely that other plaintiffs' verdicts will now be reversed on the same ground. And, needless to say, that holding protects defendants who manufacture other drugs from being forced into a similar evidentiary bind at trial.

Finally, the Appellate Division briefly addressed Roche's remaining arguments. The court affirmed the trial court's application of the New Jersey statute of limitations to this Alabama plaintiff and found that equitable tolling of the statute rendered plaintiff's lawsuit timely. Id. at 106. The court found "reasonable factual support" for the jury's conclusion that the warning label on Accutane was inadequate. Id. at 107. And the court remanded for the trial court to consider Roche's preemption defense in light of the holding in Wyeth v. Levine. In particular, the trial court is to address whether "Roche can show by 'clear evidence' that the FDA would not have approved a change to the Accutane label." Id. at 112. We don't know enough about the administrative record surrounding Accutane to speculate on how that issue will ultimately play out.

That's not a home run for Roche, but it's a hit of some kind: Score it a single, with the batter taking second on an error.

How The Chief Resolved The Recusal Issue

Last month, the web was ablaze with speculation about whether Chief Justice Roberts would recuse himself from Wyeth v. Levine, because the Chief owns stock in Pfizer, and Pfizer had announced its intention to acquire Wyeth. Coverage of that issue appeared here, here, and here, among other places.

Here's what the Chief did: He participated in deciding Wyeth v. Levine (as one of the three dissenters in a 6 to 3 vote), perhaps because Pfizer's future acquisition of Wyeth is subject to conditions and ultimately may not close, so the Chief has only a speculative, future financial interest in Wyeth.

But the Chief recused himself from Colacicco v. Apotex (not participating in the decision to grant cert, vacate, and remand for reconsideration in light of Levine), a case involving Pfizer as a party. The Chief presumably still owns Pfizer stock and thus has a current interest in that case.

Everyone's Talking About Levine

So far, we've learned of the following upcoming webinars with panels analyzing the implications of Wyeth v. Levine:

On Friday, March 27, at noon Eastern, the Defense Research Institute presents "Supreme Court's Preemption Decision in Wyeth v. Levine," featuring Michael Davis and Rebecca Wood (both of Sidley Austin), who wrote an amicus brief in Levine on behalf of DRI.

On April 1, at 1 p.m. Eastern, the Practicing Law Institute offers "Wyeth v. Levine: Supreme Court Rules on Implied Conflict Preemption for Prescription Drugs," in which Russell Jackson (of Skadden Arps) will host a discussion featuring David Frederick (of Kellogg Huber), who argued for Levine in the Supreme Court, and Bert Rein (of Wiley Rein), who was on the defense team for Wyeth. That's a great panel.

On April 8, at 1 p.m. Eastern, Strafford offers "Federal Preemption After Wyeth v. Levine," featuring Scott Angstreich (of Kellogg Huber), who worked on the briefs for Levine, and Russell Jackson again. Russell must be making a career of talking about the case.

Finally, on April 15, at 11:30 a.m. Eastern, the Center for Business Intelligence presents "Buried Treasure: Preemption After Wyeth v. Levine," with Rob Weiner (of Arnold & Porter) and our own Herrmann. Well -- at least Weiner's okay.

UPDATE: We just learned about another one. On March 24, at 1:30 p.m. Eastern, FDA News presents "The Real Impact of Wyeth v. Levine: How to Survive in a Post-Preemption World," with Kurt Karst and John Fleder, both of Hyman, Phelps & McNamara.

Thursday, March 12, 2009

Device Preemption Bookends

We’ve decided to blog on a less depressing preemption subject than Wyeth v. Levine today. We’ve seen a couple of recent medical device preemption cases that just about bookend the field. In Hofts v. Howmedica Osteonics Corp., 2009 WL 331470 (S.D. Ind. Jan. 12, 2009), the court found just about as little preemption (and probably less) as there could possibly be under Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). On the other hand, the court in Horowitz v. Stryker Corp., 2009 WL 436406 (E.D.N.Y. Feb. 20, 2009), found just about as much preemption (express, anyway) as any court since Riegel.

No matter what the Supreme Court does, courts continue to view tort preemption questions through the lenses of their own particular philosophies.

Since legal bloggers are necessarily masochists, we’ll do the icky one first. In Hofts the defendant, which made a premarket approved (“PMA”) hip implant, moved to dismiss a plaintiff’s complaint that alleged most of the usual claims – strict liability and negligent manufacture, breach of express and implied warranties (both merchantability and fitness for a particular purpose), and (since when did this become usual?) consumer fraud. 2009 WL 331470, at *1.

Memo to selves – Defense counsel takes a big risk raising preemption on a motion to dismiss. Unless we know how a judge leans, it’s best to build a record – especially where the plaintiff is seriously arguing “parallel claim” in opposition to preemption.

Somewhat amazingly in light of Riegel, Hofts managed to hold that every one of these claims escaped preemption – at least on motion to dismiss. It didn’t take long to figure out that this decision was coming from the gut:

Even so, some medical device manufacturers. . .have tried recently to stretch Riegel beyond recognition by transforming its protection for FDA-approved devices that comply with federal law into a grant of civil immunity for FDA-approved devices that violate federal law.
2009 WL 331470, at *1.

Pretty stong stuff – especially since Riegel didn’t even decide any question about violation claims, since the Supreme Court held that such allegations had been waived. Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1011 (2008) (“Although [plaintiffs] now argue that their lawsuit raises parallel claims, they made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari.”). In the Supreme Court’s determination that violation claims in Riegel were waived, Hofts nevertheless found “clear instructions” that such claims survive preemption. 2009 WL 331470, at *3.

Wham! You know what they say about when you’ve got a hammer, the whole world looks like a nail. Well, every claim in Hofts hid a violation claim somehow. And the defendant in Hofts got nailed.

Manufacturing Defect – Plaintiff alleged that the defendant was “not in compliance with Current Good Manufacturing Practice requirements approved by the FDA and [the product] had an impurity, imperfection, and/or another product defect” which defect “was a deviation from design and quality manufacturing standards. . .approved by the FDA. Id. at *4 (quoting complaint). Not only that, incorporated by reference was negligence language that the defendant “failed to exercise reasonable care and/or was reckless in the testing, manufacture, quality assurance, and sale of the [device].” Id. That appears (from the opinion anyway) to be it.

Boilerplate alert! Not a fact in sight.

We’ve known for over a year now that under Bell Atlantic Corp. v. Twombly, 127 S. Ct. 1955 (2007), the plaintiff has to plead at least a couple of real, live facts to make such allegations plausible. Like what? How about that such a violation exists somewhere other than in the imagination of plaintiff’s counsel. Something the FDA said about the particular device comes to mind. Its warning letters are all online, after all. Heck, even an opinion by the plaintiff’s own paid expert (how hard could that be?) might be enough, if based on an actual fact or two.

The response in Hofts? Forget pleading facts; gotta have discovery:

[The plaintiff] has brought claims premised on [defendant’s] alleged failure to manufacture the [device] in accordance with the PMA issued by the FDA. . . . With discovery, he may or may not be able to prove those claims, but his claims are premised on requirements that are parallel to the federal requirements. His claims are not preempted at the pleading stage.
2009 WL 331470, at *7.

But that’s not Twombly – something Hofts more or less admits when it protests against “an unusually stringent application of Twombly.” 2009 WL 331470, at *6 (discussing In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009)).

What’s Twombly then? This is Twombly:
  • “Asking for plausible grounds. . .does not impose a probability requirement at the pleading stage; it simply calls for enough fact to raise a reasonable expectation that discovery will reveal evidence of illegal agreement.” 127 S. Ct. at 1965.
  • A “formulaic recitation of the elements of a cause of action will not do.” Id. at 1965.
  • “[I]t is one thing to be cautious before dismissing [a] complaint in advance of discovery, but quite another to forget that proceeding to antitrust discovery can be expensive . . . . It is no answer to say that a claim just shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process.” Id. at 1967.
  • “[I]t is only by taking care to require allegations that reach the level suggesting conspiracy that we can hope to avoid the potentially enormous expense of discovery.” Id.
  • “[B]efore proceeding to discovery, a complaint must allege facts suggestive of illegal conduct.” Id. at 1969 n.8.
Thus we’d say (we’re defense counsel, right?) that Hofts put the discovery cart before the pleading horse when it credited a boilerplate violation that could be slapped without changing a word into any complaint about any device.

Hofts also points out that the plaintiff’s “claims and theories are more specific than those that survived dismissal in Lohr.” 2009 WL 331470, at *7. That may well be true. The Supreme Court in Lohr certainly couldn’t tell what the plaintiffs meant. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (“the precise contours of their theory of recovery have not yet been defined”). But last time we looked 1996 was before 2007 – which means that Lohr was decided before Twombly. So Hofts’ reliance on Lohr for a specificity-of-pleading point is just another way of ignoring the Supreme Court’s more recent opinion in Twombly.

Hofts then goes on the kind of rant that would be worthy of us on one of our more hacked off days – like just about every day:

The ability to bring civil claims based on violations of federal requirements is not a “back door” that was inadvertently left open by the MDA and Riegel, but a familiar part of the common law: an alleged tortfeasor's violation of the law (a speed limit, a building code requirement, or a PMA requirement) serves as evidence that the defendant breached a duty owed to the plaintiff. If the law were otherwise-if it were as [defendant] argues – then Riegel and the MDA would be turned upside down and Lohr would be overruled. . . . But if the MDA were construed as [defendant] argues here, the legislation would be transformed into a grant of immunity from civil liability for manufacturers who violate those same federal requirements. That result was rejected by the Court in Lohr, and neither the MDA nor Riegel supports it.

2009 WL 331470, at *7 (citations and non-rant portions omitted).

The problem is we don’t know if the premise of the rant is true or not, because plaintiff failed to plead anything other than “I got hurt, therefore defendant must have violated the FDCA” – which is even more of a stretch than “I got hurt, therefore defendant must be liable.” The latter isn’t enough to state a claim under Indiana (or any other) law. See Smith v. Michigan Beverage Co., 495 F.2d 754, 757 (7th Cir. 1974) (“Just as it is the general rule that the mere fact of injury will not create an inference of negligence, the mere fact of the accident cannot create an inference of a defect in a products case”) (applying Indiana law); Gaskin v. Sharp Electronics Corp., 2007 WL 2819660, *5 (N.D. Ind. Sept. 26, 2007) (“the mere fact that an accident occurred does not create an inference of a defect in a products liability case”; just so nobody thinks this is some outdated principle).

We also need facts to evaluate what Hofts said about Lohr because, just as Lohr isn’t the Supreme Court’s last word about pleading (assuming Lohr had anything to say about pleading at all), it’s not the last word about so-called “parallel” claims either. The Court in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), elaborated upon the brief discussion in Lohr:

We must also reject respondent’s attempt to characterize both the claims at issue in [Lohr] and the fraud claims here as “claims arising from violations of FDCA requirements”. . . . [I]t is clear that the [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.

Id. at 352-53. Because Hofts let the plaintiffs get away with pleading nothing about the nature of the purported violation, it’s impossible to tell whether the unspecified violation has any equivalent in Indiana common law.

We do know that, for a statute to constitute negligence per se under Indiana law, it must have a “construction consistent with the legislative purpose of both Indiana and federal” law. Walling v. Appel Service Co., 641 N.E.2d 647, 652 (Ind. App. 1994). We also know, because Congress told us in the statute itself, that violations of the Food, Drug and Cosmetic Act (“FDCA”) are only enforceable by the federal government, and not state tort litigants. 21 U.S.C. §337(a) ("all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States"). The Supreme Court held precisely this in Buckman. 531 U.S. at 349 n.4 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions”) (citing §337(a)).

Thus the rant in Hofts about defense preemption arguments somehow overruling Lohr or turning Riegel upside down appears to us to be unencumbered by either facts (which aren’t pleaded) or law (which would seem to be otherwise). But we can tell you from experience, that kind of rant often makes the ranter feel better.

But we digress.

Express Warranty – That’s not preempted either. Plaintiff “claims that the [device] did not live up to the FDA-approved promises contained in its label and that he was harmed as a result.” 2009 WL 331470, at *7. Riegel didn’t hold express warranty claims are preempted, and neither has the Seventh Circuit. Id. That’s true enough, and we’ve noted in our device preemption scorecard the split of authority on this point. But then Hofts goes on to “find[] that [plaintiff’s] breach of express warranty claim is also a parallel claim and is not preempted.” Id.

Hold on, then. We’re willing to concede that there's a split of authority post-Riegel (like there was pre-Riegel) on express warranty claims. But how did they turn into “parallel” violation claims? Since when did a breach of express warranty become an FDCA violation? Hofts cites Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir. 1997), for this proposition, so we took a look:

As we noted in our earlier opinion, such warranties arise from the representations of the parties and are made as the basis of the bargain between them. A state judgment based on the breach of an express representation by one of the parties does not necessarily interfere with the operation of the PMA, and therefore we cannot say that such a cause of action is preempted.
Id. In other words, Mitchell held just the opposite – that express warranty claims escaped preemption because they had nothing at all to do with FDA oversight. See also the “earlier opinion” Mitchell v. Collagen Corp., 67 F.3d 1268, 1285 (7th Cir. 1995) (express warranty claims “seek[] recovery solely for the [defendant’s] alleged breach of its own, self-imposed undertakings”). So we have to say, while there’s an argument that express warranty claims aren’t preempted, it’s not because they’re somehow “parallel” claims as Hofts held.

Implied Warranty – Mitchell (which is binding on Indiana federal courts) held, in the paragraph immediately before the express warranty discussion we just got done quoting, “[i]f the [plaintiffs] meant to allege an implied warranty, it is preempted.” 126 F.3d at 915. But Hofts doesn’t quite see it that way:

The FDA’s own regulations explicitly restrict the reach of the MDA’s preemption clause from state law claims brought under regulations of general applicability, including the Uniform Commercial Code. The regulations specifically note that breach of implied warranty claims are not preempted . . . . See 21 C.F.R. §808.1(d)(1).
2009 WL 331470, at *8. Because the defendant “failed to demonstrate at the pleading stage” that the implied warranty claims “rest on allegations about standards other than those permitted by the FDA,” they aren’t preempted “in light of the FDA’s regulation specifically permitting breach of implied warranty claims.” Id.

So there.

But let’s see. Hmmmm…. Section 808.1(d)(1)…. Haven’t we seen that somewhere before? What’s the name of that case? Yeah, something called Riegel, we think. The Supreme Court explicitly found that same regulation to be a hash:

All in all, we think that §808.1(d)(1) can add nothing to our analysis but confusion. Neither accepting nor rejecting the proposition that this regulation can properly be consulted to determine the statute’s meaning; and neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally; the regulation fails to alter our interpretation of the text insofar as the outcome of this case is concerned.
128 S. Ct. at 1011. And to think that Hofts stated elsewhere that under the defendant’s argument “Riegel and the MDA would be turned upside down.” 2009 WL 331470, at *7. Suffice it to say, that we have a pretty hard time squaring Hofts’ reliance upon §808.1(d)(1) with the Supreme Court’s holding that the very same section – with respect to the very same implied warranty claims – “add nothing. . .but confusion.” Maybe we’re just confused. Being upside down gets disorienting.

Consumer Fraud – These aren’t preempted for the exact same reason that implied warranty claims aren’t, because §808.1(d)(1) “specifically permits” them. 2009 WL 331470, at *8. Any other reason? Nope. There’s just a reprise of the same statement as before – that the defendant “failed to demonstrate at the pleading stage” that the (substitute consumer fraud for implied warranty) “rest on allegations about standards other than those permitted by the FDA,” they aren’t preempted “light of the FDA’s regulation specifically permitting” them. Id. We’re not going to repeat ourselves on what Riegel held about that regulation. The dead horse has been thoroughly beaten.

That’s Hofts. As we’ve described, it’s reasoning provides a roadmap for plaintiffs trying to avoid preemption of product liability claims involving PMA medical devices after Riegel: Ignore Twombly, rant, ignore state law, ignore Buckman, ignore Riegel, turn controlling circuit court precedent on its head, and finally, ignore Riegel some more. Very persuasive. So persuasive that we highly recommend it to our opponents.

That’s one bookend.

Horowitz v. Stryker Corp., 2009 WL 436406 (E.D.N.Y. Feb. 20, 2009), is the other. Like Hofts, Horowitz decided a motion to dismiss. Like Hofts, Horowitz involved claims concerning a PMA hip implant. Id. at *1. Actually it involves the very same hip implant (Stryker and Howmedica are affiliated – we’re not going to bother explaining how). So did Horowitz reach the very same result on preemption?

Hardly. Or is that not hardly?

This complaint (at least as far as we can tell) was pleaded far more specifically than the complaint in Hofts – there being allegations in Horowitz about device recalls and FDA warning letters. 2009 WL 436406, at *2-3.

Even so, Horowitz took a much harder line on the alleged “parallel requirements” claims. In between Twombly cites, Horowitz held:

[G]eneralized allegations cannot withstand preemption because they fail to establish the necessary link between defendants’ federal violations and her alleged causes of action. . . . In an effort to satisfy the pleading standard and bring forth facts demonstrating the parallel nature of her claims, [plaintiff] points to two warning letters issued by the FDA. However, such letters do not provide the necessary connection to the specific [device] at issue in this case.
2009 WL 436406, at *6-7. The plaintiff’s bare recitation of warning letters and device recall didn’t establish any connection to the plaintiff’s injury. “[S]imply alleging that the defendants violated federal regulations did not necessarily mean that the plaintiff's strict liability claim was premised on those violations.” Id. at *7. That looks a lot like Buckman’s “solely by virtue” language to us.

Neither the warning letters nor the recall cut the mustard because they didn’t involve the product at issue. Id. at *8. What a shocking proposition. You mean, because a 1960 Corvair was "unsafe at any speed," that doesn’t mean that the 1957 Belair is defective? That logic didn’t pass muster in Horowitz:

In the present action plaintiff lacks such a tie to the device in question. Although plaintiff cites to recalls instituted by defendants, such recalls did not include the [device in question] or any of its components. Plaintiff introduces FDA warning letters mentioning defendants’ violations of federal regulations, but she never alleges that her particular product was included in the devices which were the subject of those letters nor does she provide a necessary link between the federal violations and her specific injury. Finally, plaintiff never alleges that any enforcement action was brought against defendants concerning the allegedly defective hip implant.
Id.; cf. Wyeth v. Levine, 2009 WL 529172, at *8 (U.S. March 4, 2009) (“the FDA’s belief that a drug is misbranded is not conclusive”).

Horowitz then evaluated many of the very same claims that cleared the preemption hurdle in Hofts.

Manufacturing defect – Pleading the FDA warning letters wasn’t enough. There was no explanation how the claimed violations in those 2006 and 2007 letters had anything to do with plaintiff’s device implanted in 2005. There’s no allegation that the letters involved the same production facility where plaintiff's device was made. 2009 WL 436406, at *8. So just because a defendant once received an FDA warning letter about something doesn’t mean that every product it ever made violated the FDCA. “Plaintiff cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.” Id.

But isn’t it asking too much under Twombly to require the plaintiff to plead that the alleged violation involved the product that allegedly caused injury? After all, that wasn’t a requirement in Hofts. The Hofts argument drew a footnote in Horowitz:

Requiring the plaintiff to plead his claims with more specificity, according to the Hofts court, would amount to an unusually stringent application of Twombly. On the contrary, requiring amplification as to how the defendants’ alleged federal violations relate to the plaintiff's claims is exactly what Twombly contemplates, especially where such a connection is implausible.
Horowitz, 2009 WL 436406, at *9 n.5. Because the plaintiff hadn’t shown that the alleged violation had anything to do with the device that was implanted, “for plaintiff to be successful in her negligence/recklessness claim a jury would have to find that the FDA requirements themselves were deficient." Id. at *9. Such claims were necessarily preempted by Riegel. Id.

Express Warranty – “Plaintiff's breach of express warranty claim is preempted to the extent that it is premised on FDA approved representations made by the manufacturer.” 2009 WL 436406, at *10. Some express warranty claims might escape preemption, but not those based upon statements that were contained in the labeling submitted to, and approved by, the FDA:

In order to avoid preemption, the plaintiff's breach of express warranty claim must identify specific representations of the manufacturer which exceed the scope of the FDA approved statements, thereby establishing a contractual obligation voluntarily entered into by the manufacturer. Any claim for breach of express warranty premised on the [device’s] FDA-approved label, however, must be preempted.

Id. at *11. Horowitz didn’t even bother to address Hofts on this point. Perhaps plaintiff's counsel, knowing the right argument to make, didn’t bother raising Hofts, since Hofts got the main argument against preemption of such claims precisely backwards.

Implied WarrantyHorowitz viewed the implied warranty claims as directly precluded by Riegel, since in Riegel the Supreme Court had analyzed such claims and held them preempted. 2009 WL 436406, at *10 (“a jury would have to find that defendants breached the implied warranty of merchantability by manufacturing a medical device that was unsafe in its federally approved design or manufacture”). The Hofts analysis of implied warranty was again dealt with in a footnote:

In Hofts[], in addressing the plaintiff’s breach of implied warranty claims, the district court found that “[t]he FDA’s own regulations explicitly restrict the reach of the MDA’s preemption clause from state law claims brought under regulations of general applicability including the Uniform Commercial Code.” The Hofts court ignores, however, that Riegel explicitly rejected that the regulation alters the outcome of the case, reasoning that such an interpretation would effectively swallow the preemption

2009 WL 436406, at *10 n.6. Yup, we thought there was a slight Riegel problem with the Hofts analysis of that claim.

Consumer Fraud – The plaintiff’s pleading in Horowitz was even worse with the consumer fraud claim than generally. “[P]laintiff makes no reference to the specific “acts, representations and/or omissions” that she claims are deceptive nor does she allege why these acts were deceptive.” Id. at *12. The FDCA violation allegations again failed because they had no connection to the plaintiff and the plaintiff’s device, and because they called FDA-approved labeling into question:

Even if the deceptive or misleading conduct [plaintiff] refers to has something to do with the FDA’s findings described in the warning letters and defendants’ failure to reveal such information to plaintiff, [plaintiff] provides no connection between the defendants’ deceptive conduct and a specific injury that she suffered as a result of that activity. . . . Similar to plaintiff’s breach of express warranty claim, plaintiff never specifies what false representations defendants made nor does she allege that she ever relied on any representations made by defendants. Moreover, using the [consumer fraud act] to attack the [device’s] FDA-approved label would run afoul of the MDA’s preemption provision.

2009 WL 436406, at *12.

Warning and Design Defect – In addition to the claims at issue in Hofts, Horowitz addressed, and held preempted, the same sorts of warning and design defect claims that were before the Supreme Court in Riegel. A “defective design claim, which challenges the FDA’s findings concerning the safety of the [device’s] design, necessarily imposes requirements that are different from, or in addition to, federal regulations.” Horowitz, 2009 WL 436406, at *10. A warning claim “would permit a jury to find that defendants were required to provide warnings above and beyond those on the [device’s] product label-a label that was specifically approved by the FDA as part of the PMA process.” Id. at *12. Nor was there even a pretense of a “parallel requirements” claim, because the FDA warning letters did not concern the product’s label. Id.

Just as Hofts was the plaintiff’s roadmap, so too is Horowitz a roadmap for the defense. We recommend it to our colleagues. What’s the difference between the two? More than anything else, we’d have to say their application of Twombly. If it’s enough to allege only that a defendant is “not in compliance” with some general type of FDA regulations and that a device “had an impurity, imperfection, and/or another product defect” which “was a deviation from” an unspecified something that was “approved by the FDA,” Hofts, 2009 WL 331470 at *4, then some of what Hofts holds about manufacturing defect, express warranty and consumer fraud (but not implied warranty) is understandable. But if Twombly means what it appears to say – and we tend to take the Supreme Court at its word – then the only result that makes sense is Horowitz.

Updates: Sprint Fidelis and Seroquel MDLs

Last week (we think; it was before Levine anyway) we reported on the belated and meritless recusal motion filed by the plaintiffs in the Sprint-Fidelis litigation. We were remiss in not reporting sooner, but the other day, the court denied the motion, as it well should have. The last section of the opinion discussed some of the practical implications that we raised about how requiring recusal in that situation could cause significant problems in the judiciary.

Also, we (well, Herrmann, because Bexis is part of the Seroquel defense team) blogged earlier about the magistrate's evidentiary rulings in the Seroquel MDL, one of which was to exclude foreign regulatory actions. We're happy to report that this decision was upheld by the judge yesterday, with a nice little opinion discussing how foreign regulatory decisions are irrelevant because they are based upon different regulatory standards than prevail in this country.

Herrmann on Levine in Chicago Tribune

We're delighted when the mainstream media occasionally picks up on things that we say here.

But we've noted before how silly it seems to echo at our little blog things that we've previously said in prominent papers.

Tuesday, March 10, 2009

Reaction To Wyeth v. Levine

As you know, we've had a few words to say about the Supreme Court's decision last week in Wyeth v. Levine (here, here, and here).

But we weren't alone.

Jim Copland argues in Monday's Washington Times that Congress should adopt an adminstrative compensation scheme (akin to the vaccine act) that would simultaneously (1) protect drug companies from liability for drugs produced according to the FDA's requirements and (2) provide compensation to patients who suffered adverse events.

Gordon Cravitz argues in Monday's Wall Street Journal that the Wyeth v. Levine decision will put a drag on innovation by drug companies.

(Hat tip to Point of Law for both of those links.)

Peter Schuck argues in The New Republic that the FDA is more institutionally competent to assess the warnings on drug labels than are lay juries. Moreover, "the FDA's flaws -- and there are many -- can at least be remedied by Congress, to which it is highly accountable."

Michael Krauss at Point of Law deplores the state of preemption jurisprudence generally and suggests that the effect of Levine "may be confined to FDA matters, because of the lack of a pre-emption clause in the statute."

Russell Jackson analyzes at his blog how Levine will affect preemption analysis under regulatory schemes that differ from the Federal Food, Drug, and Cosmetic Act.

And Jonathan Adler (at the Volokh Conspiracy) says that Levine is further evidence that the "Roberts Court" may not be as pro-business as some have suggested it would be.

If that's not enough, Point of Law has another post that collects other reactions to the decision from around the web.


Monday, March 09, 2009

Colacicco and Pennsylvania Employees Benefit Trust Fund GVR'ed

As we predicted last week (here and here), the Supreme Court this morning granted petitions for certiorari, vacated the appellate decisions, and remanded for reconsideration in light of Wyeth v. Levine the Third Circuit decisions in Colacicco v. Apotex and Pennsylvania Employees Benefit Trust Fund v. Zeneca.

Here's a link to today's Order List at the Supreme Court reflecting those two GVR's.