Argument recap: Court troubled by tort protections for generic pharmaceutical manufacturers

Although the argument in Mutual Pharmaceutical Co. v. Bartlett took the Court to common ground essentially a replay of last years decision in PLIVA, Inc. v. Mensing — the Justices seemed far from certain over how to treat the case.

Bartlett is the third case in the last five Terms on the question of FDA preemption of state torts related to pharmaceutical labels. First, the Court in 2009 in Wyeth v. Levine held that a failure-to-warn claim related to a branded pharmaceutical was not preempted. Last year, the Court held in PLIVA, Inc. v. Mensing that a negligence claim for failure to warn by a generic manufacturer was preempted. The distinction on which those cases turn was the freedom to make changes to the products label: available under federal law to the branded manufacturer in Wyeth, but denied to the generic manufacturer in PLIVA. Because federal law denied the generic manufacturer in PLIVA discretion to use a different label, the Court could not tolerate a state-tort action premised on the poor quality of that label.

This case arose when the First Circuit upheld a strict-liability verdict premised on the finding that a generic version of sulindac was unreasonably dangerous. All agree that the injuries suffered by respondent Karen Bartlett, who was the plaintiff below, were horrific — burns over most of her body associated with Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN). All agree that the condition is a recognized, though rare, side effect of administration of sulindac. And all agree that at the time the plaintiff consumed the pharmaceutical, the generic product and label conformed to FDA standards requiring that it be substantially similar to the branded product and its label.

At first glance, the case seems squarely governed by PLIVA. But counsel for Bartlett (Court veteran David Frederick) interjected the intriguing argument that this case is different because it involves a strict-liability tort. Where negligence recoveries are designed to change the defendants conduct, strict liability recoveries (he argues) are not. Rather, they simply require the manufacturer that sells a dangerous product to internalize the inevitable costs associated with use of the product.

From the beginning of his argument, Jay Lefkowitz (fresh from his victory in PLIVA) drew sharp questioning from the PLIVA dissenters. First, Justice Kagan challenged him as to why a generics protection from a claim for a design defect should be any different than the protection of the branded pharmaceutical maker. He tried hard to avoid answering the question, emphasizing the emphasis by the plaintiff on the inadequacy of the warning. In a similar vein, Justice Ginsburg emphasized the arbitrariness of the distinction between generics and branded pharmaceuticals: [S]he didnt take * * * the brand-name drug because the pharmacist gave her the generic, but she didnt know * * * isnt that correct?

On the other hand, Justice Alito (from the PLIVA majority) emphasized the unreasonableness aspect of the tort under examination. When he asked Mr. Lefkowitz if the case would come out the same if the tort was truly strict liability without a state-law finding that the federally authorized product was unreasonable, Mr. Lefkowitz could refer to the Vaccine Act program discussed earlier that day in the Sebelius v. Cloer argument (for which an argument analysis is available here) and suggest that such a program would not be preempted.

At that point, Justice Kagan steered Mr. Lefkowitz back to one of the weaker points of his argument, challenging the idea that it really was impossible to comply with both state and federal law.

After a relatively uneventful appearance by Anthony Yang on behalf of the Solicitor General, David Frederick appeared for the plaintiff Bartlett. He started off by attacking Mr. Lefkowitzs response to Justice Alito. Because Mr. Lefkowitz had conceded an absolutely strict liability regime wasnt preempted, why, he asked, should it be worse if the state allows the manufacturer a chance to avoid liability by showing to that its product isnt unreasonably dangerous. At that point, Justice Scalia interrupted him to challenge the wisdom of letting juries decide such questions:

JUSTICE SCALIA: The jury decides all of this, right?

DAVID FREDERICK: Thats correct.

JUSTICE SCALIA: Thats wonderful. Twelve tried men and * * * true decide for the whole State what the * * * cost/benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives.

And Chief Justice Roberts immediately followed, honing in on the point raised by Justice Alito, suggesting that it does seem inconsistent with the * * * Federal regime for the State to determine whether the risks [of the product] outweigh the benefits.

The hardest part of the argument for Mr. Frederick surely was a lengthy interchange on the role of the warnings in the trial-court litigation. The discussion started with Justice Breyer (one of the PLIVA dissenters). Frederick repeatedly emphasized that the defendant had an opportunity to argue that the warning was adequate, but chose not to do so. In his view, that means that the defendant shouldnt be able to complain about liability imposed because of an allegedly defective warning. The idea, Frederick argued, was that the warning could only benefit Mutual, because liability was going to be found in spite of the warning and not because of the warning.

Justice Breyer noted, however, that part of the plaintiffs initial case on the unreasonable dangerousness of the product depended on the nature of the warning provided:

I was thinking well, * * * I dissented in the other case, but I lost, okay? So I lost, I lost. The * * * point is that you have a drug, and you say to the jury, well, if there were no warning here at all, then it would be unreasonably dangerous.

I think, yes, that probably applies to chemotherapy, it probably applies to Parkinsons. * * * * But it seems to me * * * lots of drugs would be dangerous, too dangerous, unreasonably so without a warning. * * * * But properly labeled theyre not, and so that seems to be your case.

The plain implication of the exchange was an effort on Breyers part to convince himself that the case does not follow directly from the decision in PLIVA. When Justice Kennedy took up the same topic a few minutes later, the point was underscored even more plainly. He asked pointedly: Do you want me to write down in this case, from my understanding, that under New Hampshire law, strict liability is determined quite without reference to the adequacy of warning. Trying very hard to offer the yes likely to gain Kennedys vote, Mr. Frederick said: You can do that. Yes, Justice Kennedy, you can do that. It is a factor for the jury to consider. It is not an element of the claim.

But Justice Kennedy noticed his admission that the jury could consider it, and responded: Now wait. Whats * * * a factor? The warning is or is not a factor. When Frederick admitted with candor that the warning can be a factor, Justice Kennedy wouldnt let the point go. He asked again: [W]as the warning relevant or not relevant to the determination of strict liability? And Frederick admitted. Yes, it was relevant as in this case. Although he tried mightily to limit the necessary force of that admission, Justice Kennedy seemed unpersuaded.

It is not easy to know what to make of the argument. Both counsel endured withering questioning from Justices who seem strongly disinclined to vote for them. But all that suggests is that there is likely to be a dissent. The best way to understand the argument is to look back to the lineup in PLIVA and ask whether the argument suggests any Justices are likely to depart from the positions they took in PLIVA. There was not a word suggesting any of the PLIVA majority would treat this case differently (though of course the author of PLIVA, Justice Thomas, did not ask any questions). On the other hand, at least Justice Breyer suggested he might be considering joining the majority from PLIVA to say this case is governed by PLIVA. Where that leaves me is thinking that despite all his efforts David Frederick will have a most difficult time in eking out an affirmance in this one.