Bartlett - Take It Up

by Dechert LLP

The First Circuit decided Bartlett v. v. Mutual Pharmaceutical Co., No. 10-2277, slip op. (1st Cir. May 2, 2012) today - suggesting that it is the worst court of appeals in the country for defendants in prescription pharmaceutical product cases.  There are various grounds for disliking the opinion, but the preemption ruling is probably the worst.  The court allows a design defect claim, without an alternative design, to survive preemption under Mensing (which it calls "PLIVA"), even though the FDCA requires that generic drugs' design be just as identical to the branded drugs' as their warnings are.  The court allows plaintiffs to argue that state law can penalize defendants simply for making FDA approved drugs.  Admitting the conflict, Bartlett  essentially punted the entire question to the Supreme Court:

"[Defendant] argues with some force that the generic maker also cannot alter the composition of the drug and so PLIVA's policy of encouraging generics by preempting state tort claims should extend to design defect as well as claims based on inadequate warning.  But although [defendant] cannot legally make [the drug] in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell [defendant] it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context.

This is second-guessing the FDA (unless new information emerged known to the maker but not the FDA), but Wyeth resolved the conflict against general preemption.  And, not only has the Supreme Court not yet said it would extend PLIVA's exception to design defect claims, but - while the generic maker has no choice as to label - the decision to make the drug and market it in New Hampshire is wholly its own. Thus, [plaintiff] having lost her warning claim by the mere chance of her drug store's selection of a generic, the Supreme Court might be less ready to deprive [plaintiff] of her remaining avenue of relief.
True, such arguments can be turned on their head.  To refuse preemption here is consistent with Wyeth but in tension not with the holding but with part of PLIVA's rationale; a generic maker can avoid defective warning lawsuits as well as design defect lawsuits by not making the drug; and while PLIVA is itself a limited departure from a general rule of Wyeth, an extension of PLIVA to design defect claims would comprise a general rule for generics (although not one PLIVA expressly adopted).

On balance, we conclude that the Court adopted a general no-preemption rule in Wyeth and that it is up to the Supreme Court to decide whether PLIVA's exception is to be enlarged to include design defect claims. Given the widespread use of generic drugs and the developing split in the lower courts, see note 3, above, this issue needs a decisive answer from the only court that can supply it."

Bartlett, slip op. at ??? (no pagination on the First Circuit's website) (other citations omitted) (emphasis added).

We here at DDLaw hope that the defendant takes the court up on its invitation.  We can't conceive that the same court that found a warning claim preempted because the warnings must be the same, wouldn't also find preempted the much more extreme claim that the manufacturer of an FDA-approved generic drug, the design of which must also be the same as the branded equivalent, can be liable simply for selling its FDA approved product.  We've always said that strange things happen when courts apply preemption in personal injury cases, but this one takes the cake.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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