The recent decision in In re Fosamax Products Liability Litigation, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013), put it squarely in the red in explaining why no type of design defect claims survive preemption in generic drug cases after Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).
In Bartlett the Supreme Court held that, because drugs – all drugs − cannot be redesigned without prior FDA approval, state-law claims alleging design defects were preempted:
Once a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.
133 S. Ct. at 2471 (regulatory citation and quotation marks omitted) (emphasis added). Generic drugmakers (as opposed to innovator manufacturers) also cannot change their warnings without prior FDA approval. Id. (“[g]eneric manufacturers are also prohibited from making any unilateral changes to a drug’s label”). The Court also rejected taking a drug off the market as an exception to preemption. Id. at 2477 (“[w]e reject this ‘stop-selling’ rationale as incompatible with our pre-emption jurisprudence”).
However, in a footnote, the Court pointed out that the relevant state law (New Hampshire) used risk-utility balancing to determine design defect, and declined to speculate on other design-related product liability regimes:
At least where a State imposes liability based on a balancing of a product’s harms and benefits in light of its labeling − rather than directly prohibiting the product’s sale − the mere fact that a manufacturer may avoid liability by leaving the market does not defeat a claim of impossibility.
Id. at 2478 n.5.
Of course, that’s where generic plaintiffs (having few post-Bartlett opportunities) have tried to go. Some have tried to distinguish “consumer expectation” theories. Others have alleged simply that “the risks of the defendants’ drug outweigh the benefits of taking the drug,” without claiming that any safer alternative design exists. That’s what the plaintiffs tried in Fosamax. 2013 WL 4306434, at *6. Pure risk-utility without alternative design is not the law of any state in the union. It is “categorical liability” – adopted only by courts in New Jersey and Louisiana, and quickly overturned in both states by legislation. For a general critique of this theory, see Restatement (Third) of Torts, Products Liability §2, Reporters Notes at pp. 87-89 (1998).
We’ve always thought that this attempt to split hairs by distinguishing theories is a red herring. What’s important is the conflict. How can the defendant drugmaker comply with federal law while also satisfying whatever duty state tort law imposes? If there isn’t any, then impossibility preemption bars the state claim.
That’s where the recent Fosamax decision nails it. The plaintiffs, not having an answer (at least not one that could help their clients), tried playing dumb and ignoring the question. The court called them out:
Plaintiffs try to rescue their design defect claims by refusing to specify what they believe the generics should have done differently with respect to the design of [the generic drug]. In light of this omission, the Court is left to speculate; all the potential claims the Court can imagine have been preempted by Bartlett. As discussed above, Bartlett squarely preempts design defect claims where the proposed solution is a label change, as well as design defect claims based upon chemical composition flaws. It also found preempted the possibility of design defect claims based on a generic defendant’s failure to stop selling the product. Since no other way that Generic Defendants could comply with their federal and state duties has been proffered, impossibility preemption applies.
2013 WL 4306434, at *6 (emphasis added).
That’s the whole point. The niceties of legal theory are immaterial unless there’s some way for the defendant to avoid state-law liability while simultaneously remaining compliant with the FDA’s federal scheme. That’s true whether the purported theory is risk/utility with alternative designs (the Third Restatement and other states such as Pennsylvania), consumer expectations (the other pre-Third Restatement alternative formulation), or some half-baked form of disguised absolute liability masquerading as risk/utility without alternative design.
And, as the Court pointed out in Bartlett, when different warnings are not part of the plaintiff’s claim, the same preemption rationale applies to innovator as well as generic drugs.