In In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), --- F.3d ---, No. 12-2250, 2014 WL 1687811 (3d Cir. Apr. 30, 2014), the United States Court of Appeals for the Third Circuit affirmed the dismissal of multiple plaintiffs’ complaints against generic pharmaceutical manufacturers, holding that Plaintiffs’ strictliability design-defect claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA).
Plaintiffs alleged that the defendants were liable for injuries Plaintiffs suffered after taking branded and/or generic Fosamax because the manufacturers had concealed the drug’s risks, exaggerated the drug’s benefits, and promoted the drug for off-label indications. Id. at *2. Plaintiffs’ claims were brought under the theories of design defect, failure-to-warn, negligence, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation. Id. The defendants that manufactured the generic drug (Generic Defendants) moved to dismiss, arguing that the claims against them were preempted because they related to duties under state tort law that directly conflict with duties under federal regulations. Id. The district court granted Generic Defendants’ motion. In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), No. 11-3045, 2012 WL 1118780 (D.N.J. Apr. 3, 2012).
The Third Circuit affirmed. The Court first determined that the only claims on appeal were Plaintiffs’ strictliability design-defect claims. In re Fosamax, 2014 WL 1687811, at *4. Although the claims at issue were brought under the laws of 28 different states, the Court held that Plaintiffs’ design-defect claims were preempted because the Generic Defendants could only avoid liability by changing the drug’s labeling, altering the drug’s design, or ceasing sales of the drug. Id. at *8. The Court explained that because Plaintiffs did not— and could not under PLIVA, Inc. v. Mensing, --- U.S. ---, 131 S. Ct. 2567 (2011) and Mutual Pharmaceutical Co., Inc. v. Bartlett, --- U.S. ---, 133 S. Ct. 2466 (2013)—seek a change in the labeling or a change in the drug’s design, the only option under which Generic Defendants could avoid state-law liability would be by halting sales of the drug. In re Fosamax, 2014 WL 1687811, at *8. The Court noted, however, that the Supreme Court had “categorically rejected” exiting the market as a viable theory of liability in Bartlett. Id. (footnote omitted). Although the Court explicitly “decline[d] to consider whether there is any basis for distinguishing between negligence-based design-defect claims and strict-liability design-defect claims for preemption purposes,” id. at *5, it implied that the result would likely be the same because it had “yet to hear how the Generic Defendants’ duties under negligence-based design-defect claims would be any different from their duties . . . under strict-liability design-defect claims.” Id. at *5 n.17.
Plaintiffs in product liability actions against generic pharmaceutical manufacturers often allege design-defect claims based on the drug’s labeling and design, and imply that the manufacturer could simply avoid liability by halting sales of the drug at issue. The Third Circuit’s decision in In re Fosamax clearly articulates that such arguments are preempted by the FDCA.