It’s been more than two years since we reported on the appeal in the Darvocet MDL (In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, No. 11-md-2226-DCR, MDL 2226), which involves claims against generic manufacturers of a generic equivalent of the drug Darvon. The biggest news is that the panel did not decide whether to recognize claims for parallel misbranding, the theory suggested in the famous “Footnote 4” in Mutual Pharmacy Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2477 n.4 (2013). In such a claim, the plaintiffs would bring a state law claim that parallels the federal misbranding statute that requires a manufacturer to immediately stop selling an FDA-approved drug where new data, not considered by the FDA, shows additional potential for injury. Judge Suhrheinrich’s opinion found that the plaintiffs had failed to plead such a claim under Iqbal, and set a high standard for pleading such claims.
The panel also applied Iqbal to dismiss claims that the generic manufacturers could be liable for failing to change their labeling soon enough after a change to the label by the brand-name manufacturer. Failure-to-communicate claims and a host of other state law claims were dismissal under the preemption analysis under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Such claims against generic manufacturers often get a very tough reception in the Sixth Circuit.
Plaintiffs’ claims for false representations against the brand-name manufacturers fared no better. They claimed that doctors relied on brand-name manufacturers’ representations when writing prescriptions for generic propoxyphene. The Sixth Circuit noted that an “overwhelming majority” of courts has rejected this theory because such claims seek to circumvent state product liability statutes or no duty of care is owed to consumers of generic drugs. The panel then found that the highest courts in all 22 relevant states would hold the same and included an appendix explaining its decision in each of the 22 jurisdictions.
The appeal resulted in a complete win for the generic manufacturers—only one of sixty-eight cases survived to be remanded (and that case involved the use of a brand-name drug).