United States: US FDA Argues That State-law Failure-to-Warn Claims Against Generic Drug Manufacturers Are Not Preempted by Federal Law

Originally published November 12, 2010

Keywords: FDA, FDCA, drug labeling, generic drugs, preemption, failure-to-warn

The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., sets out a complex regulatory framework for the labeling and approval of drugs. A name-brand manufacturer seeking to market a new drug must submit an application to the Food and Drug Administration (FDA) that contains, among other things, proposed labeling for the drug. Once a drug is approved, manufacturers that wish to market generic forms of the drug may submit abbreviated applications, but these applications must show that the generic drug will contain the same labeling as its name-brand equivalent.

In response to the Supreme Court's request for the Solicitor General's views in PLIVA, Inc. v. Mensing, Nos. 09-993, 09-1039, the US Government filed an amicus brief on November 2, 2010 taking the position that the FDCA's labeling and approval process does not preempt state-law failure-to-warn claims against generic drug manufacturers. In their petition for certiorari, the generic manufacturers contended that the FDCA impliedly preempts such claims: The "same labeling" requirement, they argued, prevents generic manufacturers from satisfying any state-law obligations to warn about additional dangers of a drug because they could not change the generic drug's labeling.

In its amicus brief, the government agreed that the FDCA prevents generic manufacturers from unilaterally strengthening a generic drug's labeling or unilaterally sending "Dear Health Care Professional" (DHCP) letters advising of additional dangers of a drug. But the government interpreted the regulations implementing the FDCA to provide generic manufacturers with certain other relevant options, including alerting the FDA about newly discovered dangers, proposing labeling changes, or proposing DHCP letters. Where state law requires a generic manufacturer to take steps such as these, the government argued, there is no conflict with the FDCA. Thus, the government's position is that, while failure-to-warn claims presumably are preempted when based solely on a failure to change a generic drug's labeling, these claims are not preempted if the claims are based on a generic manufacturer's failure to notify the FDA of newly discovered dangers or the manufacturer's failure to press the FDA to strengthen the warnings contained in a drug's labeling.

This position is consistent with the two federal appellate courts that have addressed the issue. See Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (discussed in this previous Legal Update); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) (discussed in this previous Legal Update). As a result, the government recommended that the pending petition for certiorari be denied. Cases are also pending in the Sixth and Ninth Circuits, presenting the same question. See Smith v. Wyeth, Inc., No. 09-5460 (6th Cir. filed Apr. 16, 2009); Gaeta v. Perrigo Pharms. Co., No. 09-15001 (9th Cir. filed Jan. 6, 2009).

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