The Lawletter Vol 35 No 5, March 25, 2011
The U.S. Court of Appeals for the Ninth Circuit recently addressed the issue of federal preemption of state negligence and breach-of-warranty claims against a manufacturer of generic, over-the-counter ibuprofen. See Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir. 2011). The parents of a minor child who sustained liver failure brought state law claims against the drug maker. The manufacturer defended on the ground that federal law preempted the parents' causes of action. The U.S. District Court for the Northern District of California entered summary judgment in the defendant's favor. The court of appeals reversed, holding that federal law did not preempt the plaintiffs' claims.
The Ninth Circuit began its analysis by reviewing the regulation of drugs by the Federal Food and Drug Administration ("FDA") beginning in the 1930s, when it became evident to Congress that there were significant problems with unsafe drugs and fraudulent marketing. The court noted that under the Food, Drug, and Cosmetic Act ("FDCA"), which was enacted by Congress in response to such problems, every drug maker is required to submit to the FDA a new-drug application, in which the manufacturer must reveal reports of investigations and include specimens of proposed labeling. In 1962, Congress amended the FDCA to shift the burden of proof from the FDA to the manufacturer. As a result of this change, a drug maker must show that its product is safe and effective before the drug can be marketed to the public. A less demanding approval process is required for the selling of generic drugs. Once such a drug is approved and the drug is listed by the FDA, any manufacturer may seek permission to market a generic version of that drug by submitting an abbreviated application. The maker need only show that its drug is "the same as" the drug previously approved by the FDA as to the relevant elements, including conditions of recommended use specified on the label.
In rejecting the defendant's assertion that it was shielded from liability because the generic drug's label had previously been approved by the FDA, the court of appeals noted that in Wyeth v. Levine, 129 S. Ct. 1187 (2009), the U.S. Supreme Court concluded that state law failure-to-warn claims are not preempted by the FDCA, because a manufacturer is permitted to make changes to its label prior to FDA approval of the change if such action is made necessary by the manufacturer's developing knowledge about the dangers of its drug. The plaintiffs in Gaeta alleged that the defendant was liable because it had failed to warn physicians and consumers about the increased risk of acute liver injury and renal failure when ibuprofen is taken with other drugs known to be hepatoxic. The court observed that FDA regulations permit makers of generic drugs to strengthen their warnings when necessary to reflect newly acquired information and do not prohibit manufacturers from proposing label changes through the prior-approval process. The court also noted that there was no clear evidence that the FDA considered and rejected stronger warnings than those proposed by consumers. According to the court, although the FDA is the final arbiter of whether a labeling revision is appropriate, primary responsibility for the adequacy of a drug label is always with the manufacturer. Because the drug maker thus had the ability under federal law to effect the changes for which the plaintiffs were contending under their state causes of action, federal law did not preempt the plaintiffs' claims.
Gaeta is thus another decision in an expanding body of jurisprudence rejecting efforts by makers of drugs with known dangers to shield themselves behind FDA approval of labeling language. Gaeta stands for the proposition that as a drug maker learns of the harm being caused by its drug after the drug has been marketed under an initial approval, the manufacturer is required to reform its label in order to protect the consuming public.