U.S. Supreme Court Holds That Federal Drug Labeling Requirements Do Not Preempt a State Law Failure-To-Warn Claim Brought Against Drug Manufacturer

In Wyeth v. Levine (March 4, 2009), the U.S. Supreme Court concluded that federal law did not preempt a failure-to-warn claim brought under state law against a drug manufacturer.

The plaintiff in Wyeth had part of her arm amputated after the drug Phenergan was injected directly into her vein, leading her to develop gangrene. Subsequently, plaintiff brought a failure-to-warn action in state court against the drug's manufacturer based on negligence and strict liability theories, alleging that the labeling for the drug was defective because it was inadequate. A jury concluded that the drug manufacturer was negligent because the drug was a defective product as a result of inadequate warnings and instructions.

State courts rejected the manufacturer's argument that a direct conflict existed between Food and Drug Administration (FDA) regulations governing drug labeling and plaintiff's state law failure-to-warn claims. The U.S. Supreme Court agreed to decide the preemption issue, granting the manufacturer's petition for a writ of certiorari.

The manufacturer made two conflict preemption arguments in Wyeth, each of which was rejected by the Supreme Court:

First, the manufacturer argued that it would have been impossible for it to comply with a state law duty to modify the drug's labeling without violating federal drug labeling requirements. The Supreme Court disagreed, explaining that an FDA regulation permitted the manufacturer to make certain changes to its labels without waiting for the FDA's approval for a particular drug label. The Supreme Court refused to conclude it would have been impossible for a manufacturer to comply with both federal and state law unless there was clear evidence that the FDA would not have approved the labeling change (the Court found no such evidence in Wyeth).

Second, the manufacturer argued that the state law failure-to-warn action would obstruct the purposes and objectives of federal drug labeling requirements because the failure-to-warn action would allow a lay jury to substitute its decision about drug labeling for the expert judgment of the FDA. The Supreme Court rejected this argument too. The manufacturer took the position that these requirements established both a floor and ceiling for drug regulation and thus, once the FDA had approved a drug's label, a state law verdict could not find the label inadequate. The Supreme Court disagreed, holding that "evidence of Congress' purposes is to the contrary. . . . If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the [Food, Drug, and Cosmetic Act's] 70-year history. . . . Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."