Wyeth loses Supreme Court case over 'implied' pre-emption

The lives of regulatory compliance officers in the U.S. biopharma industry have been made markedly more complicated by a Supreme Court decision handed down on March 4. The case heard last fall, Wyeth vs. Levine, became a testbed for the doctrine of pre-emption: that a federal agency (in this case, FDA), through its regulatory decsionmaking, immunizes companies against liability when the agency’s instructions are followed.

In its ruling, the Supreme Court found that FDA has never been expressly given pre-emption by Congress, and therefore, even when FDA or other agencies make rulings that manufacturers follow, the manufacturers will still be open to liability torts. “It is a central premise of the Food, Drug and Cosmetic Act (FDCA) and the FDA’s regulations that the manufacturer bears responsibility for the content of its labels at all times.”

The case involves a patient, Diana Levine, who lost her arm due to the administration of a Wyeth drug (Phenergan, an anti-nausea medication) via a risky “IV push” method (other methods of administration are available). Levine developed gangrene and ultimately lost a hand and forearm. She won one settlement with the medical clinic where the intravenous administration had taken place, then went on to sue Wyeth for not having a severe enough warning about the type of administration that was used.

The Vermont Supreme court, the previous level of the litigation, had ruled in Levine’s favor, saying that “federal labeling requirements create a floor, not a ceiling, for state regulation”—a decision that the U.S. Supreme Court has now essentially validated.

A near-term result will be that individual states might overrule or at least seek modifications in FDA-approved pharmaceutical literature or regulatory decisions. A longer-term prospect would be that Congress could rewrite FDCA to include pre-emption—an unlikely prospect at the current time. For now, the liability picture for the biopharma industry is going to be very cloudy.