News from the Circuits

• Author: Ben Massarsky; Sandra Seitman
• Pages: 09

Page 53

Wyeth v. Levine, 2009 WL 529172

Diana Levine brought an action against the drug manufacturer Wyeth under Vermont’s failure to warn statutes. She developed gangrene requiring the amputation of her arm after the company’s drug Phenergan was administered to her using the IV-Push method. Ms. Levine alleged that the warning label for Phenergan did not adequately explain the dangers in using the IV-Push method to deliver the drug. The trial court rejected Wyeth’s argument that Levine’s failure to warn claim was pre-empted by the Food and Drug Administration’s approval of the warning label at issue. The Vermont Supreme Court affirmed the lower court decision and Wyeth thus appealed to the Supreme Court of the United States.

In a 6-3 decision, with Justice Stevens writing the opinion and Justices Alito, Roberts, and Scalia dissenting, the Supreme Court held that the failure to warn claims were not preempted by the FDA’s approval of the warning label. The Court rejected Wyeth’s argument that it could not comply with federal and state laws because it was bound to display the exact label the FDA had already approved. In highlighting the FDA’s “changes being effected” (CBE) regulation which allowed the manufacturer to add or strengthen an instruction about dosage and administration intended to increase the safe use of the drug product, the Court demonstrated that manufactures could make labeling changes upon filing a supplemental application with the FDA and need not wait for FDA approval. Wyeth argued that the CBE regulation stated that revisions could only be made to reflect newly acquired information, and that the company had no such new information. The Court rejected this “cramped reading” of the CBE regulation by pointing to the FDA’s own interpretation of the provision, which explained that newly acquired information was not limited to new data, but also encompassed new analyses of previously submitted data and adverse event information. The Court noted that Wyeth had evidence of such adverse event information and could have used an appropriately stronger warning label without FDA pre-approval.

Wyeth’s second argument, that requiring them to submit to state law claims regarding the warning label would obstruct the purpose and objectives of the FDA’s labeling regulation, was also rejected. The Court explained that the FDA had always held the position that state law offered complimentary protection to its own regulations, and that...