Supreme Court Rules Against Wyeth in Federal Preemption Case

Ending a long, closely watched debate over the issue of federal preemption, the US Supreme Court on March 4, upheld a $6.8-million verdict by the Vermont Supreme Court in the case involving Diana Levine against Wyeth Pharmaceuticals (Madison, NJ) (see PharmTech’s coverage of Levine v. Wyeth). Levine had part of her arm amputated as a result of a gangrene infection after a physician's assistant injected Wyeth’s “Phenergan” drug into her vein (known as an intravenous push method). Levine claims the company should have provided some warning on the drug’s label that described the risks of the method, even though the label was approved by the US Food and Drug Administration. The Vermont state jury agreed. The 6-3 US Supreme Court decision rejects the drugmaker’s claim that it was impossible to comply with both the state and federal requirements and its compliance with federal labeling requirements preempts requirements at the state level.

In a prepared statement, Wyeth officials called the decision “disappointing, not only for Wyeth but for patients and public health in general.” Others have pointed to implications for the industry.

“Wyeth’s labeling of Phenergan provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case,” said Bert Rein, an attorney representing Wyeth.  “The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product’s label.”