US Supreme Court Rules Against Wyeth in Pre-emption Case

In a significant defeat for pharmaceutical giant Wyeth and the pharmaceutical industry as a whole, the US Supreme Court ruled on Wednesday, March 4, 2009 that US Food and Drug Administration (FDA) approval of drug warning labels does not shield drugmakers from civil liability suits.

By a 6-3 vote, the Court decided that FDA approval does not pre-empt state law and that drug companies are ultimately responsible for the labeling of their products.

Wyeth v. Levine – Case Background

The case before the Supreme Court revolved around a lawsuit filed by Diana Levine. Levine had received an injection of Phenergan, an anti-nausea medication manufactured by Wyeth, in 2000. The method of delivery, known as IV push, allowed Phenergan to mix with Levine's arterial blood, causing irreversible gangrene and necessitating the amputation of her arm.

Levine sued Wyeth, claiming that Phenergan's label did not adequately warn of the dangers associated with administering the drug through IV push. A Vermont jury awarded her $7 million in damages, a verdict which was later upheld by the Vermont Supreme Court.

Wyeth fought the verdict, saying that, since the FDA had previously approved Phenergan's warning label, the company could not be held liable for Levine's injury. Wyeth v. Levine was appealed to the US Supreme Court in 2008.

What the Supreme Court's Ruling Means

Wyeth's defense boiled down to the doctrine of pre-emption, a legal theory supported by the Bush administration, as well as several business interest groups. A ruling upholding this theory would have barred consumers from suing for damages under state law if the product that injured them had previously met federal standards of approval.

The Supreme Court's rejection of pre-emption doctrine, however, means that injured consumers do have a right to hold manufacturers responsible for the products they sell.