Constitutional Law

High Court Upholds Drug Lawsuit Outcome

The Supreme Court today sustained a $6.7 million jury verdict award to a musician who lost her arm because of improper use of an anti-nausea medication. In a 6-3 ruling the high court turned away arguments from Wyeth Pharmaceuticals that it was shielded from personal injury claims because drug labeling for its medicine, Phenegran, had been approved by the Federal Drug Administration (FDA).

The high court in Wyeth v. Levine, noted that directly injecting the drug into a patient's vein significantly increases the risk of 'catastrophic consequences.' Diana Levine, a musician from Vermont, lost her arm after physicians directly injected the drug into her arm, and a Vermont jury awarded her $6.7 million in a personal injury lawsuit.

Levine argued that even though Phenegran's labeling warned of the danger of gangrene and amputation following injection, it failed to instruct physicians to use an IV-drip method, and that the drug is not reasonably safe for intravenous administration because of the foreseeable risks of gangrene. In August 2004, a trial court found in favor of Levine, rejecting the drug company's federal preemption argument.

Writing for the Wyeth majority, Justice John Paul Stevens noted that the trial court 'determined that there was no direct conflict between FDA regulations and Levine's state-law claims because those regulations permit strengthened warnings without FDA approval on an interim basis and the record contained evidence of the at least 20 reports of amputations similar to Levine's since the 1960s.' The Vermont Supreme Court subsequently upheld the trial court's finding. Stevens concluded that, 'In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling. Congress has repeatedly decline to pre-empt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.'

SCOTUSblog's Lyle Denniston noted that the majority opinion did not rule 'on the preemptive effect on any official rule that FDA might impose that had the force of law.'

In a guest ACSblog post, Allison Zieve, staff attorney at Public Citizen and cert-stage co-counsel in Wyeth, examined the high court's recent preemption cases. Her post is available here.

Wyeth was the only decision issued by the high court today.

Full post as published by ACS Blog on March 04, 2009 (boomark / email).