As healthcare reform took several strides forward at the White House this week--with the appointment of the new HHS head and director of the White House Office of Health Reform, and the White House summit on health reform --a decision from the Supreme Court might have a significant impact on the future costs of pharmaceuticals and medical devices.
In Wyeth v. Levine, the Court ruled that pharmaceutical manufacturer Wyeth’s compliance with FDA labeling requirements for its anti-nausea drug, Phenergan, did not preempt a state product liability lawsuit for an injury resulting from use of the drug. The label had warned that “extreme care should be exercised” in a method of administering the drug known as an “IV push” and that gangrene resulting in amputation was the likely result if the drug came into contact with arterial blood. A Vermont-based musician, Diane Levine, received an IV push of Phenergan that went awry, resulting in the amputation of her right hand and forearm. A state jury awarded her $7.4 million, agreeing with her argument that the label should have barred intravenous injection of the drug.
An article in the Washington Post notes that the decision is “a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.” The decision also rejected a 2006 Food and Drug Administration policy, which had asserted that FDA approval of labeling preempts conflicting state law. Writing for a 6-member majority of the Court, Justice John Paul Stevens said that there was nothing to suggest that Congress had intended that FDA approval would preempt state lawsuits.
More change on the preemption front may be on the way. In a decision last year, the Supreme Court had ruled in favor of medical device maker Medtronic, Inc. in another preemption case. In that decision, Riegel v. Medtronic, Inc., the Court found express language in a federal law establishing a scheme of federal oversight for medical devices that preempted state product liability lawsuits.
The Wyeth decision does not overrule Riegel, as there was no express language regarding preemption in the law at question in Wyeth. Congress may, however, be on its way to nullifying the Riegel decision. The day after the Wyeth decision was announced, Democratic legislators in the House of Representatives introduced a bill that would allow state product liability lawsuits against medical device manufacturers.
