What is the decision on the products liability Landmark case?

Question: What is the landmark products liability case decided by the United States Supreme Court during its 2008-2009 term?

Response: On March 4, 2009, the United States Supreme Court upheld a $6.7 million judgment against the Wyeth pharmaceutical corporation. Diana Levine lost her hand and forearm to gangrene after she received an injection of the nausea medication Phenergan into an artery during a push IV injection, which is more potent and takes less time to act than a traditional injection. The Phenergan label, which FDA approved, includes a push IV injection as an option for administration but warns about risks associated with the practice, such as gangrene. Levine filed a lawsuit against drug manufacturer Wyeth in state court in Vermont over the allegedly deficient Phenergan label. A jury ruled in her favor; the Vermont Supreme Court upheld the decision.

In its appeal to the United States Supreme Court, Wyeth argued that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels – i.e., that the federal regulations preempted state actions. Wyeth argued that because the federal government (via the FDA) regulates drugs, patients shouldn’t be allowed to sue in state court when drug makers follow the rules established by the FDA. The Supreme Court rejected that argument – “we conclude that it is not impossible for Wyeth to comply with its state and federal law obligations,” Justice Stevens wrote for the majority opinion, which was joined by Justices Kennedy, Souter, Ginsburg and Breyer. Justice Thomas wrote a concurring opinion, while Roberts, Alito and Scalia dissented.

Several health care and patient’s rights organizations joined the litigation as amici. As just one example, in its brief the California Medical Association disputed Wyeth’s argument that the company was not liable because its warning label was approved by the federal government: “Because preempting failure-to-warn claims would make the U.S. Food and Drug Administration approval the final word on a drug’s safety, it would significantly weaken manufacturers’ incentives to conduct new safety studies, to monitor their drugs in the marketplace, to improve them post-approval, and to supply FDA and doctors with new or revised safety information,” the brief said. “Moreover, it would deprive physicians of the important drug safety information that has unfortunately come to light only in failure-to-warn litigation. In the absence of viable alternative sources for this information, physicians would be unable to provide patients with the best possible care and patient safety would be at risk.”

Answered by Jamilla Moore

Additional Resources: Wyeth v. Levine

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