Drug Label No Defense For Wyeth

          I recently wrote about how contaminated peanuts fit into the law as a products liability case. Another recent event brings products liability law back to the fore. A victim in neighboring Vermont suffered serious injury from the effects of a drug given to her and she brought a lawsuit against the drug manufacturer.

          Vermont musician Diana Levine sued giant drug company manufacturer Wyeth when she lost her forearm in 2000 to gangrene because of improper administration of Phenergan. In Wyeth v. Levine, Ms. Levine alleged that the labeling on the Wyeth-produced anti-nausea drug had failed to adequately warn medical personnel that the method used to give her the drug, an "IV-push," was dangerous and could lead to gangrene. Ms. Levine prevailed in state court and was awarded damages for her injuries. (The health clinic had settled the claim brought against them for their administration of the drug.)

          Wyeth requested a new trial, challenging Ms. Levine’s very ability to bring her state law products liability claim, alleging that federal law preempted state products liability law on the subject. The drug company continued their defense all the way to the United States Supreme Court. On Wednesday, March 4, 2009, the Supreme Court ruled 6-3 in favor of Ms. Levine’s ability to bring the suit, which brings the litigation to its final conclusion and means that Ms. Levine will finally benefit from the $6.7 million jury award she won in 2004, plus interest.  

          At the heart of defendant Wyeth’s preemption argument was the federal regulation of drug industry labeling. The Supreme Court ruled that the federal drug labeling law did not pre-empt Ms. Levine’s the state court claim. Justice John Paul Stevens wrote for the majority that “Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling."  Wyeth had asserted that it could not meet any state duty to improve the warnings on Phenergan without violating the federal drug labeling law, which calls for FDA approval of labels. But Justice Stevens rebutted that argument stating that, in fact, the FDA regulations allow manufacturers to add or strengthen labeling in advance of receiving FDA approval.

          The majority also rejected Wyeth's argument that adhering to state labeling requirements would thwart the purposes of Congress in enacting federal drug labeling regulations. "The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary," Stevens wrote. While many disputes around the issues of if and when if a preemption argument can thwart a drug or other federally regulated products liability claim (e.g., a tobacco case was argued in October 2008), Ms. Levine’s 9 year long battle with Wyeth has reached a successful conclusion.  

Timothy G. Kerrigan is a director at Hamblett & Kerrigan, P.A. His present practice focuses on complex legal situations both in the litigation and in the ADR context. He is available as a litigator, client advocate or as an ADR neutral. Mr. Kerrigan is certified by the State Office of Mediation and Arbitration both as a mediator and as an arbitrator. You can reach Attorney Kerrigan by e-mail at tkerrigan@nashualaw.com.

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