The U.S. Supreme Court’s decision in Wyeth v. Levine on March 4, 2009, represents a resounding triumph for all Americans who take prescription drugs. In short, the Court found by a 6-3 margin that the federal regulations of the Food and Drug Administration (FDA) do not prevent a consumer from bringing a state court product liability claim against a pharmaceutical company that negligently manufactures, distributes or labels a prescription drug. The case preserves the rights of Massachusetts consumers to obtain compensation for personal injuries resulting from defective drug products.
Details of the Case
Diane Levine brought suit against Wyeth Pharmaceuticals after being forced to amputate her right forearm nearly nine years ago. A professional musician, Deborah had suffered from persistent migraine headaches and visited a local clinic for treatment. She was prescribed Phenergan, an antihistamine used to treat nausea. A physician assistant administered the drug by “IV-push,” which caused the drug to come into contact with arterial blood. As a result, she developed gangrene, leaving her no choice but to amputate half of her right arm.
Levine sued Wyeth Pharmaceuticals, claiming that Wyeth failed to adequately warn medical professionals and consumers of the risks of IV administration. At trial, evidence indicated that since the approval of the drug in 1955, more than 20 other patients had suffered from similar amputations. A Vermont jury concluded that Phenergan was a defective product, and awarded Levine $6.7 million to compensate for her devastating injury.
Wyeth appealed the verdict, and argued that because the drug’s label had been approved by the FDA – a federal agency – a consumer such as Deborah could not sue the company in state court. The Supreme Court rejected Wyeth’s argument, and ruled that a drug manufacturer ultimately “bears responsibility for the content of its label at all times.” The FDA’s purpose is to regulate, not to compensate consumers for injuries caused by drugs. “State law remedies further consumer protection,” Justice Stevens wrote, “by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.”
What does this mean for Massachusetts consumers?
The Wyeth decision will make it much harder for drug manufacturers to hide behind a shield of compliance with federal regulations. FDA approval will not provide immunity for a drug company with a defective product. If you are injured by a negligently produced prescription drug, your right to bring a product liability action in state court against the drug company is preserved, and drug companies cannot hide behind a wall of federal preemption.
Another important effect of the decision is that pharmaceutical companies will likely pay closer attention to their labels and instructions, therefore improving consumer protection and safety in the prescription drug marketplace.
To read the entire decision, click here: Wyeth v. Levine
What if I have been harmed after taking a prescription drug?
If you believe that you have been injured as a result of a negligently produced prescription drug, you should seek immediate legal assistance. The Massachusetts attorneys at Breakstone, White & Gluck, PC specialize in personal injury, medical malpractice and drug product liability cases. Contact us for a free initial consultation, toll-free, at 800-379-1244.