Diana Levine was the plaintiff in the U.S. Supreme Court case Wyeth v. Levine—a case in which the court ruled that Food and Drug Administration approval of a drug’s label does not block, or “preempt,” consumers from holding the manufacturers accountable for injuries caused by the drug.
Levine’s story began when she checked into a Vermont health clinic with a severe migraine and nausea. She left three weeks later with her hand and half of her forearm amputated due to the improper administration of Wyeth’s anti-nausea drug Phenergan. She was given the drug through a push IV, a method of administering the drug that Wyeth knew to be unsafe, but failed to warn medical caregivers about in the drug’s label.
The loss of Levine’s arm ended her 30-year career as a professional musician. She sued Wyeth in 2004, and a Vermont jury ruled in her favor, requiring Wyeth to compensate her for her economic losses, damages and medical expenses. Wyeth appealed the decision, arguing that victims cannot hold manufacturers accountable for drug labels approved by the FDA.
The Supreme Court took up the case, issuing in March 2009 a 6–3 decision upholding the Vermont jury’s decision that Levine could hold Wyeth responsible for the injuries she suffered after taking one of its drugs, and that FDA approval of a drug’s label does not preempt consumers from filing state-level product liability lawsuits against drug companies.
More recently, the 6th Circuit affirmed the Wyeth v. Levine decision when it determined that the estate of Mary Buchanan could proceed with its negligence case against the drug company Wyeth (now part of Pfizer). Mary Buchanan took Wyeth’s weight loss drug Redux for several months in 1996 and 1997. In 2001 she was diagnosed with primary pulmonary hypertension and she died two years later. Redux was taken off the market after only two years because it created an elevated risk in users for developing primary pulmonary hypertension, which may be fatal.
These decisions do not provide a legal remedy for all injured patients: the Supreme Court issued a contradictory 2008 ruling in Riegel v. Medtronic that says medical device manufacturers cannot be sued for damages in state courts if the device was approved by the FDA. The Medical Device Safety Act has been introduced to reverse this decision and restore injured consumers’ rights to hold negligent medical device manufacturers accountable.