The issue was federal preemption and whether Congress effectively barred lawsuit once a drug was approved by the Food and Drug Administration. The Bush Administration entered the case on behalf of Wyeth and against Levine to try to block patients from being able to seek recovery against drug manufacturers.
Here are the facts of the case:
Phenergan is Wyeth’s brand name for promethazine hydrochloride, an antihistamine used to treat nausea. The injectable form of Phenergan can be administered intramuscularly or intravenously, and it can be administered intravenously through either the “IV-push” method, whereby the drug is injected directly into a patient’s vein, or the “IV-drip” method, whereby the drug is introduced into a saline solution in a hanging intravenous bag and slowly descends through a catheter inserted in a patient’s vein. The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery.
Levine’s injury resulted from an IV-push injection of Phenergan. On April 7, 2000, as on previous visits to her local clinic for treatment of a migraine headache, she received an intramuscular injection of Demerol for her headache and Phenergan for her nausea. Because the combination did not provide relief, she returned later that day and received a second injection of both drugs. This time, the physician assistant administered the drugs by the IV-push method, and Phenergan entered Levine’s artery, either because the needle penetrated an artery directly or because the drug escaped from the vein into surrounding tissue (a phenomenon called “perivascular extravasation”) where it came in contact with arterial blood. As a result, Levine developed gangrene, and doctors amputated first her right hand and then her entire forearm. In addition to her pain and suffering, Levine incurred substantial medical expenses and the loss of her livelihood as a professional musician.
The decision by Justice John Paul Stevens upholds a nearly $7-million jury verdict against Wyeth and will clear the way for more such lawsuits Levine argued that Wyeth failed to warn of the dangers in the use of its drug. Levine noted that she would obviously had passed on an anti-nausea drug if told of this danger.
Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer joined Stevens. Stevens cited the important deterrent role presented by these lawsuits: ” “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”
Justice Clarence Thomas concurred in the result while Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr. dissented. Justice Alito wrote that “This case illustrates that tragic facts make bad law” and criticized the ruling as “a frontal assault on the FDA’s regulatory regime for drug labeling.”
For a copy of the opinion, click here.