Solicitor General Sides with Wyeth in Supreme Court Pre-emption CaseJun 9, 2008 | Parker Waichman LLP The Bush Administration has taken the side of the pharmaceutical industry in a case before the US Supreme Court that could greatly curtail consumers' right to sue over injuries caused by a defective drug. In the case before the court, Wyeth vs. Levine, Wyeth has argued that Food & Drug Administration (FDA) approval of a drug bars consumers from bringing product liability lawsuits in state courts if they suffer injury.
Wyeth vs. Levine involves a Vermont woman who alleged she lost her arm from adverse events tied to Wyeth's nausea and motion sickness drug Phenergan. Levine, who was awarded more than $6 million in her state court claim against Wyeth, said she was administered Phenergan at her local hospital emergency room. The product normally is administered intramuscularly, but hospital staff used a method called I.V. push of injecting the drug into her vein, which resulted in an inadvertent arterial injection. Levine, a guitar player, developed gangrene in her arm, which resulted in it being amputated.
Inadvertent arterial injection of Phenergan is known to be dangerous, and some hospitals have banned Phenergan. Levine has contended that Phenergan's labeling failed to adequately warn about the dangers of using the I.V. push method. In 2000, the same year Levine sustained her injury, Wyeth changed the label of Phenergan to warn that the drug should not be given by intra-arterial injection because of the risk of gangrene.
The FDA backs Wyeth's argument, and now U.S. Solicitor General Paul D. Clement has filed an amicus brief with the Supreme Court supporting the drugmaker's case. Most Supreme Court observers believe that the Supreme Court will find in favor of Wyeth. In February, the high court ruled in favor of medical device makers in a similar case, Riegel vs. Medtronic, Inc. There is little reason to suspect that the court will act differently towards pharmaceutical companies.
Many members of Congress are disturbed by these developments, and some are taking steps to nullify the Supreme Court's Riegel decision. Reps. Henry Waxman (D-Calif.) and Frank Pallone (R-N.J.) are in the process proposing such legislation.