FDA Approval Does Not Bar Suits, Supreme Court Rules

Article excerpt

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6-3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was "meritless," according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes. …