The Supreme Court said drug makers can be sued in state court over
alleged defects, even if the Food and Drug Administration has approved
a medication's use.
The 6-3 ruling undercuts years of business efforts to block state
suits over the safety of products from motorcycle brakes to railway
cars. "This is a very sweeping decision, with significant implications
for areas other than the regulation of prescription drugs," said Jay
Lefkowitz, a former policy adviser to President George W. Bush.
have long sought to establish federal rules as a single standard
trumping state law, and enjoyed a push under the Bush administration to
shield industries from negligence suits.
The case was brought by Vermont musician Diana Levine, who went to a
clinic complaining of migraines. She was injected with antinausea drug
Phenergan, made by Wyeth.
Though the drug label permitted intravenous injection, it said "extreme
care" was needed to avoid hitting an artery, because "likely"
complications included "gangrene requiring amputation."
That happened to Ms. Levine, whose right forearm was amputated. She
sued Wyeth, alleging the label should have barred intravenous
injection, and a state jury awarded her $7.4 million. Wyeth appealed to
the Supreme Court, arguing that Ms. Levine had no right to sue, because
the FDA approved the drug's label.
Writing for the court, Justice John Paul Stevens concluded that
Congress saw state liability laws as bolstering, not undercutting, the
FDA's mission of ensuring drug safety. With 11,000 drugs on the market
in the U.S., he wrote, the FDA's own advisory panels have said it lacks
resources to protect the public.
A 2006 Bush regulation reversed prior FDA policy by declaring state
law interfered with the agency's mission. Justice Stevens wrote that
the agency's new position was "inherently suspect" because it supplied
no supporting evidence and failed to follow procedures for public
comment. "Congress has repeatedly declined to pre-empt state law," he
Dissenting Justice Samuel Alito argued that being covered by federal
regulation gave Wyeth immunity from state law. "This case illustrates
that tragic facts make bad law," he wrote.