WASHINGTON (AP) - The Supreme Court on Wednesday upheld a $6.7
million jury award to a musician who lost her arm because of a
botched injection of an anti-nausea medication. The court brushed
away a plea that it limit lawsuits against drug makers.
In a 6-3 decision, the court rejected Wyeth Pharmaceuticals'
claim that federal approval of its Phenergan anti-nausea drug
should have shielded the company from lawsuits like the one filed
by Diana Levine of Vermont.
Levine, 63, struggled with her emotions when told of the ruling
in a phone call from an Associated Press reporter Wednesday: "Oh,
my God. I'm so, so happy. I can't believe this phone call," she
"This is going to go down in history for me. I've been waiting
for so long, and I had no idea of what the chances were," Levine
said. "I'm just ecstatic. I'm going to have to sit down."
The decision is the second this term to reject business groups'
arguments that federal regulation effectively pre-empts consumer
complaints under state law.
A Vermont jury agreed with Levine's claim that Wyeth failed to
provide a strong and clear warning about the risks of quickly
injecting the drug into a vein. Gangrene is likely if the injection
accidentally hits an artery - precisely what happened to Levine.
The company appealed and, backed by the Bush administration,
argued that once a drug's warning label gets approval from the Food
and Drug Administration, the label can't be changed without further
FDA approval and consumers cannot pursue state law claims that they
Justice John Paul Stevens, writing the majority opinion, said
Wyeth could "unilaterally strengthen its warning."
Stevens said he was persuaded that until a recent change by the
FDA, the agency "traditionally regarded state law as a
complementary form of drug regulation" because it monitors 11,000
Justice Clarence Thomas agreed with the outcome of the case, but
did not join Stevens' opinion.
Justice Samuel Alito wrote a dissent that was joined by Chief
Justice John Roberts and Justice Antonin Scalia.
"This case illustrates that tragic facts make bad law," Alito
said. "The court holds that a state tort jury, rather than the
Food and Drug Administration, is ultimately responsible for
regulating warning labels for prescription drugs."
The FDA has approved the use of Phenergan by injection,
including the method at issue in Levine's case. The drug has been
available for decades to treat nausea and when used properly, both
sides agree it is safe and effective.
The Bush administration and business groups aggressively pushed
limits on lawsuits through the doctrine of pre-emption - asserting
the primacy of federal regulation over rules that might differ from
state to state.
The Supreme Court had largely agreed, ruling last term that FDA
approval shields medical devices from most lawsuits. That case
turned on a provision of federal law prohibiting states from
imposing their own requirements on the devices.
The Levine case drew a lot of attention because the
administration and Wyeth contended that, although the federal Food,
Drug and Cosmetic Act lacks a similar provision, drug manufacturers
also are protected from most suits over federally approved drugs.
(Copyright 2009 by The Associated Press. All Rights Reserved.)