Federal approval of a prescription drug does not provide a shield against lawsuits from injured patients, the Supreme Court ruled earlier this month.


Wyeth, Supreme Court, prescription drug, Diana Levine, Phenergan, Wyeth Pharmaceuticals, Food and Drug Administration, John Paul Stevens, Bush administration, drug manufacturers, Richard Monks


















































































































































































































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Wyeth Supreme Court case’s impact far-reaching

March 16th, 2009

WASHINGTON – Federal approval of a prescription drug does not provide a shield against lawsuits from injured patients, the Supreme Court ruled earlier this month.

The court’s 6-3 decision affirmed a $6.7 million jury verdict in favor of Diana Levine, a Vermont musician whose right arm was amputated after she was injected with Wyeth Pharmaceuticals’ antinausea drug Phenergan.

The ruling applies to the more than 11,000 over-the-counter and prescription drugs on the market in the United States.

The Supreme Court’s decision also reverses a signature Bush administration legal policy.
In 2006 the Bush administration switched long-standing Food and Drug Administration policy and announced that federal approval of a drug preempted or barred suits from being filed in state courts.

Wyeth used that policy change as the centerpiece of its defense, arguing that FDA approval of the drug and its warning label should have shielded the company from Levine’s suit.

Last fall the administration’s lawyers joined the case on the side of Wyeth and urged the high court to adopt the new FDA policy as federal law.

But Justice John Paul Stevens, writing for the majority, said the Bush administration’s view “does not merit deference.”

Congress has passed laws regulating drugs for a century, he said, yet lawmakers have never barred consumers from suing drug makers.

Lawsuits not only compensate injured individuals but also “uncover drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly,” Stevens wrote.

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