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Drug Maker Sued for Woman''s Amputation

Drug maker Wyeth and Co. must pay about $6.8 million to a woman who had to have her arm removed after she was injected with one of its drugs.

In the Supreme Court''s opinion, the court said that drug companies can issue more serious warnings than the FDA recommends if they believe it is necessary.

What Happened?

In 2000, Diana Levine went to the Health Center in Plainfield, Vermont complaining of nausea and migraine headaches. She was given an injection of Phenergan.

Levine returned later and was given more of the drug through intravenous injection. The injection inadvertently went into an artery in the second injection. The artery was severely damaged and eventually lead to gangrene.

Levine''s condition worsened for several weeks until finally, her limb had to be amputated at the forearm.

The Lawsuit

Levine''s suit against the Health Center that administered the errant IV was settled before the trial for an undisclosed amount.

A Wyeth spokesman tried to argue that Wyeth had attempted to strengthen the warning, but the FDA rejected their request.

However, the majority opinion of the appellate court said that the FDA''s labeling requirements are in place to “create a floor, not a ceiling” for state regulation, adding that the federal regulations allow drug makers to give warnings beyond those required by the agency.

Justice Denise Johnson said, “When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA''s continued approval of its labels as a shield against state tort liability.”

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