Woman loses arm after Phenergan injection but government says she can't claim damages

If a drug has a dangerous side effect, but nobody knew of the drug's problem beforehand, could a patient blame the drug company? Probably not.

What if the drug company knew about the adverse reaction, but the FDA did not think it important enough to tell consumers? That might be a different case, according to lawyers representing a Vermont woman who went into a hospital with a migraine headache and ended up with gangrene and an amputation of her arm where the drug was injected.

The case will be heard by the U.S. Supreme Court soon following a multi-million dollar award against a drug company in a Vermont state court.

At issue was the administration of Phenergan intravenously. The injection missed the vein, spread into the surrounding tissue, caused gangrene, which caused the need for an arm amputation. Doctors did not know that this could happen. But lawyers for the woman contend the drug company knew.

But the drug company contends that their data was not clinically significant because the FDA judged the findings were not sufficient to inform consumers on the medication guide issued with the drug. The federal Department of Justice argues that if the courts do not respect the FDA drug approval process, it would effectively shut down the production of new drugs, which would have a negative impact on patient care.

Lawyers for the plaintiff argue that drug warnings do not prevent new drugs from getting government approval. At issue is a concept known as "pre-emption" which means that FDA approval of a drug constitutes a scientific judgment that should hold up in court, equivalent to federal law, which pre-empts state law and state courts.

For more information on the case, Wyeth vs. Levine, read the articles at the following links:

NEJM Editors Enter Supreme Court Fray Over Drug Risks
Wall Street Journal, Aug. 15, 2008

Feds Back Wyeth in Supreme Court Case
Wall Street Journal, June 6, 2008

Wyeth vs. Levine,
Drug and Device Law, June 5, 2008

--news analysis by Chris Lareau, D.O.

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