A stunning surprise victory for consumers over drug companies

Sometimes the good guys win, and sometimes the good guys win big. But they rarely win this big.

A few months ago I told you about the legal journey of Diana Levine, a Vermont musician who lost part of her right arm to gangrene after a hospital misused an anti- nausea drug called Phenergan.

Diana sued Wyeth, the maker of the drug, claiming the warnings weren’t adequate. She won, and the Vermont Supreme Court upheld the ruling on appeal. But Wyeth took the case to the U.S. Supreme Court, claiming Diana couldn’t sue because the FDA had approved the drug, along with the drug’s warnings.

You may have already heard the news: The Supreme Court recently ruled 6-3 that Diana can sue Wyeth. This is obviously a wonderful moment for Diana – she’s vindicated, and she’ll also be receiving several million dollars in damages awarded by the earlier state court ruling.

More importantly, it’s a huge victory for consumers.

Manufacturers who produce drugs and medical devices won’t be shielded from lawsuits simply by gaining FDA approval, so (in theory) the pressure is still on to ensure the safety of a device or drug before they’re put on the market.

On the day of the Supreme Court ruling, this comment from a reader appeared in response to a Wall St. Journal blog: “Shame on Big Pharma for trying to hide behind the skirts of the FDA at the very same time that they have done everything in their considerable power to weaken the agency’s ability to protect consumers. Justice has been served today.”

I couldn’t agree more.

You can find a more complete telling of Diana’s tragic experience in the e-Alert “Diana & The Supremes” (10/21/08).


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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