Posts Tagged With: Food and Drug Administration

Generic Drugs Resistant to Lawsuits

Waiting for my plane at La Guardia, I see that the NYT has an article on page one about the disparity between suing brand name vs. generic drug makers for failure to adequately warn of serious side effects on their drug labels. Can it be that no one is responsible for monitoring/updating drug label warnings once a drug becomes generic?

Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall.

That result stands in sharp contrast to the highly publicized case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.

“Explain the difference between the generic and the real one — it’s just a different company making the same thing,” Ms. Schork said.

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