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Generic Drugs Shielded from the Law


Posted on Apr 02, 2012

Thanks to a unusual FDA rule and its recent upholding in the Supreme Court, generic drug manufacturers cannot be sued for the same failure-to-warn offense committed by corresponding brand-name manufacturers.

In Wyeth v. Levine (2008), the Supreme Court upheld a $6.8 million damage award for Diana Levine of Vermont. In 2000, Ms. Levine was injected with the brand name Phenergan for a migraine. Her hand and forearm then turned black and had to be amputated. It was known at the time that the drug may cause gangrene if injected into the artery. The manufacturer, Wyeth, claimed to have placed a relevant warning on the bottle but the Court sided with Ms. Levine that it was not enough.

In 2007, Debbie Schork, 52, of Indiana was given a generic version of the same exact drug to treat a stomach ache and nausea related to her Crohn's disease. Her right hand developed gangrene and had to be amputated. However, when she sued Baxter Healthcare Corporation last fall in a direct repeat of Ms. Levine's case, her claim was thrown out because the medication she used was generic.

The reasoning goes back to a Supreme Court case from last June, Pliva v. Mensing. In 1984 the FDA gave a liability exemption to generic drugs because generics are generally forced to follow the activities of their brand-name alternatives, which are themselves regulated directly by the FDA. Because generics don't have the ability to unilaterally change their own labels, the logic goes, they should not be liable for not doing so.

Since then, over 40 judges have thrown out similar generic drug cases. Ms. Schork, meanwhile, won a "limited" medical malpractice settlement from the offending hospital.

OBSERVATION:
What's the moral of this story? Take only name-brand medication? Or, if you take generic medication, make sure you understand the risks.

If you would like more information about how medical malpractice and accident cases work in the state of New York, I encourage you to explore my educational website. If you have legal questions, I encourage you to pick up the phone and call me at 516-487-8207 or by e-mail at lawmed10@yahoo.com to answer your questions. That's what I do every day. I welcome your call.


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