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Cheap generic drugs face possible legal liabilities

David Gura Mar 19, 2013
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Cheap generic drugs face possible legal liabilities

David Gura Mar 19, 2013
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According to John Hertig, associate director of the Center for Medication Safety at Purdue University’s College of Pharmacy, a generic drug and a brand name drug are chemically identical.

“We are talking about medications that are intended to do the same thing,” he says, and they can have the same adverse reactions.

Later this morning, the Supreme Court hears arguments in Mutual Pharmaceutical v. Bartlett, a case that could have big implications on the availability of generic drugs in the U.S. 

In 2004, New Hampshire resident Karen Bartlett took a generic drug, which had some really horrible side effects. So, she sued the company that made it, arguing the drug was “defective.” A jury awarded her $21 million.

John Hertig says there are risks to every medication, and the side effects Bartlett experienced were part of the drug’s profile.

“So, this isn’t necessarily a defect of the drug,” he says. “It’s something that was known from the generic drug and the brand drug.”

Allison Hoffman, who teaches law at UCLA, says that if the Food and Drug Administration tells a company it can make a generic drug, that company makes the drug, “and it harms somebody, the question is, ‘Who should pay for that harm?’”

If it’s the drug maker, the company may decide it’s too risky and perhaps too costly to make it at all. If the drug maker is not liable, the company may have no incentive to pull a potentially dangerous drug off the market. 

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