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Congress Examines Medical Device Safety: Key Issue for Older Nevadans

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 By Mike CliffordContact
February 17, 2012

LAS VEGAS – Congress tackled the issue of faulty medical devices this week, hearing testimony on Wednesday about whether Nevadans and people in other states should have the right to sue for damages in such cases.

In 2008, the U.S. Supreme Court gave manufacturers immunity from lawsuits for any medical device that received "pre-market approval" from the Food and Drug Administration (FDA). Now, Congress is considering restoring some legal rights.

Peter Wetherall is a Las Vegas attorney who specializes in prescription drug and medical device cases. He says the issue is especially important in Nevada, a favorite spot for retirees who are more likely to have implants like stents and artificial hearts.

"Those individuals, that have defective medical products in their body, should have an equal right to access to the courts that everyone else does."

Medical device manufacturers say subjecting them to lawsuits could hurt their profits, which in turn could kill jobs. Wetherall counters that it's the potential financial jeopardy from lawsuits that keeps corporations honest and forces them to focus on safety.

In recent years, he says, Congress has considered measures like the Medical Devices Safety Act of 2009, which would have restored the right to sue in state courts.

"There would still be some immunity in the federal courts, but most injury cases are pursued in state courts anyway. So, this would restore those people's right to go to court and plead their case for a defect in the product which caused them harm."

More than 100 members of Congress were co-sponsors of the bill, which did not pass.

Many people don't realize the FDA does not do its own testing on these devices before they are surgically implanted, he adds.

"The FDA relies on information provided by the manufacturer. If the manufacturer is driven by profits over safety, then these devices sometimes cause catastrophic harm to a whole bunch of people."

This session, consumer advocates are pressing lawmakers to strengthen the Medical Device User Fee Act to include more patient safety reforms, including conflict-of-interest rules and rules about advertisements for medical devices.

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