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Congress Examines Medical Device Safety: Key Issue for Older New Mexicans

March 19, 2012

ALBUQUERQUE, N.M. - This year, Congress has taken up the issue of faulty medical devices, looking at whether patients should have the right to sue for damages. In 2008, the U.S. Supreme Court gave manufacturers immunity from lawsuits for any medical device that received "premarket approval" from the U.S. Food and Drug Administration (FDA). Now, Congress is considering restoring some of patients' legal rights.

New Mexico attorney Lee Coleman, a partner at Bell, Hughes and Coleman, has worked on such cases. He says restoring patients' rights to sue helps keep manufacturers honest.

"When you take away the right of the consumer to hold companies accountable, historically companies will become more aggressive, and you'll see actions by the companies that harm consumers."

Medical device manufacturers say subjecting them to lawsuits could hurt their profits, which in turn could kill jobs. Coleman says the potential financial jeopardy from lawsuits is one factor that keeps corporations honest and forces them to focus on safety.

Congress has already considered measures like the Medical Devices Safety Act of 2009, which would have restored the right to sue in state courts. But it did not pass, even with more than 100 co-sponsors. Coleman says in today's polarized political environment, getting such a law passed could still be difficult.

"The lobby for all the business interests, Chamber of Commerce, whatever it might be, is so strong these days that you're going to have a hard time getting that passed. I personally favor it. Whether or not it ever happens, I don't know."

Many in New Mexico may not realize the FDA does not do its own testing on medical devices before they are surgically implanted. Coleman warns it is dangerous to leave the testing only to the manufacturers, but acknowledges it would be impractical for the FDA to do it.

"In most situations, you want the company doing its own testing and the FDA reviewing it. I don't think you can expect the FDA to be able to hire enough people and experts to know how to test all these various products."

This year, consumer advocates are pressing lawmakers to strengthen another bill, the Medical Device User Fee Act, with more patient safety reforms, including conflict-of-interest rules and rules about advertisements for medical devices. The General Accounting Office says more than 700 medical devices are recalled every year.

Beth Blakeman, Public News Service - NM