Medical Device Safety Act of 2008

Madam Speaker, I rise in support of H.R. 6381, the Medical Device Safety Act of 2008. I am proud to be an original cosponsor of this legislation, which will address the Supreme Court's flawed decision in Riegel v. Medtronic that completely ignored Congressional intent regarding the ability of injured patients to hold medical device manufacturers accountable for their injuries. This bill will restore Congress's original intent to allow injured patients to seek recourse for their injuries suffered at the hands of negligent device manufacturers.

American patients need the Medical Device Safety Act of 2008 to ensure that they have the ability to hold negligent device manufacturers accountable for injuries caused by unsafe products. It also would prevent these manufacturers from receiving total immunity from any claims simply by virtue of receiving a Food and Drug Administration device approval.

It is important for Congress to quickly make its intent clear, as the Supreme Court will likely take up a parallel issue this fall regarding accountability for pharmaceutical manufacturers. Earlier this year, I was proud to participate in a hearing in the Committee on Oversight and Government Reform which looked deeper into this issue. Witness testimony made it clear that when we allow the FDA to have the final say on device safety, patient safety is compromised. Strong State laws are critical to maintaining accountability for device manufacturers, and allowing the FDA to pre-empt these State laws is a surefire way to lead to negligence and the production of unsafe products.

The civil justice system and the Federal regulatory system were always meant to complement each other. Both are necessary to adequately protect Americans. The FDA simply cannot do it alone. The agency is understaffed and underfunded, and I support additional funding to help this critical agency. However, allowing the buck to stop solely with the FDA on issues of life and death is simply contradictory to our system of checks and balances. This is just one more reason that it is

vital that Congress pass the Medical Device Safety Act of 2008 to restore the balance between the civil justice system and the Federal regulatory system that Congress intended when it passed the Medical Device Amendments of 1976.

I rise today in support of the recently introduced Medical Device Safety Act of 2008. This much-needed legislation would restore an injured consumer's ability to hold negligent medical device manufacturers accountable for product-related deaths and injuries.

The Medical Device Safety Act addresses the problems created by the Supreme Court's February 20, 2008, decision in Riegel v. Medtronic. This decision stripped away essential consumer rights by supplying device manufacturers with total immunity from liability.

It's difficult to see the reasoning behind this special treatment for device manufacturers when you consider what happened to Bridget Robb. In May 2005, Ms. Robb was diagnosed with nonischemic, viral cardiomyopathy and congestive heart failure. To prevent her from dying from a fatal arrhythmia, she had a Medtronic cardiac defibrillator and pacemaker implanted in her chest. On December 31, 2007, a wire in Ms. Robb's defibrillator broke, causing the device to send a strong electric current to her heart. Ms. Robb suffered 31 electric shocks in 13 minutes in front of her 6-year-old daughter. Medtronic knew about this defect, but issued only a voluntary recall. Since this frightening experience, Ms. Robb has undergone two surgeries to replace her defibrillator and goes to doctor's appointments almost weekly for follow-up appointments and testing.

Prior to the Supreme Court's decision in Riegel, the FDA and State courts protected consumers, like Ms. Robb, together. Since Riegel, consumers only have the FDA to protect them; and the FDA has insufficient resources to do so effectively. The Medical Device Safety Act ensures that consumers like Bridget Robb will be able to seek legal recourse for their injuries and reiterates Congressional intent that State laws must work hand in hand with Federal regulations to protect consumers.

For these reasons, I urge support for Congressman Pallone and Congressman Waxman's bill, H.R. 6381. I look forward to working towards passage of this legislation and restoring these, critical, basic consumer protections.