[Congressional Record (Bound Edition), Volume 154 (2008), Part 10]
[Extensions of Remarks]
[Page 14349]
[From the U.S. Government Publishing Office, www.gpo.gov]




       REGARDING H.R. 6381, THE MEDICAL DEVICE SAFETY ACT OF 2008

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                          HON. BRUCE L. BRALEY

                                of iowa

                    in the house of representatives

                         Tuesday, July 8, 2008

  Mr. BRALEY of Iowa. 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.

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