[Congressional Record (Bound Edition), Volume 155 (2009), Part 5]
[Extensions of Remarks]
[Pages 6610-6611]
[From the U.S. Government Publishing Office, www.gpo.gov]




                   MEDICAL DEVICE SAFETY ACT OF 2009

                                 ______
                                 

                          HON. BRUCE L. BRALEY

                                of iowa

                    in the house of representatives

                        Thursday, March 5, 2009

  Mr. BRALEY of Iowa. Madam Speaker, I rise in support of the Medical 
Device Safety Act of 2009. This legislation was introduced today, and 
I'm proud to be an original cosponsor.
  The Medical Device Safety Act of 2009 is needed to ensure that every 
American patient has the ability to hold manufacturers of defective 
medical devices accountable for injuries and deaths caused by unsafe 
products. It would also prevent these manufacturers from receiving 
total immunity from any claims simply by virtue of receiving a Food and 
Drug Administration device approval. This bill clarifies the intention 
of Congress to keep American patients safe by maintaining complementary 
systems to protect consumers through the FDA and American courts.
  The need for this legislation was made evident in the Supreme Court's 
flawed decision in Riegel v. Medtronic, which 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 
recover from their injuries caused by manufacturers of defective and 
dangerous medical devices.
  It's important for Congress to promptly clarify its intent, because 
these types of issues continue to come up in courts around the country. 
Last Congress, I was proud to participate in a hearing in the Committee 
on Oversight and Government Reform which looked deeper into these types 
of issues. The medical safety experts agree that patient safety is 
compromised when we allow the FDA to have the final say on device 
safety. 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 place sales over safety and profits over 
people.
  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, and we see 
examples of this all the time, from pacemakers to peanuts. The agency 
is understaffed and underfunded, and I support additional funding to 
help this critical agency. However, making the FDA the ``court of last 
resort'' on issues of life and death is a violation of the Bill of 
Rights and ignores over 200 years of Common Law precedents. This is 
just one more reason why Congress must pass the Medical Device Safety 
Act of 2009 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.

[[Page 6611]]



                          ____________________