[Congressional Record (Bound Edition), Volume 154 (2008), Part 10]
[Extensions of Remarks]
[Page 14141]
[From the U.S. Government Publishing Office, www.gpo.gov]




 THE MEDICAL DEVICE SAFETY ACT: PROVIDING CRITICAL CONSUMER PROTECTIONS

                                 ______
                                 

                       HON. JANICE D. SCHAKOWSKY

                              of illinois

                    in the house of representatives

                        Thursday, June 26, 2008

  Ms. SCHAKOWSKY. Madam Speaker, I rise today in strong support of the 
Medical Device Safety Act of 2008, which has been introduced today by 
my colleagues Representatives Frank Pallone and Henry Waxman. I am 
proud to be original cosponsor of this legislation, which will restore 
consumer protections that were eliminated in the Supreme Court's recent 
Riegel v. Medtronic decision.
  The Riegel v. Medtronic decision ignored congressional intent and 
disregarded 30 years of experience under the 1976 Medical Device 
amendments, during which FDA regulation and State tort law worked 
together to protect consumers from dangerous devices. The Riegel 
decision gives total immunity to device manufacturers who fail to 
adequately warn consumers about device risks. It is now the 
responsibility of Congress to correct the Court's dangerous mistake.
  Patients who are injured by medical devices often suffer permanent, 
debilitating injuries or even death. They need the ability to hold the 
negligent medical device manufacturer accountable for their injuries. 
If not, private health insurance companies and Medicare or Medicaid 
would be left footing the bill to pay for those injuries; and, 
ultimately, the taxpayer pays for the medical device manufacturer's 
mistake.
  This narrow piece of legislation is necessary to address the Riegel 
decision and to ensure that it is not then applied to afford total 
immunity to medical device manufacturers throughout the country. It 
also will make certain that patients injured by medical devices can 
have their claims heard by a judge and jury and will prevent courts 
from summarily dismissing claims without ever hearing the facts. 
Finally, it restores congressional intent by explicitly stating that 
actions for damages under State law are preserved.
  I urge my colleagues to join me in cosponsoring and enacting the 
Medical Device Safety Act so that we can restore long-standing consumer 
protections.

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