The Medical Device Safety Act: Providing Critical Consumer Protections

Floor Speech

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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