March 2, 2009
The Honorable Frank Pallone
Chairman of the Energy and Commerce Subcommittee on Health
United States House of Representatives
Washington, DC 20515
Dear Chairman Pallone:
The National Research Center (NRC) for Women & Families strongly supports the Medical Device Safety Act of 2009. This Act will restore the rights of injured patients and consumers to sue the manufacturers of defective medical devices in state courts.
Last year, the U.S. Supreme Court ruled in Riegel v. Medtronic, Inc. that medical devices makers are shielded from personal injury lawsuits, if their defective or unsafe product was approved by the Food and Drug Administration’s (FDA) pre-market approval (PMA) process.
The Supreme Court and the medical device manufacturing industry stated that the FDA’s “rigorous pre-market approval process” will protect patients and consumers from dangerous devices, so patients do not need state protections. However, numerous recent product recalls make it clear that many medical devices that are sold in the United States are not safe.
The Institute of Medicine and the U.S. Government Accountability Office have issued reports concluding that poor management, scientific inadequacies, and lack of resources, inspections, and post-market surveillance systems have undermined the agency’s ability to protect Americans from unsafe drugs and medical devices.
NRC for Women & Families is gravely concerned that the Supreme Court ruling will shield from lawsuits manufacturers who received FDA approval through inadequate or false data or by withholding important safety and effectiveness data. In the past, lawsuits have helped to elicit information about false or misleading data. Without the discovery process from lawsuits, risk information that was covered-up by a company might never be made public.
It is clear that patients and consumers cannot have full confidence in the ability of the FDA to protect them from dangerous and deadly medical devices. The Supreme Court ruling has already had a negative impact on patients. Recently, a Minnesota district court relied on Riegel to dismiss the state law claims of more than 1,000 patients who were injured or died from Medtronic’s faulty Sprint Fidelis implantable defibrillator. According to news reports, “More than 235,000 people received the Sprint Fidelis leads before they were recalled, and many of those patients still have them in place.”
The Medical Device Safety Act of 2009 would allow injured patients to seek redress in state courts, and the threat of litigation would provide a financial incentive to manufacturing companies to ensure that their products are as safe as possible. For the above reasons, NRC for Women & Families strongly supports this legislation.
Diana Zuckerman, PhD
 Meier, B. 2009, February 24. “Study Finds More Failure of Heart Device,” The New York Times