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June 26, 2008

Bills Would Restore Rights of Patients Injured By Faulty Medical Devices

Legislation Would Overrule U.S. Supreme Court’s  Anti-Consumer Decision in Riegel v. Medtronic  

WASHINGTON, D.C. – Public Citizen urged Congress to promptly pass legislation introduced today that would restore the rights of patients injured by defective or inadequately labeled medical devices to seek compensation for their injuries from the device manufacturers.

The Medical Device Safety Act of 2008 would overrule the U.S. Supreme Court’s February decision in Riegel v. Medtronic, which held that the 1976 federal law that gives the Food and Drug Administration (FDA) authority to regulate medical devices also severely limits the right of injured patients to sue device manufacturers. Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.)   sponsored the bill (HR 6381) introduced in the U.S. House of Representatives. Sens. Ted Kennedy (D-Mass) and Patrick Leahy (D-Vt.) are expected to introduce a similar bill in the Senate.

The legislation would restore Congress’ intent in enacting the 1976 law – that traditional state common-law remedies for injuries and deaths caused by medical devices would work in tandem with federal medical device regulation to protect consumers.

“The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels as soon as they become aware that they are inadequate and to remove unsafe products from the market,” said Public Citizen lawyer Allison Zieve, who argued on behalf of the Riegels in Riegel v. Medtronic. “By eliminating this possibility, the Supreme Court decision removed a significant layer of consumer protection, which makes passage of the Medical Device Safety Act of 2008 so essential.”

The Riegel case stemmed from a defective balloon catheter used during an angioplasty procedure. When the balloon burst during the operation, Charles Riegel was seriously injured. Riegel and his wife sued Medtronic, the maker of the catheter, alleging that the company had violated state-law duties not to market unreasonably dangerous products and to provide adequate instructions and warnings of the risks associated with the product.

Federal regulation plays a crucial role in protecting patients from dangerous products, but, inevitably, some dangerous products will reach the market and some patients will be harmed, Zieve said.  Certain Medtronic defibrillators, Guidant defibrillators, St. Jude’s Silzone-coated heart valve, and Sulzer’s hip and knee prostheses are recent examples of devices that have caused great injury. The National Academy of Sciences’ Institute of Medicine, the Government Accountability Office and the FDA itself, among others, have questioned the FDA’s ability to protect the public.

“Given the FDA’s failure to prevent numerous medical device tragedies in recent years, the continued availability of common-law remedies is essential,” Public Citizen President Joan Claybrook said.

READ the House bill.

LEARN more about the Riegel case.


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