Public Citizen has urged Congress to pass legislation without delay 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 new legislation – the Medical Device Safety Act of 2008 – would overrule the U.S. Supreme Court’s February decision in Riegel v. Medtronic, which held the 1976 federal law that gives the Food and Drug Administration authority to regulate medical devices also severely limits the right of injured patients to sue device manufacturers.

Reps. Henry Waxman and Frank Pallone sponsored the bill (HR 6381) introduced in the U.S. House of Representatives. Senators Ted Kennedy and Patrick Leahy are handling 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. Public Citizen lawyer Allison Zieve, who argued on behalf of the Riegels in Riegel v. Medtronic, observed:

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. 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. The victim 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. Admittedly, 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.

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 even the FDA itself, among others, have questioned the FDA’s ability to protect the public. No knowledgeable person can honestly say that the FDA does an acceptable job of protecting the American people from defective and unsafe drugs and medical devices. Public Citizen President Joan Claybrook made this observation:

Given the FDA’s failure to prevent numerous medical device tragedies in recent years, the continued availability of common-law remedies is essential.

Congress must protect the American people by passing this legislation. Now that ordinary citizens are catching on to what the Bush Administration is trying to do to them by way of federal preemption, they are demanding congressional action. If you agree that Congress must act in this area of concern, contact your members of the U.S. House and Senate.

Source: Public Citizen

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