Correcting Injustice--The Medical Device Safety Act
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The decision in the Supreme Court case of Riegel v Medtronic created special protection for medical device manufacturers that defied all logic and contradicted 30 years of experience in medical device regulation. The Riegel case set forth that lawsuits against medical device manufacturers were preempted where the manufacturer had properly submitted the device to and received approval from the food & Drug Administration. This decision ignored real world issues. Nearly everyone knowledgeable at the FDA will tell you they have neither the time nor the budget to conduct sufficient independent analysis of every medical device. Largely, their approval relies on the truthfulness and sufficiency of the testing reported to them by the device manufacturer. By necessity, the FDA’s process is somewhat like the fox guarding the henhouse, in situations where the manufacturer has failed, intentionally or negligently, to put the medical device through the testing that would best evaluate the product’s safety. The Medical Device Safety Act, currently in Congress, would seek to correct this error and place consumers back on level footing with medical device manufacturers. US Representative Henry Waxman summarized the situation well when he said:
"As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety," said Chairman Waxman. "The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products."
The bill has now garnered support from many organizations including:
AARP
Center for Justice & Democracy
Consumer Federation of America
Consumers Union
Homeowners Against Deficient Dwellings
National Association of Consumer Advocates
National Consumers League
OWL - The Voice of Midlife and Older Women
Progressive States Network Public Citizen
U.S. Public Interest Research Group
The New England Journal of Medicine
National Conference of State Legislators
National Research Center for Women & Families
What can you do?
Call your legislators and ask them to do the correct and just thing—vote in favor of the bill.
Go here to find contact information for congressional members!!