Contact: Jennifer Fuson
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Device Manufacturer’s Guilty Plea Shows Need for Medical Device Safety Act
When manufacturers make defective products and hide safety data, civil justice system critical for patients
Washington, DC—Yesterday’s admission by Guidant that the company suppressed critical safety information from the Food and Drug Administration (FDA) regarding two defibrillators shows why Congress must pass the Medical Device Safety Act so patients can hold manufacturers accountable for their defective products.
Boston Scientific’s Guidant subsidiary agreed to a $296 million plea agreement for concealing crucial safety information from the FDA. The devices – implantable defibrillator models Ventak Prizm 2 and the Contak Renewal – were approved by the FDA’s premarket approval process.
Despite its admission of wrong-doing, Guidant has complete immunity from civil claims because of the 2008 U.S. Supreme Court decision in Riegel v. Medtronic, which held manufacturers of medical devices approved by the FDA’s premarket approval process cannot be held liable for the product’s defects.
“This case shows manufacturers are using flawed and inaccurate data to remain in good favor with the FDA, while potentially dangerous devices remain on the market,” said American Association for Justice Executive Vice President for Public Affairs Linda Lipsen. “Device manufacturers should be held accountable not only to our government, but also to patients in our courts to ensure the safety of their products.”
The FDA does not perform their own testing on medical devices; instead, the agency relies on manufacturers to supply accurate and timely information on which they base their medical device approvals.
Congress has introduced the Medical Device Safety Act (S. 540 / H.R. 1346) to restore the rights of medical device patients to seek remedy in court as Congress had intended when they passed legislation on medical device safety in 1976.
“Passage of the Medical Device Safety Act is critical for patient safety, especially when the FDA is relying on manufacturers to provide accurate information on the safety of their medical devices,” said Lipsen.
At this point, trial attorneys are intervening in the case on behalf of Guidant patients, so those injured may be compensated; however, thousands of people injured by other defective medical devices are left without recourse.