This week, Boston Scientific Corp.’s Guidant agreed to a $296 million plea deal for concealing crucial safety information from the FDA. The devices involved – 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. As a result of the Riegel decision, thousands of cases of patients injured by defective medical devices, like Guidant’s, are being dismissed. Usually, this leaves consumers, insurance companies, and the government stuck paying for a manufacturer’s defect.
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. 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. 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.
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.
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.
Read the American Association for Justice’s press release for more information.
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