The Medical Device Safety Act of 2008

Riegel v. Medtronic -

Under Riegel, manufacturers of FDA-approved medical devices are given complete immunity from liability for product-related deaths and injuries. This immunity protection even extends to manufacturers who fail to warn about device problems that arise after FDA approval. By eradicating manufacturer accountability, thousands of consumers injured by defective devices are left unable to obtain any remedies for their injuries. In the last decade alone, consumers were harmed by defective devices like the Trident prosthetic hip and the Prodisc spinal implant. An upcoming Supreme Court case dealing with prescription drugs could further limit the rights of consumers to hold drug manufacturers accountable. Alliance for Justice believes that passage of the Medical Device Safety Act of 2008 would address these gaps and capitalize on 30 years of experience under the 1976 Medical Device Amendment by utilizing both FDA regulation and state tort law to ensure the safety of medical devices.

 

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