Patients’ Legal Rights in Jeopardy with FDA’s Proposal to Reclassify Metal-on-Metal Hips

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For Immediate Release: April 18, 2013

Contact: Jennifer Fuson
American Association for Justice

Patients’ Legal Rights in Jeopardy with FDA’s Proposal to Reclassify Metal-on-Metal Hips

Taxpayers, Patients Pay the Price for Faulty Medical Devices 

Washington, DC—The U.S. Food and Drug Administration (FDA) announced the agency is set to reclassify several metal-on-metal hips, requiring manufacturers to complete a premarket approval application (PMA) or product development protocol (PDP) in order to receive the agency’s approval.  The reclassification may put patients’ legal rights in question, according to comments submitted today by the American Association for Justice to the FDA.

“Reclassifying metal-on-metal hips to make the products deemed safer after the initial FDA approval must not jeopardize patients’ legal remedies,” said American Association for Justice (AAJ) president Mary Alice McLarty.  "The FDA is understaffed and underfunded.  A manufacturer’s legal responsibility for the safety of their medical device should never be determined based merely on which process the FDA used to approve the medical device." 
In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that patients harmed by medical devices approved by the FDA’s PMA process cannot sue the manufacturer for injuries because the FDA gave the product the agency’s stamp of approval.  Since then, thousands of medical device product liability cases have been dismissed or never brought before a court (Smith and Nephew and Stryker hips, St. Jude cardiac defibrillators, Boston Scientific spinal cord stimulators, Essure birth control), simply because of the method the FDA used to approve the device.  The Riegel rationale applies even when a product has been withdrawn from the market for safety, as in Medtronic’s Sprint Fidelis Leads.
“Metal-on-metal hips have cost thousands of consumers’ needless pain and suffering. The FDA’s goal should be to protect the consumer from unsafe medical devices, not further harm those who have suffered,” added McLarty.  “When an injured patient cannot hold the manufacturer responsible for harm, it is insurance, Medicare, Medicaid, and patients who pay the financial price for an unsafe device.  Reclassifying metal hips cannot be allowed to result in negative financial consequences just because the government determined the device needed additional safety testing, said the comments filed today.

Read AAJ’s full comments here and the real stories of Howard and Avery, patients injured by medical devices who have limited recourse as a result Riegel.

For more information on medical devices, visit

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