Wednesday, April 24, 2013

Legal Rights in Question with FDA Action on Metal Hips

Take Justice Back


Taxpayers and patients could pay the price for faulty metal-on-metal hips when the U.S. Food and Drug Administration (FDA) reclassifies 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.

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 the FDA used the PMA process to approve a 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  The Riegel rationale applies even when a product has been withdrawn from the market for safety, as in Medtronic’s Sprint Fidelis leads.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.  We know 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 and the necessary medical care.  Reclassifying metal hips for added safety cannot be allowed to result in negative financial consequences just because the government determined the device needed additional testing.

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