Questions about FDA Oversight of Medical Devices Leave Patients Vulnerable

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For Immediate Release: June 18, 2009

Contact: Jen Fuson
202-965-3500, ext. 369
media.replies@justice.org

Questions about FDA Oversight of Medical Devices Leave Patients Vulnerable

Recent Recall of Medtronic Pacemaker Further Shows Why Manufacturers Need to be Held Accountable through the Civil Justice System

Washington, DC—Patients’ health and safety should not  be compromised because of the on-going questions surrounding the Food and Drug Administration (FDA) and their oversight of medical devices, according to the American Association for Justice (AAJ). 

Today’s hearing by the U.S. Energy and Commerce Subcommittee on Health examining the regulation of medical devices comes a week after another Medtronic device -- 37,000 pacemakers -- were recalled because the devices were found to seriously, even fatally, injure patients.   Medtronic has recommended the removal of the pacemakers, further putting patients’ health at risk by subjecting them to invasive surgery. 

“Manufacturers must play a role in ensuring their products are safe and that when their products fail, they must be held accountable,” said Sue Steinman, Director of Policy for AAJ.  “Patients of faulty medical devices should not have to suffer when manufacturers rush-to-market a product, putting profits over patients’ safety.” 

Earlier this year, thousands of patients were denied their day in court for another Medtronic medical device that was recalled, the Sprint Fedelis defibrillator lead. 

Currently, makers of medical devices have complete immunity for their devices because of a 2008 Supreme Court ruling in Riegel v. Medtronic.  The Court ruled that because the FDA had approved the medical devices, the manufacturer cannot be held accountable if the device is defective, even in cases when the device has been recalled.  In March 2009, the Court ruled in Wyeth v. Levine that manufacturers bear the responsibility for the safety of prescription drugs and do not have immunity.

The Medical Device Safety Act has been introduced in Congress to restore the rights of injured consumers to hold negligent medical device manufacturers accountable for the safety of their products in state tort actions. The legislation, introduced by Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), has over 90 cosponsors in the U.S. House.

The FDA’s oversight of medical devices has been called into question by the GAO, members of Congress, and even the FDA’s own physicians and scientists, who sent a letter to President Obama in April outlining numerous instances where “wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior.” The scientists call on manufacturers to revisit medical devices that were not made in accordance with the laws, rules and regulations that govern the process.  The letter is available at http://finance.senate.gov/press/Gpress/2009/prg040209a.pdf.

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