Contact: Jennifer Fuson
202-965-3500, ext. 8369
Two Years After Riegel, Patients Still Without Legal Recourse
FDA’s Public Hearing on Medical Device Approval Process Shows Need for Legislation to Hold Manufacturers Accountable
Washington, DC—With the two-year anniversary of the Supreme Court’s decision in Riegel v. Medtronic approaching Saturday, thousands of patients still have no legal recourse when they have been injured by faulty medical devices.
The Riegel decision gave complete immunity to manufacturers of class III medical devices that have been approved by the Food and Drug Administration’s (FDA) premarket approval process, eliminating a check and balance that helped ensure device safety for decades prior.
Meanwhile, the FDA today is holding a public meeting on 510(k) medical device approvals – a process used by manufacturers to obtain quicker approval of devices they claim are similar to ones that already exist – which puts more patients at risk of being injured by faulty products.
“While the FDA’s thorough review of medical devices is necessary to protect patients, device manufacturers also need to be held accountable for their defective products through the civil justice system,” said American Association for Justice President Anthony Tarricone.
For example, Katie Meyer was just three days away from her 31st birthday when a defective medical device malfunctioned and shocked her three times. The device was a Medtronic Sprint Fidelis lead attached to her defibrillator, which she needed because of a cardiac condition developed while undergoing treatment for cancer. Katie beat cancer, but in the end, it was the removal of the faulty medical device that led to her death.
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 in 1976 when they passed legislation on medical device safety.
The Government Accountability Office reported last January that the FDA inadequately tested many class III medical devices. The study found in a recent five-year period the FDA did only minimal testing before approving 228 high-risk medical devices, instead of going through the agency’s more stringent premarket review process as Congress had intended.
The FDA has asked the Institute of Medicine (IOM) to conduct a comprehensive study of the approval process, to be completed in March 2011.