The Food and Drug Administration should continue to be the sole regulator of medical devices, the Advanced Medical Technology Association, or AdvaMed, urged in a joint amicus brief filed with the U.S. Supreme Court in the case of Riegel v. Medtronic Inc.
For the first time, the Supreme Court will be deciding whether a patient is precluded from seeking state court remedies against the manufacturer of a device that has been approved by FDA through its pre-market approval process.
It was Congress intent that the FDA be responsible for the timely approval of medical technologies, said Christopher White, AdvaMeds executive vice president and general counsel, in a written statement. Encouraging states to insert state court liability suits into the process would undermine the science-based approach to approvals currently in place, and would likely result in inconsistencies in standards and delayed access to products.
The case arose after a physician inappropriately used an FDA-approved balloon catheter that was once manufactured by Medtronic. Two previous lower-court rulings upheld the FDAs ultimate regulatory authority in these matters, AdvaMed stated.
Several groups joined AdvaMed in the brief, including DRI, an international organization that represents defense attorneys, Medmarc Insurance Group and the Medical Device Manufacturers Association. The Supreme Court is scheduled to hear oral arguments on Dec. 4, a Medtronic spokesman said. -- by Jennifer Lubell
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