Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtr...( Filed in Support of Federal Pre-E...),Health

Filed in Support of Federal Pre-Emption in Riegel v. Medtronic, Inc.

WASHINGTON, Oct. 22 /PRNewswire-USNewswire/ -- Leading a group of concerned organizations, the Advanced Medical Technology Association (AdvaMed) filed a joint amicus brief Friday in the U.S. Supreme Court in the matter of Riegel v. Medtronic, Inc. arguing that the FDA should continue to be the sole regulator of medical devices. The brief states that no other legislative or regulatory entity is better positioned than the Food and Drug Administration to ensure the timely access to safe and effective medical devices.

The brief also contends allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies.

Joining AdvaMed are DRI, Medmarc Insurance Group and the Medical Device Manufacturers Association.

"The safety and efficacy of medical technologies are best determined by FDA scientists -- not by lawsuits filed in courtrooms throughout the country. It was the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies. 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," said Christopher White, AdvaMed Executive Vice President and General Counsel.

Two previous rulings in this case have made clear that the Medical Device Amendments (MDA) to the Federal Food Drug and Cosmetic Act (FDCA) expressly provides for FDA's ultimate regulatory authority in these matters.

"We hope the Supreme Court re-affirms the two previous lower court rulings and prevents any erosion in FDA's existing regulatory approval authority," said White.

Other key arguments made in the filing include:

-- FDA currently exercises substantial
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