WASHINGTON, D.C. - Leading a group of concerned organizations, the Advanced Medical Technology Association (AdvaMed) filed a joint amicus brief 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.

(Note: Mr. Charles Riegel was injured when a balloon catheter burst during angioplasty and he sued the manufacturer, Medtronic. The company moved to dismiss the case because the law pre-empts state court actions as a remedy for people injured by devices that have received FDA approval. The case was dismissed but is now under appeal to the Supreme Court.)

The AdvaMed brief contends that 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 pre-marketing oversight of medical devices;
-Enhanced state-law liability would interfere with FDA's extensive pre- and post-marketing oversight of medical devices, not fill a regulatory "gap;"
-State tort liability would stifle the innovation of important and life-saving medical devices and would undermine the affordability of medical treatments; and
-State tort liability would encourage defensive labeling and over-warning that undermines rational prescribing by physicians.

Counsel for Amici Curiae include Daniel E. Troy, former Chief Counsel at the FDA, and Carter G. Phillips, former Assistant to the Solicitor General, both Partners at Sidley Austin LLP.

To read the amicus brief, go to:
http://www.advamed.org/NR/rdonlyres/A1530F93-14C4-4398-92DF-4E2478A2159A/0/FINAL10172007asfiledRiegelAmicus.pdf


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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

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