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Industry seeks to sway Supreme Court on FDA role

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 5, 2007

AdvaMed and the Medical Device Manufacturers Association are paying close attention to a pivotal case before the Supreme Court. The Supreme Court will hear arguments about whether the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act preempts state law liability for injuries linked to FDA-approved devices.

AdvaMed announced in an October 22 press release that it filed a joint amicus brief asserting that the FDA should have sole authority to regulate medical devices. AdvaMed's brief argues a "state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies." The press release notes two lower courts affirmed the FDA's exclusive authority to regulate devices.

The press release summarizes the brief's arguments:

• FDA already oversees medical devices
• state-law liability would "interfere" with FDA authority
• state tort liability would hurt development of new devices and make them less affordable
• state tort liability would lead to over-warning and "defensive labeling"

According to the U.S. Supreme Court's Web site, the case is to be argued December 4, 2007.

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