-- 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.
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 http://www.advamed.org.
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