WASHINGTON – AdvaMed, the medtech association, asked the Supreme Court to affirm the judgments of the court of appeals in the Seventh Circuit in a significant case concerning the False Claims Act (FCA) Scienter Standard.
The regulatory landscape in which medical technology companies operate involves highly complex, often ambiguous regulations. The regulation of medical devices involves FDA exercise of policy judgments that preclude certainty regarding their applications. However, manufacturers are frequently subject to FCA suits for product communications that allegedly violate outdated, incomplete, and ambiguous regulations.
As AdvaMed, the world’s largest trade association representing medical technology companies, noted in its brief, the Supreme Court has already recognized that FDA must balance the key factors in determining whether a device is safe and effective for public use. The FDA review process involves numerous, highly technical steps and calls upon FDA to make decisions and judgments that only it can.
“Adopting a scienter standard that penalizes actions consistent with an objectively reasonable understanding of ambiguous legal obligations would stifle innovation and chill protected speech,” said Pat Fogarty, Deputy General Counsel & Senior VP of Legal at AdvaMed. “Adopting such a standard would have a powerful impact on AdvaMed members’ ability to bring innovative life-saving medical devices to market, and to communicate freely with health...
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