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The Ninth Circuit Court of Appeals allowed False Claims Act allegations against drug manufacturers Gilead Sciences to move forward despite a US Supreme Court ruling last year that raised FCA standards.
Medtech's legal realm wants the US Supreme Court to correct the record on 510(k)s next term, and they say they've found the right case to make that happen: a J&J/Ethicon mesh device suit where the lower court refused to let the jury hear any mention at all of US FDA or the product's 510(k) clearance. Courts say 510(k)s lack sufficient relevance to support a company's case for product safety, but industry says that view is based on outdated facts and is fundamentally unfair.
A $17.2m fine Chinese regulators imposed on Medtronic may just be the tip of the enforcement iceberg as the country attempts to discipline overseas manufacturers who break new antitrust laws.
Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.
The US Department of Justice recently announced the largest-ever civil settlement in a device-related False Claims Act case. But otherwise it was a textbook FCA case, attorneys say, and many device companies still have a lot of work to do to ensure compliance and that their executives stay out of trouble. This is the first article in an occasional series in which Medtech Insight talks to attorneys to get the best takes on hot legal topics.
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