STORY FROM: Drugs & Medical Devices

FCA Action’s ‘Fraud-On-The-FDA’ Claims Should Not Proceed to Trial, 1st Cir. Affirms

BOSTON — A federal appeals court has upheld rejection of a proposed amended complaint accusing the makers of two medical devices of violating the False Claims Act, ruling that the plaintiff’s allegations fall within the “fraud-on-the-FDA” category of claims that have been barred by the U.S. Supreme Court.

In a Dec. 23 opinion, the 1st Circuit U.S. Court of Appeals ruled that allowing the case to proceed to trial could allow a jury to undercut the FDA’s regulatory authority.

Ev3 Inc. and its subsidiary, Micro Therapeutics Inc., manufacture the Onyx Liquid Embolic System and the Axium Detachable Coil System. Onyx ...

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