Judge: FDA Decision To Revoke Device Approval Was Substantially Justified

(April 6, 2016, 10:54 AM EDT) -- WASHINGTON, D.C. — Although a medical device company was the prevailing party in a lawsuit against the Food and Drug Administration for revoking a device’s approval, the company is not entitled to attorney fees and expenses because the government’s position was “substantially justified,” a District of Columbia federal judge ruled March 31 (Ivy Sports Medicine, LLC v. Sylvia M. Burwell, et al., No. 11-1006, D. D.C.; 2016 U.S. Dist. LEXIS 43261).

(Opinion available. Document #28-160407-034Z.)

In 2005 and 2006, ReGen Biologics Inc. of New Jersey sought...
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