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IVY SPORTS MEDICINE, LLC v. SEBELIUS

Civil Action No. 11-cv-1006 (RLW).

938 F.Supp.2d 47 (2013)

IVY SPORTS MEDICINE, LLC, Plaintiff, v. Kathleen SEBELIUS, et al., Defendants.

United States District Court, District of Columbia.

April 10, 2013.

Attorney(s) appearing for the Case

Mark A. Heller , Matthew Michael Hoffman , Goodwin Procter, LLP, Washington, DC, for Plaintiff.

Adrienne Elise Fowler , U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

ROBERT L. WILKINS, District Judge.

This litigation is the latest chapter in a decades-long effort seeking government approval of a medical device. Plaintiff Ivy Sports Medicine, LLC ("Ivy"), or its predecessor ReGen Biologics, Inc. ("ReGen"), have been trying to get the medical device at issue in this litigation approved for at least 16 years; that is when ReGen began clinical research trials. The Food and

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