Legal Opinion

Ivy Sports Medicine, LLC v. Sebelius

District Court, District of Columbia

Decided April 10, 2013No. Civil Action No. 2011-1006PublishedCited by 4 opinions

1Opinion of the Court

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 Biologies, 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 Drug Administration (“FDA”) 1 rejected multiple applications from ReGen before eventually approving the device in December 2008. But at present, the device is no longer…

2Cases cited31 opinions

  1. Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
  2. Burlington Truck Lines, Inc. v. United StatesSupreme Court of the United States · 1962
  3. Marsh v. Oregon Natural Resources CouncilSupreme Court of the United States · 1989
  4. Compton James Richards v. Immigration and Naturalization ServiceCourt of Appeals for the D.C. Circuit · 1977
  5. Serono Labs Inc v. Ferring Pharm. Inc.Court of Appeals for the D.C. Circuit · 1998

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3Cited by4 opinions

  1. Ivy Sports Medicine, LLC v. Sylvia Mathews BurwellCourt of Appeals for the D.C. Circuit · 2014
  2. Ivy Sports Medicine, LLC v. BurwellDistrict Court, District of Columbia · 2016
  3. Ivy Sports Medicine, LLC v. Sylvia Mathews BurwellCourt of Appeals for the D.C. Circuit · 2014
  4. Voyageur Outward Bound School v. United States of AmericaDistrict Court, District of Columbia · 2020

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