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U.S. v. REGENERATIVE SCIENCES, LLC

No. 12-5254.

741 F.3d 1314 (2014)

UNITED STATES of America, Appellee v. REGENERATIVE SCIENCES, LLC, A Corporation, et al., Appellants.

United States Court of Appeals, District of Columbia Circuit.

Decided February 4, 2014.

Attorney(s) appearing for the Case

Andrew S. Ittleman argued the cause for appellants. With him on the briefs was Mitchell S. Fuerst.

Jonathan W. Emord was on the brief for amicus curiae American Association of Orthopaedic Medicine in support of appellants.

Lawrence J. Joseph was on the brief for amicus curiae Association of American Physicians and Surgeons, Inc., in support of appellants.

James S. Turner was on the brief for amicus curiae Tim Moore in support of appellants.

Abby C. Wright , Attorney, U.S. Department of Justice, argued the cause for appellee. With her on the brief were Stuart F. Delery , Principal Deputy Assistant Attorney General, Ronald C. Machen, Jr. , U.S. Attorney, Mark B. Stern , Attorney, William B. Shultz , Acting General Counsel, Food and Drug Administration, and Eric M. Blumberg , Deputy Chief Counsel. Alisa B. Klein , Attorney, U.S. Department of Justice, entered an appearance.

Opinion for the court filed by Circuit Judge GRIFFITH.

GRIFFITH, Circuit Judge:

In this civil enforcement action, we must decide whether the appellants — three individuals and a related corporate entity — violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient's stem cells and the antibiotic doxycycline. Because we conclude that they did, we affirm the district court's...

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