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TMJ IMPLANTS v. U.S. DEPT. HEALTH & HUMAN SERVICES

No. 08-9539.

584 F.3d 1290 (2009)

TMJ IMPLANTS, INC.; ROBERT W. CHRISTENSEN, Petitioners, v. UNITED STATES DEPARTMENT OF HEALTH & HUMAN SERVICES, Respondent.

United States Court of Appeals, Tenth Circuit.

October 27, 2009.

Attorney(s) appearing for the Case

Lynn M. Watwood, Jr., Counsel, TMJ Implants, Inc., Golden, CO, appearing for Petitioners.

Peter R. Maier, Attorney, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C. (Gregory G. Katsas, Assistant Attorney General, and Douglas N. Letter, Attorney, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C.; Thomas R. Barker, Acting General Counsel, Gerald F. Masoudi, Chief Counsel, Food and Drug Division, Eric M. Blumberg, Deputy Chief Counsel, and Michele Svonkin, Attorney, Food and Drug Administration, Rockville, MD, with him on the brief), appearing for Respondent.

Before TACHA, EBEL, and HARTZ, Circuit Judges.

TACHA, Circuit Judge.

TMJ Implants, Inc. ("TMJI") manufactures and distributes temporomandibular joint ("TMJ") implants. Dr. Robert W. Christensen is TMJI's founder and president. In July 2005, the Food and Drug Administration ("FDA") filed a complaint for money penalties ("CMP") against TMJI and Dr. Christensen (collectively, "petitioners") after concluding that they had knowingly failed to submit seventeen medical device reports ("MDRs") relating to TMJI's implants...

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