498 F.3d 272 (4th Cir. 2007), 05-2300, Korangy v. Unites States F.D.A.

Docket Nº:05-2300, 06-1860.
Citation:498 F.3d 272
Party Name:Amile A. KORANGY, M.D.; Korangy Radiology Associates, P.A., Petitioners, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent. Amile A. Korangy, M.D.; Korangy Radiology Associates, P.A., Petitioners, v. United States Food and Drug Administration, Respondent.
Case Date:August 17, 2007
Court:United States Courts of Appeals, Court of Appeals for the Fourth Circuit
 
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498 F.3d 272 (4th Cir. 2007)

Amile A. KORANGY, M.D.; Korangy Radiology Associates, P.A., Petitioners,

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent.

Amile A. Korangy, M.D.; Korangy Radiology Associates, P.A., Petitioners,

v.

United States Food and Drug Administration, Respondent.

Nos. 05-2300, 06-1860.

United States Court of Appeals, Fourth Circuit.

August 17, 2007

Argued: May 24, 2007.

Page 273

ARGUED:

Timothy Cronin Lynch, Offit & Kurman, Maple Lawn, Maryland, for Petitioners.

Anne Lobell Murphy, United States Department of Justice, Appellate Staff, Civil Division, Washington, DC, for Respondent.

ON BRIEF:

Alex M. Allman, Offit & Kurman, Maple Lawn, Maryland, for Petitioners. Daniel Meron, General, Sheldon T. Bradshaw, Chief Counsel, Food and Drug Division, Eric M. Blumberg

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Deputy Chief Counsel, Litigation, Marci B. Norton, Associate Chief Counsel for Enforcement, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, Washington, D.C.; Peter D. Keisler, Assistant Attorney General, Douglas N. Letter, Appellate Staff, Civil Division, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Respondent.

Before WILKINSON, MOTZ, and TRAXLER, Circuit Judges.

Petition for review denied by published opinion. Judge TRAXLER wrote the opinion, in which Judge WILKINSON and Judge MOTZ joined.

OPINION

TRAXLER, Circuit Judge:

Dr. Amile Korangy and Korangy Radiology Associates ("KRA") petition this court for review of an order of the Food and Drug Administration imposing monetary sanctions on Korangy and KRA for allowing a statutorily-required certification to lapse and for per-forming mammograms after the certification expired. For the reasons that follow, we deny the petition for review.

I.

Under the Mammography Quality Standards Act ("MQSA"), facilities that provide mammographies must be certified by the FDA. See 42 U.S.C.A. § 263b(b) (West Supp. 2007). In accordance with the MQSA, the FDA in 1999 issued a certificate for the operation of a mammography facility, known as "Baltimore Imaging Center, " in Catonsville, Maryland. The 1999 certificate issued by the FDA was set to expire on May 6, 2002, and the expiration date was noted on the certificate itself. By 1999, Baltimore Imaging Center was operated by KRA, which is wholly owned by Korangy.

The American College of Radiology ("ACR") is an FDA-approved accreditation body that inspects mammography equipment to deter-mine compliance with the MQSA. ACR inspected Korangy's equipment and informed Korangy by letter in April 2002 that his mammography equipment failed the quality standards for clinical image and that he should immediately stop using the equipment. ACR's letter explained to Korangy that the failure would be reported to the FDA and that the FDA would "officially notify" Korangy to stop using the equipment. See J.A. 32.

Notwithstanding his knowledge that his mammography produced images of unacceptable quality, Korangy continued to use the machine. He bought a new mammography unit that was provisionally certified for use on July 25, 2002. From May 7 (the day after his original certificate expired) until July 25 (the day before the new unit was certified), Korangy was operating without the required certification. During that uncertified period, he performed 192 mammograms at the Catonsville facility.

The FDA learned that Korangy was performing mammograms without the proper certification, and it filed a complaint in September 2003 seeking civil penalties against Korangy and KRA. An administrative law judge granted partial summary judgment in favor of the FDA, concluding that KRA and Korangy were each liable for one penalty for failing to obtain the required certificate. See 42 U.S.C.A. § 263b(h)(3)(A) (West Supp. 2007). Because the Act prohibits con-ducting an examination or procedure without a certificate, the ALJ also concluded that Korangy and KRA each had committed an additional 192 separate violations by performing mammograms during the certification lapse. In a separate proceeding,

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the ALJ determined the appropriate amount of the sanctions. The FDA initially sought $10, 000 (the statutory maximum) for each violation by Korangy and KRA. Korangy contended, however, that...

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