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GENUS MEDICAL TECH. v. U.S. FOOD AND DRUG ADMIN.

Civil Action No. 19-544 (JEB).

427 F.Supp.3d 74 (2019)

GENUS MEDICAL TECHNOLOGIES, LLC, Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant.

United States District Court, District of Columbia.

Signed December 6, 2019.

Editors Note
Applicable Law: 05 U.S.C. § 702
Cause: 05 U.S.C. § 702 Administrative Procedure Act
Nature of Suit: 899 Administrative Procedure Act / Review or Appeal of Agency Decision
Source: PACER

Attorney(s) appearing for the Case

Sara Wexler Koblitz , Douglas B. Farquhar , Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

Jason Lee , U.S. Department of Justice, Washington, DC, for Defendant.

MEMORANDUM OPINION

Those drinking the contrast agent Vanilla SilQ before undergoing an X-ray or other imaging procedure likely spend no time pondering the central issue in this case: is this barium-sulfate product a drug or is it a medical device?

Plaintiff...

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