Opinion
No. SA CV 18-996-DOC (JDE)
05-15-2020
UNITED STATES OF AMERICA, Plaintiff, v. INNOVATIVE BIODEFENSE, INC. ET AL., Defendants.
PRESENTED BY JOSEPH H. HUNT Assistant Attorney General ETHAN DAVIS Principal Deputy Assistant Attorney General GUSTAV W. EYLER Director, Consumer Protection Branch DOUGLAS ROSS SARAH WILLIAMS Trial Attorneys U.S. Department of Justice Consumer Protection Branch, Civil Division 450 5th St. NW Washington, D.C. 20001 Telephone: (202) 616-4269, Facsimile: (202) 514-8742 Email: Sarah.Williams@usdoj.gov Of Counsel: ROBERT P. CHARROW General Counsel STACY CLINE AMIN Chief Counsel Food and Drug Administration Deputy General Counsel Department of Health and Human Services ANNAMARIE KEMPIC Deputy Chief Counsel for Litigation YEN HOANG Associate Chief Counsel for Enforcement United States Food and Drug Administration Office of the Chief Counsel 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Telephone: 240-402-0484 Counsel for the United States of America. MILLER & CHEVALIER CHARTERED KIRBY D. BEHRE Benjamin A. Nix (SBN 138258) Payne & Fears LLP Jamboree Center 4 Park Plaza, Suite 1100 Irvine, CA 92614 Tel.: 949-851-1100 Fax: 949-851-1212 Email: ban@paynefears.com Marc C. Sanchez (Admitted pro hac vice) Contract In-House Counsel & Consultants LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave. NW, Suite 1025 Washington, DC 20006 Tel.: 202-765-4491 Fax.: None Email: msanchez@fdaatty.com Kirby D. Behre (Admitted pro hac vice) Nina C. Gupta (Admitted pro hac vice) Amelia Hairston-Porter (Admitted pro hac vice) Calvin Lee (Admitted pro hac vice) Miller & Chevalier Chartered 900 Sixteenth St. NW Washington, DC 20006 Email: kbehre@milchev.com Email: ngupta@milchev.com Email: ahairstonporter@milchev.com Email: clee@milchev.com Tel.: 202-626-5800 Fax.: 202-626-5801 Attorneys for Defendants INNOVATIVE BIODEFENSE, INC., COLETTE COZEAN, AND HOTAN BAROUGH
JOINT JUDGMENT
Bench Trial Concluded March 2, 2020
In this case the Plaintiff, the United States of America, sought a statutory injunction under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332(a) ("the Act"), to permanently enjoin and restrain the Defendants, Innovative BioDefense, Inc., a corporation, Colette Cozean, an individual, and Hotan Barough, an individual doing business as Zylast Direct (collectively, "Defendants") from directly or indirectly violating 21 U.S.C. § 331(d) by introducing or delivering, or causing to be introduced or delivered, into interstate commerce new drugs that are neither approved pursuant to 21 U.S.C. § 355(b), nor exempt from approval pursuant to 21 U.S.C. § 355(i). This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1345, and 21 U.S.C. § 332(a).
On November 15, 2019, the Court entered an Order Granting in Part the Plaintiff's Motion for Summary Judgment and Denying Defendant Barough's Motion for Summary Judgment, finding as a matter of law that the Defendants violated the Act, and ordering a trial on the Defendants' affirmative defenses and the scope of injunctive relief. Dkt. 124. An eight-day bench trial was held on December 16 through 20, 2019, and January 22 through 23, 2020, with closing arguments heard on March 2, 2020.
On May 4, 2020, the Court entered Findings of Fact and Conclusions of Law, denied the Defendants' Motion for Reconsideration on Plaintiff's Motion for Summary Judgment as moot, and held that, after considering the Parties' arguments, the Defendants had not met their burden on their affirmative defenses and that injunctive relief was appropriate. Dkt. 214. On the same day, the Court entered an Order of Permanent Injunction, permanently restraining and enjoining the Defendants from directly or indirectly manufacturing, processing, packaging, labeling, holding, or distributing any new drugs unless and until they take specific actions to comply with the Act as described in that Order. Dkt. No. 215.
Having considered the pleadings, the evidence presented, and the credibility of the witnesses at trial, and in accordance with the Court's Findings of Fact and Conclusions of Law, Dkt. 214, and Order of Permanent Injunction, Dkt. 215, judgment is hereby entered for the Plaintiff, the United States of America, and against Defendants, Innovative BioDefense, Inc., Colette Cozean, and Hotan Barough. May 15, 2020
Date
/s/_________
DAVID O. CARTER
United States District Judge PRESENTED BY JOSEPH H. HUNT
Assistant Attorney General ETHAN DAVIS
Principal Deputy Assistant Attorney General GUSTAV W. EYLER
Director, Consumer Protection Branch /s/ Sarah Williams
DOUGLAS ROSS
SARAH WILLIAMS
Trial Attorneys
U.S. Department of Justice
Consumer Protection Branch, Civil Division
450 5th St. NW
Washington, D.C. 20001
Telephone: (202) 616-4269, Facsimile: (202) 514-8742
Email: Sarah.Williams@usdoj.gov Of Counsel:
ROBERT P. CHARROW
General Counsel STACY CLINE AMIN
Chief Counsel
Food and Drug Administration
Deputy General Counsel
Department of Health and Human Services ANNAMARIE KEMPIC
Deputy Chief Counsel for Litigation YEN HOANG
Associate Chief Counsel for Enforcement
United States Food and Drug Administration
Office of the Chief Counsel
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: 240-402-0484 Counsel for the United States of America. MILLER & CHEVALIER CHARTERED
KIRBY D. BEHRE By: /s/ Kirby D. Behre
KIRBY D. BEHRE
Attorneys for Defendants Benjamin A. Nix (SBN 138258)
Payne & Fears LLP
Jamboree Center
4 Park Plaza, Suite 1100
Irvine, CA 92614
Tel.: 949-851-1100
Fax: 949-851-1212
Email:
ban@paynefears.com Marc C. Sanchez (Admitted pro hac vice)
Contract In-House
Counsel & Consultants LLC (d/b/a FDA Atty)
1717 Pennsylvania
Ave. NW, Suite 1025
Washington, DC 20006
Tel.: 202-765-4491
Fax.: None
Email:
msanchez@fdaatty.com Kirby D. Behre (Admitted pro hac vice)
Nina C. Gupta (Admitted pro hac vice)
Amelia Hairston-Porter (Admitted pro hac vice)
Calvin Lee (Admitted pro hac vice)
Miller & Chevalier Chartered
900 Sixteenth St. NW
Washington, DC 20006
Email:
kbehre@milchev.com
Email:
ngupta@milchev.com
Email:
ahairstonporter@milchev.com
Email: clee@milchev.com Tel.: 202-626-5800
Fax.: 202-626-5801