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Global Health Solutions, LLC v. Steriweb Medical, LLC

United States District Court, C.D. California

March 31, 2017

GLOBAL HEALTH SOLUTIONS, LLC, a Delaware limited liability company, Plaintiff,
v.
STERIWEB MEDICAL, LLC, a Washington limited liability company, R&S RESEARCH, LLC, a California limited liability company, BERTRAM P. ROSENTHAL, an individual, and AIME MEDICAL, INC., a Florida corporation, inclusive, Defendants.

          JUDGMENT AND PERMANENT INJUNCTION

          HON. JUDGE DALE S. FISCHER, UNITED STATES DISTRICT COURT

         THIS CAUSE came before the Court on the Stipulation for Entry of Judgment and Permanent Injunction by and in favor of plaintiff Global Health Solutions (“Plaintiff” or “GHS”) and by and against Defendants SteriWeb Medical, LLC (“SteriWeb”), R&S Research, LLC (“R&S”), Bertram P. Rosenthal (“Rosenthal”) and Aime Medical, Inc. (“AMI”) (collectively, “Defendants”).

         HAVING CONSIDERED the Stipulation and all papers, evidence and other matter of record, and GOOD CAUSE appearing therefor under Federal Rules of Civil Procedure 54 and 65, THE COURT HEREBY FINDS, AND DECREES:

         1. More likely than not Defendants are liable for false advertising and unfair competition under Section 45(a) of the Lanham Act (15 U.S.C. § 1125(a)) and California's Unfair Competition Law and False Advertising Law (Bus. & Prof. Code §§ 17200, 17500) in connection with the production, distribution, marketing and/or sales of an anti-microbial gel referred to as Omnicide Antimicrobial Gel (“Omnicide”), including by allegedly making literally false and unlawful “new drug” claims, such as “FDA approved, ” “clinically proven” superiority claims, and “same as” claims relative to GHS's anti-microbial gel, and by allegedly facilitating the unlicensed production and/or distribution of drugs in and from California;

         2. Plaintiff has demonstrated that such false advertising and unfair competition are creating a real and present health and safety risk and causing, or likely causing, irreparable harm to Plaintiff;

         3. The balance of hardships tips against false advertising and unfair competition and in favor of GHS's substantial undertaking to comply with the Food, Drug & Cosmetic Act (including to obtain 510(k) approval for its advanced wound dressing), which restricts GHS's advertisements for its drug and approved device; and

         4. The public interest weighs in favor of an injunction against false advertising and unfair competition and in favor of the protection of the health and safety of consumers.

         BASED ON THESE FINDINGS and the Stipulation of the parties, THE COURT ISSUES THE FOLLOWING PERMANENT INJUNCTION:

         Defendants SteriWeb, R&S and Rosenthal, along with their officers, agents, servants, employees, and attorneys, and all other persons who are in active concert or participation with anyone described in Rule 65(d)(2)(A) or (B), are hereby restrained and enjoined until further Order of the Court as follows:

         Labeling

         1. From omitting any ingredient from the labeling of Omnicide or any other antimicrobial gel manufactured, distributed and/or sold by Defendants, including the physical and electronic versions of such labeling, regardless of whether the ingredient is an active or inactive ingredient;

         2. Except as agreed below in paragraph 2, from making any efficacy claim in or on product labeling of Omnicide or any other antimicrobial gel manufactured, distributed and/or sold by Defendants, including in or on tubes, boxes or other packaging, or any product insert or instructional information in any packaging of Omnicide or any other antimicrobial gel, including the following claims made by Defendants in or on product labeling:

● “F ea rst new FDA approved topical Antimicrobial in over 40 ...

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