JUDGMENT AND PERMANENT INJUNCTION
DALE S. FISCHER, District Judge.
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:
• "First new FDA approved topical Antimicrobial in over 40 years";
• "Kills MRSA in 40 seconds or less";
• "Effective against most bacteria, yeasts, molds and fungi";
• "No known resistance";
• "Doctor recommended"; and
• "Speeds healing."
Provided Defendants have adequate substantiation supporting the claim, Defendants may include on product labeling for Omnicide or any other antimicrobial gel manufactured, distributed and/or sold by Defendants, that the product is indicated to "to help prevent, decrease or reduce the risk or chance of, or guard or protect against, infection, bacterial contamination, or skin infection in minor cuts, scrapes, and burns," or equivalent language.
Advertising & Promotion
3. From advertising, marketing, promoting or selling Omnicide, or any other anitimicrobial gel, in any way with any of the following claims, or any claims substantially similar to these claims, regardless of the medium, i.e., whether on any package, product, website (e.g., SteriWeb.com, Amazon.com, Ebay.com, Youtube.com, etc.) or other form of commercial advertising or promotion:
• "FDA-Approved";
• "Fully evaluated by the FDA";
• "Clinically-proven";
• "Superior to any other antimicrobial gel";
• "Essentially the same as CurX";
• "Eliminates All Causes of Infections";
• "Eliminates all infections caused by harmful bacteria, fungi, molds or yeasts";
• "Eliminates MRSA and all other Staph Infections on contact";
• "[E]liminat[es] 99.99% of all bacteria, fungi, molds and yeasts";
• "A non-toxic, topical antimicrobial gel without any known resistance by even the most dangerous bacteria including MRSA, VRE, and CRE";
• "Kills MRSA in 40 seconds or less";
• "No known resistance";
• "[H]eal[s] all your wounds 100x's faster than any other leading brand... Guaranteed!";
• "Effective for a minimum of one week";
• "2 year shelf life"; and
• "No other First Aid product can make these claims."
4. From advertising, marketing or promoting SteriWeb, any officer, director and/or owner of SteriWeb, and/or any commonly owned business (e.g., R&S) in any way with any of the following claims, or any claims substantially similar to these claims, regardless of the medium, i.e., whether on any package, product, website or other form of commercial advertising or promotion:
• As residing in a large commercial office building; and
• As being the inventor of an antimicrobial gel with a patent pending covering the product;
5. From advertising, marketing, promoting or selling Omnicide or any antimicrobial gel with any efficacy claims (a) that are not substantiated with product-specific testing if the claim is about the product, and (b) that are not substantiated with other competent and reliable scientific evidence if the efficacy claim is limited to the ingredients in the product; and
6. From advertising, marketing, promoting or selling any drug with an active ingredient or combination of active ingredients that is not the subject of a final monograph under the Food, Drug & Cosmetic Act including but not limited to Omnicide, unless (a) the safety, stability, shelf-life, and efficacy of the drug's indicated uses and advertised claims are substantiated with competent and reliable product-specific studies in Defendants' possession that were conducted by independent laboratories and investigators, including batch-testing that corresponds to lot numbers and certificates of analysis of each lot produced, and (b) the drug is formulated, manufactured, filled, packaged, repackaged, and distributed at/by registered, licensed and/or certified facilities in accordance with state and federal laws, including the Good Manufacturing Practices under the FDCA (to avoid any confusion, without proper licensure, R&S is not permitted to manufacture, produce, package, repackage, or distribute any drug for SteriWeb, and this prohibition covers the loading tubes of Omnicide in boxes with package inserts).
IT IS HEREBY FURTHER ORDERED that, except as provided below, this Judgment and Permanent Injunction shall (a) become immediately effective on execution by the Court, (b) be viewed and treated as any other judgment and permanent injunction under Fed. R. Civ. Proc. 54 and 65, and (c) remain in effect until further order of the Court.
With respect to inventory of Omnicide that existed prior to January 1, 2017, Defendants' boxes and other packaging containing Omnicide tubes must be in compliance with the stipulated injunction. With respect to those existing tubes of Omnicide, themselves, Defendants shall have until April 10, 2017 to sell those tubes in compliant boxes or other packaging, or discontinue or destroy those tubes, or ensure that they are in compliance with the stipulated injunction.
IT IS HEREBY FURTHER ORDERED that Plaintiff shall otherwise take nothing by way of its Complaint, and the parties are responsible for their own respective costs and fees in this matter.
IT IS SO ORDERED.
