LAW 360: Class Claims Homeopathic Eye Products Being Sold Illegally

Sep 28, 2023

By Mike Curley

Law360 (September 27, 2023, 3:52 PM EDT) -- A proposed class of buyers is suing an eye drop maker in Colorado federal court, alleging that its "homeopathic" products are being sold as drugs without approval from the U.S. Food and Drug Administration and their manufacturer does not follow proper safety standards.

In a complaint filed Tuesday, named plaintiff David Plowden alleges several Similasan Corp.'s eye drop products are labeled as homeopathic and claim they can treat or cure a number of ailments, including pink eye, making them drugs subject to the U.S. Food Drug and Cosmetic Act's regulations.

But the company has not obtained approval from the FDA to market and sell the products as new drugs, according to the complaint, nor has Similason shown that they are generally recognized as safe and effective.

According to the complaint, the FDA has found that some of the ingredients in the products are not generally considered safe and effective, and the agency has noted concerns about the safety of silver sulfate as a preservative as it is known to cause argyria, a permanent bluish-gray discoloration of the skin and eyes.

The complaint further alleges that the products are manufactured by a contract company that does not follow current good manufacturing practices, or CGMPs.

Plowden told the court the FDA sent a warning letter two weeks ago stating that it found the products were not manufactured to CGMP standards, as the company does not have appropriate written procedures to prevent contamination, or laboratory controls and records of complete data from all tests.

As a result, Plowden wrote, the products are adulterated and should not be sold as homeopathic drugs without FDA approval.

The complaint further alleges that the products are sold at a significant premium, with prices between $20 and $40 per fluid ounce, while competitors' eyedrops range from $1.98 per fluid ounce to $9.38 per fluid ounce.

Plowden aims to represent a class of all buyers of the products for personal use in the U.S., as well as a multi-state consumer protection class and a Florida class. The complaint includes claims for violation of state consumer protection statutes, the Florida Deceptive and Unfair Trade Practices Act and unjust enrichment.

The complaint seeks unspecified monetary damages, including disgorgement of profits.

Representatives for the parties could not immediately be reached for comment Wednesday.

Plowden is represented by William H. Anderson and Simon Wiener of Handley Farah & Anderson PLLC, Nick Suciu III, Trenton R. Kashima and Rachel Soffin of Milberg Coleman Bryson Phillips Grossman PLLC and Melissa S. Weiner and Ryan T. Gott of Pearson Warsaw LLP.

Counsel information for Similasan was not available on Wednesday.

The case is Plowden v. Similasan Corp., case number 1:23-cv-02511, in the U.S. District Court for the District of Colorado.

--Editing by Vaqas Asghar.

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