April 5, 2023 – ExeGi Pharma, LLC, owner of the Visbiome probiotic, has secured a significant legal victory against Brookfield Pharmaceuticals, LLC. ExeGi alleged that Brookfield engaged in false advertising and unfair competition by promoting its High Potency Probiotic (“HPP”) as a generic equivalent of Visbiome. The United States District Court for the Eastern District of Wisconsin ruled in favor of ExeGi, entering summary judgment and finding Brookfield liable for false advertising under the Lanham Act. The court also issued a permanent injunction against Brookfield to prevent the company from making any such false claims in the future.
The court found that the Brookfield HPP product has a different composition than that of Visbiome, and Brookfield attempted to pass off HPP as a Visbiome generic equivalent. In a 44-page opinion, Judge J.P. Stadtmueller found that numerous statements made by Brookfield about HPP were false, including claims that HPP contained “the same strains” and “the same probiotic bacteria” as Visbiome. These statements were found to have violated the Lanham Act, which governs false advertising and unfair competition in commerce.
In an effort to inform those misled by Brookfield’s false claims, the Court ordered Brookfield to send corrective letters confirming that HPP is not the generic equivalent of Visbiome and does not contain the same strains of probiotic bacteria as Visbiome. Represented by their attorneys at Schulman Bhattacharya, ExeGi’s legal team will proceed to trial to determine damages and pursue a possible cause of action for tortious interference.
“ExeGi Pharma welcomes the court’s decision, which reinforces consumer protections related to accurate and truthful information in marketing,” said Marc Tewey, CEO of ExeGi Pharma. “As a manufacturer committed to producing high-quality probiotics, it is critical we ensure that our patients get medical products appropriate for their conditions. Consumers deserve to have access to reliable, rigorously tested probiotic formulations supported by scientific evidence. We urge consumers to use caution when considering probiotic products that claim to be ‘generic equivalents’ especially those without clinical data to back up those assertions.”
About ExeGi Pharma
ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi’s team leverages scientific expertise in the field of microbiome science to deliver novel, clinically supported live biotherapeutic and probiotic products for a variety of unmet health and medical needs. ExeGi is headquartered in Rockville, MD.
About Visbiome
Visbiome (De Simone Formulation) is available in the U.S. as a medical food for the dietary management of dysbiosis associated with IBS, antibiotic-associated diarrhea, ulcerative colitis, pouchitis, and hepatic encephalopathy. Visbiome contains live, lyophilized, probiotic cultures for oral administration in doses of 112.5 billion to 900 billion live bacteria. The De Simone Formulation is sold under the name Vivomixx® in Europe.