Class Action Accuses Pharma Companies of Secretly Reformulating VSL#3 Probiotics Product

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Probiotic product VSL#3 is at the center of a proposed class action out of Maryland that claims VSL Pharmaceuticals, Inc. deceived consumers by passing off a cheaper, less effective formulation as the original product.

The case explains that VSL#3 was originally developed by Professor Claudio De Simone and manufactured and sold by VSL and co-defendant licensees Leadiant Biosciences, Inc. and Alfasigma USA, Inc. VSL#3, the lawsuit continues, is a probiotic originally made up of eight strains of live bacteria cultures that are known to be effective in mitigating the symptoms of certain gastrointestinal disorders such as inflammatory bowel disease, ulcerative colitis, pouchitis, and irritable bowel syndrome.

According to the lawsuit, De Simone resigned from his position as CEO of VSL and a member of its board of directors after refusing to participate in a plan to reformulate VSL#3 using cheaper ingredients and thereby increase profit margins. After his resignation, the professor allegedly sent written notice to VSL that he was terminating its “Know How Agreement,” which the case says stripped the company of its right to manufacture and sell VSL#3 after the expiration of its License Agreement in May 2016.

The case alleges that the defendants nevertheless engineered a new formulation for VSL#3 and continued selling it as the original product, which the suit notes was backed by over 60 clinical studies and more than 15 years of clinical use. Although the defendants informed customers that they had switched to a new manufacturer in Italy, they allegedly failed to disclose that the product itself had changed as well.

“Defendants omitted in their marketing the fact that the post-May 2016 formulation of VSL#3 was materially different from the De Simone Formulation, and the clinical evidence concerning the De Simone Formulation simply does not apply to the Fraudulent Formulation currently sold under the VSL#3 brand name,” the complaint states.

The lawsuit argues that the new formulation was “fundamentally different” from the previous version, and that “not even a single clinical study” had been performed to support the company’s claims of the new product’s efficacy and safety.

In fact, the case alleges, the defendants continued to sell VSL#3 using the same branding and citing the same clinical studies despite knowing the product was a “cheaper, inferior, untested formulation.”

The lawsuit points out that De Simone and ExeGi Pharma, LLC—the company to whom De Simone granted exclusive rights to sell his probiotics formulation—previously sued the defendants for false advertising. In November 2018, a jury found that the companies had indeed been advertising a “knock-off” product as De Simone’s original formulation, which is now sold under ExeGi’s “Visbiome” brand, and awarded the plaintiffs more than $18 million.

This lawsuit seeks to represent a proposed class of consumers who purchased VSL#3 from June 2016 to the present.