On October 19, 2021, Schulman Bhattacharya filed suit in the United States District Court for the Southern District of Florida on behalf of ExeGi Pharma, LLC, the distributor of the probiotic Visbiome®, against the Editor of the European Review for Medical and Pharmacological Services (ERMPS). The lawsuit asserted that the Editor had used the journal “as a commercial tool fraudulently to advertise a second-rate medical product,” namely the VSL#3 probiotic. The lawsuit further alleged that “by refusing to withdraw, and facilitating the active promotion of, an article published by ERMPS in January of 2020 –“The safety profile of probiotic VSL#3. A meta-analysis of safety data from double-blind, randomized, placebo-controlled clinical trials,” the Editor “actively contributed to the false advertising of the probiotic VSL#3 by the Actial Group (Actial Srl and its U.S. affiliate, VSL Pharmaceuticals Inc. (“VSL Inc.”)) through VSL Inc.’s licensee, Alfasigma USA, Inc. (“Alfasigma”).”
The lawsuit argued that “[t]he VSL#3 Article, which was funded by Actial Farmaceutica, an entity that acts on behalf of the Actial Group, falsely concludes that VSL#3 is safe. This improper conclusion is based upon incomplete and unverified data assembled from unrelated clinical studies that were approved to be conducted on humans based upon fraudulent data. The Actial Group, to secure approval of the studies, presented to a group of clinical investigators involved in the studies information and research pertaining to the safety and efficacy of an entirely different probiotic, one created by Professor Claudio De Simone (and sold in the United States exclusively by ExeGi). Once these investigators were informed of this subterfuge, all halted the studies. Yet the authors of the VSL#3 Article went ahead with their analysis anyway, using incomplete data that had been gathered before the studies were halted, and misrepresenting why the studies had been shut down. Upon information and belief, their plowing ahead with these dubious claims was the result of the Actial Group’s influence over them and the article.”
ExeGi asserted claims for Contributory False Advertising under the Lanham Act, Violation of the Florida Deceptive and Unfair Trade Practices Act, and Tortious Interference with Business Relationships, and sought, among other relief, an injunction requiring withdrawal of the VSL#3 article.
Following filing of the lawsuit, on November 16, 2021, the European Review for Medical and Pharmacological Services issued a Notice withdrawing the VSL#3 article that was the subject of the suit. The Notice stated, among other things, that the article “has been retracted based on commentary received from a new set of reviewers” and that “[t]he Publisher apologizes for any inconvenience this may cause.”
Professor Claudio De Simone, inventor of the original probiotic formulation no longer contained in VSL#3, stated: “I am very pleased the European Review for Medical and Pharmacological Services has done the right thing by withdrawing the VSL#3 article. We will not permit the sponsors of VSL#3, or anyone else, to falsely represent that they are selling the same original probiotic formulation that I invented more than 20 years ago and that has successfully undergone more than 70 clinical trials around the world. My formula is available in the United States only through ExeGi Pharma under the brand name Visbiome.”
Schulman Bhattacharya, LLC is an international law firm based in the Washington, D.C. area focused on resolving the most complex and challenging commercial disputes facing its clients— through litigation, arbitration, mediation, and informal negotiation. The Firm has vast experience representing clients in nearly every industry sector. The Firm represents companies of all sizes, locally, regionally, nationally, and internationally, and it represents individuals with valuable commercial and personal interests to protect.
A copy of ExeGi’s complaint in the matter styled ExeGi Pharma, LLC v. Ricordi, Case No. 1:21-cv-23688, can be found by clicking here.
Media coverage of the case can be found by clicking here.