On July 23, 2019, Schulman Bhattacharya commenced a class action lawsuit against the U.S. licensor (VSL Pharmaceuticals, Inc.) and distributors (Alfasigma USA, Inc. and Leadiant Biosciences, Inc.) of the VSL#3 probiotic product. Our complaint, which was filed in the United States District Court for the District of Maryland, asserts sixteen cause of action on behalf of a nationwide class of victims who purchased VSL#3 since June 2016, as well as consumers in subclasses in Massachusetts, California, Texas, New Jersey, Michigan, Illinois, Washington, Florida, and Idaho. The complaint asserts that the defendants deliberately defrauded consumers across the United States by telling them that the VSL#3 probiotic product contained the same original proprietary formula invented by Professor Claudio De Simone, despite that they knew the formula had materially changed in June 2016 and that the new formula had never been tested to demonstrate efficacy. Unlike the untested and unproven new formula being sold as VSL#3 to unsuspecting consumers since June 2016, the original De Simone Formulation has been the subject of more than 60 published clinical studies and has more than 15 years of successful clinical use. The De Simone Formulation had been sold as VSL#3 from 2002-2016. However, the defendants lost the right to sell the original De Simone Formulation in 2016, which prompted them to try (unsuccessfully) to create a copycat product via manufacturing facilities in Italy and to sell that product under the same previously-trusted brand name VSL#3.
A federal court jury and judge have already concluded that the new version of VSL#3 is not the same as the extensively studied De Simone Formulation, finding defendant Alfasigma liable for false advertising under the Lanham Act and awarding $15 million in damages to the new, authorized distributor of the De Simone Formulation, ExeGi Pharma, LLC. Our class action lawsuit seeks to recover damages suffered by retail consumers across the United States who purchased VSL#3 under false pretenses concocted by the defendants. The complaint asserts claims under the Racketeer Influenced and Corrupt Organizations Act (“RICO”), for breach of express warranties in violation of the Uniform Commercial Code, for unjust enrichment, and for engaging in deceptive and/or unfair acts in violation of consumer protection laws in Massachusetts, California, Texas, New Jersey, Michigan, Illinois, Washington, Florida, and Idaho. The plaintiffs seek tens of millions of dollars in actual damages and/or disgorgement of defendants’ ill-gotten gains, plus treble damages and other relief.
The case is styled Starr et. al. v. VSL Pharmaceuticals, Inc. et al., Civil Action No. 8:19-cv-2173. A copy of the complaint can be found here.