Maryland Federal Jury Unanimously Finds Probiotic Sellers Liable for False Advertising and Awards Product Inventor More than $18 Million in Damages

Claudio De Simone, inventor of high-potency probiotic, sued pharmaceutical companies for making false advertising claims, ownership rights to the product formula and unpaid royalties

GREENBELT, Md. - A federal jury on Tuesday, Nov. 20, unanimously ruled in favor of a probiotic inventor who sued his former business partners after an international dispute concerning false advertising, ownership of a proprietary formulation and unpaid royalties. The inventor accused his former partners of attempting to make a copy of his invention and selling it to unsuspecting patients under the same brand name, even though the copy product had never been clinically tested.

The three-week trial in the U.S. District Court for the District of Maryland in Greenbelt included plaintiffs Professor Claudio De Simone and ExeGi Pharma LLC, of Rockville, Md., against defendants VSL Pharmaceuticals Inc., Leadiant Biosciences Inc. and Alfasigma USA Inc. The jury unanimously ruled that the pharmaceutical companies collectively owe the probiotic inventor, De Simone, more than $18 million in damages, including $15 million for defendant Alfasigma USA’s violation of the Lanham Act by deceiving patients, physicians and other stakeholders concerning the probiotic product they have been marketing since 2016.

De Simone successfully argued in court that VSL Pharmaceuticals had attempted to create a “knock-off” of De Simone’s product, even though they never had access to the propriety formula. They continued to call this knock-off by its original brand name, “VSL#3®”, a trademark owned by VSL Pharmaceuticals Inc., and continued to reference the extensive clinical research on the product proving the product was efficacious and safe, even though they never fully tested the copy product. During the trial, De Simone was able to prove that the defendants’ copy product was not the same as De Simone’s original invention and had never been tested in humans to ensure that it performs the same way as the original formula. De Simone is currently partnered with co-plaintiff ExeGi Pharma to sell the formulation under the brand name Visbiome®.

Prof. De Simone and ExeGi were represented in the case by Jeremy W. Schulman of the law firm Schulman Bhattacharya, LLC.

“We are proud that we’re protecting the life’s work of a brilliant scientist, Prof. Claudio De Simone, who is responsible for helping thousands of patients worldwide to live better lives by managing their serious medical conditions through the invention of a superior, high-potency probiotic product,” Schulman said.

De Simone commented: “I am grateful that the jury saw through the falsehoods of the defendants and ruled in our favor. I created the probiotic product to help patients who had suffered for years with gastrointestinal illnesses and diseases. I never imagined that a multi-national pharmaceutical company and the other defendants would attempt to steal my invention and then pass off an inferior and fake product as mine. Now I will turn my attention to supporting patients in Europe, Asia and other parts of the world who are at risk of being similarly misled.”


ExeGi Media:
Andrea Fetchko

Michael O’Brien