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Schulman Bhattacharya Wins Major Federal Jury Trial—$18 Million Awarded to Clients Claudio De Simone and ExeGi Pharma for False Advertising, Unjust Enrichment and Unpaid Royalties

Nov 20

A federal jury today in the United States District Court for the District of Maryland unanimously ruled in favor of the Firm’s clients, Claudio De Simone and ExeGi Pharma, LLC, awarding them damages totaling $18,014,041.  De Simone, a renowned Italian inventor and university professor, sued his former business partners as part of a bitter international dispute concerning false advertising, ownership of his proprietary high-potency probiotic formulation, and unpaid royalties.

Professor De Simone accused his former partners of making a counterfeit copy of his invention and selling it to unsuspecting patients under the same brand name that had been used to sell the original formulation over the past 15 years, even though the copy product had never been clinically tested.

The three-week jury trial in Greenbelt, Maryland included defendants VSL Pharmaceuticals Inc., Leadiant Biosciences Inc., and Alfasigma USA Inc.  The jury unanimously found that the defendant pharmaceutical companies must pay Professor De Simone and ExeGi a total of more than $18 million in compensatory 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.  We successfully argued that VSL Pharmaceuticals had attempted to create a “knock-off” of Professor De Simone’s product, even though they never had access to the proprietary formula that he patented in the 1990s.  They continued to call this knock-off by its original brand name VSL#3Ò, a trademark owned by VSL Pharmaceuticals Inc., and continued to reference the extensive clinical research on the original product showing the original product to be efficacious and safe.  During the trial, we proved that the defendants’ copy product was not the same as Professor De Simone’s original invention and had never been tested in humans to ensure that it performs the same way as the original formula.

The trial team representing Professor De Simone and ExeGi was led by Jeremy W. Schulman and Jeffrey Gavenman, assisted by Koushik Bhattacharya, Sabina Schiller, Jessica Bustamante, Jonathan Barnes, and Natalie Moskovchenko.  The win at trial was the culmination of more than three years of hard fought litigation spanning the globe.  Not only did the Firm secure favorable findings from the jury on every count presented to them, we also defeated all 52 of the defendants’ counterclaims, most of which had been disposed of by pre-trial dispositive motion and dismissal during trial.  We also prevailed on summary judgment with regard to the hotly contested issue of who owns the Know-How for the original probiotic formulation, obtaining a clear declaration from the Court that “Professor De Simone owns the Know-How.”

“We are very pleased with the results we were able to obtain for our clients, Professor De Simone and ExeGi, during the course of this three-year legal battle,” Jeremy Schulman said.  “Establishing that Professor De Simone owns the Know-How, winning a large cash judgment, securing a finding of false advertising, and defeating 52 counterclaims aggressively asserted by a team of more than 30 lawyers and staff for the three defendants is very gratifying.  We are immensely proud that we have played a part in 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.”

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 fake product as mine.”

For further information about our client Professor Claudio De Simone, please click here.

Recent media reports about our success in the De Simone/ExeGi trial: