ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers Posted on 26 Jun 08:31
Federal district court finds in favor of ExeGi and probiotic inventor, prohibits VSL#3 sellers from citing studies on original formulation
ROCKVILLE, Md., June 25, 2019 /PRNewswire/ -- ExeGi Pharma LLC is pleased to announce that on Friday, June 21, the United States District Court for the District of Maryland ruled in favor of a probiotic inventor and his business partner, ExeGi Pharma, LLC, in post-trial motions concerning the probiotic product VSL#3®. The ruling concludes over four years of litigation in which the inventor of the well-studied De Simone formulation probiotic (sold until July 2016 under the name VSL#3) sought to defend his ownership rights and prevent his former business partners from claiming that a reverse-engineered imitation product was, in fact, his own formulation.
On November 2018, a federal jury unanimously found in favor of the plaintiffs, inventor Professor Claudio De Simone and ExeGi, awarding over $18 million in damages for violations including false advertising under the Lanham Act. De Simone proved that, after leaving his long-term partnership with VSL Pharmaceuticals, VSL attempted and failed to reverse-engineer his formula. De Simone's original formulation had been studied extensively and established as a "medical food" for dietary management of serious gastrointestinal issues, such as ulcerative colitis and irritable bowel syndrome (IBS). VSL launched their version of VSL#3, an untested imitation product, without informing patients or physicians of the change.
Following the jury finding, the defendants (VSL Pharmaceuticals Inc., Leadiant Biosciences, and Alfasigma USA, Inc.) filed post-trial motions against key jury findings and requested a new trial. The Court denied each motion and affirmed that the original VSL#3 product containing De Simone's formulation was materially different from the imitation. The Court also found that, in marketing their product as the original, the defendants had advertised falsely with the intent to confuse or deceive the public.
Citing public health and wellbeing, the Court also issued a permanent injunction preventing the defendants from linking their product with the original De Simone formulation in other ways, including by citing clinical studies that were, in fact, performed only on the De Simone formulation. To date, more than 70 human clinical trials have been conducted on the original formulation, currently sold as VISBIOME®.
Marc Tewey, CEO of ExeGi, said: "We are very pleased with Friday's rulings. Ultimately, they will help protect the countless patients depending on VISBIOME® from further marketplace deception. We hope this sends a message to other probiotic manufacturers and resellers that not all probiotics are the same. Quality and testing matter when it comes to products with health implications and we will go to any lengths necessary to protect patient safety."
About ExeGi Pharma
ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.
About Claudio De Simone
Claudio De Simone, MD, PhD, is an internationally recognized scientific leader in the field of probiotics and the human gut microflora. Professor De Simone invented the formulation of the probiotic tested and currently sold under the name VISBIOME®, which has been the subject of more than 70 clinical trials and is used for the dietary management of pouchitis, IBD and IBS. In addition, Professor De Simone has authored over 200 published scientific articles, reviews, case reports and book chapters.
*VSL#3 is a registered trademark of VSL Pharmaceuticals Inc.
Maryland Federal Jury Unanimously Finds Probiotic Sellers Liable for False Advertising and Awards Product Inventor More than $18 Million in Damages Posted on 26 Nov 10:27
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.”