In 54 pages of rulings issued on June 21, 2019, Judge Theodore D. Chuang of the United States District Court for the District of Maryland found decisively in favor of myself and ExeGi Pharma, LLC — upholding our $18 million jury verdict from November 2018 and entering a permanent injunction against the current and former distributors of VSL#3, halting their false advertising of the product. The rulings concludes over four years of litigation in which I have sought to defend my ownership rights and prevent my former business partners from claiming that a reverse-engineered imitation VSL#3 product is equivalent to the formulation I invented (the De Simone Formulation) and previously sold under the brand VSL#3 from year 2002 until June 2016.
Actial/VSL attempted and failed to reverse-engineer my 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). The distributors of this “fake” VSL#3 product have commercialized an untested imitation product, without properly informing patients or physicians of the change and instead affirmatively claiming that their VSL#3 product contained the original formula backed by studies.
The Court issued a permanent injunction preventing the distributors from linking their VSL#3 product with the original De Simone Formulation, including by citing all clinical studies that were, in fact, performed only on the De Simone Formulation.
In Germany, Ferring Arzneimittel GmbH withdrew its appeal against the provisional measures decision of the Hamburg Court of First Instance of 25 January 2018 in which Ferring Arzneimittel GmbH was ordered not to make a series of statements for the product currently distributed under the brand name “VSL # 3”.
And specifically Ferring was forbidden to write in its promotional material for the VSL#3®*.
“Recommended several times in national and international guidelines”.
- DGVS/DGNM guideline irritable bowel syndrome (2011)
- DGVS guideline ulcerative colitis (2011)
- ECCO Guideline Ulcerative colitis, Part 1 (2017)
- ECCO Guideline Ulcerative colitis, Part 2 (2017)
- ECCO/ESPGHAN guideline on pediatric ulcerative colitis (2015)
* VSL#3 is a trademark of Actial Farmaceutica Srl.