Pr De Simone is the creator of the De Simone Formulation

By a pioneer of the intestinal microbiota, inventor of the De Simone Formulation Read More

Major decision made by US Court
ruled against VSL#3®

A federal jury in the United States District Court for the District of Maryland unanimously ruled on 20 November 2018 in favour of myself and ExeGi Pharma, which distributes my Formulation in the US under the brand Visbiome, against VSL Inc, Leadiant and Alfasigma, for false advertising, unjust enrichment, and unpaid royalties.

The jury unanimously found that the defendant pharmaceutical companies must pay a total of more than $18 million in compensatory damages, including $15 million for violation of the Lanham Act by deceiving patients, physicians, and other stakeholders concerning the probiotic product, VSL#3®, they have been marketing since 2016. It was successfully argued that VSL Pharmaceuticals had attempted to create a “knock-off” of my product, even though they never had access to the proprietary formula. During the trial, it was proved that the defendants’ copy product was not the same as my original invention and had never been tested in humans to ensure that it performs the same way as the original formula.

I created the probiotic product to help patients who had suffered for years with gastrointestinal illnesses and diseases, and I am grateful that the jury saw through the falsehoods of the defendants and ruled in our favour. Read the comprehensive ruling.

Read the comprehensive ruling.

VSL#3® already withdrawn from Canada

(extract of nutritional information) Each vegetarian capsule contains per serving 0.52g/capsule - VSL#3 Probiotic blend of following SEVEN bacterial strains

As of 15 November 2018, days before the US Court ruling, the VSL#3® produced in Italy by CSL and marketed in Canada by Ferring was withdrawn. Concerns were raised that the new VSL#3® is a “fake” VSL#3® and that the studies previously conducted with my original formulation are not applicable to VSL#3® made in Italy and have never been tested in subjects with IBD, IBS, hepatopathies, etc.

Currently the Court of Hamburg, Germany, has prohibited the Italian-made VSL#3® formulation to make reference to my own previous studies.

Also, a few months ago, the Central Drugs Standard Control Organization in India, responsible for approval of licences of specified categories of drugs in India, rejected the application by Sun Pharma searching for the approval of the same formulation.

I believe that it is my ethical duty to provide correct information to doctors and patients.

Claudio De Simone, MD

VSL#3 trademark is property of Actial Farmaceutica Srl, Italy

A pioneer of R&D in the field of probiotics, Prof De Simone currently runs a blog to share his views.