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VSL#3 Probiotics Change of Formula False Advertising Class Action

Box of VSL#3

When people buy a certain product, which goes by a certain name, they expect the product to remain the same, unless they’re told otherwise. However, the complaint for this class action alleges that, when VSL Pharmaceuticals lost the rights to the formula for their VSL#3 probiotic medical food formula, they simply replaced it with an inferior formula and continued to sell it under the same name. Their distributor was Leadiant Biosciences, Inc., later replaced with Alfasigma USA, Inc.

The Nationwide Class for this action is all persons who bought VSL#3 anywhere in the US from June 1, 2016 through the present. There are also state classes for Massachusetts, California, Texas, New Jersey, Michigan, Illinois, Washington, Florida, and Idaho.

Between 2012 and May 2016, VSL, which owns the VSL trademark, and Leadiant, its distributor, marketed and sold the original version of VSL#3. It had been invented by Professor Claudio De Simone and was known as the De Simone Formulation. However, in 2016, De Simone licensed his formulation to another company and VSL lost the rights to it. 

VSL and its licensee Leadiant then replaced the De Simone formula with what the complaint calls the Fraudulent Formulation and continued to sell this new product under the VSL#3 name.

The complaint claims that the companies did not conduct any tests to see if the Fraudulent Formulation produced the same results as the De Simone Formulation. “Instead, [the companies] simply continued using the VSL#3 mark to sell this inferior product, intentionally passing off the Fraudulent Formulation as the real De Simone Formulation to consumers nationwide.” The complaint says they did this “combined with a coordinated campaign to falsely invoke the clinical history and scientific support for the De Simone Formulation as proof for the efficacy of the Fraudulent Formulation…”

On July 1, 2015, Alfasigma replaced Leadiant as the US distributor of VSL#3 and, according to the complaint, the same deceptive practices continued. 

The De Simone Formulation “had been the subject of more than sixty published clinical studies and has more than 15 years of successful clinical use[,]” the complaint says. It alleges the companies have deceived consumers “by continuing to describe the product as ‘VSL#3,’ and by directly usurping the De Simone Formulation’s clinical history and scientific support” for their Fraudulent Formulation. 

Also, the complaint alleges that the companies represent that the current formulation of VSP#3 “contains the same eight distinct strains of bacteria, in the same proportions, as the De Simone Formulation, when in fact it does not.”

In 2017, the new licensee of the De Simone Formulation, ExeGi Pharma, LLC, sued Leadiant and Alfasigma for false advertising. The jury awarded ExeGi $15 million.

However, the complaint claims that the two companies have continued to make false representations. A court has now granted in part an injunction against them. 

This complaint claims that the companies breached warranties, violated various state consumer protection laws, and violated the Racketeer Influenced and Corrupt Organizations  (RICO) Act.

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