Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 1 of 33
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF FLORIDA
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`COMPLAINT
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`Case No. _____________
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`EXEGI PHARMA, LLC
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`Plaintiff,
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`v.
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`CAMILLO RICORDI ,
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`Defendant.
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`Plaintiff ExeGi Pharma, LLC (“Plaintiff” or “ExeGi”), by and through its undersigned
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`counsel, as and for its Complaint against Defendant Camillo Ricordi (“Defendant or “Dr.
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`Ricordi”), alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This lawsuit stems from Defendant’s role in a continuing false advertising
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`campaign that has damaged and continues to harm ExeGi, as well as thousands of consumers of
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`probiotics.
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`2.
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`Defendant is the Editor-in-Chief of European Review for Medical and
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`Pharmacological Services (“ERMPS”), a medical journal with a broad reach both inside and
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`outside of the United States. In this role, Defendant is ultimately responsible for what is published
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`in ERMPS – the buck stops with him.
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`3.
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`Defendant, however, has abdicated his responsibilities to the medical journal and,
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`rather than dedicating it to independent scientific inquiry, has used it as a commercial tool
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`fraudulently to advertise a second-rate medical product. Specifically, by refusing to withdraw,
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`and facilitating the active promotion of, an article published by ERMPS in January of 2020 –“The
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 2 of 33
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`safety profile of probiotic VSL#3. A meta-analysis of safety data from double-blind, randomized,
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`placebo-controlled clinical trials” (hereinafter, “VSL#3 Article”) – Defendant not only has
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`violated editorial and journalistic ethics in his role as editor of a scientific journal, but also has
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`actively contributed to the false advertising of the probiotic VSL#3 by the Actial Group (Actial
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`Srl and its U.S. affiliate, VSL Pharmaceuticals Inc. (“VSL Inc.”)) through VSL Inc.’s licensee,
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`Alfasigma USA, Inc. (“Alfasigma”).
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`4.
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`The VSL#3 Article, which was funded by Actial Farmaceutica, an entity that acts
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`on behalf of the Actial Group, falsely concludes that VSL#3 is safe. This improper conclusion is
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`based upon incomplete and unverified data assembled from unrelated clinical studies that were
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`approved to be conducted on humans based upon fraudulent data. The Actial Group, to secure
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`approval of the studies, presented to a group of clinical investigators involved in the studies
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`information and research pertaining to the safety and efficacy of an entirely different probiotic,
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`one created by Professor Claudio De Simone (and sold in the United States exclusively by ExeGi).
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`Once these investigators were informed of this subterfuge, all halted the studies. Yet the authors
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`of the VSL#3 Article went ahead with their analysis anyway, using incomplete data that had been
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`gathered before the studies were halted, and misrepresenting why the studies had been shut down.
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`Upon information and belief, their plowing ahead with these dubious claims was the result of the
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`Actial Group’s influence over them and the article.
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`5.
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`The VSL#3 Article, therefore, is itself a fraud. And the Actial Group, with
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`Defendant’s knowing participation, has used it aggressively for commercial purposes, sending it
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`to physicians and other healthcare providers that prescribe the product, and trumpeting it in
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`marketing and advertising to further the entirely unsubstantiated – and literally false – notion that
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`2
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 3 of 33
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`VSL#3 is clinically proven to be safe, when no published clinical study actually has reached that
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`conclusion.
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`6.
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`All of the issues with the VSL#3 Article, the studies upon which it was based, and
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`its improper use in commercial advertising have been brought to the attention of Defendant on
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`numerous occasions. Yet Defendant simply ignored multiple emails from Professor De Simone
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`until, when contacted by Plaintiff’s counsel, he ran to the Actial Group for guidance instead of
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`seeking to exercise his editorial control over the publication and investigate the issues raised. As
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`a result of Defendant’s actions and inaction, ERMPS has not withdrawn or provided any sort of
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`editorial correction to the VSL#3 Article. The article remains widely available in its original form,
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`and, with Defendant’s knowledge and active participation, VSL Inc. has made it the centerpiece
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`of its marketing to United States health care professionals and customers.
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`7.
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`This fraudulent use of pseudo-medical literature is but the latest attempt of the
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`Actial Group to falsely advertise VSL#3. The Actial Group, through VSL Inc. and its distributors,
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`has falsely represented the safety of its product, and promoted, either directly or indirectly, a false
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`equivalence between VSL#3 and the unique, eight-strain, high-potency probiotic formula created
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`by Professor De Simone (“De Simone Formulation”) that is sold by ExeGi under the brand name
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`“Visbiome.”
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`8.
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`Professor De Simone previously had worked for VSL Inc., and the De Simone
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`Formulation was sold under the brand name VSL#3 until 2016. Professor De Simone left VSL
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`Inc., however, and took his know-how and Formulation with him. The De Simone Formulation
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`now is exclusively licensed to and sold by ExeGi under the brand name Visbiome, while VSL#3
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`3
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 4 of 33
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`now contains a new formula (“Italian VSL#3”). VSL Inc. has used this history to its advantage,
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`however, blurring what should be clear lines between the products.1
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`9.
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`Initially, VSL Inc. simply made blatantly false statements linking Italian VSL#3 to
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`the De Simone Formulation. It baldly stated, for example, that Italian VSL#3 contained: (1) the
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`same formulation as that found in the De Simone Formulation; (2) the “original proprietary blend”;
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`and (3) the “same mix in the same proportions as earlier versions of VSL#3.”
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`10.
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`None of those statements is (or was) true, and VSL Inc. now is forbidden, by order
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`of a federal court, from making any one of them. In 2018, a jury in the United States District Court
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`for the District of Maryland unanimously found that the distributors of Italian VSL#3 were liable
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`for false advertising by misrepresenting that product to be the same as the De Simone Formulation.
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`The jury awarded damages of $15 million on ExeGi’s false advertising claim, which represented
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`one of the distributors’ wrongfully earned profits on the sales of the product.
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`11.
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`The jury’s verdict was then upheld by the federal district court judge, who also
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`entered a permanent injunction to prevent further misrepresentation of Italian VSL#3 as being
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`equivalent to Visbiome (the jury verdict alone was not enough, apparently, to stop VSL Inc. from
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`making false statements about its product and comparing it to the De Simone Formulation).
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`Specifically, the injunction prohibited VSL Inc.’s licensees, Alfasigma and Sigma-Tau
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`Pharmaceuticals, Inc. (n/k/a Leadiant Biosicenses, Inc. (“Leadiant”)), from citing clinical studies
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`performed on the De Simone Formulation or otherwise implying a false continuity between Italian
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`1 It is not shocking that VSL Inc. has tried to link Italian VSL#3 with the De Simone Formulation.
`While Italian VSL#3 is but a poor imitation of the De Simone Formulation and has not been
`rigorously tested, the De Simone Formulation is one of the most extensively studied probiotics
`now available, having been the subject of more than 70 human clinical trials. Based upon those
`trials and studies, the De Simone Formulation is widely considered the gold standard for this type
`of probiotic.
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`4
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 5 of 33
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`VSL#3 and the De Simone Formulation. These rulings were upheld by the United States Court of
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`Appeals for the Fourth Circuit.
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`12.
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`Alfasigma and VSL Inc., however, defiantly continued marketing Italian VSL#3 in
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`a manner that compares it to the De Simone Formulation – stating Italian VSL#3 was “equivalent”
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`to the De Simone Formulation, that clinical studies performed on the De Simone Formulation
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`could be “relied upon to show the efficacy and safety” of Italian VSL#3, and that Italian VSL#3
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`“ha[d] not changed.”
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`13.
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`On July 30, 2020, the Maryland Federal District Court granted in part ExeGi’s
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`contempt motion filed against Alfasigma and VSL Inc. for failing to abide by the injunction. The
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`Court found that Alfasigma and VSL Inc. had committed “blatant” violations.
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`14.
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`But VSL Inc. is undeterred. Now, in addition to making direct statements, it is
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`attempting, with the help of scientists like Defendant, to establish a connection to the De Simone
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`Formulation and to establish that its product is certified “safe” via corrupt, back-door routes under
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`the guise of science. It is doing so by using studies and research conducted on the De Simone
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`Formulation to establish (fraudulently) Italian VSL#3’s bona fides.
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`15.
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`First, VSL Inc. hired a company called Intertek to put together a report on Italian
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`VSL#3 and assemble a panel of professors who would review the report and then certify Italian
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`VSL#3 as “Generally Recognized as Safe” (“GRAS”) – a critical standard for probiotic products.
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`Three professors, including Dr. Roberto Pacifici, a professor at Emory University (who also had
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`been engaged by VSL Inc. to be a paid consultant), signed off on the report, which touted the safety
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`and efficacy of Italian VSL#3 and certified that it met the criteria to qualify as a “medical food”
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`and “GRAS.”
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`5
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 6 of 33
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`16.
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`This report became the foundation for VSL Inc.’s (and its distributors’) marketing
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`of Italian VSL#3 as a “medical food” and GRAS certified. But there is a major problem with the
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`report: it was based entirely upon studies and research performed on the De Simone Formulation,
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`not Italian VSL#3. When Dr. Pacifici refused to withdraw his support for the GRAS Panel’s
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`report, despite being informed that the studies upon which it was based were conducted on an
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`entirely different probiotic, ExeGi filed a lawsuit against Dr. Pacifici for, inter alia, contributory
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`false advertising. Such lawsuit currently is pending in the United States District Court for the
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`Northern District of Georgia (ExeGi Pharma, LLC v. Pacifici, Case No. 1:21-CV-02134-TWT).
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`17.
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`The Actial Group now has exploited the limited and immaterial connections
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`between its imitation product and the De Simone Formulation to fraudulently secure approval for
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`clinical studies that it then can manipulate via commercial advertising masquerading as medical
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`literature. In the VSL#3 Article published by ERMPS, the authors “conclude that VSL#3 is a safe
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`and well-tolerated agent.” But, like the GRAS Panel Report, the VSL#3 Article is built on a false
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`premise and fundamentally flawed.
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`18.
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`Notably, the VSL#3 Article was first published when Professor Antonio Gasbarrini
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`was the editor of ERMPS. Dr. Gasbarrini, in addition to being an employee of Fondazione
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`Policlinico Universitario Gemelli IRCCS, Università del Sacro Cuore (the same institution where
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`one of the authors of the VSL#3 Article holds a position), was a member of the “Scientific Board”
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`for Actial Group and is a scientific advisor for the VSL#3 product. Based upon this (and other)
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`blatant conflicts of interest, it is clear that the VSL#3 Article was the result of a coordinated effort
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`by the Actial Group to promote the false notion that VSL#3 has been proven safe through studies
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`and testing. Indeed, the Actial Group’s fingerprints are all over the VSL#3 Article, which has the
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`feel of an infomercial rather than an unbiased piece of journalism.
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`6
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 7 of 33
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`19. Most significantly, the studies from which the VSL#3 Article’s authors draw their
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`conclusions were halted upon the respective investigators of the studies being informed that the
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`studies were authorized based upon fraudulently represented data. Specifically, because the
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`studies were human clinical trials, they required approval from investigators and ethics committees
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`before they could move forward. Dr. Gasbarrini’s associate, Dr. Lucrezia Laterza, put together
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`materials to provide to those charged with approving the various studies. The materials, however,
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`included information based upon, and studies conducted upon, the De Simone Formulation (not
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`Italian VSL#3), as well as the aforementioned GRAS panel report that also was based entirely
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`upon research, studies and documents related to the De Simone Formulation (not Italian VSL#3).
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`Thus, the clinical investigators – as well as the participants – were misinformed that the product
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`they would be using was safe based upon safety information relating to an entirely different
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`substance. Not only did this compromise the study itself, but it also put the health of the
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`participants in danger.
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`20.
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`Professor De Simone and his counsel contacted the clinical investigators and
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`informed them that the Actial Group had misled physicians and patients into believing that (a) the
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`version of VSL#3 offered for the clinical trials would have the same safety and efficacy as the De
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`Simone Formulation and that (b) prior studies on the De Simone Formulation actually were
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`performed on Italian VSL#3. When these studies’ investigators learned the truth about the data
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`and the rulings of the U.S. District Court for the District of Maryland, they immediately stopped
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`their clinical trials. And for good reason: Fragile populations had been convinced to participate in
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`these studies – and to consume Italian VSL#3 – based upon the misrepresentation that the product
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`had been clinically proven safe over a period of 15 years. Because they had been duped, the
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`7
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 8 of 33
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`organizers of these studies could not in good conscience continue the studies or certify the results
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`thereof.2
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`21.
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`The Actial Group has no such conscience, as not even the halting of the studies put
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`a stop to its ongoing quest to falsely market Italian VSL#3. Indeed, the Actial Group assembled
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`authors who were not a part of the clinical studies, and these authors went ahead and used the
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`incomplete results from the clinical trials anyway to support their improper conclusion regarding
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`the safety of VSL#3.
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`22.
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`In sum, the authors combined incongruous, incomplete, and unreliable data for the
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`sole purpose of forcibly extrapolating false or misleading conclusions regarding VSL#3. The
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`VSL#3 Article is thus merely commercial speech. It is to medical journalism what QVC is to
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`Dateline.
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`23.
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`Defendant was informed of the fraudulent underpinnings of the VSL#3 Article on
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`multiple occasions. After three emails from Professor De Simone (on August 27, September 5,
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`and September 8 of this year) were ignored, Professor De Simone’s counsel sent Defendant a letter
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`on September 23, 2021. Notably, just five days later, Defendant sent an email to Giacomo Gori
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`(general manager of Actial Farmaceutica), Dr. Gasbarrini, and several others, including a co-editor
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`of ERMPS. In it, Defendant requested a detailed answer on the validity of the article’s
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`underpinnings and suggested there might be a consensus to withdraw the article. He indicated,
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`however, that he would not want to withdraw the article without first hearing the opinions of those
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`on the email, including the Actial Group representative (who was not listed as an author of the
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`article and, thus, should have no role in the editorial process).
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`2 Indeed, none of the clinical investigators that performed the studies is listed as an author of the
`VSL#3 Article.
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 9 of 33
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`24.
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`Defendant, the Editor-in-Chief of ERMPS, was, thus, shelving medical and
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`journalistic ethics in favor of seeking permission from the company that paid for the article, which
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`payment redounded to the financial benefit of Defendant and the journal he runs. While stating
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`the article should be withdrawn as false, he left the decision to the company that was falsely
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`marketing the product via that very article. The article has not been withdrawn to date, evidencing
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`that Defendant takes his orders from the Actial Group and remains a knowing and willing
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`participant in their false advertising of VSL#3.
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`25.
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`Based on Defendant’s continued authorization of the VSL#3 Article, VSL Inc.
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`continues, with Defendant’s knowledge and participation, to claim in its marketing materials and
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`on its web site that “multiple clinical trials” have demonstrated the safety of this product. Such
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`claims are entirely false and, when relied upon by consumers, harm not only ExeGi but also those
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`consumers. Yet, Defendant has refused to back down from publishing the VSL#3 Article.
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`26.
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`ExeGi requests this Honorable Court enter judgment against Defendant for his
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`ongoing role in VSL Inc.’s false advertising, order that he withdraw the VSL#3 Article, and award
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`ExeGi damages for the harm caused by Defendant’s conduct.
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`THE PARTIES
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`27.
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`Plaintiff ExeGi Pharma, LLC is a limited liability company organized under the
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`laws of New York with its principal place of business at 90 Church Street, Rockville, Maryland
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`20850. The members of ExeGi are citizens of Maryland and Switzerland; ExeGi is therefore a
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`citizen of Maryland and Switzerland.
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`28.
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`Defendant Camillo Ricordi is an individual residing at 550 Bay Point Road, Miami,
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`Florida 33137. He is a domiciled in and a citizen of Florida.
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 10 of 33
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`JURISDICTION AND VENUE
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`29.
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`As the sole plaintiff in this action is a citizen of Maryland and Switzerland, and the
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`sole defendant is a citizen of Florida, there is complete diversity between the parties.
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`30.
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`As alleged herein, the amount in controversy between the parties exceeds
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`$75,000.00, exclusive of interest and costs.
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`31.
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`By virtue of the foregoing facts, this Court has jurisdiction over the subject matter
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`of the claims brought by Plaintiff under 28 U.S.C. § 1332(a)(1).
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`32.
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`In addition, because this dispute concerns a federal question under Section 43(a) of
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`the Lanham Act, this Court has jurisdiction under 28 U.S.C. § 1331.
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`33.
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`34.
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`This Court has personal jurisdiction over Defendant as he is domiciled in Florida.
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`Venue is properly laid in this judicial district under 28 U.S.C. § 1391(b)(1), as
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`Defendant is a resident of this judicial district.
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`FACTUAL ALLEGATIONS
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`A. Professor De Simone’s Groundbreaking Work Inventing Probiotic Formulations
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`35.
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`Professor De Simone is a renowned scientist, inventor, physician, and leader in the
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`field of medical research focused on the health benefits of certain “friendly” bacteria that live on
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`and within the human body. He is a Professor of Infectious Diseases and has degrees in
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`Gastroenterology and Immunology, is a Fellow of the American Gastroenterology Association,
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`and is an inventor of bacterial compositions used in the fields of human and veterinary nutrition
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`and hygiene. Professor De Simone has authored hundreds of clinical studies and scholarly papers
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 11 of 33
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`in the field of probiotics3, and he also has developed a series of new probiotic products that have
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`helped thousands of people afflicted with gastrointestinal disorders, such as Inflammatory Bowel
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`Disease (“IBD”), Ulcerative Colitis (“UC”), Pouchitis, and Irritable Bowel Syndrome (“IBS”).
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`36.
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`During the early 1980s and 1990s, Professor De Simone conducted extensive
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`research into the clinical use of bacterial strains to treat the symptoms associated with various
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`serious diseases, including IBD, IBS, enteral feeding, liver diseases, and many other conditions.
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`Professor De Simone’s work resulted in the synthesis of several probiotic formulations, which
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`clinical experience and data demonstrated had beneficial effects on those suffering from these
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`maladies. Professor De Simone obtained several patents and other intellectual property rights
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`relating to his probiotic formulations in multiple countries, including in the United States. One of
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`Professor De Simone’s probiotic formulations was the eight-strain probiotic mix known as the De
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`Simone Formulation.
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`B. VSL Inc. Commercializes the De Simone Formulation
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`37.
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`About 20 years ago, Professor De Simone and two brothers, Claudio and Paolo
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`Cavazza, formed VSL Inc., and Professor De Simone served for a time as its CEO and as a member
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`of its board. Beginning in 2002, after Professor De Simone decided to license (temporarily) his
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`patent for the De Simone Formulation to VSL Inc., the formulation was launched in the United
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`States under the trademark “VSL#3.”
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`3 Probiotics are formulations comprised of living microorganisms, most often live bacterial
`cultures, which may be similar to those normally present in the human gastrointestinal tract, and
`which have a beneficial effect on the host. Probiotics are supplied commercially in a variety of
`forms, including capsules, tablets and sachets containing a powder dosage form, as well as in some
`foods, such as yogurt. The consumption of probiotics can help to re-establish a healthy balance of
`bacteria in the intestine by replenishing beneficial bacterial strains.
`11
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 12 of 33
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`38.
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`In the ensuing years, VSL Inc. sold VSL#3 with great success. Dozens of human
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`clinical trials of the De Simone Formulation were completed successfully, and the results of these
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`studies were published in peer-reviewed medical and scientific journals. Such trials demonstrated
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`the safety and effectiveness of the De Simone Formulation in the dietary management of, inter
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`alia, IBD, IBS, and Pouchitis, a very serious and rare chronic disorder. With respect to Pouchitis,
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`the De Simone Formulation was ultimately recognized by
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`the world’s professional
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`gastroenterology societies as a “standard of care” – an achievement that no other probiotic had
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`attained previously.
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`39.
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`Eventually, some of the other owners of VSL Inc., including members of the
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`Cavazza family, proposed reducing VSL#3’s production costs by changing the product’s
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`composition and substituting cheaper bacterial strains without informing customers. Professor De
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`Simone rejected this idea, recognizing the potential harm to those who had come to depend upon
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`his formula. This ignited a long conflict between Professor De Simone and the Cavazzas that
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`included years of litigation in federal court. During this time, the Cavazzas also entered into an
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`agreement with Alfa Wassermann through which they merged their own company, Sigma Tau,
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`with Alfa Wasserman to create a new company, Alfasigma.
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`40.
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`Professor De Simone resigned from VSL Inc. in November of 2014 and took with
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`him the “Know-How” that was necessary to manufacture his De Simone Formulation. However,
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`Leadiant and VSL were authorized to continue to sell VSL#3 containing the De Simone
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`Formulation until January 2016.4 He eventually licensed his De Simone Formulation to ExeGi,
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`which began to sell it under the name Visbiome in February of 2016.
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`4 Leadiant and VSL Inc. failed to pay Professor De Simone for the privilege of selling the De
`Simone Formulation during this period, however. Based on that failure, the jury in the Maryland
`District Court Action found VSL Inc. liable for breach of contract and both VSL Inc. and Leadiant
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 13 of 33
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`41.
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`The Cavazzas, meanwhile, hired a team of dairy experts to attempt to reverse
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`engineer the De Simone Formulation. When that task proved impossible, as the dairy experts were
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`unable to ascertain the exact strains used in the product or the correct proportions of the strains
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`they did identify, they instead created a new product – a poor imitation of the De Simone
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`Formulation, Italian VSL#3 (also, the “Fake Formula”). The Cavazzas went to a new manufacturer
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`in Italy and then began producing the Fake Formula. Beginning in mid-2016, Leadiant began
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`selling this Fake Formula under the trademark “VSL#3” without informing the public of the
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`change in formula.
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`42.
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`Rather, Leadiant usurped the history of and research into the De Simone
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`Formulation and simply used it for the Fake Formula. Leadiant publicly announced that
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`production of VSL#3 would move from the Danisco facility in the United States to a new
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`manufacturer in Italy, but it went to great lengths to assure the public that there would be “no
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`effect” on patients because of that change in manufacturer. In reality, Leadiant was converting
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`from selling the De Simone Formulation as VSL#3 to selling the Fake Formula as VSL#3 and
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`simply pretended there merely had been a change in manufacturing location and nothing more.
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`43.
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` But the Fake Formula is entirely, materially different from the De Simone
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`Formulation, in numerous ways: the Fake Formula uses different bacterial strains, in a different
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`ratio, has a different biological and immunologic profile, is made with different manufacturing
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`methods, and is not the subject of the extensive studies and research that were performed on the
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`De Simone Formulation.
`
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`liable for unjust enrichment and awarded several million dollars in damages to Professor De
`Simone.
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 14 of 33
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`44.
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`Furthermore,
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`independent
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`testing (corroborated by anecdotal reports and
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`complaints from consumers) confirmed that the Fake Formula was demonstrably different from
`
`the original De Simone Formulation (then being sold by ExeGi as Visbiome). Since the launch of
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`the Fake Formula (first in Europe, in early 2016, then in the U.S. and Canada, in mid-2016),
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`multiple investigators in Europe have compared the Fake Formula to the De Simone Formulation
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`and found striking differences between them.
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`C. Litigation in the District of Maryland
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`45.
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`Professor De Simone filed suit in the United States District Court for the District
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`of Maryland (“Maryland District Court Action”), bringing various claims against VSL Inc.,
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`including a claim for a declaratory judgment that he owned the Know-How. When ExeGi learned
`
`that Leadiant and Alfasigma were selling the Fake Formula and marketing it as “the same” as, and
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`equally efficacious to, the De Simone Formulation, ExeGi joined the Maryland District Court
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`Action and brought claims against Leadiant and Alfasigma for false advertising under the Lanham
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`Act. In response, Alfasigma filed a series of counterclaims against both ExeGi and Professor De
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`Simone. In total, VSL Inc., Alfasigma, and Leadiant brought 52 counterclaims.
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`46.
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`The District Court granted summary judgment for Professor De Simone on the issue
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`of the Know-How, ruling Professor De Simone owned it. Then, in November of 2018, after a
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`three-week trial, the jury reached a unanimous verdict in favor of Professor De Simone and ExeGi
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`and against VSL, Inc., Alfasigma, and Leadiant. The jury awarded Professor De Simone and
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`ExeGi $18,014,041 in damages, including $15,000,000 to ExeGi for its false advertising claim.
`
`47.
`
`The jury’s verdict and award of $15 million in damages on the false advertising
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`claim was necessarily premised on the finding that the two probiotic products are materially
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`different. As a basic matter, as the evidence showed at trial, the De Simone Formulation contains
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 15 of 33
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`eight strains of bacteria, while Italian VSL#3 contains seven. In addition, the De Simone
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`Formulation contains lactose (Italian VSL#3 does not), and the products are made by different
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`manufacturers, using different processes. The evidence at trial, including expert testimony, further
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`showed that Italian VSL#3 and the De Simone Formulation have materially different biological,
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`enzymatic, and immunological profiles. And, per expert testimony, those differences would have
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`a material effect on how the two products would perform in the body, including the conclusion
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`that the differences were substantial enough that there was no expectation that Italian VSL#3
`
`would have any of the beneficial effects that were studied, and documented, to belong to the De
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`Simone Formulation in the clinical studies and clinical history.
`
`48. When Leadiant and Alfasigma challenged the sufficiency of the evidence to support
`
`this jury conclusion in post-trial motions, the Court heartily disagreed. Indeed, the Court adopted
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`the jury’s conclusion as its own. The Court stated in its Opinion that “the scientific evidence
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`established that the products are not the same,” and “the harm to ExeGi was the promoting of a
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`false continuity between Italian VSL#3 and the De Simone Formulation.” De Simone v. VSL
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`Pharm. Inc., No. CV TDC-15-1356, 2019 WL 2569574 (D. Md. June 20, 2019), *3-4.
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`49.
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`Based on those findings, the Court entered a permanent injunction that forbid
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`distributors from claiming that Italian VSL#3 (1) continues to contain the same formulation found
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`in the De Simone Formulation; (2) contains the “original proprietary blend”; or (3) contains the
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`“same mix in the same proportions as earlier versions of VSL#3.” The injunction further forbid
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`distributors from citing or referring to any clinical studies performed on the De Simone
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`Formulation or earlier versions of VSL#3 as relevant or applicable to Italian VSL#3.
`
`50.
`
`Despite the entry of this injunction, VSL Inc. continued to promote a false
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`equivalency with its product. VSL Inc. also has attempted to link its product to the De Simone
`
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`Case 1:21-cv-23688-XXXX Document 1 Entered on FLSD Docket 10/19/2021 Page 16 of 33
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`Formulation and falsely market its Fake Formula as safe through more subtle, but just as improper,
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`methods.
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`D. The GRAS Report
`
`51.
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`In early 2017, a consulting company called Intertek provided Dr. Pacifici, Professor
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`I. Glenn Sipes of the University of Arizona, and Dr. Gary Williams of New York Medical College
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`with a draft report on Italian VSL#3. Intertek had prepared the draft report and put together the
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`dossier of reports and studies upon which this initial draft purportedly was based. Intertek then
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`asked the three professors to serve as a “GRAS Panel” that would review the draft Report and
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`information in the dossier and then sign a revised report. It was made clear that this was a
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`commercial, rather than scientific, project meant to commercialize Italian VSL#3.
`
`52.
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`Dr. Pacifici knew, and it was reasonably foreseeable, that his endorsement of the
`
`purported GRAS status of the Italian VSL#3 product would be used by VSL Inc. as the premise
`
`for marketing the product as a safe and effective medical food for the dietary management of
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`specific, serious gastrointestinal diseases and disorders. Indeed, around this time, on March 30,
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`2017, Dr. Pacifici received an email from Tomas Jonaitis at Intertek. In the email, Dr. Pacifici
`
`was specifically informed that his signing onto the GRAS Panel Report “allows VSL to market
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`the product as described in the document.”
`
`53.
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`Despite the serious consequences of his endorsement, and despite his scientific and
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`ethical duties, Dr. Pacifici (and the other two professors who worked on