David Starr et al. v. VSL Pharmaceuticals, Inc. et al.

District Court, D. Maryland·Decided July 9, 2026·No. 8:19-cv-02173·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

) DAVID STARR et al., ) ) Plaintiffs, ) ) Civil Action No. 19-cv-02173-LKG v. ) ) Dated: July 8, 2026 VSL PHARMACEUTICALS, INC. et al., ) ) Defendants. ) )

MEMORANDUM OPINION AND ORDER ON THE PLAINTIFFS’ MOTION FOR PRELIMINARY APPROVAL OF CLASS ACTION SETTLEMENT

I. INTRODUCTION The Plaintiffs in this class action litigation have filed an unopposed motion for preliminary approval of class action settlement, to resolve their claims against the Defendants, VSL Pharmaceuticals, Inc. (“VSL”), Leadiant Biosciences, Inc., f/k/a Sigma-Tau Pharmaceuticals, Inc. (“Leadiant”), and Alfasigma USA, Inc. (“Alfasigma”). See ECF No. 376. The Court held a hearing on this motion on July 7, 2026. ECF No. 378. For the reasons that follow, and those stated during the July 7, 2026, hearing, the Court: (1) GRANTS the Plaintiffs’ motion for preliminary approval of class action settlement (ECF No. 376); (2) CONDITIONALLY CERTIFIES the Settlement Class; (3) APPROVES Plaintiffs David Starr, Bernadette Mavrikos, Edmund Quiambao, James Tettenhorst, Jeremy Hansen, Krista Karo, Arlene Reed- Cossairt, Peter Stavros and Heather Farkas to represent the Settlement Class; (4) APPOINTS Jeremy W. Schulman, Esq., and Jeffrey S. Gavenman, Esq., of Hughes Hubbard & Reed LLP, and Edward F. Haber, Esq., Michelle H. Blauner, Esq., Ian J. McLoughlin, Esq., and Patrick J. Vallely, Esq., of Shapiro Haber & Urmy LLP as the Settlement Class Counsel; (5) APPOINTS Angeion Group LLC as the Settlement Administrator; and (6) PRELIMINARILY APPROVES the Settlement Agreement. II. FACTUAL BACKGROUND AND PROCEDURAL HISTORY1 A. Factual Background Case Background This class action matter concerns the marketing and sale of VSL#3, a high-potency probiotic medical food used in the dietary management of gastrointestinal conditions, such as ulcerative colitis, irritable bowel syndrome and pouchitis. ECF No. 93 at ¶¶ 1, 42–45. The Plaintiffs allege that, from in or about 2002, until mid-2016, VSL#3 contained a proprietary blend of bacterial strains developed by Professor Claudio De Simone (the “De Simone Formulation”). Id. at ¶¶ 2, 47–54. The Plaintiffs also allege that the Defendants lost the right to sell the De Simone Formulation and began selling a different and inferior formulation (the “Fraudulent Formulation”) under the “VSL#3,” while continuing to invoke the clinical history and scientific support associated with the original De Simone Formulation and omitting to disclose that the formulation had changed. Id. at ¶¶ 4–8, 65–67. And so, the Plaintiffs assert claims against the Defendants for: (1) violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. § 1962(c) and (d); (2) breach of express warranty in violation of the Uniform Commercial Code (“UCC”); (3) unjust enrichment; and (4) violations of the consumer protection statutes of several states. Id. at ¶¶ 185–299; ECF No. 376-1 at 3. The Settlement Agreement

The parties have entered into a settlement agreement and release (the “Settlement Agreement”) to resolve the Plaintiffs’ claims. ECF No. 376-3 at 5–36 (Exhibit A). The key provisions of the Settlement Agreement are summarized below. First, the parties propose defining and certifying a “Settlement Class” in this case as follows: [A]ll persons who purchased a VSL#3 Class Product in the United States beginning June 1, 2016, and ending June 19, 2019. The following individuals are excluded from the Settlement Class: officers and directors of Defendants Alfasigma, Leadiant, and VSL, and their parents, subsidiaries, affiliates, and any entity in which

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