A proposed $20 million class action settlement may provide cash payments to people who bought VSL#3 in the United States from June 1, 2016, through June 19, 2019. The court-authorized settlement website says valid claims must be submitted online or postmarked by October 20, 2026.
The case is Starr et al. v. VSL Pharmaceuticals, Inc., et al., No. 8:19-cv-02173-LKG, in the U.S. District Court for the District of Maryland. The court granted preliminary approval on July 8, 2026. The defendants deny the plaintiffs’ allegations, and the proposed settlement is not a finding that any defendant violated the law.
Key facts
- Settlement fund: $20 million before approved fees, expenses, administration costs, and service awards.
- Who may be included: People who purchased a VSL#3 class product in the United States from June 1, 2016, through June 19, 2019, subject to the exclusions in the official notice.
- Claim deadline: October 20, 2026, for online submissions or mailed forms.
- Potential benefit: A starting approved claim amount of $20 per eligible unit, with different proof rules and possible pro rata adjustment.
- Final approval hearing: January 6, 2027, at 2:30 p.m., subject to change.
A purchase is required The settlement is for qualifying VSL#3 purchasers during the defined class period. Receiving a notice may indicate that purchase records identified someone, but it does not guarantee an approved claim or payment.
What VSL#3 is and why the formulation matters
VSL#3 is a high-potency probiotic medical food marketed for the dietary management of gastrointestinal conditions including irritable bowel syndrome, ulcerative colitis, and pouchitis. A medical food is a product intended for the dietary management of a disease or condition under medical supervision; it is not the same category as an ordinary snack or conventional food.
The official VSL#3 product site currently describes the product as containing multiple probiotic strains. Probiotics are live microorganisms used in products intended to support or manage aspects of digestive health. The number and identity of bacterial strains, their concentrations, and the clinical evidence associated with a particular formulation can therefore matter to consumers choosing a product.
The settlement concerns VSL#3 products sold during the 2016–2019 class period, not a general determination about every product currently sold under the brand. The court’s preliminary-approval order explains that the plaintiffs alleged the original VSL#3 used a proprietary blend developed by Professor Claudio De Simone. According to the plaintiffs, the defendants later sold a different formulation under the VSL#3 name while continuing to invoke clinical history and scientific support associated with the earlier formulation.
The plaintiffs characterize the later formula as different and inferior and allege that purchasers overpaid because of the challenged representations. Those are allegations. VSL Pharmaceuticals, Leadiant Biosciences, and Alfasigma USA dispute the claims and deny wrongdoing.
Who may qualify for the VSL#3 settlement
The conditionally certified settlement class generally includes all people who purchased a VSL#3 class product in the United States between June 1, 2016, and June 19, 2019.
The official notice lists exclusions. Officers and directors of the defendants and certain related entities are excluded. People or entities that purchased VSL#3 exclusively for resale to consumers are also excluded. The assigned judges and their staff or immediate families, settlement class counsel, and certain related people are excluded as well.
The settlement agreement defines a “unit” as a bottle or box of VSL#3. If a package contained multiple bottles, each bottle may count as a unit under the agreement. The settlement administrator—not Class Action Pulse—decides whether a claim and its supporting purchase information satisfy the settlement rules.
People who are uncertain whether a purchase falls within the class definition should review the official notice and contact the settlement administrator or class counsel. This article cannot determine individual eligibility.
The class period is specific The proposed settlement does not cover every historical or current VSL#3 purchase. The controlling window is June 1, 2016, through June 19, 2019, and the purchase must otherwise meet the official class definition.
How the cash benefit is calculated
The defendants agreed to create a $20 million common fund. A common fund is a pool used to pay approved claims and other court-approved settlement expenses. Before payments reach claimants, the fund may be reduced by notice and administration costs, attorneys’ fees and expenses, service awards for the class representatives, and other amounts approved by the court.
The settlement agreement starts approved claims at $20 per eligible unit, but proof rules affect how many units may be counted:
- A claimant without proof of purchase may claim one unit per household by signing the required purchase attestation. The starting approved claim amount is $20.
- A claimant who provides proof for one to three units receives a starting approved claim amount based on three units, or $60.
- A claimant with proof for more than three units may receive $20 for each supported unit, up to 40 units total. The maximum starting approved claim amount with proof is therefore $800.
Proof of purchase can include retail transaction records or other documentation accepted by the administrator under the agreement. Some online claim forms may be prepopulated when purchase records are available. A prepopulated record does not remove the administrator’s authority to review the claim.
The amounts above are not guaranteed final payments. They are approved-claim calculations before the settlement’s pro rata process. Pro rata means payments can be adjusted proportionally based on the money available and the total value of all approved claims.
If approved claims exceed the amount available from the net settlement fund, payments will be reduced proportionally. If approved claims are lower than the available amount, the agreement permits a proportional increase, subject to its stated limits. The administrator must complete the calculation after claims are reviewed and after the settlement becomes effective.
$20 per unit is a starting calculation The final payment may be lower or higher because the net fund and total approved claims are not yet known. The $800 figure is the pre-adjustment maximum approved amount for a claimant who supports at least 40 units with proof, not a promised check.
How to submit a claim
The court-authorized website provides an online claim form and a downloadable paper form. To seek payment, an eligible class member must submit a valid claim online by October 20, 2026, or mail a completed form postmarked by that date.
Claimants should use the official settlement website rather than a third-party claims site. Filing directly with the settlement administrator is free. The form asks for purchase information and, when applicable, proof supporting the number of units claimed.
The administrator may reject claims that are untimely, incomplete, invalid, or associated with fraud or abuse. The settlement agreement also describes a cure process for some claims that appear potentially valid but are missing information. Anyone contacted about a deficiency should follow the official administrator’s instructions and deadlines.
The claim form allows a claimant to choose a physical check or an available electronic payment method. Payment timing depends on final approval and the settlement’s effective date. Appeals can delay the effective date. The official materials do not promise that approved claimants will receive money immediately after the January hearing.
What happens if a class member does nothing
A class member who does nothing will not receive a settlement payment. If the settlement becomes final, that person may still be bound by the release for claims covered by the settlement unless they validly excluded themselves.
Excluding yourself, also called opting out, means asking not to participate in the settlement. A person who validly opts out will not receive settlement benefits but generally preserves the ability to pursue an individual lawsuit over the released issues, subject to applicable law and deadlines.
Objecting is different. A class member who objects remains in the settlement but tells the court why they oppose some or all of it. The official notice sets separate procedures for exclusions and objections, even though both are due October 20, 2026.
One date controls three different choices Claims, exclusions, and objections are all due October 20, but they have different legal consequences. People considering exclusion or an objection should read the official notice and consult a lawyer if they need advice.
What the lawsuit alleges
The named plaintiffs are VSL#3 purchasers who brought claims on behalf of a larger group. The defendants are VSL Pharmaceuticals, Inc.; Leadiant Biosciences, Inc., formerly known as Sigma-Tau Pharmaceuticals, Inc.; and Alfasigma USA, Inc. The settlement agreement describes them as companies involved in licensing, marketing, or selling VSL#3 during the class period.
The operative complaint asserted claims under the federal Racketeer Influenced and Corrupt Organizations Act, commonly called RICO, along with breach-of-warranty, unjust-enrichment, and state consumer-protection claims. RICO is a federal law that can apply to an alleged pattern of specified unlawful conduct; naming a RICO claim does not mean that conduct has been proven.
The plaintiffs alleged that the defendants continued to market the later VSL#3 formulation using clinical evidence associated with the earlier De Simone formulation and did not adequately disclose the change. They say consumers paid more than they otherwise would have paid.
The defendants deny all wrongdoing and dispute the allegations. The court has not decided after a trial that the plaintiffs are correct. The parties reached the proposed settlement after litigation and arm’s-length negotiations to avoid further cost, delay, and uncertainty.
Preliminary approval and what happens next
On July 8, 2026, U.S. District Judge Lydia Kay Griggsby conditionally certified the settlement class, appointed the named representatives and class counsel, appointed Angeion Group as settlement administrator, and preliminarily approved the agreement.
Preliminary approval allows notice and the claims process to move forward. It is not final approval. At the January 6, 2027 hearing, the court will consider whether the settlement is fair, reasonable, and adequate, along with any timely objections and requests for attorneys’ fees, expenses, or service awards.
The hearing is scheduled for 2:30 p.m. at the U.S. District Court for the District of Maryland in Greenbelt, Maryland. The date, time, or format may change, so anyone planning to attend should check the official website.
If the court grants final approval, payments still wait until the settlement becomes effective. That generally requires the time for appeals to expire or any appeals to be resolved. No payment is guaranteed, and the final amount for an approved claimant cannot be known until the administrator applies the agreement’s allocation rules.
Class Action Pulse evaluated whether a motion graphic would materially improve this report. A benefit-comparison graphic was omitted because the proof tiers, three-unit floor for supported claims, 40-unit cap, and possible upward or downward pro rata adjustments require qualifications that are clearer and more accessible in text. An animated dollar comparison could incorrectly present starting approved amounts as guaranteed payments.
This article provides general information, not legal advice. It does not determine whether a person is a class member, whether proof is sufficient, what legal option someone should choose, or how the court will rule.
Frequently asked questions
What is the VSL#3 settlement claim deadline?
Claims must be submitted online or postmarked by October 20, 2026, according to the court-authorized website and notice.
Who is included in the VSL#3 settlement?
The settlement class generally includes people who purchased a VSL#3 class product in the United States from June 1, 2016, through June 19, 2019, subject to exclusions in the official notice.
Can I file without proof of purchase?
The settlement agreement permits one unit per household without proof when the claimant signs the required attestation. That creates a starting approved claim amount of $20, subject to validation and pro rata adjustment.
How much can someone claim with proof?
A claimant who provides proof for one to three units receives a starting approved claim amount of $60. Supported purchases above three units are calculated at $20 each, up to 40 units and a starting approved amount of $800. Final payments may be adjusted.
Has the settlement received final approval?
No. The court granted preliminary approval. The final approval hearing is scheduled for January 6, 2027.
Does filing a claim guarantee payment?
No. The administrator must approve the claim, the court must grant final approval, the settlement must become effective, and the final amount depends on the net fund and all approved claims.