The Entyvio lawsuit is a developing product liability matter in which patients allege that Takeda Pharmaceuticals failed to warn them and their doctors that Entyvio (vedolizumab), a biologic used to treat ulcerative colitis and Crohn’s disease, can cause interstitial lung disease. As of mid-2026, no multidistrict litigation has been established, no bellwether trials are scheduled, and no settlements have been reported. Plaintiff firms are still in the investigation and case-building phase.
What the Lawsuits Allege
The core claim is that vedolizumab can cause interstitial lung disease (ILD), a category of conditions involving inflammation and scarring around the lung’s air sacs. Specific forms tied to the drug in published case reports include hypersensitivity pneumonitis, organizing pneumonia, necrobiotic pulmonary nodules, and acute respiratory distress syndrome.1PubMed Central. Vedolizumab-Induced Interstitial Lung Disease: A Case of Delayed-Onset Pulmonary Toxicity Symptoms in those reports range from progressive shortness of breath and persistent cough to respiratory failure requiring mechanical ventilation.2PubMed Central. Vedolizumab-Associated Diffuse Interstitial Lung Disease in Patients With Ulcerative Colitis At least one reported case was fatal: a 2022 Chinese report described a patient with ulcerative colitis who died of severe diffuse ILD linked to vedolizumab.3ResearchGate. Vedolizumab-Induced Interstitial Lung Disease: A Case of Delayed-Onset Pulmonary Toxicity
The medical literature on this association is small. As of late 2025, roughly ten cases had been documented in peer-reviewed journals.1PubMed Central. Vedolizumab-Induced Interstitial Lung Disease: A Case of Delayed-Onset Pulmonary Toxicity Plaintiffs’ attorneys contend Takeda knew or should have known about the risk and failed to warn.
The Label Change That Anchors the Cases
For years after Entyvio’s 2014 approval, the prescribing information said nothing about interstitial lung disease. Warnings focused on other risks, including serious infections, progressive multifocal leukoencephalopathy, and liver injury.4FDA. Entyvio Prescribing Information (2019)
That changed on April 18, 2024, when the FDA approved a safety-related labeling supplement adding “interstitial lung disease, pneumonitis” to the Postmarketing Experience section of the label.5FDA Sentinel Initiative. FDA Labeling Change: Vedolizumab — Interstitial Lung Disease The change followed a safety signal the FDA identified in January 2023 and a review of adverse event reports from the FDA Adverse Event Reporting System and the medical literature.6FDA. January–March 2023 Potential Signals of Serious Risks The European Medicines Agency had earlier concluded that “the contribution of vedolizumab could not be excluded” as a cause of ILD.7FDA Sentinel Initiative. Entyvio (Vedolizumab) and Tysabri (Natalizumab) Studies
The FDA’s own Sentinel System analysis did not find an increased incidence of ILD in vedolizumab patients compared to patients on other advanced inflammatory bowel disease therapies. The agency nevertheless concluded the “entire body of evidence,” including case reports, warranted the label change.5FDA Sentinel Initiative. FDA Labeling Change: Vedolizumab — Interstitial Lung Disease
That timeline is central to the legal theory. Plaintiffs allege that during the roughly ten years before the 2024 label update, patients developed serious lung conditions with no warning that Entyvio could be responsible, leading to delayed diagnoses and worse outcomes.
Who May Qualify to File a Claim
The qualification criteria described by firms investigating cases are consistent. A potential plaintiff generally must have been prescribed Entyvio for ulcerative colitis or Crohn’s disease, later received a diagnosis of interstitial lung disease or a related pulmonary condition, and had no prior history of lung problems before treatment. Individual firms set their own intake standards, and some that once accepted cases have stopped. Johnson Becker, for instance, is no longer taking new Entyvio matters.8Johnson Becker. Entyvio Lawsuit
Where the Litigation Stands
Entyvio cases have not been consolidated into a mass tort or MDL. There are no scheduled bellwether trials and no reported settlement figures. Individual firms are evaluating claims one at a time. A large international observational safety study enrolled more than 5,000 patients between 2015 and 2021 comparing vedolizumab to other biologics; respiratory tract infections were more common among vedolizumab patients, but broader ILD findings from that study have not been publicly detailed.9UK Health Research Authority. Entyvio (Vedolizumab) Long Term Safety Study Its eventual results, and any additional adverse event data, could shape whether the litigation grows.
How Takeda’s Actos History Compares
Takeda has faced large-scale pharmaceutical litigation before. Its Actos (pioglitazone) diabetes drug was linked to bladder cancer, drawing more than 10,000 lawsuits, with over 3,700 consolidated into an MDL in the Western District of Louisiana. One early jury returned a $9 billion punitive damages verdict, later reduced by a judge to $36.8 million.10Consumer Safety. Actos Lawsuit In April 2015, Takeda agreed to a $2.4 billion global settlement resolving roughly 9,000 cases, without admitting liability.11Takeda. Takeda Agrees to Settle Actos Product Liability Lawsuits and Claims Since 2000, Takeda and its subsidiaries have accumulated over $4 billion in cumulative penalties across drug safety, False Claims Act, and antitrust matters.12Good Jobs First Violation Tracker. Takeda Pharmaceutical Violation Tracker
That history is context, not a forecast. Actos rested on a well-established epidemiological link to bladder cancer and years of consolidated federal proceedings. Entyvio claims currently rest on a rare adverse event supported by a small number of case reports and a Postmarketing Experience label entry. Whether the litigation reaches similar scale will depend on claim volume, future safety data, and how courts weigh the causal evidence.