Ocaliva Lawsuit: Withdrawal and Liver Injury Claims

Patients treated with Ocaliva for primary biliary cholangitis face severe risks of liver injury, transplant, and death. Here is what the regulatory actions and emerging lawsuits mean for you.

Ocaliva has been linked to liver failure, liver transplants, and death. If you or a loved one took it and had one of these outcomes, you may be eligible to seek compensation through an individual lawsuit. Ocaliva was removed from the United States commercial market in November 2025. Federal regulators found the medication can accelerate severe liver damage, even in patients without advanced liver scarring.

At LawfareClaims.org, we help patients and their families understand complex pharmaceutical disputes. Drug manufacturers have a strict legal duty to warn patients and prescribing physicians about dangerous medication risks. Intercept Pharmaceuticals, the manufacturer of Ocaliva, now faces individual lawsuits alleging that it failed to provide adequate safety warnings about potential liver decompensation and organ failure. Here is what you need to know about the regulatory record, qualification criteria, and current legal proceedings.

Ocaliva and Its Accelerated Approval

Ocaliva is the brand name for obeticholic acid. It is an oral prescription tablet designed to treat primary biliary cholangitis (PBC). PBC is a chronic autoimmune condition that slowly destroys the small bile ducts inside the liver. When bile ducts fail, toxic bile builds up and damages healthy liver tissue over time.

The standard first-line therapy for PBC is ursodeoxycholic acid, often called UDCA. Some patients do not respond well to UDCA alone. Others cannot tolerate its side effects. For those specific patients, Intercept developed obeticholic acid as a targeted second-line therapy.

The Food and Drug Administration (FDA) granted accelerated approval to Ocaliva in May 2016. Accelerated approval allows promising medications for serious conditions to reach patients before full clinical trials finish. In exchange, the pharmaceutical company must conduct postmarket confirmatory studies to prove real clinical benefit. If those studies show harm or fail to show a survival benefit, federal regulators can revoke marketing clearance.

FDA Safety Warnings and Evidence of Liver Damage

Federal regulators placed restrictions on Ocaliva in two distinct phases. The first intervention happened five years after approval.

On May 26, 2021, the FDA added a contraindication barring Ocaliva use in PBC patients who had advanced, decompensated cirrhosis. The agency took this step after its safety review uncovered 25 cases of severe liver injury leading to decompensation or liver failure among patients taking recommended doses. In that group, four patients with compensated cirrhosis received a liver transplant within about 1.3 years of starting therapy. One of those patients died from liver failure. Two additional deaths occurred among patients who already had decompensated cirrhosis before taking the drug. The median time to liver decompensation for compensated-cirrhosis patients was about four months, with cases appearing as early as two weeks after the first dose.

Troubling evidence continued to accumulate. On December 12, 2024, the agency published a new drug safety communication. This warning went far beyond the earlier restriction. Postmarket data revealed that severe liver injury occurred even in PBC patients who had no cirrhosis at all.

Between May 26, 2021, and September 18, 2024, the agency recorded 20 additional reports of liver transplant, transplant listing, or liver-related death in patients taking Ocaliva. Those 20 cases comprised seven liver transplants, eight evaluations or formal listings for a transplant, and six liver-related deaths.

The comparative trial data proved striking. Among study participants without cirrhosis who were considered ideal candidates for the drug, seven out of 81 Ocaliva patients required a liver transplant. Only one out of 68 placebo patients needed a transplant. In addition, four Ocaliva patients died, compared with only one death in the placebo control group. Regulators reported a hazard ratio of 4.77 for the combined endpoint of transplant or death.

Regulators responded immediately. The agency directed doctors to run frequent liver function tests, watch closely for signs of disease progression, and stop Ocaliva at the first sign of worsening function. Regulators instructed patients to seek medical care right away if they noticed a swollen belly, yellow eyes or skin, or sudden mental confusion.

The 2025 Commercial Market Removal

Clinical trials quickly ground to a halt. Following the December 2024 findings, the FDA placed a formal clinical hold on Intercept's ongoing clinical trials of obeticholic acid.

Next came an advisory committee meeting. An FDA advisory panel reviewed the complete safety record and voted 10 to 1 against Ocaliva. The committee concluded that the drug's benefit-risk profile did not support continued commercial marketing. Regulators subsequently issued a complete response letter denying full approval.

The product could not remain on pharmacy shelves. As documented in the Federal Register, the FDA formally withdrew approval for branded Ocaliva and generic obeticholic acid tablets. Commercial market removal took effect on November 14, 2025. That federal action brought an end to nine years of commercial sales in the United States.

Current Multidistrict Litigation Status

When thousands of personal injury lawsuits involve the same prescription medication, federal courts often combine them into a single multidistrict litigation (MDL). Consolidating pre-trial discovery before one federal judge saves time and resources. You can read more about how federal consolidation works in our guide to mass torts and multidistrict litigation.

No MDL exists for Ocaliva yet. As of September 2026, the Judicial Panel on Multidistrict Litigation pending-MDL list does not include an Ocaliva or obeticholic acid docket.

That absence has practical consequences. Lawsuits against Intercept are currently handled individually across various state and federal courts. Attorneys are actively investigating potential claims and filing standalone complaints. Whether the federal court system will eventually consolidate these claims into an MDL remains an open question.

You do not need to wait for an MDL to protect your rights. An attorney can evaluate your medical history and file an individual claim on your behalf right now.

Eligibility Criteria for an Ocaliva Claim

Filing an obeticholic acid claim requires clear medical proof. Legal teams looking at these cases focus on specific clinical milestones.

First, you must have a documented medical diagnosis of primary biliary cholangitis. The underlying prescription must match the drug's approved indication.

Second, your pharmacy and medical charts must establish that you took branded Ocaliva or an approved generic obeticholic acid tablet.

Third, you must have developed documented liver failure or severe liver decompensation after starting the medication. Qualifying injuries typically include sudden jaundice, ascites, acute liver failure, emergency listing on the national liver transplant registry, an actual liver transplant, or fatal liver complications.

Surviving family members may also act. If a spouse, parent, or dependent died from liver complications while taking Ocaliva, eligible relatives can pursue a wrongful death claim.

Documenting your timeline is critical. You will need pharmacy records, prescribing notes, lab results showing changes in liver enzyme levels, hospital admission summaries, and any surgical documentation related to a transplant evaluation.

Allegations and Potential Legal Compensation

Plaintiffs in these lawsuits pursue claims based on product liability. More details on these legal theories can be found in our overview of defective product claims.

The complaints center on a failure to warn. Plaintiffs allege that Intercept knew or should have known about the serious risk of liver decompensation and death. They further assert that the manufacturer failed to alert prescribing doctors and vulnerable patients in a timely manner. These assertions are legal allegations from filed complaints and ongoing investigations, not proven facts or final judicial determinations.

Financial outcomes remain unresolved. No global or aggregate settlement has been announced in the Ocaliva litigation. Furthermore, there is no confirmed, publicly disclosed settlement figure or jury verdict for any Ocaliva plaintiff as of this writing. Any website quoting a guaranteed dollar amount or average payout is speculating.

In a successful lawsuit, damages may cover past and future hospital bills, surgical costs for a liver transplant, post-transplant immunosuppressive therapy, lost earnings, and physical pain and suffering. If you lost a loved one, compensation may also address funeral costs and lost financial support.

Filing Deadlines and Time Limits

Every state enforces strict legal deadlines called statutes of limitations. If you miss your state's deadline, courts will dismiss your lawsuit regardless of how severe your injuries are.

Time limits vary state to state. Most states give injured consumers two to three years to initiate a product liability or personal injury lawsuit. Wrongful death actions frequently have shorter statutory windows, sometimes giving families only one or two years from the date of death.

Determining when the clock starts running requires careful legal analysis. In many jurisdictions, the statutory period begins on the day you were diagnosed with liver decompensation or learned of the medication's connection to your injury. In other states, different discovery rules apply.

Do not delay your review. Identifying your prescribing history and securing hospital records takes time. A licensed personal injury attorney can review your dates and ensure your complaint is submitted before deadlines expire.

Frequently Asked Questions

What is the Ocaliva lawsuit about?

The lawsuits allege that Intercept Pharmaceuticals failed to adequately warn physicians and patients about the risk of severe liver injury associated with Ocaliva. Plaintiffs claim the medication caused rapid liver decompensation, liver failure, the need for an organ transplant, or death.

Why was Ocaliva pulled from the market?

The FDA withdrew approval for Ocaliva and generic obeticholic acid after clinical data revealed a serious risk. Patients without cirrhosis had a 4.77-fold higher hazard of liver transplant or death compared with those on a placebo. An FDA advisory committee voted 10 to 1 against the drug, leading to commercial market removal in November 2025.

Is there an Ocaliva MDL?

No. As of September 2026, the Judicial Panel on Multidistrict Litigation has not created an MDL for Ocaliva lawsuits. Attorneys are filing and investigating cases individually in state and federal courts across the country.

Has anyone won or settled an Ocaliva case yet?

No global settlement has been announced. As of this writing, there are no confirmed, publicly disclosed settlement amounts or trial verdicts in the Ocaliva litigation.

Who may qualify to file an Ocaliva lawsuit?

You may qualify if you were diagnosed with primary biliary cholangitis and took Ocaliva or generic obeticholic acid. You must also have suffered a serious liver outcome afterward: acute liver failure, liver decompensation, a transplant evaluation, an actual transplant, or fatal liver injury.

What liver problems has Ocaliva been linked to?

Federal regulators linked the drug to acute liver decompensation, jaundice, ascites, rapid progression to complete liver failure, and death, even in patients who began treatment with no cirrhosis.

How long do I have to file an Ocaliva claim?

Statutes of limitations vary state to state, generally running two to three years from the date of your injury or discovery of the harm. Wrongful death deadlines may be shorter, so you should speak with an attorney promptly.