Ocaliva Lawsuit

To qualify for an Ocaliva liver injury lawsuit, you must have experienced specific injuries after taking Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC).

We’ve provided a general example of Ocaliva lawsuit criteria. Even if you don’t think you qualify, you should contact a licensed product liability lawyer to find out about your legal options.

Each state has a statute of limitations, or a time limit, to file an Ocaliva lawsuit. Make sure to contact a lawyer to find out the time limits for your case and preserve your right to file a claim.

Ocaliva lawsuits are still in the early stages, and lawyers are investigating liver injury claims on behalf of individuals and families who lost loved ones because of Ocaliva liver injuries. There haven’t been any settlements or jury verdicts in Ocaliva litigation.

So far, there is no motion to consolidate Ocaliva lawsuits into a multidistrict litigation (MDL). However, if case numbers grow, plaintiffs’ attorneys may consider it.

The FDA withdrew Ocaliva from the market on Nov. 24, 2025, because it found the drug didn’t provide enough of a clinical benefit and too many patients suffered liver injuries. These serious injuries included liver transplants and death.  

Prior to withdrawing the drug from the market, the FDA released several liver injury warnings and made label changes from 2017 through 2024. 

Lawsuits claim that Intercept didn’t make adequate Ocaliva label changes to warn the public about serious liver injuries and that the manufacturer continued to promote the drug despite the FDA safety communications.

People harmed by Ocaliva may bring different kinds of product liability claims depending on the nature of their liver injury and what the manufacturer allegedly failed to disclose.

You may have suffered other signs or symptoms that aren’t listed here. If you are concerned about your health after taking Ocaliva, make sure to see your doctor. 

Ocaliva Liver Failure Lawsuits

Lawsuits in this group typically involve patients who were hospitalized for acute or worsening chronic liver failure after taking Ocaliva. These people often required emergency care, intensive monitoring and aggressive treatment to stabilize their condition. 

Claims may argue that the manufacturer did not adequately warn that Ocaliva could trigger serious liver injury, especially in people with underlying disease who were already vulnerable to decompensation (failing liver function).

Many of these cases also highlight long-term complications and lifestyle changes, including inability to work, lower quality of life and the emotional impact of living with progressive liver disease.

Liver Transplant and Wrongful Death Claims

More severe Ocaliva liver injury lawsuits involve patients who progressed to end-stage liver failure and needed a liver transplant after using the drug. These claims often allege catastrophic financial losses, ongoing transplant treatment, reduced life expectancy and profound impacts on daily life and family responsibilities.

Families may also pursue wrongful death lawsuits when a loved one dies from liver or transplant complications. These cases may claim loss of income, medical and funeral expenses, and the loss of companionship and support. 

Not every injury will fit neatly into “liver failure” or “transplant/wrongful death,” and anyone who believes Ocaliva harmed their liver should still speak with a lawyer to see how their specific circumstances might qualify.

Ocaliva’s safety record includes multiple liver injury communications and warnings made by the FDA since 2017. These reports all warn of serious risks of liver injury, hepatic decompensation (worsening liver function) and liver failure. 

In addition, a 2021 study in Hepatology Communications found that people with cirrhosis who took Ocaliva had a 3.9-fold increased risk of hepatic decompensation compared to people with cirrhosis who did not take Ocaliva. 

Ultimately, the FDA found the risk of liver injuries too great to keep Ocaliva on the market.

Choosing an experienced Ocaliva lawyer can make the litigation process less stressful and help protect your rights at every stage of a potential claim. Firms that routinely handle drug and device litigation understand the medical issues, the FDA regulatory background and the tactics large manufacturers use to fight these cases.

An Ocaliva lawyer can review your medical records, pharmacy history and timeline of Ocaliva use to see whether your liver problems may be linked to the drug. They will also prepare and file all legal paperwork, handle negotiations with the drug manufacturer or its insurers and take the case to trial if a fair settlement is not offered.

Many pharmaceutical injury law firms offer free case reviews, so you can find out whether you may qualify for an Ocaliva lawsuit without any upfront cost. These firms often work on a contingency fee basis, meaning you generally do not pay attorney fees unless they recover compensation through a settlement or verdict.

The information on this page is meant to be a guide, not legal advice. For help filing a claim, request a free, no-obligation case review through Consumer Notice. We’ll match you with an experienced, vetted Ocaliva lawyer.