Ocaliva® Lawsuit | Ocaliva Liver Injury Lawyer, Attorney

Ocaliva was pulled off the U.S. market after multiple FDA warnings about the risk of serious liver injury and death.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Ocaliva liver injury cases in all 50 states. If you or somebody you know was diagnosed with a serious liver injury from Ocaliva, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Ocaliva Linked to Serious Liver Injury and Deaths

Ovaliva® (generic: obeticholic acid) is a prescription medicine for a rare liver disease called primary biliary cholangitis (PBC).

Ocaliva was developed by Intercept Pharmaceuticals and received fast-track approval in 2016. Less than a decade later, Intercept pulled Ocaliva off the U.S. market in 2025 after a series of FDA Safety Warnings about the risk of serious liver injury and death.

What is the Problem?

During the time Ocaliva was on the market, the FDA investigated reports of deaths and serious liver injuries. Tragically, many patients believed Ocaliva would help prevent liver damage due to PBC. Instead, they suffered from worsening liver damage, liver failure, needed a liver transplant, or died.

What is the Risk?

Ocaliva has been linked to many severe side effects, including:

Hepatic Cirrhosis
Biliary Cirrhosis
Chronic Hepatic Failure
Hepatic Failure
Drug-Induced Liver Injury
Liver Transplant
Liver Transplant Rejection
Death

Intercept Pulls Ocaliva Off U.S. Market at FDA Request

Intercept Pharmaceuticals announced the Ocaliva recall on September 11, 2025, pulling it off the market in the U.S. at the request of the FDA, which said the risk of liver injury and death outweighed any benefits from Ocaliva. The FDA also put all U.S. clinical trials involving Ocaliva on hold.

What is PBC?

Primary biliary cholangitis (PBC) is a rare, progressive liver disease that occurs when the body’s immune system damages the small bile ducts in the liver.

Over time, long-term inflammation of the bile ducts causes a buildup of bile in the liver, leading to liver damage and complications like cirrhosis and liver cancer. For unknown reasons, about 90% of patients with PBC are women, and it is most common in women over 40 years old.

Ocaliva Fast-Track Approval for PBC

Ocaliva was fast-tracked through the FDA’s accelerated approval process in May 2016, giving earlier access for patients with PBC who could not take another medication called ursodeoxycholic acid.

Unlike this other medication, Ocaliva works by activating the farnesoid X receptor (FXR), which reduces the liver’s production of bile acids, and increases their flow out of the liver.

FDA Warnings for Ocaliva Liver Injury Risks

As a condition of this fast-track approval, Intercept Pharmaceuticals was required to continue studying the safety of Ocaliva. These studies quickly uncovered evidence of life-threatening side effects in the liver, which resulted in FDA Safety Communications in September 2017 and February 2018.

In May 2021, the FDA updated the Prescribing Information for Ocaliva with a “Boxed Warning” that it should not be used in patients with advanced cirrhosis of the liver after some patients developed liver failure.

In December 2024, the FDA heightened this warning after some patients who did not have cirrhosis were diagnosed with serious liver injuries after taking Ocaliva. Some patients needed liver transplants or suffered death.

What Should Patients Do?

The FDA urged patients to contact a healthcare professional immediately if you develop symptoms of worsening liver injury:

Swollen belly
Yellow eyes or skin (jaundice)
Bloody or black stools
Coughing up or vomiting blood
Mental status changes such as confusion, slurred speech, mood swings, changes in personality, or increased sleepiness or difficulty waking up

Other General Signs & Symptoms of Liver Damage

There are also general symptoms, which may be a sign of liver damage if they are severe or do not go away after a few days:

Belly pain
Nausea, diarrhea, or vomiting
Loss of appetite or weight loss
New or worsening tiredness
Weakness
Fever and chills
Lightheadedness
Less frequent urination

Ocaliva Class Action Lawsuit

Intercept Pharmaceuticals was hit with a class action lawsuit from investors who accused the company of misleading them about Ocaliva. This lawsuit was filed after the company’s stock crashed after early studies found evidence of liver injury risks. The class action was dismissed in March 2022.

Are There Lawsuits Against Ocaliva?

Ocaliva patients who were diagnosed with serious side effects (or family members of patients who died) could be eligible to file a lawsuit.

Every case is unique, but in general, lawsuits for people who were harmed by dangerous medications will accuse pharmaceutical companies of failing to adequately warn patients and doctors about the risk of side effects. Patients claim they never would have used the medication, or been harmed by it, had they been aware of the risks.

How Can a Lawsuit Help?

If a lawsuit is successful, plaintiffs could receive a settlement or financial compensation. The payout may include compensation for the victim’s pain and suffering, medical expenses, long-term injuries, lost income or earning ability, wrongful death of a loved one, and more.

Do I Have an Ocaliva Lawsuit?

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Ocaliva Lawsuit