OCALIVA LIVER INJURY LAWSUITS

Ocaliva Liver Injury and Market Withdrawal

Levy Konigsberg is investigating legal claims against Intercept Pharmaceuticals, a subsidiary of Alfasigma headquartered in Morristown, New Jersey, following the market withdrawal of the liver disease drug Ocaliva. Originally granted accelerated approval in 2016 for the treatment of primary biliary cholangitis (PBC), Ocaliva was marketed as a second-line therapy for patients who did not respond to standard treatments. However, post-marketing data and clinical trials allegedly revealed that the medication was associated with a 377% higher risk of liver transplant or death compared to a placebo. Despite mounting evidence of rapid cirrhosis progression and acute liver failure, the manufacturer allegedly failed to provide adequate warnings to the medical community, particularly for patients without pre-existing cirrhosis. These failures led the FDA to request a voluntary withdrawal of the drug, which was officially removed from U.S. commercial shelves on November 14, 2025.

Intercept Pharmaceuticals allegedly failed to timely warn about Ocaliva liver injury risks. If you or a loved one was harmed, contact us today.

Research and Lawsuits involving Ocaliva Liver Injury

• In September 2025, Intercept Pharmaceuticals voluntarily withdrew the liver disease drug Ocaliva from the U.S. market at the request of the Food and Drug Administration (FDA) due to serious safety concerns. By November 2025, the medication was officially removed from pharmacy shelves after regulators determined that its risks, including liver failure and death, outweighed its benefits. Legal investigations into Ocaliva are now focusing on whether the manufacturer failed to adequately warn patients and doctors about these potential dangers.

The FDA has linked at least 367 deaths and over 6,600 adverse event reports to Ocaliva since its 2016 approval. In December 2024, the agency reported that the drug was associated with a 377% higher risk of liver transplant or death based on post-marketing clinical trials. Specific instances of alleged injury included patients requiring liver transplants after taking the drug, while others suffered rapid cirrhosis progression or acute liver failure. 

Further research published in September 2025 indicated that patients who did not respond biochemically to the treatment faced an increased risk of liver damage. These non-responsive patients were allegedly 20 times more likely to develop cirrhosis and twice as likely to develop jaundice compared to others. 

In 2016, Ocaliva was originally granted accelerated approval, but safety concerns led to restricted use in 2021 for patients with advanced liver cirrhosis who were developing liver failure. 

Additional post-market clinical data identified new cases of serious liver injury in patients who did not have cirrhosis. These findings revealed that the risk of death or needing a liver transplant was higher for those taking the medication than for those receiving a placebo.

Criteria for Filing an Ocaliva Liver Injury Lawsuit

At Levy Konigsberg, we are investigating claims on behalf of patients who were prescribed Ocaliva (obeticholic acid). You may qualify if you meet the following criteria:

• You were prescribed Ocaliva.
• You experienced serious liver-related complications, such as liver failure, jaundice, or the need for a liver transplant.

If you or a loved one has been affected, you may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages.

Legal Representation for involving Ocaliva Liver Injury Lawsuits

If you have suffered from liver-related complications after using Ocaliva, you are not alone. 

Levy Konigsberg’s experienced attorneys are here to help you understand your rights and guide you through the legal process.

Our firm has a strong history of successfully representing victims in mass tort and product liability cases. We work tirelessly to ensure our clients receive the compensation they deserve.

To learn more about your legal options and determine whether you qualify for a lawsuit, contact us for a free, confidential consultation. Our attorneys will review your case, explain the legal process, and answer any questions you may have.

Why Choose Levy Konigsberg?

• Experience: With decades of experience in complex litigation, our attorneys are well-equipped to handle product liability lawsuits.
• Results: We have recovered billions of dollars on behalf of our clients in mass tort and product liability cases.
• Personalized Attention: Each case is unique, and we provide personalized legal strategies tailored to our clients’ needs.

There are time limits for filing claims, so don't wait to seek legal advice.