Ocaliva Lawsuit | Liver Injury, Liver Failure & Wrongful Death Claims

Legal Help for Patients Harmed by Ocaliva (Obeticholic Acid)

Salenger, Sack, Kimmel & Bavaro is investigating Ocaliva liver injury lawsuits on behalf of patients who suffered severe complications after using the drug to treat primary biliary cholangitis (PBC). If you or a loved one experienced liver damage, liver failure, a liver transplant, or a related death after taking Ocaliva, you may qualify for financial compensation.

Ocaliva — manufactured by Intercept Pharmaceuticals — was withdrawn from the U.S. market on November 14, 2025, following an FDA request due to growing concerns about the drug’s connection to serious liver injury.

What Is Ocaliva?

Ocaliva (obeticholic acid) is a prescription medication used to treat primary biliary cholangitis, an autoimmune disease that gradually damages the bile ducts in the liver. Many patients took Ocaliva believing it would help manage a chronic condition. Instead, some suffered life-threatening liver complications they were never adequately warned about.

Why Was Ocaliva Recalled?

The U.S. Food and Drug Administration asked Intercept Pharmaceuticals to withdraw Ocaliva from the U.S. market after mounting evidence showed the medication could cause serious liver injury — even in patients who did not have cirrhosis before starting treatment.

Key timeline:

• 2016 – The FDA grants accelerated approval based on early data showing reduced ALP levels.
  
• August 30, 2024 – The European Commission removes marketing authorization for Ocaliva.
  
• Almost a year later (Nov. 14, 2025) – The FDA requests full U.S. withdrawal of Ocaliva for PBC.
  
• Before the recall – The FDA warns doctors to “monitor liver tests often for early identification of worsening liver function.”

Patients continued using Ocaliva in the United States for more than a year after Europe had already removed it from the market.

FDA Safety Concerns: Liver Transplants & Deaths Reported

Post-approval safety data raised significant red flags:

• The FDA’s required clinical trial found increased risks of liver transplant and death among Ocaliva users — even in patients deemed healthy enough for treatment.
• 7 out of 81 patients treated with Ocaliva in a key study required liver transplants.
• 4 Ocaliva patients died during the same trial.

These alarming outcomes occurred despite early testing suggesting the medication was safe for use.

Contact Us Today for a FREE Consultation

If you or a loved one has experienced health complications due to Ocaliva, don’t wait to seek legal help.

Contact Salenger, Sack, Kimmel & Bavaro today for a FREE consultation.

Call (800) 675-8556 or contact us online to get started. 

Symptoms of Potential Ocaliva Liver Injury

Patients taking Ocaliva should seek immediate medical attention if they experienced symptoms such as:

Signs of severe liver damage:

• Yellowing of the skin or eyes
• Swollen abdomen
• Black or bloody stools
• Vomiting or coughing up blood
• Confusion, slurred speech, or personality changes
  

General symptoms that may indicate worsening liver function:

• Persistent nausea, vomiting, or diarrhea
• Abdominal pain
• Loss of appetite or weight loss
• Fever or chills
• Extreme fatigue or weakness
• Lightheadedness
• Reduced urination
  

Any of these symptoms may indicate serious complications linked to Ocaliva use.

Do You Qualify for an Ocaliva Lawsuit?

You may be eligible to file an Ocaliva lawsuit if you or a family member:

• Took Ocaliva (obeticholic acid) for primary biliary cholangitis
• Developed significant liver injury, liver failure, or required a liver transplant
• Lost a loved one due to complications associated with Ocaliva

Our attorneys can review your medical history, prescriptions, and injury documentation to determine your eligibility for compensation related to:

• Medical expenses
• Lost income
• Pain and suffering
• Funeral costs (in wrongful death claims)

SSKB Advocates for Patients Harmed by Dangerous Drugs

Our defective drug attorneys are committed to holding large pharmaceutical companies accountable when their products endanger patients. We understand the devastating impact of severe liver injury, and we work hard to ensure injured individuals and families get the justice they deserve.

SSKB has extensive experience in:

• Complex drug and medical device litigation
• Evaluating medical records and FDA safety data
• Pursuing claims against national drug manufacturers

If you or a loved one was harmed by Ocaliva, we are prepared to take action on your behalf.

Contact SSKB for an Ocaliva Case Review

If you used Ocaliva and developed liver injury or related complications, now is the time to explore your legal options. You may be entitled to significant financial compensation.

Call us today for a free, confidential case evaluation or submit our secure online form to get started.