Ocaliva Liver Injury Lawsuit Lawyer

The defective drug attorneys at Buckfire Law represent individuals and families nationwide affected by serious liver injuries linked to Ocaliva (obeticholic acid).

Ocaliva is a prescription medication used to treat a rare liver disease called primary biliary cholangitis (PBC). While intended to improve liver function, the drug has been linked to severe liver injury, liver failure, transplant, and death in some patients.

The U.S. Food and Drug Administration has issued multiple safety warnings about Ocaliva, including findings that even properly selected patients may face an increased risk of serious liver damage.

• What Is Ocaliva Used For?
• What Injuries Are Linked to Ocaliva?
• What Are the Warning Signs of Liver Injury?
• Contact an Ocaliva Lawsuit Attorney for a Free Case Review

What Is Ocaliva Used For?

Ocaliva was approved in 2016 under an accelerated approval pathway to treat primary biliary cholangitis, a chronic liver disease that damages bile ducts.

However, post-market studies and adverse event reports revealed serious safety concerns, including:

• Severe liver injury in patients with and without cirrhosis
• Increased risk of liver transplant
• Increased risk of death

FDA analysis found that patients taking Ocaliva had a higher rate of liver transplant and death compared to placebo in clinical data.

Due to these risks:

• The FDA restricted its use in certain patients in 2021
• Additional warnings were issued in 2024 for patients without cirrhosis
• The drug was voluntarily withdrawn from the U.S. market in 2025

Lawsuits allege that the manufacturer failed to adequately warn about these serious risks.

What Injuries Are Linked to Ocaliva?

Ocaliva has been associated with significant liver-related complications, including life-threatening conditions.

Reported injuries include:

• Severe liver injury or liver damage
• Liver failure or hepatic decompensation
• Need for liver transplant
• Worsening of existing liver disease
• Death

FDA safety data identified multiple cases where patients experienced liver failure and required transplant, and others who died after taking the drug.

Even patients without advanced liver disease have developed serious complications.

What Is Primary Biliary Cholangitis (PBC)?

Primary biliary cholangitis (PBC) is a chronic autoimmune disease that slowly destroys the bile ducts in the liver.

Over time, PBC can lead to:

• Liver scarring (cirrhosis)
• Liver failure
• Increased risk of liver cancer

Ocaliva was prescribed to help manage this condition, but safety concerns have raised questions about whether its risks outweigh its benefits.

Who Is at Risk?

Patients taking Ocaliva for PBC may be at risk of liver injury, including:

• Patients with advanced cirrhosis (highest risk)
• Patients without cirrhosis who were considered appropriate candidates
• Patients taking the drug at standard or adjusted doses

FDA findings show that serious liver injury can occur even in patients without prior advanced liver disease.

What Are the Warning Signs of Liver Injury?

Patients taking Ocaliva should be aware of symptoms that may indicate liver damage.

Warning signs include:

• Yellowing of the skin or eyes (jaundice)
• Severe fatigue
• Abdominal pain or swelling
• Nausea or vomiting
• Dark urine
• Confusion or mental changes

The FDA recommends frequent monitoring of liver function to detect problems early.

What Should Current Ocaliva Patients Do?

If you took Ocaliva and are experiencing symptoms of liver injury, you should:

• Seek immediate medical attention
• Request liver function testing
• Obtain copies of your medical records
• Ask your doctor about alternative treatments

Prompt evaluation is critical to preventing further liver damage.

Do I Qualify to File an Ocaliva Lawsuit?

You may qualify to file a lawsuit if:

• You were prescribed Ocaliva
• You developed liver injury, liver failure, or required a transplant
• A loved one died after taking the medication

Even if you are unsure whether Ocaliva caused your injury, a legal review can help determine your eligibility.

Compensation Available in an Ocaliva Lawsuit

Patients and families affected by Ocaliva may be eligible to recover compensation for:

• Medical expenses, including hospitalization or transplant
• Lost wages or reduced earning capacity
• Pain and suffering
• Long-term disability
• Wrongful death damages

Settlement amounts depend on the severity of the injury and its long-term impact.

Contact an Ocaliva Lawsuit Attorney for a Free Case Review

If you or a loved one suffered liver injury after taking Ocaliva, Buckfire Law can help. Contact us today for your free case review. We provide a free, no-obligation case review. If you qualify for a claim, we will file your lawsuit with no upfront legal fees or costs, and we will only receive a fee if you win a settlement! 

Legally reviewed by:

Lawrence J. Buckfire, J.D., Lead Trial Attorney at Buckfire Law
Lawrence J. Buckfire, J.D. has over 30 years of experience specializing in personal injury and wrongful death cases. He earned his undergraduate degree from the University of Michigan and attended Wayne State University School of Law. Lawrence has been named a Super Lawyer, U.S. News Best Lawyer, and in The National Trial Lawyers-Top 100 Trial Lawyers.
Date of Review: May, 2026