Weitz & Luxenberg is pursuing cases of significant liver injury in people who took Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC), an autoimmune condition that causes gradual destruction of the bile ducts in the liver. Following a request from the U.S. Food and Drug Administration (FDA), the manufacturer Intercept Pharmaceuticals withdrew Ocaliva from the U.S. market for the treatment of PBC on November 14, 2025. (1)
Almost a year prior to the recall, the FDA advised doctors prescribing Ocaliva to their patients to “monitor liver tests often for early identification of worsening liver function.” (2)
Notably, on August 30, 2024, the European Commission removed the marketing authorization for the Ocaliva but its withdrawal in the United States did not happen until more than a year later. (3)
If you, or a loved one, used Ocaliva to treat PBC and developed liver injury, liver failure, and/or suffered a liver transplant or related death, we encourage your family to reach out to us right away. We can help you evaluate your legal options. You may be able to file a lawsuit seeking financial compensation.
“The FDA delayed request for withdrawal of Ocaliva should be concerning to all of us,” says Ellen Relkin, W&L partner and practice group chair of our Drug and Medical Device Litigation unit. “Frequently, we see the European regulators and scientific community employing a more proactive approach to medication safety.”
She continues, “When you are prescribed a medication for what is otherwise a manageable medical condition — and then develop severe liver injury — it is alarming. Deaths have been reported as being due to Ocaliva. We need to take a good, hard look at some of these medications for which the FDA is accelerating its approval process.”
FDA Concerned About Ocaliva and Liver Injury
The FDA identified instances where people developed serious liver injury after taking Ocaliva for PBC. These patients did not have cirrhosis of the liver prior to taking Ocaliva. (4)
When researchers first tested Ocaliva, they noted a decrease in alkaline phosphatase (ALP). At first, the report looked like good news. The FDA accelerated Ocaliva’s approval, and granted agency approval in 2016. (5)
Patient Risk Increases for Liver Transplants and Death
Since then, the FDA required a postmarket clinical trial to ensure Ocaliva offered a benefit to patients. In that study, the FDA noted a risk of “both liver transplant and death” in patients taking Ocaliva. These patients had been evaluated prior to receiving treatment. It was thought their health was good enough that they would be less likely than other patients to develop liver injury. (6)
However, 7 out of 81 patients who received Ocaliva in this clinical trial ultimately needed a liver transplant. In addition, 4 patients who received the Ocaliva treatment died. (7)
The FDA alerted health care professionals and patients about this new safety advisory and stressed that doctors should monitor any of their patients who took Ocaliva to check for signs of worsening liver function. (8)
Signs of Possible Ocaliva Liver Injury
Patients who took Ocaliva should contact their health care providers immediately if they developed any of these symptoms indicating possible worsening liver injury: (9)
- Swollen belly.
- Yellow eyes or skin.
- Bloody or black stools.
- Coughing up or vomiting blood.
- Mental status changes — such as confusion, slurred speech, mood swings, changes in personality, and increased sleepiness or difficulty waking up.
Also, patients who took Ocaliva should alert their doctors if any of these more general symptoms occurred, particularly if they are severe or do not stop after a few days: (10)
- Belly pain.
- Nausea, vomiting, or diarrhea.
- Loss of appetite or weight loss.
- New or worsening tiredness.
- Weakness.
- Fever and chills.
- Lightheadedness.
- Less frequent urination.
Weitz & Luxenberg Takes Action in Liver Injury Cases
W&L attorneys are investigating cases of people injured by Ocaliva. We encourage you to reach out to us if you used Ocaliva and developed significant liver injury.
You may be able to seek financial compensation from the manufacturer. Weitz & Luxenberg can pursue compensation on your behalf if you were diagnosed with severe liver injury after using Ocaliva to treat PBC.
Feel welcome to contact us by calling (917) LAWYERS or filling out the form on this page.
At W&L, our team of defective drug attorneys are prepared to go up against large national pharmaceutical companies. We can help you consider your legal options. We offer guidance throughout the litigation process — each and every step of the way.
Reach Out to W&L for Help If You Were Injured by Ocaliva
We are prepared to file a lawsuit on your behalf. Our goal: to make sure you receive the compensation you are due for your pain and suffering.
For nearly 40 years, Weitz & Luxenberg continues to demonstrate a strong history of winning and notable success. On behalf of our clients, we have secured more than $26 billion. Over the years, we have represented other clients who developed liver failure as a result of other medications, including Rezulin and Tylenol, as well as certain over-the-counter dietary supplements.
We made it our mission to help people suffer significant harm due to the negligent actions and inactions of large corporations nationwide. Call, so we can help you.
