Published by If you took Ocaliva (obeticholic acid) and later experienced worsening liver injury, transplant, or death, you could be eligible to seek compensation through a pharmaceutical liability claim.
At Schmidt & Clark, LLP, we help individuals and families harmed by dangerous drugs understand their legal rights and explore claims. Contact us today for a free, no-obligation case evaluation.
Call (866) 588-0600 or click to begin your free case review.
Table Of Contents
What’s the Problem?
Ocaliva (obeticholic acid) was developed to treat primary biliary cholangitis (PBC), but post-market data revealed that patients without cirrhosis have developed serious liver injury, including need for transplant or death. In September 2025, Intercept Pharmaceuticals announced voluntary withdrawal of Ocaliva from the U.S. market after FDA requested removal.
These developments have raised alarm among patients and healthcare professionals, and legal inquiries are underway into whether the manufacturer failed to adequately warn of risks or misrepresented the drug’s safety profile.
Latest Ocaliva Updates
- September 11, 2025 – Intercept announces the voluntary withdrawal of Ocaliva in the U.S. following FDA’s request [2]
- September 11, 2025 – News agencies report that FDA placed Intercept’s Ocaliva clinical trials on hold amid safety concerns [3]
- December 2024 – FDA issues safety communication that serious liver injury has occurred in Ocaliva users without cirrhosis, including instances of transplant and death [1]
- Earlier years – FDA had already restricted Ocaliva use in PBC patients with advanced cirrhosis due to risk of liver failure [1]
Ocaliva Usage & Market Facts
- Ocaliva was approved under accelerated pathway in 2016 for PBC patients with inadequate response to ursodeoxycholic acid.
- In 2021, FDA added a contraindication for use in patients with advanced cirrhosis. [1]
- FDA’s December 2024 review found that among non-cirrhotic patients, 7 of 81 on Ocaliva underwent liver transplant vs. 1 of 68 on placebo; 4 deaths occurred vs. 1 in placebo group. [1]
- Following the withdrawal announcement, Ocaliva will no longer be commercially available after November 14, 2025, though transitional supply may remain under FDA agreement. [4]
FDA Reports & Safety Communications
The FDA’s recent safety communication highlights previously unrecognized risk of serious liver injury in non-cirrhotic patients taking Ocaliva. The agency had earlier issued warnings in 2017 about overdose and dosing errors leading to liver dysfunction.
FDA now recommends frequent liver function monitoring and immediate discontinuation of Ocaliva upon signs of hepatic decompensation, worsening bilirubin, or liver enzyme elevations.
Injuries & Side Effects
Patients and families using Ocaliva have reported or may face:
- Acute liver injury requiring hospitalization or transplant
- Progressive liver failure in persons without prior cirrhosis
- Death linked to hepatic decompensation
- Severe symptoms: jaundice, ascites, hepatic encephalopathy
Do You Qualify for an Ocaliva Lawsuit?
- You were prescribed Ocaliva for PBC or related indication before 2025
- You developed liver injury, transplant necessity, or died after starting Ocaliva
- The injury was not solely due to underlying disease progression
- You can provide medical records, labs, transplant or death certificate, and prescription history
Evidence Required
- Medical records and laboratory tests before, during, and after Ocaliva use
- Prescription records and dosing information
- Hospital documentation, transplant records, pathology reports
- Death certificate, autopsy report (if applicable)
- Manufacturer labeling, warning documents, and FDA communications
Damages You Can Recover
- Past and future medical costs including transplant and follow-up care
- Lost wages and diminished earning capacity
- Pain, suffering, and emotional distress
- Wrongful death damages for families of deceased patients
- Punitive damages if willful misconduct is demonstrated
Market Withdrawal vs. Recall
Importantly, Ocaliva’s removal is a voluntary market withdrawal, not a recall for a manufacturing defect. The withdrawal stems from safety and regulatory concerns, not contamination or defect. Patients must work with physicians to transition to alternative therapies.
Statute of Limitations
Statutes for pharmaceutical injury claims vary by state, often ranging from two to five years from date of injury or discovery. Because liver damage may evolve over time, prompt legal consultation is essential to preserve rights.
Frequently Asked Questions
- How do I know if my liver injury was caused by Ocaliva? – A hepatologist’s opinion and timeline of onset strengthens causation analysis.
- Can I file even if I’m recovering? – Yes, as long as medical evidence supports your claim.
- Is this a class action case? – Possible, depending on how many patients come forward.
- Will attorneys take it on contingency? – Many pharmaceutical injury firms work on contingency basis.
- Does withdrawal mean the drug was faulty? – Withdrawal was based on safety signals and regulatory pressure, not defect per se.
References
- https://www.fda.gov/drugs/drug-safety-and-availability/serious-liver-injury-being-observed-patients-without-cirrhosis-taking-ocaliva-obeticholic-acid-treat
- https://www.webmd.com/drugs/updates/ocaliva-pulled-us-market
- https://www.reuters.com/business/healthcare-pharmaceuticals/intercept-pharma-pulls-liver-disease-drug-us-after-regulators-request-2025-09-11/
- https://www.interceptpharma.com/about-us/ocaliva-withdrawal-faq/
- https://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-serious-liver-injury