If you or a loved one suffered from liver injury or complications (such as liver failure, cirrhosis, liver transplant, hospitalization or death) after taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC), you may be entitled to recover compensation from an Ocaliva liver injury lawsuit case or settlement claim.
A team of drug injury lawyers and class action attorneys is investigating potential Ocaliva liver injury lawsuit and settlement cases of individuals who suffered from liver injury or complications (such as liver failure, cirrhosis, liver transplant, hospitalization or death) after taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC).
Ocaliva (obeticholic acid) is prescription medication (a farnesoid X receptor FXR agonist) that was used to treat primary biliary cholangitis (PBC), an autoimmune liver condition. PBC can cause bile acid to accumulate in the liver, leading to inflammation and scarring (fibrosis), which, if not treated, can result in liver failure, cirrhosis, liver transplant, or death.
Unfortunately, in December of 2024 the FDA issued a drug safety communication warning that it had identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. Specifically, the FDA found that the patients studied who received Ocaliva were 3.77 times more likely than placebo patients to need a liver transplant or die from liver injury. Following an FDA request, Intercept Pharmaceuticals (the maker of Ocaliva) announced that Ocaliva was being officially withdrawn from the U.S. market on November 14, 2025.
Primary biliary cholangitis affects about 105,500 adults in the U.S., about 90% of whom are women. Thousands of those suffering from PBC may have been prescribed and taken Ocaliva (obeticholic acid).
Patients who suffered liver damage (and families of patients who died) after using Ocaliva are now coming forward and filing injury lawsuits seeking compensation and justice for the harm they may have suffered.
Ocaliva Liver Injury Lawsuit: Overview
- What Is Ocaliva (Obeticholic Acid)?
- Who May Qualify For an Ocaliva Lawsuit or Settlement?
- Was Ocaliva Withdrawn From the Market Due To Liver Injury?
- What Is The Ocaliva Liver Injury Lawsuit About?
- Has Ocaliva Been Linked To Liver Injury?
- What Are Possible Signs of Drug-Induced Liver Injury?
- Are There Medical Treatments for Liver Injury?
- Can Compensation Be Recovered From An Ocaliva Lawsuit?
- Is There A Time Limit To Filing an Ocaliva Liver Injury Lawsuit?
- Request A Free Case Review From An Ocaliva Injury Lawyer
Ocaliva Liver Injury Lawsuit & Settlement Cases
Ocaliva liver injury lawsuit and settlement cases potentially being investigated include claims involving individuals who, after taking Ocaliva (obeticholic acid), suffered liver injury, including:
- Liver failure
- Liver decompensation
- Cirrhosis of the liver
- Hepatic cirrhosis
- Biliary cirrhosis
- Chronic hepatic failure
- Hepatic failure
- Drug-induced liver injury
- Liver transplant needed
- Received liver transplant
- Jaundice
- Bleeding disorders
- Coma
- Seizures
- Fluid buildup
- Liver cancer
- Hospitalization
- Death
- Other Ocaliva liver injury
If you or someone you love suffered from a liver injury after using Ocaliva, you may be eligible to recover compensation from an Ocaliva liver injury lawsuit case or settlement claim.
Ocaliva Injury Lawsuit Complaints
Plaintiffs who file Ocaliva lawsuits may allege, among other things, that they were not adequately warned about the risk of serious liver injury, including liver failure, transplant, or death.
The Ocaliva lawsuit complaints may assert claims for, among other things, negligence, negligent failure to warn and design defect, strict liability (failure to warn and design defect), negligent misrepresentation fraudulent misrepresentation, and breach of warranty (express and implied).
Plaintiffs in Ocaliva lawsuits may seek to recover compensatory damages (including compensation for physical pain, mental suffering, inconvenience, loss of the enjoyment of life, expenses, incidental past and future expenses, medical expenses, and loss of earnings and earning capacity), punitive damages, and/or attorneys’ fees and costs, among others.
Studies Linking Ocaliva Use to Liver Injury
Researchers and regulatory agencies have identified cases of serious liver injury associated with the use of Ocaliva (obeticholic acid) in patients treated for primary biliary cholangitis (PBC). In a December 2024 safety communication, the FDA reported that post-market clinical trial data revealed occurrences of serious liver injury (including cases leading to liver transplant) even in patients without advanced cirrhosis who were treated with Ocaliva.
Earlier safety reviews by the FDA had already revealed risks of serious liver injury in PBC patients with advanced cirrhosis taking Ocaliva. In 2021, the agency restricted its use in this patient group due to reports of liver failure and decompensation, including cases that required liver transplantation. These adverse events were identified in both compensated and decompensated cirrhosis and appeared even when patients were taking the drug at recommended dosages.
In addition to regulatory analyses, some observational and clinical research has raised concerns about the safety profile of Ocaliva at higher doses or in certain patient subgroups. For example, clinical reviews and pooled analyses have noted increased adverse event rates and discontinuations with higher doses of obeticholic acid in trials, suggesting that side effects (including liver-related issues) may be dose-dependent and contribute to safety concerns.
Other individual studies have suggested that exposure to Ocaliva in patients with PBC cirrhosis may be associated with an increased risk of hepatic decompensation compared with similar patients not treated with the drug. In one study, obeticholic acid exposure in cirrhotic patients was linked to nearly a 4-fold higher risk of hepatic decompensation.
Signs Of Possible Ocaliva Liver Injury
Signs and symptoms of possible Ocaliva liver injury can include:
- Swollen belly
- Yellow eyes or skin
- Jaundice
- Hepatic encephalopathy
- Ascites (buildup of fluid in liver)
- Portal hypertension
- Bloody or black stools
- Coughing up or vomiting blood
- Mental status changes
- Confusion
- Slurred speech
- Mood swings
- Changes in personality
- Increased sleepiness
- Difficulty waking up
- Belly pain
- Nausea
- Vomiting
- Diarrhea
- Loss of appetite
- Weight loss
- New or worsening tiredness
- Weakness
- Fever and chills
- Lightheadedness
- Less frequent urination
- Other liver injury symptoms or signs
Procedures and tests used by hepatologists, gastroenterologists and other physicians to diagnose liver injury can include, among others, a patient history, physical examination, blood tests to evaluate liver enzymes and function, liver biopsy, FibroScan (transient elastography to detect fibrosis or cirrhosis and monitor progression of chronic liver disease) and imaging studies such as ultrasound, CT, or MRI.
Medical Treatment For Liver Injury
Drug-induced liver injury is mainly treated by stopping the medicine that may have caused the problem, since continued exposure can worsen hepatotoxicity. This is the most important step. Once the offending drug is removed, the liver often begins to heal on its own. Doctors may also review medications and supplements to make sure nothing else is adding stress to the liver.
Once the medication is stopped, clinicians usually monitor liver enzymes, bilirubin, INR, and symptoms closely to determine whether the injury is stabilizing or progressing. Early recognition and cessation greatly improve the chances of recovery.
Medical treatment after discontinuation focuses on maintaining adequate hydration, controlling nausea or abdominal discomfort, treating pruritus caused by cholestasis, and carefully monitoring for signs of worsening hepatic function (such as rising bilirubin, coagulopathy, ascites, or confusion).
In addition, clinicians often continue or optimize ursodeoxycholic acid (UDCA) therapy, since it is the standard treatment for primary biliary cholangitis and can support bile flow, although it does not directly reverse drug-induced liver injury.
In cases of severe or rapidly progressive liver dysfunction, additional interventions may be necessary. N-acetylcysteine (NAC) can be used in acute liver failure of non-acetaminophen causes and may provide benefit in severe drug-induced injury by improving antioxidant capacity and supporting hepatocyte recovery. If the pattern of injury resembles an autoimmune response (characterized by marked inflammation or autoimmune markers) clinicians may consider a trial of corticosteroids. Severe complications such as coagulopathy, hepatic encephalopathy, or worsening jaundice require management in a hospital setting with possible transfer to a liver transplant center.
Compensation For Ocaliva Liver Injury Claims
Plaintiffs who bring Ocaliva lawsuits may be able to recover compensation for injuries they suffered, including money damages for:
- Physical Pain and Suffering: Individuals who experienced liver injury after taking Ocaliva may endure significant physical pain and suffering as a direct result of their condition. Liver damage can cause persistent abdominal pain, swelling, nausea, vomiting, fatigue, jaundice, and other uncomfortable or debilitating symptoms that interfere with a person’s daily functioning. Many patients also undergo painful medical procedures, repeated blood draws, biopsies, imaging studies, and in severe cases, interventions related to liver failure or transplant evaluation. This ongoing physical discomfort can affect sleep, mobility, appetite, and overall stamina, leaving individuals in constant or recurring distress. Compensation for physical pain and suffering acknowledges the real, measurable, and often long-lasting bodily harm caused by the injury.
- Mental Anguish/Emotional Distress: In addition to physical harm, individuals who suffered liver injury after taking Ocaliva may also experience profound mental anguish and emotional distress. The uncertainty surrounding their diagnosis, the fear of worsening liver damage, and the possibility of needing invasive procedures or even a transplant can create significant psychological strain. Many patients struggle with anxiety, depression, irritability, or constant worry about their health and future. The disruption to daily life, limitations on normal activities, and the stress of ongoing medical monitoring can further intensify emotional suffering. Compensation for mental anguish and emotional distress recognizes the deep psychological impact that accompanies serious liver injury and the lasting burden it may impose on patients and their families.
- Medical Care Expenses: Individuals who suffered liver injury after taking Ocaliva may incur substantial medical care expenses as they work to diagnose, manage, and treat their condition. These costs can include hospitalizations, emergency room visits, specialist consultations, diagnostic testing, imaging studies, laboratory work, and prescription medications. Patients may also require ongoing monitoring of liver function, follow-up appointments, and in more serious cases, procedures related to liver failure or transplant evaluation. The financial burden can grow significantly over time, especially for those who need long-term treatment or supportive care. Compensation for medical care expenses is intended to reimburse individuals for their past costs and reasonably anticipated future expenses associated with managing the effects of liver injury.
- Lost Income or Earnings: Individuals who experienced liver injury after taking Ocaliva may also face significant lost income and diminished earning capacity as a result of their condition. Liver-related symptoms such as fatigue, weakness, pain, and medical complications can make it difficult or impossible to maintain regular employment. Many patients require time away from work for doctor visits, diagnostic tests, treatment, and recovery, leading to lost wages in the short term. In more severe cases, ongoing health issues or permanent liver damage may limit the types of jobs a person can perform or reduce their ability to work full-time, affecting their future earning potential. Compensation for lost income and earning capacity is intended to address financial disruption caused by the injury and the long-term economic impact on a person’s career and livelihood.
- Lost Quality or Enjoyment of Life: Individuals who experienced liver injury after taking Ocaliva may also suffer a significant loss of quality or enjoyment of life. Persistent symptoms such as fatigue, weakness, pain, and digestive discomfort can limit a person’s ability to participate in everyday activities, hobbies, and social events that once brought them joy. Physical restrictions, reduced stamina, and the need for ongoing medical monitoring can interfere with travel, exercise, family responsibilities, and personal goals. Many individuals find themselves unable to engage fully in the routines and experiences that define their normal life. Compensation for loss of quality or enjoyment of life acknowledges the profound disruption caused by liver injury and the ways in which it diminishes a person’s ability to live comfortably, independently, and meaningfully.
- Punitive Damages: In some Ocaliva lawsuit cases, plaintiffs may also pursue punitive damages, which are intended to punish the defendant for reckless or egregious conduct. Punitive damages may be awarded when there is evidence suggesting that a manufacturer acted with willful disregard for patient safety (for example, by failing to disclose known risks, delaying necessary label changes, minimizing reports of serious liver injury, or continuing to market a drug despite clear warning signs of harm). These damages serve as a deterrent, signaling that companies must prioritize safety and transparency in the development and monitoring of prescription medications.
- Wrongful Death Damages: In the most tragic cases, liver injury linked to Ocaliva may result in a patient’s death, giving rise to a wrongful death claim on behalf of surviving family members. Wrongful death damages are intended to compensate loved ones for the losses they suffer when a drug-related injury leads to the death of a spouse, parent, or child. These damages may cover funeral and burial expenses, the loss of the decedent’s financial support and services, and the value of the companionship, guidance, and care that the individual can no longer provide. Family members may seek compensation for the emotional pain and grief caused by the loss.
Time Is Limited To File A Ocaliva Liver Injury Lawsuit
Deadlines called statutes of limitation and statutes of repose may limit the time that individuals have to file an Ocaliva lawsuit to try to recover compensation for injuries they claim to have suffered (e.g., complications relating to liver damage) after using Ocaliva.
This means that if an Ocaliva lawsuit claim is not filed before the applicable deadline or limitations period, the injured party may be barred from ever pursuing litigation or taking legal action regarding their Ocaliva injury claim. That is why it is important to connect with an Ocaliva injury lawyer or attorney as soon as possible.
If you or a loved one have suffered from a liver injury after using Ocaliva, you may be entitled to recover compensation from an Ocaliva liver injury lawsuit case or settlement claim. Contact a drug injury lawyer to request a free case review.
*If you or a loved one are experiencing health issues, side effects or complications after taking a prescription drug or medication, we urge you to promptly consult with your doctor or physician for an evaluation.
**The listing of a company (e.g., Intercept Pharmaceuticals, Inc.) or product (e.g., Ocaliva) is not meant to state or imply that the company acted illegally or improperly or that the product is unsafe or defective; rather only that an investigation may be, is or was being conducted to determine whether legal rights have been violated.
***The use of any trademarks, tradenames or service marks is solely for product identification and/or informational purposes.
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