Ocaliva Liver Injury Lawsuit Overview

Ocaliva lawsuits are being reviewed for former users who suffered liver failure, cirrhosis progression, transplant, or death, with allegations indicating that Intercept Pharmaceuticals failed to provide adequate warnings about dosing risks and liver injury hazards associated with the drug.

Ocaliva (obeticholic acid) is an FXR agonist approved through the FDA’s accelerated approval pathway in 2006, for treatment of primary biliary cholangitis (PBC) in patients who did not respond to ursodiol. It was marketed as a therapy intended to slow bile duct damage and delay liver progression, becoming a commonly prescribed option for PBC patients.

However, soon after its approval, postmarketing safety data began documenting cases of liver decompensation, hospitalization, and fatal injury, particularly among individuals with underlying cirrhosis or reduced liver function. In December 2024, the FDA issued a safety communication warning that Ocaliva users faced a 377% higher risk of liver transplant or death compared to placebo.

Following this discovery, the FDA requested a market withdrawal of Ocaliva in early 2025, after determining the medication carried an unacceptable risk of liver failure, transplant, and death. Intercept Pharmaceuticals complied with the request and issued an Ocaliva recall from the U.S. market in September 2025.

Lawsuit investigations now claim Intercept withheld critical risk information, delayed safety communications, and failed to instruct physicians to discontinue the drug in high-risk cases, leaving patients exposed to preventable liver injury and death.

Who Qualifies for an Ocaliva Lawsuit?

Individuals may qualify for an Ocaliva lawsuit if they were prescribed Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC) and:

• Experienced liver failure or liver decompensation after starting Ocaliva
• Suffered rapid progression of cirrhosis while on the medication
• Were hospitalized for liver-related complications, including ascites, jaundice, or portal hypertension
• Were evaluated for or placed on a liver transplant list
• Underwent a liver transplant after Ocaliva use
• Died due to liver injury or complications linked to Ocaliva

If you or a family member suffered one of these Ocaliva side effects or injuries, you may be eligible to pursue financial compensation. Free case reviews are available, and there are no legal fees unless a recovery is obtained.

2025 Ocaliva Lawsuit Investigation Updates

• October 14, 2025 Update: A new study published just weeks after the Ocaliva recall confirms that patients who showed little or no treatment response were significantly more likely to suffer liver failure and cirrhosis progression. Researchers found these non-responders faced more than a fourfold increase in serious liver-related events, raising further concerns that the drug may have caused harm without providing meaningful benefit.
• September 11, 2025: Following a formal request from the FDA to remove the drug from the market, Intercept Pharmaceuticals initiated the recall of Ocaliva from U.S. distribution and all ongoing clinical trials involving obeticholic acid were placed on hold.
• December 12, 2024: The FDA issued a safety communication reporting that Ocaliva users had a 377% higher risk of liver transplant or death compared to placebo, even in patients without obvious signs of advanced cirrhosis.
• May 26, 2021: The FDA updated the prescribing information with a formal contraindication, stating that Ocaliva should not be used in patients with advanced cirrhosis or signs of liver decompensation after documenting 25 cases of severe liver injury including transplant and fatal outcomes.
• February 1, 2018: The FDA added a Black Box Warning to Ocaliva’s label after confirming at least 19 deaths and multiple hospitalizations caused by incorrect daily dosing in patients with liver impairment.
• September 21, 2017: The FDA issued its first safety alert warning that Ocaliva could cause liver failure in PBC patients receiving standard doses despite underlying cirrhosis, marking the first regulatory concern over prescribing safety.

About Ocaliva (obeticholic acid)

Ocaliva (obeticholic acid) was introduced by Intercept Pharmaceuticals in 2016 under the FDA’s accelerated approval pathway for adults with primary biliary cholangitis (PBC) who did not respond to ursodiol. The drug was marketed as a disease-modifying therapy meant to reduce bile buildup and slow liver scarring, with the goal of delaying cirrhosis and transplant progression.

Ocaliva works by activating FXR receptors in the liver to regulate bile acid flow and reduce inflammation in damaged and inflamed bile ducts.

However, after approval, a growing number of Ocaliva users reported worsening liver function, rapid decompensation, and in some cases, liver failure requiring hospitalization or transplant. These outcomes raised concern that, instead of preventing disease progression, Ocaliva may have accelerated liver damage in patients with existing cirrhosis or reduced hepatic reserve.

Ocaliva Side Effects Worsen Liver Damage​

Ocaliva is designed to activate farnesoid X receptors (FXR) in the liver to reduce bile acid production and improve bile flow. These receptors act like control switches, signaling the liver to ease bile pressure and reduce inflammation in the bile ducts.

This mechanism may benefit some patients, but in those with existing liver damage or cirrhosis, forcing this pathway can strain an already compromised liver. When the liver cannot properly process or clear Ocaliva, FXR activation may:

• Disrupt normal bile acid signaling
• Increase cellular stress in scarred liver tissue
• Cause bile to back up rather than flow correctly
• Trigger inflammation and fluid buildup
• Accelerate the shift from stable disease to decompensation

This is why some patients experienced sudden liver failure shortly after starting Ocaliva or after a dosage increase, even when taken exactly as prescribed.

Ocaliva and Liver Cirrhosis

Cirrhosis occurs when long-term inflammation and bile buildup cause the liver to form scar tissue. In early or compensated cirrhosis, the liver is damaged but still able to function. Once the liver loses that ability, it enters decompensated cirrhosis, a serious stage marked by fluid retention, jaundice, internal bleeding, and transplant risk.

Ocaliva was intended to reduce bile acid stress, but in patients with existing scarring, the liver may be too weak to handle the drug’s FXR activation. Instead of improving bile flow, Ocaliva can:

• Force bile regulation pathways that the liver can’t keep up with
• Increase bile pressure in blocked or narrowed ducts
• Push scarred tissue into metabolic stress, triggering fluid buildup and jaundice
• Cause a sudden shift from compensated to decompensated cirrhosis

Many Ocaliva users who were previously told their cirrhosis was “stable” experienced rapid decline after starting or increasing the medication, which is now a central issue in liver failure lawsuits.

Symptoms of Ocaliva Liver Injuries

According to FDA reports, many Ocaliva users showed a sudden shift from stable PBC to acute liver decline, often following a dose increase or continued use despite early warning signs:

• Early fatigue and itching: Skin irritation and tiredness that appeared worse than typical PBC symptoms
• Rising bilirubin and jaundice: Yellowing of the eyes or skin and lab values showing elevated bilirubin
• Abdominal swelling and fluid retention: Rapid development of ascites or bloating that progressed faster than expected
• Sudden liver stress signs: Dark urine, pale stool, or unexplained weight gain from trapped fluid
• Portal hypertension symptoms: Bloating, pressure in abdominal veins, or warning signs of internal bleeding
• Cognitive and mental decline: Confusion, brain fog, or personality changes linked to hepatic encephalopathy
• Emergency hospitalization: Rapid deterioration requiring immediate medical intervention
• Transplant evaluation: Fast progression to transplant consideration, sometimes within weeks

This pattern is now being cited in Ocaliva lawsuit allegations, which claim Intercept Pharmaceuticals failed to warn doctors that the drug could trigger sudden hepatic decline in at-risk patients.

Ocaliva Regulatory Action Timeline

After Ocaliva entered the market, regulators began tracking an unusual pattern of liver complications that differed from the typical progression of primary biliary cholangitis. Instead of reporting gradual disease advancement, many patients experienced sudden declines shortly after starting treatment.

This triggered increasing scrutiny from the FDA, which responded with a series of escalating safety actions over the years, each acknowledging a deeper concern about the drug’s risk profile.

Initial FDA Safety Alert on Liver Failure Risks (2017)

Shortly after Ocaliva entered the market, the FDA issued a Drug Safety Communication warning that liver failure and death had been reported in PBC patients taking the drug at standard dosing levels. At the time, dosing adjustments for cirrhotic patients were not clearly emphasized in prescribing materials.

Key concerns noted by the agency included:

• Reports of serious liver injury and death in PBC patients with cirrhosis
• Standard dosing was being used in patients with impaired liver function
• FDA advised dose reduction, but no boxed warning or contraindication was required yet

The agency warned doctors to closely monitor liver status and bilirubin levels, but Ocaliva remained widely prescribed without mandatory restrictions.

Boxed Warning Added After 19 Confirmed Deaths (2018)

In February 2018, the FDA issued an Ocaliva Boxed Warning after confirming the drug was being incorrectly prescribed daily instead of weekly in patients with moderate to severe liver impairment (Child-Pugh B and C).

The agency reported that this dosing mistake led to cases of liver decompensation, liver failure, and death, prompting an emergency label update. The FDA’s revised label and safety communication instructed doctors to:

• Calculate Child-Pugh classification before prescribing
• Reduce dosing to once weekly for patients with liver impairment
• Stop Ocaliva immediately if signs of liver worsening appear
• Educate patients and caregivers to monitor for abdominal swelling, jaundice, cognitive changes, or gastrointestinal bleeding

The agency stated directly that dosing higher than recommended can increase the risk for liver failure and death and required Intercept to provide a Medication Guide warning patients about dosing and monitoring obligations.

FDA Issues Contraindication for Advanced Cirrhosis (2021)

In May 2021, the FDA issued a stronger regulatory action by adding a formal contraindication, stating that Ocaliva should not be used in patients with advanced cirrhosis or signs of decompensation. This came after continued injury reports despite the boxed warning.

The contraindication update stated:

• FDA confirmed 25 cases of severe liver injury, including transplant referrals and deaths
• The agency stated Ocaliva must not be used in PBC patients with portal hypertension, ascites, jaundice, or hepatic decompensation
• Required stronger monitoring instructions for bilirubin and MELD scores
• Warned that Ocaliva could accelerate liver decline if continued in decompensated patients

Despite this, patients with known liver impairment continued to receive standard dosing, fueling further litigation concerns.

FDA Confirms 377% Increased Risk of Transplant or Death (2024)

In December 2024, the FDA released a significant safety evaluation update, confirming that Ocaliva users had a 377% higher risk of liver transplant or death compared to placebo in postmarketing surveillance data.

This safety notice signaled that the damage profile outweighed the claimed benefits, setting the stage for full withdrawal.

Ocaliva Recall After FDA Request (2025)

In September 2025, Intercept Pharmaceuticals issued a press release stating it would “voluntarily withdraw” Ocaliva from the U.S. market, but this announcement came only after the FDA formally requested removal due to ongoing reports of liver failure, transplant, and death. The agency also placed all U.S. clinical trials involving obeticholic acid on hold, effectively shutting down its use in active research.

While Intercept’s statement attempted to frame the withdrawal as a strategic decision, the company acknowledged that it “respect[ed] the FDA’s request”—confirming that the action was not initiated out of safety leadership, but regulatory pressure.

This withdrawal marks one of the strongest regulatory actions the FDA can take against a drug still on market, and it is now being cited in Ocaliva lawsuits investigations as evidence that critical safety risks were not adequately communicated to patients and prescribing physicians.

Ocaliva Lawsuit Allegations

Current legal investigations into Ocaliva focus on whether Intercept Pharmaceuticals failed to protect patients from known liver risks associated with the drug. Attorneys reviewing these claims indicate that the litigation will center on the following allegations:

• Failure to warn about the risk of liver failure and decompensation in patients with cirrhosis, even when taken at labeled doses
• Inadequate dosing guidance, leading doctors to prescribe Ocaliva daily instead of weekly in liver-impaired patients, despite FDA-issued clarification
• Delay in communicating risk escalation, including failure to issue direct warnings to patients after the boxed warning, contraindication, and safety advisories were added
• Continued promotion of Ocaliva after regulators identified preventable deaths, without instructing users to discontinue or seek liver monitoring
• Withholding postmarketing safety data that showed rising transplant evaluations and injury reports linked to Ocaliva therapy
• Failure to issue a direct discontinuation advisory after the FDA requested market withdrawal in 2025

These allegations are being used to evaluate potential wrongful death, liver failure, and failure-to-warn product liability claims on behalf of former Ocaliva users and their families.

Ocaliva Recall Settlements and Compensation

If Ocaliva is found to have contributed to liver failure or death, affected users and families may be entitled to compensation for:

• Hospitalization and emergency treatment costs
• Liver transplant surgery and long-term medical care
• Home care, monitoring, and follow-up diagnostics
• Loss of income or ability to work due to liver injury
• Pain, suffering, and reduced quality of life
• Wrongful death damages for surviving family members
• Future medical monitoring for those at risk of liver failure progression

Contact an Ocaliva Lawyer

If you or a loved one were prescribed Ocaliva (obeticholic acid) and later experienced liver failure, rapid cirrhosis progression, hospitalization, transplant evaluation, or death, you may be eligible to pursue compensation through an Ocaliva liver injury lawsuit.

Ocaliva injury lawyers are currently reviewing cases involving liver decompensation, transplant-related complications, and wrongful death, and are offering free case evaluations to patients and families seeking answers.

These claims are handled on a contingency fee basis, which means there are no upfront costs or legal fees unless compensation is recovered through an Ocaliva settlement or verdict.