Ocaliva Lawsuit Attorney | Get Legal Help for Liver Injury Claims

Key Takeaways

• Ocaliva is linked to serious liver complications, including rapid liver decline, liver failure, and death, risks that appeared even in patients without advanced cirrhosis.
  
• Lawsuits claim Intercept Pharmaceuticals failed to warn patients and doctors about the severity of these risks and continued marketing the drug despite repeated FDA alerts.
  
• FDA actions escalated year after year, from safety warnings in 2017 to a Black Box Warning in 2018, a contraindication in 2021, and ultimately a full market withdrawal in late 2025.
  
• Patients may qualify for an Ocaliva lawsuit if they experienced liver decompensation, hospitalization, transplant evaluation, or death after taking the drug for primary biliary cholangitis.
  
• Key documentation—medical records, lab results, dosing history, and hospitalization details—plays a critical role in determining eligibility and causation.
  
• The lawsuit has broad implications for drug safety, accelerated approvals, and how liver-disease medications are monitored moving forward.
  
• Litigation and investigations are ongoing, and many cases are expected to unfold throughout 2026 as more patients come forward.
  
• Anyone affected should consult a pharmaceutical injury attorney to determine whether they have a viable claim and what compensation may be available.

If you or a loved one has suffered from adverse effects, call us today at (866) 881-0403 or  fill out our online contact form. We serve clients nationwide and are committed to ensuring you receive the compensation you deserve.

Ocaliva (generic name obeticholic acid) was approved in 2016 under the FDA’s accelerated approval pathway. It was designed for adults with primary biliary cholangitis (PBC) who did not respond adequately to ursodeoxycholic acid (UDCA), the standard first-line therapy.

How Ocaliva Works

Ocaliva is an FXR agonist, a drug that helps regulate bile acid flow and reduce inflammation in the liver. In theory, activating these receptors should slow the progression of bile duct damage.

Important Usage Notes

Ocaliva is:

• Intended only for certain PBC patients
  
• Not recommended for individuals with advanced liver disease
  
• Highly dose-dependent, especially in patients with cirrhosis
  
• Known to require careful monitoring of bilirubin, liver enzymes, and symptoms of liver stress

Despite these warnings, many patients with impaired liver function continued to receive standard doses, an issue now central to several Ocaliva legal claims.

1. Failure to Warn About Liver Injury Risks

Patients and doctors claim that Intercept Pharmaceuticals:

• Did not adequately communicate the risk of liver failure and liver decompensation
  
• Failed to warn that the drug could trigger a rapid decline, even in non-cirrhotic or early-stage liver disease patients
  
• Continued to promote the drug despite repeated FDA safety communications

2. Design Defect / Failure-to-Warn Defect

Some lawsuits argue that the drug:

• Carried inherent safety risks even when used correctly
  
• It was unsafe for a significant portion of the population it was approved to treat

3. Inadequate Dosing Instructions

Reports show many patients received:

• Incorrect daily dosing instead of weekly dosing (especially those with cirrhosis)
  
• Prescriptions without proper screening for liver impairment
  
• No direct instruction on when to discontinue the drug due to early warning signs

Improper dosing is linked to multiple cases of Ocaliva liver failure, hospitalization, and transplant.

4. Delayed or Insufficient Safety Communication

Despite mounting reports, critics say:

• Risk updates came slowly
  
• Important warnings were buried in labeling updates
  
• Physicians were not directly alerted about escalating dangers

5. Consequences for Patients

As a result, patients experienced unexplained liver decline, emergency hospitalization, transplant evaluation, and death in documented cases

These allegations form the basis of both individual lawsuits and broader investigations.

Understanding the Ocaliva lawsuit means understanding how safety concerns evolved. Here is a clear, chronological overview of key FDA actions and drug-market events.

2017 — First FDA Safety Alert

Early warnings surface about liver failure, deaths tied to dosing errors, and serious liver injury even at recommended doses.

Feb 2018 — Black Box Warning Issued

FDA confirms at least 19 deaths linked to dosing mistakes. Doctors are instructed to screen for cirrhosis, adjust dosing for impaired patients, and monitor for rapid decline.

2021 — Ocaliva Contraindication Added

The FDA states Ocaliva should not be used in patients with advanced cirrhosis or signs of decompensation. At least 25 severe cases have been reported, including transplants and deaths.

Dec 2024 — FDA Confirms 377% Higher Risk

New data reveals Ocaliva users face a 377% increased risk of liver transplant or death, even in some non-cirrhotic patients.

Sept 2025 — FDA Requests Market Withdrawal

Intercept Pharmaceuticals announces Ocaliva’s removal from the U.S. market. All ongoing obeticholic acid trials are stopped.

Nov 14, 2025 — Final Transition Ends

Ocaliva is fully withdrawn and no longer available in the United States.

Individuals may be eligible to bring an Ocaliva liver injury lawsuit if they were prescribed the drug for PBC and later experienced:

• Sudden liver decompensation
  
• Liver failure
  
• Accelerated cirrhosis progression
  
• Jaundice, ascites, or portal hypertension
  
• Hospitalization for liver-related complications
  
• Evaluation for a liver transplant
  
• Placement on a transplant list
  
• A liver transplant
  
• Death related to liver complications

Key Documentation That Strengthens a Claim

Legal teams typically look for:

• Medical records showing diagnosis and progression
  
• Pharmacy prescription history
  
• Lab results (bilirubin, MELD score, liver enzymes)
  
• Hospitalization details
  
• Transplant evaluations or surgical reports

Because Ocaliva’s risks are tied directly to dose, duration, and liver status, these documents help attorneys determine timeline, causation, and eligibility.

For Patients and Families

Many individuals who suffered liver injury or rapid decline face significant medical expenses that can stretch over months or years. Hospitalizations, specialist consultations, ongoing diagnostics, and transplant-related costs can quickly become overwhelming. When symptoms force patients to reduce their work hours or leave their jobs entirely, the income loss compounds the strain. 

Families may also take on caregiving roles, leading to additional lost wages and long-term stress. In the most tragic cases, surviving loved ones now confront the realities of wrongful death losses, which include funeral costs, lost income, and the emotional toll of a preventable death.

Staying Informed and Knowing Your Options

The Ocaliva lawsuit reflects a complex mix of patient safety concerns, regulatory action, and questions about pharmaceutical responsibility. With the drug now fully withdrawn from the U.S. market and new data confirming serious risks, many patients and families are looking for answers, and, in some cases, accountability.

If you or a loved one took Ocaliva and later developed liver complications, get in touch with a legal professional at Bradley Grombacher. We can review your circumstances and help you understand potential options. And as new developments unfold, staying informed is one of the most important steps you can take.

• No Upfront Fees: We only get paid when you do!
  
• Proven Track Record: Our results speak for themselves.
• Compassionate and Attentive Legal Team: We treat every case with the attention and respect it deserves. Expect nothing short of excellent communication from our attorneys.
• Hablamos Español! We can assist you in both English and Spanish.

Contact Bradley/Grombacher LLP to schedule your free initial consultation. Serving clients nationwide!