Nationwide Ocaliva Lawsuit Attorneys

Ocaliva Injury Lawyers Fighting for Patients Harmed by a Dangerous Drug and Their Families

Patients diagnosed with primary biliary cholangitis (PBC) turned to Ocaliva, hoping it would help manage a chronic and progressive liver disease. Instead, many suffered serious and potentially life-threatening liver complications, including liver failure, the need for a liver transplant, and, in the most devastating cases, death. Across the country, individuals and families are now pursuing legal action against Intercept Pharmaceuticals, the maker of Ocaliva. Our Ocaliva lawsuit attorneys at Anapol Weiss are actively investigating these claims. We are drawing on our extensive experience handling mass tort matters of all kinds to fight for the compensation injured patients deserve.

Ocaliva is a prescription medication approved to treat primary biliary cholangitis, a chronic autoimmune liver disease that can progressively destroy the liver. Patients who took it trusted that a drug approved by the FDA and prescribed by their doctors was reasonably safe. But that trust was broken. Intercept Pharmaceuticals, the manufacturer, is now accused of failing to adequately warn patients about the serious and potentially life-threatening liver complications the drug could cause.

Our team has seen firsthand what it means to face serious liver complications, hospitalizations, and life-altering medical decisions while also trying to understand your legal rights. That is why we are taking action: to give Ocaliva injury victims a voice in the legal system and stand up to the pharmaceutical corporation responsible for putting this drug on the market.

Leading this litigation are shareholder Tracy A. Finken Magnotta, partner Shayna Slater, and partner Emily Ashe, all of whom bring deep experience in pharmaceutical and product liability litigation to these cases. Together, our Ocaliva injury lawyers embody the kind of dedicated, client-focused legal team that Anapol Weiss has built over more than 45 years of advocating for the injured.

If you or a loved one suffered serious liver complications after taking Ocaliva, you should not have to navigate the legal process alone. Our team is handling these cases on a contingency basis, meaning you pay nothing upfront, and no legal fees are owed unless we recover compensation for you. Reach out by phone or through our online contact form for your free consultation, and find out whether you may have grounds to pursue a claim.

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Ocaliva Lawsuits: Who May Qualify to File a Claim?

Ocaliva lawsuits are being filed by patients who suffered serious liver injuries after taking the medication for primary biliary cholangitis. Recent safety concerns and regulatory actions have raised questions about whether patients prescribed Ocaliva may have suffered serious and potentially life-threatening complications. Our Ocaliva lawsuit attorneys are actively investigating claims on behalf of injured individuals in the civil legal system, seeking compensation that reflects the full physical, emotional, and financial toll of what they have endured.

If you or a loved one experienced serious liver complications after taking Ocaliva, you may have legal options. Complications associated with Ocaliva use that may give rise to a legal claim include:

• Liver failure
• Liver decompensation
• Acute-on-chronic liver disease
• Liver transplant
• Worsening liver function
• Hospitalization due to liver complications
• Wrongful death

You may also have a valid claim if you were prescribed Ocaliva and did not have advanced cirrhosis. The FDA initially considered patients without cirrhosis appropriate candidates for the drug, but later identified serious liver injuries, including transplant and death, occurring in exactly this population. If you were harmed while taking Ocaliva as prescribed, the absence of a pre-existing cirrhosis diagnosis does not disqualify you from pursuing a claim.

Even if you are uncertain whether your situation qualifies, speaking with our Ocaliva injury lawyers costs nothing and carries no obligation. A free consultation is the first step toward understanding your rights.

Taking Action: What to Know About Filing an Ocaliva Lawsuit

Filing a lawsuit can feel overwhelming, particularly when you are already dealing with serious health complications or the loss of a loved one. Our Ocaliva lawsuit attorneys are here to carry the legal burden so you can focus on what matters most. At Anapol Weiss, we are actively investigating claims and building cases on behalf of individuals harmed by this drug.

While every case is unique, most Ocaliva injury claims involve a similar process:

• Seek and document medical care: Your health comes first. If you have not already done so, work with your medical team to address your condition and obtain thorough documentation of your diagnosis, treatment, and prognosis.
• Preserve any available evidence: Retain prescription records, pharmacy records, pill bottles or packaging, and any other documentation related to your Ocaliva use. Records showing when you were prescribed the drug and for how long can be important to your claim.
• Document the impact on your life: Keep records of hospitalizations, medical procedures, lost income, and the ongoing personal and emotional effects of your injuries. This documentation helps paint a complete picture of what you have experienced.
• Consult our Ocaliva lawsuit attorneys: Our legal team can evaluate your situation, assess whether you have a viable claim, and identify all parties that may be held legally responsible, including Intercept Pharmaceuticals and its parent company.

Once you retain our firm, we take on the full legal process: conducting in-depth investigations, working closely with medical professionals to document the extent of your injuries, and building a custom-tailored legal strategy designed to pursue the maximum possible recovery on your behalf.

Mass Torts, MDLs, and Individual Claims: Your Legal Options and What They Mean for You

If you are new to pharmaceutical litigation, the different types of legal proceedings can be confusing. Here is what you need to know as a potential claimant.

Mass Torts Give Each Plaintiff Their Own Case and Their Own Recovery

A mass tort arises when a large number of people are injured by the same product or conduct. Unlike a class action, each plaintiff in a mass tort brings an individual claim and receives compensation based on their own specific injuries and losses.

Cases may be coordinated in the courts to streamline pretrial proceedings, but each person's case remains their own.

Multidistrict Litigation Consolidates Cases for a More Streamlined Process

When related federal lawsuits are filed across multiple districts, a judicial panel may consolidate them before a single judge for pretrial proceedings, such as discovery and expert testimony. This helps avoid duplicative effort and creates much-needed efficiency in large-scale litigation.

Individual cases maintain their own identity within the MDL and may be resolved through settlement or returned to their original courts for trial. Anapol Weiss has extensive experience in MDL matters, with our attorneys having served in leadership roles across numerous complex pharmaceutical and product liability MDLs.

Individual Lawsuits Offer a Direct Path to Compensation Outside Consolidated Proceedings

Some Ocaliva injury cases may proceed as standalone matters, particularly in the early stages of litigation. Your legal team will determine the most appropriate path based on the specifics of your case and the evolving state of Ocaliva litigation.

As of the time of publication, Ocaliva cases have not yet been consolidated into an MDL, though this may change as more individuals come forward with claims. By working with our team now, you can position your case within a growing body of litigation and take advantage of the investigative groundwork we are already laying on behalf of clients nationwide.

Putting Profits Ahead of Patients: The Claims Against Intercept Pharmaceuticals

At the center of Ocaliva lawsuits are serious allegations that Intercept Pharmaceuticals failed to adequately protect patients from known and foreseeable risks. These are not minor oversights. Plaintiffs allege that the manufacturer of a prescription medication entrusted with managing a serious liver disease placed profits ahead of patient safety.

Legal claims surrounding Ocaliva injuries commonly include the following allegations:

Patients Were Not Adequately Warned About the Risks of Serious Liver Injury

From early in the drug's post-market history, safety signals emerged linking Ocaliva to dangerous liver complications. Despite this, plaintiffs allege that patients were never given a full and accurate picture of what they were risking. FDA data ultimately revealed that serious injuries, including transplant and death, were occurring even in patients without advanced cirrhosis, the population the agency had initially considered appropriate for the drug. Plaintiffs argue this expanding risk profile should have prompted far earlier and more prominent warnings.

Known Safety Data Was Not Acted Upon Promptly

The regulatory timeline surrounding Ocaliva spans nearly a decade of escalating warnings, restrictions, and safety communications. Plaintiffs allege that Intercept Pharmaceuticals had access to post-marketing safety data that should have prompted more aggressive action, including stronger warnings or removal from the market, well before the drug was ultimately withdrawn in November 2025.

Clinical Trial Data Failed to Support the Drug's Continued Use

The confirmatory COBALT trial, which Intercept was required to complete as a condition of the drug's accelerated approval, failed to demonstrate that Ocaliva produced better outcomes than a placebo on the primary endpoint of liver transplant, death, and other serious liver-related events. An FDA advisory committee voted 10 to 1 that the evidence did not support full approval. Despite this, the drug remained available to patients until late 2025, when Intercept Pharmaceuticals withdrew Ocaliva from the U.S. market following an FDA request.

Patients Faced a Significantly Elevated Risk of Transplant or Death

Based on post-market clinical trial data showing that 7 of 81 patients receiving Ocaliva required a liver transplant compared to 1 of 68 patients receiving a placebo, and that patients receiving Ocaliva faced a significantly higher risk of liver transplant or death, with a hazard ratio of 4.77, according to the FDA.

For individuals who took this medication to help them address a progressive autoimmune disease and suffered life-altering consequences as a result, these lawsuits represent a path toward accountability and financial recovery.

The Time to Act Is Now: Do Not Wait to Speak With Our Ocaliva Lawsuit Attorneys

Every state has its own statute of limitations governing how long you have to file a personal injury or wrongful death lawsuit. In pharmaceutical product liability cases, these deadlines can be strict, and missing one may permanently bar your ability to pursue compensation, regardless of the severity of your injuries.

Timing also matters for practical reasons. Critical evidence, including medical records, prescription histories, and documentation connecting your injuries to Ocaliva, becomes harder to gather with the passage of time. Filing sooner allows your legal team to begin building the strongest possible case on your behalf, while the record is still fresh and intact.

If you lost a loved one whose death may be connected to Ocaliva use, it is especially important to act without delay. Wrongful death claims carry their own deadlines, and families who wait risk losing the legal options available to them.

Contacting our Ocaliva injury lawyers today does not commit you to anything. It gives you the information you need to make a well-informed decision about your rights, and it allows our team to begin taking protective steps on your behalf before time runs out.

What an Ocaliva Liver Injury Lawsuit Can Do for You and Your Family

Filing an Ocaliva lawsuit is about more than financial recovery, though that matters deeply. Serious liver injuries bring overwhelming costs. The law recognizes that patients harmed by dangerous or defective medications should not have to bear those burdens alone.

A successful claim may allow you to seek compensation for:

• Medical expenses, including hospitalization, surgery, medication, and ongoing treatment
• Liver transplant-related costs, including long-term follow-up care and a lifelong regimen of anti-rejection drugs
• Lost wages and reduced future earning capacity
• Physical pain and suffering
• Emotional distress and diminished quality of life

For families who lost a loved one, wrongful death claims may also pursue compensation for funeral and burial costs, the loss of financial support, and the profound personal losses that no settlement can fully address but that the law still recognizes.

Beyond the financial dimension, a lawsuit can uncover the truth. It can compel a pharmaceutical company to produce internal communications, clinical data, and decision-making records that may shed light on what Intercept Pharmaceuticals knew about Ocaliva's risks and when. For many families, accountability matters, too. Knowing that a corporation was forced to answer for its conduct can carry meaning that goes beyond any dollar figure.

Pursuing legal action with our experienced Ocaliva lawsuit attorneys on your side also plays a role in making medications on the market safer. Cases like these push the pharmaceutical industry toward greater transparency and responsibility, and they can help protect other patients from suffering the same harm in the future.

Serious Liver Complications Linked to Ocaliva

For patients managing a chronic liver disease, the complications associated with Ocaliva use represent some of the most serious and life-altering outcomes imaginable. The injuries at the center of the current litigation include:

Liver Failure

When the liver loses its ability to function, the consequences can be sudden and catastrophic. Patients may face a medical emergency requiring intensive hospitalization, and in some cases, there is no path to recovery without a transplant.

Liver Decompensation

This occurs when a damaged liver can no longer compensate for its reduced function, often triggering a cascade of serious complications that can include fluid buildup, internal bleeding, and cognitive impairment. For many patients, decompensation marks a turning point from manageable disease to a medical crisis.

Acute-on-Chronic Liver Disease

This condition involves a sudden, severe deterioration in a patient who already has chronic liver disease. It carries a high risk of organ failure and death, and it can develop rapidly, leaving patients and families with little time to respond.

Liver Transplantation

When liver damage reaches a point of no return, a transplant may be the only option. Transplantation is not a cure. It means a lifetime of anti-rejection medications, ongoing monitoring, and the physical and emotional burden of a major surgical procedure with serious risks of its own.

Worsening Liver Function

Even short of full failure, a significant decline in liver function can dramatically affect a patient's quality of life, limiting their ability to work, care for their family, and manage daily activities.

Hospitalization Due to Liver Complications

Serious Ocaliva-related complications have sent patients to the hospital for extended stays, accumulating medical bills and separating them from the people and routines that sustain them.

Wrongful Death

In the most devastating cases, Ocaliva-related liver complications have proven fatal. These losses have left families without a parent, a partner, or a provider, and they form the basis of wrongful death claims against Intercept Pharmaceuticals.

A Decade of Warnings: The Regulatory History Behind the Ocaliva Withdrawal

The story of how Ocaliva reached the point of a full market withdrawal is not one of a sudden discovery. It is a decade-long record of escalating safety signals, regulatory interventions, and a manufacturer that continued to sell the drug while the evidence against it mounted.

Ocaliva received accelerated FDA approval in May 2016, based not on demonstrated improvements in long-term outcomes like survival or transplant-free survival, but instead on improvements in a blood biomarker called alkaline phosphatase.

That distinction matters: accelerated approval is a pathway reserved for drugs that treat serious conditions, contingent on later confirmation that the drug actually delivers clinical benefit. But, in the case of Ocaliva, that confirmation never came.

Problems emerged almost immediately after the drug reached patients. In September 2017, the FDA issued a drug safety communication warning that Ocaliva was being incorrectly dosed in some patients with reduced liver function, resulting in serious liver injury and death. The following February, the agency added a Boxed Warning, its most prominent warning designation, to address correct dosing requirements.

By May 2021, the FDA had identified 25 cases of serious liver injury in PBC patients taking Ocaliva, including liver decompensation, liver failure, transplant, and death. The FDA responded by adding a formal Contraindication to the drug's prescribing information, restricting its use in patients with advanced cirrhosis. A Contraindication is the FDA's strongest warning.

For many patients and prescribers, this restriction may have created a false sense of security: if the danger applied to patients with advanced cirrhosis, those without it might reasonably have believed they were safe.

They were not. In September 2024, an FDA advisory committee voted 10 to 1 that available data did not support the clinical benefit needed for full approval, according to HCPLive. The confirmatory COBALT trial, which Intercept had been required to complete as a condition of accelerated approval, failed to show that Ocaliva produced better outcomes than a placebo on the primary endpoint of transplant, death, and serious liver-related events, according to Liver Disease News. The FDA denied full approval in November 2024.

A month later, in December 2024, the FDA issued a safety communication based on post-market clinical trial data showing that 7 of 81 patients receiving Ocaliva required a liver transplant compared to 1 of 68 patients receiving a placebo. Patients receiving Ocaliva faced a significantly higher risk of liver transplant or death, with a hazard ratio of 4.77, according to the FDA. The agency identified 20 additional cases of liver transplant, evaluation for transplant, or liver-related death reported since the 2021 label changes.

By September 2025, the FDA formally requested that Intercept Pharmaceuticals withdraw Ocaliva from the U.S. market. The company complied, and on November 14, 2025, Ocaliva was officially removed from pharmacy shelves, according to Managed Healthcare Executive.

Pulling Ocaliva from the U.S. market could protect patients from further risk. But for patients who were harmed before that withdrawal, the damage was already done.

A Team of Ocaliva Lawsuit Attorneys Who Have Spent Years Taking on Pharmaceutical Companies

When you are facing the aftermath of serious pharmaceutical harm, the legal team you choose matters. At Anapol Weiss, the attorneys leading Ocaliva injury litigation bring a track record of results in complex, high-stakes pharmaceutical and product liability matters.

Shareholder Tracy A. Finken Magnotta has spent more than two decades concentrating her practice on pharmaceutical and product liability litigation, class actions, and complex civil litigation. She has held leadership appointments in MDLs, including Co-Chair of the Plaintiffs' Executive Committee in the Depo-Provera Products Liability MDL, appointed by the court; Plaintiffs' Executive Committee member in the Tepezza MDL and the Proton Pump Inhibitor litigation; and Co-Lead Counsel in the Zantac MDL. Over the course of her career, Tracy and her team have recovered more than $750 million for clients in pharmaceutical and product liability matters.

Partner Shayna Slater brings significant depth in mass tort, pharmaceutical, and toxic tort litigation, with a practice that has included complex matters involving defective hip and knee implants and pharmaceutical drugs such as Yaz, among others. Shayna has been recognized as a National Trial Lawyers Top 100 Trial Lawyer in Pennsylvania, a Fellow of the Litigation Counsel of America, an honor extended to fewer than one-half of one percent of American lawyers.

Partner Emily Ashe concentrates her practice on defective medical devices and pharmaceutical drug cases in the firm's Mass Tort Department. She is admitted to practice in Pennsylvania, New Jersey, New York, and before the U.S. Court of Federal Claims, and has been recognized in Best Lawyers in America for her work in personal injury litigation.

Let our team put our firm’s long history of taking on major corporations and Fortune 500 companies to work for you.

Why Choose Anapol Weiss as Your Ocaliva Lawsuit Attorneys?

Choosing the right legal team is one of the most consequential decisions you will make in an Ocaliva injury case. Across the country, injured patients and their families are turning to Anapol Weiss to pursue compensation, accountability, and answers.

A Record Built on Pharmaceutical Litigation

Our attorneys do not simply understand mass tort law in the abstract. They have lived it, serving in MDL leadership roles, going to trial in high-stakes product liability cases, and recovering hundreds of millions of dollars for clients harmed by dangerous drugs and defective products. That depth of experience informs every decision we make in cases like these.

A Client-Centered Approach From the First Call

We know that people who come to us are often dealing with serious health crises, grief, financial pressure, and uncertainty about what comes next. Our approach is to take on the legal heavy lifting. We work with medical professionals to document your injuries and build your case, keeping you informed and supported throughout. Maximizing your recovery and minimizing your stress are not competing goals. They are both critical parts of what we do.

Contingency Representation With No Upfront Cost

Cost should never stand between an injured person and justice. We represent Ocaliva injury clients on a contingency fee basis, meaning you owe nothing in attorney fees unless we recover compensation on your behalf. Our free consultation is genuinely free, with no obligation to move forward.

A Nationally Recognized, Award-Winning Team

With more than 45 years of experience and a national reputation for excellence in personal injury, product liability, and mass tort litigation, Anapol Weiss has the standing and resources to pursue these cases at the highest level.

Contact the Ocaliva Injury Lawyers at Anapol Weiss for a Free Consultation

If you or someone you love suffered serious liver complications after taking Ocaliva, your next step should be a conversation with an attorney who understands exactly what is at stake. At Anapol Weiss, we offer free, confidential consultations with no pressure and no obligation. You can ask questions, get honest answers about whether you may have a viable claim, and decide how you want to move forward, all at no cost to you.

Our Ocaliva injury lawyers are actively investigating cases and standing by to hear your story. Reach out by phone or through our online contact form for the compassionate, committed advocacy you deserve.

Recent Developments in Ocaliva Safety Research and Injury Litigation

• November 14, 2025: Ocaliva was officially removed from U.S. pharmacy shelves after Intercept Pharmaceuticals agreed to withdraw the drug at the FDA's request. The FDA determined that the risks of the medication, including liver failure, liver transplant, and death, outweighed its uncertain clinical benefits, according to Managed Healthcare Executive.
• September 11, 2025: Intercept Pharmaceuticals announced it would withdraw Ocaliva from the U.S. market in direct response to a formal FDA request, according to HCPLive. The FDA simultaneously placed a clinical hold on all Intercept clinical trials involving obeticholic acid.
• December 12, 2024: The FDA issued a drug safety communication based on post-market clinical trial data showing that 7 of 81 patients receiving Ocaliva required a liver transplant compared to 1 of 68 patients receiving a placebo. The patients receiving Ocaliva also faced a significantly higher risk of liver transplant or death, with a hazard ratio of 4.77, according to the FDA.
• November 27, 2024: The European Commission's revocation of Ocaliva's conditional marketing authorization took full effect across EU member states and the European Economic Area after a court-ordered temporary suspension was lifted. The revocation, originally issued on August 30, 2024, followed a determination by the European Medicines Agency that the drug's benefits no longer outweighed its risks, according to HCPLive.
• November 12, 2024: The FDA denied full approval for Ocaliva after the confirmatory COBALT trial failed to demonstrate that the drug produced better outcomes than a placebo on the primary endpoint of transplant, death, and serious liver-related events, according to Liver Disease News. An advisory committee had voted 10 to 1 against approval in September 2024, according to HCPLive.
• May 26, 2021: The FDA added a formal Contraindication to Ocaliva's prescribing information, its strongest warning designation, restricting the drug's use in PBC patients with advanced cirrhosis after identifying 25 cases of serious liver injury, including liver decompensation, liver failure, transplant, and death.
• February 2018: The FDA added a Boxed Warning to Ocaliva's prescribing information, its most prominent warning label, to address correct dosing requirements following reports of serious liver injury related to dosing errors.
• September 2017: The FDA issued its first drug safety communication warning that Ocaliva was being incorrectly dosed in some patients with reduced liver function, resulting in an increased risk of serious liver injury and death.