Filing Ocaliva Lawsuits to Get Justice for Our Clients with Liver Damage
If you or a loved one were prescribed Ocaliva to manage Primary Biliary Cholangitis (PBC) only to experience a rapid progression in liver failure (cirrhosis), needing a transplant, or the loss of a family member, I am sure you feel angry and betrayed. You have every right to feel this way. We understand that liver problems, cirrhosis, and PBC already have a host of their own challenges and serious concerns. That’s why patients rely on their doctors and the medications they prescribe to slow the progression of their disease. No one ever thought it would speed it up.
However, that’s what happened when Ocaliva rapidly accelerated liver failure, the need for a transplant, or caused patients to die prematurely, sometimes in as little as a few weeks; if they had not taken Ocaliva, it could have taken 15-20 years for things to reach the level of cirrhosis or death. This is unacceptable, and Dolman Law Group is ready to fight for you!
Scrutiny over the information that has been released and the FDA records indicate that at least 19 people died and many cases of severe liver injury have been linked to Ocaliva so far. Even when taken as prescribed, many patients experienced worsening liver function. The risk was so significant that the FDA had to issue a Black Box Warning (its most serious safety alert) to highlight the potential for fatal liver decompensation.
At Dolman Law Group, we are currently investigating claims that Ocaliva (obeticholic acid) caused more harm than good. After the drug was pulled from the U.S. market in September 2025, it has become increasingly clear that the risks of taking Ocaliva were massive, and the manufacturer, Intercept Pharmaceuticals, may have known more than they let on and potentially failed to warn doctors and the public about the crazy risks.
We strongly believe that negligent pharmaceutical companies that prioritize profits over patient safety need to be stopped. It happens far too much in our country!
Our lawyers are dedicated and ready to hold Intercept Pharmaceuticals and any other negligent manufacturers accountable.
If you have suffered a serious liver injury after taking Ocaliva or have lost a family member, we want to hear your story. Hopefully, through diligence and skill, we can get you the money you need and deserve to pay for your medical bills, pain and suffering, and the host of costs that come with this kind of illness.
Why is Ocaliva Being Withdrawn from the Market?
On September 11, 2025, Intercept Pharmaceuticals announced that it would be removing Ocaliva from the U.S. market. Although it was “voluntary,” this decision surely cost them millions of dollars in lost sales and manufacturing; it’s more likely they were strongly pushed to withdraw the drug.
This major decision did not happen in a vacuum. It followed an urgent request from the U.S. Food and Drug Administration (FDA). The FDA was relying on a comprehensive review of clinical data that finally confirmed what many had been fearing or questioning for years: Ocaliva’s risks likely outweigh its benefits—massively.
The Failure of Study 747-302
Ocaliva initially received “accelerated approval” back in 2016, BEFORE the FDA even knew if the drug worked. You read that right.
The FDA granted accelerated approval as long as Intercept Pharmaceuticals conducted post-market studies to verify that the drug actually improved survival, reduced the need for transplants, and prevented liver failure. Spoiler alert: it did not.
As I mentioned, these studies were performed AFTER the drug was on the market. Doctors were literally prescribing Ocaliva before Intercept had proved to our nation’s Food and Drug Administration that the drug even worked, much less that it was safe.
After the drug was already in the mouths of who knows how many patients, Intercept Pharmaceuticals started its series of studies, known as Study 747-302 or The COBALT Study.
These studies did not go as Intercept planned, I am guessing, since they revealed some seriously alarming results.
According to the FDA’s own analysis of the data from the study:
- Ocaliva Increased Risk of Death: Patients taking Ocaliva showed a higher rate of liver-related deaths compared to those taking a placebo.
- Ocaliva Increased Need for Transplants: A higher percentage of Ocaliva users needed liver transplants or were added to transplant waiting lists.
- Lack of Proven Benefit of Ocaliva: The drug failed to prove that it significantly improved the patient’s long-term health through treatment of PCB, which it was designed to address.
After over 8 years on the market, Ocaliva was officially removed from commercial shelves in the United States in November 2025.
Today, the manufacturer continues to stand by the drug’s benefit-risk analysis, even though the FDA’s findings have shown a very clear pattern of danger.
If you or a family member were prescribed Ocaliva during its time on the market and it caused your liver disease to worsen, accelerate, or, unfortunately, led to death, we want to help.
Dolman Law Group is here to help victims of Ocaliva navigate the fallout of the drug’s removal from the market and to help them determine (and prove) their injuries were a direct result of the medication.
Ocaliva’s Timeline: Increasing Concern over Increasing Illness
To understand the whole picture of Ocaliva’s journey to and removal from the market, we have put together a brief timeline of Ocaliva.
The history of Ocaliva, its rush to market, and years of safety concerns that were overlooked or downplayed will help you to understand why we are filing these lawsuits and why you deserve compensation if this drug causes your family severe consequences.
- May 27, 2016: FDA grants “accelerated approval” for Ocaliva to treat Primary Biliary Cirrhosis (PBC). Intercept brags that Ocaliva is the “first new medicine for PBC in nearly 20 years.” This started the selling of the drug before long-term clinical trials ever proved it actually extended lives or that it was safe.
- May 26, 2021: Five years and one day later, after reports of severe liver injury and death, the FDA restricts Ocaliva’s use. It is no longer recommended for patients with advanced cirrhosis (compensated cirrhosis with evidence of portal hypertension).
- December 12, 2024: A new Drug Safety Communication is issued. The FDA highlights that even patients without cirrhosis are suffering serious liver injuries after taking Ocaliva (obeticholic acid).
- September 11, 2025: Intercept Pharmaceuticals announces a voluntary withdrawal from the U.S. market after the FDA determines the drug’s risks far outweigh its benefits.
- November 14, 2025: Ocaliva is officially removed from the U.S. commercial market, ending its nearly decade-long run.
Understanding the Risks: Ocaliva and Severe Liver Injury
When we talk about Ocaliva injuries, we are describing a “paradoxical” effect. While the drug was intended to treat a liver disease (PBC), it often ended up accelerating the very damage it was meant to prevent.
Liver Decompensation and Failure
For many of our clients, the most devastating side effect is liver decompensation. This occurs when the liver is so scarred and damaged that it can no longer perform its essential functions, such as filtering toxins from the blood.
We have found that Ocaliva can trigger a rapid decline in two specific ways:
- Direct Toxicity: In some patients, the drug appears to have a toxic effect on liver cells, leading to acute failure even in those with relatively stable PBC.
- Dosing Complications: For years, confusion over daily vs. weekly dosing led to patients with impaired liver function receiving too much of the drug, essentially poisoning their systems.
Symptoms that may indicate Ocaliva-related damage include:
- Jaundice: A noticeable yellowing of the skin or the whites of the eyes.
- Ascites: Severe swelling or fluid buildup in the abdomen.
- Hepatic Encephalopathy: Mental confusion or altered consciousness caused by toxins that the liver failed to filter.
- Variceal Bleeding: Internal bleeding caused by high pressure in the veins of the esophagus or stomach.
Our firm has been closely monitoring the litigation surrounding Ocaliva and its impact on those with PBC. Dolman Law Group’s managing partner, Matt Dolman, emphasizes that this is a matter of transparency and patient safety in the following quote:
“Patients with PBC already face a complex, chronic disease requiring careful management,” says Matt Dolman. “Ocaliva was marketed as a safe, effective therapy, yet serious safety risks were not adequately disclosed. This failure to warn deprived patients and their healthcare providers of the critical information they needed to make informed decisions, which, as we can see, led to preventable injuries and deaths.”
The Real-World Impact of Ocaliva
The following are three stories from the PBC community that were gathered from various PBC and health discussion boards online. We have removed anything that could identify
1. The “Unbearable” Itch
On Reddit’s r/PBC community, many patients discussed how the annoyance of what they called the “Ocaliva Itch” (aka pruritus, an intense, persistent itching that is almost impossible not to scratch, often has no visible rash, and can stem from something simple like dry skin, allergies, eczema, but it can also stem from serious systemic diseases like kidney or liver disease).
One user said, “he has extreme itching. He tries to manage it with meds and lotions, but it doesn’t always work as well as he’d hope.”
Another user recounted how they were prescribed Ocaliva after they didn’t respond to Ursodiol (another medication used to treat PBC and other liver conditions). While their lab numbers showed slight improvement, their quality of life plummeted.
They described the sensation as “a thousand fire ants crawling under my skin that no amount of scratching could reach.”
The itching became so severe at night that they suffered from chronic insomnia and depression, eventually choosing to stop the medication because the “cure” felt more debilitating than the disease itself.
2. The Rapid Decline (The Warning That Came Too Late)
In discussions about the FDA’s “Black Box” warnings, one family member shared a story about their loved one who was categorized as having “compensated cirrhosis” (aka their cirrhosis was stable). Within months of starting Ocaliva, their family member experienced sudden jaundice and abdominal swelling (ascites).
They rushed them to the hospital to find that their loved one actually had acute liver decompensation, the very condition the drug was supposed to be preventing.
The family member said that while they were told the Ocaliva was a “lifeline,” it felt more like a “catalyst” that pushed their loved one toward needing an emergency liver transplant evaluation much sooner than their doctors had ever predicted. Things went from stable to “wholly crap we might need an emergency transplant in what felt like no time,” the poster said.
3. The “Guinea Pig”
After it was announced in September 2025 that Ocaliva would be removed from the market, users on r/biotech and other health subreddits expressed frustration with the drug’s initial “Accelerated Approval” process.
One former clinical trial participant noted that they felt like a “medical guinea pig” for a drug that generated billions for Intercept Pharmaceuticals but failed to prove it actually helped patients live longer. They shared that while they had trusted the FDA’s initial green light, they were left feeling betrayed after realizing the drug manufacturer hadn’t provided enough data to confirm long-term survival benefits, despite the mounting reports of liver failure and death within the patient community.
Who Qualifies for an Ocaliva Lawsuit?
If you used Ocaliva and your health took a turn for the worse, you may be eligible to join the growing number of families seeking justice. At Dolman Law Group, we are currently reviewing cases that meet the following criteria provided by our legal team:
Documented Prescription
You must have a medical history showing Ocaliva use for the treatment of PBC.
Severe Liver Injury
The core of an Ocaliva claim is a “clinical event” that occurred after you began taking the medication. This typically includes:
- Liver Failure: A formal diagnosis of acute or chronic hepatic failure.
- Liver Transplant: You were placed on a transplant list or underwent a transplant surgery.
- Worsening Cirrhosis: Your PBC rapidly progressed to advanced cirrhosis shortly after starting the drug.
- Hospitalization: You were admitted to the ER for liver-related complications, like variceal bleeding or severe jaundice.
Intensive Medical Intervention
You required hospitalization, intensive treatment, a transplant evaluation, or a liver transplant surgery.
Linked Deterioration
You have medical documentation or professional opinions (or can obtain such) linking the sudden deterioration of your health to Ocaliva use.
Wrongful Death Claims
If you lost a spouse, parent, or child who was taking Ocaliva for PBC, we can help you file a wrongful death lawsuit. In these cases, we work to prove that the drug contributed to the fatal liver failure, allowing your family to seek compensation for funeral expenses and the loss of companionship.
Allegations Against Intercept Pharmaceuticals
When we take on a pharmaceutical giant like Intercept Pharmaceuticals, we do so because we believe their actions, or lack of action, have caused preventable suffering to our clients. Our investigation into Ocaliva focuses on several key allegations of corporate negligence:
- Failure to Warn: We allege that Intercept knew, or should have known, about the increased risk of liver failure long before the 2025 withdrawal. We believe the warnings provided to doctors and patients were insufficient and did not reflect the true severity of the drug’s toxicity.
- Prioritizing Profits Over Safety: Ocaliva was an expensive “orphan drug” that generated massive revenue. We are looking into whether the company downplayed safety signals in Study 747-302 to maintain its market share and protect its stock price.
- The “Accelerated Approval” Trap: While the FDA allowed Ocaliva on the market early to help PBC patients, that permission was contingent on proving the drug actually worked. We argue that Intercept continued to market the drug aggressively even after it became clear that it failed to show a survival benefit.
When you work with us, we dig deep into records to prove that your injury wasn’t an “unavoidable side effect,” but a result of a manufacturer’s failure to put your safety first.
Why Accountability Matters for PBC Patients
We believe pursuing these claims is about more than just financial recovery; it is about ensuring accountability and transparency in drug safety. PBC patients are a vulnerable population, often with limited treatment options. When a drug company fails to disclose risks, it takes away the patient’s right to choose their own medical path. By filing these lawsuits, we are working to protect future patients from similar corporate negligence.
Compensation for Damages from Ocaliva
A liver injury is more than just a medical diagnosis; it is a life-altering event that impacts your finances, your family, and your future. At Dolman Law Group, we fight to ensure that the compensation you receive covers the full scope of your losses.
Economic Damages
We work to recover every dollar you have lost due to Ocaliva, including:
- Medical Expenses: The cost of hospitalizations, specialized liver care, and the astronomical costs of a liver transplant and lifelong anti-rejection medications.
- Lost Wages: If you were forced to stop working or reduce your hours due to illness or recovery from surgery.
- Future Costs: We consult with medical and economic experts to estimate the cost of the care you will need for the rest of your life.
Non-Economic Damages
Not all losses appear on a receipt. We also pursue compensation for:
- Pain and Suffering: The physical pain of liver failure and the grueling recovery process following a transplant.
- Emotional Distress: The anxiety and trauma of facing a life-threatening complication from a medication you trusted.
- Loss of Quality of Life: The inability to enjoy the hobbies, family time, and daily activities you participated in before your health declined.
The Legal Process: How We Work for You
We know that the thought of a lawsuit can feel overwhelming, especially when you are focused on your health. That is why we make the process as seamless as possible for you.
- Free, Confidential Consultation: We will sit down with you (in person or virtually) to hear your story and explain your legal options at no cost.
- No Fees Unless We Win: We handle Ocaliva cases on a contingency basis. This means you never pay us anything out of pocket. We only get paid if we successfully recover a settlement or verdict for you.
- Compassionate Advocacy: We aren’t just your lawyers; we are your advocates. We handle the paperwork, the depositions, and the negotiations so you can focus on healing.
Contact Dolman Law Group Today
If you or a loved one took Ocaliva and suffered liver failure or required a transplant, time is of the essence. Statutes of limitations apply to these cases, meaning there is a limited window in which you can file a claim.
We are ready to stand by your side and fight for the justice you deserve. Contact us today by calling our office or filling out our online contact form for a free case evaluation. Let us help you hold the manufacturers accountable and secure your family’s future. You can contact us at 727-451-6900 or by using our simple online form.
Frequently Asked Questions about Ocaliva Lawsuits
Why was Ocaliva taken off the market in 2025?
Ocaliva (obeticholic acid) was voluntarily withdrawn from the U.S. market in September 2025 following a formal request from the FDA. Clinical data, specifically from Study 747-302, revealed that the drug’s risks outweighed its benefits. The study showed that patients taking Ocaliva faced a significantly higher risk of liver transplant and death compared to those receiving a placebo. By November 14, 2025, the drug was officially removed from commercial distribution.
What are the most serious side effects of Ocaliva?
While Ocaliva was intended to treat Primary Biliary Cholangitis (PBC), it has been linked to severe, life-threatening liver complications. We are primarily seeing cases involving:
- Acute Liver Failure: Sudden loss of liver function in patients who were previously stable.
- Hepatic Decompensation: A rapid decline where the liver can no longer compensate for damage, leading to fluid buildup (ascites) and mental confusion.
- Need for Transplant: Patients requiring emergency placement on a liver transplant list.
- Severe Jaundice: Yellowing of the eyes and skin, indicating high levels of bilirubin.
Do I qualify for a lawsuit if I already had PBC or liver scarring?
Yes. Because Ocaliva was specifically designed for patients with PBC, having the condition does not disqualify you. In fact, our investigation focuses on how the drug accelerated liver damage in people who were already vulnerable. If you had “compensated” (stable) cirrhosis and then experienced a rapid decline or liver failure after taking Ocaliva, we believe the drug manufacturer should be held responsible for failing to warn you of that specific risk.
Is the Ocaliva litigation a class action?
Currently, Ocaliva claims are generally handled as individual lawsuits rather than a single class action. This is beneficial for you because liver injuries vary greatly in severity. Individual lawsuits—often consolidated into a Multidistrict Litigation (MDL)—allow us to focus on your specific medical expenses, your unique pain and suffering, and your personal loss, rather than splitting a single settlement among thousands of people.
How much does it cost to hire an Ocaliva attorney?
At Dolman Law Group, we operate on a contingency fee basis. This means there are zero upfront costs to hire us. We cover all the expenses related to investigating your case, hiring medical experts, and filing your lawsuit. We only receive a fee if we successfully secure a settlement or jury verdict on your behalf. If we don’t win your case, you owe us nothing.
What should I do if I am still taking Ocaliva?
Do not stop taking any prescribed medication without first consulting your doctor. While Ocaliva has been withdrawn from the market, stopping treatment abruptly can have its own risks. We recommend you schedule an appointment with your hepatologist or gastroenterologist immediately to discuss alternative PBC treatments. Once you have a medical plan in place, call us to discuss your legal rights.
