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The Tavneos lawsuit involves claims that Amgen and ChemoCentryx failed to adequately warn patients that Tavneos (avacopan), a prescription drug for severe active ANCA-associated vasculitis, can cause drug-induced liver injury (DILI), vanishing bile duct syndrome (VBDS), liver failure, and death. The FDA identified 76 Tavneos-related liver injury cases in postmarketing data, including 54 hospitalizations and 8 deaths, and issued a safety alert on March 31, 2026. Patients who developed serious liver injury after taking Tavneos may be eligible to file a claim. Cases are currently being filed as individual product liability lawsuits; no MDL has been established.
As of June 2026, Tavneos (avacopan) lawsuits are being filed as individual product liability claims and have not been consolidated into a multidistrict litigation (MDL). The FDA proposed withdrawing Tavneos’ approval on April 27, 2026, citing a lack of substantial evidence of effectiveness and untrue statements in the original approval application. Amgen had until June 1, 2026, to request a formal hearing on that proposal [VERIFY: confirm hearing request status]. The FDA previously issued a Drug Safety Communication on March 31, 2026, identifying 76 cases of serious drug-induced liver injury, including 54 hospitalizations and 8 deaths, with VBDS identified as a new safety concern. Tavneos remains on the market as proceedings continue. Law firms are actively investigating and filing new claims.
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Tavneos lawsuits involve claims that Tavneos® (avacopan), a prescription drug used with standard therapy for severe active ANCA-associated vasculitis, is linked to serious liver injuries, including drug-induced liver injury, vanishing bile duct syndrome, liver failure, hospitalization, and death.
Our law firm is currently investigating Tavneos injury lawsuits nationwide, including claims involving serious liver injury, vanishing bile duct syndrome, liver transplant, hospitalization, and wrongful death after Tavneos use.
Tavneos, also known as avacopan, is an oral medication approved by the FDA on October 7, 2021. It is used with glucocorticoids and other standard-of-care medications to treat adults with severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis. The FDA notes that Tavneos does not eliminate the need for glucocorticoids.
April 2026
In April 2026, the FDA took the significant step of proposing to withdraw approval of Tavneos, citing concerns that there is no substantial evidence the drug is effective and alleging that material facts in the approval application were untrue. The agency also raised concerns that clinical trial data may have been manipulated to achieve a statistically significant result.
March 2026
Just weeks earlier, on March 31, 2026, the FDA issued a public safety alert warning of serious drug-induced liver injury (DILI) and cases of vanishing bile duct syndrome (VBDS), including fatal outcomes. The agency specifically identified VBDS as a new safety concern emerging in postmarketing reports.
The FDA identified 76 Tavneos-related drug-induced liver injury cases with reasonable evidence of a causal association, including 54 hospitalizations and 8 deaths.
January 2026
Earlier in 2026, the regulatory conflict between the FDA and Amgen escalated. On January 16, 2026, the FDA formally requested that Amgen voluntarily withdraw Tavneos from the market due to concerns about the integrity of the pivotal clinical trial data and the drug’s overall benefit-risk profile, particularly in light of hepatotoxicity risks. However, on January 28, 2026, Amgen declined to withdraw the drug and indicated it would continue to defend Tavneos.
2023-2025
These actions followed years of growing safety signals after the drug entered the market. Between 2023 and 2025, postmarketing surveillance identified increasing reports of serious liver injury, including drug-induced liver injury and vanishing bile duct syndrome, with some cases resulting in hospitalization and death.
November 2022
Notably, the first known case of vanishing bile duct syndrome associated with Tavneos was reported to the FDA on November 1, 2022, shortly after the drug’s approval.
October 2021
Tavneos was originally approved by the FDA on October 7, 2021, as an adjunct treatment for adults with severe active ANCA-associated vasculitis. At the time of approval, the label did not identify vanishing bile duct syndrome as a risk with the use of the drug.
You may qualify for a Tavneos lawsuit if you took Tavneos (avacopan) for ANCA-associated vasculitis, granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA), and subsequently developed drug-induced liver injury, vanishing bile duct syndrome, liver failure, jaundice, or required hospitalization, a liver transplant evaluation, or died from liver-related complications. Claims may also be brought by surviving family members of patients who died after Tavneos-related liver injury. Eligibility depends on your medical records and your state’s filing deadline, which an attorney can review at no cost.
Potential Tavneos claims may involve patients who:
Tavneos (avacopan) lawsuits cover serious liver injuries documented in FDA postmarketing surveillance, including drug-induced liver injury (DILI), vanishing bile duct syndrome (VBDS), liver failure requiring transplant evaluation, and death from hepatic complications. VBDS, characterized by progressive destruction and disappearance of bile ducts, was identified as a new safety concern not disclosed in the original labeling. Additional reported injuries include cholestatic jaundice, severe itching, elevated liver enzymes, and hepatotoxicity requiring hospitalization. The majority of VBDS cases occurred within 60 days of starting Tavneos and primarily affected patients aged 65 and older.
Patients who took Tavneos should seek medical attention if they experience symptoms of liver injury, including:
The FDA has advised healthcare professionals to conduct liver panel testing frequently during the first months of Tavneos treatment and to discontinue Tavneos when certain liver abnormalities or symptoms occur.
Compensation in a Tavneos lawsuit depends on the severity of the liver injury and the documented financial and personal harms it caused. Because no global settlement has been reached and no MDL exists to publish common benefit fund figures, individual claim values are evaluated on a case-by-case basis. Claims generally seek damages for medical treatment and hospitalization costs, liver specialist care and transplant evaluation, lost income during recovery, pain and suffering, and wrongful death damages for surviving family members. In comparable pharmaceutical failure-to-warn cases involving serious organ injury, individual settlements have ranged from tens of thousands to hundreds of thousands of dollars, depending on injury severity, documented expenses, and causation strength.
The deadline to file a Tavneos lawsuit is set by the statute of limitations in your state, which typically ranges from two to three years for personal injury claims [VERIFY: confirm preferred jurisdiction range]. In many states, the clock starts not on the date you first took Tavneos but on the date you knew or reasonably should have known that Tavneos caused your liver injury, a rule called the discovery rule. For wrongful death claims, the deadline generally runs from the date of death. Because these deadlines vary by state and can be shorter than patients expect, a prompt case review is the best way to protect your right to file.
If you or a loved one suffered liver injury, vanishing bile duct syndrome, or other serious complications after taking Tavneos, you may have a legal claim.
Recent FDA actions, including safety warnings about fatal liver injuries and a proposal to withdraw approval of Tavneos, raise serious concerns about the drug’s safety and effectiveness. These developments may be important to your case.
Our attorneys are actively investigating Tavneos lawsuits nationwide and are available to evaluate your claim.
There are time limits for filing a claim. It is important to act promptly to protect your rights.
Call us today at 800.277.1193, or complete our online form to speak with a member of our Tavneos team.
The Tavneos lawsuit involves claims that the manufacturer failed to adequately warn patients and physicians that Tavneos (avacopan) can cause serious drug-induced liver injury, vanishing bile duct syndrome, liver failure, and death. The FDA identified 76 cases of Tavneos-related liver injury in postmarketing data, including 54 hospitalizations and 8 deaths, and issued a safety alert on March 31, 2026. Lawsuits allege that patients and doctors were not warned about these risks, particularly vanishing bile duct syndrome, which was not identified in the original labeling.
You may be able to sue if you took Tavneos and developed drug-induced liver injury, vanishing bile duct syndrome, liver failure, or another serious hepatic condition, and your medical records document that injury. Eligibility generally depends on the severity of the harm, whether the condition required hospitalization or specialist care, and your state’s filing deadline. An attorney can evaluate your records at no cost to determine whether you have a viable claim.
Tavneos has not been formally recalled or removed from the market as of June 2026. The FDA proposed withdrawing approval of Tavneos on April 27, 2026, citing concerns about clinical trial data integrity and hepatotoxicity risks, and Amgen had until June 1, 2026, to request a formal hearing on that proposal [VERIFY: confirm hearing request status]. The FDA’s March 31, 2026, safety communication identified serious liver injuries and deaths, but did not mandate removal. Tavneos remains available by prescription while the regulatory process continues.
Vanishing bile duct syndrome (VBDS) is a rare and severe liver condition characterized by progressive destruction and disappearance of the bile ducts inside the liver. When bile ducts are destroyed, bile cannot flow properly, leading to a buildup that damages liver tissue and can cause permanent liver damage or failure. VBDS associated with Tavneos typically presented with jaundice, severe itching, and elevated liver enzymes, with the majority of cases occurring within 60 days of starting treatment and primarily affecting patients aged 65 and older. The FDA identified VBDS as a new safety concern not disclosed in Tavneos’s original labeling.
Symptoms of Tavneos-related liver injury include yellowing of the skin or eyes (jaundice), severe itching, unusual fatigue, nausea or vomiting, dark urine, light-colored stools, pain or swelling in the upper right abdomen, and elevated liver enzyme results on blood tests. These symptoms may indicate drug-induced liver injury or vanishing bile duct syndrome. The FDA advises that patients who experience these symptoms while taking Tavneos contact their healthcare provider immediately. Anyone who has already stopped Tavneos and developed these symptoms should also seek medical care, as liver damage can continue after the drug is discontinued.
No. As of June 2026, there is no multidistrict litigation (MDL) or class action lawsuit for Tavneos personal injury claims involving liver damage. A separate securities fraud class action was previously filed against ChemoCentryx by investors over allegations related to clinical trial data; that case settled for $35 million in March 2026 and involved investor claims rather than patient injuries. Tavneos liver injury claims are currently being filed and investigated as individual product liability lawsuits. If enough cases are filed, consolidation into an MDL could follow, but that has not occurred yet.
The filing deadline for a Tavneos lawsuit depends on your state’s statute of limitations, which typically ranges from two to three years for personal injury claims. Most states apply the discovery rule, which starts the clock on the date you knew or reasonably should have known that Tavneos caused your liver injury, rather than the date you first took the drug. For wrongful death claims, the deadline generally runs from the date of death. Because deadlines vary and missing one can permanently bar your claim, having your case reviewed as soon as possible is the safest course.
The FDA has taken two significant actions regarding Tavneos in 2026. On March 31, 2026, the agency issued a Drug Safety Communication identifying 76 cases of serious drug-induced liver injury associated with Tavneos, including 54 hospitalizations and 8 deaths, and flagging vanishing bile duct syndrome as a new safety concern. On April 27, 2026, the FDA proposed withdrawing approval of Tavneos entirely, citing a lack of substantial evidence of effectiveness and untrue statements in the original approval application. Amgen, which markets Tavneos through its ChemoCentryx subsidiary, declined the FDA’s earlier January 2026 voluntary withdrawal request, and Tavneos remains on the market while the regulatory process continues.
Family members may be able to file a wrongful death lawsuit if a loved one died after developing drug-induced liver injury, vanishing bile duct syndrome, or liver failure associated with Tavneos. Wrongful death claims are filed by surviving spouses, children, or other eligible family members, depending on state law. The deadline for wrongful death claims typically runs from the date of death rather than the date of drug use. A free case evaluation can help the surviving family determine whether they have a viable claim and how much time they have to file.
No settlement amounts have been established for Tavneos personal injury claims, because the litigation is in early stages and no MDL or global resolution process exists yet. The value of an individual claim depends on the severity of the liver injury, the cost of medical care and hospitalization, lost income, long-term effects, and, for wrongful death claims, the financial support the deceased provided to family members. In comparable pharmaceutical failure-to-warn cases involving serious organ injury, individual settlements have ranged widely based on these factors. An attorney can estimate a value range after reviewing your specific records.