Tavneos Liver Injury Claims — October 2026 Status: On April 27, 2026, the FDA’s drug center proposed withdrawing approval of Tavneos (avacopan), citing problems with the pivotal trial data. Amgen requested a hearing, and as of October 20, 2026 no decision has been made public. Tavneos has not been recalled, and no personal-injury lawsuit has been reported yet. The FDA’s March 31, 2026 safety communication identified 76 cases of drug-induced liver injury linked to the drug, including 54 hospitalizations and 8 deaths. In Georgia, an injury claim generally must be filed within two years under O.C.G.A. § 9-3-33, and that clock may have started when your liver injury began, not with any FDA announcement. Call (205) 407-6009 for a free review of your dates and records.
This page is for Georgia patients who took Tavneos for ANCA vasculitis and then developed liver trouble: jaundice, a hospital stay, a biopsy showing bile duct loss, or a liver that never fully came back. It’s also for the spouses and grown children who usually end up making the calls, because the patient is often older, worn down by months of steroids and infusions, and sometimes still in the hospital.
We’re Fob & Foster Personal Injury Lawyers, based in Birmingham, and we review Tavneos claims from anywhere in Georgia. Below is what we know as of October 20, 2026, what nobody knows yet, and how much time Georgia law gives you.
Georgia Deadline Warning: Georgia generally allows two years (O.C.G.A. § 9-3-33), and in most cases the clock starts when the injury happens. A narrower discovery rule may help for injuries that developed gradually, but don’t count on it. A wrongful death claim is generally two years from the death. Call (205) 407-6009 with your diagnosis date.
Tavneos and the Georgia Patients Who Take It
Tavneos is the brand name for avacopan, a capsule the FDA approved on October 7, 2021, as an add-on treatment for adults with severe active ANCA-associated vasculitis (granulomatosis with polyangiitis, or GPA, and microscopic polyangiitis, or MPA), taken with standard therapy that includes glucocorticoids. The usual dose is three 10 mg capsules twice a day with food.
ANCA vasculitis is a rare autoimmune disease that inflames small blood vessels, often in the kidneys, lungs and sinuses. Patients are typically older adults already taking prednisone, rituximab or cyclophosphamide. Some of those can stress the liver too, and a serious case has to account for them.
The drug was developed by ChemoCentryx, Inc., now a wholly owned Amgen subsidiary after a roughly $3.7 billion acquisition completed October 20, 2022. Amgen says more than 8,000 U.S. patients have been treated.
Tavneos isn’t stocked at the corner drugstore. It ships from select specialty pharmacies (the manufacturer currently lists two, PANTHERx Rare Pharmacy and Biologics, and the network has changed over time) after enrollment through a manufacturer hub called TAVNEOS Connect, which handles start forms, copay help and home delivery. That gives you a clean paper trail. The prescribers are mostly rheumatologists and nephrologists. In Georgia, vasculitis patients are commonly treated through the large metro Atlanta health systems, such as Emory and Piedmont, and through specialty practices in Augusta, Savannah, Macon and Columbus. We name them only because that’s where records tend to be, not to fault any doctor.
What the FDA Reported About Liver Injury in March 2026
On March 31, 2026, the FDA issued a Drug Safety Communication on serious liver injury with Tavneos. The core numbers:
| FDA finding | Number |
|---|---|
| Drug-induced liver injury (DILI) cases with reasonable evidence of a causal link | 76 (74 serious) |
| Hospitalizations / deaths | 54 / 8 |
| Biopsy-confirmed vanishing bile duct syndrome (VBDS) | 7 (all hospitalized, 3 died) |
| Median time to onset | 46 days (range 22 to 140) |
| Cholestatic or mixed pattern, of 60 cases with lab data | 38 |
| Where reports came from | Japan 66, U.S. 5, Europe 4, Canada 1 |
Two things stand out to a lawyer. The timing is tight: liver trouble that started within the first few months fits what the FDA described. And most reports came from Japan. Amgen says there are “no known deaths in the U.S.” tied to serious liver injury, and the defense will use that. Our answer is that adverse-event reporting is voluntary and doctors often don’t tie a liver problem to one drug among several. It’s still a real argument.
What the Label Has Said About the Liver
Tavneos carries no Boxed Warning. Hepatotoxicity has been in the label’s Warnings and Precautions (section 5.1) since approval; in the pivotal trial, hepatic adverse reactions hit 13.3% of Tavneos patients versus 11.6% on prednisone (serious: 5.4% versus 3.7%). In May 2026 that section was strengthened to describe postmarketing VBDS, including fatal cases (mostly Japanese patients 65 and older), to call for liver tests before starting and every four weeks for six months, and to require permanent discontinuation if VBDS is suspected. The gap between the 2021 warning and the 2026 one is where a failure-to-warn case would live.
Vanishing Bile Duct Syndrome Explained
The liver makes bile, which drains through tiny ducts inside the liver. In VBDS, those small ducts are progressively destroyed and disappear. Bile backs up, a condition called cholestasis; MedlinePlus has a plain-language page on cholestasis. Doctors usually work it up in stages: blood tests (bilirubin, alkaline phosphatase or ALP, GGT, ALT and AST), then an ultrasound or MRCP to rule out a stone or tumor blocking the ducts, then a liver biopsy, which is the gold standard.
What makes VBDS so serious is that it can keep progressing after the drug is stopped. Some patients recover. Some are left with chronic liver disease, and some need a transplant or die. NIH Drug-Induced Liver Injury Network data found that bile duct loss on biopsy predicted worse outcomes, with chronic injury in most. Future care belongs in any claim. And not every Tavneos injury is VBDS; broader drug-induced liver injury with jaundice or a hospital stay can support a claim too.
Symptoms and When to Get Care
Your Health Comes First: Don’t stop or change Tavneos on your own, because uncontrolled vasculitis can damage the kidneys and lungs. If you have yellow skin or eyes, dark urine, unusual tiredness, itching or pain in the upper right belly, contact your doctor right away. Go to an emergency room for jaundice with confusion, vomiting or severe abdominal pain.
The FDA told Tavneos patients to contact a health care professional right away for possible signs of liver injury, including unusual tiredness, nausea or vomiting, unusual itching, light-colored stools or dark urine, yellowing of the skin or eyes, and abdominal swelling or pain in the upper right abdomen. If you have any of these, call your prescriber today or go to an emergency room. The legal questions can wait a day.
Please don’t stop or change a prescription on your own because of this page. Uncontrolled vasculitis is dangerous, and that decision belongs to you and your doctor.
The FDA also advised doctors to check liver tests every two weeks in the first month, then monthly for five months; to stop the drug promptly if ALT or AST passes three times the upper limit of normal, ALP passes twice the limit, or jaundice or itching appears; and to refer to a hepatologist if the numbers don’t improve. If your labs climbed and nobody acted, note the dates.
How Regulators Have Treated Tavneos
The liver reports are a safety issue. The FDA’s effort to pull the drug rests mainly on whether the approval trial can be trusted.
| Regulator | Action | Date |
|---|---|---|
| U.S. FDA (CDER) | Asked Amgen to withdraw voluntarily; Amgen declined January 28. CDER then proposed withdrawing approval. Amgen requested a hearing; no decision is public, and the drug is still sold. | January 16 and April 27, 2026 |
| European Union | EMA’s committee recommended revocation; the European Commission revoked the authorization. EMA told doctors not to start new patients and to switch current patients to other options. | June 2026 (announced June 26); Commission decision August 4, 2026 |
| United Kingdom (MHRA) | Stopped new-patient supply of the drug (now sold there as Avacopan Vifor); full revocation scheduled. Said the pivotal study “can no longer be relied upon.” | September 1, 2026; revocation scheduled March 1, 2027 |
| Japan | Ordered an urgent label revision after Kissei reported 20 fatal serious liver-injury cases among about 8,500 patients. Japan’s PMDA later found a causal link could not be ruled out in 2 of the 20. | May 15 and May 21, 2026 |
| Canada | Health Canada advised against new starts during a data-integrity review. | July 7, 2026 |
The Trial-Data Problem Behind the Withdrawal Proposal
According to the FDA’s withdrawal announcement, CDER’s legal grounds are a lack of substantial evidence of effectiveness and untrue statements of material fact in the application. In its Federal Register notice, CDER says that after the first database lock of the pivotal ADVOCATE trial on November 5, 2019, when the primary endpoint missed significance (p=0.1025), unblinded company personnel picked nine subjects for readjudication, producing a second lock on November 20, 2019 (p=0.0132), and the application didn’t disclose the original analysis. The New England Journal of Medicine retracted the 2021 ADVOCATE paper on June 29, 2026. Amgen disputes the FDA. Its July 23, 2026 submission included an independent Duke Clinical Research Institute re-review that, Amgen says, confirmed Tavneos was non-inferior to the steroid comparator but did not show the superiority the original analysis reported.
Your injury case would be about your liver, but the trial findings still matter. Warnings and design are judged against what a drug actually offers, and if its benefit was overstated, the liver risk weighs more. The FDA’s announcement of the proposal calls VBDS and liver-injury cases with fatal outcomes “new safety concerns,” as background to its legal grounds.
Who May Have a Tavneos Claim in Georgia
We want to hear from anyone who took Tavneos while living or being treated in Georgia and then had:
- jaundice (yellow skin or eyes)
- a hospital admission for liver injury or cholestasis
- a biopsy showing bile duct loss, or a VBDS diagnosis
- chronic liver disease or liver failure
- a liver transplant or transplant evaluation
Families of a patient who died from liver injury may have a wrongful death claim.
Being candid: a mild enzyme bump that cleared quickly after the drug was stopped, with no hospital stay and no lasting harm, usually won’t support a lawsuit. We’ll also tell you if your timing falls outside the FDA’s pattern or another drug looks likelier, because a weak causal link tends to collapse later. Being older or already sick doesn’t disqualify anyone.
Did your liver trouble start after Tavneos? Tell us when you started the drug and when symptoms began, and we’ll tell you whether the dates and injury fit a claim under Georgia law. Call (205) 407-6009 or send us your question online.
How a Tavneos Case Would Be Built
No Tavneos injury case has been reported filed anywhere, so there’s no complaint or ruling to point to. Here is how we expect a Georgia case to be put together.
Failure to Warn and the Learned Intermediary Doctrine
Georgia applies the learned intermediary doctrine: a drug maker’s duty to warn runs to the prescribing doctor. So the case asks what ChemoCentryx and Amgen told rheumatologists and nephrologists about liver risk, and when. Did the label say VBDS could happen, could kill, and could keep going after the drug was stopped? Did it say how often to test? Then comes the follow-up question: would your doctor have prescribed or monitored differently with today’s warning? The prescriber’s testimony usually answers it.
The April 2024 Label Proposal Amgen Describes
In its July 23, 2026 FDA submission, Amgen said it proposed a VBDS label update in April 2024. The strengthened VBDS language reached the label in May 2026. What happened in those two years, and why, is a discovery question. If you started Tavneos during that stretch, we’ll want your start date.
Strict Liability, Negligence and Benefit-Risk
Georgia holds manufacturers strictly liable for defective products under O.C.G.A. § 51-1-11(b)(1). For a prescription drug that usually becomes a benefit-versus-risk argument, and the FDA’s trial findings bear directly on the benefit side. A negligence claim adds a separate question: did the company act reasonably in tracking adverse events and updating doctors as the Japanese reports came in?
Causation and Competing Explanations
This is the hard part. Vasculitis patients take several drugs, and some affect the liver. A credible case needs a hepatologist or similar expert to weigh the timing, the lab pattern, the biopsy and the other medicines, and explain why Tavneos is the likeliest cause. We’d rather answer that early than hear it first from Amgen’s experts.
Discovery
Once cases are filed, the companies’ internal files take center stage: adverse event reports, safety reviews, label talks with the FDA, and the readjudication records. Our national co-counsel relationships matter in a document fight this size.
Records That Prove a Tavneos Case
You don’t need all of this before calling us, but start the requests today.
| Record | Who holds it | What it proves |
|---|---|---|
| Dispensing and shipment history | The specialty pharmacy that shipped it (currently PANTHERx Rare Pharmacy or Biologics; earlier patients may have used others) | When Tavneos reached you, at what dose, and when it stopped |
| Enrollment and start form; copay records | TAVNEOS Connect hub and copay program | Start date, enrolling prescriber, and a second proof of use |
| Prior authorization and claims | Your insurer, Medicare plan or Medicaid | Approval dates and every related bill |
| Prescriber notes | Rheumatologist or nephrologist | Why the drug was started, what monitoring was ordered, what you were told |
| Liver labs and imaging | Labs, doctor’s office, hospital | The dated rise in bilirubin, ALP, GGT, ALT and AST; ultrasound or MRCP ruling out blockage |
| Biopsy and pathology report | Hospital pathology | Bile duct loss or VBDS |
| Hospital chart and discharge summary | The hospital | What the treating team thought caused the injury |
| Hepatology and transplant records | Hepatology clinic or transplant center | Severity, prognosis and future care |
| Death certificate and any autopsy | County vital records or medical examiner | Cause of death |
Keep leftover capsules, bottles and shipping boxes, and screenshot your patient-portal lab results now; portals don’t always keep old results visible.
Georgia Law on Tavneos Liver Injury Claims
This is general information, not advice on your dates. Drug-case deadlines turn on facts in your records, so call us rather than calculating your own.
The Two-Year Deadline Under O.C.G.A. § 9-3-33
Georgia allows two years to file a personal injury suit, and the clock generally starts when the injury happens. Georgia courts apply a discovery rule mainly to injuries that develop gradually from continued exposure, sometimes called a continuing tort. In those cases the clock runs from when you knew, or reasonably should have known, about the injury and its likely cause. Whether a liver injury that built up over weeks on Tavneos qualifies is a fact question, and that is where the fights happen. Plan around the earlier date.
Picture a hypothetical Macon patient who turned yellow six weeks after starting Tavneos in late 2025 and whose hospital chart says the drug was the likely cause. The defense will argue her clock started that week, not when the FDA went public on March 31, 2026. Compare a Savannah patient whose doctors blamed his liver numbers on something else until his daughter read the news this summer. He may have an argument for a later start under the discovery rule, but Georgia applies it narrowly and there is no guarantee. If you were diagnosed in 2025 or early 2026, assume your time may be shorter than you’d like.
Ten-Year Repose and the Disease Exception
Georgia’s statute of repose generally bars strict liability claims more than ten years after the product’s first sale for use or consumption, O.C.G.A. § 51-1-11(b)(2), regardless of when you discovered anything. Section 51-1-11(c) extends that ten-year limit to most negligence claims against a manufacturer, but not to negligence claims over products that cause a disease or birth defect, or to conduct showing willful, reckless or wanton disregard for life or property, and a manufacturer keeps a duty to warn once it learns of a danger. For Tavneos, approved in October 2021, repose shouldn’t be the obstacle. The two years is.
Comparative Fault: the 50% Bar
Under O.C.G.A. § 51-12-33, you recover nothing if you’re 50% or more at fault; below that, your award is reduced by your share. Expect the defense to point at missed lab draws or late symptom reports. We answer with the record: what the label told your doctor to monitor and what your doctor told you.
Damages and the 75% Punitive Rule
Georgia doesn’t cap compensatory damages: medical care past and future (including transplant and lifelong monitoring), lost earnings, and pain and suffering. Punitive damages in product liability cases aren’t held to Georgia’s general $250,000 cap, but under O.C.G.A. § 51-12-5.1(e), 75% of a product liability punitive award, less a proportional share of costs and fees, goes to the state treasury.
Wrongful Death: the “Full Value of the Life”
When a Tavneos liver injury is fatal, O.C.G.A. § 51-4-2 lets the family recover the “full value of the life” of the person who died, measured from that person’s own perspective. That reaches beyond lost income to the value of living itself. The claim generally belongs first to the surviving spouse and children, and the estate may have a separate claim for medical and funeral expenses. The deadline is generally two years from death. Our wrongful death claims page explains more.
Georgia Residents Treated Across State Lines
Dalton and Rome families often see specialists in Chattanooga; Columbus patients cross into Alabama; Augusta sits on the South Carolina line. If any of your prescribing, dosing or hospital care happened outside Georgia, which state’s law and deadline apply can depend on where the injury happened and where the case is filed. Tennessee generally gives injury claimants one year, and Alabama’s contributory negligence rule can bar a claimant found even slightly at fault. Mention every state involved on your first call.
What a Tavneos Claim May Be Worth
No Tavneos injury case has been filed, tried or settled, so there’s no figure to quote, and anyone offering one is guessing. Value in a drug case usually turns on:
- Severity: biopsy-confirmed VBDS, liver failure, transplant or death at the top; a hospital stay with full recovery lower.
- Permanence: chronic liver disease means years of specialists and monitoring.
- Medical costs, past and future.
- Lost income and family caregiving.
- Causation proof: onset inside the FDA’s window, a cholestatic pattern, and a doctor who documented the link.
- Corporate knowledge: what the company knew, and when, compared with what doctors were told.
- Defenses: other liver-toxic drugs, prior liver disease and comparative fault.
Why You Shouldn’t Wait for a Lawsuit to Be Filed
Georgia’s two years run from your own injury (or, at best, your own discovery of it), not from the first filing somewhere else. If the first cases come in 2027 and you were diagnosed in early 2025, you could be out of time. Records also scatter as insurance changes, portals purge results and doctors retire. Early work, like a biopsy review and a charted lab trend, is what makes a case filed on time and filed right. Firms across the country are investigating now, and a call commits you to nothing.
Steps to Take This Week
- Get medical care if symptoms continue, and don’t stop or change Tavneos without your doctor.
- Write a one-page timeline: start date, first symptoms, hospital visits, and when anyone first blamed the drug.
- Ask the specialty pharmacy for your full dispensing history.
- Download portal lab results back to before you started Tavneos.
- Save bottles, boxes, inserts, letters and copay cards.
- List every prescriber, hospital, lab and other medicine involved.
- Call us for a free review of your deadline.
Talk to a Georgia-Licensed Lawyer
Attorney James Z. Foster is licensed in Georgia. We review Tavneos claims statewide by phone or video, and a family member can join the call. If you searched for a Tavneos lawyer near me in Atlanta, Marietta or Alpharetta, or you’re in Athens, Albany or Valdosta, the process is the same. If cases are later consolidated in one court, our co-counsel work lets a Georgia client keep working with us.
Tavneos Lawsuit Timeline
Regulatory events a case would be built on, newest first.
October 20, 2026 – No Hearing Decision, No Injury Suits Reported
No FDA decision on Amgen’s hearing request is public. Tavneos stays on the U.S. market until Amgen removes it or the FDA Commissioner orders withdrawal. No injury lawsuit, MDL or JPML petition has been reported.
September 1, 2026 – UK Halts New Patients
The MHRA stopped new-patient supply and scheduled full revocation for March 1, 2027.
August 6, 2026 – EU Revocation Announced
The European Commission’s August 4 decision revoking Tavneos’s EU authorization was announced.
July 23, 2026 – Amgen’s Hearing Submission
Amgen filed data, including the Duke re-review, and said it had proposed a VBDS label update in April 2024.
July 13, 2026 – FDA Page Updated
The FDA’s Tavneos page, last updated July 13, advises doctors to discuss with patients whether to use or continue Tavneos while a final decision is pending. Health Canada had advised against new starts on July 7.
Late June 2026 – EMA Recommendation and NEJM Retraction
EMA announced its committee’s revocation recommendation on June 26, and NEJM published its retraction of the ADVOCATE paper on June 29.
June 1, 2026 – Amgen Requests a Hearing
Amgen formally contested the withdrawal proposal.
May 21, 2026 – Japan’s Urgent Label Revision
Japan’s regulator ordered the revision after Kissei’s May 15 report of 20 fatal cases. The U.S. label’s liver warning was strengthened the same month.
April 27, 2026 – Withdrawal Proposed
CDER proposed withdrawing approval (Federal Register April 30, 2026; Docket FDA-2026-N-1321).
March 31, 2026 – FDA Liver Injury Communication
The FDA reported 76 liver injury cases, including 8 deaths.
January 16 and 28, 2026 – Voluntary Withdrawal Requested and Declined
CDER asked Amgen to withdraw Tavneos voluntarily; Amgen said no.
October 7, 2021 – FDA Approval
The FDA approved Tavneos (NDA 214487).
Georgia Tavneos Lawsuit FAQs
Is there a Tavneos lawsuit I can join in Georgia?
Not yet. As of October 20, 2026, no personal-injury lawsuit over Tavneos liver injury has been reported anywhere in the United States, and there is no MDL, though law firms nationally are investigating. Georgia patients still shouldn’t wait. The state’s two-year deadline generally runs from your own injury, or in some cases from when you discovered it and its likely cause, not from when someone else files, so a lawyer should review your records now.
Has Tavneos been recalled?
No. On April 27, 2026, the FDA’s drug center proposed withdrawing Tavneos’s approval, mainly over problems it found in the pivotal ADVOCATE trial data. Amgen requested a hearing, and no decision had been announced as of October 20, 2026, so the drug remains on the U.S. market. The European Union has revoked its authorization, and the United Kingdom has stopped supplying new patients.
Will my Tavneos case be filed in Georgia?
That isn’t decided yet. A case could be filed in a Georgia state court, in federal court, or in another state connected to the defendants. When many similar drug cases are filed nationwide, they are often gathered before one federal judge for pretrial work, and a Georgia case could be sent there. Clients usually don’t travel for that stage.
What if the FDA never withdraws Tavneos?
An injury claim doesn’t depend on withdrawal. It asks whether the company adequately warned doctors about liver risk and whether the drug was unreasonably dangerous, while the FDA’s proposal rests on trial data and effectiveness. Drugs that stay on the market can still support injury claims. Georgia’s two-year deadline keeps running either way, so the FDA’s schedule shouldn’t set yours.
How long do I have to file a Tavneos claim in Georgia?
Generally two years under O.C.G.A. § 9-3-33. The clock generally starts when the injury happens; Georgia applies a discovery rule only in narrower cases of gradually developing injury. Either way, the start is likely your liver injury, diagnosis or hospital stay, not the FDA’s March 2026 announcement. A wrongful death claim is generally two years from the death. Because the start date is fact-specific, call a lawyer with your dates instead of counting on your own.
Can I file if I live in Georgia but was prescribed Tavneos in another state?
Usually, yes, but another state’s rules may come into play. Which state’s law and deadline apply can depend on where the injury happened and where the case is filed. A Georgia resident treated in Chattanooga could face questions under Tennessee’s one-year deadline, and one treated in Alabama could face that state’s contributory negligence rule. Tell your lawyer every state involved so each possible deadline gets checked.
Do I need a Georgia lawyer for a Tavneos claim?
You want a lawyer who knows Georgia’s deadline, repose, comparative fault and wrongful death rules. At Fob & Foster, attorney James Z. Foster is licensed in Georgia, and the firm works alongside national co-counsel who litigate pharmaceutical mass torts. We review claims from anywhere in Georgia by phone or video, so you don’t have to travel while you’re recovering.
How much does it cost to hire a Tavneos lawyer?
Nothing up front at Fob & Foster. The case review is free, and we handle Tavneos claims on a contingency fee, meaning no fee unless we recover money for you. The fee is a percentage of any recovery, and the terms are put in writing before work begins. If your claim doesn’t fit, we’ll say so on the first call.
Is there a Tavneos class action?
Not for patients. The case in the news, Homyk v. ChemoCentryx in federal court in Northern California, is a securities class action for investors. It was revised to a $69 million settlement in May 2026, with a final approval hearing currently scheduled for October 29, 2026. Patients aren’t part of it, and drug injury claims are usually filed individually because each person’s injury and records differ.
Talk to a Georgia Tavneos Lawyer Today
Fob & Foster Personal Injury Lawyers is based at 2226 1st Ave S, Suite 105, in Birmingham, Alabama, and works alongside national co-counsel litigating pharmaceutical mass torts.
A free review is a conversation. We’ll ask when you started Tavneos, when the liver trouble began, what your doctors found and what else you were taking. Then we’ll tell you straight whether we see a claim and which deadline likely applies. There’s no fee unless we recover for you.
Call (205) 407-6009 or toll-free (866) 837-1010, or send us your question online. Georgia’s two-year clock may already be running.