Tavneos Liver Injury Claims — October 2026 Status: No personal-injury lawsuit or MDL over Tavneos (avacopan) has been reported as of October 20, 2026, but the injuries are documented. On March 31, 2026, the FDA identified 76 cases of drug-induced liver injury linked to Tavneos, including 54 hospitalizations and 8 deaths; 7 of those cases were biopsy-confirmed vanishing bile duct syndrome. In April 2026 the FDA’s drug center proposed withdrawing approval over trial-data problems; Amgen requested a hearing, and no decision has been made. Tennessee generally allows one year to file, and that year may have started at your diagnosis, not at any FDA announcement. If you or a family member took Tavneos and developed jaundice or liver injury, call (205) 407-6009 for a free case review.
This page is for Tennessee patients who took Tavneos for ANCA vasculitis and then ended up with jaundice, a hospital stay or a liver biopsy, and for families of patients who didn’t survive it. Many Tavneos patients are older adults who see a rheumatologist or nephrologist and take a stack of medicines. Some are still in the hospital when a son or daughter starts looking for answers.
We’re Fob & Foster Personal Injury Lawyers in Birmingham, Alabama, and we review Tavneos claims from anywhere in Tennessee by phone or video. We’ll tell you straight what the FDA found, where the law stands, and what Tennessee’s one-year deadline means for you. That deadline is the reason this page exists. Tennessee gives injured people less time than almost any other state, and the clock doesn’t wait for someone else’s lawsuit.
Tennessee Deadline Warning: Tennessee generally gives you one year to file a personal injury claim (Tenn. Code Ann. § 28-3-104), usually counted from when you knew or should have known about the injury and its likely cause. For many Tavneos patients that date is a 2025 or early 2026 diagnosis, so the year may be nearly gone. Call (205) 407-6009 before assuming you have time.
What Tavneos Is and Who Takes It in Tennessee
Tavneos is the brand name for avacopan, a capsule made by ChemoCentryx, Inc., a wholly owned subsidiary of Amgen. The FDA approved it on October 7, 2021, as an add-on treatment for adults with severe active ANCA-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), taken with standard therapy that includes steroids. Amgen completed its roughly $3.7 billion purchase of ChemoCentryx on October 20, 2022. Amgen says more than 8,000 U.S. patients have been treated.
ANCA vasculitis is a rare autoimmune disease that inflames small blood vessels, often in the kidneys, lungs and sinuses. Kidney involvement is common, so Tavneos is mostly prescribed by rheumatologists and nephrologists. In Tennessee, these patients are commonly treated through systems like Vanderbilt in Nashville and UT and Methodist in Memphis, with specialists in Knoxville, Chattanooga and Johnson City, and patients driving in from Clarksville, Murfreesboro, Franklin and Jackson.
You won’t find Tavneos at the corner drugstore. It’s dispensed only through select specialty pharmacies (currently PANTHERx Rare and Biologics), with patients enrolled through a hub called TAVNEOS Connect that handles start forms, copay help and home shipment. That leaves a clean paper trail of exactly when you started and how long you took it.
What the FDA Found About Tavneos and Liver Injury in March 2026
On March 31, 2026, the FDA issued a Drug Safety Communication on serious liver injury in Tavneos patients, based on postmarketing reports through October 9, 2024:
| FDA finding (March 31, 2026) | Number |
|---|---|
| Drug-induced liver injury (DILI) cases with reasonable evidence of a causal link | 76 |
| Serious cases | 74 |
| Hospitalizations | 54 |
| Deaths | 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 with lab data) | 38 |
| Where reports came from | Japan 66, U.S. 5, Europe 4, Canada 1 |
Two numbers deserve a second look. A median onset of 46 days means half the injuries began within about six or seven weeks of starting the drug, and every reported onset fell within about five months. And a cholestatic pattern means the damage mainly affects bile flow, which is the kind of injury VBDS causes.
To be fair about geography: most reports came from Japan, and Amgen says there are “no known deaths in the U.S.” tied to serious liver injury. Expect the company to lean on that. It doesn’t change what happened to a Tennessee patient whose records show liver failure after starting the drug.
The FDA told doctors to check liver tests every two weeks for the first month, then monthly for five months, and to stop Tavneos promptly if ALT or AST rises above three times the upper limit of normal, ALP above two times, or the patient has jaundice or itching.
What the Tavneos Label Says About the Liver
Tavneos has never carried a Boxed Warning. Hepatotoxicity has been in the label’s Warnings and Precautions since approval; in the pivotal trial, hepatic adverse reactions hit 13.3% of Tavneos patients versus 11.6% on prednisone (serious: 5.4% vs 3.7%). In May 2026 that warning was strengthened to describe postmarketing VBDS, including fatal cases, to require liver tests before starting and every four weeks for six months, and to direct permanent discontinuation if VBDS is suspected.
One date stands out. In a July 23, 2026 submission, Amgen said it proposed a VBDS label update in April 2024. That’s Amgen’s own statement, and it raises the question any failure-to-warn case will ask: what were Tennessee prescribers told about bile duct loss in the two years before the label changed?
Why the FDA Wants Tavneos Off the Market
On January 16, 2026, the FDA’s drug center (CDER) asked Amgen to withdraw Tavneos voluntarily. Amgen declined on January 28. On April 27, 2026, CDER proposed withdrawing approval and issued a Notice of Opportunity for a Hearing (Federal Register, April 30, 2026; Docket FDA-2026-N-1321).
The legal grounds concern how the drug got approved: a lack of substantial evidence of effectiveness and untrue statements of material fact in the application. CDER says that after the first database lock of the pivotal ADVOCATE trial on November 5, 2019, the primary endpoint wasn’t statistically significant (p=0.1025). Unblinded company personnel then selected subjects for readjudication, producing a second lock on November 20, 2019 (p=0.0132), and the application didn’t disclose the original analysis. On June 29, 2026, the New England Journal of Medicine retracted the 2021 ADVOCATE paper at the request of its two academic authors.
Amgen requested a hearing on June 1, 2026 and filed data on July 23, 2026, including a Duke Clinical Research Institute re-review it says found Tavneos non-inferior, but not superior, to the steroid comparator. No decision has been announced. Until Amgen pulls it or the FDA Commissioner orders withdrawal, Tavneos stays on the U.S. market.
The FDA’s Effectiveness Case Versus a Tennessee Liver Injury Claim
The FDA’s withdrawal case is about effectiveness and data integrity, with the FDA also saying it is “increasingly concerned about the safety profile” of Tavneos. A Tennessee injury claim is about liver damage and warnings. The two connect: a drug of doubtful benefit with a known liver signal is a harder product to defend in front of a jury.
How Regulators Outside the U.S. Have Acted
- Europe: The EMA‘s committee recommended revocation on June 25, 2026 (announced June 26), and the European Commission revoked the EU authorization on August 4, 2026. Doctors were told not to start new patients and to move current patients to other treatments.
- United Kingdom: The MHRA suspended supply to new patients from September 1, 2026 and plans to revoke the UK authorization on March 1, 2027, saying the pivotal study “can no longer be relied upon.” The UK product is now called Avacopan Vifor.
- Japan: Kissei reported on May 15, 2026 that 20 fatal serious liver-injury cases occurred among more than 8,500 patients (causality not determined in all). On May 21, Japan’s health ministry ordered a label revision adding a liver warning and issued a rapid safety alert to doctors.
- Canada: On July 7, 2026, Health Canada advised against starting new patients during its data-integrity review.
There has been no Tavneos recall. A proposed withdrawal of approval is a different legal process, and it isn’t finished.
Vanishing Bile Duct Syndrome Explained
The smallest bile ducts sit inside the liver. In vanishing bile duct syndrome they’re progressively destroyed, bile backs up into the liver and bloodstream, and doctors call the result cholestasis. VBDS can keep getting worse after the drug is stopped. Some patients recover; others are left with chronic liver disease, 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.
How VBDS Is Diagnosed
- Blood tests: bilirubin, alkaline phosphatase (ALP), GGT, ALT and AST.
- Imaging: ultrasound or MRCP to rule out a stone or blockage in the larger ducts.
- Liver biopsy: the gold standard, where a pathologist reports whether the small ducts are missing.
If you had a biopsy on or after Tavneos, that pathology report may be the most important document in your case. MedlinePlus has a plain-language overview of cholestasis.
Other Medicines the Defense Will Point To
Vasculitis patients are rarely on one drug. Most take steroids, and many have had rituximab or cyclophosphamide. Amgen’s lawyers will point at every one. A credible case accounts for each medication from the start: when it began and ended, what the liver numbers did, and what the hepatologist concluded. The FDA’s timing data gives a window to measure your labs against.
Tavneos Liver Injury 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 patients to contact their health care professional immediately for signs of liver injury such as:
- Feeling more tired than usual
- Nausea or vomiting
- Unusual itching
- Light-colored stools
- Yellowing of the skin or eyes
- Dark urine
- Swelling in the stomach or abdomen
- Pain in the upper right abdomen
Itching and pale stools are typical when bile backs up. Do not stop or change a prescription without talking to your doctor. Uncontrolled vasculitis can damage the kidneys and lungs quickly. Call your rheumatologist or nephrologist, ask when your last liver panel was, and ask whether you should stay on Tavneos. If you have jaundice, confusion, vomiting or severe abdominal pain, go to an emergency room.
Who May Have a Tavneos Claim in Tennessee
No court has set eligibility rules, because no Tavneos injury case has been reported in any court yet. When we review a Tennessee claim, we look for:
- Use of Tavneos. The specialty pharmacy records prove it; you don’t need the bottles.
- A serious liver injury after starting it: jaundice, a hospitalization for liver injury, a VBDS diagnosis (especially biopsy-confirmed), acute liver failure, a transplant or transplant referral, chronic liver disease that didn’t resolve, or death from liver injury.
- Timing that fits. In the FDA’s cases, onset ranged from 22 to 140 days after the first dose.
- A filing date inside Tennessee’s limits, or a real argument that you’re inside them.
Who probably doesn’t have a case: someone whose enzymes bumped up on a routine panel, who never had symptoms, and whose labs returned to normal within weeks. We’ll still look, and we’ll say so if it isn’t a case worth bringing.
If you searched for a Tavneos lawyer near me from Nashville, Memphis or Knoxville, location isn’t a barrier. These cases run on records, and we can review yours without you leaving home.
Not sure your liver injury is serious enough to count? Tell us what happened and what your doctors said, and we’ll tell you whether it fits what the FDA has reported. Call (205) 407-6009 or send us your question online.
Records That Prove a Tavneos Case
A Tavneos claim needs proof you took the drug and proof of what it did to your liver. Because Tavneos runs through a specialty pharmacy and a hub, the proof of use is unusually good.
| Record | Where to get it | Why it matters |
|---|---|---|
| Specialty pharmacy dispensing records | PANTHERx Rare or Biologics | Exact start date, refills and dose, to line up against your labs |
| TAVNEOS Connect enrollment and start form | The hub program or your prescriber’s office | Confirms the prescriber and planned start |
| Copay card records | The copay program, or your statements and emails | Independent proof of use and dates |
| Insurance prior authorization and claims | Your insurer or Medicare Part D plan | The doctor’s stated reason and every paid fill |
| Prescriber notes | Your rheumatologist or nephrologist | What monitoring was ordered and why the drug was stopped |
| Liver labs (ALT, AST, ALP, bilirubin, GGT) | Patient portal or the lab | When the injury started and how bad it got |
| Imaging (ultrasound, MRCP) | Hospital or imaging center | Rules out blockage and other causes |
| Liver biopsy and pathology report | Hospital pathology department | The strongest evidence of VBDS |
| Hospital and hepatology records | Each hospital and the liver specialist | Diagnosis, treatment and the doctors’ opinion on cause |
| Transplant evaluation records | The transplant program | Severity and the cost of future care |
| Death certificate and autopsy | Vital records, the hospital or medical examiner | Ties a death to liver injury for a wrongful death claim |
You can pull your portal labs and discharge summaries today. We’ll handle the formal requests for the rest.
How Tennessee’s One-Year Deadline and Ten-Year Repose Apply to a Tavneos Liver Injury
This is the section Tennessee readers should take most seriously.
The One-Year Statute of Limitations
Tennessee gives most injured people one year to file, under Tenn. Code Ann. § 28-3-104(a)(1). Alabama and Georgia give two. Tennessee applies a discovery rule: the year generally runs from when you knew, or reasonably should have known, that you were injured and that someone’s conduct may have caused it.
Don’t assume your clock started with the FDA’s March 2026 announcement. If a hepatologist told you in 2025 that Tavneos probably caused your liver injury, a court may find your year started at that diagnosis. If your discharge papers say “drug-induced liver injury, suspected avacopan,” the defense will argue you knew then. Some patients are already near or past a year from the day a doctor connected the two.
Accrual is fact-specific, so please call rather than self-calculate. Your discharge summary is often enough for us to give you a working date.
The Statute of Repose
The Tennessee Products Liability Act’s statute of repose, Tenn. Code Ann. § 29-28-103(a), generally requires suit within six years of the injury, and in any event within ten years from the date the product was first purchased for use or consumption, or one year after the product’s anticipated life expires, whichever is shorter, with narrow exceptions. Tavneos was approved in October 2021, so the ten-year limit isn’t close for anyone. How the “anticipated life” language applies to a prescription capsule is something we’d check against your fill dates.
| Tennessee time limit | Statute | General effect on a Tavneos claim |
|---|---|---|
| Personal injury | Tenn. Code Ann. § 28-3-104(a)(1) | One year from when you knew or should have known of the injury and its likely cause |
| Wrongful death | Tenn. Code Ann. §§ 20-5-106, -107, -113 | Generally the same one-year limit |
| Statute of repose | Tenn. Code Ann. § 29-28-103(a) | Six years from injury; ten years from first purchase or one year after anticipated life, whichever is shorter |
Tennessee Product Liability Law for Tavneos Claims
A Tavneos lawsuit in Tennessee would fall under the Tennessee Products Liability Act, Tenn. Code Ann. § 29-28-101 et seq.
The Learned Intermediary Doctrine
Tennessee follows the learned intermediary doctrine (Pittman v. Upjohn Co., Tenn. 1994): a drugmaker’s duty to warn runs to the prescribing doctor. So the case asks what Amgen and ChemoCentryx told rheumatologists and nephrologists about liver injury, and when. If a better warning would have led your doctor to monitor more closely, stop the drug sooner or never prescribe it, that’s the core of a failure-to-warn claim.
Comparative Fault
Under modified comparative fault (McIntyre v. Balentine, Tenn. 1992), you can recover if you’re less than 50% at fault, reduced by your share. The defense may say a patient skipped lab draws. That can reduce a Tennessee award but doesn’t automatically end the case.
Tennessee Damages Caps
- Economic damages (medical bills, lost earnings, future care): not capped.
- Noneconomic damages (pain, suffering, loss of enjoyment): capped at $750,000, or $1,000,000 for catastrophic losses as defined by statute, Tenn. Code Ann. § 29-39-102.
- Punitive damages: generally capped at the greater of twice compensatory damages or $500,000, Tenn. Code Ann. § 29-39-104. For an FDA-approved drug, the same statute generally bars punitive damages unless the maker withheld material information from the FDA or misrepresented it.
In a liver case the uncapped side matters. A transplant, anti-rejection drugs and years of hepatology care are expensive.
Wrongful Death Claims After a Tavneos Liver Injury
When a patient dies, the claim passes to the surviving spouse, children or next of kin (Tenn. Code Ann. §§ 20-5-106, -107, -113), generally within the same one year. Families lose months to grief and the estate. Call sooner than feels comfortable.
What a Tavneos Claim May Be Worth
There are no Tavneos settlements or verdicts, and anyone quoting a Tavneos settlement figure is guessing. What drives value in a drug-induced liver injury case:
- Severity and permanence: a full recovery after a hospital stay versus biopsy-confirmed VBDS, chronic disease or a transplant
- Causation proof: biopsy findings, a hepatologist’s written opinion, and timing that fits the FDA’s window, weighed against other liver-toxic drugs
- Past and future medical costs
- Lost income and a spouse’s caregiving
- Age and life expectancy
- Tennessee’s noneconomic cap and whether the catastrophic tier applies
- What the company knew and when, including the April 2024 label proposal
Why No Tavneos Injury Lawsuit Has Been Reported Yet, and Why You Shouldn’t Wait
As of October 20, 2026, there are no reported Tavneos personal-injury lawsuits, no MDL and no petition to the Judicial Panel on Multidistrict Litigation. Firms nationally are investigating. For a drug this new and this rarely prescribed, with the FDA fight unresolved, that’s not surprising.
But in Tennessee, waiting is the wrong move. Your one-year limit runs on your own facts whether or not any Tavneos case is on file. A national MDL, if one is ever formed, won’t revive a claim that has already expired. And pharmacy, hub and pathology records are kept on retention schedules, not forever. We work alongside national co-counsel, and early work helps get your records pulled and your filing deadline identified.
One case that isn’t yours: Homyk v. ChemoCentryx, a securities class action in the Northern District of California for investors. It reached a proposed $69 million settlement (revised May 15, 2026), with a final approval hearing scheduled for October 29, 2026. It doesn’t compensate patients.
What to Do This Week if You Took Tavneos
- Get medical care for any liver symptoms, and don’t stop Tavneos without your doctor.
- Write down when you started Tavneos, when symptoms began, when you were hospitalized, and when a doctor first linked the drug to your liver.
- Download your liver labs, discharge summaries, biopsy and imaging reports from the patient portal.
- Keep specialty pharmacy packing slips, TAVNEOS Connect emails and copay statements.
- Don’t sign anything from Amgen or an insurer about your injury before talking to a lawyer.
- Call (205) 407-6009 for a free review and a working deadline.
Tavneos Lawsuit Timeline
October 20, 2026 – No FDA Decision; No Injury Lawsuits Reported
Tavneos remains on the U.S. market. The investor settlement’s final approval hearing is scheduled for October 29.
September 1, 2026 – UK Stops New-Patient Supply
The MHRA suspended new-patient supply and plans to revoke the UK authorization on March 1, 2027.
August 4, 2026 – European Commission Revokes EU Authorization
The EU authorization was revoked after the EMA committee’s June recommendation.
July 23, 2026 – Amgen Files Data With FDA
Amgen submitted the Duke re-review and stated it had proposed a VBDS label update in April 2024.
July 13, 2026 – FDA Update
The FDA said Tavneos stays available pending a decision and advised doctors to discuss starting or continuing it.
July 7, 2026 – Health Canada Advisory
Health Canada advised against starting new patients.
June 29, 2026 – NEJM Retracts the ADVOCATE Paper
The New England Journal of Medicine retracted the 2021 pivotal trial paper at the request of its two academic authors.
June 25, 2026 – EMA Committee Recommends Revocation
The EMA announced the recommendation on June 26.
June 1, 2026 – Amgen Requests a Hearing
Amgen contested CDER’s withdrawal proposal.
May 21, 2026 – Japan Orders Label Revision
Japan’s health ministry added a liver warning and issued a rapid safety alert, following Kissei’s May 15 report of 20 fatal cases. Also in May, the U.S. Hepatotoxicity warning was strengthened to describe VBDS.
April 27, 2026 – CDER Proposes Withdrawing Approval
Notice of Opportunity for a Hearing published April 30, 2026 (Docket FDA-2026-N-1321).
March 31, 2026 – FDA Drug Safety Communication
The FDA reported 76 DILI cases, 54 hospitalizations, 8 deaths and 7 biopsy-confirmed VBDS cases.
January 28, 2026 – Amgen Declines Voluntary Withdrawal
Amgen refused CDER’s January 16 request.
October 7, 2021 – FDA Approves Tavneos
Approved under NDA 214487, with hepatotoxicity in Warnings and Precautions and no Boxed Warning.
Tennessee Tavneos Lawsuit FAQs
Is there a Tavneos lawsuit?
Not yet. As of October 20, 2026, no personal-injury lawsuits over Tavneos liver injury have been reported, and there is no MDL. Firms are investigating after the FDA’s March 31, 2026 report of 76 liver-injury cases, including 8 deaths. Tennessee’s one-year deadline runs on your own facts regardless, so have a claim reviewed now.
Is Tavneos being recalled?
No. There has been no Tavneos recall. On April 27, 2026, the FDA’s drug center proposed withdrawing approval, citing a lack of substantial evidence of effectiveness and untrue statements about the ADVOCATE trial data. Amgen requested a hearing, and no decision has been announced as of October 20, 2026.
Is Tavneos still sold in Tennessee?
Yes, for now. Tavneos stays on the U.S. market until Amgen removes it or the FDA Commissioner orders withdrawal. It ships only through select specialty pharmacies, currently PANTHERx Rare and Biologics. The FDA has advised doctors to discuss with patients whether to start or continue it.
How long do I have to file a Tavneos claim in Tennessee?
Generally one year, under Tenn. Code Ann. § 28-3-104(a)(1), usually running from when you knew or reasonably should have known you were injured and that someone’s conduct may have caused it. That may have been your diagnosis, not an FDA announcement. Wrongful death claims are generally the same. Call us rather than calculating it yourself.
Do I need a Tennessee lawyer for a Tavneos claim?
You need a lawyer who knows Tennessee’s one-year deadline, the Tennessee Products Liability Act and Tennessee’s damages caps. Fob & Foster, based in Birmingham, Alabama, reviews Tavneos claims from anywhere in Tennessee by phone or video and works alongside national co-counsel on mass tort cases.
How much does it cost to hire a Tavneos lawyer?
Nothing up front. Fob & Foster handles Tavneos liver injury claims on a contingency fee, so there is no fee unless we recover for you. The first case review is free, by phone or video, with no obligation. We explain the fee agreement in writing before you sign.
My liver tests were abnormal on Tavneos but I recovered. Do I have a claim?
It depends on how serious the injury was. A mild enzyme rise that resolved without symptoms usually isn’t a strong case. Jaundice, a hospital stay, a biopsy or months of hepatology follow-up is different, even with recovery, because those injuries carry real bills and suffering. We will review your labs and tell you where you stand.
A family member died after taking Tavneos. Can we file a claim?
Possibly. In Tennessee a wrongful death claim passes to the surviving spouse, children or next of kin, and it is generally subject to the one-year limit. The FDA reported 8 deaths among its 76 Tavneos liver-injury cases. Gather the death certificate and final hospital records, and call us for a free review.
Is there a Tavneos class action?
Not for patients. The only related class action is Homyk v. ChemoCentryx, a securities case for investors in federal court in Northern California. It reached a proposed $69 million settlement, with a final approval hearing scheduled for October 29, 2026. It does not compensate anyone for liver injury.
Should I stop taking Tavneos?
Talk to your doctor before stopping or changing any prescription, because uncontrolled vasculitis can damage the kidneys and lungs. The FDA has told doctors to discuss Tavneos with patients. If you have yellow skin or eyes, dark urine, unusual tiredness, itching or upper right abdominal pain, the FDA says to contact your health care professional immediately.
Talk to a Tennessee Tavneos Lawyer Today
Fob & Foster Personal Injury Lawyers is a personal injury firm at 2226 1st Ave S, Suite 105, Birmingham, Alabama 35233. We review Tavneos liver injury claims from Memphis to Johnson City by phone or video, and we work alongside national co-counsel.
A free review is a phone call. We’ll ask when you started Tavneos, what your liver did, what your doctors told you and when, and what records you have. Then we’ll tell you whether we see a claim and give you a working Tennessee deadline. 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. With a one-year clock, make the call this week.