Tavneos Lawsuits Over Liver Injury Side Effects May Follow Recall Proposals

Manufacturers will be unable to claim preemption from liability if regulators determine Tavneos was approved under false pretenses.

As regulators worldwide scrutinize allegations that ChemCentryx manipulated clinical trial data to make its autoimmune disease drug appear safer and more effective, the company may face growing exposure to Tavneos lawsuits.

ChemCentryx first introduced Tavneos (avacopan) in the U.S. in 2021, following U.S. Food and Drug Administration (FDA) approval. Now owned by Amgen, the drug is prescribed to adults suffering from a rare autoimmune disease known as active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The condition affects the lungs and kidneys in particular, causing small blood vessels to become inflamed and damaging organs.

The treatment was supposed to be an alternative to long-term steroid use and has been used by more than 7,000 patients.

Tavneos Liver Injury Risks

The FDA issued a drug safety communication in February, warning of the risks of Tavneos liver damage after reports of elevated liver enzymes and signs of acute liver damage in certain users of the medication. The agency indicated it was aware of at least 74 cases of liver complications, 54 hospitalizations and eight deaths.

In April, FDA investigators announced they believed that key clinical trial data used to gain the drug’s approval was manipulated to make the drug appear more effective than it actually was. The agency has proposed issuing a Tavneos recall and has asked Amgen to pull the drug from the market, which the company has refused to do thus far.

The FDA’s warning to Amgen indicated the agency was ready to force Tavneos off the market permanently, revoking the drug’s approval. It indicates that the agency received new information that study personnel manipulated the data in ChemCentryx’s original New Drug Application. According to regulators, this manipulation was done because the real results showed Tavneos’s benefits were not statistically significant, meaning it did not work.

FDA officials say that if the agency had been given the real data, the drug would have never been approved.

That strips Amgen of many of the legal protections drug companies use to avoid litigation. Allegations that the FDA’s approval of Tavneos was based on false data also make it difficult for the manufacturers to argue that lawsuits are preempted by the agency’s approval of the label, and may strengthen claims seeking punitive damages for wanton and reckless endangerment. 

Even more damaging, not only does Tavneos not appear to actually work, but it may be linked to a condition known as vanishing bile duct syndrome (VBDS), a severe form of liver injury that destroys the intrahepatic bile ducts over time. This can cause blocked bile flow, severe injury problems and death, often requiring a liver transplant to treat.

Tavneos Regulatory Concerns

Now, additional agencies around the world are launching their own investigations into the drug’s safety. On June 26, the European Medicines Agency announced that evidence of falsified data has led to recommendations that Tavneos be pulled from the European Union market, calling for revocation of the drug’s authorization.

The UK’s drug regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), also issued a press release last month, announcing it has launched a Tavneos investigation. MHRA says the signs of falsified data are making the agency reassess the drug’s effectiveness.

“The review is being undertaken under the Human Medicines Regulations 2012 Section 68 which states that the licensing authority, the MHRA, may revoke, vary or suspend a UK marketing authorisation if the licensing authority considers that the application, or the material supplied with it, is incorrect or no longer supports a positive benefit–risk balance for the product.”

– Medicines and Healthcare Products Regulatory Agency

Additionally, Kissei, which controls Tavneos distribution in Japan under license from Amgen, issued a warning in May. The warning states that Japanese authorities indicate at least 22 people have died of Tavneos injury risks since the drug was first introduced. They are cautioning doctors to stop giving the drug to new patients, and assess whether its use should be continued for existing patients.

The growing evidence that the original creators lied to drug regulators worldwide, and the number of liver injury deaths associated with its use, significantly increases the likelihood that the manufacturers of Tavneos could face regulatory action. As a result, they also may be the target of Tavneos liver injury lawsuits as more patients realize the drug they were told would help them could be what is killing them.

Tavneos Liver Injury Lawsuits

Tavneos injury lawyers across the U.S. are currently reviewing cases for those who have suffered injuries, or lost loved ones, to what appears to be a purposeful deception of many major drug regulatory agencies worldwide.

Compensation could be available through a product liability lawsuit for those who have suffered:

• Acute liver injury
• Liver failure
• Vanishing Bile Duct Sytndrome (VBDS)
• Chronic cholestasis
• The need for liver transplantation
• Death

Consultations are free, and all claims are handled on a contingency fee basis, meaning the attorneys are only paid if a Tavneos settlement or trial verdict are reached.

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