Lawsuit Alleges Andexxa Administered To Reverse Xarelto Effects Caused Near-Fatal Thrombotic Event

High blood clot risks led AstraZeneca to issue a global Andexxa recall in December, following multiple post-marketing surveillance reports of severe injuries, deaths.

An Oregon man has filed an Andexxa lawsuit against several health care professionals, accusing them of malpractice, saying they misused the blood thinner reversal agent, which resulted in serious injuries.

The complaint (PDF) was brought by Michael Cassel in Oregon Circuit Court on May 11. It names Radiology Associates PC, Dr. Bernardo H. Isuani, McKenzie Physician Services, Dr. Andre C. McIvor and Alex C. Bauer as defendants.

Cassel indicates he was taking Xarelto, a newer-generation blood thinner prescribed to treat atrial fibrillation, when he went to the emergency room in May 2024. Before surgery to address his pain, doctors allegedly administered Andexxa to reverse the blood-thinning effects of Xarelto and reduce the risk of serious bleeding complications.

However, Cassel claims Andexxa carries a known risk of thrombotic events, which may occur in about 7% of patients, and was never approved for use as a preventive treatment before any bleeding had actually occurred.

Andexxa Blood Clot Risks

The U.S. Food and Drug Administration (FDA) first approved Andexxa (andexenet) in 2018, through a fast-track review process. The drug was designed to stop uncontrollable bleeding events linked to a new generation of direct oral anticoagulants, including Xarelto and Eliquis. Unlike their older predecessor warfarin, these drugs’ blood thinning effects could not be stopped through the use of vitamin K, and doctors often found themselves in situations where they could not prevent patients from bleeding out.

However, Andexxa was launched carrying a black box warning for certain thromboembolic risks, like blood clots, deep vein thrombosis and pulmonary embolism. In December, the FDA issued an Andexxa safety communication, indicating that the risk of blood clots was much higher than originally anticipated. This resulted in the manufacturer, AstraZeneca, issuing an Andexxa recall, removing the drug from the market.

FDA analysis of post-marketing data indicated that taking Andexxa more than doubled the risk of thrombosis, or blood clots, with 14.6% of Andexxa patients experiencing clotting, as opposed to 6.9% of patients who underwent standard medical care. Andexxa patients were also more than twice as likely to die than those given standard care, with 2.5% of patients dying on the Andexxa side of the trial, compared to just 0.9% treated via standard care.

Andexxa Thrombosis Allegations

According to the medical malpractice claims, Cassel was diagnosed with an inflamed gallbladder after suffering severe abdominal pain. Doctors decided that the organ needed to be removed yet was too inflamed to do so at the time. Therefore, they decided to try decompression of his gallbladder first.

Cassel indicates that he was given Andexxa as a prophylactic, before any bleeding problems were diagnosed. However, the drug was never designed, nor approved, to be used in that capacity.

Following placement of a percutaneous cholecystostomy tube by Dr. Isuani on May 27, 2024, Cassel says he underwent sudden heart problems, resulting in ventricular fibrillation arrest that required emergency resuscitation. An examination and cardiac catheterization revealed he suffered severe blood clots, which blocked vital arteries, including the right coronary artery (RCA) and left anterior descending (LAD) artery. Both were 99% to 100% blocked.

The filing indicates these symptoms are consistent with an acute thrombotic event, which could have been caused by Andexxa.

While Cassel’s lawsuit focuses on malpractice allegations, it comes as a growing number of Andexxa lawsuits are expected to be filed in the coming weeks and months, although most claims are likely to target the drug’s manufacturers rather than the physicians who prescribed it.

Cassel presents claims of medical negligence and lack of informed consent. He seeks nearly $11 million in economic and noneconomic losses.

Andexxa Lawsuits

In the wake of the market removal, product liability lawyers are investigating potential Andexxa lawsuits over injuries and wrongful deaths linked to the reversal agent’s side effects and complications, which can include:

• Stroke
• Heart attack
• Pulmonary embolism
• Deep vein thrombosis (DVT)
• Other dangerous blood clots requiring emergency treatment
• Sudden or unexpected clotting shortly after Andexxa was administered
• Death caused by a blood clot or clot-related complication

Lawyers are offering free consultations and claim evaluations to help families determine whether financial compensation may be available through an Andexxa lawsuit, as a result of the drug makers failure to adequately research the side effects and warn about potential risks associated with the reversal agent.

All lawsuits over Andexxa side effects are being investigated on a contingency fee basis, which means there are no upfront costs to hire a lawyer, and no fees or expenses are charged unless a recovery is obtained through an Andexxa settlement or verdict.

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