Trifecta Heart Failure Lawsuit Alleges Defective Valve Set Caused Death

Lawsuit claims manufacturers failed to warn doctors and patients certain Trifecta GT tissue heart valves could fail within a few years of implantation.

A Nebraska man has filed a wrongful death lawsuit, alleging that the premature failure of a Trifecta GT tissue heart valve caused his wife’s rapid decline into congestive heart failure, ultimately leading to her death after emergency replacement surgery.

The complaint (PDF) was originally brought by Charles R. Warren, individually and as administrator of the estate of his wife, Jean Boletta Warren, in Nebraska District Court late last year. It names Abbott Laboratories Inc. and St. Jude Medical LLC as defendants. The case was removed to the U.S. District Court for the District of Nebraska on June 1.

Charles claims the defendants failed to properly monitor post-market safety data, investigate reports of premature valve failures and provide timely warnings about Trifecta GT valve risks to physicians and patients. As a result, he alleges his wife’s device failed prematurely, setting off a chain of events that included heart failure, repeat surgery, postoperative complications and her death.

Trifecta Heart Valve Complications

In 2017, Abbott Laboratories acquired St. Jude Medical, the original manufacturer of the Trifecta Heart Valve. This prosthetic device is used to replace diseased or damaged aortic valves, which regulate the flow of oxygenated blood from the heart to the rest of the body.

The original Trifecta valve received federal approval in 2011, followed by the next-generation Trifecta GT model in 2016.

However, Abbott halted sales and distribution of all Trifecta heart valves in the United States on July 31, 2023, amid growing concerns about premature structural valve deterioration (SVD). The U.S. Food and Drug Administration (FDA) warned that certain Trifecta devices appeared to experience early valve failure at higher rates than other commercially available bioprosthetic replacement valves.

According to federal regulators, nearly 3,000 adverse event reports involving Trifecta valves were submitted between 2011 and 2023, including more than 2,100 injury reports and at least 191 deaths.

Trifecta Valve Failure Risks

According to the lawsuit, Jean underwent surgical aortic valve replacement at Nebraska Methodist Hospital in Omaha on September 10, 2018, in which she  received a Trifecta GT Tissue Heart Valve. The complaint indicates the device functioned normally following implantation and was expected to provide long-term durability.

However, the lawsuit alleges the valve began to fail approximately five years later, causing severe stenosis and acute congestive heart failure. Warren was hospitalized in December 2023 and underwent urgent repeat aortic valve replacement surgery on December 22, 2023.

Following the procedure, she suffered cardiogenic shock, progressive hypoxia, multi-organ failure and other severe complications before dying on December 26, 2023, at age 78. Prosthetic aortic valve stenosis was identified on her death certificate as part of the chain of events leading to her death.

The lawsuit claims Abbott and St. Jude knew or should have known for years that Trifecta-family heart valves were susceptible to premature structural valve deterioration, or SVD, due to their externally mounted leaflet design.

Warren indicates that post-market data, adverse event reports and published medical literature revealed that some Trifecta valves were failing within three to five years of implantation, far sooner than physicians reasonably expected.

The filing cites a 2025 Cleveland Clinic study that found Trifecta valves demonstrated reduced durability and heightened susceptibility to premature deterioration compared to other surgical bioprosthetic valves. Researchers identified the externally mounted leaflet design as a factor associated with early failure.

“Defendants’ failure to timely translate known early-failure data and identified failure mechanisms into meaningful warnings, labeling updates, and risk-mitigation guidance was a substantial factor in causing Decedent’s injuries and death.”

— Charles R. Warren v. Abbott Laboratories Inc. et al.

The lawsuit raises allegations of negligence, failure to warn, manufacturing defect and breach of warranty. It seeks to recover all damages available under Nebraska’s survival statute, as well as wrongful death and other damages.

Trifecta Heart Valve Lawsuits

Following the withdrawal of Trifecta and Trifecta GT heart valves from the U.S. market, attorneys have been reviewing potential Trifecta heart valve lawsuits on behalf of patients who experienced premature valve failure, required revision or replacement procedures, suffered serious injuries, or lost a loved one after receiving one of the devices.

Individuals who believe they were harmed by an early Trifecta valve failure may qualify to seek compensation through a product liability lawsuit. Case evaluations are available at no cost, and attorneys’ fees are only collected if compensation is recovered on the claimant’s behalf.

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