Patient sues Abbott after early heart valve replacement

A patient in Kentucky is suing Abbott for negligence after his heart valve had to be replaced due to structural valve deterioration (SVD) less than six years after it was implanted. 

Ronald Luckey received Abbott’s Trifecta GT surgical valve in October 2018. In September 2024, his care team determined that the valve was showing early signs of SVD and a replacement would be required. According to Luckey, this replacement procedure resulted in additional injuries that will require ongoing care. 

As a result of this experience, Luckey said he “sustained serious, grievous and permanent injuries” and his “ability and capacity to labor and earn money” has been permanently impaired.

Subscribe to Cardiovascular Business News

Abbott and the U.S. Food and Drug Administration (FDA) are warning healthcare providers about the potential risk of early structural valve deterioration (SVD) with Abbott’s line of Trifecta bioprosthetic heart valves. This includes the original Trifecta valve and the Trifecta GT, which are both designed to treat disease, damaged or malfunctioning aortic heart valves.
Image courtesy of Abbott.

Abbott valves at heart of lawsuit were taken off market in 2023

In 2023, Abbott announced that it was no longer selling or distributing its Trifecta heart valves in the U.S. market due to the increased risk of early SVD. At the time, it said it was working with the U.S. Food and Drug Administration to further evaluate these risks. Click here to read the full letter Abbott sent to customers at the time about these ongoing issues.

In the lawsuit, Luckey claimed Abbott “knew” or “should have known” that the valves were prone to early SVD. He added that the company “breached its duty … by negligently designing, manufacturing, assembling, testing, inspecting, labeling, packaging, failing to warn, distributing and selling the Trifecta valve when it was not in a reasonably safe condition.” The lawsuit also claims Abbott breached multiple warranties by saying the valve would last at least 15 years.

The lawsuit was filed in the U.S. District Court of the Eastern District of Kentucky. Luckey’s legal team is demanding a jury trial.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

Subscribe to Cardiovascular Business News

Subscribe to Cardiovascular Business News