Judge Rejects Lawsuit Over Impella Cardiac Device

The original claim filed in Missouri state court was not sufficiently pled, resulting in a ruling that dismisses the Impella lawsuit now being pursued by the family in the federal court system.

A product liability lawsuit brought against the makers of the Impella cardiac device has been dismissed, after a federal judge determined that claims brought by the family of a Missouri woman who allegedly died after the pump was implanted during heart surgery were not sufficiently pled, meaning the case cannot move forward.

The original Impella lawsuit was filed in 2024, by the family of Nancy June Urqhart, who died during heart surgery in September 2022. According to allegations raised in the complaint, the wrongful death occurred when the Impella heart pump failed during the procedure, due to design defects.

Impella Heart Pump Safety Concerns

The Impella cardiac device is about the size of a pencil, and is intended to move oxygen-rich blood from the ventricle into the ascending aorta, to help maintain blood flow to vital organs during heart surgery. However, the small heart pump has been plagued with a number of serious safety problems in recent years, resulting in several recalls and warnings.

In 2023, the FDA issued a Class I recall for Impella Left Sided Blood Pumps due to reports of heart ventricle perforations, after identifying 129 injuries and 49 deaths linked to the device. That same year, a recall for Impella 5.5 with SmartAssist pumps addressed purge fluid leaks that caused device failures, heart valve damage and an increased risk of severe injuries, with 179 related complaints.

Another Impella class I recall was issued that same year for the Impella RP Flex catheter system due to inadequate instructions on addressing blood clot risks linked to 12 reported injuries.

In the wake of these recalls, lawyers across the U.S. began investigating potential Impella cardiac device lawsuits, like the one filed by Urqhart’s family. Each of the claims raise similar allegations, indicating that the manufacturer knew about Impella heart pump problems for years, yet placed profits before patients’ safety by failing to remove the products from the market.

Originally filed in St. Louis circuit court, the case was later removed to the U.S. District Court for the Eastern District of Missouri and assigned to Chief U.S. District Judge Stephen R. Clark. In January, the family amended the complaint to indicate that Nancy Urqhart’s widower, Christopher Urqhart, who was one of the original plaintiffs, had died. As a result, Amy Ehlers, the surviving daughter, submitted an amended Impella lawsuit.

The complaint claimed the Impella device used during surgery was dangerously defective and improperly manufactured, with a specific flaw that prevented the pump’s lead from releasing properly after the procedure. This defect disrupted normal blood circulation, leading to severe complications that culminated in Nancy’s death just three days later, on September 12, 2022, according to the complaint.

The amended complaint adjusted its language due to the husband’s death and set out the claims with more specificity. However, Judge Clark issued a memorandum and order (PDF) on July 21, indicating that the complaint was not sufficiently pled, resulting in dismissal.

“The Court finds that federal law does preempt each of her claims and grants Abiomed’s motion and denies Ehlers’s motion, as the proposed amended complaint fails to allege any claim that could survive federal preemption.”

-Judge Stephen R. Clark, Memorandum and Order

The Impella lawsuit has been dismissed with prejudice, meaning that it cannot be refiled.