Abiomed Challenges Impella Blood Pump Class Action Claims

Judge is giving plaintiffs until October 3 to amend the complaint before rulings on the case begin.

After meeting with the lawyers involved in an Impella class action lawsuit for the first time late last month, the U.S. District Judge presiding over the case has issued an order indicating that it is too soon to consider settlement talks, as the manufacturers of the blood pump move forward with attempts to strike certain parts of the complaint.

An initial status conference was held on July 29, involving a wrongful death claim brought by Rebecca L. Lester against Abiomed Inc. and Johnson & Johnson. The lawsuit alleges that a defective Impella blood pump caused the death of Lester’s husband, Garry, who suffered a fatal heart injury in 2021. However, Lester also presented class action claims in the lawsuit, seeking to pursue damages on behalf of others who were also seriously injured or killed by Impella pumps.

Impella Blood Pumps

The Impella is a small blood pump that is about the size of a pencil, which is used during open-heart procedures. The device is inserted through the femoral artery in the leg and guided to the heart’s left ventricle, where it is intended to ensure a steady blood flow to vital organs during surgery.

However, Impella pumps have been plagued with problems since they were first introduced, resulting in dozens of patient deaths and multiple recalls. In 2023, the U.S. Food and Drug Administration (FDA) announced a Class I recall for Impella Left Sided Blood Pumps, following reports of heart ventricle perforations, which linked the device to 129 injuries and 49 deaths. That same year, another recall was issued for Impella 5.5 with SmartAssist pumps due to purge fluid leaks that led to device malfunctions, heart valve damage and a heightened risk of severe injuries, with 179 related complaints.

Additionally, the FDA issued a Class I recall for Impella RP Flex catheter systems in June 2023, following inadequate safety instructions regarding blood clot risks. This issue was associated with 12 reported injuries and posed a serious risk of death and other complications.

As a result of these problems, several individuals have filed personal injury, wrongful death and class action lawsuits against the manufacturers, each alleging that the company designed or manufactured a defective device which led to severe injuries during heart surgery.

Lester’s Impella blood pump lawsuit maintains that Abiomed and Johnson & Johnson failed to address known safety problems with the device, including risks of left ventricle perforations and manufacturing defects.

The parties met with U.S. District Judge Patricia A. Gaughan for the first time on July 28, for an initial status conference. The judge called the conference to allow the parties to bring her up to date on the status of the litigation.

As a result of the meeting, Judge Gaughan issued a case management order (PDF) late last week, indicating that the case is not suitable for a mediation settlement conference at this time. The judge also stayed all discovery until rulings are issued on two pending motions brought by the manufacturer, one of which is a motion to strike the class action claims (PDF), while the other motion seeks to partially dismiss (PDF) the lawsuit, including Lester’s claims of fraudulent concealment, fraudulent misrepresentation and violations of Ohio’s Consumer Sales Practices Act.

Abiomed argues that the class action claims cover too wide a range of devices and models.

“Her theorized class would include an unknown number of patients from various time periods who claim to have suffered many different kinds of injuries allegedly caused by any model of Impella blood pump, regardless of the clinical setting or indications, and asserting claims arising under laws from all fifty states. The class could hardly be broader.”

–Memorandum in Support of Defendants’ Motion to Strike Plaintiff’s Class Allegations

Judge Gaughan gave Lester until October 3, 2025, to amend the complaint before she begins issuing rulings on the case.

As concerns around the device continue to mount, Impella blood pump lawyers are continuing to investigate similar cases on behalf of patients and families throughout the U.S. who may have experienced complications with the device during heart surgery. Free case evaluations are being provided to help individuals determine whether they may be eligible to pursue a product liability or wrongful death lawsuit.