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The FDA has linked Abiomed’s Impella Left Sided Blood Pumps to at least 49 deaths and over 120 serious injuries, according to a recent article by the New York Times. Abiomed is a cardiovascular medical technology company completely owned by Johnson & Johnson. Johnson & Johnson is one of the largest medical companies in the world, with approximately $85 billion in revenue in 2023.
The Times article also reported that the FDA told Abiomed that it should have notified the agency of the risk that the device can perforate the walls of the heart at least two years ago, when Abiomed added a brief post about the risks on their website. According to the FDA, the company has blamed doctors for the numerous injuries related to the device, citing “operator handling” as the cause of the problems.
When the FDA investigated Abiomed last year, the agency found many complaints that had not been reported as required by the FDA regulations. As a result, the FDA issued a warning letter to Abiomed in September 2023, which is one of the most serious actions the agency can take.
Many of the individuals who undergo temporary implantation of the device are already in a fragile state and in need of interventional treatment to restore normal heart function. Yet if the device perforates the wall of the heart or the blood vessels, it can necessitate emergency cardiac surgery, which has a very low survival rate.
Our medical device attorneys are investigating cases in which Abiomed Impella heart pump recipients suffered injury or death due to the failure of these devices.
The defective Abiomed Impella Left Sided Blood Pump underscores the importance of transparent communication and ongoing vigilance in medical device safety. In this vein, it’s worth comparing the Impella device defect with those of another device also used for circulatory support in patients with heart failure: Abbott’s HeartMate II and HeartMate 3 devices.
On April 15, 2024, the FDA issued a Class 1 recall, its most serious, for Abbott’s HeartMate II and HeartMate 3 devices due to hundreds of injuries and 14 deaths. Manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, the devices are considered vital in treating end-stage heart failure.
Abbott/Thoratec Corp. recalled the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called Extrinsic Outflow Graft Obstruction (EOGO). The problem occurs when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery.
The buildup obstructs the device, making it less effective in helping the heart pump blood. It can trigger alarms indicating low blood flow and affect the device’s ability to function properly. The accumulation of biological material typically occurs over two years or more.
Since 1955, we have been representing people who suffered personal injury or wrongful death at the hands of large corporations. With over $40 billion in settlements and jury verdicts, our lawyers have the knowledge and passion to seek justice on your behalf.
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The U.S. Food and Drug Administration (FDA) has previously announced multiple recalls of the instructions for use for the Impella device, including for risks that the device may fracture when used on individuals who have had an artificial valve implanted, and the risk that the device may increase the possibility of throwing a clot, which could cause stroke.
The focus of current investigations is legal claims related to injuries resulting from heart perforation due to the Impella device. Individuals who have been injured or died as a result of heart perforations during the use of an Abiomed Impella heart pump may have legal claims against the company to recover for the damages they suffered due to the device.
If you or a loved one has been injured following the use of an Abiomed Impella heart pump, it is important that you act promptly to ensure the viability of any legal claim.
For decades, our lawyers have focused on complex product liability cases, including medical device litigation. We will investigate serious injury or death claims against Abiomed due to the Impella heart pump.
If you are unsure if the device used in the operation was an Impella device or whether the injury suffered was a perforation, our lawyers will gather the necessary information from the medical provider to verify the identification of the device and the injury.
Articles have been published in multiple scientific journals involving individual case reports of perforation of the heart by Impella devices. The earliest published case reports date to 2016, and since then, there have been several other individual case reports.
No articles have been published yet to compare, specifically, the risk of perforation with Impella versus other blood pumps, such as traditional balloon pumps. However, as the New York Times article reports, there are several studies indicating that Impella devices are linked to overall higher mortality than balloon pumps.
Now that the FDA has raised the issue to the medical community that there is a specific risk of perforation associated with these devices, the scientific community will likely focus on this critical safety issue in future studies of the Impella devices.
Levin Law