The Food and Drug Administration (FDA) issued an alert that the Impella heart pumps carry a risk of puncturing the heart walls. According to studies, Impella heart pump devices increase the risk of mortality in patients suffering from unstable conditions. The FDA warned against using them in patients in organ failure or who have major neurologic injury. Abiomed claims the cause for heart wall tears are due to “operator handling” as opposed to a defect in the pump. Abiomed cautions surgeons to use imaging tools when placing and removing the pump to help prevent perforations. The company conceded that four deaths were linked to a malfunction when the pump hit an artificial heart valve. In the event the Impella heart pump does puncture a heart wall, the only way to remedy it is through open heart surgery (to drain out the leaking fluid) and blood transfusions. However, many patients are already too fragile for an operation. Heart failure with Impella support of left ventricle Impella heart pump devices may perforate heart walls.
Has it been recalled?
The Impella heart pump devices have not been recalled and remain available for surgeons to use. However, Abiomed did recall the instruction manual and issued a new one urging increased caution with use.
The following Impella heart pumps are currently on the market despite the risk of heart wall perforations:
- Impella CP
- Impella 5.5
- Impella RP
The following Impella heart pumps are no longer on the market, but hospitals may still be using them despite their risk of heart wall perforations:
- Impella 2.5
- Impella 5.0
- Impella LD
Can I sue?
If you suffered a heart perforation from an Impella heart pump device – or if your family member died from one – you can sue Abiomed on the ground that they: designed a defective device that causes heart perforations, sold a device with manufacturing defects that cause heart perforations, and/or failed to warn doctors and consumers about the risk of heart perforation. As things currently stand, the strongest claim is failure to warn. Abiomed actually updated its website with a bulletin back in October of 2021 about the perforation risk, but it failed to notify the FDA (which they were supposed to do within 10 days).4 Had Abiomed notified the FDA like they were supposed to, the agency could have broadcast the warning to physicians and hospitals. Had doctors and patients known of the risks of torn heart walls, they might have opted to avoid using Impella heart pumps at all.
What is the current state of litigation?
Impella heart pump victims or their families are beginning to file individual lawsuits against Abiomed. Eventually, all these lawsuits may be joined in a multi-district litigation (MDL) to help expedite the litigation process. In most MDLs, about four or five representative cases go through the trial process. The results of these “bellwether trials” sets the starting point for negotiations between Abiomed and the remaining plaintiffs.
What money can I get?
While every case is different, we are predicting seven-figure payouts for each Impella heart pump case. Impella heart pump lawsuits seek the following compensatory damages for victims and families of deceased victims: Medical bills for open heart surgeries to repair the heart perforation, hospital stays, doctor’s appointments, medicines, home health care, etc. Lost wages and loss of future earnings for work that victims are unable to do because they are too ill. Pain and suffering from the emotional distress of having heart problems. Funeral expenses and loss of financial support for family members of deceased victims. In addition to compensatory damages, we may be able to recover punitive damages to punish Abiomed for creating a defective product and failing to warn about its hazards. These actions are all the more shocking considering the millions Abiomed spent on grants to hospitals and consulting fees to heart doctors.
Who makes the Impella heart pump?
The Impella heart pump is manufactured by Abiomed, which makes several temporary external and implantable mechanical circulatory support devices. It was founded in 1981 and is headquartered in Danvers, Massachusetts. In 2022 alone, its revenue exceeded one billion dollars. Johnson and Johnson acquired Abiomed in 2022, though it remains a stand-alone business within J&J’s MedTech Segment. At this time, there are 66,000 Impella pumps in the U.S. About 26,000 are in other countries.
How do heart pumps work?
FDA-approved in 2008, Impella heart pumps are thin, rod-like devices that a cardiovascular surgeon temporarily places in the heart to keep it pumping. They can be lifesaving if the patient is suffering from a heart attack or cardiogenic shock. Many surgeons prefer Impella heart pumps over intra-aortic balloon pumps during such procedures as implanting stents. However, some studies show that heart pumps are linked with a higher rate of mortality and bleeding complications than balloon pumps.
How do I know if I have been injured?
If you suffered a heart wall perforation from an Impella heart pump device, the complication likely became apparent very quickly. If you know you have had an Impella heart pump device and want to check your heart, you can ask your cardiologist for an echo-cardiogram. This test should reveal if you are suffering from pericardial effusion (fluid and blood around the heart). If you have an Impella heart pump currently implanted, you probably cannot get an MRI because the magnetics would interfere with the device. Diagram of Impella support in heart failure Impella heart pump victims or their families may have grounds to sue Abiomed.
Do I need an attorney?
Yes. Our Impella heart pump lawyers manage the entire legal process so you can center your attention on getting on with your life. As your legal team, we collect all the relevant medical records; Composes all the necessary legal correspondence and court filings from the beginning to the end of the settlement and litigation process; and aggressively negotiate with Abiomed to award you the largest financial settlement possible as soon as possible.
