An Impella® heart pump lawsuit is a claim against Abiomed for manufacturing a defective medical device that causes heart perforations. This can be fatal if there is no intervention.
Shouse Law Group is suing Abiomed – a subsidiary of Johnson & Johnson – in pursuit of the largest financial settlement available for Impella heart pump victims. We are accepting clients across the United States who fit the following criteria:
- The injured party was hospitalized and had a temporary blood pump implanted; and
- Shortly after implantation of the pump, the injured party died or suffered serious injury; and
- The injured party experienced at least one of the following conditions/procedures:
- Heart perforation;
- Fluid buildup around the heart requiring drainage;
- Severe blood loss requiring transfusion;
- Emergency open heart or laparoscopic surgery other than for the condition that necessitated the hospitalization; or
- Critical loss of blood pressure and/or rapid heart rate.
In this article, our Impella heart pump attorneys answer these frequently asked questions:
- 1. Is the Impella heart pump dangerous?
- 2. Has it been recalled?
- 3. Can I sue?
- 4. What is the current state of litigation?
- 5. What money can I get?
- 6. Who makes the Impella heart pump?
- 7. How do heart pumps work?
- 8. How do I know if I have been injured?
- 9. Do I need an attorney?
1. Is the Impella heart pump dangerous?
To date, 49 fatalities – and dozens of injuries – have been linked to Impella heart pumps manufactured by Abiomed.1
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.2
Impella heart pump devices may perforate heart walls.
2. 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.3
The following Impella heart pumps are currently on the market despite the risk of heart wall perforations:
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
3. 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.
4. 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.
5. 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.5
6. 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.6
Johnson and Johnson acquired Abiomed in 2022, though it remains a stand-alone business within J&J’s MedTech Segment.7
At this time, there are 66,000 Impella pumps in the U.S. About 26,000 are in other countries.8
7. 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.9
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.10
8. 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.
Impella heart pump victims or their families may have grounds to sue Abiomed.
9. 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, Shouse Law Group:
- Collects 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 negotiates with Abiomed to award you the largest financial settlement possible as soon as possible.
Legal References
- Christina Jewett, Heart Pump Is Linked to 49 Deaths, the F.D.A. Warns, New York Times (March 29, 2024).
- See note 1. Warning letter, MARCS-CMS 663150, FDA (September 19, 2023). Sanket S. Dhruva et. al., Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock, JAMA (February 10, 2020). Amit P. Amin et. al., The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support, Circulation (Nov 17, 2019). Benedikt Schrage et. al., Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock, Circulation (March 5, 2019). Gene Hu, et. al., Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit, JAMA Internal Med. (July 18, 2022). James J. Glazier et. al., The Impella Device: Historical Background, Clinical Applications and Future Directions, International Journal of Angiology (June 28, 2019). Ellie Kincaid, Abiomed Sells $600 Million Worth Of Its Pencil-Size Heart Pump. But Some Doctors Have Big Questions About It, Forbes (Dec 18, 2018).
- See note 1. Class 1 Device Recall Impella, FDA (February 09, 2024).
- See note 1.
- See note 1. Abiomed, Totals by payment type in 2022, OpenPaymentsData.CMS.gov.
- Johnson & Johnson Annual Report Pursuant to Section 13 of the Securities Exchange Act of 1934 (December 31, 2023).
- Johnson & Johnson Completes Acquisition of Abiomed, JNJ.com. (December 22, 2022)
- See note 1.
- See note 1.
- Elliott Miller et. al., Clinical Outcomes and Cost Associated With an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction Complicated by Cardiogenic Shock, JAMA Internal Medicine (July 18, 2022). Stéphane Manzo-Silberman, et. al., Percutaneous left ventricular assistance in post cardiac arrest shock: comparison of intra aortic blood pump and IMPELLA Recover LP2.5, Resuscitation (May, 2013).