/>iAfter issuing multiple recalls for its Impella-branded heart pump devices, Abiomed, Inc. is now facing lawsuits from patients and families across the country. As awareness of the issues with Abiomed’s Impella heart pumps continues to grow, the number of lawsuits filed against the company is expected to grow as well. Large-scale multi-district litigation (MDL) appears likely, as tens of thousands of patients and families potentially have claims for substantial economic and non-economic damages.
If you are thinking about filing an Abiomed Impella lawsuit, what do you need to know? How much can you expect to recover, and how can you ensure that you are making informed decisions with your (and your family’s) best interests in mind? How do you file a lawsuit against Abiomed, and what can you expect in MDL? These are all important questions that patients and families can—and should—have answered by an experienced attorney.
“Abiomed’s defective Impella heart pumps present significant risks for patients. These defective medical devices have already been blamed for hundreds of injuries and dozens of deaths in the United States. Due to the costs that patients and families face when Abiomed’s defective Impella heart pumps fail, filing a successful lawsuit can be essential for avoiding unnecessary financial strain and psychological harm.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.
While all patients and family members who are thinking about filing an Abiomed Impella lawsuit need to speak with an attorney about their specific circumstances, there are some general principles that apply in all cases. This article provides an introduction to some key considerations for patients and families who are coping with the financial and non-financial effects of complications from defective Abiomed Impella heart pumps.
10 Important Facts About the Abiomed Impella Litigation for Patients and Their Families
What do you need to know about filing an Abiomed Impella heart pump lawsuit? Here are 10 important facts for patients and their families about the Impella devices:
1. Abiomed Has Issued Multiple Recalls Related to Impella Heart Pumps
Abiomed issued the first recall related to its Impella heart pump devices on April 17, 2023. Since the first Impella heart pump recall, it has issued at least three additional recalls, with the most-recent recall coming on December 27, 2023. Combined the recalls cover approximately 75,000 of the company’s heart pumps sold and distributed to healthcare providers across the United States, including all of their left sided blood pumps. The specific devices covered under the recalls include:
- Impella 2.5, Product Number 005042
- Impella 5.0, Product Number 005062
- Impella 5.5 with SmartAssist, Product Numbers 0550-0008 and 1000100
- Impella CP, Product Number 0048-0032
- Impella CP with SmartAssist, Product Numbers 0048-0024, 0048-0045, and 1000080
- Impella LD, Product Number 005082
- Impella RP Flex with SmartAssist, Product Number 1000323
The Abiomed Impella heart pump complications range from problems with the devices themselves to deficiencies in their Instructions for Use (IFU). In all cases, the issues with Abiomed’s defective heart pumps present risks for both serious and fatal complications.
2. All of the Abiomed Impella Heart Pump Recalls Are Class I Recalls
The U.S. Food and Drug Administration (FDA) has classified all of the Abiomed Impella heart pump recalls as Class I recalls. This means that use of the recalled devices presents, “a reasonable probability . . . [of] serious adverse health consequences or death.” As a result, all patients who have received recalled Abiomed Impella heart pumps should take the issues with these devices seriously, and they should consult with their doctor promptly if they experience any signs of potential failure or have concerns for any other reason.
3. Abiomed’s Defective Impella Heart Pumps Have Well-Known (and Serious) Risks
Each of Abiomed’s recall notices related to its Impella heart pump devices disclosed additional risks related to these devices’ implantation and use. As awareness of these risks continues to grow, more and more patients and families are coming forward. The FDA has identified the following as the primary risks associated with Abiomed Impella heart pump failures:
- Left ventricle perforation
- Hypertension
- Lack of blood flow
- Death
While some patients whose Impella heart pumps break apart or otherwise fail start to notice symptoms immediately, this isn’t always the case. As a result, anyone who has received an Impella heart pump implant should seek treatment right away upon developing concerns. Signs of potential complications from Abiomed Impella heart pump defects include:
- A “pins and needles” sensation
- Abnormal heart rhythm or loss of blood pressure
- Agitation, anxiety, or confusion
- Blurred vision, buzzing in the ears, or difficulty breathing
- Chest pain
- Cold fingers or toes
- Dizziness, nausea, and vomiting
- Swelling, bulging veins, or pale or blue skin
This list is not exhaustive, and is not intended as medical advice. Due to the substantial health risks associated with Abiomed Impella heart pump failures, anyone who has concerns for any reason should see their doctor immediately.
4. Numerous Patients and Families Have Already Filed Lawsuits Against Abiomed
Even though the concerns with Abiomed’s defective Impella heart pumps have not been widely publicized, numerous patients and families have already filed lawsuits against the company. While Abiomed’s defective heart pumps may not yet be receiving widespread publicity, the effects of these defects can be devastating for individual patients and their families. Patients who file lawsuits against Abiomed can seek to recover damages for their medical expenses, lost earnings, pain and suffering, and other financial and non-financial losses, while grieving families can seek to recover damages for their funeral and interment costs, their loved ones’ medical expenses prior to death, and other losses as well.
5. Multi-District Litigation Provides the Opportunity to Fully Recover Plaintiffs’ Losses
As noted above, it is widely anticipated within the legal community that the issues with Abiomed’s defective Impella heart pumps will lead to large-scale multi-district litigation. Large-scale MDL differs from class action litigation in several ways that are beneficial to affected patients and family members.
Most significantly, MDL provides the opportunity for patients and affected family members to seek full compensation for their specific losses resulting from the receipt of a defective Impella heart pump implant. While MDL often results in a global settlement in which all plaintiffs can participate, these settlements frequently provide for different levels of financial recovery depending on plaintiffs’ losses, and plaintiffs can generally opt out of global settlements if they wish to pursue additional compensation.
6. Strict Time Limits Apply to Filing an Abiomed Impella Heart Pump Lawsuit
Since Abiomed just disclosed the issues with its Impella heart pump devices last year, the vast majority of patients and families affected by these defective devices still have time to file a lawsuit against the company. However, strict time limits apply; and, once the statute of limitations for a patient’s or family’s claim expires, it is no longer possible to seek just compensation. With this in mind, it is advisable for anyone who has concerns about possible complications from a defective Impella heart pump to consult with a lawyer promptly.
7. Patients and Families Must Determine How Much They Are Entitled to Recover
When seeking damages for complications and costs caused by defective Abiomed Impella heart pumps, it is up to patients and families to determine how much they are entitled to recover. This involves working closely with a lawyer to assess not only their total out-of-pocket costs to date (and anticipated out-of-pocket costs in the future), but also their loss of income or inheritance and other direct and indirect adverse financial consequences. In Abiomed Impella lawsuits, patients and families can seek damages for their non-financial losses as well, and determining an appropriate amount of compensation for pain, suffering, emotional trauma, loss of consortium, and other types of non-financial loss will also involve working closely with their legal counsel.
8. Patients and Families Can Hire a Lawyer at No Out-of-Pocket Cost
Lawyers handle these types of lawsuits on a contingency-fee basis. This means that patients and families can engage experienced legal counsel at no out-of-pocket cost. If a patient’s or family’s lawsuit against Abiomed is successful, their lawyer’s fees will be calculated as a percentage of their recovery.
9. While Settlement is Likely in Successful Cases, There Are No Guarantees
While lawsuits such as those that have been filed against Abiomed to date often result in out-of-court settlements, it is important for patients and families to understand that there are no guarantees. Every patient’s and family’s situation is unique, and factors ranging from how long they wait to take action to their choice of legal representation can impact the outcome of their case.
10. The First Step is to Learn About Your Legal Rights
With everything we’ve discussed in mind, the first step for patients and family members who have concerns about defective Abiomed Impella heart pump implants is to speak with a lawyer about their legal rights. Talking to a lawyer will allow you to make informed decisions based on your specific circumstances; and, if you decide to move forward, working closely with an experienced lawyer will be essential for maximizing your chances of recovering financial compensation.
