Abiomed Impella Lawsuit (July Update)
WSJ logo
Forbes logo
Fox News logo
CNN logo
Bloomberg logo
Los Angeles Times logo
Washington Post logo
The Epoch Times logo
Telemundo logo
New York Times
NY Post logo
NBC logo
Daily Beast logo
USA Today logo
Miami Herald logo
CNBC logo
Dallas News logo

Abiomed Impella Lawsuit (July Update)

Dr. Nick Oberheiden
Attorney Nick Oberheiden
Abiomed Impella Lawsuit Team Lead

Abiomed is the medical device company that manufactures and sells Impella heart pump devices. These heart pumps, however, have been found to be defective in ways that can be life-threatening to the people who have had the Impella device implanted. While Abiomed and the U.S. Food and Drug Administration (FDA) have implemented an Impella Heart Pump recall to correct the instructions for using the device, numerous people have been hurt and some others have been killed by the Impella heart pump complications. Now, lawsuits are being filed to recover compensation for the losses caused by these defective medical devices.

The personal injury and mass tort lawyers at the national law firm Oberheiden P.C. legally represent victims of Abiomed’s defective heart pumps and work to get them the compensation that they need and deserve.

Update for July 12, 2024: Abiomed Impella Lawsuits

There were no significant developments in the Abiomed Impella litigation this week. The FDA is continuing to look into safety concerns associated with both the Abiomed Impella and Abbot HeartMate Touch Systems, and the multi-district litigation (MDL) against Abiomed is continuing forward at a rate that is typical at this stage of the process. Our lawyers are continuing to actively monitor for updates, and we will bring them to you as we have them. Once again, if you think you may have a claim (or don’t know and would like to find out), we invite you to contact us for a free, no-obligation consultation.

Previous Abiomed Impella Lawsuit Updates

July 5, 2024 – As we mentioned last week, the U.S. Food and Drug Administration (FDA) is now looking into safety concerns associated with heart pumps manufactured by both Abiomed and Abbott. Information about the recalls underway for Abiomed’s Impella heart pump devices and Abbott’s HeartMate Touch System can be found here and here. While the FDA has not updated these pages since March and May, respectively, they are useful resources for patients and family members who have questions about the specific devices that are currently subject to recalls. Additionally, if there are any updates in the future, this is likely where the FDA will post them.

As we move into July, we are still yet to see any significant updates in the Abiomed Impella litigation. This is not unusual, as complex multi-district litigation (MDL) involving dangerous and defective products typically takes some time to get rolling. With that said, since the litigation is still in its early stages, now is a good time for new plaintiffs to join; and, at this stage, most people are still well within the time window to file.

June 28, 2024 – According to recent reports, Abiomed isn’t the only medical device manufacturer facing concerns about the safety of its heart pumps. Reports indicate that Abbott has also issued a recall for a system monitor used with its HeartMate heart pump due to safety concerns with its screen. This follows Abbott’s recall of its HeartMate Touch System earlier this year, which is also used to monitor its HeartMate devices. The U.S. Food and Drug Administration (FDA) has classified both of these as Class I recalls.

Knowledge of the safety risks associated with Abiomed’s Impella device is continuing to grow as well. As more patients and families come forward to tell their stories, doctors, researchers, and the public are gaining an even clearer picture of why these devices fail and what failure means for patients who are using these potentially dangerous devices. As the litigation against Abiomed continues to move forward, we are strongly encouraging anyone who has been harmed—or who has a loved one who has been harmed—by an Abiomed Impella heart pump to speak with one of our lawyers for free.

June 21, 2024 – The latest medical research looking into the risks associated with Abiomed’s defective Impella heart pumps has identified several concerns. These concerns include aortic regurgitation, hemolysis, and severe bleeding, among others. As concerns about these devices continue to grow, the number of lawsuits filed against Abiomed is continuing to grow as well; and, as more people learn about the pending Abiomed Impella litigation, this number will only continue to climb.

Currently, the Abiomed Impella litigation is still in its early stages. We are continuing to take on new cases, and we encourage anyone who has concerns about the risks or complications associated with Abiomed’s defective Impella heart pumps to get in touch. While the Abiomed Impella recall remains ongoing, there have been no updates from the FDA since it announced the recall in March of this year.

Abiomed

Abiomed is a medical device company that was founded in Woburn, Massachusetts, and is now headquartered in Danvers, Massachusetts. It specializes in medical implants and other devices that improve a patient’s circulation, oxygenation, and blood flow, particularly in and around the heart.

Founded in 1981 in an attempt to create artificial hearts, Abiomed grew to the point that it became a publicly traded company in 1987. Over the years, the company moved away from creating artificial hearts and towards implants that improved how well the heart worked, including during and in the immediate aftermath of serious heart surgeries. In 2005 and 2013, Abiomed acquired a couple of German medical device companies and became a global medical device company. In 2022, it was acquired by the world’s largest healthcare products company, Johnson & Johnson, for $16.6 billion, with Johnson & Johnson pulling Abiomed into its conglomerate as a standalone company within J&J’s medical technology division. At this point, Abiomed had been generating a revenue of $1.03 billion per year.

Previous Litigation Against Abiomed for Kickbacks

Abiomed is the same company that came under fire for its marketing techniques in the years prior to becoming a part of Johnson & Johnson.

Back in 2018, Abiomed agreed to settle a civil case brought by the U.S. Federal Bureau of Investigation (FBI) and the Department of Justice (DOJ) for $3.1 million. That case involved alleged violations of the False Claims Act and the Anti-Kickback Statute, with Abiomed’s salespeople treating doctors and surgeons to lavish and luxurious meals in an attempt to persuade them into using Abiomed’s heart implants, some of which can cost up to $20,000 apiece. According to the settlement announcement, Abiomed’s sales team took physicians, as well as their spouses, to upscale restaurants in Los Angeles, Boston, and New York City. Many of these meals exceeded Abiomed’s own $150-per-person policies, reaching up to $450 per-attendee in one case. Additionally, Abiomed’s salespeople altered the lists of people in attendance at these extravagant meals to both hide their identity and to add fake attendees so that the per-person costs would be lower. Nevertheless, executives at Abiomed signed off on these “business expenses.”

Given the exorbitant costs of the meals, the amount of alcohol served during them, and the presence of spouses at them, federal investigators claimed that these meals were “inconsistent with legitimate scientific discussion” and amounted to kickbacks and illegal benefits that were aimed at improperly influencing the physicians’ medical decisions.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd
Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara
Linda Julin McNamara

Federal Appeals Attorney

Aaron L. Wiley
Aaron L. Wiley

Former DOJ attorney

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (DOJ)

Chris Quick
Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow
Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

The Abiomed Impella Heart Pump System

Abiomed is known for making the smallest heart pumps in the world. Shaped like a thin, bent rod with a hook on the end, these pumps are implanted into the ventricles of the patient’s heart on a temporary basis in order to supply additional strength to the organ when it has been weakened or compromised. The pumps are minimally invasive and can be lifesaving devices when used properly and the heart is having difficulties, such as during a heart attack, cardiogenic shock, or during surgery like a transcatheter aortic valve replacement. The pump can assist the heart in its compromised state by maintaining blood flow through the body while the heart heals from an injury, surgery, or some other medical condition. The most common conditions that can call for a heart pump like Abiomed’s are:

  • Heart failure
  • Enlarged heart
  • Weakened heart
  • Heart attack
  • Blocked arteries
  • Percutaneous coronary intervention procedures

They are also commonly implanted into patients who are waiting for a heart transplant.

Chief among the products that Abiomed has designed, manufactured, and sold in the United States is the Impella line of heart pumps. These include the following models:

  • Impella 2.5
  • Impella 5.0
  • Impella 5.5
  • Impella CP
  • Impella LD
  • Impella RP

Many of these models are now being produced with Abiomed’s new SmartAssist technology. Computer chips in the implant can tell surgeons when the device has been correctly positioned in the ventricles of the heart, and can provide real-time information about how well the heart and the device are working through Abiomed’s cloud-based platform, Impella Connect.

Some of Abiomed’s Impella heart pump models, however, have been recalled due to defects in the device that can pose a severe risk to patients who have them implanted.

Defects in the Heart Pump

Unfortunately, Abiomed’s heart pumps have had a tendency to perforate, or cut into, the tissues of the heart. Obviously, this can cause severe medical complications, as the continued beating of the heart can rupture even small perforations and create serious and potentially fatal problems very quickly. In many cases, the only solution to the perforations in the heart is to conduct an emergency open heart surgery to remove the device and repair the torn tissues. However, because the Abiomed devices are so frequently used as temporary heart pumps for people who already have heart problems, these surgeries are often far too strenuous and risky for the people who need them.

Like many medical device manufacturers, Abiomed’s initial response to the growing list of perforation injuries and deaths was to blame the surgeons who had conducted the implants in order to deflect blame from their products. The U.S. Food and Drug Administration (FDA), however, rightly responded by updating the pumps’ instructions for use (IFU). The IFU informs surgeons how to properly implant the devices in their patient’s heart. The new updates warned surgeons about the risks for the device to perforate through the myocardial wall of the heart’s left ventricle. They were implemented on February 9, 2024.

In the meantime, though, reports continued to come in about the risks of using Abiomed’s Impella heart pumps. Additionally, Abiomed continued to butt heads with the FDA over regulations related to its devices.

FDA Critical of Abiomed’s Business Practices

In September, 2023, the FDA issued a warning letter to Abiomed. This letter criticized Abiomed on two fronts:

  1. Not getting premarket authorization for the technology that it added to its heart pumps, and
  2. Failing to take corrective action when notified of defective pumps.

The FDA first covered the company’s new cloud-based information platform, Impella Connect, and its related technology in the implant, SmartAssist. According to the FDA, under section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321(h)), these technological innovations in Abiomed’s heart pumps amounted to a distinct medical device, separate from the heart pump itself. Such devices need premarket authorization by the FDA before they can be sold in the U.S. Failing to get that premarket authorization amounted to a “significant violation” of federal law.

Second, the FDA criticized Abiomed for how it handled consumer complaints about its heart pumps. In particular, the FDA pointed to several complaints about the Impella 5.5 heart pump and its “unacceptable elevated rate” of causing purge sidearm leaks. These leaks would trigger notifications through the SmartAssist programs and, if left unchecked, would reduce the pump’s pressure until it no longer functioned. Upon learning of these problems, though, Abiomed “failed to conduct health hazard evaluations and issue formal recall actions.”

The back-and-forth communication between Abiomed and the FDA that led to the issuance of the warning letter was likely the impetus for Abiomed’s voluntary recall of the Impella 5.5 heart pump in June, 2023. According to the FDA, Abiomed had reported 179 complaints about purge sidearm leaks in its Impella 5.5 pump, leading to three injuries.

Class I Recall for Heart Pump’s IFU

Finally, on March 21, 2024, Abiomed issued a recall for the IFUs for six of its heart pumps:

  1. Impella 2.5
  2. Impella CP
  3. Impella CP with SmartAssist
  4. Impella 5.0
  5. Impella 5.5 with SmartAssist
  6. Impella LD

The FDA then classified this as a Class I recall, the most serious type of recall. Class I recalls are for medical devices that can cause serious injuries or fatalities.

The recall affected 66,390 devices, and was limited to Impella Left Sided Blood Pumps, which are implanted on the left side of the heart. Importantly, the recall did not remove the products from use; it just corrected the instructions for how surgeons were to use the implants, warning them of the risks of perforating or rupturing the left ventricle wall.

According to the recall, there had been 129 reported serious injuries and 49 deaths related to heart perforations caused by the Impella devices.

Victims Suffer Severe and Sometimes Fatal Injuries

Because Abiomed’s Impella devices are heart implants, when they go wrong the patient can suffer severe and often lethal injuries. Perforations in the wall of the heart tend to cause severe repercussions, including:

  • Blood getting into the lungs, which causes increasing shortness of breath and eventually respiratory failure
  • Blood getting into the chest
  • Further deterioration of heart tissue

These are often fatal medical complications, particularly if they are not corrected immediately. Unfortunately, heart perforations are often only treatable with an emergency open heart surgery. Because Abiomed’s Impella heart pumps are frequently used by patients who have had heart problems that were serious enough to need a heart pump, these patients are rarely capable of going through another serious heart procedure. This makes the prognosis even worse.

Demands for Compensation

The serious repercussions from heart perforations caused by Abiomed’s Impella heart pumps have left numerous victims severely hurt and many deceased. Those who have been hurt have the legal right to file a personal injury lawsuit against Abiomed and demand compensation for their losses. The family members of deceased victims have the right to file a wrongful death claim against the company and demand compensation on behalf of their loved one.

For victims who survived, they can recover compensation for all of the ways that they have suffered from the heart implant. This includes financial compensation for their:

  • Medical bills associated with the heart pump, including the costs of the open heart surgery needed to repair heart perforations, which can be quite substantial
  • Medical expenses that will arise in the future and that stem from the injuries caused by the pump, such as occupational and physical therapy and follow-up appointments with a cardiologist
  • For patients who were working at the time of their injuries, lost wages or other income from the extra time spent in the hospital and in recovery, including future wage loss if their injuries from the heart perforation are debilitating enough to limit their professional life in some way
  • Physical pain, which can be quite significant in these painful circumstances
  • Emotional distress from the fear and the uncertainty of the situation
  • Mental anguish from not knowing how things will turn out

For wrongful death claims, the types of compensation available depend on the state in which the lawsuit is filed. However, they generally include the costs of the medical expenses that were incurred, which are paid into the decedent’s estate, and financial compensation for the victim’s family’s loss of consortium and companionship.

Products Liability Claims

The personal injury and wrongful death lawsuits against Abiomed are going to be based on products liability law. This area of personal injury law focuses on holding companies accountable for putting innocent victims in danger by designing, manufacturing, and marketing products that carried a hidden risk of harm when used correctly.

There are three types of product liability claims:

  1. Defective design
  2. Defective manufacture
  3. Defective marketing, also known as “failure to warn”

As is typical when it comes to allegedly defective medical devices, the lawsuits against Abiomed are going to focus on the first and, more importantly, on the third of these types.

Typically, a product is defectively designed when either of the following is true:

  • The way that the product is designed is not as safe as a normal consumer would expect it to be when it is used as it was intended to be used, or misused in a reasonably foreseeable way, or
  • The inherent risks of the product’s design outweigh its benefits.

In the Abiomed lawsuits, victims and plaintiffs are going to argue that the way the device was designed made it too likely to cause perforations in the heart tissue. These are going to be extremely technical arguments that go into extensive detail about how the Impella heart pumps work, how they could work instead, and whether the benefits of the design is worth the drawbacks.

Claims of defective marketing, or Abiomed’s failure to warn physicians and the public about the risks of its heart pumps, are probably going to get more traction in these cases.

A product is defectively marketed if the company selling it fails to warn people of the known or knowable dangers of using their product.

Plaintiffs suing Abiomed for injuries caused by their Impella heart pumps are likely going to point to numerous pieces of evidence to support their case, including:

  • The recalled and corrected instructions for use, which showed that the company admitted that it could have better warned surgeons, who were about to implant one of their Impella heart pumps in a patient, about the risks of the device perforating heart tissue
  • How foreseeable perforation was, given the design and intended use of the heart pumps, and how this raised the expectation that Abiomed would conduct extensive research to understand and mitigate the dangers of serious perforation injuries
  • Abiomed’s history of aggressively marketing its products, as shown through its settlement of the charges under the Anti-Kickback Statute, and rushing its products to the market, as shown through the inclusion of the SmartAssist and Impella Connect technology to the implants without getting the necessary premarket authorization by the FDA

Abiomed will likely defend against these allegations by trying to blame surgeons for poorly positioning their heart pumps in patients.

State of Litigation Against Abiomed

The injuries and fatalities caused by Abiomed’s Impella heart pumps have all of the characteristics of a mass tort case. We have:

  1. A single company responsible for allegedly defective products
  2. Products that have caused harm in a single way
  3. Hundreds of victims from across the U.S., all of whom have been hurt in similar ways
  4. Identical legal claims and defenses that will demand access to the same types of evidence

This makes the lawsuits against Abiomed ripe for consolidation into either a class action or multidistrict litigation (MDL). However, as of June, 2024, this has not happened. Instead, individual plaintiffs are filing their own lawsuits against Abiomed for damages caused by the company’s heart pumps in courthouses across the country. This will lead to numerous logistical issues for the court system and for the parties to the lawsuits, including:

  • The application of different states’ product liability laws, which can have nuanced differences that can drastically alter the trajectory of the lawsuit
  • Problems for Abiomed personnel, who will be subject to depositions in dozens and, soon, hundreds of lawsuits throughout the United States
  • Evidentiary issues, as those depositions lead to conflicting or potentially contradictory remarks
  • An inefficient use of court resources

Therefore, it is likely that, if any more lawsuits are filed over injuries caused by Abiomed’s Impella heart pumps, they will get consolidated into an MDL.

In an MDL, the lawsuits are brought together for pre-trial procedures before a single judge in a single courtroom. The MDL then gathers evidence related to the collection of cases, rather than each individual lawsuit acting on its own behalf. This significantly streamlines the process. The MDL will also handle pre-trial motions, including the inevitable motion to dismiss the case and competing motions for summary judgment by the court without a trial.

Throughout this process, settlement negotiations will be taking place. They will heat up as evidence is gathered and the plaintiffs and Abiomed can better see who would be likely to prevail, should the case proceed.

If a settlement is not reached, several claims in the MDL that are well-representative of the others in it will go through a bellwether trial. This is a legitimate, binding jury trial where both sides present their case to a jury, a verdict is reached, and the individual claim brought to a resolution. The outcome of these bellwether trials then informs Abiomed and the other plaintiffs how to settle the remainder of the MDL.

In all, this process can take multiple years to complete.

Mass Tort Lawyers at the National Law Firm Oberheiden P.C.

The Impella Heart Pump Lawsuit lawyers at the national law firm Oberheiden P.C. strive to legally represent plaintiffs, victims, and their loved ones in products liability claims against Abiomed over its defective heart pumps. Call our national intake number at 866-781-9539 or contact us online.

Abiomed Impella Lawsuit (July Update)

WordPress Lightbox