As medical device product liability lawyers, we investigate recalls. The Impella medical device is one such recall. There have been several Impella recalls since 2023.

We have covered the Impella device for quite some time, going all the way back to 2019. We discussed the Impella recall in several blog posts. Here is more information of the Impella heart pump. Check back on our main Impella page for a major update on Impella in the coming weeks (by Jan. 2024).

Understanding the Impella Heart Pump and Associated Legal Concerns

The Impella heart pump, sometimes referred to as the “world’s smallest heart pump,” is a medical device. Surgeons used it for the first time recently.  the Company designed to assist patients with severe heart conditions.

Abiomed manufactured this percutaneous device to support heart function temporarily by helping circulate blood. This would allow the heart to rest and recover during high-risk procedures or acute heart failure. While the Impella may have provided life-saving benefits, it has also faced scrutiny over alleged complications and subsequent lawsuits.

Complications and Lawsuits Related to the Impella Device

As happens at times with medical devices, post market reports link the Impella heart pump to reports of adverse events. For the Impella device, the adverse events include device malfunction, vascular damage, and bleeding complications.

Some of these events will lead to lawsuits against Abiomed. Claims we anticipate concerning the Impella device will assert the device caused harm due to defects or inadequate warnings, design defect, negligence, and other variations depending on the states involved. These lawsuits typically fall into the following categories:

1. Product Liability Claims: Plaintiffs allege that design or manufacturing defects in the Impella device injured the patient. These cases often focus on whether the device was flawed or failed to meet safety standards. Because of the device involved, claims may focus on safety risks that emerged after the product hit the market, what the company knew and what it did in response.
2. Failure to Warn: Some lawsuits claim that Abiomed did not adequately disclose potential risks or complications associated with the device, leaving patients and healthcare providers unable to make fully informed decisions. Though it uses the term “warn” these claims are often broader. It may include instructions for use.
3. Negligence: Certain legal actions argue that Abiomed failed to conduct proper testing or monitoring of the device, leading to foreseeable patient harm.

These claims will vary because FDA approved the Impella device. Medical device companies can get to market generally two ways – FDA clearance or FDA approval. The latter presents a legal issue called preemption. This applies to what are called Class III or PMA (pre market approval) devices.

Federal Preemption and the Impella Heart Pump

A significant legal hurdle for plaintiffs in some medical device cases, including those involving the Impella, is federal preemption. The doctrine of federal preemption stems from the Supremacy Clause of the U.S. Constitution and limits state law claims that conflict with federal regulations. In the context of medical devices, the Medical Device Amendments (MDA) of 1976 to the Federal Food, Drug, and Cosmetic Act (FDCA) provide that:

• Devices approved through the Premarket Approval (PMA) process are subject to stringent FDA oversight.
• State law claims that impose requirements “different from, or in addition to” federal regulations are preempted.

For example, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court held the federal Act preempted that design defect and failure-to-warn claims because the FDA had already determined the safety and efficacy of the device.

The Impella device is classified as a Class III medical device requiring PMA approval. Therefore, lawsuits against Abiomed concerning the Impella heart pump will likely face challenges under federal preemption.

Navigating the Legal Landscape for the Impella Device

While federal preemption makes it more difficult to bring state law claims against Class III medical devices like the Impella heart pump, it is not an absolute bar. Plaintiffs may succeed in cases where they can demonstrate:

1. Parallel Claims: Claims alleging violations of federal regulations, rather than imposing additional state requirements, may survive preemption. For instance, if a plaintiff can show that Abiomed failed to adhere to FDA-mandated manufacturing standards, their claim may proceed.
2. Postmarket Issues: Claims related to post-approval conduct, such as failure to report adverse events to the FDA or failure to recall a defective device, may fall outside the scope of preemption.

This complex legal analysis depends on the law of the venue and case facts. It may require getting discovery about Impella from the Defendant.

Conclusions about the Impella Device

The Impella heart pump presents concerns. Adverse events and legal claims underscore the complexities of medical device litigation. Patients and their legal representatives face significant challenges, particularly due to federal preemption. For those navigating these legal waters, understanding the interplay between state and federal laws is essential.

If you or a loved one experienced complications related to the Impella device, consulting with an attorney experienced in medical device litigation is crucial. Additionally, they should have experience with preemption. KBA has such experience with various devices including recent ones like artificial hips to Cartiva toe implants. Cases involving Class III devices require careful analysis of federal regulations, case law, and the specific facts of the incident.

For more information on this topic, feel free to reach out to our team at Ketterer, Browne, and Davani, LLC. We handle personal injury cases, medical device product liability cases particularly and are here to help you understand your rights and options concerning the Impella medical device. The Impella recall presents challenges that require experience, expertise, and authority.

Citations:

• Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
• Medical Device Amendments of 1976, 21 U.S.C. § 360c.

Note: it is the Impella medical device, not impela medical device (two lls, not one). We have seen folks looking for the impela medical device mistakenly. If you’re searching your medical records or a loved one who had the Impella heart pump to see if you had a specific Impella implant that is subject to the Impella recall, be sure to spell it with two, not one, or you may miss it in the records.