FDA Fails to Protect Public From Defective Heart Device

By Ferrara & Gable | August 14, 2021

In today’s society, Americans rely on certain institutions to keep us safe from harm. From protein powder to medical devices, regulatory agencies are in charge of ensuring all products conform to a set of safety and health standards that prevent the threat of undue harm. When agencies fail in their obligation, product liability attorneys are often called to investigate the evidence and determine if litigation is appropriate.

Of these regulatory agencies, perhaps none is as well known and trusted as the federal Food and Drug Administration (FDA). In a recent article by investigative journalism site ProPublica, it was reported that the FDA knew about a faulty heart pump device, the HeartWare Ventricular Assist Device (HVAD), but failed to take the action necessary to prompt the device manufacturer to make necessary improvements.

The article goes on to explain that it was the FDA, not Heartware, that ultimately failed the public. By relying on the device manufacturer to fix the problem themselves, the FDA was actually the one perpetuating a disregard for product liability laws and the greater public good.

New Jersey’s Product Liability Laws

At the state level, New Jersey is like many other states in that it has enacted legislation that provides guidance for residents on when they can and cannot pursue legal action to recover compensation for damages in product liability court.  Specifically, the New Jersey Product Liability Act outlines three categories under which victims can make an allegation of negligence: Defective design, defective manufacturing, and defective marketing (i.e. failure to warn).

As the ProPublica piece notes that the HVAD device was implanted into more than 19,000 patients, it stands to reason that some of these patients were New Jersey residents. Reviewing the framework of the New Jersey Product Liability Act, it becomes apparent that victims in New Jersey are likely able to make a product liability lawsuit case based on all three possible allegations.

If you have been injured by a consumer product, consulting with an experienced product liability attorney is always the best course of action. The following is a general idea of how each type of allegation would look in regards to the HVAD device and the FDA’s failure to intervene.

Defective Design

To allege defective design, a plaintiff must show that HeartWare failed to use reasonable care in the design of their device, and that design improvement could have been made. While this is the designer’s responsibility, when regulatory agencies fail to force these designers to make the changes on life-altering devices, these agencies may be held liable, as well.

Defective Manufacturing

The plaintiff must show that the product was carelessly assembled regardless of design. While this claim may be harder to show on your own, in collaboration with a product liability attorney it may be possible to determine if manufacturing deficits, separate from design flaws, played a role in harming victims.

Defective Marketing/Failure to Warn

Here is where a good deal of evidence can be put together to show that HeartWare and the FDA failed to properly warn patients about the risks involved in the device. Without proper guidance and warning, patients may have unwittingly submitted themselves to a risky procedure and a permanently implanted device.

When to Contact an Attorney

For years, the attorneys at Ferrara & Gable have been helping victims in New Jersey who have been harmed by faulty and defective products. If you or someone you know has been impacted by a faulty HeartWare device or any faulty product, contact Ferrara & Gable today to explore your options.

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Posted in News, Product Liability