Abbott Eterna Lawsuit Alleges Spinal Cord Stimulator Malfunction Resulted in Worsening Pain

Device remains implanted after Abbott sales representatives, who were not licensed medical providers, repeatedly claimed they could program the Eterna to function properly.

A Hawaiian woman’s lawsuit alleges Abbott sales representatives misled her about the safety and effectiveness of the Eterna spinal cord stimulator and improperly programmed the device without a medical license.

The complaint (PDF) was filed by Laverne Livingston in the Northern District of Illinois on May 7. It names both Abbott Laboratories, the manufacturer, and the U.S. Food and Drug Administration (FDA), which approved the device for the market, as defendants.

Livingston claims Abbott defectively designed the device, and then fraudulently marketed it. In addition, she says the FDA failed in its duty to approve safe medical devices by allowing the Eterna to be fast-tracked to approval without adequate testing.

Spinal Cord Stimulator Problems

Spinal cord stimulators have grown in popularity in recent years as a means of treating chronic back, leg or nerve pain after other treatments have proven ineffective. They are medical implants made of a small, battery-powered pulse generator placed beneath the skin, thin electricity-conducting leads placed near the spinal cord and a handheld remote control that allows stimulation levels to be adjusted.

Made by several manufacturers, such as Abbott, Boston Scientific and others, they are designed to be permanently implanted in the back after a trial period that involves a temporary stimulator system to ensure the device works.

However, a growing number of spinal cord stimulator lawsuits brought in courts nationwide say the permanent implants have very different effects than the trial devices. These cases involve claims that patients suffered worsening pain, injuries, and the need for removal surgery due to problems with random electric shocks, device failures, electrodes protruding from the skin and other complications.

In many instances, patients say sales representatives from the manufacturers overhyped the effectiveness and, when the devices failed to provide relief, delayed removal by claiming they could reprogram the components to work better. This has allegedly led to patients dealing with the pain longer than they should have.

Eterna Spinal Cord Stimulator Malfunction Allegations

According to Livingston’s lawsuit, she was implanted with the Abbott Eterna spinal cord stimulator in December 2023 for the treatment of chronic pain. Before the permanent implant was placed, she underwent a trial period using a temporary, external device that appeared to provide some relief.

Abbott sales representatives then encouraged her to receive the permanent implant, saying it would be just as effective, if not more so. However, Livingston says it was not.

While she experienced some initial pain relief, that relief soon stopped and was replaced with severe complications, including shocks, numbness in her extremities, increased pain, balance problems, difficulty walking and incontinence.

After the initial surgery, and multiple times when Livingston complained, Abbott sales representatives without medical licenses made programming adjustments to the Eterna, claiming they were the only ones allowed to do so. These multiple adjustments failed to improve the situation and have prolonged the device’s removal, the lawsuit indicates.

“Plaintiff has been stuck in this cycle ever since, in which she complains to her physicians about the SCS and her complications, they refer her to the Abbott representatives or ask Abbott representatives to contact her regarding the complications, and Plaintiff’s complaints are dismissed by the physicians and Abbott representatives. Plaintiff continues to suffer from pain and symptoms caused and exacerbated by the malfunctioning system. To date, she has been unable to find a physician who will remove the device.”

– Laverne Livingston v. Abbott Laboratories et al

The lawsuit presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, violation of Hawaii’s Unfair or Deceptive Acts and Practices Statute, unauthorized practice of medicine, and violation of the Administrative Procedure Act by the FDA. It seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

Livingston’s complaint comes amid an increasing number of similar claims being filed nationwide against Boston Scientific, Abbott, Medtronic and Nevro. 

In April, a group of plaintiffs involved in spinal cord stimulator claims against Boston Scientific and Abbott filed a motion with the Judicial Panel on Multidistrict Litigation (JPML), requesting all federal lawsuits over devices from those manufacturers be consolidated in the Northern District of Illinois for coordinated pretrial proceedings and discovery in the form of a multidistrict litigation (MDL) before one judge.

The manufacturers have asked the panel to reject the request, claiming they lack a common, identified defect that would justify consolidation, as well as claiming the individual cases are too far along to benefit. The manufacturers also claim the cases will be dismissed due to federal preemption laws.

However, as more lawsuits are being filed against Abbott, Boston Scientific and other SCS manufacturers, spinal cord stimulator injury attorneys continue evaluating claims for individuals who experienced serious complications, including:

• Lead wire fractures or migration
• Painful electrical shocks or overstimulation
• Unexpected loss of pain relief
• Increased back pain or worsening nerve symptoms
• Revision procedures or surgical device removal
• Permanent nerve injuries
• Long-term spinal cord damage

All spinal cord stimulator injury lawsuits are handled on a contingency fee basis, meaning there are no upfront costs and legal fees are only collected if compensation is recovered through a settlement or trial verdict.

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