Abbott Proclaim Elite Lawsuit Alleges Spinal Cord Stimulator Malfunction Worsened Chronic Pain

Lawsuit claims Abbott representatives repeatedly adjusted a spinal cord stimulator that ultimately required surgical removal.

A Texas resident has filed a product liability lawsuit against Abbott Laboratories, alleging a spinal cord stimulator caused serious complications that continued even after the device was surgically removed more than five years later.

The complaint (PDF) was brought by Dayton Williams in the U.S. District Court for the Northern District of Illinois on October 20, naming Abbott Laboratories as the sole defendant.

Williams claims Abbott made significant changes to its spinal cord stimulators without adequate testing or warnings, exposing patients to potentially serious complications.

Spinal Cord Stimulator Problems

Spinal cord stimulators (SCS) are implantable medical devices that deliver electrical impulses intended to interfere with pain signals traveling to the brain. The systems typically include a battery-powered generator, electrodes and connecting leads implanted beneath the skin near the spine, along with an external controller that allows stimulation levels to be adjusted.

Reports of spinal cord stimulator complications have raised concerns about devices malfunctioning unexpectedly, delivering painful electric shocks, shifting out of position or eroding through the skin. Patients have also described burning sensations, increased pain, nerve injuries and other problems associated with the implants.

Some patients allege their injuries were aggravated by company sales representatives who frequently assist with programming the devices despite lacking medical licenses. The representatives may adjust stimulation settings to address pain complaints, sometimes allegedly without sufficient supervision from a physician, potentially exposing patients to additional risks.

These concerns have led to a number of Abbott spinal cord stimulator lawsuits along with similar claims involving devices manufactured by Boston Scientific, Nevro and Medtronic. Complaints allege defects in the implants and raise concerns about device programming or adjustments performed by company representatives without appropriate medical oversight.

Abbott Proclaim Elite Malfunction Allegations

According to the complaint, Williams received an Abbott Proclaim Elite spinal cord stimulator on April 5, 2019, after undergoing a temporary trial to determine whether the treatment could relieve his chronic pain.

Before the permanent implantation, an Abbott representative identified only as “Kassie” allegedly assured Williams the device was safe, clinically validated and capable of providing long-term pain relief comparable to the trial system. She also indicated it would reduce his need for additional chronic pain treatments.

Following surgery, Abbott representatives, including Kassie, allegedly programmed the device and repeatedly adjusted its therapeutic settings without meaningful physician supervision. The lawsuit claims the representatives were not licensed medical professionals, raising concerns that company personnel were improperly making treatment decisions.

After implantation, Williams allegedly experienced inadequate pain relief, worsening nerve pain and unpredictable electrical shocks. The complaint also describes interruptions in therapy, communication failures and lead migration.

Despite these complications, Abbott representatives allegedly continued to assure Williams that reprogramming could resolve the problems, attributing his symptoms to underlying medical conditions rather than the device.

On October 23, 2024, Williams underwent surgery to permanently remove the Proclaim Elite system because of its alleged mechanical failures and inability to provide adequate pain relief, maintaining that pain and other complications have persisted despite the removal.

The lawsuit also alleges Abbott substantially modified its original spinal cord stimulator platform through successive FDA premarket approval supplements without conducting adequate new clinical testing. Williams claims the changes affected the devices’ firmware, stimulation patterns, batteries and wireless programming, introducing risks that were not properly disclosed to patients or physicians.

“The defects in the Proclaim Elite system, its design, firmware, labeling, and risk disclosure, were a direct and proximate cause of Plaintiff’s injuries. These defects existed at the time the device left Abbott’s control and were not known or reasonably knowable to Plaintiff or his physicians at the time of implantation.”

— Dayton Williams v. Abbott Laboratories

Williams raises allegations of manufacturing defects, failure to warn, negligence, negligent misrepresentation, fraud, breach of warranties and unauthorized practice of medicine. He seeks compensatory and punitive damages for physical injuries, medical expenses, emotional distress, pain and suffering, and diminished quality of life.

Spinal Cord Stimulator Lawsuits

The lawsuit follows a recent decision by the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all Abbott spinal cord stimulator lawsuits in the Northern District of Illinois. U.S. District Judge Lindsay C. Jenkins will oversee coordinated discovery and pretrial proceedings involving the claims.

The panel also established a separate multidistrict litigation (MDL) for Nevro spinal cord stimulator lawsuits in the Northern District of California. Meanwhile, Boston Scientific SCS implant lawsuits have already been consolidated in the Central District of California, where U.S. District Judge Josephine L. Staton is expected to begin selecting representative cases for early bellwether trials.

As the litigation moves forward, spinal cord stimulator lawyers are continuing to investigate potential claims involving device malfunctions and complications such as:

Individuals who believe they suffered injuries that may qualify for a spinal cord stimulator lawsuit can obtain a free case review. Lawyers pursuing these claims work on a contingency fee basis, requiring no upfront payment and collecting legal fees only if compensation is obtained.

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