SCS Injury Lawsuit Alleges Unlicensed Abbott Representatives Modified Device After Implantation

Lawsuit contends Abbott representatives made real-time spinal cord stimulator programming decisions based on patient’s responses.

A product liability lawsuit has been filed alleging that unlicensed representatives for Abbott Laboratories contributed to a Texas woman’s spinal cord stimulator (SCS) injuries by improperly participating in modifications of the system.

The complaint (PDF) was brought by Stephanie Stookey in the U.S. District Court for the Northern District of Illinois on April 14, naming Abbott Laboratories and the U.S. Food and Drug Administration (FDA) as defendants.

Stookey indicates she received an Abbott Proclaim spinal cord stimulator implant as a treatment for chronic pain. However, instead of providing relief, the device allegedly caused worsening pain, loss of function and neurologic complications that ultimately required additional surgical intervention and left her with permanent injuries.

Spinal Cord Stimulator Injuries

Spinal cord stimulators are implantable devices designed to deliver electrical pulses to the spinal cord to interrupt pain signals before they reach the brain. They are most often used in patients suffering from chronic back, leg or nerve pain when other treatment options have proven ineffective.

These systems generally include a small, battery-powered pulse generator implanted beneath the skin, along with thin leads placed near the spinal cord and a handheld controller that allows stimulation levels to be adjusted. Once implanted, the device is intended to remain in the body on a long-term basis.

Stookey’s claim is one of a growing number of spinal cord stimulator lawsuits filed in recent months, which allege that unlicensed Abbott Laboratories representatives improperly took part in both the implantation procedure and subsequent adjustments to these SCS devices, resulting in serious injuries.

In addition, many plaintiffs claim that recent design changes were neither adequately tested nor properly approved, increasing the risk of device malfunction. According to the complaints, these alterations have been linked to complications such as lead breakage or migration, unexpected electrical shocks, reduced effectiveness in managing pain and other neurological issues.

SCS Improper Programming Allegations

According to the lawsuit, Stookey first underwent a temporary, external trial implantation of an SCS device before receiving a permanent Abbott Proclaim system.

The complaint indicates the trial system was intended to demonstrate the device’s safety and effectiveness before permanent implantation. However, it failed to accurately predict the complications Stookey later experienced. In fact, she alleges the device never provided meaningful pain relief and instead contributed to increased discomfort and functional limitations.

The lawsuit claims that while the SCS device was implanted, Abbott representatives, who were allegedly not licensed to practice medicine, played an ongoing and active role in configuring and repeatedly adjusting the device. These representatives are accused of participating in programming decisions, interpreting Stookey’s responses to stimulation and making real-time changes to the system’s settings.

Stookey argues these actions went beyond permissible technical support and constituted the unlicensed practice of medicine, directly influencing how the device interacted with her body. The complaint indicates the system was ultimately removed after failing to provide relief, which required additional surgery and left her with ongoing complications.

In addition to the conduct of company representatives, the lawsuit alleges Abbott’s spinal cord stimulator systems were approved and modified through a regulatory process that failed to adequately evaluate safety. The complaint claims the device line was repeatedly altered through supplemental approvals without new clinical testing, resulting in a product that differed significantly from what was originally reviewed.

“Plaintiff and her healthcare providers reasonably relied on Abbott’s representations and omissions in deciding to proceed with implantation of the SCS devices. Had they been adequately warned of the known risks and benefits of the SCS device, the device would not have been implanted, or alternative treatments would have been pursued.”

— Stephanie Stookey v. Abbott Laboratories et al

The lawsuit raises allegations of strict products liability, manufacturing defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraudulent concealment, unauthorized practice of medicine, and violations of various state and federal regulatory policies.

It seeks compensatory, statutory and punitive damages for Stookey’s injuries, as well as injunctive relief related to oversight of the approval process.

Spinal Cord Stimulator Lawsuits

Stookey’s claim adds to a growing number of spinal cord stimulator lawsuits being pursued nationwide against many major medical device manufacturers.

Last month, a group of plaintiffs with allegations against Abbott and Boston Scientific sought to consolidate all federal SCS claims against those companies before a single judge in the Northern District of Illinois, requesting the creation of a multidistrict litigation (MDL) to streamline pretrial proceedings.

Abbott and Boston Scientific have opposed the consolidation, arguing the lawsuits involve different products and do not share a common defect warranting federal coordination. The companies also assert that many of the cases are already far along and that combining them would provide limited efficiency. Boston Scientific has also raised arguments that some claims may be preempted by federal law. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has not yet issued a decision on whether the cases will be centralized.

Across these lawsuits, plaintiffs frequently claim that design and manufacturing issues have made certain SCS systems susceptible to complications, including:

• Ineffective pain management
• Lead migration or fracture
• Unintended electrical stimulation
• Neurological side effects

Many complaints indicate that, rather than improving symptoms, the devices allegedly led to worsening pain, additional surgeries and long-term health complications.

As filings continue to increase, spinal cord stimulator injury attorneys are reviewing potential claims for individuals who experienced adverse outcomes following implantation of these pain management devices.

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