Boston Scientific Neuromodulation Lawsuit Claims Implanted SCS Devices Exacerbated Chronic Pain Symptoms

Growing number of spinal cord stimulator lawsuits allege inadequately tested or unapproved design changes have made neuromodulation devices more prone to complications and failure.

A product liability lawsuit has been filed against Boston Scientific Corporation, alleging that spinal cord stimulator (SCS) systems for at least three different individuals failed to provide pain relief, and instead worsened chronic pain symptoms following implantation.

The complaint (PDF) was brought by Stacy Neal, Angelina Lynn Mena and Tiffany Putterman in the U.S. District Court for the Central District of California on April 2. It names Boston Scientific Corporation, Boston Scientific Neuromodulation Corporation and the U.S. Food and Drug Administration (FDA) as defendants.

Spinal cord stimulators are designed to deliver electrical pulses to the spinal cord, with the goal of interrupting pain signals before they reach the brain. These systems are typically recommended for individuals suffering from chronic back, leg or nerve pain that has not responded to more conservative treatments.

SCS devices consist of a battery-powered pulse generator implanted under the skin, thin electrical leads positioned along the spinal cord and an external controller that allows doctors or patients to adjust stimulation levels. After implantation, they become a permanent part of the person’s body.

Although marketed as effective pain management solutions, an increasing number of spinal cord stimulator lawsuits have been filed in recent months, many centering on allegations that design modifications were not properly tested or approved and have made the devices more susceptible to failure. Plaintiffs claim these changes are associated with complications such as lead fractures or movement, unintended electrical stimulation, diminished pain relief and other neurological problems.

Boston Scientific SCS Device Allegations

According to the complaint, Neal, Mena and Putterman all underwent implantation of Boston Scientific neuromodulation systems in an effort to manage their chronic pain, yet they all experienced increased discomfort and complications following the procedure.

In Neal’s case, the lawsuit indicates the device failed to deliver consistent or effective pain relief and may have caused new or worsening symptoms. The complications reportedly required additional medical intervention, including potential revision procedures or device removal, along with ongoing care. The other two plaintiffs suffered similar side effects.

As a result, the plaintiffs allege that all of their devices were defectively designed and unreasonably dangerous, particularly due to issues affecting their abilities to provide reliable electrical stimulation without causing adverse conditions.

The complaint further claims that Boston Scientific failed to adequately test the devices and did not provide sufficient warnings or instructions regarding the risks of worsening pain, device malfunction or other complications associated with implantation.

The complaint also raises concerns that the devices were modified through FDA premarket approval supplement processes without requiring new clinical testing, potentially allowing significant design changes to reach individuals without full safety review.

“As a direct and proximate result of the defective and misrepresented nature of the device, Plaintiffs suffered physical injury, worsening pain, emotional distress, and economic damages including medical expenses and loss of quality of life.”

— Stacy Neal et al v. Boston Scientific Corporation et al

The plaintiffs are raising allegations of strict product liability, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraudulent concealment and unauthorized practice of medicine. They also raise claims of violations of state consumer protection laws for Texas, New York and Pennsylvania, where Neal, Mena and Putterman reside, respectively, in addition to violations of the U.S. Administrative Procedure Act (APA) by the FDA.

The lawsuit is seeking compensatory, statutory and punitive damages against Boston Scientific, as well as injunctive relief requiring the FDA to initiate enforcement proceedings or premarket approval reevaluation of the affected SCS devices.

Spinal Cord Stimulator Lawsuits

The case joins a growing number of spinal cord stimulator lawsuits being filed nationwide against medical device manufacturers, including Boston Scientific, Abbott, Medtronic and others.

Last month, a group of plaintiffs pursuing similar SCS claims against Boston Scientific and Abbott asked to centralize all of those federal cases before a single judge in the Northern District of Illinois, seeking to establish a multidistrict litigation (MDL) to coordinate the proceedings.

However, Abbott and Boston Scientific have asked the JPML to reject centralizing spinal cord stimulator lawsuits, arguing the cases involve different products and lack a common defect that would justify consolidation. The companies also contend that many of the lawsuits are already well advanced and that combining them would offer little efficiency, while Boston Scientific maintains the claims may ultimately be barred by federal preemption. The JPML has not yet ruled on the request, and a decision on whether to form an MDL is still pending.

Regardless of whether the cases are ultimately centralized, plaintiffs in this litigation commonly allege that design changes and manufacturing issues have made certain SCS systems prone to complications such as:

• Ineffective pain control
• Lead migration or breakage
• Unintended electrical shocks
• Neurological side effects

In many complaints, individuals indicate that instead of improving their quality of life, the devices resulted in additional pain, repeated surgeries and long-term complications.

As more claims are filed, spinal cord stimulator attorneys are continuing to evaluate potential lawsuits on behalf of individuals who experienced adverse outcomes following implantation of spinal cord stimulator devices.

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