Spinal Cord Stimulator Lawsuits

Spinal cord stimulator (SCS) systems manufactured by Abbott Laboratories and Boston Scientific Corporation have been linked to more than 107,000 adverse event reports and thousands of reported device malfunctions, painful injuries, and failed treatments. Federal lawsuits allege that both companies introduced major design changes through a regulatory shortcut that avoided the rigorous clinical testing required for new Class III medical devices, and a motion to consolidate all cases into a multidistrict litigation (MDL) was filed on February 20, 2026.

Spinal Cord Stimulator Lawsuit Overview

As of February 2026, at least 15 spinal cord stimulator lawsuits have been filed against Abbott Laboratories and Boston Scientific Corporation in five federal court districts. Approximately 400 additional injured patients have retained legal counsel, and multiple law firms have indicated they intend to file additional cases in the near future.

The lawsuits allege that both manufacturers introduced successive generations of SCS devices that incorporated significant design modifications — including redesigned leads, expanded stimulation capabilities, Bluetooth-enabled programming, and major battery architecture changes — without conducting the independent clinical testing required by federal law. Instead, plaintiffs argue, the companies submitted these changes as minor PMA (Premarket Approval) supplements to avoid the heightened regulatory scrutiny that would apply to new device applications.

On February 20, 2026, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that all federal spinal cord stimulator lawsuits be consolidated in the Northern District of Illinois for coordinated pretrial proceedings. If granted, the cases would be assigned to a single U.S. District Judge who would oversee discovery, pretrial motions, and potential bellwether trials.

About Abbott and Boston Scientific SCS Devices

Spinal cord stimulators are surgically implanted neuromodulation systems designed to treat severe, chronic pain that has not responded to other treatments. Each system typically includes three components: an implantable pulse generator (IPG) placed under the skin, one or more thin electrical leads positioned along the spinal cord, and an external controller that allows doctors or patients to adjust stimulation levels. The devices work by delivering small electrical pulses to the spinal cord, interrupting pain signals before they reach the brain.

SCS devices are classified by the FDA as Class III medical devices, the highest-risk category, which requires Premarket Approval (PMA) before a device can be sold. Any changes to the device's design, labeling, or manufacturing process must be submitted to the FDA as a PMA supplement and approved before the change can be implemented.

Abbott's Spinal Cord Stimulator Line

Abbott's entire SCS product line traces back to the Genesis spinal cord stimulator, which received its original FDA approval in 2001 under PMA P010032. Since that initial approval, Abbott has introduced multiple new generations of devices through a series of PMA supplements, including the Abbott Eterna spinal cord stimulator and other successor models. The lawsuits allege that these newer devices incorporated multi-waveform stimulation (simultaneous tonic, burst, and sub-perception modes), posture-adaptive programming, expanded electrode arrays, and major revisions to battery architecture and lead designs — changes so substantial that the current products are, in the words of the legal filing, "technologically unrecognizable" from the device originally approved.

Boston Scientific's Spinal Cord Stimulator Line

Boston Scientific's SCS line originates from the Precision spinal cord stimulator, initially approved by the FDA in 2004 under PMA P030017. Like Abbott, Boston Scientific introduced successive generations of devices through PMA supplements, including the Precision Montage MRI and the WaveWriter Alpha spinal cord stimulator systems. The lawsuits contend that updated stimulation technology and modified lead designs fundamentally altered how electrical impulses are delivered along the spine, contributing to lead instability, device malfunction, and neurological complications.

A central allegation in the litigation is that neither Abbott nor Boston Scientific submitted clinical studies demonstrating the safety and efficacy of their original SCS devices when they applied for PMA approval. Instead, both companies relied on published literature related to similar devices manufactured by other companies, a shortcut that plaintiffs argue fell short of federal requirements.

FDA Reports and Adverse Events

In September 2020, responding to a report by the consumer advocacy organization Public Citizen, the FDA issued a letter to healthcare providers disclosing that over the preceding four-year period, the agency had received 107,728 adverse event reports associated with spinal cord stimulator devices. The letter also disclosed 30,321 separate reports of unsatisfactory pain relief.

Based on the number of devices implanted during that period, the plaintiffs' motion estimates that approximately 70 percent of all SCS recipients either experienced an adverse event or unsatisfactory pain relief. The lawsuits allege that despite this extensive adverse event history, neither Abbott nor Boston Scientific made any substantial safety or efficacy improvements to their SCS devices after 2020, while continuing to market and sell the products.

The FDA's adverse event database (MAUDE) has documented a wide range of SCS-related complications, including device malfunctions, lead fractures and migration, battery failures, electrical overstimulation, infections, and cases where patients required additional surgery to repair or remove the device.

Injuries Linked to Spinal Cord Stimulators

The spinal cord stimulator lawsuits describe a consistent pattern of injuries reported by patients implanted with Abbott and Boston Scientific SCS devices. In many cases, these injuries required additional invasive surgery to revise or completely remove the device.

MDL Consolidation and Litigation Status

On February 20, 2026, attorneys representing plaintiffs in 15 pending spinal cord stimulator lawsuits filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting consolidation of all federal SCS cases into a single multidistrict litigation in the Northern District of Illinois.

The cases are currently pending in five federal jurisdictions: five in the Central District of California, five in the Northern District of Illinois, and individual cases in the Northern District of Mississippi, Southern District of Mississippi, and Western District of Michigan. At least one case in the Western District of Michigan already has a fully briefed preemption motion awaiting a ruling.

The JPML has not yet scheduled oral arguments on the consolidation motion. If the panel grants the request, the MDL would be assigned case number 3181.

Legal Claims Against Abbott, Boston Scientific, and the FDA

The spinal cord stimulator lawsuits raise multiple legal theories against the manufacturers, along with a separate set of regulatory claims against the FDA.

Claims Against Abbott and Boston Scientific

The product liability claims against both manufacturers center on allegations that the companies introduced devices with significant design changes that increased the risk of failure without adequate testing or warnings. The lawsuits assert that both companies used serial PMA supplements to bring what were effectively new products to market while avoiding the independent clinical evaluation required for original PMA applications. Common legal claims include defective design, failure to warn physicians and patients of known risks, breach of federal device regulations, misrepresentation of device safety and regulatory status, negligence, breach of warranty, and violations of consumer protection laws.

Both Abbott and Boston Scientific have begun asserting a federal preemption defense in several pending cases, arguing that because their SCS devices received FDA Premarket Approval as Class III devices, certain state law product liability claims are preempted by federal law. This defense is a central issue in the litigation and one of the primary reasons plaintiffs argue consolidation is necessary — to prevent different courts from reaching inconsistent rulings on the preemption question.

Allegations of Unauthorized Sales Representative Involvement

Several of the pending lawsuits also allege that Abbott and Boston Scientific sales representatives were directly involved in programming SCS devices, making therapeutic adjustments, and providing medical advice to patients, both during and after implantation. According to the complaints, these representatives allegedly performed these activities without physician supervision and without medical licensure, conduct that some lawsuits characterize as the unauthorized practice of medicine and assert as a basis for negligence per se claims.

Individual complaints allege that sales representatives reassured patients about device performance, recommended continued use of the stimulators, and made programming changes that affected how electrical impulses were delivered to the spinal cord. According to the lawsuits, this involvement allegedly led some patients to keep devices implanted longer than they otherwise would have, potentially worsening their injuries.

Claims Against the FDA

In a less common move, most of the pending lawsuits also name the U.S. Food and Drug Administration as a defendant under the Administrative Procedure Act (APA). The APA claims do not seek monetary damages. Instead, plaintiffs are asking the court to review whether the FDA properly followed federal law when it approved the original PMA applications and subsequent PMA supplements for both companies' SCS devices.

Specifically, the lawsuits allege that the FDA failed to require adequate evidence of safety and effectiveness, accepted PMA supplements for changes that were substantial enough to require entirely new applications, and allowed devices that were materially different from their original versions to remain on the market under prior approvals. The plaintiffs seek declaratory and injunctive relief under 5 U.S.C. §§ 706(1) and 706(2).

Spinal Cord Stimulator Lawsuit Examples

The following are examples of individual spinal cord stimulator lawsuits that have been filed against Abbott and Boston Scientific. The allegations described below are claims made by the plaintiffs and have not been proven in court.

Who Qualifies to File a Spinal Cord Stimulator Lawsuit

If you were implanted with an Abbott or Boston Scientific spinal cord stimulator and experienced complications, you may be eligible to file a lawsuit. Attorneys are currently reviewing claims for individuals who experienced any of the following:

• Lead wire fracture, migration, or dislodgement requiring surgical correction
• Painful electrical shocks or uncontrolled overstimulation from the device
• Burning sensations at or near the implant or lead sites
• Complete loss of pain relief or worsening chronic pain following implantation
• New neurological symptoms, autonomic dysfunction, or nerve damage
• Revision surgery or complete device removal due to complications
• Battery failure or device malfunction requiring medical intervention

All spinal cord stimulator injury lawsuits are handled on a contingency-fee basis, meaning there are no upfront costs to retain an attorney. Legal fees are only paid if compensation is obtained through a settlement or trial verdict.

Frequently Asked Questions