MDL Sought for Spinal Cord Stimulator Lawsuits Against Abbott, Boston Scientific

At least 15 spinal cord stimulator lawsuits have been brought against Abbott Laboratories and Boston Scientific in the federal court system, each involving similar allegations involving device failures and injuries.

As reports of device failures and neurological injuries linked to Abbott and Boston Scientific spinal cord stimulators continue to mount, a group of plaintiffs is asking a federal panel of judges to consolidate the growing number of lawsuits now being filed, indicating that they should be centralized before one U.S. District Judge for coordinated pretrial proceedings.

Spinal cord stimulators are surgically implanted devices designed to help patients living with severe, chronic pain. The systems deliver small electrical pulses to the spinal cord, interrupting pain signals before they reach the brain. For many individuals suffering from failed back surgery syndrome, nerve damage or persistent lower back pain, the devices are marketed as a last-resort treatment when medications, injections and additional surgeries have failed.

Each system typically includes 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. Once implanted, the device becomes a permanent part of the patient’s body.

While various different spinal cord stimulator models have been introduced by Abbott and Boston Scientific since the early 2000s, over time both companies allegedly made substantial design changes to the devices’ stimulation modes, leads and battery systems, which lawsuits now claim increased the risk of failure.

Over the last several months, a series of spinal cord stimulator lawsuits have been filed against Abbott and Boston Scientific, each alleging that inadequately tested design changes increased the risk of device malfunction, including lead fracture or migration, electrical overstimulation, unsatisfactory pain relief and other neurological complications.

Individuals have reported sudden jolts of electricity, burning sensations, worsening pain and new neurological symptoms, while others say the devices stopped working altogether. In many cases, patients were required to undergo painful spinal cord stimulator revision or removal surgeries.

Boston Scientific and Abbott SCS Lawsuits Raise Similar Claims

Due to the common questions of fact and law raised in each of the SCS lawsuits, a group of plaintiffs filed a motion to transfer (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 20. They are requesting that all Boston Scientific spinal cord stimulator lawsuits and Abbott spinal cord stimulator lawsuits brought throughout the federal court system be centralized in the Northern District of Illinois, as part of a multidistrict litigation, or MDL.

According to the motion, at least 15 lawsuits are pending across five federal jurisdictions, including five cases in the Central District of California, five in the Northern District of Illinois, and individual cases filed in the Northern and Southern Districts of Mississippi and the Western District of Michigan. Attorneys indicate that hundreds of additional injured patients have already retained counsel, signaling that the litigation could expand significantly in the coming months.

Although the cases involve different product lines, the motion argues that over time, the devices evolved into products that were materially different from their original versions, without undergoing the same level of regulatory scrutiny required for brand-new Class III medical devices.

Many of the Abbott spinal cord stimulator lawsuits focus largely on design changes introduced through successive generations of its devices, with plaintiffs alleging that newer versions incorporated redesigned leads, expanded stimulation capabilities and updated internal components without adequate long-term safety testing. According to the complaints, these changes increased the risk that implanted leads could fracture or migrate, resulting in painful electrical shocks, loss of pain relief and the need for additional surgeries.

Similarly, Boston Scientific spinal cord stimulator lawsuits raise parallel concerns, with plaintiffs contending that the company’s updated stimulation technology and modified lead designs altered how electrical impulses are delivered along the spine. The lawsuits allege that these design changes contributed to lead instability, device malfunction and neurological complications. In many cases, patients report that the stimulators either failed to control pain as promised or caused new and worsening symptoms.

The motion also cites prior FDA safety communications noting tens of thousands of adverse event reports associated with spinal cord stimulators in recent years, including reports of device malfunctions and inadequate pain control. Plaintiffs argue that despite these reports, the companies failed to fully warn physicians and patients about the risks associated with the evolving device designs.

FDA Named in Many Spinal Cord Stimulator Lawsuits

In addition to claims against the manufacturers, many of the lawsuits also raise allegations against the U.S. Food and Drug Administration over its approval and oversight of the devices.

Most of the complaints assert claims under the Administrative Procedure Act, a federal law that allows courts to review certain agency decisions. Plaintiffs argue that the FDA permitted substantial design changes to be introduced through supplemental approval pathways, rather than requiring entirely new applications supported by independent clinical testing.

According to the lawsuits, successive updates to stimulation modes, lead configurations and internal components by both manufacturers were approved without sufficient scrutiny, allowing devices that were materially different from earlier versions to remain on the market under prior approvals.

While the claims against the FDA do not seek monetary damages, plaintiffs are asking the court to determine whether the agency properly followed federal law when reviewing and approving the devices and subsequent design modifications.

Attorneys argue that these regulatory claims are nearly identical across the pending cases, which they say further supports consolidating the litigation before one judge to ensure consistent rulings on both the product defect and regulatory issues.

The motion also notes that the manufacturers have already begun asserting federal regulatory defenses in several cases, contending that because the devices received FDA premarket approval as Class III medical devices, certain state law claims are preempted by federal law. Plaintiffs argue that allowing different courts to rule on these issues separately could lead to inconsistent decisions that shape the future of the litigation.

While the JPML has not yet scheduled a hearing for oral arguments on whether the cases should be centralized, if the panel grants the motion, the spinal cord stimulator lawsuits would be consolidated before one U.S. District Judge, who would oversee coordinated discovery, pretrial proceedings and, if necessary, a series of early bellwether trials.

Spinal Cord Stimulator Lawyers Reviewing New Cases

As the number of lawsuits being filed against Abbott, Boston Scientific, Medtronic and other manufacturers continues to grow, spinal cord stimulator lawyers are actively reviewing claims for individuals who suffered injuries such as:

• Lead wire fracture or migration
• Electrical shocks or overstimulation
• Sudden loss of pain relief
• Worsening chronic back or nerve pain
• Revision surgery or device removal
• Permanent nerve damage
• Long-term spinal cord complications

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