For patients suffering from chronic pain, spinal cord stimulators have been presented as a last-resort solution—a way to reclaim quality of life when other treatments have failed. But a series of lawsuits allege that the implants have delivered not relief but harm.
“The lawsuits allege that these devices may be effective for zero to three months,” said Behram Parekh, an attorney at Wisner Baum. “And that in part is what is not being properly communicated to these patients.” He described the patient population as “very vulnerable” because “they’re people with chronic pain. And so they will grasp at anything to have their pain relieved.” Christian Simmons, a reporter with Drugwatch.com, has tracked the litigation closely. “What people who are filing lawsuits are claiming is that not only did these devices not alleviate their pain, but that it worsened their pain, that it caused nerve damage or even paralysis, that it led to loss of bowel control, that it led to electrical burns, that there were infections,” he said. The scale of alleged patient harm is substantial. FDA data shows that 107,728 adverse events 428 patient deaths involving spinal cord stimulators were reported between 2016 and 2020. These numbers must be interpreted with caution: Adverse event reports do not necessarily establish causation, and reporting can be inconsistent. Nevertheless, the volume of complaints has drawn regulatory and legal scrutiny.
Simmons noted that approximately 50,000 spinal cord stimulator procedures are performed annually in the US. With four major manufacturers—Medtronic, Boston Scientific, Abbott and Nevro—dominating the market, the potential pool of affected patients is considerable.
The Allegations
Plaintiffs have advanced several categories of claims against manufacturers. The most common include:
Failure to Warn: Lawsuits allege that manufacturers knew or should have known about serious risks but failed to inform patients and the medical community. “They’re just saying you did not even warn your patients and your customers that this was possible,” Simmons explained. The argument is that patients might have declined the procedure if they had been told they could lose bowel control or suffer paralysis.
Design and/or Manufacturing Defects: Plaintiffs claim the devices were inherently defective. Allegations include battery instability, lead wires that migrate to different parts of the body, programming issues, and faulty firmware. Some lawsuits allege that specific devices deviated from their intended design during manufacturing, leading to overheating, electrical shocks or other malfunctions.
Unauthorized Practice of Medicine: Parekh noted that “in the filed lawsuits, virtually every plaintiff had direct contact with the sales representatives from the manufacturer who made representations to these plaintiffs directly.” These interactions often occurred “outside the presence of the doctor.”
“These sales reps are not doctors, they’re not medically trained,” Parekh said. Lawsuits allege that sales representatives effectively practiced medicine without a license by programming devices and advising patients on medical matters.
The involvement of sales representatives in patient care has emerged as a recurring theme in the litigation. Plaintiffs allege that representatives not only programmed devices but also made representations about risks and benefits that contradicted the official labeling.
“The lawsuits allege that a lot of times, even when the side effects occur, these sales reps are telling the patient, ‘Oh, I’ve never seen this before. This is a really unusual side effect. It’s you, not the device,’” Parekh said. He said that the lawsuits allege that representatives “have seen this all over the place” but make these statements “to try and get these people to either keep their device in or not report it as a malfunction of the device.”
Recent lawsuits have documented these allegations in detail. In one case, a patient alleged that a Nevro sales representative programmed and managed his implant despite having no license to practice medicine.
Simmons noted that while he could not speak to specific claims about sales representatives, “when things like that happen, that typically is a big part of the lawsuit.”
The Complications
The injuries alleged in spinal cord stimulator lawsuits span a wide spectrum of severity.
Paralysis and Spinal Cord Injury: While rare, spinal cord injury after spinal cord stimulator implantation has been documented in medical literature. One case report describes a 54-year-old woman who suffered spinal cord injury after spinal cord stimulator reimplantation. Another report documents permanent paraplegia following spinal epidural hematoma.
Nerve Damage: Patients have reported neurological changes, including loss of sensation and motor function.
Loss of Bowel and Bladder Control: This complication is frequently cited in lawsuits as a devastating outcome that patients were not warned about.
Electrical Burns and Shocks: Lawsuits allege that devices have delivered painful electrical shocks or caused internal burns. In one case, a Boston Scientific device allegedly malfunctioned immediately after implantation, subjecting the patient to “severe electrical shocks and intense pain.”
Worsened Pain: The allegation is that the devices intended to relieve pain actually made it worse. In a recent case, a patient alleged that an Abbott Eterna device was “improperly programmed and led to worsened pain.”
Lead Migration and Fracture: The leads (wires) implanted near the spine can move or break, rendering the device useless and requiring invasive surgery.
Inadequate Pain Relief: Even when devices function as intended, many patients reportedly do not experience meaningful long-term relief.
What Lies Ahead
The litigation is still in its early stages. The multidistrict litigation (MDL) was only established in June 2026, and the bellwether trial process is likely years away.
Simmons noted that “MDLs can take a long time. This is going to be a years-long thing. This is not going to be something that’s solved by Christmas.”
For patients who have already suffered complications, the legal process offers a path to compensation—but no guarantee of a quick resolution. For manufacturers, the litigation represents a significant financial and reputational risk.
Meddevicetracker report forecasts that sales of spinal cord stimulation systems will increase at a compound annual growth rate (CAGR) of 8%, reaching $4.7bn by 2030. Boston Scientific reported net sales of $1.2bn in 2025 for its neuromodulation segment, which includes spinal cord stimulation systems and other devices. Abbott reported $1bn in sales for the segment in 2025.
Parekh offered a sobering perspective on what patients should expect: “If you ask someone, do you want to go through all this surgery and stuff because it will help you for three months, they’re going to say no.”
Company Responses
Boston Scientific: “Because this is an active legal matter, we intend to address this matter through the appropriate legal process and do not have further comment.”
Abbott: “We stand behind the safety, quality, and performance of our spinal cord stimulation systems. These technologies help manage chronic pain and provide meaningful relief, improving patients’ overall quality of life. They are highly regulated medical devices that have been approved and updated in accordance with federal law through the FDA’s rigorous premarket approval and supplement processes. We strongly disagree with the allegations in this lawsuit and believe they are without merit.”
