Spinal cord stimulators (SCS) – neuromodulation devices that deliver mild electrical signals to manage the likes of chronic back and neck pain – represent a growing market. However, in 2026, the sector’s major players are facing personal injury lawsuits.
Boston Scientific, Abbott, Nevro, and Medtronic all face lawsuits, alleging that their SCS devices caused patient harm.
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GlobalData analysis found that the global SCS market is growing at a compound annual growth rate (CAGR) of 6.8% and is set to almost double its valuation to around $4.8bn in 2035. Medtronic held a 29.8% share of the US rechargeable SCS market in 2025, followed by Nevro, Boston, and Abbott with market share of 29.5%, 21.4%, and 16.9%, respectively, as per a GlobalData market model.
Each of the lawsuits began escalating throughout 2025 and were triggered either by earlier US Food and Drug Administration (FDA) recalls or by increased reports of product malfunction. In the lawsuits, which, except that against Medtronic, have now been consolidated into single federal multidistrict litigation (MDL) cases to streamline proceedings, patient allegations range from battery issues that resulted in pain, through to more severe accusations that SCS devices worsened pain over time and resulted in a need for revision surgery. Moreover, at least one of the lawsuits contests that SCS devices underwent unauthorised or improper programming by company representatives.
Medtronic and Nevro did not immediately respond to requests for comment on the pending legal proceedings, while Boston Scientific declined to comment on its ongoing lawsuit.
An Abbott spokesperson told Medical Device Network that the company “stands behind” the safety, quality, and performance of its SCS systems. Abbott disputed the allegations and said it was confident that the “evidence and science” would support its position.
The personal injury lawsuits’ roots
The company lawsuits are currently in the early stages, with no trial dates set, remaining in motion despite the SCS devices demonstrating strong long-term efficacy in pain reduction across multiple indications.
SCS devices are comprised of facets including electronics, software, stimulation parameters, and interactions with human physiology. Classified as Class III medical devices by the FDA, they are required to obtain US market approval via the agency’s pre-market approval (PMA) pathway and undergo supplemental review processes for any updates over time.
Due to SCS devices’ complex amalgamation of systems, Michel Khoury, CEO of product innovation and development firm Go Vertical ICM, notes that safety depends not only on initial design validation, but also on manufacturing consistency, implantation, programming, and performance over time.
With this in mind, Khoury’s view is that the current litigation may come down to the potential gap between regulatory approval and long-term, real-world device performance. The current litigation therefore raises “important questions” about whether clinical evidence and regulatory scrutiny have kept pace with device modifications over time, and whether emerging risks for the respective parties’ SCS devices were “adequately identified and communicated” to the FDA.
“I would not automatically conclude that the FDA’s approval process is flawed,” said Khoury, noting that PMA is a rigorous evaluation process. “However, approval is not a lifetime guarantee of safety.”
An evaluative fault at the FDA?
Behram Parekh, partner at law firm Wisner Baum, and lead patient representative for the lawsuit against Boston Scientific, says one of the case’s key contestations is that the FDA effectively “broke its own rules” regarding its evaluative process for SCS devices.
Medtronic was a pioneer in the SCS space, Parekh notes, receiving FDA approval over 25 years ago for its first-generation SCS device.
“Since then, there have been additional devices by other manufacturers, and they piggyback off the same data that the Medtronic device was done on,” Parekh explains.
The prevailing issue is that there have been “hundreds” of changes to SCS technology since that first device, yet with the FDA’s evaluative posture, they are effectively viewed as minor changes to the device over this 25-year period.
The way these devices are programmed has changed, according to Parekh, along with other factors including how the electrical stimulation is applied to the nerves, which are significantly different.
As a result, Parekh asserts that modern SCS devices being approved on the basis of comparison to an older device is akin to comparing a cell phone released in the ‘90s to a modern smartphone.
Parekh’s view is that the FDA did not follow its own rules and should have required new safety and efficacy studies on newer SCS devices following significant change.
Regarding the impact these factors had on patient harm in the Boston case, Parekh says the lawsuit is examining how changes in voltage and wave patterns, device miniaturisation, and other manufacturing processes may have contributed to the broad range of injuries suffered by the patients it represents.
Meanwhile, another notable element of the case against Boston is Wisner’s intention to pursue patient allegations that the company’s sales representatives may have misled customers and “engaged in the unauthorised practice of medicine” regarding device reprogramming undertaken without a doctor’s supervision.
A loophole that manufacturers have exploited?
Matthew Clark, founder and lead attorney at Michigan-based The Clark Law Office, refers to the FDA’s evaluative process for SCS devices as effectively being a “loophole” manufacturers have “exploited for decades”. And according to Clark, the FDA has “allowed this to happen”.
For SCS devices, manufacturers have been able to claim that a new device revision was “small enough” or didn’t “functionally change” the product and could therefore bypass more stringent regulatory scrutiny, Clark explains.
“This became a shield to protect manufacturers from state-level product liability claims on the assumption that the FDA’s vetting process is infallible and comprehensive,” he says.
“I’d even argue that the FDA has become less proactive and more reactive in this regard, or at worst, negligent. Despite receiving well over 100,000 adverse event reports detailing severe patient complications, the regulation sat on these complaints, basically disregarding them, and only acted once widespread injuries forced the legal system to intervene,” Clark adds.
The possible legacy of the SCS lawsuits
Irrespective of the ultimate litigation outcomes, Khoury’s view is that he would expect increased attention to evaluative areas regarding cumulative design changes and “whether successive modifications require additional clinical validation”.
For post-market surveillance, there may be an uptick in how effectively “long-term device performance, failure patterns, and adverse events are captured and investigated”, Khoury says, while for real-world validation, the case may lead to greater scrutiny surrounding whether clinical evidence “adequately represents the conditions” under which patients “actually use” SCS devices.
Khoury concludes that the broader lessons these cases give rise to should extend beyond SCS devices. “As medical devices become increasingly software-driven, connected, and programmable, development teams need to treat clinical validation, engineering verification, risk management, and post-market monitoring as a continuous process,” he comments.
“The objective is much bigger than simply obtaining regulatory approval. It should be about maintaining demonstrable safety and performance throughout the product’s lifecycle.”
Proving patient harm allegations
Conceding that it will be an “uphill battle” to prove a deferential FDA regulatory cadence, Parekh says: “But if we can show that the FDA didn’t follow its own rules, then I think that will be very significant in terms of setting a precedent for other devices where similar things have happened.”
Meanwhile, Clark’s view is that the key evidence required will be in proving that a specific device implanted in a patient physically deviated from the FDA-approved specifications, or that a company “failed to report known adverse events” to the FDA.
He highlights, however, that even if it can be proven that a manufacturer bypassed regulations, a case is still likely to “crumble” in the absence of patient-specific medical proof.
“The ultimate evidence in a single case consists of device interrogation logs showing unexplained voltage spikes, combined with explant surgical notes explicitly documenting migrated leads, fractured wires, or localised tissue burns,” Clark comments. “When that data shows the device behaved outside its own specifications, you have the foundation of a claim pre-emption can’t easily touch.”
Thousands of patients across the US, involved either in the cases against Boston, Medtronic, Nevro, or Abbott, assert that the SCS devices they were implanted with caused them harm.
Providing sufficient proof to convince a judge once these cases make it to a courtroom, however, is another matter. It remains to be seen, therefore, whether the discovery period for each of the law firms representing the patients in each suit can uncover evidence that meets a sufficient threshold to result in potential settlements, an outcome that could potentially catalyse a shift in the way the FDA evaluates SCS devices moving forward.
