Spinal Cord Stimulator Lawsuit

A spinal cord stimulator is an implanted device that delivers electrical pulses to the spinal cord to treat chronic pain. It consists of an implantable pulse generator, leads placed in the epidural space, and an external programmer. Patients typically undergo a trial period before a permanent implant. FDA's own estimate, from a 2020 letter to health care providers, puts implant volume at roughly 50,000 devices per year in the United States.

The MDL-3181 transfer order identifies two shared factual questions. First, that Boston Scientific sought premarket approval "based on published literature related to SCS devices manufactured by other companies, rather than offering clinical studies demonstrating their safety and efficacy." Second, that it abused "the PMA supplement process by introducing new SCS devices under successive PMA supplements with significant modifications to avoid heightened scrutiny" and clinical evaluation. Failure-to-warn and concealment claims accompany those theories.

A third allegation is distinctive to this litigation. Every complaint in MDL-3181 alleges that sales representatives practiced medicine without a license, by entering surgical suites, advising on intraoperative lead positioning, programming devices and adjusting stimulation parameters. Some complaints elsewhere in the litigation also allege representatives pressured patients to report a successful trial period so they would qualify for a permanent implant. It is worth being precise about the status of this theory: no court has endorsed it on the merits, and in one Medtronic case it was dismissed for lack of a private right of action. A narrower version, failure to train sales representatives, was allowed to proceed as ordinary negligence in DiToto v. Nevro.

The injuries pleaded in the transfer order are unsatisfactory pain relief, shocking, burning, lead migration, autonomic dysfunction and neurological injuries. Across the broader litigation plaintiffs also allege lead wire fracture, generator migration or protrusion through the skin, loss or surge of stimulation, muscle weakness and loss of balance, battery failure and premature depletion, overheating, infection and sepsis, cerebrospinal fluid leak, and the need for revision, replacement or explant surgery.

This is the most misreported fact in the litigation, so it is worth stating plainly. Plaintiffs asked the JPML for one industry-wide docket covering at least Boston Scientific, Abbott and Nevro, and asked the Panel to name it In re Spinal Cord Stimulator Products Liability Litigation. All four manufacturers opposed. The Panel refused, holding that movants failed to meet their burden.

The Panel went further, saying an industry-wide MDL "may even be counterproductive," would complicate case management given the need to protect trade secrets, and "may prolong pretrial proceedings." It cited its standing hesitancy to centralize litigation against multiple competing defendants that marketed similar products.

One important nuance about Abbott. The June 5 order denied centralization as to Abbott on a technicality, not on the merits. All four Abbott cases before the Panel were pending in the Northern District of Illinois, and Section 1407 requires actions pending in different districts. As the Panel put it in a footnote, it "cannot grant a request for centralization of the cases against only Abbott." The denial was without prejudice, and a fresh petition followed weeks later.

The practical consequence for anyone with a claim: which manufacturer made your device determines which court your case goes to and what procedural posture it faces. There is no single spinal cord stimulator case to join.

Revision and explant rates are the strongest evidence in this litigation, and unlike settlement figures they are actually documented in peer-reviewed sources.

In the pooled systematic review, the reasons for explantation were lack of efficacy 38%, lead failure 15%, and infection 14%. A reasonable synthesis of both datasets: roughly one in ten devices is explanted within one to four years, about one in five by seven years, and about one in three requires generator replacement by seven years in the Medicare population.

Note on the Medicare study: several of its authors are industry-compensated implanting physicians, which if anything would bias the figures toward understating failure.

Adverse-event reporting is also substantial. FDA's September 2020 letter to health care providers reported 107,728 medical device reports in the four years after July 2016, of which 30,321 reported unsatisfactory or inadequate pain relief. That 30,321 figure is frequently misdescribed online as a malfunction count. It is not. It is inadequate pain relief, and stating it correctly matters.

Spinal cord stimulators are Class III devices approved through FDA premarket approval, which can preempt state-law claims. Whether plaintiffs can get around that is the central question in the litigation, and courts have gone both ways.

The defense high point: the Schiltz order, July 14, 2026

Judge Patrick J. Schiltz, District of Minnesota, resolved four consolidated Medtronic cases in a single order. Three plaintiffs were dismissed entirely as time-barred and the fourth partially. Leave to amend was denied. On the merits, he rejected the PMA-supplement-abuse theory, writing that plaintiffs "do not cite any language in any statute or regulation that even describes when a new PMA, as opposed to a PMA supplement, is required," and that 21 CFR 814.39(a) "says absolutely nothing about when a change to a device is so significant that the FDA must insist on a new PMA."

What survived, for one plaintiff and only as to a 2024 device: strict liability manufacturing defect, negligence on the manufacturing aspect, and negligence per se on cGMP violations. Preempted: failure to warn, fraudulent concealment, negligent misrepresentation, and design, testing and labeling negligence. Impliedly preempted under Buckman: adverse-event-reporting and complaint-file claims.

One detail worth studying. The court used plaintiffs' own pleading against them, noting that they had alleged Medtronic reported thousands of adverse events between 2017 and 2022, and that "those adverse events were publicly disclosed in the FDA's MAUDE database." Pleading the public adverse-event record to build the regulatory theory destroyed the concealment argument.

The plaintiff high point: DiToto v. Nevro, May 2026

In the District of Maryland, the court granted Nevro's motion to dismiss only as to implied warranty and denied it as to eight other counts. It held a manufacturing defect was adequately pleaded from device failure alone at the pleading stage, held failure-to-report claims are not preempted, and let failure to train sales representatives through as ordinary negligence.

That last holding is a genuine split. The Eighth Circuit line followed by Judge Schiltz treats adverse-event-reporting claims as impliedly preempted. The Maryland court, relying on the Fifth Circuit's Hughes v. Boston Scientific, does not. Venue is therefore outcome-relevant on that theory.

Two Nevro dismissals

Yusnukis v. Nevro (D.N.M., February 2026) granted dismissal in full without prejudice, holding directly that a plaintiff "cannot avoid preemption by challenging the FDA's approval process." Greene v. Nevro (M.D. La., January 2025) also granted dismissal without prejudice.

In the July 14, 2026 Schiltz order, the limitations periods applied were one year in both Kentucky and Tennessee. Three of four plaintiffs were dismissed as time-barred and the fourth was time-barred as to one of his two devices.

The court assumed the discovery rule applied to every claim and dismissed anyway, because of where it located the trigger. The practical accrual event was the earlier of being advised to turn the device off, or the onset of dramatic new symptoms after implant. One plaintiff experienced shock-like pain and urinary incontinence "within two weeks" of implant, which the court held "would have been enough to put a reasonably diligent plaintiff on inquiry notice."

Two things follow that are worth knowing before you assume you have time. None of the four plaintiffs had an explant, and revision or explant surgery was never treated as the trigger. And the argument that a patient was reassured the device was working normally was raised and rejected: the court held the plaintiff "still should have known, by the time he was advised to turn off the device, that the device was a likely source of his injuries."

Deadlines vary by state and this analysis will not control everywhere. But if you have a spinal cord stimulator injury, the honest advice is that the timeline may be far shorter than you have been told, and that the relevant date is probably earlier than you think. Speak with a licensed attorney in your state promptly rather than waiting for the MDL to develop.

Eligibility is being assessed case by case, and no court-approved criteria exist because no settlement program exists. Broadly, the factors that matter are:

• •A permanent implant of a spinal cord stimulator, as opposed to a trial period only
• •The manufacturer and model, which determines the venue and procedural posture
• •The implant date, and the date symptoms began
• •Whether you were ever advised to turn the device off, which may be the date a filing deadline started running
• •Whether you underwent revision, replacement or explant surgery
• •Documented injury: shocking or burning, lead migration or fracture, infection, neurological injury, autonomic dysfunction, or loss of stimulation

Because the filing-deadline analysis above can turn on a single date, gathering your implant records and the date you first reported problems is the most useful thing you can do before speaking with a lawyer.