Spinal Cord Stimulator Litigation - Fast Evaluation (MDL Claims & State Claims)

Michael Stanisci

Sep 17

15 min read

Written by Michael Stanisci (MassTortMichael) - September 17, 2026.

About This Evaluation

This is not legal advice and it is not medical advice. Nothing here creates an attorney-client relationship or a doctor-patient relationship.
This is a prospectus-style evaluation of a litigation as a project. Its purpose is to jumpstart your informed decision making, not to replace it.
Every projection is a sample based on conservative assumptions. Every fact is sourced in the Citations section, and open items are marked where the public record runs out.
If you are an attorney, do your own diligence and read the primary sources. If you are a patient, talk to your doctor about your health and to a licensed attorney about your legal rights.

1) Snapshot

A spinal cord stimulator (SCS) is a small implanted device. It sends electrical pulses to the spine to dull chronic pain. Patients are suing Boston Scientific, Abbott, Medtronic, and Nevro. They say the devices caused electric shocks, worse pain, nerve injury, and repeat surgeries.

This is not one litigation. It runs on three tracks.

Track 1, the federal MDL. On June 5, 2026, the JPML sent the Boston Scientific cases to Judge Josephine L. Staton in the Central District of California as MDL No. 3181. It refused to create an industry-wide MDL.
Track 2, federal cases with no MDL yet. The JPML hears argument on September 24, 2026 in Chicago on separate Abbott and Nevro MDLs. The order lists 15 Abbott cases in seven districts and 17 Nevro cases in six. Medtronic has no MDL and no petition.
Track 3, state claims. Some plaintiffs are suing Medtronic in Minnesota state court, its home state, partly to avoid transfer into federal MDL proceedings.

Who was hurt, based on filed complaints. These are allegations, not findings.

An Arizona man with an Abbott Proclaim Plus 5 says he was shocked the day after implant and was paralyzed from the waist down by December 2024. He says movement began returning after the leads were removed.
A New Mexico man with an Abbott Proclaim XR5 alleges leg weakness, loss of bladder and bowel control, and a violent shock during an MRI attempt.
An Ohio woman had a Nevro system removed after four months. Her next device, a Boston Scientific WaveWriter Alpha, needed revision surgery for lead migration and was later removed.
A New York woman says her WaveWriter Alpha caused shocks, burning, and atrial fibrillation. It is turned off, and she cannot find a doctor to remove it.
A New Mexico Nevro plaintiff alleged fainting episodes and incontinence until his device was explanted after 49 days.

2) Plaintiff Numerosity

Exposure pools in the United States:

About 50,000 devices are implanted each year across the four makers.
A Medicare study tracked 106,462 generators implanted from 2013 to 2020.
Abbott's 2023 Class I recall covered 155,028 U.S. devices shipped from November 2015 to June 2023. That count includes the Infinity deep brain line, so it is not SCS only.
Boston Scientific reported 1,081 serious injuries tied to one lead model as of May 27, 2026.

Revision and reoperation examples:

One center reviewed 1,014 implants and 175 reoperations over ten years. At least one reoperation happened in 97 cases (9.5%).
Among 54 patients who had a first revision, 15 (28%) needed a second. Lead migration caused 65% of revisions.
The literature reports revisions in up to one-third of patients.
The Medicare cohort showed seven-year explant rates of 19.2% to 22.0% and generator replacement rates of 29.5% to 33.7%. I am relying on a secondary summary for this.
A Swedish study of 400 patients found a 38% explant risk at ten years.
A 2025 systematic review by Wahezi and colleagues pooled 25 studies and 13,026 patients to look at SCS explant rates and the reasons for explant. This evaluation does not rely on its figures, because only the published abstract was reviewed and not the full paper. Attorneys and their experts should read the full study for themselves. It is linked in the Citations section.

A point the defense will use: complication rates appear to be falling. One center reported 38.9% for implants from 1999 to 2015 and 14.0% for 2016 to 2021.

Filed and retained claimants:

The JPML counted 46 related actions in 14 districts in June 2026: 12 Boston Scientific, 9 Abbott, 1 naming both, 17 Nevro or Globus, 1 Nevro plus Boston Scientific, and 6 Medtronic.
MDL 3181 grew from 24 cases in July to 29 in September.
As of February 2026, about 400 more injured patients had reportedly retained counsel. The lawyer behind the first Medtronic cases said in 2025 he had "hundreds" of similar clients. One plaintiff-side outlet expects thousands of filings. These come from interested sources.
The plaintiffs' JPML motion estimated that about 70 percent of SCS recipients had an adverse event or poor pain relief. That is an advocacy number. I would not underwrite to it.

Sample pool math: 50,000 implants a year over ten years is about 500,000 patients. At a 9.5% reoperation rate, that is roughly 47,500 people. At a 20% seven-year explant rate, roughly 100,000. SOL cuts this hard. If only the last three years of implants are still timely, that is 150,000 implants and roughly 14,000 early revision or explant candidates, before preemption and before splitting by maker. These are sample projections based on conservative estimates. All of these assumptions are subject to change as the litigation develops.

Mensing does not apply to devices. Open item: market share by maker is not verified, so I cannot split the pool by defendant.

Research note: This is a young litigation and the published data is still catching up to it. Several figures above come from abstracts, summaries, or single-center studies. More information and research is needed before any of them should be treated as settled. I will update this evaluation as better data comes in.

3) Defendant Viability and Liquidity

None of the four is a collectability risk today. One structure question sits with Nevro.

Boston Scientific (public).
- 2025 net sales were $20.074 billion.
- It held $1.453 billion in unrestricted cash on March 31, 2026 and signed a new $3.0 billion revolving credit line in February 2026.
- Its 10-Q says liquidity is enough to pay legal-related liabilities.
- It recorded $76 million in litigation-related net charges in the first half of 2026 across all matters. That figure is not SCS specific.
- Neuromodulation is about 6 percent of sales, so this business is not core to the company's survival.
Abbott (public).
- 2025 sales were $44.3 billion.
- Operating cash flow was $3.8 billion in the first six months of 2026, with working capital of $6.7 billion at June 30, 2026.
- Debt ratings are A+ (S&P) and Aa3 (Moody's).
- Cash dropped this year to fund the Exact Sciences deal, and Abbott repaid nearly all of the $2.8 billion in debt it assumed.
Medtronic (public).
- FY26 revenue was $36.364 billion, operating cash flow $7.330 billion, and free cash flow $5.426 billion.
- Total debt was $28.2 billion at July 31, 2026.
- The 10-K describes a strong financial position backed by a credit facility and commercial paper.
Nevro and Globus Medical.
- Globus bought Nevro on April 3, 2025 for about $250 million. Nevro is now a wholly owned subsidiary.
- Globus booked a $110.5 million bargain purchase gain on the deal, which tells you Nevro sold cheap.
- Globus is healthy. Q2 2026 net sales were $789.6 million, with net income of $151.6 million. It held $840.5 million in cash and marketable securities at June 30, 2026, and 2026 revenue guidance is $3.18 to $3.22 billion.
- Nevro is the soft spot. Its revenue fell 14.3% year over year in Q2 2026.
- The viability question is whether Globus stands behind pre-2025 Nevro implants or whether claims are limited to the Nevro subsidiary. Plaintiffs are naming both. This is the classic parent and child trap. It is an open item that needs a lawyer's read of the merger agreement.

4) Financial Viability

No verdicts and no settlements exist against any SCS maker, in state or federal court. A $4.5 million Georgia verdict cited online was medical malpractice, and a $20 million award was a patent case.
Open item: I have not verified any SCS-specific reserve in any defendant's filings. Not publicly available as of today as far as I can confirm. A reserve announcement is my marker for the settlement phase.

5) Scientific Viability: The Adverse Events, One by One

The big picture:

Reviews put overall complications at 30% to 40% of patients.
Hardware problems are more common than biological ones.
From July 2016 to July 2020, FDA received 107,728 SCS reports: 497 death reports, 77,937 injury reports, and 29,294 malfunction reports.
FDA cautioned that these reports often cannot prove the device caused the event.

Device and hardware events:

Loss of pain relief.
- It is the top problem in FDA reports at 28.1%, with 30,321 reports.
- It is the leading reason for explant. In the Swedish study it drove 55.2% of explants.
- On its own, this is the weakest legal claim.
Lead migration.
- The wire moves away from its target. It is the most common complication.
- A 20-year review found 13.2%. Later reviews found 20% to 22.6%.
- It drives 65% of revision surgeries.
Lead fracture or disconnect.
- It occurs in 5.9% to 9.1% of devices.
- This is the defect behind Boston Scientific's September 2026 Infinion CX recall. The lead body can fracture at the anchor site, with 1,081 serious injuries reported.
- Impedance problems, a sign of lead damage, make up 10.6% of FDA device-problem reports.
Shocks, jolts, and overstimulation.
- Nearly every complaint alleges these.
- The closest FDA code, unexpected therapeutic effects, is 10.9% of reports.
- Open item: I found no clean published rate for shocks.
Burning, overheating, and charging problems.
- Charging problems are the top FDA device code at 11.2%.
- Burns are alleged in complaints.
- Open item: no published rate verified.
Battery failure.
- An older review found 1.7%, with most cases after three years.
- FDA codes show battery problems at 6.4% and premature discharge at 4.2%.
MRI mode lockout (Abbott).
- The device cannot leave MRI mode, so therapy stops.
- There were 186 incidents and 73 injuries, and the fix may require surgery to replace the generator.

Biological events:

Infection.
- Studies range from 2% to 10%.
- A review of 2,737 implants found 2.45%.
- Infection is 7.5% of FDA reports.
- It usually starts in the pocket that holds the generator.
Pain at the generator site.
- About 9% in one pooled review.
- It caused 13% of revisions at one center.
Dural puncture and spinal fluid leak.
- Rarely observed.
Epidural hematoma, which is bleeding that presses on the spinal cord.
- Older reviews report 0.25% to 0.3%. A newer review reports 0.81% to 2.6%.
- It shows up as growing weakness and numbness.
Neurological injury, including paralysis.
- Most reviews report 0.03% to 0.25%. One study found 2.35%.
- It can come from the needle or lead, or later from a hematoma or infection.
- One case report describes scar tissue compressing the spinal cord seven years after implant.
Autonomic and cardiac problems.
- These are pled in the MDL and in individual complaints, including atrial fibrillation and Ogilvie's syndrome.
- Open item: I found no published incidence data. This is the thinnest science in the case.
Death.
- The 497 death reports covered 428 patients.
- Almost one-third of the deaths with known timing happened within 30 days of implant.
- The average age was 69, and many patients had other illnesses.
Revision surgery.
- Revision is itself an adverse event: 9.5% need at least one reoperation and 28% of those need a second.
- About 7% of revision procedures had their own complications.

Efficacy is disputed. A 2023 Cochrane review of 13 trials and 699 patients found probably no sustained benefit over placebo for low back pain. Pain physicians published a rebuttal attacking its methods.

6) Legal Viability

This is where the litigation will be won or lost.

The barrier:

SCS devices are Class III devices approved through PMA.
Under Riegel v. Medtronic, a patient generally cannot use state law to hold a PMA device to a standard different from what FDA required.
The opening is a "parallel" claim, meaning one that enforces the maker's own duty to follow FDA's rules.

Plaintiffs' way around the barrier:

They say the makers won approval using other companies' published literature.
They say the makers then abused PMA supplements to launch heavily changed devices without new clinical review.
There is a claim that surgeries were attended by a representative of the manufacturer.

What has failed so far:

The PMA supplement theory. Judge Schiltz rejected it on the merits because plaintiffs cited no statute or rule saying when a new PMA is required. He denied leave to amend.
Failure to warn, fraudulent concealment, negligent misrepresentation, and design claims. All were preempted in the Medtronic order.
Reporting claims, in some courts. The Medtronic order found them impliedly preempted under Buckman.
Claims against FDA. They were dismissed for lack of standing.
Every claim in a Western District of Michigan case against Boston Scientific.
The theory that sales reps practiced medicine without a license. It was dismissed in one Medtronic case for lack of a private right of action, and no court has endorsed it.
A self-inflicted wound. Plaintiffs pled that adverse events were public in FDA's database, and the court used that to defeat their concealment claim.

What has survived:

Manufacturing defect claims tied to FDA-approved specs. These survived for one Medtronic plaintiff on a 2024 device, along with negligence per se on manufacturing rules.
DiToto v. Nevro in Maryland, where eight of nine claims survived. The court held that failure-to-report claims are not preempted and let a failure to train sales reps claim proceed as negligence.

The split:

Courts disagree on failure-to-report claims, so venue affects outcome.
MDL 3181 sits in the Ninth Circuit. Boston Scientific complaints cite Stengel v. Medtronic, 704 F.3d 1224 (9th Cir. 2013) (en banc), in support of their claims. This evaluation does not analyze Stengel. Attorneys weighing Boston Scientific cases should read it for themselves, along with how district courts in the Ninth Circuit have applied it to PMA devices. I can introduce you to the attorneys in the MDL as well as state.

SOL:

One-year limits from Kentucky and Tennessee ended three of four Medtronic cases.
The clock potentially starts at different times subject to Discovery Rule or State SoL.

Proof:

In Hunt v. Medtronic, the Ninth Circuit affirmed a defense win because the plaintiff had no expert on breach and causation.
Every case will need a case-specific expert.

My read: legal viability is moderate today. The strongest cases share three things: a documented hardware failure such as a lead fracture, a revision or explant, and a recent, clean SOL date. The Infinion CX recall may help Boston Scientific plaintiffs plead a manufacturing claim, but no court has ruled on that yet.

A note for attorneys on what this section covers:

What is included: a plain-language summary of seven rulings. They are the JPML transfer order creating MDL 3181, the July 14, 2026 Medtronic order in the District of Minnesota, DiToto v. Nevro in Maryland, Yusnukis v. Nevro in New Mexico, Greene v. Nevro in Louisiana, the Western District of Michigan dismissal of a Boston Scientific case, and Hunt v. Medtronic in the Ninth Circuit.
How they were reviewed: the JPML transfer order was read in full from the Panel's own copy. Hunt and Yusnukis were reviewed in part from free public copies. The Medtronic order, DiToto, Greene, and the Michigan ruling are summarized from legal press and litigation trackers, not from the full text of the orders.
What is not included: any analysis of Stengel v. Medtronic, any circuit-by-circuit preemption analysis, any state court ruling, and any opinion on how a given court will rule.
What to do with it: read the orders linked in the Citations section before relying on any of them. Preemption outcomes turn on the specific claims pled and the law of each circuit.

7) Time to Resolution

Emerging phase for all defendants. My framework assumes no MDL pays in under three years. For planning, use five to six years. These are sample projections based on conservative estimates. All of these assumptions are subject to change as the litigation develops.

8) Venue of MDL

C.D. California, Judge Staton, whom the JPML called an experienced transferee judge.
Orders so far:
- June 23 order setting the first conference.
- August 13 order naming 19 plaintiffs' attorneys to leadership.
- August 18 direct filing order.
- Next conference October 7, 2026.

9) Bellwether Results

None scheduled. When they come, verdict size does not equal settlement value.

10) Daubert and Frye Analysis

No rulings yet. See Hunt in Section 6. Expert proof will be required case by case.

11) State of Litigation, by Track

Track 1, MDL claims. Motions to dismiss on preemption are pending before Judge Staton, and FDA has asked to be dismissed. That ruling is the key event.
Track 2, federal non-MDL claims.
- The JPML decides after September 24 whether Abbott and Nevro get MDLs.
- Two Nevro cases were dismissed without prejudice: Yusnukis in New Mexico and Greene in Louisiana. Greene failed on pleading, not preemption.
- Medtronic cases proceed one by one.
Track 3, state claims.
- A New York woman sued Medtronic in Minnesota state court in May 2026.
- State court changes the forum and avoids the MDL common benefit tax. It does not avoid preemption or SOL.
- Open item: I could not verify any state coordinated proceeding, state case counts, or a state preemption ruling.

12) Business View

The economics here are largely unknown and speculative. Nothing has settled, so every dollar figure below is a planning tool, not a forecast.

Risk level (1-10): 8. Preemption could end most claims, and the biggest rulings so far favored the defense.
PPN signal: high in raw numbers, medium after SOL and preemption screening.
PACV range: no data-backed number exists. One plaintiff firm publishes its own illustrative estimates, from $90,000 to $250,000 for one revision up to $800,000 to $1.5 million for permanent bowel, bladder, or autonomic injury. The firm says these are not reported settlements.

Note: These are estimated values and individual results will vary.

These are sample projections based on conservative estimates. All of these assumptions are subject to change as the litigation develops.
TCPCA guidance: the method matters more than the number right now. As a sample only: $100,000 x 40% fee, less 7% common benefit, x 40% referral share = $14,880 per paid case. Discounted with daily compounding, that supports about $166 per case at risk 8 (RR 75%, six years), $1,224 at risk 6-7 (RR 50%, five years), and $3,672 at risk 4-5 (RR 35%, four years). The target moves with risk, and risk moves with the preemption ruling. These are sample projections based on conservative estimates. All of these assumptions are subject to change as the litigation develops.
Acquisition cost check: The going rate for claimant acquisition is roughly $350 to $600 per claimant, based on MassTortMichael market data. I'm not seeing large fallout as of now, though litigations can always evolve with broader or tighter criteria. So let's assume 50% attrition in nascent projections for the purpose of this evaluation. At that rate, the cost per surviving case doubles to $700 to $1,200. A sample book of 100 signed claimants costs $35,000 to $60,000 and leaves 50 surviving cases. Medical records, record review, and intake labor are extra. These are sample projections based on conservative estimates. All of these assumptions are subject to change as the litigation develops.
Intake screens:
- Permanent implant.
- Maker and model.
- Hardware failure on record.
- Revision or explant records.
- The date the patient was first told to turn the device off.
Suggested posture: Watch, or enter small with a hard cap. Acquisition is cheap, but the outcome turns on one preemption ruling, and the return side cannot be priced yet. Spend only what you can lose in full.

Acronyms

APA: Administrative Procedure Act
CMO / PTO: Case Management Order / Pretrial Order
CPCA / ACPCA / TCPCA: Cost, Average Cost, and Target Cost Per Client Acquired
DFV: Defendant Financial Viability
FDA: Food and Drug Administration
IPG: Implantable Pulse Generator (the battery unit)
JPML: Judicial Panel on Multidistrict Litigation
LVC: Legal Viability of the Case
MDL: Multidistrict Litigation
MDR: Medical Device Report
PACV: Potential Average Case Value
PCD: Potential Case Duration
PMA: Premarket Approval
PPN: Potential Plaintiff Numerosity
RR: Required Rate of Return
SCS: Spinal Cord Stimulator
SOL: Statute of Limitations

Contact Michael

MassTortMichael works directly with the media buyers who acquire these claimants. Many of the media buyers I work with sell to the large marketing agencies you buy from every day. There is value in knowing both sides of that market, and I can help you navigate it. Whether you need capital, claimant acquisition, case work-up solutions, co-counsel introductions, or support all the way through resolution, I can introduce you to the right people.

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If you are a potential claimant, I can help connect you with the right law firm.
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