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Pending consolidation● EMERGING36 eventsMedical Device

Nevro Spinal Cord Stimulators

Medical Device · claims that Nevro HFX, Senza, and Omnia spinal cord stimulator systems caused neurological injury, device malfunction, autonomic complications, worsened pain, and failed pain relief

Defendant

Nevro Corporation

MDL / Track

MDL 3195

N/A — pending JPML ruling

Judge

N/A — pending JPML ruling

Plaintiffs

17 federal cases pending across six districts

Bellwether / Trial

No verdicts yet

Settlement Status

  • No settlement or global fund exists
  • no settlement talks scheduled
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← Torts Case overview Litigation status Geographic exposure Key defendants Timeline Statute of limitations Live activity News PubMed openFDA Court filings

Case overview

Seventeen federal cases against Nevro Corp. are pending across six districts, with oral arguments on MDL consolidation scheduled for September 24, 2026. The U.S. Judicial Panel on Multidistrict Litigation declined on June 5, 2026, to fold Nevro cases into the industry-wide Boston Scientific MDL (MDL-3181, Judge Josephine L. Staton, C.D. Cal.), leaving Nevro-specific litigation to proceed separately. Core allegations target the Senza, Senza II, Senza Omnia, HFX, and HFX iQ systems for defective design, failure to warn, and manufacturing deviations from FDA-approved specifications.

Causation Theory

Plaintiffs allege Nevro's high-frequency 10 kHz spinal cord stimulators cause autonomic nervous system dysfunction through vagus nerve overstimulation, resulting in dysmotility, arrhythmias, and incontinence. Device-specific harms include lead migration, infection, and painful stimulation due to alleged firmware, waveform, battery, and lead modifications introduced through supplemental FDA submissions rather than full premarket review. The FDA MAUDE database documents explant events, necrotic tissue, and persistent pain at inactive generator sites.

Case Management Orders

Litigation status

Nevro spinal cord stimulator litigation awaits JPML consolidation ruling after September 24, 2026 oral arguments on proposed MDL 3195. Seventeen federal cases currently pend across six districts; Nevro formally opposes consolidation, arguing cases lack common defects. No transferee court or judge assigned.

MDL Track

MDL 3195

Nevro HFX, Senza, and Omnia spinal cord stimulator products liability

State Court Activity

No state court activity reported

Geographic exposure

Nevro reports its 10 kHz Therapy has impacted more than 80,000 patients globally as of October 2022. Devices involved: Senza, Senza II, HF10/HFX, HFX iQ, Senza Omnia. Reported complications include lead migration, lead fracture, infection, neurological injury, syncope, incontinence, loss of pain relief, undesirable stimulation changes, and explantation. No MDL or settlement; state SOL windows govern filing deadlines.

  • Louisiana

    Greene v. Nevro Corp., 3:23-cv-01648 (M.D. La. Jan. 31, 2025), Judge John W. deGravelles. Plaintiff Ashley Greene alleges permanent nerve damage, loss of mobility, and inability to live independently following implantation of Nevro spinal cord stimulator by neurosurgeon Charles Bowie, M.D. Court granted Nevro's motion to dismiss with leave to amend; plaintiff given 28 days to plead parallel federal violation to avoid preemption under Medical Device Amendments.

  • New Mexico

    Yusnukis v. Nevro Corp., 1:24-cv-00355 (D.N.M. Feb. 24, 2026), Judge Sarah M. Davenport/Magistrate Judge Jerry F. Rael. Plaintiff Ron Yusnukis alleges syncopal episodes and incontinence from Nevro Omnia SCS, explanted after 49 days. Court granted dismissal: manufacturing defect and implied warranty claims preempted; parallel federal violation claims not plausibly pled. Device implanted March 2021.

  • N.D. California

    First Nevro lawsuits filed March 23, 2026. Part of 17 federal cases pending across six districts as of September 2026. Proposed MDL 3195 hearing before JPML scheduled September 24, 2026.

  • Costa Rica (manufacturing)

    Nevro FDA-approved manufacturing facility in Coyol Free Trade Zone, Alajuela, Costa Rica, operational since October 2022. Produces Senza, Senza II, and HFX platform devices for global distribution. FDA approval announced October 4, 2022.

  • Nationwide (proposed MDL)

    17 federal Nevro cases pending across six districts as of September 22, 2026. JPML oral arguments September 24, 2026 on proposed MDL 3195. Nevro formally opposed consolidation August 6, 2026, arguing cases lack common defects. No MDL established; no settlement or global fund exists.

Key defendants

Nevro Corporation

Role: Manufacturer / primary product-liability defendant

The petition targets HFX, Senza, and Omnia SCS systems and alleges product defect, warnings, negligence, warranty, misrepresentation, consumer-protection, PMA supplement, and surveillance failures.

Globus Medical, Inc.

Role: Parent / named defendant where applicable

The motion states Nevro became a wholly owned subsidiary of Globus Medical in April 2025, and Globus is named in some cases where applicable.

United States Food and Drug Administration

Role: APA defendant in many listed cases

Nine federal cases reportedly name FDA under APA theories involving PMA supplement handling, QSR/CGMP obligations, adverse-event reporting, labeling, warnings, and post-market surveillance.

DefendantRoleIntelligence Note
Nevro CorporationManufacturer / primary product-liability defendantThe petition targets HFX, Senza, and Omnia SCS systems and alleges product defect, warnings, negligence, warranty, misrepresentation, consumer-protection, PMA supplement, and surveillance failures.
Globus Medical, Inc.Parent / named defendant where applicableThe motion states Nevro became a wholly owned subsidiary of Globus Medical in April 2025, and Globus is named in some cases where applicable.
United States Food and Drug AdministrationAPA defendant in many listed casesNine federal cases reportedly name FDA under APA theories involving PMA supplement handling, QSR/CGMP obligations, adverse-event reporting, labeling, warnings, and post-market surveillance.

Timeline

  1. 2015

    FDA Approves Senza SCS System

    FDA grants premarket approval for Nevro's Senza Spinal Cord Stimulation System for 10 kHz high-frequency therapy based on SENZA-RCT 12-month results.

  2. 2025-01-31

    Greene Dismissed With Leave to Amend

    Middle District of Louisiana Judge John W. deGravelles grants Nevro's motion to dismiss in Greene v. Nevro Corp., No. 3:23-cv-01648-JWD-RLB, finding plaintiff failed to plead parallel federal violations to avoid preemption under Medical Device Amendments; 45 days to amend.

  3. 2025-04-03

    Globus Medical Acquires Nevro

    Globus Medical completes all-cash acquisition of Nevro Corp. for approximately $250 million ($5.85 per share); Nevro survives as wholly owned subsidiary. Globus Medical records bargain purchase gain of approximately $110.6 million.

  4. 2026-02-24

    Yusnukis Preemption Motion Fully Briefed

    District of New Mexico case Yusnukis v. Nevro Corp., No. 1:24-cv-00355, alleges manufacturing defect, failure to warn, fraud, and breach of warranties regarding HFX Omnia implant; Nevro's preemption motion fully briefed and pending decision.

  5. 2026-03-23

    First Federal Product Liability Filings

    Three lawsuits filed in U.S. District Court for the Northern District of California allege Nevro's Senza spinal cord stimulators are defectively designed, worsened chronic pain, and failed to warn of performance differential between trial and permanent devices.

  6. 2026-06-05

    JPML Declines Industry-Wide MDL

    U.S. Judicial Panel on Multidistrict Litigation denies motion for industry-wide spinal cord stimulator MDL in MDL-3181 Transfer Order, citing differences in regulatory histories and device lines; creates separate MDL for Boston Scientific cases before Judge Josephine L. Staton in Central District of California. Panel notes seventeen pending cases naming Nevro and Globus Medical, to be handled separately.

  7. 2026-06-26

    Plaintiffs File MDL 3195 Petition

    Plaintiffs file motion asking JPML to create proposed MDL 3195 for Nevro spinal cord stimulator cases, seeking consolidation separate from Boston Scientific MDL.

  8. 2026-08-06

    Nevro Opposes Consolidation

    Nevro formally opposes MDL 3195 consolidation, arguing the cases lack common defects.

  9. 2026-09-24

    JPML Oral Arguments on Nevro MDL

    Judicial Panel on Multidistrict Litigation holds oral arguments on whether to consolidate Nevro cases as MDL 3195 and Abbott cases as MDL 3194; written ruling expected fall 2026. Seventeen federal Nevro cases pending across six districts.

Statute of limitations

Nevro SCS claims depend on state product-liability statutes, implant/explant dates, symptom onset, discovery of device causation, and tolling agreements. The JPML petition specifically flags a tolling agreement through August 1, 2026 for movants’ counsel, but that may not protect every claimant.

⚠ 4 states with critical SOL — act immediately

⚠California

Generally 2 years for personal injury

Rule: Accrual generally turns on injury and discovery of suspected wrongful cause.

Discovery: May defer accrual until plaintiff reasonably suspects Nevro device involvement.

⚠Pennsylvania

Generally 2 years for personal injury

Rule: Important because petition identifies several Pennsylvania state-court Nevro filings.

Discovery: Discovery rule may apply when device causation was not reasonably knowable.

⚠Texas

Generally 2 years for personal injury

Rule: Product-injury claims often require prompt filing from injury or discovery.

⚠Florida

Generally 2 years for negligence-based personal injury after 2023 tort-reform changes

Rule: Accrual and choice-of-law analysis can be case-specific for device implantation and injury locations.

StateSOLRuleDiscovery RuleNotes
⚠CaliforniaGenerally 2 years for personal injuryAccrual generally turns on injury and discovery of suspected wrongful cause.May defer accrual until plaintiff reasonably suspects Nevro device involvement.—
⚠PennsylvaniaGenerally 2 years for personal injuryImportant because petition identifies several Pennsylvania state-court Nevro filings.Discovery rule may apply when device causation was not reasonably knowable.—
⚠TexasGenerally 2 years for personal injuryProduct-injury claims often require prompt filing from injury or discovery.——
⚠FloridaGenerally 2 years for negligence-based personal injury after 2023 tort-reform changesAccrual and choice-of-law analysis can be case-specific for device implantation and injury locations.——

Live intelligence

AI litigation brief

Nevro Spinal Cord Stimulators remains pending consolidation with 36 current signals in the accepted feed.

Overview

Nevro spinal cord stimulator litigation awaits JPML consolidation ruling after September 24, 2026 oral arguments on proposed MDL 3195. Seventeen federal cases currently pend across six districts; Nevro formally opposes consolidation, arguing cases lack common defects. No transferee court or judge assigned.

Key developments

  • PACER court filing on Sep 16: Afshar v. United States Food and Drug Administration
  • Eastern Progress news on Aug 31: Wisner Baum Named to Leadership in Federal Spinal Cord Stimulator Litigation - Eastern Progress
  • MAUDE FDA alert on Aug 29: MAUDE Filing 50510183: Senza

Trajectory

Court filings and press coverage are both active in MDL 3195, pointing to sustained litigation pressure rather than a one-off headline cycle. 5 live sources are contributing current context.

Editorial intelligence

MDL 3195 should stay on the lead docket watch because it is the primary consolidation vehicle for Nevro SCS.

Generated Sep 30, 2026, 10:00 AM UTC

36 events detected

Google News (10)

  • Wisner Baum Named to Leadership in Federal Spinal Cord Stimulator Litigation - Eastern Progress

    Eastern ProgressAug 31, 2026, 7:00 AM UTC
  • How Do Spinal Cord Stimulators Fail? The Technology Behind Growing Defective Device Lawsuits - The Legal Examiner

    The Legal ExaminerJul 27, 2026, 7:00 AM UTC
  • How Do Spinal Cord Stimulators Fail? The Tech Behind Growing Defective Device Lawsuits - The Legal Examiner

    The Legal ExaminerJul 27, 2026, 7:00 AM UTC
  • Wisner Baum's Lawsuits Challenge FDA Oversight of Spinal Cord Implants - PR Newswire

    PR NewswireJul 22, 2026, 12:06 PM UTC
  • FDA, others sued for injuries from spinal cord stimulator - The Black Chronicle

    The Black ChronicleJul 14, 2026, 5:45 PM UTC
  • Plaintiffs Say Stimulator Makers Used FDA Supplement Pathway To Avoid New Trials - insights.citeline.com

    insights.citeline.comJul 2, 2026, 7:00 AM UTC
  • Spinal Cord Stimulator Lawsuits Grow, New MDL Created - The Legal Examiner

    The Legal ExaminerJun 18, 2026, 7:00 AM UTC
  • Defective Spinal Cord Device Case Survives Motion To Dismiss In Md. Federal Court - Mealey's

    Mealey'sMay 28, 2026, 7:00 AM UTC
  • Woman Says Spinal Device Caused Permanent Nerve Damage - Law360

    Law360May 18, 2026, 7:00 AM UTC
  • Spinal Cord Stimulator Lawsuit 2026 Updates & Facts - LawFold.com

    LawFold.comApr 26, 2026, 7:00 AM UTC

No recent PubMed signals. Monitoring is active — this section updates automatically.

COURTLISTENERNYSD1:26-cv-08147Sep 16, 2026, 12:00 AM UTC

Afshar v. United States Food and Drug Administration

S.D.N.Y.

This filing is a lawsuit against the FDA under the Administrative Procedures Act regarding Nevro spinal cord stimulators, directly involving one of the MDL primary defendants (FDA) in a related regulatory challenge concerning the same medical devices at issue in the MDL.

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LexGenius Ranking

80Score

Court, news, and regulatory activity are elevated

Evidence16 / 20
Momentum12 / 20
Exposure16 / 20
Regulatory16 / 20
Legal20 / 20

Monitoring

Live

monitoring

Last: Sep 30, 2026, 10:00 AM UTC

Next: —

Source Monitoring

PACER

40s

PACER

Pending

Google News

40s

MAUDE

40s

PubMed

15m 40s

Event feed

36

events detected

Google NewsPACERMAUDE

AI Brief

Nevro Spinal Cord Stimulators remains pending consolidation with 36 current signals in the accepted feed.

Overview

Nevro spinal cord stimulator litigation awaits JPML consolidation ruling after September 24, 2026 oral arguments on proposed MDL 3195. Seventeen federal cases currently pend across six districts; Nevro formally opposes consolidation, arguing cases lack common defects. No transferee court or judge assigned.

Key developments

PACER court filing on Sep 16: Afshar v. United States Food and Drug Administration. ‖ Eastern Progress news on Aug 31: Wisner Baum Named to Leadership in Federal Spinal Cord Stimulator Litigation - Eastern Progress. ‖ MAUDE FDA alert on Aug 29: MAUDE Filing 50510183: Senza.

Generated Sep 30, 2026, 10:00 AM UTC

Tracked MDLs

MDL 3195

Pending consolidation

Nevro HFX, Senza, and Omnia spinal cord stimulator products liability

Motion to Consolidate

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