MDL Track
MDL 3181
Spinal cord stimulator products liability
Medical Device · claims that spinal cord stimulator devices caused serious injuries including lead migration, nerve damage, paralysis, and failed pain relief
Defendant
Medtronic Inc.
MDL / Track
MDL 3181
Judge
Various
Plaintiffs
15 pending
Bellwether / Trial
No verdicts yet
Settlement Status
No settlements
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Case overview
Plaintiff attorneys are pursuing spinal cord stimulator (SCS) lawsuits against Abbott, Boston Scientific, Medtronic, Nevro, and St. Jude Medical alleging lead wire fractures, device migration, and electrical malfunctions causing nerve damage, burns, and revision surgeries. No MDL has been established; cases remain in state and federal courts nationwide. A February 2026 filing alleges Boston Scientific WaveWriter Alpha battery malfunction requiring surgical removal.
Causation Theory
Lawsuits allege manufacturing defects in SCS lead wires cause premature fracture and migration, while design changes to software, electrical output, and batteries altered device function without adequate long-term testing. The FDA has issued over 40 recalls since 2010, including a 2023 Class I recall of 155,000+ Abbott Proclaim devices. Adverse event reports cite lead-related complications as a primary failure mode, with Public Citizen estimating 30-40% complication rates.
Case Management Orders
Litigation status
Plaintiffs filed a motion to transfer with the JPML on February 20, 2026, seeking MDL status for spinal cord stimulator lawsuits against Abbott and Boston Scientific. At least 15 federal cases are pending across five districts, with plaintiffs proposing the Northern District of Illinois for centralized proceedings. The JPML has not yet scheduled oral argument.
MDL Track
MDL 3181
Spinal cord stimulator products liability
Geographic exposure
FDA data: 107,000+ medical device reports yielded ~500 deaths, ~80,000 injuries, ~30,000 malfunctions; 50,000+ devices implanted annually; 40+ recalls since 2010 — AP/FDA data cited in litigation materials
Essex County: $1.25 million settlement August 2024 for incontinence and partial paralysis following spinal stimulator implantation — Law.com/NJ Law Journal, cited in Schmidt & Clark litigation materials
Two-year statute of limitations from date of injury; state identified in practitioner guidance as requiring timely action
Class I recall 2023 for 155,000+ Proclaim XR 5 IPG Model 3660 devices due to MRI mode defect; surgical replacement may be required — FDA recall cited in Sokolove Law materials
Battery malfunction litigation: February 2026 filing alleges device failure requiring surgical removal with worsening pain — specific product line identified in recent filings
Unnecessary shocking sensation lawsuits filed; False Claims Act litigation referenced (United States ex rel. Forney v. Medtronic, Inc., Casetext) — device-specific claims ongoing
Named defendant in spinal cord stimulator litigation per 2025-2026 practitioner intake materials
Key defendants
Medtronic Inc.
Role: Manufacturer
Named in Hughes v. Medtronic Inc., S.D. Ill. Feb. 23, 2026. Claims over Vectris surgical leads (Model 977A260) and unqualified rep programming. Part of MDL push with 15+ cases; JPML motion filed Feb. 20, 2026 seeking N.D. Ill. centralization.
Nevro Corp.
Role: Manufacturer
Sued in C.D. Cal. May 2025 for defective SCS design and FDA collusion claims. Complaint alleges bypassed statutory safeguards and inadequate testing of modified device. Early-stage exposure.
Boston Scientific Corp.
Role: Manufacturer
Named in MDL motion Feb. 20, 2026. Multiple individual suits pending including WaveWriter Alpha system failures and battery defects. Active coordination exposure if MDL granted.
Abbott
Role: Manufacturer
Named in MDL motion Feb. 20, 2026. Growing case volume across federal districts. Posture tied to broader SCS defect coordination effort.
| Defendant | Role | Intelligence Note |
|---|---|---|
| Medtronic Inc. | Manufacturer | Named in Hughes v. Medtronic Inc., S.D. Ill. Feb. 23, 2026. Claims over Vectris surgical leads (Model 977A260) and unqualified rep programming. Part of MDL push with 15+ cases; JPML motion filed Feb. 20, 2026 seeking N.D. Ill. centralization. |
| Nevro Corp. | Manufacturer | Sued in C.D. Cal. May 2025 for defective SCS design and FDA collusion claims. Complaint alleges bypassed statutory safeguards and inadequate testing of modified device. Early-stage exposure. |
| Boston Scientific Corp. | Manufacturer | Named in MDL motion Feb. 20, 2026. Multiple individual suits pending including WaveWriter Alpha system failures and battery defects. Active coordination exposure if MDL granted. |
| Abbott | Manufacturer | Named in MDL motion Feb. 20, 2026. Growing case volume across federal districts. Posture tied to broader SCS defect coordination effort. |
Timeline
First SCS Human Implant
C. Norman Shealy performs first dorsal column stimulation implant on March 24, 1967, at Case Western Reserve University. Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967;46(4):489-491.
First Commercial SCS System Released
First commercially available spinal cord stimulation system enters market. Device featured bulky implanted receiver with external antenna power delivery.
First Rechargeable IPG Available
First rechargeable implantable pulse generator becomes available, eliminating ~4-year replacement cycle for non-rechargeable devices.
First MRI-Safe SCS System Cleared
Medtronic receives FDA clearance for first MRI-safe neurostimulation system for chronic pain, addressing prior contraindication barrier.
Stimwave Freedom-8A Cleared
FDA clears Stimwave Freedom-8A spinal cord stimulation system, advancing miniaturized wireless neuromodulation technology.
SCS Technology Review Published
Ali R, Schwalb JM. History and Future of Spinal Cord Stimulation. Neurosurgery. 2023. Comprehensive review documents evolution from gate theory to modern waveform programming and hardware advances.
PubMed SCS History Review
Ali R, Schwalb JM. History and Future of Spinal Cord Stimulation. PMID: 37681953. Peer-reviewed summary of SCS indications, surgical technique, and technological advances.
Statute of limitations
No federal MDL currently established for spinal cord stimulator litigation as of March 2026. FDA data: 80,000+ injury reports, 40+ recalls since 2010, including Class I recall for Abbott Proclaim devices (2023). Review PMA vs. 510(k) pathway for preemption defense.
California
2 years from injury
Rule: Products liability claims governed by Cal. Code Civ. Proc. § 335.1; medical malpractice 3 years from injury or 1 year from discovery per § 340.5
Discovery: Discovery rule applies to medical malpractice; products liability accrues at injury
AB 2777 adult sexual assault revival window runs through Dec. 31, 2026 but does not cover medical device claims. No medical device-specific revival window currently open.
Texas
2 years from injury
Rule: Tex. Civ. Prac. & Rem. Code § 16.003
Discovery: Discovery rule narrowly applied; generally accrues at manifestation of injury
No medical device-specific revival legislation. Minority tolling until age 18 plus 2 years.
Florida
4 years from injury
Rule: Fla. Stat. § 95.11(3)(a); statute of repose at 12 years from manufacture per § 95.031(2)(b)
Discovery: Discovery rule applies; accrues when injury discovered or should have been discovered with due diligence
Statute of repose may bar claims on devices manufactured before 2014. No active revival window.
New York
3 years from injury
Rule: N.Y. C.P.L.R. § 214
Discovery: Discovery rule applies for latent injuries
Adult Survivors Act revival window closed Nov. 24, 2024. No current medical device revival window.
Pennsylvania
2 years from injury
Rule: 42 Pa. Cons. Stat. § 5524
Discovery: Discovery rule applies; accrues when plaintiff knows or reasonably should know of injury and its cause
No revival window currently open. Minority tolling: age 18 plus 2 years.
Illinois
2 years from injury
Rule: 735 Ill. Comp. Stat. 5/13-202
Discovery: Discovery rule applies; accrues when plaintiff knows or reasonably should know of injury and its cause
No medical device revival legislation. Minority tolling: age 18 plus 2 years.
Ohio
2 years from injury
Rule: Ohio Rev. Code § 2305.10; statute of repose at 10 years from manufacture per § 2305.10(C)
Discovery: Discovery rule applies
Statute of repose may bar claims on devices manufactured before 2016. No active revival window.
| State | SOL | Rule | Discovery Rule | Notes |
|---|---|---|---|---|
| California | 2 years from injury | Products liability claims governed by Cal. Code Civ. Proc. § 335.1; medical malpractice 3 years from injury or 1 year from discovery per § 340.5 | Discovery rule applies to medical malpractice; products liability accrues at injury | AB 2777 adult sexual assault revival window runs through Dec. 31, 2026 but does not cover medical device claims. No medical device-specific revival window currently open. |
| Texas | 2 years from injury | Tex. Civ. Prac. & Rem. Code § 16.003 | Discovery rule narrowly applied; generally accrues at manifestation of injury | No medical device-specific revival legislation. Minority tolling until age 18 plus 2 years. |
| Florida | 4 years from injury | Fla. Stat. § 95.11(3)(a); statute of repose at 12 years from manufacture per § 95.031(2)(b) | Discovery rule applies; accrues when injury discovered or should have been discovered with due diligence | Statute of repose may bar claims on devices manufactured before 2014. No active revival window. |
| New York | 3 years from injury | N.Y. C.P.L.R. § 214 | Discovery rule applies for latent injuries | Adult Survivors Act revival window closed Nov. 24, 2024. No current medical device revival window. |
| Pennsylvania | 2 years from injury | 42 Pa. Cons. Stat. § 5524 | Discovery rule applies; accrues when plaintiff knows or reasonably should know of injury and its cause | No revival window currently open. Minority tolling: age 18 plus 2 years. |
| Illinois | 2 years from injury | 735 Ill. Comp. Stat. 5/13-202 | Discovery rule applies; accrues when plaintiff knows or reasonably should know of injury and its cause | No medical device revival legislation. Minority tolling: age 18 plus 2 years. |
| Ohio | 2 years from injury | Ohio Rev. Code § 2305.10; statute of repose at 10 years from manufacture per § 2305.10(C) | Discovery rule applies | Statute of repose may bar claims on devices manufactured before 2016. No active revival window. |
Live intelligence
AI litigation brief
Spinal Cord Stimulators remains pending consolidation with 52 current signals in the accepted feed.
Overview
Plaintiffs filed a motion to transfer with the JPML on February 20, 2026, seeking MDL status for spinal cord stimulator lawsuits against Abbott and Boston Scientific. At least 15 federal cases are pending across five districts, with plaintiffs proposing the Northern District of Illinois for centralized proceedings. The JPML has not yet scheduled oral argument.
Key developments
Trajectory
Court filings and press coverage are both active in MDL 3181, pointing to sustained litigation pressure rather than a one-off headline cycle. 4 live sources are contributing current context.
Editorial intelligence
MDL 3181 should stay on the lead docket watch because it is the primary consolidation vehicle for Spinal Stimulators.
Generated Apr 5, 2026, 3:00 PM UTC
52 events detected
Google News (10)
Revision of an Eight-lead Boston Scientific® Spinal Cord Stimulator With Epidural Migration: A Case Report - Cureus
Revision of an Eight-lead Boston Scientific® Spinal Cord Stimulator With Epidural Migration: A Case Report - Cureus
FDA clears spinal cord stimulator for home use - statnews.com
FDA clears Onward Medical's spinal cord stimulator for home use | STAT - statnews.com
FDA clears Onward Medical's spinal cord stimulator for home use | STAT - statnews.com
FDA clears Onward Medical's spinal cord stimulator for home use | STAT - statnews.com
FDA Sued Over Allegedly Defective Spinal Cord Stimulators - Law.com
Effect of epidural spinal cord stimulation in individuals with sensorimotor complete spinal cord injury: a pilot study - Frontiers
Effect of epidural spinal cord stimulation in individuals with sensorimotor complete spinal cord injury: a pilot study - Frontiers
Spinal Cord Stimulators Market Size & Growth 2025 to 2035 - Future Market Insights
AJR. American journal of roentgenology • Sharpe R • PMID 41879732 • Journal Article.
Neuromodulation : journal of the International Neuromodulation Society • Glen P • PMID 41790093 • Journal Article.
Regional anesthesia and pain medicine • Bhatia A • PMID 41781150 • Journal Article.
Pain and therapy • Karantonis DM • PMID 41774424 • Journal Article.
Neurosurgery • Veeravagu A • PMID 41718492 • Journal Article.
J.B. Mounteer v. Nevro Corporation et al.
Plaintiff J.B. Mounteer is suing Nevro Corporation, Globus Medical, Inc., and the United States Food and Drug Administration for injuries sustained from a defective spinal cord stimulator (SCS) system. Plaintiff claims that the device, implanted to treat chronic pain, failed and caused painful neurologic symptoms and potentially permanent injuries due to undisclosed modifications approved by the FDA without proper safety validation. They allege that Nevro concealed risks and misled regulators, leading to harm. Plaintiff is seeking compensatory damages and injunctive relief to require the FDA to restore integrity to the approval process. Product Liability.
Tripp v. Nevro Corporation et al.
Plaintiff James Trip is suing Nevro Corporation, Globus Medical, Inc., and the United States Food and Drug Administration for injuries sustained from a defective spinal cord stimulator (SCS) system. Plaintiff claims that the Nevro SCS device, implanted to treat chronic pain, failed to perform as promised and caused painful neurologic symptoms and potentially permanent injuries due to undisclosed material changes made through FDA supplements without proper safety validation. They allege that Nevro concealed risks and misled patients, physicians, and regulators, leading to harm. Plaintiff is seeking compensatory damages for injuries and equitable relief requiring the FDA to restore integrity to the regulatory process. Product Liability.
Lutke v. Nevro Corporation et al.
Plaintiff Richard Lutke is suing Nevro Corporation, Globus Medical, Inc., and the United States Food and Drug Administration because he suffered injuries from a defective spinal cord stimulator (SCS) system implanted to treat chronic pain. Plaintiff claims that the device, designed and marketed by Nevro, failed to perform as promised and caused painful neurologic symptoms and potentially permanent injuries due to undisclosed material changes made through FDA supplements without proper safety validation. They allege that Nevro concealed risks and misled patients and regulators, leading to implantation of a device materially different from its original FDA-approved version. Plaintiff is seeking compensatory damages for his injuries and equitable relief requiring the FDA to restore integrity to the regulatory process. Product Liability.
Ramirez v. Nevro Corporation et al.
Plaintiff Patricia Ramirez is suing Nevro Corporation, Globus Medical, Inc., and the United States Food and Drug Administration for injuries sustained from a defective spinal cord stimulator (SCS) system. Plaintiff claims that the Nevro SCS device, implanted to treat chronic pain, failed and caused painful neurologic symptoms and potentially permanent injuries due to undisclosed modifications approved by the FDA through PMA supplements. They allege that Nevro concealed risks and misled about the device's safety, and that the FDA failed in its regulatory duties. Plaintiff is seeking compensatory damages for injuries and equitable relief to restore integrity to the PMA process. Product Liability.
Manley v. Nevro Corporation et al.
Plaintiff Anita Manley is suing Nevro Corporation, Globus Medical, Inc., and the United States Food and Drug Administration because she suffered injuries from a defective spinal cord stimulator (SCS) system. Plaintiff claims that the Nevro SCS device, implanted to treat chronic pain, failed and caused painful neurologic symptoms and potentially permanent injuries due to undisclosed modifications approved by the FDA through PMA supplements. They allege that Nevro concealed risks and misled regulators, and the FDA failed in its regulatory duties. Plaintiff is seeking compensatory damages for injuries and equitable relief to restore integrity to the FDA's approval process. Product Liability.
Gooding v. Nevro Corporation et al.
Plaintiff Victoria Gooding is suing Nevro Corporation, Globus Medical, Inc., and the United States Food and Drug Administration because she suffered injuries from a defective spinal cord stimulator (SCS) system. Plaintiff claims that the Nevro SCS device, implanted to treat chronic pain, failed to perform as promised and caused serious harm, including painful neurologic symptoms and worsening pain. She alleges that Nevro made hundreds of material changes to the device through FDA supplements without proper safety validation or disclosure, transforming its risk profile, and that the FDA failed in its regulatory duties. Plaintiff is seeking compensatory damages for her injuries and equitable relief requiring the FDA to restore integrity to the approval process. Product Liability.
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LexGenius Ranking
84Score
Court, news, and regulatory activity are elevated
Monitoring
Live
monitoring
Last: Apr 5, 2026, 3:00 PM UTC
Next: 18:47
Source Monitoring
PACER
PACER
Google News
MAUDE
PubMed
Event feed
52
events detected
AI Brief
Spinal Cord Stimulators remains pending consolidation with 52 current signals in the accepted feed.
Overview
Plaintiffs filed a motion to transfer with the JPML on February 20, 2026, seeking MDL status for spinal cord stimulator lawsuits against Abbott and Boston Scientific. At least 15 federal cases are pending across five districts, with plaintiffs proposing the Northern District of Illinois for centralized proceedings. The JPML has not yet scheduled oral argument.
Key developments
PACER court filing on Mar 23: J.B. Mounteer v. Nevro Corporation et al.. ‖ Cureus news on Nov 20: Revision of an Eight-lead Boston Scientific® Spinal Cord Stimulator With Epidural Migration: A Case Report - Cureus. ‖ MAUDE FDA alert on Feb 27: MAUDE Filing 24476510: PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR. ‖ PubMed research on Mar 25: Breast MRI in Patients With Active Implanted Metallic Devices: How We Do It..
Generated Apr 5, 2026, 3:00 PM UTC
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