MDL Track
MDL 3181
Spinal cord stimulator products liability
Medical Device · claims that Boston Scientific spinal cord stimulator devices caused serious injuries including lead migration, nerve damage, paralysis, and failed pain relief, centralized in MDL 3181
Defendant
Medtronic Inc.
MDL / Track
MDL 3181
C.D. Cal.
Judge
Judge Josephine L. Staton
Plaintiffs
26 pending
Bellwether / Trial
No verdicts yet
Settlement Status
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Case overview
A dozen federal lawsuits filed since May 2025 name Abbott Laboratories, Boston Scientific Corp., Medtronic Inc., and Nevro Corp. as defendants over spinal cord stimulators, with plaintiffs alleging electric shocks, device malfunctions, urinary problems, and exacerbated pain requiring surgical removal. The suits, pending in Illinois, California, Minnesota, and New York federal courts, include novel Administrative Procedure Act claims against the FDA citing Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024), to challenge the agency's failure to require new pre-market approval review despite substantial device modifications including Bluetooth-enabled programming and new battery architecture.
Causation Theory
Plaintiffs allege spinal cord stimulators are defective due to material changes made through hundreds of pre-market approval supplements—specifically Bluetooth-enabled programming and new battery architecture—that altered device safety profiles without new clinical trials. The 2023 FDA recall of Abbott's Proclaim series due to connection problems causing surgical removal and injuries supports the failure-to-warn theory.
Case Management Orders
Litigation status
MDL 3181 (In re: Boston Scientific Corp. Spinal Cord Stimulator Products Liability Litigation) was created June 5, 2026, and assigned to Judge Josephine L. Staton in the Central District of California. Pretrial Order No. 1 set an initial scheduling conference for August 5, 2026; leadership appointments were expected at that conference. No bellwether schedule or substantive rulings have issued. The JPML declined to create an industry-wide MDL, leaving Abbott and Nevro cases to proceed separately; centralization petitions for both manufacturers remain pending.
MDL Track
MDL 3181
Spinal cord stimulator products liability
State Court Activity
Abbott and Nevro centralization petitions pending before JPML as of June-July 2026; no hearing dates set
Geographic exposure
No MDL established as of July 2025. Litigation decentralized across four federal districts (Minnesota, California, Illinois, New York) with cases filed 2025. FDA named as defendant in multiple suits citing Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024). Primary manufacturers: Medtronic, Boston Scientific, Abbott, Nevro Corp./Globus Medical.
Federal suits pending in U.S. District Court for District of Minnesota against Medtronic by plaintiffs Angela Yates, Dilly Anderson (Kentucky), and Cathryn Keys (Tennessee). Devices implanted 2015-2020. Medtronic employs thousands in Minnesota. Complaints cite 400+ PMA supplements filed with FDA for generator and lead changes to Itrel II system since 1984 approval.
Federal suit pending against Boston Scientific in California federal court. Plaintiff Dena Lawler (Kentucky) received Precision system implant October 2022, experienced burning pain, lead migration requiring reimplantation, chest pain, cardiac arrhythmia. Allegation: material changes to device altered safety/effectiveness profile without new clinical data submission.
Federal spinal cord stimulator litigation pending. Part of multi-district filing wave by Hood Law Firm and Carlson Law Firm targeting Abbott, Medtronic, Boston Scientific, Nevro Corp./Globus Medical.
Federal spinal cord stimulator litigation pending. Same plaintiff firms active.
Three identified plaintiffs: Dilly Anderson (Medtronic device, still implanted), Angela Yates (Medtronic device, explanted 2023), Dena Lawler (Boston Scientific device, implanted 2022). All allege electric shocks, burning sensations, erratic stimulation, exacerbated pain.
Plaintiff Cathryn Keys (Medtronic device, still implanted) among Minnesota federal filings. Allegations mirror Kentucky plaintiffs: unpredictable stimulation, diminished quality of life.
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
FDA Classifies SCS Devices Class II
FDA proposed and finalized classification of 'implanted spinal cord stimulators for pain relief' as Class II devices with performance standards under 21 C.F.R. § 882.5880. First epidural electrode lead (K780001) and stimulator (K780758) approved.
Abbott Proclaim Series Recalled
FDA recalled Abbott's Proclaim series spinal cord stimulator devices due to hundreds of complaints about connection problems requiring surgical removal or causing patient injuries.
First SCS Suits Name FDA Defendant
Plaintiffs filed spinal cord stimulator product liability suits naming FDA as defendant under Administrative Procedure Act, citing Loper Bright Enterprises v. Raimondo. Suits pending in federal courts in Illinois, California, Minnesota and New York against Abbott, Boston Scientific, Medtronic, and Nevro/Globus Medical.
Latest SCS Complaint Filed
Most recent spinal cord stimulator complaint filed as of July 24, 2025 reporting. No defense counsel yet entered. Plaintiffs allege devices require new pre-market approval review due to substantial changes including Bluetooth-enabled programming and new battery architecture.
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 79 current signals in the accepted feed.
Overview
MDL 3181 (In re: Boston Scientific Corp. Spinal Cord Stimulator Products Liability Litigation) was created June 5, 2026, and assigned to Judge Josephine L. Staton in the Central District of California. Pretrial Order No. 1 set an initial scheduling conference for August 5, 2026; leadership appointments were expected at that conference. No bellwether schedule or substantive rulings have issued. The JPML declined to create an industry-wide MDL, leaving Abbott and Nevro cases to proceed separately; centralization petitions for both manufacturers remain pending.
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. 5 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 Boston Sci. SCS.
Generated Aug 12, 2026, 2:00 AM UTC
79 events detected
Google News (28)
How Do Spinal Cord Stimulators Fail? The Tech Behind Growing Defective Device Lawsuits - The Legal Examiner
Wisner Baum's Lawsuits Challenge FDA Oversight of Spinal Cord Implants - PR Newswire
Medtronic, FDA pick up legal victories in spinal cord stimulator suits - MassDevice
FDA, others sued for injuries from spinal cord stimulator - The Black Chronicle
Centralization Of Cases Against Additional Spinal Cord Device Manufacturers Sought - Mealey's
Boston Scientific Spinal Cord Stimulator Lawsuit 2026 - LawFold.com
Plaintiffs Say Stimulator Makers Used FDA Supplement Pathway To Avoid New Trials - insights.citeline.com
Centralization Of Cases Against Abbott Sought For Spinal Cord Device Injuries - Mealey's
Spinal Cord Stimulator Plaintiffs Allege Harm Far Beyond Device Failure - insights.citeline.com
Personalizing Electrical Stimulation Therapy Improves Outcomes for Spinal Cord Injury Patients - University of Miami
Merging neural stimulation and exoskeletons to enhance sensorimotor hand functions after brain or spinal cord injury - Science | AAAS
Spinal Cord Stimulator MDL Created as Similar Cases Grow - The Legal Examiner
Spinal Cord Stimulator Lawsuits Grow, Boston Scientific MDL Created - The Legal Examiner
Spinal Cord Stimulator Lawsuits Grow, New MDL Created - The Legal Examiner
Can Spinal Cord Stimulation Help Reduce Chronic Pain After a Spinal Cord Injury? - University of Colorado Anschutz
JPMDL Limits Scope Of Spinal Cord Stimulator MDL, Centralizes Cases In California - Mealey's
Boston Scientific Spinal Cord Simulator Suits Sent to California - Bloomberg Law News
JPML Denies Industrywide Spinal Device Injury MDL Bid - Law360
Neuronoff Implants First Patient in DOD-Funded Trial of Injectrode® for Neurogenic Bladder in Spinal Cord Injury - PR Newswire
Abbott Labs Spinal Cord Device Causes Shocks, Suit Claims - Law360
Reconnecting body and brain: Europe’s breakthrough in reversing paralysis after spinal cord injury - Innovation News Network
Spinal Cord Stimulator Erectile Dysfunction: What the Evidence Shows for Nerve-Related Challenges - Portal CNJ
Western Pennsylvania rehab facility first to use spinal cord injury device - WTAE
Spinal implants are driving a hidden medical crisis - Troy Media
Spinal stimulation data reveal why high-frequency pulses may miss key nerve pathways - Medical Xpress
Western PA rehab facility first to use spinal cord injury device - WTAE
Lawsuit alleges Abbott’s Eterna spinal cord stimulator malfunctioned, worsened pain - Becker's Spine Review
Rebuilding brain–spinal communication: brain–computer interfaces open new paths for spinal cord injury recovery - EurekAlert!
Neuromodulation : journal of the International Neuromodulation Society • Barone DG • PMID 42573544 • Journal Article.
Obstetrical & gynecological survey • Sinha A • PMID 42561103 • Journal Article.
Neuromodulation : journal of the International Neuromodulation Society • Xu GH • PMID 42530508 • Journal Article.
Journal of Parkinson's disease • Contarino MF • PMID 42530887 • Letter.
Frontiers in neurology • Townsend KL • PMID 42577123 • Journal Article.
Pretrial Order No. 1 — Setting Initial Scheduling Conference
govinfo_search
This Pretrial Order sets an initial scheduling conference for August 5, 2026, in the MDL, and establishes initial procedures for the coordinated pretrial proceedings.
MDL Transfer Order
govinfo_search
This document is a transfer order from the Judicial Panel on Multidistrict Litigation, transferring cases to MDL No. 3181.
JPML Transfer Order — Centralized in C.D. Cal. before Judge Josephine L. Staton (Boston Scientific only)
The Panel considers a motion to centralize litigation involving spinal cord stimulator devices from Abbott and Boston Scientific, with 46 related actions pending in 14 districts, and orders transfer to a single MDL.
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LexGenius Ranking
98Score
Court, news, and regulatory activity are elevated
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Last: Aug 12, 2026, 2:00 AM UTC
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Event feed
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events detected
AI Brief
Spinal Cord Stimulators remains pending consolidation with 79 current signals in the accepted feed.
Overview
MDL 3181 (In re: Boston Scientific Corp. Spinal Cord Stimulator Products Liability Litigation) was created June 5, 2026, and assigned to Judge Josephine L. Staton in the Central District of California. Pretrial Order No. 1 set an initial scheduling conference for August 5, 2026; leadership appointments were expected at that conference. No bellwether schedule or substantive rulings have issued. The JPML declined to create an industry-wide MDL, leaving Abbott and Nevro cases to proceed separately; centralization petitions for both manufacturers remain pending.
Key developments
Case Management Orders court filing on Jun 23: Pretrial Order No. 1 — Setting Initial Scheduling Conference. ‖ The Legal Examiner news on Jul 27: How Do Spinal Cord Stimulators Fail? The Tech Behind Growing Defective Device Lawsuits - The Legal Examiner. ‖ MAUDE FDA alert on Jul 31: MAUDE Filing 50108003: Precision? Montage? MRI. ‖ PubMed research on Aug 10: Off-Label Applications of Epidural Spinal Cord Stimulation: A Scoping Review..
Generated Aug 12, 2026, 2:00 AM UTC
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