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
29 pending
Bellwether / Trial
No verdicts yet
Settlement Status
No settlement program exists
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Case overview
MDL 3181 consolidated Boston Scientific spinal cord stimulator cases in the Central District of California in June 2026. A late September 2026 hearing will determine whether Abbott-related litigation merits similar consolidation. Plaintiffs allege manufacturers failed to disclose material risks of uncommanded shocks, lead migration, and nerve damage, with some suits naming the FDA for allegedly fast-tracking Abbott's Eterna SCS approval without adequate clinical testing.
Causation Theory
Device malfunction theories center on lead migration or fracture causing stimulation of wrong tissue, high impedance and wiring faults delivering irregular current, and charging-related events including shocks during charging and device heating. The FDA's MAUDE database contains over 11,000 adverse event reports describing electric shock from spinal cord stimulators. Abbott's Proclaim and Infinity systems were subject to a 2023 Class I recall for MRI-mode failures.
Case Management Orders
Litigation status
MDL 3181 — In re: Boston Scientific Corp. Spinal Cord Stimulator Products Liability Litigation — was created June 5, 2026, in the C.D. Cal. before Judge Josephine L. Staton (Dkt. 2:26-ml-03181-JLS-E). The JPML declined industry-wide consolidation; separate Abbott (MDL No. 3194) and Nevro (MDL No. 3195) petitions are pending with oral arguments scheduled September 24, 2026. On September 23, 2026, Judge Staton entered Pretrial Order No. 5 regarding a consolidated APA claim complaint (Dkt. 68).
MDL Track
MDL 3181
Spinal cord stimulator products liability
State Court Activity
17 Nevro federal cases pending across six districts; 15 Abbott federal cases pending
Geographic exposure
FDA received 372,000+ adverse event reports for spinal cord stimulators, including 11,000+ describing electric shocks (reports not verified causation). Four manufacturers targeted: Boston Scientific, Abbott (St. Jude), Medtronic, Nevro. Common injury events: revision/replacement/explant surgery, electrical shocks/burning at battery site, lead migration/fracture, infection, new weakness/numbness/paralysis/bowel-bladder dysfunction, loss of pain relief. Revision surgery not required for case review.
MDL 3181 (Dkt. 2:26-ml-03181) consolidated Boston Scientific spinal cord stimulator cases June 5, 2026, before JPML; Abbott and Nevro centralization petitions pending fall 2026 decisions. Kathleen Poore v. Boston Scientific filed July 30, 2026 (C.D. Cal.) alleging worsening pain, numbness, shocking sensations post-October 2023 implant.
Abbott Eterna SCS litigation filed spring 2026 by Dorothy Furia, Roseann Maroulis, Laverne Livingston, and Anita McClellan. Allegations include failed reprogramming, nerve damage, extremity numbness, shock sensations, bladder incontinence; Maroulis underwent battery pocket revision surgery for wire extrusion. Livingston unable to locate physician for device removal. FDA named defendant for fast-track approval without adequate testing.
One-year statute of limitations among shortest nationally; discovery rule applies from when patient knew or should have known device caused injury. Courts dismissed SCS cases as untimely in 2026. Medicare fee-for-service funded 867 permanent implants and 1,183 trials in CY2024 per CMS data — floor estimate, not total volume. Filing venues: E.D., M.D., or W.D. Tennessee or state court; qualifying federal cases transferrable to MDL 3181.
Hunt v. Medtronic USA Inc., 3:21-cv-05854 (W.D. Wash. Jan. 31, 2025). Patient self-extracted SCS with incision and mallet after Medtronic refused removal requests; independent physician explanted June 2021. Alleged adaptive stim2 feature caused repeated shocks, device deterioration culminating in convulsive spinal shocks by March 2021. Medtronic representative reprogrammed device without physician oversight post-December 2019 car accident despite lead displacement concern.
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 gains device authority
Medical Device Amendments of 1976 grant FDA authority to regulate all medical devices. FDA proposes and finalizes Class II classification for implanted spinal cord stimulators for pain relief (21 C.F.R. § 882.5880) from 1978-1979.
First FDA-approved SCS devices
FDA approves first epidural electrode lead (K780001) and stimulator (K780758) under Class II performance standards for implanted spinal cord stimulators for pain relief.
FDA expands SCS indications
FDA expands market indications for spinal cord stimulation to include persistent spinal pain syndrome type 2, radicular pain syndrome, peripheral causalgia, and other chronic pain conditions.
First rechargeable SCS system approved
FDA approves first rechargeable (secondary cell) implantable pulse generator SCS system (P030017), enabling longer device lifetime and reduced surgical replacement burden.
MRI-conditional SCS approved
FDA approves conditional magnetic resonance imaging compatibility for SCS systems (P840001/S219; P840001/S239).
Advanced waveform SCS approvals
FDA approves burst stimulation waveform (P010032/S125) and kilohertz frequency waveform (P130022) for expanded patient-tailored therapy options including subparesthesia therapy.
DRG stimulation FDA approved
FDA approves dorsal root ganglion stimulation for treating chronic nerve pain associated with complex regional pain syndrome and/or peripheral causalgia in the groin and lower limb.
Closed-loop SCS trial published
Lancet Neurology publishes EVOK trial results: double-blind randomized controlled trial demonstrates long-term safety and efficacy of closed-loop spinal cord stimulation with sensing-based feedback for chronic back and leg pain. Mekhail et al., Lancet Neurology 19(2):123-134.
FDA SCS timeline review published
Ho et al. publish comprehensive visual and narrative timeline of SCS technology and FDA milestones in Neuromodulation, documenting regulatory evolution from 1967 first case through contemporary advanced waveform systems. Neuromodulation 27(6):1020-1025.
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 emerging with 82 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, in the C.D. Cal. before Judge Josephine L. Staton (Dkt. 2:26-ml-03181-JLS-E). The JPML declined industry-wide consolidation; separate Abbott (MDL No. 3194) and Nevro (MDL No. 3195) petitions are pending with oral arguments scheduled September 24, 2026. On September 23, 2026, Judge Staton entered Pretrial Order No. 5 regarding a consolidated APA claim complaint (Dkt. 68).
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 Sep 30, 2026, 10:00 AM UTC
82 events detected
Google News (29)
Inside MDL 3181: Key Issues in Spinal Stimulator Injury Claims - t2conline.com
How Lead Migration Can Cause a Spinal Stimulator Injury Claim - Muddy River News
FDA Issues Recall Notice For Boston Scientific Spinal Cord Stimulator Leads - Mealey's
Boston Scientific recalls spinal cord implant in wake of more than 1k serious injuries - Fierce Biotech
Boston Scientific recalls spinal cord stimulator leads after 1,081 serious injuries - MassDevice
Class I Recall Adds To Growing Scrutiny Of Boston Scientific SCS Devices - insights.citeline.com
1,081 Injuries Prompt Boston Scientific to Recall Spinal Cord Stimulation Leads - Medical Device and Diagnostic industry
Boston Scientific Recalls Spinal Cord Stimulator Leads Over Fracture Risk - Benzinga
Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries - MedTech Dive
Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alert - Medical Device Network
Boston Scientific Pulls Unused Spinal Cord Stimulator Leads Tied to Fractures, but Implanted Devices Stay in Place - Medical Daily
Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alert - medicaldevice-network.com
Wisner Baum Named to Leadership in Federal Spinal Cord Stimulator Litigation - PR Newswire
Wisner Baum Named Co-Lead Counsel in Boston Scientific Spinal Cord Stimulator MDL - scanx.trade
JPMDL To Mull Creating Nevro, Globus Medical Spinal Cord Stimulator Injury MDL - Mealey's
JPMDL To Consider Abbott-Only MDL For Spinal Cord Stimulator Injury Cases - Mealey's
Abbott Opposes Consolidating 23 Spinal Cord Stimulator Injury Lawsuits - Medical Device and Diagnostic industry
Abbott opposes consolidation of spinal cord stimulation lawsuits - massdevice.com
Abbott Says Spinal Cord Stimulator Injury Cases Do Not Warrant Centralization - Mealey's
Nevro, Globus Medical Oppose Bid To Centralize Spinal Cord Stimulator Injury Cases - Mealey's
How Do Spinal Cord Stimulators Fail? The Technology Behind Growing Defective Device Lawsuits - The Legal Examiner
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
Pain medicine (Malden, Mass.) • Chadwick AL • PMID 42789748 • Journal Article.
Journal of pain research • Yi Q • PMID 42807275 • Journal Article.
IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society • Wang F • PMID 42776871 • Journal Article.
Journal of craniovertebral junction & spine • Al-Saadi T • PMID 42788136 • Journal Article.
Interventional pain medicine • Hao D • PMID 42774665 • Journal Article.
Pretrial Order No. 5 Re: Consolidated Apa Claim Complaint
CMO filed in MDL 3181.
Pretrial Order No. 5 Re: Consolidated Apa Claim Complaint
C.D. Cal.
The court issued Pretrial Order No. 5, following the parties' joint submission and the August 5, 2026 status conference, to establish procedures governing the consolidated Administrative Procedure Act (APA) claims asserted against the FDA.
Pretrial Order No. 4: Direct Filing Order
FILING_INSTRUCTION filed in MDL 3181.
Pretrial Order No. 3: Docket Management Order
This order establishes procedures for docket management and filings in the MDL, including coordination under 28 U.S.C. §1407 and automatic pro hac vice admission for attorneys in good standing in any U.S. District Court.
Pretrial Order No. 4: Direct Filing Order
This order establishes procedures for direct filing of cases into MDL No. 3181, allowing plaintiffs to file directly in the transferee court to avoid transfer delays.
Pretrial Order No. 3: Docket Management Order
This order establishes procedures for docket management and filings in the MDL, including coordination under 28 U.S.C. §1407 and automatic pro hac vice admission for attorneys in good standing in any U.S. District Court.
Pretrial Order No. 4: Direct Filing Order
This order establishes procedures for direct filing of cases into MDL No. 3181, allowing plaintiffs to file directly in the transferee court to avoid transfer delays.
Pretrial Order No. 3 — Docket Management Order
Establishes docket management and filing procedures for all actions in the MDL to promote efficient administration and avoid duplication.
Pretrial Order No. 2 — Appointing Plaintiffs' Leadership Counsel
The Court appoints Co-Lead Counsel and other leadership roles for plaintiffs in the MDL, establishing the structure for the litigation.
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LexGenius Ranking
88Score
Court, news, and regulatory activity are elevated
Monitoring
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Last: Sep 30, 2026, 10:00 AM UTC
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PACER
PACER
Google News
MAUDE
PubMed
Event feed
82
events detected
AI Brief
Spinal Cord Stimulators remains emerging with 82 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, in the C.D. Cal. before Judge Josephine L. Staton (Dkt. 2:26-ml-03181-JLS-E). The JPML declined industry-wide consolidation; separate Abbott (MDL No. 3194) and Nevro (MDL No. 3195) petitions are pending with oral arguments scheduled September 24, 2026. On September 23, 2026, Judge Staton entered Pretrial Order No. 5 regarding a consolidated APA claim complaint (Dkt. 68).
Key developments
Case Management Orders court filing on Sep 23: Pretrial Order No. 5 Re: Consolidated Apa Claim Complaint. ‖ t2conline.com news on Sep 22: Inside MDL 3181: Key Issues in Spinal Stimulator Injury Claims - t2conline.com. ‖ MAUDE FDA alert on Aug 31: MAUDE Filing 50533340: Linear¿ ST. ‖ PubMed research on Sep 25: Identifying the Impact of Centralized Pain on Pain Outcomes after Spinal Cord Stimulator Trials (POST)..
Generated Sep 30, 2026, 10:00 AM UTC
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