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Pending consolidation● EMERGING13 eventsMedical Device

Abbott Spinal Cord Stimulators

Medical Device · claims that Abbott spinal cord stimulator systems caused serious injuries including device migration, lead breakage, neurological deficits, worsened pain, and failed pain relief

Defendant

Abbott Laboratories

MDL / Track

MDL 3194

JPML (pending)

Judge

N/A

Plaintiffs

23 pending (per Abbott August 4, 2026 filing)

Bellwether / Trial

No verdicts yet

Settlement Status

  • No settlement reached
  • no claims process established
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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

The Judicial Panel on Multidistrict Litigation denied MDL consolidation for Abbott spinal cord stimulator litigation on June 5, 2026, on technical Section 1407 grounds that all then-pending cases resided in the Northern District of Illinois; plaintiffs filed a renewed centralization petition as MDL No. 3194 on approximately June 22, 2026, identifying 15 pending cases across multiple districts, with Abbott opposing and no hearing date set as of late August 2026. Individual cases proceed in federal district courts—primarily N.D. Ill.—alleging that Abbott's Proclaim, Eterna, and Infinity systems cause painful electric shocks, lead migration, battery failures, and loss of therapeutic benefit requiring revision or explant surgery. Core claims include manufacturing defect, failure to warn, negligence, and fraud, with a central theory that Abbott made over 230 post-approval modifications to firmware, battery design, and stimulation architecture under original PMA P010032 (approved 2001) without obtaining a new PMA or adequate clinical testing.

Causation Theory

Plaintiffs allege Abbott spinal cord stimulators cause harm through device-level defects and unauthorized post-market modifications that departed materially from the original FDA-approved design. A 2020 Public Citizen report found that 143 PMA supplements were approved under PMA P010032 by end of 2019, covering new models, redesigned leads, different pulse generators, new batteries, and software updates, with the original PMA approved based on literature review rather than clinical trials of the actual device. Abbott's Class I recall of 155,028 Proclaim and Infinity implantable pulse generators for Bluetooth communication failure preventing proper MRI mode entry or exit—associated with 186 complaints and 73 reported injuries—exemplifies alleged systemic design vulnerabilities.

Case Management Orders

Litigation status

Abbott spinal cord stimulator litigation awaits JPML ruling on MDL No. 3194 following September 24, 2026 oral arguments. Abbott opposes consolidation of 23 pending cases, arguing individualized injuries defeat commonality; plaintiffs counter that shared device platforms and nerve injury patterns warrant coordination. No MDL established; cases remain individually filed across multiple districts.

MDL Track

MDL 3194

Abbott spinal cord stimulator products liability

State Court Activity

Individual cases filed in N.D. Ill., N.D. Cal., and other federal districts

Geographic exposure

No national exposure pattern identified for Abbott spinal cord stimulators from available sources. Litigation remains decentralized after JPML denied MDL centralization; 15 cases identified in June 2026 petition, expanding to 23 cases by August 2026 per Abbott opposition. No state court MDL or coordinated proceeding exists. Fresh centralization petition pending with Abbott in active opposition.

  • Northern District of Illinois

    Primary federal venue for Abbott spinal cord stimulator litigation. Tuttle v. Abbott, No. 1:25-cv-15083 (N.D. Ill.) and Melby v. Abbott Laboratories (filed March 13, 2026) allege painful electric shocks, lead migration, and battery failures in Proclaim, Infinity, and Eterna systems. JPML denied MDL centralization June 5, 2026 because all four then-pending cases resided in same district, failing 28 U.S.C. § 1407's 'different districts' requirement. Fresh centralization petition filed approximately June 22, 2026 identifying 15 pending cases; Abbott opposes, no hearing set.

  • Central District of California

    Abbott opposes MDL centralization to this district in August 2026 motion. Separate MDL No. 3181 for Boston Scientific spinal cord stimulator cases established here before Judge Josephine L. Staton. Abbott notes majority of plaintiffs have no connection to districts where suits filed; at least one plaintiff was implanted with non-SCS device; another filed two suits in two districts with conflicting allegations.

  • District of New Jersey

    Active individual federal filing venue for Abbott spinal cord stimulator cases post-JPML denial. Cases proceed individually with parallel discovery tracks; no global settlement program announced.

  • District of Hawaii

    Active individual federal filing venue for Abbott spinal cord stimulator cases post-JPML denial. Cases in early procedural phases.

Key defendants

Abbott Laboratories

Role: Manufacturer / primary product-liability defendant

The JPML memorandum targets Abbott spinal cord stimulator systems and alleges design, validation, warning, PMA-supplement, adverse-event, and post-market conduct common to the proposed MDL.

United States Food and Drug Administration

Role: APA defendant in many listed cases

Ten actions reportedly name FDA under the Administrative Procedure Act, alleging the agency failed to meaningfully review Abbott PMA submissions and supplements and unlawfully accepted serial supplement approvals.

Abbott SCS product line entities / successor device families

Role: Device-family evidence focus

The petition traces Abbott’s SCS line to the Genesis PMA P010032 and alleges later devices added material features through supplements without adequate independent clinical review.

DefendantRoleIntelligence Note
Abbott LaboratoriesManufacturer / primary product-liability defendantThe JPML memorandum targets Abbott spinal cord stimulator systems and alleges design, validation, warning, PMA-supplement, adverse-event, and post-market conduct common to the proposed MDL.
United States Food and Drug AdministrationAPA defendant in many listed casesTen actions reportedly name FDA under the Administrative Procedure Act, alleging the agency failed to meaningfully review Abbott PMA submissions and supplements and unlawfully accepted serial supplement approvals.
Abbott SCS product line entities / successor device familiesDevice-family evidence focusThe petition traces Abbott’s SCS line to the Genesis PMA P010032 and alleges later devices added material features through supplements without adequate independent clinical review.

Timeline

  1. 2023-07

    Abbott Initiates Class I Recall of Proclaim, Infinity IPGs

    Abbott recalls 155,028 Proclaim and Infinity implantable pulse generators after Bluetooth communication failures trapped devices in 'MRI mode.' FDA classified as Class I recall. Abbott reported 186 complaints and 73 injuries.

  2. 2025-10

    Abbott Issues Eterna Bluetooth Correction

    Abbott issues urgent medical device correction for Eterna SCS IPG Model 32400 after Bluetooth Low Energy circuit component failures caused loss of communication with clinician programmer and patient controller. FDA classified as Class II recall, Recall Z-0458-2026. Abbott reported 36 complaints, 21 involving implanted devices requiring surgical replacement.

  3. 2025-12-11

    Tuttle v. Abbott Filed in N.D. Ill.

    Zella Tuttle files complaint in Northern District of Illinois, Case No. 1:25-cv-15083, alleging Abbott sales representatives programmed her Eterna device without physician supervision and leads migrated two months post-implantation, requiring explant surgery in December 2023.

  4. 2026-02

    Plaintiffs Seek Industry-Wide SCS MDL

    Plaintiffs petition U.S. Judicial Panel on Multidistrict Litigation to consolidate spinal cord stimulator lawsuits against Abbott, Boston Scientific, Medtronic, and Nevro into single MDL. Abbott and Boston Scientific oppose, arguing no common signature defect exists across manufacturers.

  5. 2026-04

    Multi-Plaintiff Suit Alleges 230+ Firmware Modifications

    Tuttle v. Abbott, 3:26-cv-01945 (N.D. Cal.), alleges Proclaim Elite SCS underwent over 230 undisclosed post-approval modifications to firmware, battery, and stimulation architecture. Complaint includes APA claim against FDA seeking enforcement action.

  6. 2026-06-05

    JPML Denies Abbott MDL on Technical Grounds

    U.S. Judicial Panel on Multidistrict Litigation denies centralization of Abbott spinal cord stimulator cases in Transfer Order for MDL No. 3181. Panel finds all four pending federal Abbott cases reside in Northern District of Illinois; 28 U.S.C. § 1407 requires cases in 'different districts.' Order notes denial 'does not foreclose' future centralization. Panel simultaneously establishes MDL No. 3181 for Boston Scientific cases in Central District of California before Judge Josephine L. Staton.

  7. 2026-06-22

    Fresh Centralization Petition Filed

    Plaintiffs file new JPML petition identifying 15 pending Abbott cases across multiple districts. Abbott opposes consolidation. No hearing date set as of late August 2026.

  8. 2026-09

    JPML Hearing Scheduled on Abbott Consolidation

    Late September hearing scheduled to determine whether SCS-related litigation against Abbott should be consolidated, per ODT Magazine reporting. MDL No. 3194 remains pending before Panel with no transferee court assigned.

Statute of limitations

Medical-device product-liability deadlines vary by state and usually run from injury, implant/explant, diagnosis, or discovery of a possible device connection. SCS cases may involve PMA preemption and FDA-related theories, so counsel should preserve device records and file-specific accrual facts early.

⚠ 4 states with critical SOL — act immediately

⚠California

Generally 2 years for personal injury

Rule: Product-injury claims typically accrue on injury or discovery of facts suggesting wrongful cause.

Discovery: Discovery rule may defer accrual until plaintiff suspects or should suspect device-related injury.

⚠Texas

Generally 2 years for personal injury

Rule: Accrual often begins when injury occurs, subject to limited discovery principles for latent injury.

⚠Pennsylvania

Generally 2 years for personal injury

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

⚠Illinois

Generally 2 years for personal injury

Rule: Discovery rule focuses on when plaintiff knew or should have known injury may be wrongfully caused.

StateSOLRuleDiscovery RuleNotes
⚠CaliforniaGenerally 2 years for personal injuryProduct-injury claims typically accrue on injury or discovery of facts suggesting wrongful cause.Discovery rule may defer accrual until plaintiff suspects or should suspect device-related injury.—
⚠TexasGenerally 2 years for personal injuryAccrual often begins when injury occurs, subject to limited discovery principles for latent injury.——
⚠PennsylvaniaGenerally 2 years for personal injuryDiscovery rule may apply where device causation was not reasonably knowable.——
⚠IllinoisGenerally 2 years for personal injuryDiscovery rule focuses on when plaintiff knew or should have known injury may be wrongfully caused.——

Live intelligence

AI litigation brief

Abbott Spinal Cord Stimulators remains pending consolidation with 13 current signals in the accepted feed.

Overview

Abbott spinal cord stimulator litigation awaits JPML ruling on MDL No. 3194 following September 24, 2026 oral arguments. Abbott opposes consolidation of 23 pending cases, arguing individualized injuries defeat commonality; plaintiffs counter that shared device platforms and nerve injury patterns warrant coordination. No MDL established; cases remain individually filed across multiple districts.

Key developments

  • PACER court filing on Sep 16: Afshar v. United States Food and Drug Administration
  • Mealey's news on Aug 27: JPMDL To Consider Abbott-Only MDL For Spinal Cord Stimulator Injury Cases - Mealey's
  • MAUDE FDA alert on Aug 14: MAUDE Filing 50255135: ABBOTT SCS IMPLANT

Trajectory

Court filings and press coverage are both active in MDL 3194, pointing to sustained litigation pressure rather than a one-off headline cycle. 5 live sources are contributing current context.

Editorial intelligence

MDL 3194 should stay on the lead docket watch because it is the primary consolidation vehicle for Abbott SCS.

Generated Sep 30, 2026, 10:00 AM UTC

13 events detected

Google News (10)

  • JPMDL To Consider Abbott-Only MDL For Spinal Cord Stimulator Injury Cases - Mealey's

    Mealey'sAug 27, 2026, 1:44 PM UTC
  • Abbott Opposes Consolidating 23 Spinal Cord Stimulator Injury Lawsuits - Medical Device and Diagnostic industry

    Medical Device and Diagnostic industryAug 14, 2026, 6:27 PM UTC
  • Abbott opposes consolidation of spinal cord stimulation lawsuits - massdevice.com

    massdevice.comAug 13, 2026, 8:42 PM UTC
  • Abbott Says Spinal Cord Stimulator Injury Cases Do Not Warrant Centralization - Mealey's

    Mealey'sAug 12, 2026, 12:59 PM 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
  • Wisner Baum's Lawsuits Challenge FDA Oversight of Spinal Cord Implants - PR Newswire

    PR NewswireJul 22, 2026, 12:06 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
  • Abbott Labs Spinal Cord Device Causes Shocks, Suit Claims - law360.com

    law360.comJun 1, 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, and while the FDA is named as a defendant (one of the MDL's secondary defendants), this is an administrative challenge to agency decision-making rather than a product liability or personal injury claim directly involving Abbott spinal cord stimulators; however, since the FDA is a listed defendant in the MDL description, it meets the >90% threshold for defendant match.

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LexGenius Ranking

82Score

Court, news, and regulatory activity are elevated

Evidence16 / 20
Momentum14 / 20
Exposure16 / 20
Regulatory16 / 20
Legal20 / 20

Monitoring

Live

monitoring

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

Next: —

Source Monitoring

PACER

1m 06s

PACER

Pending

Google News

1m 06s

MAUDE

1m 06s

PubMed

16m 06s

Event feed

13

events detected

Google NewsPACERMAUDE

AI Brief

Abbott Spinal Cord Stimulators remains pending consolidation with 13 current signals in the accepted feed.

Overview

Abbott spinal cord stimulator litigation awaits JPML ruling on MDL No. 3194 following September 24, 2026 oral arguments. Abbott opposes consolidation of 23 pending cases, arguing individualized injuries defeat commonality; plaintiffs counter that shared device platforms and nerve injury patterns warrant coordination. No MDL established; cases remain individually filed across multiple districts.

Key developments

PACER court filing on Sep 16: Afshar v. United States Food and Drug Administration. ‖ Mealey's news on Aug 27: JPMDL To Consider Abbott-Only MDL For Spinal Cord Stimulator Injury Cases - Mealey's. ‖ MAUDE FDA alert on Aug 14: MAUDE Filing 50255135: ABBOTT SCS IMPLANT.

Generated Sep 30, 2026, 10:00 AM UTC

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