The Spinal Cord Stimulator Lawsuit
Spinal cord stimulators are implanted to relieve chronic pain — but for thousands of patients, these devices have instead caused electrical shocks, burns, lead migration, infection, and permanent nerve damage. Lawsuits now pending against Abbott, Boston Scientific, Medtronic, and Nevro allege that manufacturers pushed major design changes through a regulatory shortcut without proper testing, and failed to warn patients and physicians of the true risks. A federal MDL has now been formed for Boston Scientific cases, and Ron Austin Law is actively reviewing claims nationwide.
Litigation Update Log
We update this page as the Boston Scientific MDL and related litigation develop. Check back for the latest.
Ron Austin Law Is Accepting Cases Nationwide
If you or a loved one experienced complications from a spinal cord stimulator, the time to act is now. Statutes of limitations continue to run regardless of MDL proceedings — filing today protects your rights and positions your case to join coordinated litigation.
On June 5, 2026, the Judicial Panel on Multidistrict Litigation established MDL No. 3181 — In re Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation — centralizing 23 lawsuits from 9 federal districts before Judge Josephine L. Staton in the Central District of California. Claims against Abbott, Medtronic, and Nevro continue to be filed and litigated individually.
What Is the Lawsuit About?
A spinal cord stimulator (SCS) is an implantable medical device marketed to manage chronic pain — most often pain involving the back, legs, or spine — by sending mild electrical pulses that interrupt pain signals before they reach the brain. For many patients, however, the device has not delivered the relief it promised. Instead, patients are reporting electrical shocks, burning sensations, infections, lead migration, hardware failure, and the need for repeat surgeries to reposition or completely remove equipment that was supposed to improve their quality of life.
The most serious pending lawsuits do not center on a single surgical mistake. They challenge how modern spinal cord stimulators were designed, tested, and approved — and whether patients were ever adequately warned about risks that recur again and again in medical records and FDA adverse event reports.
The Core Allegation: Lawsuits allege that manufacturers — including Abbott, Boston Scientific, Medtronic, and Nevro — used a regulatory shortcut called the PMA supplement pathway to push through hundreds of hardware and firmware changes to their devices without full FDA review, while concealing the new risks those changes created from doctors and patients.
Many of these changes altered battery design, firmware, waveform architecture, and wireless programming — yet the devices continued to be marketed and sold under decades-old original approvals. Some Abbott devices, for example, trace their regulatory lineage back to a 2001 approval, despite more than 230 alleged modifications since. Plaintiffs argue this is not simply a “bad outcome.” It is a pattern of regulatory gamesmanship that left patients in the dark.
Why This Matters Now: In June 2026, the Judicial Panel on Multidistrict Litigation created a dedicated federal MDL for Boston Scientific spinal cord stimulator cases — a strong signal that courts are taking these allegations seriously. Patients harmed years ago, often told their pain or device failure was simply a “programming issue,” are now coming forward as the full scope of the alleged regulatory deception becomes public.
Not Medical Malpractice. These are product liability claims against device manufacturers — separate from any claim against your surgeon for how the device was implanted.
Core Legal Claims
- Defective design
- Failure to warn
- Manufacturing defect
- Negligence & negligence per se
- Breach of warranty
- Administrative Procedure Act claims vs. FDA
Who Is Being Sued
- Abbott Laboratories
- Boston Scientific Corporation
- Medtronic, Inc.
- Nevro Corp.
What Is a Spinal Cord Stimulator?
A spinal cord stimulator (SCS) is a surgically implanted system designed to treat chronic, intractable pain — frequently pain from failed back surgery syndrome, complex regional pain syndrome, or persistent nerve pain that has not responded to medication, physical therapy, or prior surgery.
The system works by delivering low-level electrical pulses to the spinal cord through thin electrode leads, placed in the epidural space near the spine. These pulses are intended to interrupt or mask pain signals before they reach the brain.
The Three Core Components
- Implantable Pulse Generator (IPG) — a small battery-powered device, similar to a pacemaker, implanted under the skin that powers and controls stimulation.
- Electrode Leads — thin wires placed in the epidural space near the spinal cord that deliver the actual electrical pulses.
- Handheld Remote / External Controller — used by the patient (and sometimes by sales representatives) to adjust stimulation voltage, frequency, and waveform.
How It’s Implanted — Two Steps
Step 1 — Trial Period: temporary leads are placed and connected to an external generator for 3–7 days to test whether stimulation meaningfully reduces pain.
Step 2 — Permanent Implant: if the trial is successful, a permanent IPG and leads are surgically implanted, typically under the skin near the buttock or abdomen.
Red Flag: multiple lawsuits allege patients with as little as 30% pain relief during trial were still encouraged by sales reps to proceed with permanent implantation.
The Boston Scientific MDL (No. 3181)
On June 5, 2026, the U.S. Judicial Panel on Multidistrict Litigation (JPML) formally established MDL No. 3181 — In re Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation. The case was centralized in the Central District of California before U.S. District Judge Josephine L. Staton.
The order transferred 23 pending Boston Scientific spinal cord stimulator lawsuits from nine different federal districts into this single, coordinated proceeding. The consolidated claims allege that Boston Scientific failed to comply with federal regulatory requirements, introduced new device iterations through repeated PMA supplements rather than seeking full premarket approval review, and failed to disclose complete information about device risks to physicians and patients.
Why an MDL Matters For You
- One judge oversees shared pretrial issues — discovery, expert witnesses, and key motions — preventing duplicative work and conflicting rulings
- Your case remains your own — individual facts, injuries, and damages are still evaluated separately
- Bellwether trials are typically selected to test how juries respond to the core allegations, which can inform settlement negotiations for the wider group of cases
- Filing now — rather than waiting — protects your claim and ensures it is positioned within the MDL once your case is filed and transferred
The “Preemption Deception” Theory
Manufacturers commonly argue that FDA approval shields them from state lawsuits — a defense called federal preemption. But plaintiffs’ attorneys, including ours, argue that this protection only applies when a company genuinely complied with federal law. If a manufacturer used the PMA supplement process to push through major design changes — altering safety profiles — without returning for full review or properly warning patients and physicians, it has not complied with the system. It has exploited it. Courts in this MDL will be asked to decide whether that conduct strips manufacturers of the preemption shield they are counting on.
MDL Snapshot
Case Name: In re Boston Scientific Corp. Spinal Cord Stimulator Products Liability Litigation
MDL No.: 3181
Court: U.S. District Court, Central District of California
Judge: Hon. Josephine L. Staton
Established: June 5, 2026
Initial Cases Transferred: 23 (from 9 districts)
Note: The JPML declined to create a broader industry-wide MDL covering Abbott, Medtronic, and Nevro, finding no allegation that the manufacturers acted in concert. Claims against those companies continue to be filed and litigated individually in their respective home-state courts.
Who Qualifies? What Evidence Is Necessary?
Who May Qualify
- You had a spinal cord stimulator implanted by Abbott, Boston Scientific, Medtronic, Nevro, or another manufacturer.
- You experienced shocks, burns, infection, lead migration, worsening pain, or a neurological complication after implantation.
- You required revision surgery to reposition or replace components, or complete explant (removal) of the device.
- You can show measurable harm — additional surgeries, long-term disability, lost wages, or significant related medical expenses.
- You are still within your state’s filing deadline.
Even revision-only counts. You do not need a complete device removal to qualify. Revision surgery to reposition leads or replace failed components may be enough, particularly if it was required due to device malfunction.
Evidence That Strengthens a Claim
- Medical records documenting your pain, the implant procedure, and any post-surgical complications
- Surgical / operative reports detailing device placement and any deviations from standard procedure
- Device information — manufacturer, model name, and serial number, often found on your implant card
- Device interrogation reports showing unexplained resets, shocks, or malfunction data pulled directly from the device
- Post-surgical complication records — infections, nerve damage, imaging confirming lead migration or fracture
- Records of revision or explant surgery, including the reason documented by your surgeon
- Expert medical testimony connecting your symptoms and the device’s failure (your attorney arranges this)
- Billing and financial records documenting the cost of related treatment and lost income
Don’t have these records? That’s normal — and it won’t stop your claim. Ron Austin Law will request your complete medical and implant records on your behalf at no cost to you.
State-by-State Statute of Limitations
Every state sets its own deadline for filing a product liability claim. Most use a “discovery rule” — the clock starts when you discovered, or reasonably should have discovered, that the device caused your injury — but the deadline is still real, and missing it means losing your right to compensation permanently.
Louisiana, Kentucky & Tennessee: you have only ONE YEAR from the date you discovered, or should have discovered, that your spinal cord stimulator caused your injury. If you had your device implanted or experienced complications in one of these states, contact us today — do not wait.
This reflects general product liability statutes of limitations and is provided for informational purposes only. Some states apply different rules depending on the type of claim or when harm was discovered. Always confirm your specific deadline with an attorney.
Full Litigation Timeline
Original Devices Approved
Abbott’s predecessor device (Genesis) is approved under PMA P010032 in 2001. Boston Scientific’s Precision system follows in 2004. Both later become the regulatory foundation for decades of subsequent devices.
Adverse Events Mount Quietly
The FDA receives 179,917 adverse event reports for Class III implanted SCS devices, including 757 reported deaths in that category. Hundreds of design changes are pushed through via PMA supplements rather than full
review.
AP Investigation Exposes Pattern
The Associated Press publishes an investigation of the FDA’s MAUDE database, finding that shocking and burning
had been reported for all major SCS models from every manufacturer.
FDA Issues Formal Warning Letter
The FDA publishes a letter to healthcare providers disclosing 428 individual patient deaths among SCS recipients between 2005–2020, and reminds physicians that a proper trial period is required before permanent implantation.
Plaintiffs Move for MDL
Plaintiffs file a motion with the JPML to consolidate at least 15 federal lawsuits against Abbott and Boston Scientific. Hundreds of additional injured patients have already retained counsel.
New Suits Filed; Manufacturers Push Back
Additional Abbott Proclaim XR5 and Proclaim Plus 5 lawsuits are filed, alleging sales-rep reprogramming and repeat lead migration. Abbott and Boston Scientific formally oppose consolidation.
MDL No. 3181 Is Established
The JPML creates MDL No. 3181 for Boston Scientific cases, centralizing 23 lawsuits from 9 federal districts before Judge Josephine L. Staton in the Central District of California. Claims against Abbott, Medtronic, and Nevro
continue individually.
Ron Austin Law Is Accepting Cases Nationwide
If you or a loved one experienced complications from a spinal cord stimulator, the time to act is now. Statutes of limitations continue to run regardless of MDL proceedings — filing today protects your rights and positions your case to join coordinated litigation.
