Abbott Spinal Cord Stimulator Lawsuit (MDL 3194)
On October 2, 2026, the Judicial Panel on Multidistrict Litigation (JPML) centralized federal lawsuits against Abbott Laboratories over its spinal cord stimulators (SCS) as In re: Abbott Laboratories Spinal Cord Stimulator Products Liability Litigation, MDL No. 3194, in the U.S. District Court for the Northern District of Illinois before Judge Lindsay C. Jenkins. Plaintiffs allege that Abbott’s Proclaim, Eterna, and legacy St. Jude Medical systems are defective and that Abbott failed to adequately warn physicians and patients. Abbott disputes these claims. Nigh Goldenberg Raso & Vaughn (NGRV) is accepting inquiries from patients who suffered serious complications or required revision or explant surgery.
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Abbott Spinal Cord Stimulator Litigation Overview
Patients implanted with Abbott Laboratories spinal cord stimulators, including the Proclaim and Eterna systems and legacy St. Jude Medical devices, have filed lawsuits alleging serious complications. These include uncontrolled electrical shocks, burning sensations, lead migration or fracture, sudden loss of therapy, and the need for surgical revision or removal.
On October 2, 2026, the JPML transferred the federal Abbott cases to the Northern District of Illinois for coordinated pretrial proceedings. Reporting on the order indicates that more than 25 actions were centralized at the outset, and additional cases are expected to be filed or transferred as the MDL develops.
NGRV is reviewing and filing claims for patients who experienced severe injuries or required revision surgery after implantation with an Abbott neurostimulation system. Our attorneys have more than 50 years of combined experience, and our founding partners have been appointed by federal judges to leadership positions on Plaintiffs’ Steering and Executive Committees in major national litigations. Founding partner Brett Vaughn is also a Registered Nurse (RN, BSN), which informs how our firm evaluates device records, operative reports, and neurological complaints.
If you or a loved one experienced severe nerve complications, painful shocks, or revision surgery after an Abbott spinal cord stimulator implant, call or text NGRV at (202) 792-7927 or email Intake@nighgoldenberg.com for a free case evaluation.
Important: Do not alter your device settings or schedule removal of your device without first speaking with your treating physician. A legal consultation does not replace medical advice.
What Is the Abbott Spinal Cord Stimulator?
A spinal cord stimulator is a surgically implanted neuromodulation device used to treat chronic, intractable pain of the trunk and limbs, including failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS). Spinal cord stimulators are Class III medical devices, the category of device the FDA regulates most stringently, and they reach the market through the FDA’s Premarket Approval (PMA) process.
An Abbott system generally consists of three components:
- Implantable Pulse Generator (IPG): A battery-powered generator typically placed beneath the skin of the lower back, flank, or buttock.
- Leads: Thin, insulated wires with electrodes placed in the epidural space along the spinal cord to deliver electrical pulses.
- External controllers: A clinician programmer and a patient controller, which for Abbott’s Proclaim platform is an iPhone or iPod touch that communicates with the IPG by Bluetooth and is used to adjust stimulation and place the device in “MRI mode.”
Abbott’s presence in neuromodulation expanded through its acquisition of St. Jude Medical, announced at approximately $25 billion and completed on January 4, 2017. The pending lawsuits involve both legacy St. Jude devices and current Abbott platforms:
| Device Family | Models Referenced in Litigation | Notable Features |
|---|---|---|
| Abbott Proclaim | Proclaim XR 5 and 7, Proclaim Plus 5 and 7, Proclaim DRG | BurstDR™ waveform, iOS-based patient controller, Bluetooth connectivity |
| Abbott Eterna | Eterna SCS | Abbott’s newer-generation SCS platform |
| St. Jude Medical Legacy | Prodigy, Prodigy MRI, Eon, Eon Mini | Earlier-generation neurostimulation IPGs |
Note: Abbott’s Infinity IPGs are used for deep brain stimulation (DBS), not spinal cord stimulation. They are included in the FDA recall described below but are not spinal cord stimulators.
Why Are Lawsuits Being Filed Against Abbott?
Plaintiffs in MDL 3194 allege that Abbott designed, manufactured, and marketed spinal cord stimulators with defects and without adequate warnings. The principal allegations include the following.
1. Substantial post-approval modifications
Plaintiffs allege that Abbott’s SCS product line traces back to a 2001 FDA approval under PMA P010032 and that the devices were later changed through numerous PMA supplements affecting firmware, battery systems, waveforms, leads, and user interfaces, without the clinical evidence that a new PMA would require. Abbott has opposed consolidation and contends that the cases involve different devices, injuries, and representations.
2. Failure to warn
Plaintiffs allege that Abbott knew of device instability, wireless communication failures, and lead problems but did not adequately update instructions or warn physicians and patients.
3. The FDA Class I recall for “MRI mode” failures
The FDA classified as a Class I recall, its most serious category, Abbott’s correction of Proclaim and Infinity IPGs after patients reported being unable to exit MRI mode. The patient controller can lose its ability to connect to the IPG while the device is in MRI mode, which disables therapy. Where no previously paired clinician programmer is available, the FDA notice states there is no alternative way to exit MRI mode, and the FDA states that affected devices may require surgery to remove and replace. The recall covered 155,028 devices distributed between November 2015 and June 2023. According to Abbott’s customer notice as reported by MedTech Dive, Abbott received 186 reports of the problem, including 73 reports of injury. Abbott has stated that no products needed to be returned or replaced.
4. Differences between trial and permanent implants
Plaintiffs allege that patients were not adequately informed that results from a temporary trial stimulator may not carry over to the permanent implant, and that scar tissue, lead migration, and software or hardware problems can reduce or eliminate pain relief over time.
What Injuries Are Alleged in the Abbott Spinal Cord Stimulator Lawsuits?
When a neurostimulator malfunctions, unintended electrical output near the spinal cord and nerves can cause serious harm. Complications reported by patients and alleged in the litigation include:
- Sudden electrical shocks or jolts: Abrupt, uncontrolled stimulation that can cause falls or involuntary muscle contractions.
- Burning sensations and overstimulation: Painful stimulation or heating sensations at the lead or generator site.
- Lead migration and lead fracture: Movement, bending, or breakage of leads within the epidural space, which can cause radicular pain, loss of therapeutic coverage, or nerve injury.
- Loss of therapy: Sudden device shutdown or inability to restore stimulation, including after use of MRI mode.
- Neurological injury: Reported complications include numbness, weakness, foot drop, difficulty walking, spinal cord compression, and neuropathy.
- Bowel and bladder dysfunction: Reported in cases involving nerve injury or lead displacement.
- Infection and fluid complications: Surgical pocket infection, epidural abscess, cerebrospinal fluid (CSF) leak, and seroma formation.
- Revision and explant surgery: Procedures to reposition or replace leads, replace the generator, or remove the system, each of which carries its own surgical risks.
Who May Qualify to File an Abbott Spinal Cord Stimulator Lawsuit?
You may have a claim if you meet the following criteria:
- Implanted device: You received an Abbott Proclaim (XR, Plus, or DRG), Eterna, or St. Jude Medical (Prodigy or Eon) spinal cord stimulator. Your implant identification card, operative report, or device serial number will confirm the model.
- Documented complication: You experienced one or more complications, such as:
- Sudden painful shocks, burning, or abnormal stimulation
- Severe worsening pain or loss of therapy
- Lead migration, disconnection, or fracture
- New weakness, numbness, difficulty walking, or paralysis
- Bowel or bladder dysfunction
- Deep pocket infection or tissue erosion around the generator
- Inability to exit MRI mode
- Medical intervention: You required additional treatment, such as repeated reprogramming, lead adjustment, device deactivation, revision surgery, or explant.
Eligibility depends on the facts of each case. If you are unsure of your device model, NGRV can request and review your medical records on your behalf during a confidential consultation. You do not need to have undergone explant surgery to speak with an attorney, but the severity of your injury and any surgical recommendation are relevant to evaluating a claim.
What Is the Current Status of MDL 3194?
Why Abbott Has Its Own MDL
Plaintiffs initially asked the JPML to create a single industry-wide MDL covering spinal cord stimulators from multiple manufacturers. On June 5, 2026, the Panel declined to do so and instead centralized only the Boston Scientific cases. Abbott and Nevro cases were later the subject of separate petitions, and on October 2, 2026, the Panel created separate MDLs for each manufacturer. Federal spinal cord stimulator claims are now organized as follows:
Judge Lindsay C. Jenkins
Claims involving other manufacturers, including Medtronic, are not part of these MDLs.
What Happens Next
MDL 3194 is at an early stage. Typical initial steps include appointing plaintiffs’ leadership, establishing a master docket and case management schedule, and addressing threshold legal issues. One anticipated issue is federal preemption. Under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), state-law claims that impose requirements different from or in addition to federal requirements for a PMA-approved device may be preempted under 21 U.S.C. § 360k, while claims that parallel federal requirements may proceed. How the court applies these principles to Abbott’s devices will shape the litigation. As of October 16, 2026, no bellwether trial dates or global settlement have been announced.
What Can I Expect If I File an Abbott Spinal Cord Stimulator Claim?
An MDL is not a class action. Each plaintiff keeps an individual lawsuit, and any recovery is based on that plaintiff’s own medical history, expenses, and injuries. MDL centralization coordinates pretrial proceedings such as discovery and expert issues before a single judge. Cases not resolved through settlement are generally returned to their original courts for trial.
Overview of the Process
- Case evaluation. NGRV reviews your implant details, surgical history, and the timeline of your complications at no cost to you.
- Records collection. Our team obtains your operative reports, implant records and device serial numbers, imaging, and revision or explant notes.
- Filing. Your claim is filed in federal court and coordinated with MDL 3194, either by direct filing if the court authorizes it or by transfer to the Northern District of Illinois.
- Coordinated discovery. Court-appointed plaintiffs’ leadership conducts common discovery, including review of Abbott’s internal design, testing, and regulatory documents, depositions of company witnesses, and retention of engineering, neurological, and regulatory experts.
- Bellwether trials and settlement discussions. The court may select a group of representative cases for trial. Outcomes in those cases often inform settlement negotiations, though no outcome can be guaranteed.
Damages That May Be Available
Depending on the facts and applicable state law, plaintiffs may seek compensation for:
- Past and future medical expenses, including surgery, revision or explant procedures, and ongoing pain management
- Lost wages and diminished earning capacity
- Physical pain, suffering, and permanent impairment
- Emotional distress and loss of enjoyment of life
- Wrongful death damages in cases involving fatal complications
Time Limits
Every state sets a statute of limitations, and the deadline can be as short as one to two years from the date of injury or from when you knew or should have known the device caused your harm. Because deadlines vary and can expire, we encourage you to seek a legal evaluation promptly.
Why Choose Nigh Goldenberg Raso & Vaughn?
Product liability litigation against a global medical device manufacturer requires substantial trial experience, leadership credentials, and medical literacy.
- Court-appointed MDL leadership. Our founding partners have been appointed by federal judges to Plaintiffs’ Steering and Executive Committees in national litigations, including In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation (MDL 2875), In re: Paraquat Products Liability Litigation (MDL 3004), In re: Uber Technologies, Inc., Passenger Sexual Assault Litigation (MDL 3084), and In re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation (MDL 2846).
- Clinical perspective. Brett Vaughn is both a trial attorney and a licensed Registered Nurse (RN, BSN), which supports careful review of device records, surgical notes, and neurological symptoms.
- Contingency fee representation. NGRV represents clients on a contingency fee basis. We advance litigation costs and expert expenses, and if there is no recovery on your behalf, you owe no attorney fees.
Frequently Asked Questions
What is the difference between an MDL and a class action for Abbott stimulators?
In a class action, plaintiffs are grouped together as a single class and typically receive settlements determined by a common formula. In a multidistrict litigation (MDL) such as MDL 3194, each plaintiff retains an individual lawsuit, so compensation reflects that person’s own injuries, surgeries, lost income, and other damages.
What caused the FDA Class I recall of Abbott neurostimulators?
The FDA classified as a Class I recall Abbott’s correction of Proclaim and Infinity implantable pulse generators because patients reported being unable to exit MRI mode. The patient controller can lose communication with the implanted generator while in MRI mode, which disables therapy, and the FDA states that affected devices may require surgery to remove and replace. The recall covered more than 155,000 devices.
Can I file a lawsuit if my Abbott stimulator has not been removed?
Possibly. If your device is causing shocks, overstimulation, loss of pain control, or lead migration, you may have a claim even if you have not had revision or explant surgery. A consultation can help determine whether your circumstances warrant filing.
Are Abbott Infinity devices part of the spinal cord stimulator lawsuits?
Abbott’s Infinity IPGs are used for deep brain stimulation and were included in the FDA’s MRI-mode recall. MDL 3194 concerns spinal cord stimulators. If you have an Infinity device, contact us and we can review your situation.
Has Abbott responded to the allegations?
Abbott has opposed centralization and contends that the cases involve different devices, injuries, and representations. The allegations in the lawsuits have not been proven, and the litigation is at an early stage.
How much does it cost to hire an attorney for an Abbott SCS lawsuit?
There are no upfront out-of-pocket costs. NGRV represents clients on a contingency fee basis, and attorney fees are owed only if there is a recovery. Details of the fee and cost arrangement are provided in the written retainer agreement.
How do I find my Abbott device model and serial number?
Your model and serial number appear on your patient identification card, in your hospital discharge paperwork, and in the operative report from your implant surgery. If you cannot locate these documents, our team can help you request them from your providers.
Sources and References
- JPML transfer reported by Bloomberg Law, October 2026
- AboutLawsuits.com, Abbott and Nevro MDL centralization
- Law360, JPML denies industry-wide MDL, June 5, 2026
- FDA recall notice, Abbott Proclaim and Infinity IPGs (MRI mode)
- MedTech Dive, recall injury and report figures
- Becker’s Spine, recall device count and distribution dates
- FDA PMA supplement approval letter, P010032/S191
- MassDevice, Abbott’s opposition to consolidation
- Abbott press release, completion of St. Jude Medical acquisition
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
- 21 U.S.C. § 360k
Attorney Advertising. Prior results do not guarantee a similar outcome. The information on this page is for general informational purposes and is not legal or medical advice. Allegations described are claims made by plaintiffs and have not been proven. Contacting NGRV does not by itself create an attorney-client relationship.
