Abbott Spinal Cord Stimulator Lawsuit: Allegations, Recall, and Cases

The Abbott spinal cord stimulator lawsuits allege that the company’s neurostimulation devices — including the Proclaim, Eterna, and Infinity systems — are defectively designed and manufactured, that Abbott sales representatives reprogrammed implanted devices without physician oversight, and that Abbott made hundreds of post-approval changes to the devices without securing new FDA approval. As of mid-2026, the cases are moving forward individually in federal court after a judicial panel declined to consolidate them into a multidistrict litigation.

What Plaintiffs Are Alleging

Three claim theories run through the complaints, and most lawsuits combine at least two of them.

Defective Devices Causing Injury

Plaintiffs describe painful electric shocks, unintended jolting sensations, lead migration, battery failures, and loss of pain relief. Many say the only fix was surgery — either revision surgery to reposition the leads or full explant surgery to remove the device.¹ A May 2026 case filed in New Jersey alleges a Proclaim XR device caused “painful electric shocks” and that Abbott mischaracterized the defect rather than resolving it.²

Sales Representatives Reprogramming Devices

Several lawsuits allege Abbott sales representatives routinely adjusted voltage, frequency, and stimulation parameters on implanted devices without meaningful physician supervision — conduct plaintiffs characterize as the unauthorized practice of medicine. In Melby v. Abbott Laboratories, filed March 13, 2026 in the Northern District of Illinois, the plaintiff alleges Abbott reps ran multiple reprogramming sessions on her Proclaim XR5 without noticing the leads had migrated, and told her they were the only people capable of reprogramming the device. She contends trained medical staff would have caught the migration sooner.³ A May 2026 Hawai’i filing and a December 2025 Texas complaint make similar allegations about Eterna and Proclaim devices.⁴

Unauthorized Changes to an Old Approval

Abbott’s current stimulators trace back to premarket approval PMA P010032, granted in November 2001 to a predecessor company for the Genesis Neurostimulation System. That original approval rested on a literature review rather than clinical trials of the device itself. By the end of 2019, the FDA had approved 143 supplements under that same PMA number — covering new device models, redesigned leads, new pulse generators, new batteries, and software updates.⁵

The Furia et al. v. Abbott Laboratories case, filed in April 2026 in the Northern District of California, alleges Abbott made more than 230 undisclosed post-approval modifications to firmware, battery design, and stimulation architecture on the Proclaim Elite without obtaining a new PMA. The complaint also seeks enforcement of the Administrative Procedure Act against the FDA.⁶

The 2023 MRI-Mode Recall Behind Many Cases

Much of the litigation grew out of a recall Abbott initiated on July 18, 2023 covering its Proclaim and Infinity implantable pulse generators. The FDA classified it as Class I, the agency’s most serious designation.⁷

The defect involved MRI mode, a setting that temporarily disables therapy for imaging scans. If the Bluetooth link between the implanted device and the patient’s iPhone-based controller was disrupted while the device was in MRI mode, the patient could lose the ability to turn therapy back on. Disruptions happened for ordinary reasons: an iOS update, a deleted Bluetooth pairing, or a lost phone. Without a paired clinician programmer available to override the state, surgery was the only way to restore therapy.⁸

The recall covered 155,028 devices distributed in the United States between November 2015 and June 2023, including the Proclaim XR 5 and 7, Proclaim Plus 5 and 7, Proclaim DRG, and Infinity 5 and 7. The FDA documented 186 complaints and 73 injuries, with no reported deaths.⁹

Other Abbott advisories have followed. In October 2025, Abbott issued an urgent correction for the Eterna SCS implantable pulse generator (Model 32400) after a manufacturing issue with Bluetooth Low Energy components caused some devices to lose communication with the clinician programmer and patient controller. Abbott reported 36 complaints, 21 of them requiring surgical replacement.¹⁰ An April 2026 notice reminded physicians that the devices’ “Surgery Mode” must be manually enabled before any procedure involving electrosurgical equipment or the devices could be damaged and require replacement.¹¹

Notable Cases Already Filed

A handful of representative federal filings show the range of claims:

Tuttle v. Abbott (No. 1:25-cv-15083, N.D. Ill.), filed December 11, 2025 by Zella Tuttle. She received an Eterna device in October 2023. The complaint alleges Abbott reps programmed the device without physician supervision, that surgeons found the leads had migrated two months after implantation, and that the stimulator was surgically removed in December 2023. Claims include manufacturing defect, failure to warn, negligence, breach of warranty, fraud, and negligence per se.¹²
Melby v. Abbott Laboratories (N.D. Ill.), filed March 13, 2026, alleging repeated sales-rep reprogramming of a Proclaim XR5 that missed lead migration.³
Furia et al. v. Abbott Laboratories (3:26-cv-01945, N.D. Cal.), filed April 2026, the multi-plaintiff case alleging 230-plus undisclosed modifications to the Proclaim Elite.¹³
A Proclaim XR5 case filed March 22, 2026 in the Northern District of Illinois, alleging the device failed to deliver lasting relief, that one lead migrated in July 2023 and a second in September 2023, and that the full device was removed in March 2024.¹⁴
A Proclaim XR case filed May 29, 2026 in the District of New Jersey alleging manufacturing defects caused painful electric shocks.²

Why There Is No Abbott MDL

In February 2026, plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate spinal cord stimulator lawsuits against Abbott, Boston Scientific, Medtronic, and Nevro into a single MDL in the Northern District of Illinois. Abbott and Boston Scientific opposed the motion; Abbott argued there was no “common signature defect” tying the different manufacturers and devices together.¹⁵

On June 5, 2026, the panel rejected an industry-wide MDL, citing distinct device designs, separate regulatory histories, and no allegations that the manufacturers acted in concert. For Abbott specifically, the panel denied centralization on a technical ground: all four pending federal Abbott cases were in the same district, and the MDL statute requires cases pending in “different districts.” The panel noted that this denial “does not foreclose the possibility that centralization may be appropriate at a later time” if more cases are filed in other districts.¹⁶

The panel did create MDL No. 3181 for Boston Scientific spinal cord stimulator cases, consolidating 23 actions in the Central District of California under Judge Josephine L. Staton. Abbott cases remain in individual federal courts.¹⁶

Abbott’s Preemption Defense

Abbott’s primary defense rests on the Supreme Court’s 2008 ruling in Riegel v. Medtronic, which shields manufacturers of Class III PMA-approved devices from state-law tort claims that would impose requirements “different from or in addition to” the FDA’s. Whether a given lawsuit survives depends on how closely its claims track federal requirements the device allegedly failed to meet.

A 2021 ruling in Mikos v. Abbott Laboratories in the District of Maryland shows the split that courts are drawing. Judge George Levi Russell III dismissed the plaintiff’s strict liability, breach of implied warranty, and breach of express warranty claims as preempted, agreeing that calling the Proclaim DRG “unreasonably dangerous” would go beyond FDA requirements. He allowed the negligence claim to proceed insofar as it alleged conduct violating specific federal requirements — such as failing to follow current Good Manufacturing Practices or providing leads outside FDA-approved specifications.¹⁷

Plaintiffs are trying to plead around preemption by framing their claims as “parallel” to federal requirements, arguing Abbott failed the FDA’s own standards through material device modifications without adequate testing or failures to report adverse events. The JPML itself described the law here as “evolving.”¹⁶

Potential Compensation

No major verdicts or settlements have been reached in spinal cord stimulator litigation against any manufacturer on failure-to-warn or manufacturing defect claims as of mid-2026. Most cases were filed within the past year, and no bellwether trials have been scheduled.¹⁸

Industry observers have speculated that future settlements could fall between $250,000 and $600,000 per case, depending on injury severity, economic damages, and the need for revision surgery. These figures are acknowledged as speculative.¹⁸ For scale, a single revision surgery to replace a battery or lead runs $25,000 to $60,000, and many patients face more than one over their lifetimes.¹⁹

Abbott’s fourth-quarter 2025 earnings report included a $165 million charge for “legal reserves related to certain agreed-upon settlement.” The report did not specify which matter or product line the reserve applied to.²⁰

Where the Litigation Is Headed

The Abbott cases will proceed individually for now, with the small federal docket concentrated in the Northern District of Illinois. New complaints keep arriving — 2026 filings have appeared in Illinois, California, New Jersey, Hawai’i, and elsewhere — and plaintiff attorneys expect the volume to grow as more patients come forward within their state’s statute of limitations, typically one to three years from discovery of the injury.⁶

If enough cases land in enough different districts, the JPML has said it could revisit consolidation. Until then, preemption rulings on early motions to dismiss will do more than anything else to shape whether plaintiffs’ theories reach discovery and trial.¹⁶

1
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U.S. Food and Drug Administration. Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit MRI Mode
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Becker’s Spine Review. Abbott Medical Recalling Proclaim Spinal Cord Stimulators Following 73 Injuries
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Abbott Laboratories. Abbott Reports Fourth Quarter and Full Year 2025 Results