Boston Scientific Spinal Cord Stimulator Lawsuit (MDL 3181)
On June 5, 2026, the Judicial Panel on Multidistrict Litigation (JPML) centralized federal lawsuits over Boston Scientific spinal cord stimulators (SCS) as In re: Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation, MDL No. 3181, in the U.S. District Court for the Central District of California before Judge Josephine L. Staton. Plaintiffs allege that Boston Scientific’s WaveWriter, Spectra, and Precision systems are defective and that the company failed to adequately warn physicians and patients. Boston Scientific denies the allegations. Nigh Goldenberg Raso & Vaughn (NGRV) is accepting inquiries from patients who suffered serious complications or required revision or explant surgery.
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Boston Scientific Spinal Cord Stimulator Litigation Overview
Patients implanted with Boston Scientific spinal cord stimulation systems, including the WaveWriter Alpha, Spectra WaveWriter, and Precision platforms, have filed lawsuits alleging serious complications. These include uncontrolled electrical shocks, lead fracture or migration, device failure, burns or pocket pain, infection, and the need for revision or explant surgery.
On June 5, 2026, the JPML transferred the federal Boston Scientific cases to the Central District of California for coordinated pretrial proceedings, initially covering 23 actions pending in nine federal districts. The Panel declined to create an industry-wide MDL covering other manufacturers, and Abbott and Nevro cases were later centralized separately.
NGRV represents individuals nationwide who suffered serious harm or required revision surgery after receiving a Boston Scientific spinal cord stimulator. 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 reviews device records, operative reports, and neurological complaints.
If you or a loved one experienced painful shocks, lead breakage, or revision surgery after a Boston Scientific 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 Boston Scientific 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). Boston Scientific’s spinal cord stimulators are Class III devices marketed under PMA P030017, the FDA’s most stringent pathway for medical devices.
A Boston Scientific system generally consists of three components:
- Implantable Pulse Generator (IPG): A battery-powered generator placed beneath the skin, typically in the flank, abdomen, or upper buttock.
- Leads: Insulated, multi-contact wires placed in the epidural space along the spinal cord and secured with anchors.
- External controls: A handheld remote or app-based controller for programming and, for rechargeable systems, an external charger.
The lawsuits involve several Boston Scientific platforms:
| Device System | Models Referenced in Litigation |
|---|---|
| WaveWriter Alpha Series | WaveWriter Alpha, WaveWriter Alpha Prime (16 and 32 contact IPG kits) |
| Spectra WaveWriter | Spectra WaveWriter SCS |
| Precision Series | Precision Montage, Precision Spectra |
| Leads | Infinion CX, Infinion Pro |
Note: Infinion CX leads are compatible with Boston Scientific’s Spectra WaveWriter and WaveWriter Alpha systems. Boston Scientific has stated that Infinion Pro leads have replaced Infinion CX leads for new implants.
Why Are Lawsuits Being Filed Against Boston Scientific?
Plaintiffs in MDL 3181 allege that Boston Scientific designed, manufactured, and marketed spinal cord stimulators with defects and without adequate warnings. Boston Scientific denies these allegations and asserts that it followed the FDA approval process. None of the allegations below has been proven.
1. Cumulative changes through PMA supplements
Plaintiffs allege that Boston Scientific’s product line originates from PMA P030017 and that the company introduced hundreds of supplements incorporating major changes, including multi-waveform stimulation, Bluetooth-enabled programming, battery architecture revisions, and redesigned leads, without the clinical validation a new approval would require.
2. Lead fracture and migration
Plaintiffs allege that leads have a high rate of fracture and migration that can cause loss of therapy, nerve injury, and the need for complex revision surgery.
3. Battery and charging failures
Plaintiffs allege that battery-related failures have caused serious burns and pocket injuries. Separately, the FDA’s records reflect a Class II recall of WaveWriter Alpha 16 and 32 IPG kits, initiated July 17, 2024, for devices that may reset during charging and cause a transient loss of stimulation.
4. Improper programming by company representatives
Complaints allege that clinical and sales representatives participated in selecting, programming, and adjusting implanted devices and made representations to patients, at times outside the presence of the physician.
5. Failure to warn
Plaintiffs allege that Boston Scientific did not adequately disclose complication rates or update warnings to physicians and patients.
The Infinion CX Lead Class I Recall
In June 2026, Boston Scientific notified customers to stop using and distributing unused Infinion CX leads, and the FDA announced the action as a Class I recall on September 3, 2026. Class I is the FDA’s most serious recall category. According to the notice, mechanical stress at the lead’s anchor site may cause high impedance measurements or lead fractures, which can result in inadequate stimulation or additional surgery, including lead explant and replacement. As of May 27, 2026, Boston Scientific had reported 1,081 serious injuries and no deaths associated with the issue.
Two points are important for patients. First, the recall applies to unused inventory, about 1,079 leads according to the FDA database, and the FDA stated that it does not affect devices already implanted. Second, the recall is related to but separate from the allegations in MDL 3181. Patients with implanted leads who have symptoms should consult their physician.
What Injuries Are Alleged in the Boston Scientific Lawsuits?
When a spinal cord stimulator lead fractures, migrates, or delivers unintended electrical output, the result can be serious and lasting harm. Complications reported by patients and alleged in the litigation include:
- Sudden shocks or surges: Abrupt, uncontrolled stimulation that can cause falls or involuntary muscle contractions.
- Lead fracture and fragmentation: Breakage of the lead body in the epidural space, which can cause loss of therapy, nerve irritation, or the need for surgical removal.
- Lead migration and loss of efficacy: Movement of electrodes away from the intended target, causing radiating pain or complete loss of pain relief.
- Burns and pocket pain: Heat-related injury or severe pain at the generator site, including during charging.
- 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, seroma, and skin erosion.
- Revision and explant surgery: Procedures to replace leads or generators or remove the system, each of which carries its own surgical risks, including scarring and dural injury.
Who May Qualify to File a Boston Scientific Spinal Cord Stimulator Lawsuit?
You may have a claim if you meet the following criteria:
- Implanted device: You received a Boston Scientific WaveWriter Alpha, Spectra WaveWriter, Precision, or other Boston Scientific SCS system, including systems using Infinion leads. 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 or burning sensations
- Lead fracture, lead migration, or abnormal high-impedance readings
- Burns or severe pocket pain, including during charging
- Loss of therapy accompanied by worsening nerve pain
- New weakness, numbness, or loss of mobility
- Bowel or bladder dysfunction
- Severe pocket infection, seroma, or skin breakdown
- Medical intervention: You required additional treatment, such as hospitalization, reprogramming, lead repositioning, or revision or explant surgery.
Eligibility depends on the facts of each case. If you do not have your records, NGRV can request and review them on your behalf. You do not need to have had 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 3181?
The Multi-MDL Landscape for Spinal Cord Stimulators
Federal spinal cord stimulator claims are organized by manufacturer rather than in a single industry-wide proceeding:
Judge Josephine L. Staton
Claims involving other manufacturers, including Medtronic, are not part of these MDLs. When it centralized the Boston Scientific cases, the JPML noted that Judge Staton was already overseeing several related cases and that Boston Scientific’s neuromodulation division is headquartered in the district.
Key Developments in MDL 3181
- June 23, 2026Judge Staton set an initial scheduling conference for August 5, 2026.
- August 13, 2026The court appointed 19 attorneys to plaintiffs’ leadership roles, including three Co-Lead Counsel, a Plaintiffs’ Executive Committee, a Plaintiffs’ Steering Committee, and a Leadership Development Committee.
- August 18, 2026The court issued an order allowing new cases to be filed directly in the MDL rather than first filing in a plaintiff’s home district.
- September 3, 2026The FDA announced the Infinion CX lead recall as a Class I recall.
As of October 16, 2026, no bellwether trial dates or global settlement have been announced. An anticipated threshold 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.
What Can I Expect If I File a Boston Scientific 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 date, device model, and complication history at no cost to you.
- Records collection. Our team obtains operative reports, device programming and impedance data, explant records, imaging, and billing statements.
- Filing. Your claim is filed in federal court. Under the court’s direct filing order, new cases may be filed directly in the Central District of California. Filing does not extend your statute of limitations, so timing matters.
- Coordinated discovery. Court-appointed plaintiffs’ leadership conducts common discovery, including review of Boston Scientific’s design, testing, and recall records, depositions of company witnesses, and retention of engineering, neurological, and regulatory experts.
- Bellwether trials and settlement discussions. The court may select 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 hospitalization, revision or explant surgery, and ongoing neurological care
- Lost wages and diminished earning capacity
- Physical pain, suffering, and permanent impairment
- Emotional distress and diminished quality 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 medical device manufacturer requires multidistrict litigation experience, courtroom credibility, 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 operative notes, lead impedance records, and neurological injuries.
- 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 caused the FDA Class I recall of Boston Scientific Infinion CX leads?
According to the FDA notice, mechanical stress at the anchor site of the lead body may cause high impedance measurements or lead fractures, which can lead to inadequate stimulation or additional surgery. Boston Scientific reported 1,081 serious injuries and no deaths as of May 27, 2026. The recall applies to unused leads and does not affect leads already implanted.
Does the Infinion CX recall apply to my implanted device?
The FDA stated that the recall does not affect devices already implanted and applies to unused inventory. If you have symptoms such as loss of relief, shocks, or abnormal impedance readings, speak with your physician. Your symptoms may still be relevant to a legal claim.
What is the difference between an MDL and a class action in the Boston Scientific litigation?
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 3181, each plaintiff retains an individual lawsuit, so compensation reflects that person’s own injuries, surgeries, lost income, and other damages.
Can I file a lawsuit if my Boston Scientific device has not been removed?
Possibly. If your device is causing shocks, excessive heat, lead displacement, or severe loss of therapy, you may have a claim even if you have not had explant surgery. A consultation can help determine whether your circumstances warrant filing.
Has Boston Scientific responded to the allegations?
Boston Scientific denies the allegations and asserts that it followed the FDA approval process. 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 a Boston Scientific 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.
Where can I track court orders and deadlines for MDL 3181?
You can follow pretrial orders and case management filings on our MDL 3181 case management repository.
Sources and References
- AboutLawsuits.com, spinal cord stimulator MDL overview
- Law360, JPML denies industry-wide MDL, June 5, 2026
- YouHaveALawyer.com, Boston Scientific cases centralized
- AboutLawsuits.com, MDL 3181 initial conference order
- AboutLawsuits.com, leadership appointments in MDL 3181
- AboutLawsuits.com, direct filing order
- HarrisMartin, Infinion CX recall announced September 3, 2026
- MedTech Dive, Infinion CX recall details
- MassDevice, Infinion CX recall scope and injury figures
- IPSIS, Infinion CX recall summary
- FDA recall database, WaveWriter Alpha IPG kits (Class II, PMA P030017)
- Joint preliminary report summarizing plaintiffs’ allegations, August 2026
- 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.
