Boston Scientific SCS Litigation: MDL 3181 Status

The Boston Scientific spinal cord stimulator litigation is a federal multidistrict proceeding about implantable devices that deliver electrical pulses for chronic pain. The Judicial Panel on Multidistrict Litigation created MDL No. 3181 on June 5, 2026 and assigned it to Judge Josephine L. Staton in the Central District of California. The Panel counted 41 actions pending as of October 1, 2026. A joint status report filed in the MDL on September 30, 2026 states that the docket then had 59 cases and 72 plaintiffs. The record reviewed here contains no trial date, no verdict, no approved settlement and no court finding that a Boston Scientific device caused any plaintiff’s injury.

What the device is

A spinal cord stimulator is an implanted system, not a drug. The FDA’s 2004 approval order for the PRECISION Spinal Cord Stimulation System describes the indication as “an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain” (PMA order).

The PMA summary describes a 16-output implantable pulse generator with a rechargeable battery, connected to one or two 8-contact leads. The generator is implanted under the skin and delivers stimulation pulses through selected electrodes (PMA summary). The approval order names Advanced Bionics as the applicant. Current FDA recall records for Boston Scientific Neuromodulation products list the same PMA number, P030017 (recall Z-2879-2026).

The Panel’s transfer order does not name specific Boston Scientific models. It refers to “spinal cord stimulator (SCS) devices” and to “numerous new SCS devices” introduced under PMA supplements (transfer order). The court record reviewed for this article does not tie a named model to a named plaintiff.

What is established vs. what is alleged

Established by the court and agency record

• The MDL exists. On June 5, 2026, the Panel created MDL No. 3181 and assigned it to Judge Staton. The order transferred three actions from outside the Central District of California; fourteen were already pending there, ten before Judge Staton (transfer order).
• The case count is published, and two counts differ. The Panel’s October 1, 2026 report lists 41 actions pending and 41 total actions for the docket (JPML report). The September 30 joint status report states: “There are currently 59 cases and 72 plaintiffs in the MDL” (status report). The figures come from different bodies and are not reconciled in either document.
• The FDA approved the original Precision system in 2004. The approval order is dated April 27, 2004 and carries PMA number P030017 (PMA order).
• The FDA has issued recalls for Boston Scientific SCS products. On June 17, 2026, Boston Scientific Neuromodulation initiated a Class 1 recall of Infinion CX lead kits, 1,079 units, over lead body stress that may cause “high impedance measurements or lead fractures” (recall Z-2879-2026). On July 17, 2024, it initiated a Class 2 recall of WaveWriter Alpha 16 and 32 IPG kits, 77,674 units, over a possible device reset and transient loss of stimulation during charging (recall Z-2617-2024).
• The Panel refused an industry-wide proceeding. It denied centralization of the Abbott actions, writing that “proponents of an industry-wide MDL have failed to meet their burden of demonstrating that creating an MDL with such a wide scope is appropriate here” (transfer order). On October 2, 2026, it created separate dockets for Abbott, MDL No. 3194 in the Northern District of Illinois before Judge Lindsay C. Jenkins, and for Nevro and Globus Medical, MDL No. 3195 in the Northern District of California before Judge Haywood S. Gilliam, Jr. (Abbott order, Nevro order).

Alleged in the complaints

The Panel summarized the common claims in the transfer order. Each plaintiff alleges implantation with a Boston Scientific SCS device and injury, “including unsatisfactory pain relief, shocking, burning, lead migration, autonomic dysfunction, and neurological injuries” (transfer order).

The order also describes the regulatory theory. Plaintiffs allege that Boston Scientific sought PMA approval “based on published literature related to SCS devices manufactured by other companies, rather than offering clinical studies demonstrating their safety and efficacy,” and that it abused the PMA supplement process by introducing modified devices “to avoid heightened scrutiny and clinical evaluation” (transfer order). They further allege failure to warn and concealment of known risks, and that sales representatives’ conduct amounted to the practice of medicine without a license. Those are allegations, not court findings.

The 2004 PMA record the allegations point to

The FDA file also describes how the original device was reviewed. The summary for P030017 states that the clinical data were “based on available peer reviewed published literature for similar implantable spinal cord stimulation (SCS) systems.” It reports effectiveness data for 116 implanted patients drawn from three published studies, and safety data from studies covering 1,056 intent-to-treat patients and 880 implanted patients (PMA summary).

The summary also reports the PRECISION experience at approval: “As of January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial stimulation period and were implanted with the PRECISION System. The follow-up period for the 26 implanted patients ranged from 2 weeks to 6 months” (PMA summary).

Those passages describe the 2004 review. They do not establish that later supplements were handled improperly, and they do not decide the claims. They do show that the literature-based theory has a documentary basis in the FDA file; whether later supplements crossed a legal line remains for the court.

Where the litigation stands

The MDL is in pretrial management, not trial. Pretrial Order No. 5 established two separate tracks, one for product liability claims against Boston Scientific and one for administrative claims under the Administrative Procedure Act. The order states that “any orders governing the claims against BSC shall have no applicability to the APA claims track” (status report). The FDA is a defendant on the administrative track.

The September 30 status report describes these dates:

• A status conference was scheduled for October 7, 2026.
• The Master Personal Injury Complaint is due October 23, 2026.
• The parties asked for until October 30, 2026 to submit a proposed order with a short-form complaint.
• Motions to dismiss are due November 20, 2026.

The report lists December 18, 2026 for oppositions and January 15, 2027 for replies as proposals, not court orders. It sets no trial date and reports no bellwether selection.

Key dates

• April 27, 2004: The FDA approved PMA P030017 for the PRECISION Spinal Cord Stimulation System (PMA order).
• June 5, 2026: The JPML created MDL No. 3181, assigned it to Judge Staton, and denied centralization of the Abbott actions (transfer order).
• September 24, 2026: The JPML heard the Abbott and Nevro/Globus centralization motions (status report).
• September 30, 2026: The parties filed the joint status report stating 59 cases and 72 plaintiffs (status report).
• October 1, 2026: The JPML report listed 41 actions pending in MDL 3181 (JPML report).
• October 2, 2026: The JPML created MDL 3194 for Abbott and MDL 3195 for Nevro and Globus Medical (Abbott order, Nevro order).
• October 23, 2026: The Master Personal Injury Complaint is due (status report).
• November 20, 2026: Motions to dismiss are due (status report).

What this does not establish

Nothing in the record reviewed here decides that a spinal cord stimulator caused any plaintiff’s injury. No court has ruled that Boston Scientific’s PMA submissions were unlawful or that any device was defectively designed. There is no verdict, no approved settlement and no award in the documents reviewed. The FDA recalls are regulatory actions; they are not findings that the recalled products caused any particular injury, and the records do not state that the affected models are the devices at issue in MDL 3181.

Frequently asked questions

Is MDL 3181 a class action?

No. It is a multidistrict consolidation of individual federal cases for coordinated pretrial proceedings. The record reviewed here contains no class certification.

Does MDL 3181 cover Abbott and Nevro devices?

No. The Panel denied an industry-wide MDL and created separate dockets for Abbott (MDL 3194) and for Nevro and Globus Medical (MDL 3195) on October 2, 2026 (Abbott order, Nevro order). MDL 3181 is the Boston Scientific docket.

Has a court found that spinal cord stimulators cause the alleged injuries?

Not in the record reviewed here. The injuries are alleged in the complaints, and the Panel’s order describes them as allegations. No liability finding, verdict or causation ruling appears in the documents cited.

Is there a settlement in MDL 3181?

No approved settlement appears in the record reviewed. The joint status report discusses case management, discovery sequencing and motions to dismiss, not a settlement.

What is the difference between the FDA recalls and the lawsuit?

A recall is a regulatory action by the FDA and the manufacturer about a product’s performance or labeling. A lawsuit asks a court to decide whether a defendant is liable for a plaintiff’s injury. A recall can be evidence, but it does not by itself establish causation or liability.

Sources

1. United States Judicial Panel on Multidistrict Litigation: “MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending” (link, accessed 2026-10-19)
2. United States Judicial Panel on Multidistrict Litigation: “Transfer Order, In re Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation, MDL No. 3181” (link, accessed 2026-10-19)
3. United States District Court for the Central District of California: “Joint Status Report and Proposed Agenda for October 7, 2026 Status Conference, No. 2:26-ml-03181 (C.D. Cal.)” (link, accessed 2026-10-19)
4. U.S. Food and Drug Administration: “Premarket Approval Order P030017, PRECISION Spinal Cord Stimulation System” (link, accessed 2026-10-19)
5. U.S. Food and Drug Administration: “Summary of Safety and Effectiveness Data P030017, PRECISION Spinal Cord Stimulation System” (link, accessed 2026-10-19)
6. U.S. Food and Drug Administration: “Class 1 Device Recall Z-2879-2026, Infinion CX Leads” (link, accessed 2026-10-19)
7. U.S. Food and Drug Administration: “Class 2 Device Recall Z-2617-2024, WaveWriter Alpha 16 and 32 IPG Kits” (link, accessed 2026-10-19)
8. United States Judicial Panel on Multidistrict Litigation: “Transfer Order, In re Abbott Laboratories Spinal Cord Stimulator Products Liability Litigation, MDL No. 3194” (link, accessed 2026-10-19)
9. United States Judicial Panel on Multidistrict Litigation: “Transfer Order, In re Nevro Corporation Spinal Cord Stimulator Products Liability Litigation, MDL No. 3195” (link, accessed 2026-10-19)

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