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Every spinal cord stimulator case now has a threshold preemption fight, and as of October 2 the answer to that fight depends on which company made the device — not on where the patient lives, was implanted, or filed. That is the practical consequence of the JPML's two new transfer orders, and it has gone unremarked in a week of coverage that has mostly counted the MDLs rather than located them. MDLDefendantTransferee courtJudgeCircuitCreated3181Boston ScientificC.D. Cal.Josephine L. StatonNinthJune 5, 20263194AbbottN.D. Ill.Lindsay C. JenkinsSeventhOct. 2, 20263195Nevro / GlobusN.D. Cal.Haywood S. Gilliam, Jr.NinthOct. 2, 2026 Both October orders were signed by Chair Karen K. Caldwell; Judge M. Casey Rodgers took no part in either. The Panel said preemption was the shared work, then split the forum The Abbott order is explicit. Centralization will "eliminate duplicative discovery; streamline briefing and prevent inconsistent pretrial rulings, particularly concerning Abbott's preemption defenses." The Nevro order says the same about Nevro's. Several parties asked the Panel to send the new MDLs to Judge Staton, who already has the Boston Scientific litigation. It declined: "Little efficiency will be gained by placing SCS device MDLs against multiple manufacturers before one judge," adding that "while the Abbott SCS cases and the...

On September 3, the FDA published a consumer-facing recall notice for an action it had already classified a month earlier: Boston Scientific Neuromodulation's removal of the Infinion™ CX spinal cord stimulator lead. Trade press picked it up the next day, most of it leading with a single number, 1,081 serious injuries, and going no further. The injury count is the least useful thing in the record. Two other fields do more work, and neither has been quoted anywhere I can find. What the recall record actually says The underlying entry is Recall Z-2879-2026, recall event 98974, classified Class I, the category reserved for defects that may cause serious injury or death. It covers all unused Infinion CX Lead Kits, models SC-2317-50 and SC-2317-70, 1,079 units in commerce. Domestic distribution is recorded as New York; the action also reaches eighteen other countries. Boston Scientific initiated it on June 17 and the FDA posted it on August 5, which means the classification had been sitting on the agency's site for four weeks before the consumer notice drew anyone's attention to it. The manufacturer's stated reason, verbatim from the recall record, is that the lead body "may be exposed to stress at the...

By Matthew T. Marin, Marin & Murphy Law Firm — with Morgan Green, Law Student Co-Author Permission to republish: this article may be reproduced in full, in any medium, provided authorship is attributed to the authors and Marin & Murphy Law Firm, all hyperlinks are preserved, and the original source is cited as this page. Summary of the Analysis General causation is not the contested ground in Olympus duodenoscope litigation. Specific causation is. This article proposes a two-axis screen — the interval-and-era screen — for evaluating these claims: the elapsed time between the ERCP and the documented infection, and the generation of the device and reprocessing regime in force when the procedure was performed. The second axis is the one most analyses omit, and the assumption buried in that omission is that the duodenoscope contamination problem was engineered out with the disposable-endcap redesign in 2020. The FDA record does not support that assumption. As of the most recent agency data, four FDA-classified corrective actions on Olympus duodenoscopes remain open, the most recent initiated October 14, 2025, on the redesigned model — with FDA recording the trigger as “continued reports of positive cultures and infections” and the cause as “device design.”...