Patients across the U.S. have filed lawsuits in federal court against Abbott Laboratories, Boston Scientific, Medtronic and Nevro alleging spinal cord stimulator devices caused injuries including electric shocks, worsening pain, neurological injury and repeated corrective surgeries.
The lawsuits, filed in state and federal courts, center on a spinal cord stimulator system originally approved by the FDA in 2001. Plaintiffs allege manufacturers made hundreds of modifications to the devices’ software, firmware, battery systems and stimulation settings through the FDA’s premarket approval supplement process, without new clinical trials or full regulatory review.
Three of the complaints were filed in federal court: Furia v. Abbott Laboratories and Shelp v. Abbott Laboratories were filed in the U.S. District Court for the Northern District of California, and Miller v. Boston Scientific was filed in the U.S. District Court for the Central District of California; Becker’s reviewed the lawsuits.
The lawsuits claim patients experienced device malfunctions, infections, loss of pain relief and additional surgeries to revise or remove the implants.
A Boston Scientific spokesperson declined to comment on the allegations, stating: “Because this is an active legal matter, we intend to address this matter through the appropriate legal process and do not have further comment.”
In a statement shared with Becker’s, an Abbott spokesperson said the company stands behind the safety, quality and performance of its spinal cord stimulation systems. The spokesperson said the devices have been approved and updated in accordance with federal law through the FDA’s premarket approval and supplement processes, and that Abbott “strongly disagree[s] with the allegations in this lawsuit” and believes they are “without merit.”
Becker’s has reached out to Medtronic and Nevro for comment and will update this story if more information becomes available.
The cases are part of a growing body of spinal cord stimulator litigation. In June, the Judicial Panel on Multidistrict Litigation consolidated Boston Scientific spinal cord stimulator cases into a single MDL in the Central District of California. The panel declined to create an industrywide MDL, finding the claims against Abbott, Medtronic and Nevro involve different devices and regulatory histories.
All four manufacturers continue to receive new FDA approvals for their current-generation systems, and spinal cord stimulators remain a widely used treatment for chronic pain. Wisner Baum said in a July 22 news release the lawsuits seek to hold manufacturers accountable and raise broader questions about oversight of medical devices.
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