ST. LOUIS — A Georgia woman has filed a federal lawsuit against Abbott Laboratories alleging that an implanted spinal cord stimulator failed to provide the promised treatment for chronic pain, caused painful electrical shocks and other complications, and ultimately required surgical removal.
Toni Ford filed the compaint September 18 in U.S. District Court for the Eastern District of Missouri.
The case alleges product liability and administrative law claims against Abbott Laboratories involving a Proclaim XR5 spinal cord stimulation system.
According to the complaint, Ford is a Georgia resident, while Abbott is an Illinois corporation with its principal place of business in Lake County, Ill.
The lawsuit states that the court has jurisdiction because the parties are citizens of different states and the amount in controversy exceeds $75,000.
Ford alleges she was surgically implanted with the Abbott Proclaim XR5 spinal cord stimulator on or about Sept. 15, 2023, after first undergoing a temporary external trial of an SCS system.
The complaint says Abbott sales representatives identified as Kelly and Kyle, whose last names were not provided, told Ford the permanent device would provide long-term pain relief, was safe and supported by clinical validation, would be functionally equivalent to the trial system and would reduce her need for other chronic-pain treatment.
Ford alleges she relied on those representations when deciding to proceed with permanent implantation.
The complaint alleges the implanted system failed shortly after surgery. Ford says she underwent another surgical procedure on Sept. 22, 2023, to remove the SCS system because of mechanical and therapeutic failure, including loss of therapeutic effectiveness and severe shocking.
She alleges she continues to experience pain and symptoms associated with the malfunctioning system. The complaint further alleges she suffered physical injury, worsening pain, emotional distress, medical expenses and diminished quality of life.
A central allegation in the lawsuit concerns the regulatory history of the spinal cord stimulator.
The complaint states that the device was originally approved by the Food and Drug Administration in 2001 under PMA P010032 for Advanced Neuromodulation Systems, which was later acquired by St. Jude Medical and ultimately became part of Abbott's SCS portfolio following Abbott's 2017 acquisition of St. Jude Medical.
Ford alleges that the original system was substantially changed over time through more than 230, and in other portions of the complaint nearly 250, PMA supplements involving firmware, waveform architecture, battery design, wireless communication, user interfaces and other components.
The complaint alleges those cumulative changes materially altered the device's safety and performance without a new PMA or new clinical testing of the final marketed system. It identifies numerous supplements and regulatory actions dating from 2009 through 2024, including changes involving the Proclaim XR5, Proclaim XR5 Mini, Proclaim IPG family and Proclaim SCS family.
The filing alleges the changes affected the device's stimulation effects, safety controls, battery stability and susceptibility to failure.
Ford's complaint also points to recalls involving Abbott's Proclaim-series devices. It alleges that on Sept. 11, 2023, the FDA classified five recalls of Proclaim-series spinal cord stimulation devices as Class I recalls.
The complaint says those recalls followed reports of painful electrical shocks, sudden device shutdowns and failures to provide therapeutic stimulation. It further alleges that Abbott initiated a recall of the Proclaim 5 Elite SCS pulse generator on May 16, 2024, because of a product-labeling defect.
The lawsuit alleges that the Proclaim XR5 implanted in Ford incorporated features that were not part of the original 2001 device, including firmware-dependent controls, Bluetooth-based smartphone programming and burst and high-frequency stimulation patterns.
Ford alleges she was not told that the device differed materially from the original system or that it had undergone the changes described in the complaint.
The filing also alleges that Abbott did not adequately disclose risks involving stimulation failure, lead migration, charging errors, nerve damage and device failure.
The complaint asserts eight causes of action against Abbott, including strict products liability based on an alleged manufacturing defect, failure to warn, negligence per se based on alleged federal regulatory violations, breach of express warranty, breach of implied warranty of merchantability and fitness for a particular purpose, negligence, negligent misrepresentation and fraudulent concealment.
Ford alleges Abbott failed to comply with various federal requirements involving device changes, adverse-event reporting, design validation, manufacturing-process validation, complaint investigations, corrective and preventive actions and labeling updates.
Ford also alleges Abbott represented that its spinal cord stimulation systems were safe and effective for long-term treatment of chronic pain, had been adequately tested, were FDA-approved and clinically validated, and provided reliable therapy and wireless programming.
The complaint alleges those representations were misleading because the Proclaim XR5 had not been clinically validated in its final marketed form and because of the changes and adverse events described in the filing.
The fraudulent-concealment claim alleges Abbott had access to adverse-event reports and internal product complaint information and failed to disclose information concerning alleged design and firmware changes, therapy interruptions, device shutdowns during charging and unintended stimulation. Ford alleges those issues were associated with recalls, including the Class I recalls described in the complaint.
Ford is seeking compensatory damages to be determined at trial for physical injuries, pain and suffering, emotional distress, medical expenses, loss of enjoyment of life and other damages. She is represented by Adam M. Evans of the Carlson Law Firm.
U.S. District Court for the Eastern District of Missouri case number: 1:26-cv-00213
