(Legal Newsline) – A Missouri woman has filed a federal lawsuit alleging that a Nevro spinal cord stimulation device implanted to treat chronic back pain malfunctioned, caused serious and lasting injuries and was marketed without adequate warnings.
The plaintiff, Danielle Rivera, also alleges the U.S. Food and Drug Administration improperly approved the device and its subsequent modifications.
Rivera filed the complaint on June 29 in U.S. District Court for the Western District of Missouri against Nevro Corp., its parent company Globus Medical Inc. and the FDA.
The lawsuit centers on the Nevro HFX Senza Omnia spinal cord stimulation system, an implantable device designed to manage chronic pain through electrical stimulation of the spinal cord.
Rivera contends the device was defectively designed and manufactured, that federal reporting and quality-control requirements were violated and that she suffered permanent injuries as a result.
According to the complaint, Rivera underwent implantation of a permanent Nevro Senza Omnia spinal cord stimulator on or about April 7, 2021, after first experiencing pain relief from a temporary trial stimulation device.
She alleges Nevro sales representatives made numerous representations during the evaluation process, including that the permanent implant would provide equal or better pain relief than the trial device, would allow her to resume normal daily activities, would last approximately 10 years without issues and was safe for use.
The complaint also alleges that representatives stated they would remain available to adjust the device as needed.
The lawsuit alleges Rivera decided to proceed with the permanent implant based on both the success of the trial device and those representations.
It further claims important information was omitted, including alleged risks associated with the permanent device, reports of complications experienced by other patients and alleged limitations involving the device and certain components.
Rivera alleges that the stimulator initially functioned as expected but that by July 16, 2021, she began experiencing dizziness and lower-leg pain that affected her balance, causing her to fall down a flight of stairs.
According to the complaint, the device no longer provided the advertised pain relief despite more than 10 reprogramming attempts.
She further alleges that by April 2022, the stimulator worsened her pain, producing discomfort that radiated from the base of her skull into her neck and shoulders, prompting her to turn the device off frequently.
The complaint also states she later developed gastrointestinal symptoms and was diagnosed with gastroparesis in December 2022.
Rivera ultimately had the spinal cord stimulator removed on March 1, 2023, after continued unsuccessful reprogramming efforts and worsening side effects, according to the filing.
The complaint accuses Nevro of violating federal quality system regulations, current good manufacturing practices, post-market surveillance requirements and adverse event reporting obligations.
Rivera alleges the company failed to investigate and report device malfunctions and serious adverse events properly, failed to adequately warn physicians and patients of known risks and improperly marketed the device as safe and effective beyond statements approved by the FDA.
The lawsuit also alleges Nevro permitted unlicensed sales representatives to adjust implanted devices or direct patients in adjusting settings, which Rivera contends constituted reckless conduct under state law.
The complaint further alleges Rivera’s implanted device exceeded a required electrical impedance performance standard and claims Nevro distributed devices that did not conform to federally approved manufacturing specifications.
Rivera contends the company failed to establish and maintain adequate procedures for design validation, quality control, corrective action and post-market monitoring despite receiving reports of injuries associated with the devices.
In addition to claims against Nevro and Globus Medical, the lawsuit includes claims against the FDA under the Administrative Procedure Act.
Rivera alleges the agency acted unlawfully by approving the original premarket approval application and subsequent modifications to the spinal cord stimulator system without requiring sufficient independent clinical validation or new approval applications for substantial design changes.
The complaint seeks declaratory and injunctive relief requiring the FDA to reconsider or suspend approvals for certain spinal cord stimulation systems if appropriate.
Rivera seeks compensatory damages for alleged pain and suffering, emotional distress, disfigurement, medical expenses, lost wages and other losses, along with punitive damages, attorney fees, costs, interest and any additional relief the court deems appropriate. She is represented by Adam Evans and Elijah Biedinger of the Carlson Law Firm in Killeen, Texas.
U.S. District Court for the Western District of Missouri case number: 4:26-cv-00563
