ST. LOUIS — A woman and her husband are suing Nevro Corporation alleging injuries due to a spinal cord stimulator she had implanted in her body.
Nevro’s spinal cord stimulator products, specifically the Omnia SCS, are designed to treat chronic and intractable pain by modulating electrical pain signals through electrical impulses delivered to the spinal cord, according to a complaint filed Sept. 17 in U.S. District Court for the Western District of Missouri.
Rhonda Vossmer and Michael Wersching claim the device consists of an Implantable Pulse Generator (IPG) and lead wires, which are implanted along the spinal cord.
The IPG, powered by a rechargeable lithium-ion battery, uses a current source to stimulate the spinal cord via the connected leads, according to the suit.
However, Nevro’s Omnia SCS has been linked to significant adverse effects, including overstimulation of the vagus nerve, which controls various bodily functions such as cardiac rhythm and bladder function, which can lead to complications like dysmotility, syncope, arrhythmias and incontinence.
The overstimulation may also cause permanent damage, a process known as nociception, the complaint states.
The plaintiffs allege that despite being aware of these risks, Nevro has failed to adequately warn patients or healthcare providers, unlike other manufacturers of similar devices.
Nevro's aggressive and deceptive sales practices have also been scrutinized, the complaint states.
The plaintiffs claim sales representatives who lack proper medical training, are also accused of misleading patients and healthcare providers during trial stimulation periods, encouraging the implantation of permanent SCS devices.
The misleading practices reportedly include failing to disclose that trial devices differ from permanent ones and that a significant percentage of permanent devices are eventually explanted due to failure.
"The false or misleading representations were knowingly made in connection with the sale, lease, rental or loan of goods or services," the complaint states. "The wrongful conduct described herein occurred in the regular course of the Defendant’s trade or commerce."
Nevro has also been accused of concealing complications, such as chronic pain and new onset pain syndromes, from patients.
Vossmer underwent implantation of the Omnia SCS after trial stimulation in March 2022 and while the trial device reduced the plaintiff’s lower back pain, the permanent device caused severe complications, including increased pain and gastrointestinal issues.
The plaintiff experienced esophageal dysmotility, nausea, vomiting and chest pain, which led to a diagnosis of gastroparesis caused by vagus nerve damage.
Despite attempts to seek therapeutic modifications, the plaintiff’s complaints were dismissed, and the complications persisted even after the device was removed in June 2023.
The plaintiff continues to suffer from pain, incontinence and complications arising from the device’s removal, including infection and sepsis.
The plaintiff alleges that Nevro's failure to warn healthcare providers and patients about the true risks associated with the Omnia SCS led to her injuries.
"As a result of Defendant’s conduct, Plaintiff has suffered ascertainable loss that can be calculated with a reasonable degree of certainty," the complaint states.
The plaintiffs are seeking compensatory and punitive damages. They are represented by Adam M. Evans of Dickerson Oxton in Kansas City, Mo.
The plaintiffs' attorney did not respond to requests for comment.
U.S. District Court for the Western District of Missouri case number: 4:24-cv-00607