Nevro Spinal Cord Stimulator Lawsuits Filed Over Device Malfunction, Failure

Complaints were filed just weeks after a group of individuals asked for all spinal cord stimulator lawsuits against other manufacturers to be centralized before one judge for coordinated pretrial proceedings.

Over the past couple months, a growing number of spinal cord stimulator lawsuits have been filed primarily against Abbott Laboratories and Boston Scientific over claims that the devices are defectively designed and prone to failing, making chronic pain worse.

Now, another manufacturer faces similar claims after three Nevro spinal cord stimulator lawsuits were brought in the Northern District of California simultaneously on March 23. The complaints, from Richard Lutke (PDF), J.B. Mounteer (PDF) and Anita Manley (PDF), each echo allegations raised against other manufacturers, claiming the devices are defectively designed, improperly programmed by untrained sales representatives, and falsely marketed as safe and effective.

A spinal cord stimulator (SCS) is a surgically implanted device intended to relieve chronic back pain. It consists of a battery-powered pulse generator, electrical leads placed along the spinal cord, and an external remote used to adjust stimulation, working to block pain signals before they reach the brain.

The devices first hit the market around the turn of the millennium. However, over the past two decades, the manufacturers have made major design changes, which were approved through the FDA’s fast track 510(k) approval process that only requires the implants be “substantially equivalent” to ones coming before. Plaintiffs now claim these changes to the devices were rubber-stamped by the U.S. Food and Drug Administration (FDA) without significant clinical studies.  

As a result of this allegedly flawed approval process, all three of the Nevro spinal cord stimulator lawsuits also name the FDA as a defendant, in addition to Nevro Corporation and Globus Medical Inc., saying the agency failed in its duty to ensure SCS implants were safe and effective before approving them.

Mounteer, Manley and Lutke tell very similar stories in their Nevro SCS lawsuits. They received the implants to address chronic pain, and were first given a temporary “trial” device that was supposed to test whether their conditions would be receptive to an SCS device.

All three say they reported significant pain relief from the trials, leading to the implantation of permanent Nevro SCS devices. However, the results with the permanent device were far different.

Mounteer received his Nevro SCS in September 2022, only to have the implant removed after it failed to provide relief. According to his complaint, Nevro sales representatives met with him several times to address the problem and reprogrammed the device outside of the presence of his doctor.

“Plaintiff was told by Nevro’s sales representative that the permanent device would relieve most of Plaintiff’s pain. In reality, the device caused worsening pain, avascular necrosis of both femoral heads, shocking sensations, and weakness in extremities, despite being both initially programmed by a Nevro sales representative as well as being reprogrammed after the initial programming.”

– J.B. Mounteer v. Nevro Corporation et al

The three plaintiffs say they were never made aware that the trial device would work materially differently from the actual SCS implant, and that the sales representatives oversold the benefits of the devices, in addition to making medical decisions without a license or adequate training.

According to the lawsuits, all three plaintiffs continue to suffer pain and other long-term side effects from the Nevro SCS. Manley also says she requires a foley catheter and suffered a pulmonary embolism. The health problems led to reduced mobility, the development of bedsores and overall functional decline.

The lawsuits present claims against Nevro and Globus of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment and violation of consumer protection laws, as well as another negligence per se charge for unauthorized practice of medicine. The FDA faces a claim under the Administrative Procedure Act, with plaintiffs calling for injunctive and declaratory relief.

Spinal Cord Stimulator Lawsuits

Before the filing of the three Nevro SCS lawsuits, a group of plaintiffs called for all similar claims involving Abbott and Boston Scientific devices to be consolidated before one federal judge for coordinated pretrial proceedings in the Northern District of Illinois.

It is unclear how lawsuits being filed against a third manufacturer will affect the plaintiffs’ motion for consolidation, or the U.S. Judicial Panel on Multidistrict Litigation’s (JPML) decision on whether to consolidate them.

If consolidation is granted, it is also uncertain whether Nevro claims will be included alongside those involving Abbott and Boston Scientific.

As additional claims continue to be filed, spinal cord stimulator lawyers are investigating new cases for individuals who had an SCS implanted and later experienced serious complications such as:

• Electrical shocks or burning sensations linked to stimulation or device wiring
• Device migration or lead movement after implantation
• Tissue burns or localized injury near leads or the generator
• Neurological symptoms associated with lead position or electrical output
• Revision surgery or planned explant surgery due to device complications

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