Nevro Spinal Cord Stimulator Lawsuits

Nevro received FDA approval for the Senza spinal cord stimulator system (SCS) providing HF10 therapy in May 2015. This system was different from conventional stimulators because it was designed to provide electrical pulses at a much higher frequency directly to the spinal cord. The Nevro spinal cord stimulator (SCS) lawsuits claim that specific Senza, HF10, and HFX systems don’t offer the pain relief they promise and cause significant complications. These lawsuits allege there were inadequate warnings, manufacturing defects, misrepresentations, improper device programming, and post-market reporting failures. Plaintiffs claim that changes made through the FDA’s premarket approval supplements changed the components of the device with inadequate clinical validation and disclosure. Plaintiffs requested centralization of the lawsuits. In June, an industry-wide multidistrict litigation was denied, but on October 2, 20 lawsuits against Nevro were centralized. If you were injured by a Nevro spinal cord stimulator, call the seasoned Chicago-based product liability lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

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The Nevro HF10, later called the HFX, which is a 10kHz high frequency therapy, was marketed as being better than traditional SCS therapy for back and leg pain because the HF10 didn’t cause paresthesia (abnormal skin sensations) the way the traditional therapy did. In July 2021, the FDA expanded its approval for the device to treat diabetic neuropathy. Later the indications were expanded to include refractory back pain and chronic neuropathy, and then even further expanded to treat leg pain, low back pain, and management of failed back surgery syndrome. Eventually various lawsuits were filed against Nevro because of problems that allegedly arose in connection with use of Senza, HF10, and HFX systems.

In one product liability lawsuit filed in a federal court in Ohio, the plaintiff alleged that two Nevro spinal cord stimulators didn’t offer the necessary relief and instead caused permanent nerve damage, weakness, numbness, electrical shocks and burning pain. It also alleged that Nevro representatives claimed the problems were the result of programming and sometimes adjusted the devices without a treating doctor present.

In another lawsuit filed in federal court in California in March, it was alleged that a permanently implanted Nevro spinal cord stimulator didn’t relieve the plaintiff’s chronic pain and instead resulted in numbness, muscle weakness, increased pain, urinary incontinence, blood clots and other injuries. The plaintiff also alleged that Nevro failed to properly disclose known or foreseeable risks of the device.

Under the October 2 Judicial Panel on Multidistrict Litigation order, the Nevro spinal cord stimulator cases were centralized under Judge Haywood S. Gilliam of the Northern District of California. The Nevro cases involve the Senza family of systems and HFX. The plaintiffs in these cases allege lead migration and fracture, battery and charging failures, unwanted stimulation and shocks, and need for revision surgery. Nevro is owned by Globus Medical.

Nevro opposed the centralization in August, claiming that the lawsuits didn’t have enough common questions about the defects and injuries to justify the coordination of the proceedings. The Panel disagreed reasoning that there was a single defendant, a single product family, and a single design and regulatory file.

Discuss Your Injuries With a Product Liability Attorney

If you were injured by a Nevro spinal cord stimulator, please call the experienced Chicago-based product liability lawyers of Moll Law Group to find out whether you have a viable claim. Complete our online form or call us at 312.462.1700.