Wisner Baum宣传其针对脊髓刺激器厂商的患者诉讼，质疑FDA对设备迭代监管不足

Wisner Baum's Lawsuits Challenge FDA Oversight of Spinal Cord Implants
Wisner Baum has filed state and federal lawsuits alleging spinal cord stimulators marketed as safe and effective for chronic pain caused serious injuries and failed to deliver promised relief. The cases raise broader concerns about whether repeatedly modified devices should continue to be considered truly "FDA-approved" without new clinical testing.
LOS ANGELES, July 22, 2026 /PRNewswire/ -- National law firm Wisner Baum LLP recently filed lawsuits on behalf of patients across the United States alleging that spinal cord stimulator (SCS) devices, marketed as life-changing solutions for chronic pain, have instead caused serious harm, including electric shocks, worsening pain, neurological injury and the need for multiple corrective surgeries.
The lawsuits, filed in state and federal courts, target four of the leading manufacturers of spinal cord stimulators: Abbott Laboratories, Boston Scientific, Medtronic and Nevro. Beyond the individual claims, the cases raise broader concerns about how high-risk medical devices are tested, approved and modified over time. At the center of the litigation is a spinal cord stimulator system originally approved by the U.S. Food and Drug Administration (FDA) in 2001.
"The lawsuits allege that the regulatory system is not keeping pace with these devices," said Behram Parekh, attorney at Wisner Baum. "The FDA does not have the manpower or resources to fully examine every device change, while patients are being implanted with devices that may lack sufficient evidence of effectiveness and can cause serious harm."
Allegations of Device Failures and Misrepresentation
According to the complaints, patients who received spinal cord stimulators often experienced:
- Painful electric shocks
- Loss of therapeutic effect
- Device malfunctions and shutdowns
- Infections and surgical complications
- Repeat surgeries and eventual device removal
Many patients allege they were told the devices would provide long-term pain relief, only to experience little to no benefit or new and worsening symptoms.
"Patients are often desperate for non-opioid pain relief and are told these expensive devices may change their lives," Parekh said. "Instead, many report little or no benefit, worsening pain, electric shocks and additional surgeries. That is a profound contrast between what patients believed they were receiving and what they actually experienced."
A Device That Changed Without New Testing
One of the litigation's central claims is that spinal cord stimulators approved by the FDA decades ago were modified hundreds of times without undergoing new clinical trials or full regulatory review. The lawsuits allege that manufacturers used the FDA's premarket approval (PMA) supplement process to introduce significant changes to the devices' design, such as material changes to software and firmware, battery systems, wireless and Bluetooth programming, voltage, frequencies, stimulation patterns and therapy delivery.
Despite these significant and material changes, no new efficacy or safety trials were done, and the devices were still marketed as FDA-approved, even though plaintiffs argue they were so materially different from the original version that such new trials were necessary.
"The problem is that manufacturers can submit each modification as a purportedly minor change," Parekh said. "After hundreds of those changes, the device may look and function nothing like the original product. Despite all of the cumulative changes, however, regulators never stepped back to evaluate the effect of these changes or to ask whether such a cumulative effect required new or additional testing under the law."
A Pattern of Harm Across Patients Nationwide
The cases describe a consistent pattern in which patients receive a trial implant and are encouraged to proceed with permanent implantation, then experience device failure or complications that require repeated adjustments, revision surgeries or removal.
Plaintiffs span multiple states and backgrounds, but their experiences share striking similarities. "These are not isolated complaints," Parekh said. "Patients have been reporting the same types of failures and injuries throughout the life of these products, and the manufacturers had access to those reports because most of them were made directly to the manufacturers' own sales representatives."
Attorneys say the implications extend far beyond any single product. "These lawsuits are about protecting patients who are often at their most vulnerable because they are living with chronic pain and seeking relief after exhausting every other option," Parekh said.
In questioning the FDA's heavy reliance on one-time approval, the litigation also raises broader concerns about whether current regulatory frameworks adequately protect patients when medical devices evolve over time. All four manufacturers continue to obtain new FDA approvals for their current-generation systems, and spinal cord stimulators remain a widely used treatment for difficult-to-manage chronic pain.
For example, the Australian Therapeutic Goods Administration, the country's equivalent of the FDA, conducted a post-market review of spinal cord stimulator devices. As a result, it canceled the approval of some devices and imposed stringent requirements on the rest, including revised labeling, mandatory post-market clinical follow-up studies and restrictions limiting use to specific patient populations.
"Public trust depends on medical device companies being accountable for what they sell and regulators having the resources to meaningfully review how products change over time," Parekh added. "Patients should not lose their right to seek justice simply because a device passed through an approval process that did not properly account for hundreds of later modifications."
About Wisner Baum
Wisner Baum is a nationally recognized plaintiffs' law firm with offices across the United States. For decades, the firm has represented individuals harmed by corporate misconduct, dangerous products, environmental exposure, and systemic failures. Wisner Baum is known for its trial experience, investigative rigor, and leadership in complex, high-impact litigation involving some of the world's largest companies. For more information, visit www.wisnerbaum.com.
References
- Babu, J. M., et al. (2025). Spinal cord stimulator utilization trends and predictors of trial-to-permanent implant conversion. North American Spine Society Journal, 22, 100572. https://doi.org/10.1016/j.xnsj.2025.100572
- Furia et al. v. Abbott Laboratories et al., No. 3:26-cv-01945, Complaint for damages and declaratory and injunctive relief (N.D. Cal. Mar. 6, 2026).
- Miller et al. v. Boston Scientific Corporation et al., No. 2:26-cv-05784, Complaint for damages and demand for jury trial (C.D. Cal. May 29, 2026).
- Shelp et al. v. Abbott Laboratories et al., No. 3:26-cv-02079, Complaint for damages and declaratory and injunctive relief (N.D. Cal. Mar. 10, 2026).
- Therapeutic Goods Administration. (2024, December 18). Post-market review of spinal cord stimulation devices. Australian Government Department of Health, Disability and Ageing. https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-post-market-monitoring-and-safety-updates/post-market-review-spinal-cord-stimulation-devices
- U.S. Food and Drug Administration. (2024, May 30). Abbott spinal cord stimulation (SCS) systems—P010032/S191. fda.gov/medical-devices/recently-approved-devices/abbott-spinal-cord-stimulation-scs-systems-p010032s191
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