Spinal Cord Stimulator Lawsuits: Are Defective Devices Causing Severe Injuries?

Spinal cord stimulators (SCS) are implanted medical devices designed to manage chronic pain by interrupting pain signals before they reach the brain. While intended to improve the quality of life for individuals with severe, persistent pain, a growing number of lawsuits allege that defective spinal cord stimulators are causing severe injuries. According to the FDA, over 80,000 adverse event reports related to SCS devices have been filed since 2008, including nearly 500 deaths. This raises serious questions about the safety and efficacy of these devices, and whether manufacturers are adequately warning patients about the potential risks.

What is a Spinal Cord Stimulator?

A spinal cord stimulator is a small device implanted in the back, near the spinal cord. It delivers mild electrical impulses to block pain signals from reaching the brain. SCS is often recommended when other pain management treatments, such as medication and physical therapy, have failed. The device consists of:

Electrodes: These are thin wires placed near the spinal cord to deliver electrical impulses.
Pulse Generator: This is a small, battery-powered device implanted under the skin, usually in the abdomen or buttocks, that generates the electrical impulses.
Remote Control: Patients can use a remote control to adjust the intensity and frequency of the electrical stimulation.

Allegations of Defective Design and Inadequate Warnings

Spinal Cord Stimulator Lawsuit claims allege that these devices are defectively designed and improperly marketed without adequate warnings, leading to severe injuries for patients. Lawsuits claim that manufacturers failed to conduct adequate safety testing and to provide necessary warnings, leaving patients vulnerable to severe and often life-altering injuries. Device makers cited in the spinal cord stimulator lawsuit include Boston Scientific, Medtronic, Abbott/St. Jude, and Nevro.

Common Injuries and Complications

While spinal cord stimulators can provide pain relief for some, their use also involves significant risks. Approximately 30% to 40% of patients experience complications from their implanted spinal cord stimulators. Common injuries and complications associated with defective spinal cord stimulators include:

Infection: The implantation procedure carries a risk of infection at the surgical site, which can lead to serious complications if not promptly addressed.
Device Migration and Malfunction: Issues such as lead migration (movement of the electrodes), hardware failure, or battery problems can occur, potentially diminishing the device’s effectiveness or causing discomfort. Lead migration is the most common complication of SCS.
Neurological Complications: Improper placement or movement of the device can result in nerve damage, leading to symptoms like weakness, numbness, or even paralysis. Incorrect placement or malfunctioning devices can cause nerve injuries, resulting in symptoms like numbness, tingling, or loss of function.
Electric Shocks and Burns: Defective batteries that prematurely drain, overheat, or fail to recharge can trigger painful shocks or require urgent device removal.
Increased Pain: Some patients report increased pain or discomfort due to device malfunction, leading to overstimulation and injury to nearby nerves or soft tissues.
Long-Term Health Risks: Chronic inflammation, scar tissue formation, spinal cord compression, and permanent disabilities.

Legal Recourse for Victims

Patients who have experienced complications from defective spinal cord stimulators may be eligible to file a lawsuit against the manufacturers. These lawsuits seek compensation for medical costs, emotional distress, and other damages, aiming to hold manufacturers accountable for the harm caused by these devices. Potential damages in Spinal Cord Stimulator Lawsuits may include:

Medical expenses (past and future)
Lost wages
Pain and suffering
Emotional distress
Punitive damages (in some cases)

FDA Oversight and Recalls

The U.S. Food and Drug Administration (FDA) has documented a high number of adverse event reports related to spinal cord stimulators, raising concerns about their safety and the adequacy of pre-market evaluations. Since 2010, the FDA has issued more than 40 recalls of spinal cord stimulation devices due to safety concerns, including devices made by Abbott Medical, Boston Scientific, Nuvectra, and Medtronic. Reasons for spinal cord stimulator recalls have included:

Battery problems
Connection issues
Device fractures
Device migrations
Overheating
Power failures
Therapy delivered to the wrong area of the body

A newly filed lawsuit names the U.S. Food and Drug Administration (FDA) as a defendant alongside major medical device manufacturers over alleged defects in spinal cord stimulators. Plaintiffs claim the devices caused severe injuries including nerve damage, electric shocks, and worsening chronic pain. The complaint accuses the FDA of improperly allowing device modifications without adequate safety testing or warnings, using the Premarket Approval (PMA) supplement process to bypass rigorous review.

Spinal Cord Stimulator Settlements and Verdicts

The spinal cord stimulator lawsuits are still in their early stages in civil state court; however, some victims have received compensation. For example, a New Jersey man won a $1.25 million settlement in 2024 after his spinal cord stimulator compressed his spinal column and significantly worsened his pain and mobility challenges. According to an analysis in the journal Interventional Pain Medicine, the average settlement for people hurt by spinal cord stimulators (SCS) was $1.9 million.

Do You Qualify for a Spinal Cord Stimulator Lawsuit?

If you or a loved one has suffered injuries or complications from a spinal cord stimulator, you may be entitled to seek compensation for medical expenses, pain, and the impact on your quality of life. You may be able to file a spinal cord stimulator lawsuit if you or a loved one:

Had a spinal cord stimulator implanted.
Experienced serious health complications linked to the device.
Underwent or plan to undergo surgery to remove the device.

Finding Legal Representation

If you’ve suffered injuries due to a spinal cord stimulator device, or your loved one has tragically passed away as a result of a spinal cord stimulator operation, you may be eligible to file a Spinal Cord Stimulator Lawsuit and seek compensation. Law firms specializing in medical device lawsuits and medical malpractice cases are investigating claims from individuals who have been impacted by these devices. An experienced attorney can help you navigate the complex legal process and maximize your chances of a successful outcome.

Seeking Justice and Compensation

Spinal cord stimulators, intended to provide pain relief, have left some patients facing severe complications that worsen their condition and quality of life. For some, device-related issues have led to irreversible damage and, tragically, even death. If you or a loved one has experienced severe complications or injuries, or if you’ve lost someone due to a spinal cord stimulator, you may be eligible to pursue a legal claim to seek justice and compensation. Contact a law firm today for a free consultation to discuss your case and explore your legal options.