Spinal Cord Stimulator Lawsuit Update: Are Defective Devices Causing More Harm Than Good?

Chronic pain affects millions, significantly impacting their quality of life. Spinal cord stimulators (SCS) have emerged as a promising solution, offering a chance to regain control over relentless pain. However, recent reports and a surge in lawsuits suggest that these devices, intended to improve lives, may be causing more harm than good for some patients. According to the FDA, over 80,000 adverse event reports related to SCS devices have been filed since 2008, including nearly 500 deaths. This article delves into the growing concerns surrounding spinal cord stimulators, exploring the potential defects, the resulting injuries, and the legal avenues available to those affected.

What is a Spinal Cord Stimulator?

A spinal cord stimulator is a medical device implanted in the lower back to manage chronic pain. It works by delivering mild electrical pulses to the spinal cord, disrupting pain signals before they reach the brain. The device consists of a small pulse generator and electrodes (leads) placed near the spinal cord. While SCS can be an effective treatment option for some, offering a less invasive alternative to opioids, it’s not without its risks.

The Promise and the Peril

Spinal cord stimulators are typically recommended when other pain management treatments, such as medication and physical therapy, have failed. The goal is to improve the patient’s quality of life by reducing chronic pain and increasing functionality. However, a significant percentage of patients, approximately 30% to 40%, experience complications. These complications can range from mild to severe, requiring additional surgeries and causing further distress.

Common Complications and Injuries

Lawsuits against SCS manufacturers often cite a range of complications and injuries, including:

Device Malfunction: The device may stop working correctly due to broken or migrated leads, battery failure, or other technical issues.
Lead Migration: The leads can move from their intended position, impacting the device’s effectiveness and potentially requiring corrective surgery.
Infection: Infection at the surgical site is a significant risk, sometimes necessitating device removal.
Nerve Damage: Incorrect placement or device malfunction can cause nerve injuries, leading to numbness, tingling, or loss of function.
Electric Shocks and Burning Sensations: Device malfunction or lead migration can cause unintended and painful electric shocks or burning sensations.
Pain and Overstimulation: Some patients report increased pain or discomfort due to device malfunction, leading to overstimulation and injury to nearby nerves or soft tissues.
Neurological Deficits: In rare cases, patients may experience neurological side effects like numbness or even paralysis due to issues like epidural hematoma or nerve damage during insertion.
Urinary Incontinence: Some patients have experienced urinary incontinence or retention as a result of complications from the device.
Gastroparesis and Dysphagia: Some patients have experienced gastroparesis and dysphagia as a result of complications from the device.
Cardiac Arrhythmia: Some patients have experienced cardiac arrhythmia as a result of complications from the device.

The Legal Landscape: Spinal Cord Stimulator Lawsuits

The rising number of adverse event reports and complications has led to a surge in spinal cord stimulator lawsuits. These lawsuits typically allege that the devices are defectively designed, manufactured, or marketed without adequate warnings about the potential risks.

Common Allegations in SCS Lawsuits:

Defective Design: The design of the SCS device is inherently flawed, making it prone to malfunction or failure.
Manufacturing Defects: Errors during the manufacturing process lead to defects that cause the device to fail or cause injury.
Failure to Warn: Manufacturers fail to adequately warn patients and healthcare providers about the potential risks and complications associated with the device.
Negligence: Manufacturers were negligent in the design, testing, and marketing of the SCS device.

Who is Being Sued?

Lawsuits have been filed against several major SCS manufacturers, including:

Abbott (formerly St. Jude Medical)
Medtronic
Boston Scientific
Nevro

These companies face allegations that their devices caused serious injuries due to design flaws, manufacturing defects, or inadequate warnings.

What Compensation Can Be Recovered?

Plaintiffs in spinal cord stimulator lawsuits may be able to recover compensation for a variety of damages, including:

Medical Expenses: Costs related to surgeries, hospital stays, medications, and ongoing treatments.
Lost Wages: Income lost due to time away from work during recovery or inability to return to employment.
Pain and Suffering: Compensation for the physical pain and emotional distress caused by the injury and its long-term impact.
Permanent Injuries: Damages for lasting complications, such as nerve damage, scarring, or chronic pain.
Punitive Damages: In some cases, punitive damages may be awarded to punish the manufacturer for egregious conduct.

Settlement amounts for spinal cord stimulator cases can vary widely, depending on the severity of the injuries, the extent of medical expenses, and other factors. Settlements typically range from $275,000 to $600,000, but can exceed $1,000,000 in cases involving severe injuries or manufacturer misconduct.

The FDA’s Role and Regulatory Concerns

The FDA has received numerous adverse event reports related to spinal cord stimulators, raising concerns about their safety and the adequacy of pre-market evaluations. Some lawsuits also name the FDA as a defendant, alleging that the agency allowed devices to be marketed without adequate safety testing. Public Citizen and other organizations have criticized the FDA for “dangerously lax oversight” of high-risk implantable medical devices, including SCSs. They have called for stricter premarket approval processes and reclassification of SCS devices into a higher-risk category.

What to Do If You’ve Been Injured

If you have experienced complications or injuries after receiving a spinal cord stimulator implant, it’s crucial to take the following steps:

Seek Medical Attention: Consult with your doctor to address any complications or injuries you are experiencing.
Gather Medical Records: Collect all relevant medical records, including pre-op records, surgical records, and post-op records.
Contact a Lawyer: Speak with an experienced personal injury attorney who specializes in defective medical device lawsuits.

Conclusion

Spinal cord stimulators offer hope for chronic pain relief, but the increasing reports of complications and injuries raise serious questions about their safety and effectiveness. If you or a loved one has been harmed by a defective spinal cord stimulator, it’s essential to understand your legal rights and options. Consulting with a qualified attorney can help you navigate the complex legal landscape and pursue the compensation you deserve.