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

Chronic pain affects millions, significantly impacting their quality of life. Spinal cord stimulators (SCS) offer a beacon of hope for many seeking relief. However, instead of alleviating suffering, some patients experience severe injuries due to defective devices. 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 critical questions about the safety and efficacy of these devices, prompting a surge in spinal cord stimulator lawsuits.

What is Spinal Cord Stimulation?

Spinal cord stimulators are implantable medical devices designed to manage chronic pain. They work by delivering low-level electrical impulses to the spinal cord, interrupting pain signals before they reach the brain. This technology aims to improve the quality of life for individuals with severe, persistent pain, often recommended when other treatments have failed. More than 30,000 people undergo SCS implantation annually.

The Promise and the Peril

When SCS devices function correctly, they can significantly reduce pain and improve a patient’s ability to perform daily activities. Studies show that about half of people see more than a 50% improvement in their pain. They can also help patients reduce their reliance on opioid painkillers, which often come with unwanted side effects. However, the reality isn’t always so positive.

Unfortunately, some spinal cord stimulator devices have been linked to severe injuries, defective performance, and complications stemming from medical malpractice or product defects. A recent investigation revealed over 500 serious complications linked to these devices, many of which were life-threatening.

Common Complications and Injuries

Several types of complications and injuries have been reported in connection with spinal cord stimulators:

Infection: As SCS implantation involves placing a device inside the body, there’s always a risk of infection. Infections can occur at the surgical site or around the implanted hardware, sometimes requiring surgery to treat or even remove the device entirely. The most common pathogens causing surgical site infections are gram-positive cocci (streptococcus, staphylococcus, and enterococcus spp.).
Lead Migration: This is one of the most common mechanical complications. The leads, or wires, that deliver electrical impulses can move from their intended location. If the leads (the implants) move, the tingling sensation caused by your stimulator (often called paresthesias) will shift to a different part of the body. This often reduces your device’s ability to control your pain, so it will feel more severe. Lead migration rates vary throughout the literature, ranging from 2.1% to 27%.
Device Malfunction: Spinal cord stimulators rely on a pulse generator that has a lifespan. Pulse generator batteries typically need replacement after several years. The generators themselves can also fail, and repairing or replacing them involves surgery.
Neurological Damage: Incorrect placement or migration of the device can cause nerve damage, resulting in symptoms like numbness, tingling, weakness, or even paralysis.
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.
Allergic Reactions: Some patients may experience allergic reactions to the materials used in the device, resulting in skin irritation or other systemic responses.

Legal Recourse: Spinal Cord Stimulator Lawsuits

When spinal cord stimulators fail, whether due to a design flaw, manufacturing defect, or improper implantation, patients may suffer significant harm. In such cases, they may be eligible to file a spinal cord stimulator lawsuit against the device manufacturer or the healthcare provider responsible for the implantation.

Grounds for a Lawsuit:

Product Liability: SCS manufacturers are accused of producing and distributing defective medical devices that have caused significant harm to patients.
Negligence: The class action alleges that the manufacturers failed to properly test and ensure the safety of their products before distribution.
Failure to Warn: The manufacturers are accused of not adequately warning patients and medical practitioners about the risks involved with SCS implants.
Breach of Australian Consumer Law: There are claims that the SCS devices do not meet quality standards and that manufacturers engage in misleading conduct.

Damages Recoverable:

In Spinal Cord Stimulator injury claims, damages aim to address both the financial and non-financial impacts of the injuries, helping victims recover from the consequences of faulty devices. These claims seek to cover not only direct costs, like medical bills, but also the broader effects on a person’s quality of life, earning capacity, and emotional well-being. Potential damages in Spinal Cord Stimulator Lawsuits may include:

Medical expenses (past, present, and future)
Lost wages
Pain and suffering
Emotional distress
Cost of replacement or removal of the device
Punitive damages (in some cases)

The Abbott Recall

In July 2023, Abbott initiated a recall of its Proclaim and Infinity neurostimulation systems due to issues with patients being unable to exit MRI mode, effectively locking devices in a state where therapy delivery is disabled. The FDA subsequently categorized this as a Class I recall, its most serious designation, indicating a situation where using the affected devices may cause serious injuries or death. The Class I recall classification by the FDA highlights the serious nature of the defect, which has already resulted in 73 reported injuries among the 155,028 affected devices distributed in the U.S. from 2015 to 2023.

Other Manufacturers Involved

While the current recall focuses on Abbott’s devices, it’s worth noting that other manufacturers have faced similar issues with neurostimulation technology:

Medtronic: Has faced litigation regarding its spinal cord stimulator systems, including allegations of device migration, lead breakage, and battery failures.
Boston Scientific: Previous lawsuits have involved claims of defective leads and unexpected battery depletion in their neurostimulation systems.
Nevro Corp: Has dealt with legal challenges related to their Senza system, including allegations of inadequate warnings about potential complications.

What to Do If You’ve Been Injured

If you or a loved one has suffered injuries or complications from a spinal cord stimulator, it’s essential to take the following steps:

Seek Medical Attention: Get prompt medical care to address any complications or injuries.
Document Everything: Keep detailed records of your medical treatments, expenses, and the impact of the injuries on your life.
Consult with a Lawyer: Contact a personal injury attorney experienced in medical device litigation to discuss your legal options.
Gather Evidence: Collect all relevant documents, including medical records, device information, and correspondence with manufacturers or healthcare providers.

The Future of Spinal Cord Stimulation

Spinal cord stimulation can be a life-changing treatment for chronic pain when it works as intended. However, the risks associated with defective devices cannot be ignored. As technology advances, manufacturers must prioritize patient safety and ensure their devices are thoroughly tested and properly marketed. Until then, spinal cord stimulator lawsuits will continue to play a crucial role in holding manufacturers accountable and protecting the rights of injured patients.

If you’ve experienced complications with a spinal cord stimulator, you may be entitled to compensation. Contact our firm today for a free consultation to discuss your case and explore your legal options.