Spinal Cord Stimulator Lawsuit | 2025 Latest Updates

Spinal Cord Stimulator Lawsuit Overview

Spinal cord stimulator devices, which are used to manage chronic pain, have recently been linked to an increased risk for severe health complications [1].

The Medical Device Litigation Group at Schmidt & Clark, LLP is handling cases nationwide, representing clients who have suffered injuries from spinal cord stimulators in all 50 states.

Recent settlements have reached $1.25 million for cases involving severe complications.

Latest Spinal Cord Stimulator Lawsuit Updates

• March 3, 2025 – Last updated information on spinal cord stimulator lawsuits, with ongoing litigation against major manufacturers [2].
• August 2024 – A significant medical malpractice case resulted in a $1.25 million settlement for a man who suffered severe complications, including incontinence and partial paralysis, after having a spinal cord stimulator implanted in Essex County, New Jersey [3].
• September 2020 – The U.S. Food and Drug Administration (FDA) published a letter to healthcare providers outlining hundreds of deaths, injuries, and malfunctions linked to spinal cord stimulators [4].

Experts still don’t fully understand the mechanisms behind spinal cord stimulation, but they now know that it may target multiple muscle groups directly from the spine and even alter how the brain senses pain.- Eellan Sivanesan, MD, Pain Medicine Anesthesiology.

FDA Reports and Statistics

According to FDA data and related databases:

• 428 Patient Deaths reported to FDA linked to spinal cord stimulators [5].
• 30,321 Reports of unsatisfactory pain relief in the past 4 years.
• 107,728 adverse event reports submitted in the last four years.
• 50,000+ Devices implanted yearly requiring investigation.
• All Major Brands under investigation, including Medtronic, Boston Scientific, Abbott, Nevro, and St. Jude.

Healthcare providers are supposed to trial the estimated 50,000 devices implanted each year from companies such as Abbott, Boston Scientific, Medtronic and Nevro to ensure they adequately relieve a patient’s pain. An agency review of 107,728 adverse event reports submitted in the last four years found 30,321 reports of unsatisfactory pain relief.- The U.S. Food and Drug Administration (FDA).

This warning follows a June report by Public Citizen urging the FDA to enhance its regulation of these devices [6]. Recommendations include requiring original Pre-Market Approval (PMA) submissions for all new models and reevaluating whether any approved devices should be withdrawn from the market.

The FDA in September 2020 published a letter to healthcare providers emphasizing the importance of adhering to product labels and recommending a trial stimulation in patients before the permanent implantation of SCS devices.

This warning followed a June report by Public Citizen urging the FDA to enhance its regulation of these devices, including requiring original Pre-Market Approval (PMA) submissions for all new models.

Spinal Cord Stimulator Injuries & Side Effects

Spinal cord stimulators, while intended to alleviate chronic pain, pose significant risks of serious complications that can severely impact patients’ quality of life.

• Burns: Burns caused by device overheating or malfunction.
• Electric Shock: Unexpected electrical shocks from the device.
• Migration Issues: Lead wire fracture or migration requiring additional surgery.
• Urological Problems: Urinary incontinence or retention.
• Digestive Complications: Gastroparesis and dysphagia.
• Neurological Issues: Dizziness/fainting and worsening pain.
• Cardiac Problems: Cardiac arrhythmia potentially life-threatening.
• Bowel Dysfunction: Uncontrollable diarrhea (fecal incontinence).
• Device Failure: Stimulation may cease or function intermittently.
• Infection: Risk of infection at implant site requiring removal.

Do You Qualify for a Spinal Cord Stimulator Lawsuit?

You may qualify for a spinal cord stimulator lawsuit if:

• You had a spinal cord stimulator implanted by a healthcare provider.
• You experienced complications such as burns, electric shock, lead migration, organ dysfunction, or worsening pain.
• Your complications required medical treatment, corrective surgery, or hospitalization.
• You can document the link between your injuries and the spinal cord stimulator.
• Your device was manufactured by companies like Medtronic, Boston Scientific, Abbott, Nevro, or St. Jude.

Evidence Required for a Spinal Cord Stimulator Lawsuit

To strengthen your case, you should:

• Preserve the Device: Ensure that the defective spinal cord stimulator is preserved and not discarded, as this is crucial for proving the device’s defectiveness.
• Attend Medical Appointments: Continue attending any medical appointments recommended by your doctor to demonstrate the severity of your condition.
• Document Symptoms: Keep a detailed record of your symptoms, including onset, duration, and severity.
• Keep Receipts and Invoices: Maintain records of all relevant medical bills, out-of-pocket expenses, and documentation of lost wages.

Damages You Can Recover

If you’ve been injured by a defective spinal cord stimulator, you may be eligible for compensation for:

• Lost wages from time missed at work.
• Past and future medical bills related to complications.
• Out-of-pocket expenses for treatment.
• Pain and suffering from physical and emotional trauma.
• Punitive damages in cases of gross negligence.

It’s important to consult with a legal professional experienced in product liability cases to understand your rights and pursue the compensation you deserve.

Case Spotlight: August 2024 Settlement

In August 2024, a significant medical malpractice case resulted in a $1.25 million settlement for a man who suffered severe complications, including incontinence and partial paralysis, after having a spinal cord stimulator implanted [7].

Case Details:

• Settlement Date: August 2, 2024
• Location: Essex County, New Jersey
• Plaintiff’s Condition: The man experienced incontinence and partial paralysis in his legs following the implantation of the spinal stimulator. These complications significantly impacted his quality of life.
• Medical Malpractice: The lawsuit highlighted medical malpractice claims against the healthcare providers involved in the implantation procedure. The plaintiff argued that the doctors failed to provide adequate care and oversight during and after the surgery.
• Delay in Seeking Help: The defendants contended that the plaintiff was partly responsible for his condition due to a delay in seeking medical assistance. Specifically, he waited five days after the device was implanted before reporting his symptoms.
• Negligence: The case centered around allegations of negligence in the implantation procedure and postoperative care. The plaintiff’s legal team argued that had the medical team acted promptly upon learning of the complications, they could have prevented further damage.
• Expert Testimony: Expert witnesses were likely involved to establish that the standard of care was not met during the surgical process and subsequent treatment.

Spinal Cord Stimulator Recall Information

While there is no comprehensive recall of all spinal cord stimulators, the FDA has issued warnings and manufacturers are facing increasing scrutiny over device safety. Key FDA actions include:

• September 2020 letter to healthcare providers about serious complications.
• Recommendations for so before permanent spinal cord stimulator surgery.
• Ongoing investigation of all major manufacturers.
• Enhanced monitoring of the estimated 50,000 devices implanted each year.

Statute of Limitations for Spinal Cord Stimulator Lawsuits

Time limits for filing a spinal cord stimulator lawsuit vary by state. In Ohio, for example, this is typically two years from the date of injury, meaning timely legal action is crucial.

To ensure you meet the deadline, consult with a product liability attorney as soon as possible. The duration of these lawsuits can vary widely depending on the complexity of the case, the number of plaintiffs, and whether the case goes to trial. It could take several months to several years to resolve.

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FAQs

1. Which medical device manufacturers make spinal cord stimulators?

Medical device manufacturers that make spinal cord stimulators include Abbott, Boston Scientific, Medtronic, Nevro, and St. Jude. All of these companies are currently under investigation for device complications.

2. What are the common problems with spinal cord stimulator devices?

Common problems with spinal cord stimulator devices include burns, electric shocks, device migration, heart damage, bowel and bladder dysfunction, severe pain, and in some cases, the devices may cease to function or cause cardiac arrhythmia.

3. Can I join a class action lawsuit if I have been harmed by a spinal cord stimulator?

Yes, you can join a class action lawsuit if I have been harmed by a spinal cord stimulator. Consult with an attorney for details about current litigation options.

4. What steps should I take if I’ve been harmed by a defective spinal cord stimulator?

Steps that you should take if you’ve been harmed by a defective spinal cord stimulator include seeking immediate medical attention, documenting all symptoms and complications, preserving the device if removed, keeping all medical records and receipts, and consulting with a specialized attorney to discuss your legal options.

5. How long does it typically take to resolve a spinal cord stimulator lawsuit?

The duration varies widely depending on case complexity, the number of plaintiffs, and whether it goes to trial. These cases can take from several months to several years to resolve.

6. What damages could I be awarded in a spinal cord stimulator lawsuit?

Damages that could be awarded in a spinal cord stimulator lawsuit include compensation for lost wages, past and future medical expenses, out-of-pocket costs, pain and suffering, and in some cases, punitive damages against the manufacturer.

7. Are there any significant settlements for spinal cord stimulator cases?

Yes, there are significant settlements for spinal cord stimulator cases. Settlements include a $1.25 million settlement in August 2024 for a man who suffered incontinence and partial paralysis, and a $2.5 million settlement in May 2024 for a negligently implanted device.

8. What is the FDA’s position on spinal cord stimulators?

The FDA’s position on spinal cord stimulators is that they have acknowledged serious risks, publishing a warning letter to healthcare providers in 2020 about hundreds of deaths and injuries. They recommend a spinal cord stimulator trial before permanent implantation and are considering enhanced regulatory measures for these devices.

See all related medical device lawsuits our attorneys covered so far.

Get a Free Spinal Cord Stimulator Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for injuries caused by defective spinal cord stimulators. With statutes of limitations typically ranging from just 1-2 years depending on your state, it’s crucial to speak with an attorney as soon as possible.

The Medical Device Litigation Group at Schmidt & Clark, LLP is handling individual litigation nationwide and currently accepting new spinal cord stimulator injury cases in all 50 states. Our law firm offers:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case

Don’t wait to protect your rights. If you or a loved one has suffered injuries after implantation of a spinal cord stimulator, contact our law firm immediately. You may be entitled to significant compensation by filing a lawsuit, and we can help. Contact us today for a Free Confidential Case Review or call toll-free 24 hrs/day at (866) 588-0600.

References:

1. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/treating-pain-with-spinal-cord-stimulators
2. https://www.startribune.com/spinal-cord-stimulators/601345951
3. https://trulaw.com/spinal-cord-stimulator-lawsuit/
4. https://www.medscape.com/viewarticle/936869?form=fpf
5.  https://www.justice.gov/opa/pr/medtronic-inc-pay-28-million-resolve-false-claims-act-allegations-related
6. https://casetext.com/case/united-states-ex-rel-forney-v-medtronic-inc
7. https://www.law.com/njlawjournal/2024/08/30/1-25m-settlement-reached-for-paralysis-after-spinal-stimulator-implanted/?slreturn=20241001125946