Spinal Cord Stimulator Lawsuit: Latest 2024 Updates

Complications from spinal cord stimulators can lead to significant health issues and legal action.

If you’re considering a spinal cord stimulator lawsuit, this article will help you understand the common problems, legal grounds, and the lawsuit process.

You’ll also learn how to choose the right attorney to represent your case.

Quick Summary

• Spinal cord stimulators, while intended to alleviate chronic pain, pose significant risks including device malfunctions, electrode migration, and severe side effects that can lead to lawsuits.
• Legal grounds for filing a spinal cord stimulator lawsuit include medical malpractice, product liability, and breach of warranty, each addressing different patient grievances related to these devices.
• Patients must be aware of the statute of limitations for filing claims; in Ohio, this is typically two years from the date of injury, meaning timely legal action is crucial.

What is a Spinal Cord Stimulator?

According to Johns Hopkins Medicine research, spinal cord stimulators are composed of thin wires called electrodes and a small battery pack resembling a pacemaker, known as the generator [1].

These electrodes are carefully positioned between the spinal cord and the vertebrae within the epidural space, while the generator is typically implanted under the skin, often near the buttocks or abdomen.

This setup allows patients to administer electrical impulses using a remote control when they experience pain. Notably, both the remote control and its antenna remain external to the body.

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.

Which Medical Device Manufacturers Make Spinal Cord Stimulators?

• Abbott
• Boston Science
• Medtronic
• Nevro
• St. Jude

What’s the Problem With Spinal Cord Stimulator Devices?

The lawyers at Schmidt & Clark, LLP, are investigating potential lawsuits on behalf of individuals who have been injured by allegedly defective spinal cord stimulator devices.

Based on data from U.S. Food and Drug Administration (FDA) databases, adverse health complications associated with spinal cord stimulators include burns, electric shocks, device migration, heart damage, bowel and bladder dysfunction, and severe pain.

Spinal Cord Stimulator Side Effects

Spinal cord stimulators offer relief for individuals dealing with chronic and severe pain, yet they come with notable risks. The stimulation may cease or function intermittently, the placement of the stimulator by the surgeon may be incorrect, or over-stimulation might happen, resulting in discomfort.

Moreover, the stimulator may shift or sustain damage, necessitating additional surgery.

Other adverse health complications may include:

• Burning caused by device
• Electric shock by device
• Lead wire fracture/migration
• Urinary incontinence or retention
• Gastroparesis
• Dysphagia
• Uncontrollable diarrhea (fecal incontinence)
• Dizziness/fainting
• Ineffective or worsening pain
• Cardiac Arrhythmia
• And more

Spinal Cord Stimulators Linked to 428 Patient Deaths: FDA Warning

According to MedTech Dive, the U.S. Food and Drug Administration (FDA) in September 2020 published a letter to healthcare providers outlining hundreds of deaths, injuries, and malfunctions linked to spinal cord stimulators (SCS) [2].

The letter emphasized the importance of adhering to product labels, which recommend a trial simulation in patients before the permanent implantation of SCS devices.

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.

This warning follows a June report by Public Citizen [3] urging the FDA to enhance its regulation of these devices. 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.

Organizations such as Device Events have also highlighted the risks associated with spinal cord stimulators.

$1.25 Million Settlement for Malpractice

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 [4].

Here are the details surrounding the case:

• 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 claims of medical malpractice 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.

What to do if Your Spinal Cord Stimulator is Defective?

If your spinal cord stimulator is defective and requires surgical removal, you may be entitled to compensation from the manufacturer.

Here are some steps you can take to strengthen your case:

• Preserve the Device: Ensure that the defective spinal cord stimulator is preserved and not discarded. This is crucial for proving the device’s defectiveness.
• Attend Medical Appointments: Continue attending any medical appointments recommended by your doctor. This can help demonstrate the severity of your condition to the court.
• Document Symptoms: Keep a record of your symptoms. This documentation can support your claim for pain and suffering.
• Keep Receipts and Invoices: Maintain records of all relevant receipts and invoices related to your injury. This includes out-of-pocket expenses and lost wages.

What Damages Could I Be Awarded?

• Lost wages
• Past and future medical bills
• Out-of-pocket expenses
• Pain and suffering

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

Related Articles:

• Medtronic SynchroMed Infusion Pump Lawsuit
• HawkOne Directional Atherectomy System Litigation
• Megadyne Electrode Lawsuit

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

FAQs

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

Yes, if a class action lawsuit is underway, you may be eligible to join it if your circumstances are similar to those of other plaintiffs. Consult with an attorney for details.

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

Seek medical attention for your complications, document your symptoms and any related incidents, keep all records of surgeries and treatments, and consult with an attorney to discuss your legal options.

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

The duration 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.

Get a Free Spinal Cord Stimulator Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the legal representation of plaintiffs in Spinal Cord Stimulator Lawsuits. We are handling cases nationwide and currently represent clients of spinal cord stimulator injuries in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one suffered injuries or required corrective surgery or other treatment after implantation of a Spinal Cord Stimulator for chronic pain, you should contact our law firm immediately. You may be entitled to financial compensation by filing a Spinal Cord Stimulator Lawsuit and our lawyers can help.

References:

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