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Spinal Cord Stimulator Lawsuit: Get the Right Attorney

Spinal cord stimulator devices, which are used to manage chronic pain, have recently been linked to an increased risk for severe health complications including burns, nerve damage, electric shock, device migration/malfunction, gastroparesis, cardiac arrhythmia, and ineffective or worsening pain.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

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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 us immediately for a free consultation. You may be entitled to financial compensation for medical costs and lost wages by filing a lawsuit and our law firm can help. Please click the button below for a Free Consultation or call our law firm 24 hrs/day by dialing (866) 588-0600 for legal action.

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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.

Medtronic Ordered to Pay $2.8 Million to Resolve Spinal Cord Stimulator Fraud Lawsuit

According to the U.S. Justice Department, in February 2015, Medtronic Inc. agreed to pay the United States $2.8 million to resolve allegations under the False Claims Act that Medtronic caused certain physicians to submit false claims to federal health care programs for a medical procedure known as “SubQ stimulation,” [4].

The lawsuit accused Medtronic of knowingly encouraging numerous physicians across more than 20 states to submit claims to Medicare and TRICARE for investigational medical procedures known as SubQ stimulation between 2007 and 2011. Despite lacking FDA-required establishment of SubQ stimulation’s safety and efficacy, Medtronic allegedly promoted this procedure by arranging for physician-customers to attend Medtronic-sponsored on-site training programs on using Medtronic spinal cord stimulation devices for SubQ stimulation.

Today’s settlement demonstrates our commitment to ensure that beneficiaries of federal health care plans, including Medicare recipients and military families, receive medical treatments that have been proven safe and effective, said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division. Targeting chronic pain patients with a medical procedure that lacks evidence of clinical efficacy wastes the country’s health care resources.

The lawsuit is United States ex rel. Nickel v. Medtronic, Inc. Civ. No. 09 – CV – 0203-S (W.D.N.Y.) [5].

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?

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

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Have you or a loved one suffered severe pain or injury from a defective medical device?

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.medtechdive.com/news/fda-flags-428-spinal-cord-stimulator-patient-deaths
5. https://www.citizen.org/wp-content/uploads/2526

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