What Are the Spinal Cord Stimulator Lawsuits About?
To help manage chronic pain, some patients have a spinal cord stimulator implanted into their lower back. This device uses electric currents to interrupt pain signals before they reach the brain.
However, lawsuits report that these devices may break or migrate over time, which can cause burning sensations, shocks, and other painful side effects. Some patients have had surgery to fix or remove the device.
Approximately 30% to 40% of patients experience complications from their implanted spinal cord stimulators, according to Public Citizen.
More than 80,000 injuries involving spinal cord stimulators were reported to the U.S. Food and Drug Administration (FDA) over a ten-year period, which was the third-highest total for any medical device, per the Associated Press.
Despite these risks, lawsuits allege that when manufacturers made significant design changes to spinal cord stimulators, the FDA allowed them to use a shortcut that effectively bypassed stricter safety reviews.
At Sokolove Law, we have over 45 years of experience holding negligent manufacturers accountable for prioritizing their profits over patient safety. See if our spinal cord stimulator attorneys may be able to help you.
Get the Help You Deserve
Our attorneys may be able to file a spinal cord stimulator lawsuit and fight for compensation on your behalf. Find out if you qualify now.
Gaps in FDA Oversight May Have Put Patients at Risk
The FDA sorts medical devices into classes based on their risk level. Class III devices, which include many spinal cord stimulators, pose the highest risk to patients and must undergo rigorous testing before they’re approved.
However, after receiving initial approval, manufacturers have made significant updates to spinal cord stimulators by using a shortcut known as Premarket Approval (PMA) supplements, which usually don’t require new clinical trials.
Between 1984 and 2018, the FDA approved 6 new spinal cord stimulator devices. During this time, 835 supplemental changes were made to those devices, according to an investigation by the Associated Press.
These modifications included design alterations, Bluetooth-enabled programming, multiwaveform stimulation, posture-adapting programming, changes to battery architecture, and more.
As a result, devices were cleared for use based on older studies of other products — not the updated versions now being implanted in patients. This lack of oversight allowed devices to be sold without a full understanding or disclosure of their risks.
Spinal Cord Stimulator Recalls
Since 2010, the FDA has issued more than 40 recalls of spinal cord stimulation devices due to safety concerns. These recalls have included devices made by Abbott Medical, Boston Scientific, Nuvectra, Medtronic, and more.
Reasons for spinal cord stimulator recalls have included:
- Battery problems
- Connection issues
- Device fractures
- Device migrations
- Overheating
- Power failures
- Therapy delivered to the wrong area of the body
In 2023, the FDA issued a Class I recall, which is the most serious type, for over 155,000 Abbott Proclaim™ and Infinity™ implantable pulse generators (IPGs).
Due to Bluetooth connection failures, patients were unable to reconnect to their devices and resume therapy after an MRI. The FDA noted that surgery may be needed to replace the device.
Spinal Cord Stimulator Risks & Injuries
While medical device companies often claim spinal cord stimulators are a safer alternative to opioids for managing chronic pain, these devices may not be without their own serious risks.
Patients allege the leads or wires that deliver electrical impulses to the spine can break, malfunction, or migrate. When this happens, the device may stop working correctly or send unintended shocks.
Risks associated with spinal cord stimulators may include:
- Burning sensations
- Electric shocks
- Infections
- Neurological deficits
- Orthostatic hypotension
- Scar tissue formation
- Urinary incontinence
- Worsening of pain
- Death
Some patients have had to undergo additional surgeries to remove their spinal cord stimulators due to complications.
Call (800) 995-1212 now to see if you may qualify for compensation from a spinal cord stimulator lawsuit. It costs nothing to speak with us.
Who Can File a Lawsuit for Spinal Cord Stimulator Complications?
Injuries linked to spinal cord stimulator complications can have a serious and even permanent impact on a patient’s life.
You may be able to file a spinal cord stimulator lawsuit if you or a loved one:
- Had a spinal cord stimulator implanted
- Experienced serious health complications linked to the device
- Underwent or plan to undergo surgery to remove the device
There’s only a limited amount of time to file a spinal cord stimulator lawsuit due to state laws called statutes of limitations. Once this deadline passes, you won’t be able to take legal action for your injuries again.
How to File an Abbott Spinal Cord Stimulator Lawsuit
Medical device companies have a responsibility to make sure their products are safe before putting them on the market. When they fail to do so, those harmed may be able to take legal action.
At Sokolove Law, we strive to make filing a spinal cord stimulator lawsuit as easy and stress-free as possible. You can focus on your health while we fight for the compensation you deserve.
Our spinal cord stimulator lawyers can:
- Determine your eligibility to take legal action during a free case review
- Gather evidence like medical records and information on device designs to build a strong case on your behalf
- File your spinal cord stimulator lawsuit before any deadlines
- Negotiate a spinal cord stimulator settlement with the defendant(s)
If a settlement is unable to be reached, our team is prepared to present your case in court and seek compensation from a trial verdict.
See If You Can Take Action
Contact our team to learn more about your legal options for spinal cord stimulator injuries. We can help you take the first steps toward justice.
Spinal Cord Stimulator Verdicts and Settlements
Compensation from a spinal cord stimulator lawsuit can help pay for medical bills, lost wages, pain and suffering, and other burdens linked to your injury.
In any legal case, compensation may be awarded in one of two ways:
- Spinal cord stimulator settlement: A settlement is an amount of money negotiated by the victim’s lawyer and agreed to by the defendant, potentially without the case going to court.
- Verdicts from a trial in court: If a spinal cord stimulator settlement isn’t reached, the case may continue to trial, and both sides will present their case in court. A judge or jury decides the outcome in the form of a verdict.
Settlements often allow families to access compensation quicker while avoiding the stress and uncertainty of a trial.
Get Help from Our Spinal Cord Stimulator Attorneys
At Sokolove Law, our spinal cord stimulator attorneys are committed to helping families seek the justice and compensation they deserve.
Find out how our firm stands out from the rest:
- Over 45 years of experience holding powerful companies accountable
- No upfront costs or hourly fees
- More than $1.6 Billion secured for clients harmed by dangerous medical devices and drugs
We can help patients in all 50 states file a spinal cord lawsuit against those responsible for their suffering.
Call (800) 995-1212 now or fill out our contact form to get started with a free, no-obligation case review.
Boston Scientific Spinal Cord Stimulator Lawsuit FAQs
What is the lawsuit against spinal cord stimulator systems?
Spinal cord stimulator lawsuits allege these devices may fail or malfunction, causing patients to experience severe pain and other complications. In some cases, patients have undergone additional surgeries to remove the device.
More than a dozen lawsuits have been filed against device manufacturers and the U.S. Food and Drug Administration, which reportedly allowed companies to sell these devices before the risks associated with them were fully understood.
Spinal cord stimulator lawsuits claim that the devices:
- Move out of position, malfunction, or fail after implantation
- Causes infections, electric shocks, burning sensations, and more
- Were approved by the FDA without adequate testing to check their safety
Contact Sokolove Law now to see if you may qualify for compensation from a spinal cord stimulator lawsuit.
Is there a spinal cord stimulator class action lawsuit?
Currently, lawsuits are being filed individually, rather than as a spinal cord stimulator class action lawsuit.
In a class action lawsuit, compensation is divided equally among all of the victims. Since injuries related to spinal cord stimulation devices vary, the amount of compensation each person may receive will depend on their specific situation.
Which companies are involved in the spinal cord stimulator lawsuit?
Multiple medical device companies have been named in spinal cord stimulator lawsuits, including:
- Abbott Laboratories
- Boston Scientific
- Medtronic Inc.
- Nervo Inc.
The U.S. Food and Drug Administration has also been named in some lawsuits for allegedly allowing updated devices to be marketed before undergoing clinical trials.
Call (800) 995-1212 now to see if our spinal cord stimulator attorneys may be able to hold those responsible for your injuries accountable. It costs nothing to speak with us.
Is there a spinal cord stimulator recall?
Yes. The U.S. Food and Drug Administration has issued at least 44 recalls for spinal cord stimulation devices, with more than 20 issued in the last 4 years alone.
One of these spinal cord stimulator recalls was a Class I recall, which is used when products may cause serious harm or even death.
How much does it cost to work with a spinal cord stimulator attorney?
At Sokolove Law, there are no upfront costs or hourly fees to work with our spinal cord stimulator attorneys.
We operate on a contingency-fee basis, which means you pay nothing unless we secure compensation for you.
