Each year, approximately 14,000 people have a spinal cord stimulator implanted to relieve persistent back pain, per the International Neuromodulation Society (INS). Medtronic has estimated that number to be much higher—around 50,000 Americans per year, according to a recent Wall Street Journal (WSJ) article.
If a spinal cord stimulator injured or paralyzed you, attorney Chris Mellino welcomes you to contact our office with any questions you may have. Our Cleveland Medtronic attorneys have over 30 years of experience; we are prepared to fight for you.
Contact The Mellino Law Firm online or by phone at (440) 276-3535 for a free consultation today.
How Do Spinal Cord Stimulators Work?
“In general,” says spine-health.com, “neurostimulation works by applying an electrical current to the source of chronic pain. This creates a pleasant sensation that blocks the brain’s ability to sense the previously perceived pain.” INS claims the stimulator may reduce pain by improving circulation, increasing the amount of oxygenated blood in the area, and releasing pain-relief chemicals, such as endorphins.
The FDA approved the first spinal cord stimulator in 1989, and between 50 and 70 percent of patients have reported improved quality of life, says Spine-Health. In fact, on April 8, 2014, WSJ reported that a combination of spinal cord stimulation and physical therapy enabled paraplegics to “wiggle their toes and ankles, flex their legs and stand independently for moments at a time” during a National Institutes of Health- and Christopher and Dana Reeve Foundation-funded study. Though none of the participants were able to walk on their own, “four out of four patients in whom the treatment has been attempted have regained some voluntary movement.”
Cleveland Clinic scientist Vinod Labhasetwar, who researches spinal cord injury treatments, commented that further studies would need to prove that the spinal cord is able to withstand—and will respond to—extended stimulation.
In the study, researchers used spinal cord stimulators made by Medtronic, which touts itself as “the right choice.” Unfortunately, some people would disagree.
Spinal Cord Stimulator Risks
WebMD states that people who undergo spinal cord stimulation may suffer bladder control issues, infection, pain, including headaches from overstimulation, or injury if the hardware fails, but researchers have discovered something much more troubling in the last few years.
After reviewing 12,300 insurance claim records in 2011, Duke University Medical Center researchers discovered that 1 in 100 spinal cord stimulator patients suffers “some degree of spinal-cord or spinal nerve-root damage,” such as muscle weakness or paraplegia.
On April 15, 2014, WSJ reported that experts reviewing medical malpractice lawsuits found that spinal cord stimulators may have caused paralysis in more than 100 people.
“In many cases, the injuries occurred after patients’ spinal cords were punctured or compressed by the stimulator electrodes,” WSJ stated. “In all, the FDA’s database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year.”
The culprits? Medtronic and St. Jude Medical, among others.
Medtronic spokeswoman Ana Marquard said the company keeps tabs on the FDA’s adverse event report database and, as a result, updated its product label earlier this year to include the possibility of scar tissue and subsequent nerve damage. However, FDA spokeswoman Jennifer Rodriguez told WSJ that the FDA’s adverse event report database is not an accurate reflection of the number of problems that actually occur since events often go unreported or contain unreliable information.
Is Spinal Cord Stimulation-Related Paralysis the Fault of Medtronic or the Surgeon?
“Doctors who implant the [spinal cord stimulation] devices point to a problem that may be causing the injuries: poor physician awareness about the risks of operating near the spinal cord … [i]nsufficient training and a lack of surgical guidelines,” WSJ stated. “Medical societies usually develop training standards and disseminate practice guidelines, but spinal stimulators are implanted by a variety of physicians—anesthesiologists, neurosurgeons, and orthopedic spine surgeons—and no single medical society is responsible for issuing guidelines and tracking performance.”
Still, according to Medtronic’s own website, more than 1,300 adverse events were reported from 2004 to 2012, and 34 percent of those “were categorized as product performance-related.”
The product liability attorney who handles your Medtronic lawsuit will need to be able to determine—without a doubt—who or what caused your injury or paralysis.
Why Should You Trust Chris Mellino to Litigate Your Medtronic Lawsuit?
First, The Mellino Law Firm does not advertise. Attorneys and satisfied clients send us the majority of our cases. Others find us online.
Second, Chris is respected throughout northeast Ohio for his ability to dig below the surface and make sure no fact is overlooked. In fact, he’s been involved in several landmark cases, including Moskovitz v. Mt. Sinai Medical Center (1994) and Watkins v. Cleveland Clinic Foundation (1998). In the latter, he and his previous partner were awarded the largest verdict in the state that year.
Third, injury claims are time-consuming and labor intensive, so we’re selective about the cases we accept. Some firms:
- Take every case that walks in the door
- Settle those cases for the first amount the defendant offers, so they can fund their next commercial to bring in even more clients
- Leave their clients in the hands of “case managers”
We only pursue compensation for patients who’ve suffered a severe injury, such as paralysis. By limiting the number of claims we accept, we’re able to give each one the unique attention it deserves.
Last but not least, since 2010, The Mellino Law Firm has been the only injury law firm in Cleveland to be accepted into Primerus, which screens potential members by speaking to judges, other lawyers, bar associations, clients, and insurance carriers about a firm’s integrity, work product, fee structure, education, civility, and community service.
If you have questions about a possible Medtronic lawsuit or spinal cord injury, attorney Chris Mellino invites you to contact our office for a free consultation.
Call (440) 276-3535 to discuss your legal options with one of our experienced Cleveland Medtronic attorneys today.