Patients across the United States are filing lawsuits alleging that defective spinal cord stimulators caused painful shocks, burns, paralysis, worsening pain and loss of bladder or bowel control. As the number of cases grows, a federal panel has created a multidistrict litigation (MDL) to coordinate lawsuits involving Boston Scientific devices.
The MDL marked a major development for patients who claim the company’s implanted pain relief devices, specifically WaveWriter and WaveWriter Alpha, are defective, and cause serious injuries and harm.
There were 23 cases consolidated in the spinal cord stimulator MDL in the Central District of California. The transfer allows lawsuits against Boston Scientific to proceed before one judge, streamlining pretrial proceedings and helping avoid inconsistent rulings. The court will oversee discovery, expert witness testimony, and eventually select bellwether cases for trial.
While several cases are part of the spinal cord stimulator MDL, it's important to note there are additional defective device lawsuits involving other manufacturers. These are separate and were not consolidated with Boston Scientific claims.
More lawsuits are expected to be filed as patients become aware of the litigation, and research shows what may be driving them. Analysis of spinal cord stimulator injury data from the Food and Drug Administration (FDA) indicates the pain management implants fall into a high-risk device category.
In fact, over 80,000 spinal cord stimulator injuries have been reported to the FDA. The most common issues noted in lawsuits include battery or implantable pulse generator malfunction, lead complications, and battery defects.
What are Spinal Cord Stimulators?
Hundreds of thousands of Americans have received spinal cord stimulators, which are implanted medical devices used to manage chronic pain conditions. They deliver electrical impulses to the spinal cord to interrupt pain signals before they reach the brain.
Doctors typically recommend them when medications, physical therapy, surgeries, or other treatments have failed.
The medical devices typically include electrodes placed near the spinal cord and a battery-powered pulse generator implanted under the skin. Lead migration is the most common complication of spinal cord stimulators.
When they work as intended, SCSs provide immense pain relief for patients suffering from chronic back pain, nerve pain, failed back surgery syndrome, and complex regional pain syndrome (CRPS).
What Do the Spinal Cord Stimulator Lawsuits Allege?
Spinal cord stimulator lawsuits have been filed against several major medical device manufacturers, including Abbott, Boston Scientific, Medtronic, and Nevro.
The litigation centers on allegations that certain SCS devices have manufacturing and design defects and that they weren’t properly tested to ensure their safety. Some court filings note that companies were able to bypass safety testing and make design changes without providing new data thanks to the FDA’s premarket approval pathway.
Plaintiffs claim the defects caused the devices to stop working, lose therapy settings, severely shock and burn patients, or enter a "safe mode" that prevented them from receiving effective pain relief. As a result, failed spinal cord stimulators caused costly medical bills, time off work, and significant pain and suffering. Many had to endure additional surgeries to remove or replace malfunctioning devices.
Both individual lawsuits and cases that are part of the Boston Scientific MDL claim manufacturers knew or should have known about the alleged design defects, battery defects, and faulty software. They further state manufactures failed to adequately warn physicians and patients about the risks.
The spinal cord stimulator mass tort is still in its early stages, meaning many patients who experienced problems may not yet realize that lawsuits are being filed. Defective device attorneys expect numerous cases to be added to the Boston Scientific MDL, and that individual lawsuits will also increase.
Failed Spinal Cord Stimulators and Opioid Dependence
In 2023, opioid overdoses in the U.S. took the lives of 80,000 people. As the opioid crisis continues to ravage communities across the country, many involved in the spinal cord stimulator lawsuits say they’re facing dependence on opioids – the very drugs they hoped to avoid.
These plaintiffs claim they underwent spinal cord stimulator implantation so that they didn’t need to take opioids or have additional back surgery. But when the devices failed, allegedly due to defects, they were left with few options to manage severe chronic pain.
FDA Recalls Increased Scrutiny
The spinal cord stimulator litigation grew significantly over the past few years alongside an increase of product recalls.
In December 2023, the FDA announced a Class I recall – the agency's most serious type of recall – of Abbott’s Proclaim and Infinity devices for a technical software malfunction. The FDA warned that the malfunction could lead to a loss of pain management therapy and require surgical intervention to replace the device.
Numerous other recalls involving neurostimulation devices have been issued in recent years, increasing scrutiny around spinal cord stimulators and their risks. Unfortunately, they came too late for many patients.
What to do if Injured by a Spinal Cord Stimulator
The seriousness of SCS complications and failures are being seen not just in the U.S., but around the world. Between 2012 and 2019, 79% of adverse events of spinal cord stimulators in Australia were rated as severe, with 13% rated as life-threatening.
According to mass tort attorneys, the risks, extensive research and analysis, and recurring device issues indicate that spinal cord stimulator lawsuits are likely to grow substantially. These medical devices are supposed to improve the quality of life for people suffering from chronic pain conditions. Instead, they may have caused more suffering that could have been avoided.
Patients who were injured by a failed or faulty a spinal cord stimulator should speak with a defective device lawyer. Because statutes of limitations vary by state, anyone who required revision surgery or suffered injuries after receiving one of these devices shouldn’t delay learning about their legal options.
Those who are eligible may file their case directly into the Boston Scientific MDL, whereas patients harmed by devices made by a different manufacturer may pursue individual lawsuits.
