A spinal-cord stimulator implant lawsuit is an option for patients injured as a result of electronic pain-management devices marketed by Abbot/St. Jude, Boston Scientific Corp., Medtronic, Inc., or Nevro.
The nationwide law firm of Bernstein Liebhard LLP is providing free lawsuit reviews to spinal-cord stimulator patients who suffered any of the following injuries.
To learn more about filing a spinal-cord stimulator implant lawsuit, please call (888) 994-5118.
Spinal-cord stimulator implant systems are intended to relieve chronic pain when traditional methods have failed.
These implants generally consist of a pulse generator that a surgeon implants in the buttocks or abdomen, as well as a lead placed in the spinal cord’s epidural space. The system is controlled by an external remote.
Device manufacturers claim that spinal-cord stimulators are an ideal solution for chronic pain. Among other things, it’s even been suggested that the devices could hold the key to the opioid crisis. However, a recent investigation by the Associated Press and and other media outlets revealed that spinal-cord stimulators may actually be more dangerous than many patients think.
For one thing, the U.S. Food & Drug Administration (FDA) has received more than 80,000 adverse event reports involving spinal-cord stimulator implants since 2018.
About 500 of these reports had fatal outcomes, although it’s not clear if the patient died because of the implant or the surgical procedure. Other reports involved burns, shocks, and infections.
Additionally, 21 of 40 patients interviewed for the Associated Press report said the devices actually worsened their pain.
“I told them that it feels like the lead is moving up and down my spine,” one patient said. “They said, ‘It can’t move.’ Sadly, his worsening pain has left the patient bedridden.
In some cases, patients said their complaints were ignored or downplayed. For example, a doctor and an Abbott representative told one women that her device “doesn’t do that” when she experienced repeated shocks.
Just last March, however, Abbot recalled the woman’s implant. Apparently, a glitch was causing patients “discomfort.”
Unfortunately,spinal-cord stimulator implant recalls are far from rare. In fact, manufacturers issued more than 50 such recalls since 2005. Approximately half involved Medtronic devices.
The FDA considers spinal-cord stimulator implants high-risk medical devices. Therefore, they should be subject to the agency’s most stringent clinical trial requirements.
However, the FDA’s 510(k) program allows device manufacturers to forgo clinical trials when a a new product is “substantially equivalent” to a previously-approved device.
The fact is, the FDA has allowed some spinal-cord stimulator implants to come to market without clinical trials. As is the case with all other 510(k) approvals, the agency cleared these devices on the basis of data from older implants.
Furthermore, the few spinal-cord stimulator trials that have been conducted were small, industry-funded, and exhibited a “significant” placebo effect.
“It’s kind of the story of FDA’s regulation of devices, where they’re just putting stuff on the market,” Diana Zuckerman, president of the National Center for Health Research, told the Associated Press.
The Associated Press report also suggested that some physicians are eager to implant spinal-cord stimulators for financial reasons.
For example, the report cited several instances where doctors enthusiastically promoted the devices without telling patients they had received money from medical device manufacturers.
These remittances included consulting fees and payment for travel and entertainment. To be clear, the law does not require physicians to disclose such payments to their patients. However, some experts said they had a legal obligation to do so.
Moreover, some patients said they felt pressured to undergo spinal-cord stimulator implantation. Among other things, they feared their doctors would cut off pain medications if they did not agree to the procedure.
Others said sales reps were present when their physicians recommended the devices. In some case, sales reps actually performed adjustments on their implants.
If this sounds far-fetched, consider that in 2009, a former Medtronic employee claimed in a federal whistleblower lawsuit that sales reps had encouraged physicians to perform unnecessary spinal-cord stimulation procedures.
The whistleblower further alleged that Medtronic provided doctors with “powerful” financial inducements that turned them into “salesmen” for the costly procedures.
The U.S. Department of Justice eventually joined the whistleblower lawsuit. While Medtronic denied any wrongdoing, it did agree to settle the case for $2.8 billion in 2015.
Court records indicate that Boston Scientific faces a similar spinal-cord stimulator implant lawsuit in New Jersey.
Generally speaking, patients harmed by a spinal-cord stimulator system may be entitled to compensation for:
If you wish to file a spinal-cord stimulator lawsuit, please contact Bernstein Liebhard LLP by completing the form on this page, or call our office directly at (888) 994-5118.
Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.