Boston Scientific Stimulator Problems Resulted in Burning Pain, Shocks From SCS Leads: Lawsuit

As the number of spinal cord stimulator lawsuits grows, some plaintiffs seek to consolidate the federal claims before one judge for pretrial proceedings.

According to a lawsuit filed earlier this month, Boston Scientific sales representatives directly told a Missouri man about the anticipated pain management benefits he would receive from a Precision Spectra spinal cord stimulator, without warning him about the risk of serious problems that may develop after the system is implanted.

Richard Williams brought the complaint (PDF) in the U.S. District Court for the Western District of Missouri on March 11, naming both Boston Scientific Corporation and the U.S. Food and Drug Administration (FDA) as defendants. It claims the medical device manufacturer made misleading statements and provided inadequate warnings about a device that the agency should have never approved.

The Boston Scientific Precision Spectra is a type of spinal cord stimulator (SCS), which is an implantable device to help patients suffering from severe chronic back pain. SCS work by delivering electrical pulses to the spinal cord in a way that is intended to prevent pain signals from reaching the brain.

The systems consist of the pulse generator, battery, leads that deliver the electrical pulses to the spinal cord, and the anchoring components that attach them to the spine. There is also an external controller for making adjustments to the pulses being delivered.

Boston Scientific SCS System Problems

Since they were originally introduced in the early 2000s, Boston Scientific and other manufacturers have released numerous updated versions, many of which have been approved through the FDA’s 510(k) fast-track approval process, which allows devices to be approved without full clinical trials as long as they are deemed “substantially equivalent” to previous models.

The program has drawn criticism for years due to the vague and inconsistent ways the term “substantially equivalent” has been interpreted by the agency and device manufacturers. The program’s detractors claim the FDA’s enforcement of the program is lax, indicating the agency does not adequately verify whether newer devices include major changes in operation, materials or other design features compared to the original product.

Williams is one of a growing number of plaintiffs who are now pursuing spinal cord stimulator lawsuits against Boston Scientific, Abbott Laboratories, Medtronic and other major manufacturers, each involving claims that former patients experienced sudden electrical shocks, burning sensations, leads poking through skin, lead fractures and other problems.

Although the pain management devices are intended to be permanent implants, many of these patients required revision surgery to have the failed SCS systems removed.

Williams indicates the Boston Scientific spinal cord stimulator system was implanted in February 2019, along with the accompanying Precision Spectra pulse generator, for the treatment of chronic back pain.

According to the complaint, the surgery came after Boston Scientific sales representatives convinced Williams to undergo a test trial with a temporary unit, which resulted in significant pain relief. However, the lawsuit also notes that it was clear that getting Medicaid insurance to cover the procedure relied heavily on reports of significant pain relief.

Williams states that the Boston Scientific sales reps assured him the permanent implant would be just as good if not better, and would provide long-term, reliable pain relief. He also says the sales reps told him the stimulation would be safe and localized.

However, the lawsuit notes that the sales representatives never told Williams there was a risk of electric shocks, a lack of pain relief or unit failure. They also failed to inform Williams that there was a possibility that the actual implant differed from the trial version, he alleges.

Instead, the complaint argues that the data being used and touted by the Boston Scientific sales representatives were not even from the Precision Spectra, which the lawsuit claims has never gone through intensive clinical trials. According to the lawsuit, their data came from previous versions of spinal cord stimulators, which Boston Scientific told the FDA were substantially equivalent. At the same time, its sales reps were also touting the new Precision Spectra’s improvements over previous devices.

The FDA should have noted the changes and taken a close look at the device, and should have more stringently applied the 510(k) requirements, Williams argues, alleging that the agency’s lack of action and enforcement directly contributed to his injuries.

Pain Relief Did Not Last

At first, the lawsuit states Williams felt the pain relief he expected, yet by late June 2020, he required his first revision surgery to relocate the battery due to pain he was feeling at the implant’s location. Then, in June 2023, Williams began experiencing burning and electrical shocks from the SCS leads, the pain relief diminished, and he currently receives no notable pain relief from the Boston Scientific implant.

The sales representatives tried several times to reprogram the Precision Spectra to address the shocks and lack of pain relief, according to the lawsuit. However, it also notes that they were not trained medical professionals and are not licensed to behave in that manner in the state of Missouri.

“These actions involved real-time interpretation of patient responses and materially influenced the configuration and function of the implanted system. These actions were essentially medical treatment and had a significant impact on the way the SCS system affected Plaintiff’s body.”

– Richard Williams v. Boston Scientific et al

Williams indicates that due to his experiences, he is afraid to undergo surgery to have the device removed from his spine.

Spinal Cord Stimulator Lawsuits

In late February, a group of plaintiffs with similar claims against Abbott and Boston Scientific filed a motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting that all SCS system lawsuits be centralized in the Northern District of Illinois into a multidistrict litigation, or MDL.

All of the lawsuits raise similar concerns, regarding how the devices went mostly unstudied through the FDA’s fast-track approval process, there was heavy involvement of sales representatives, and patients received allegedly misleading claims about the devices’ safety and effectiveness.

If the JPML decides the cases should be centralized, the spinal cord stimulator lawsuits would be consolidated before one U.S. District Judge, who would oversee coordinated discovery, pretrial proceedings and, if necessary, a series of early bellwether trials.

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