Spinal Cord Stimulator Lawsuit Alleges Boston Scientific Device Failure Required Removal Surgery

Lawsuit claims sales representatives delayed the broken device’s removal by claiming it just needed to be reprogrammed.

A Texas woman has filed a product liability lawsuit alleging she had a Boston Scientific spinal cord stimulator removed after she experienced no pain relief, only for doctors to discover the device had suffered a mechanical failure.

The complaint (PDF) was brought by Gloria Castleberry in the U.S. District Court for the Central District of California on September 23, naming Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation as the defendants.

Castleberry was implanted with a Boston Scientific spinal cord stimulation system in December 2021, but says the device never provided meaningful relief. According to the lawsuit, company representatives repeatedly attempted to reprogram the stimulator and encouraged her to keep the device in place, but those efforts failed and Castleberry ultimately underwent surgery to have it removed.

Spinal Cord Stimulators

A spinal cord stimulator (SCS) is a medical device implanted in a patient’s back. It consists of a battery-powered pulse generator, leads and wires implanted beneath the skin, and an external control to adjust frequency modulation.

While the devices are supposed to work by using electrical pulses to disrupt pain signals on the way to the brain, the implants have been linked to a number of complications and problems, including failures, lead migration and fractures, battery failures, painful shocks, nerve damage and the need for revision surgery.

As a result, Boston Scientific and other manufacturers including Abbott Laboratories, Nevro and Medtronic face numerous spinal cord stimulator lawsuits claiming that the devices have undergone repeated mechanical changes over the years without adequate testing or approval by federal regulators.

Former SCS implant recipients, like Castleberry, further allege that sales representatives reprogramming spinal cord stimulators take on roles that should be handled by medical professionals. Some claims maintain that company representatives repeatedly adjust device settings and discourage removal, even when the implants continue to provide little or no meaningful pain relief.

Boston Scientific Device Failure Allegations

According to the lawsuit, Castleberry’s device was immediately programmed by Boston Scientific sales representatives when she was implanted with it at the end of 2021. However, after the device was activated Castleberry experienced no relief from her pain.

The representatives allegedly told her they just needed to find the right settings, reprogramming it multiple times in an effort to give the relief they had promised when convincing her to receive the implant, but to no avail. Castleberry notes they reprogrammed the device at least five times without success.

“Plaintiff’s implanting physician declined to remove the device. Plaintiff was forced to seek treatment at a different pain management clinic, where her new treating physician administered a nerve block injection to evaluate whether removal of the SCS device was warranted.”

– Gloria Castleberry v. Boston Scientific Corporation et al.

Two weeks after the nerve block, Castleberry’s new treating physician surgically removed the Boston Scientific SCS system in September 2024. A postoperative diagnosis determined that the implant had suffered a mechanical failure.

Castleberry alleges that company sales representatives persuaded her to spend years repeatedly reprogramming the stimulator, even though the device had already suffered a mechanical failure and was not capable of providing meaningful pain relief. She claims the failure stemmed from a known design defect that Boston Scientific failed to adequately disclose to physicians or patients.

The lawsuit presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, violation of consumer protection laws and unauthorized practice of medicine. It seeks compensatory and punitive damages.

Boston Scientific SCS Implant Lawsuits

Castleberry filed her complaint in the Central District of California, where other Boston Scientific SCS lawsuits have been consolidated before U.S. District Judge Josephine L. Staton for coordinated discovery and pretrial proceedings as part of a multidistrict litigation (MDL). As of the beginning of September, there were 25 cases filed. However, that number has continued to climb.

Shortly after the Boston Scientific SCS MDL was established earlier this year, plaintiffs with claims against other companies called for Nevro implant lawsuits and Abbott SCS lawsuits to be consolidated, which would centralize those complaints in the Central District of California as well, but as separate MDLs.

The panel met last week to hear oral arguments on the additional consolidations, but has yet to issue a ruling or opinion.

If the lawsuits are consolidated, all three would likely begin preparations for selecting a few key, representative cases to serve as bellwether test trials, designed to give counsel the opportunity to see how juries weigh evidence and testimony that would be applicable to most of the claims.

Given that the litigation is still ramping up, such trials could be years away. In the interim, spinal cord stimulator lawyers will continue to review claims of injuries caused by implant system problems, including:

Individuals who believe they may qualify for a spinal cord stimulator lawsuit can request a free case evaluation. Attorneys handling these claims work on a contingency fee basis, meaning there are no upfront costs and fees are only collected if compensation is recovered.

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