Lawsuit Over Spinal Cord Stimulator Removal Claims Device Caused Numbness, Incontinence

Problems with a Boston Scientific spinal cord stimulator allegedly caused worsening pain and neurological symptoms, ultimately requiring surgery to remove the entire system.

An Alabama woman has filed a lawsuit over the removal of a Boston Scientific spinal cord stimulator, alleging the device failed to relieve her chronic pain and instead caused a multitude of serious complications.

Kathleen Poore brought the complaint (PDF) in the U.S. District Court for the Central District of California on July 30, naming Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation as defendants.

Poore claims problems emerged after she received a Boston Scientific spinal cord stimulator in October 2023, leaving her with worsening pain and neurological symptoms that ultimately required another surgery to remove the entire system.

However, she maintains the removal did not resolve all of her problems, and she continues to experience pain and other symptoms allegedly caused or worsened by the implant.

Spinal Cord Stimulator Problems

Spinal cord stimulators are implantable medical devices designed to treat chronic pain by delivering electrical impulses to the spinal cord, interfering with pain signals before they reach the brain.

The systems generally consist of an implantable pulse generator, electrical leads placed near the spinal cord and an external controller that allows stimulation settings to be adjusted.

However, spinal cord stimulators have been linked to serious complications, including lead migration, fractures, battery problems, infections, painful stimulation and failure to provide adequate pain relief.

In light of these concerns, a number of spinal cord stimulator lawsuits now allege manufacturers introduced modified versions of the devices through certain FDA regulatory processes that allowed them to reach patients without extensive clinical trials evaluating the safety of each design change.

Many of the Boston Scientific spinal cord stimulator lawsuits filed to date maintain manufacturers failed to sufficiently test the devices or warn patients and doctors about the potential for malfunctions and serious injuries. Some claims also question the involvement of company representatives in patient treatment, alleging they exaggerated potential benefits, downplayed known complications and made programming changes despite lacking the necessary medical qualifications to provide clinical care.

Spinal Cord Stimulator Removal Lawsuit

According to the lawsuit, Poore received a Boston Scientific Model SC-1232 spinal cord stimulator in October 2023 to treat chronic pain.

However, the implant allegedly failed to provide the expected pain relief. Instead, worsening pain, numbness in her legs and electric shock sensations began to develop following the procedure. As her condition deteriorated, the symptoms reportedly made it necessary for Poore to begin using a cane, which she continues to require.

The complaint also indicates she was diagnosed with bladder incontinence, which is alleged to have been caused by the spinal cord stimulator. Poore maintains she was not warned the device could cause the condition and only recently learned it may have contributed to her bladder problems.

Multiple meetings with a Boston Scientific device representative followed in an effort to address the complications. The lawsuit indicates the representative characterized Poore’s experience as uncommon and repeatedly assured her that adjustments to the device’s programming would eventually provide effective pain relief.

Those reprogramming attempts allegedly failed to improve her condition. The spinal cord stimulator remained ineffective at controlling her underlying pain, while the worsening symptoms and electric shock sensations continued.

Ultimately, the lack of pain relief and ongoing complications led Poore to undergo another surgical procedure to remove the spinal cord stimulator system. Despite the removal, the complaint indicates she continues to suffer pain and other symptoms allegedly caused or aggravated by the implant.

“Due to the device’s failure to provide therapeutic pain relief and the injuries described above, Plaintiff underwent surgical removal of the SCS system. Plaintiff continues to suffer from pain and other symptoms caused and exacerbated by the device.”

— Kathleen Poore v. Boston Scientific Corporation et al.

The filing raises allegations of strict product liability, manufacturing defect, failure to warn, negligence per se, breach of express warranty, breach of implied warranty, negligence, negligent misrepresentation, fraudulent concealment and violation of consumer protection laws. It seeks damages for Poore’s physical injuries, pain, medical expenses and other losses.

Spinal Cord Stimulator Lawsuits

Poore’s case will join other Boston Scientific spinal cord stimulator lawsuits consolidated before U.S. District Judge Josephine L. Staton in the Central District of California, where the parties will address common discovery and other pretrial matters.

As the litigation moves forward, Judge Staton is expected to direct the parties to identify a group of representative claims for early bellwether trials. Although the outcomes will not determine how other cases are resolved, the test trials may provide insight into how juries respond to evidence and testimony likely to be presented repeatedly throughout the litigation.

The results may also influence spinal cord stimulator claims involving other manufacturers, including Abbott Laboratories, Medtronic and Nevro, which face similar allegations involving complications with their devices.

Spinal cord stimulator attorneys are currently reviewing potential claims for individuals who received spinal cord stimulators manufactured by Abbott, Boston Scientific, Nevro or Medtronic and subsequently experienced complications such as:

Individuals who experienced problems following an SCS implant may be eligible to pursue a spinal cord stimulator lawsuit. Case reviews are available at no cost, and claims are handled on a contingency fee basis, meaning attorneys are paid only if compensation is recovered.

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