Boston Scientific SCS Lawsuit Filed Over Problems With WaveWriter Alpha System

Lawsuit claims that the entire SCS system had to be surgically removed after lead wires migrated out of position, causing the implant to fail.

A product liability lawsuit claims that Boston Scientific’s spinal cord stimulator (SCS) failed when leads designed to deliver electrical pulses migrated out of position, leading to a need for revision surgery and failing to alleviate a man’s back pain.

The complaint (PDF) was filed by Kenneth Davis in the U.S. District Court for the Northern District of Mississippi on February 9, naming Boston Scientific Corporation and the U.S. Food and Drug Administration (FDA) as defendants, saying the agency failed in its duty to adequately screen the SCS before approving it for medical use.

Spinal cord stimulators are implantable medical devices designed to manage chronic pain through the delivery of electrical impulses to the spinal cord, which are intended to interfere with pain signals before they reach the brain. The systems typically include thin wires, known as leads, placed near the spinal cord and a battery-powered pulse generator implanted under the skin, often near the lower back or buttocks. Patients can adjust stimulation levels using an external controller.

Many of the devices, marketed by a number of manufacturers, were approved under the FDA’s 510(k) program, which allows rapid approval for devices that are substantially equivalent to products already on the market and proven safe. However, Davis and other plaintiffs say the devices never should have been approved due to having added features and redesigns, which have not yet been adequately tested and place them far outside of the parameters of the original first generation of SCS implants.

As a result of these concerns, Boston Scientific and other manufacturers face an increasing number of SCS lawsuits brought by individuals nationwide who allege the devices were promoted and allowed to remain on the market under outdated regulatory clearances after significant design changes. Many of the lawsuits claim that those products later failed in ways that caused lead movement, erratic stimulation and the need for additional corrective or removal surgeries.

Davis, of Mississippi, was implanted with a Boston Scientific SCS in July 2022. The implant included a WaveWriter Alpha implantable pulse generator for the treatment of Davis’s chronic pain problems.

The lawsuit indicates he was told by Boston Scientific sales representatives that the WaveWriter would lead to significantly more pain reduction and would be easier to use. A sales representative also programmed the device immediately after surgery and reprogrammed the device multiple times, the complaint states.

However, by March 2023 doctors discovered that the Boston Scientific SCS lead wires had migrated out of position, after which the WaveWriter stopped functioning and the entire system was surgically removed in October 2024.

According to Davis, neither he nor his doctor were told that the WaveWriter Alpha pulse generator had never received independent validation through a new device application.

“Boston Scientific aggressively marketed its WaveWriter Alpha system and other upgraded models as offering superior pain relief through innovative stimulation patterns, despite the absence of independent premarket clinical testing validating the long-term safety and effectiveness of these substantial modifications.”

– Kenneth Davis v. Boston Scientific Corporation et al

The lawsuit also accuses the FDA of failing to notice that the device had deviated far from the original 510(k) predecessor and failed to enforce the law by requiring a full application or evidence that it was substantially equivalent to previous devices.

Davis presents claims of manufacturing defect, failure to warn, negligence per se and breach of federal regulatory duties, breach of warranty, fraudulent misrepresentation, negligent misrepresentation, negligence per se for practicing medicine without a license, and also seeks administrative and injunctive relief from the FDA.

SCS Injury Lawsuits

The WaveWriter Alpha SCS is one of several devices manufactured by Boston Scientific, Abbott, Medtronic and others that have been targeted in a series of spinal cord stimulator lawsuits. Many of these complaints indicate that defective SCS designs led to serious complications, including:

• Revision surgery to reposition or replace device components
• Complete removal (explant) of a spinal cord stimulator
• Permanent nerve damage or neurological injury
• Worsening or uncontrolled pain after implantation
• Infections or other serious post-surgical complications
• Device failures involving leads, batteries, charging or power delivery
• Long-term disability or loss of quality of life
• Deaths potentially linked to complications from implanted spinal cord stimulators

Spinal cord stimulator lawyers are pursuing claims for individuals on a contingency-fee basis, meaning there are no upfront costs, and attorney fees are only paid if compensation is obtained through a settlement or trial verdict.