WaveWriter Alpha Lawsuit Claims Defective Spinal Cord Stimulator Caused Pain and Surgical Removal

Unlicensed Boston Scientific sales representatives allegedly told plaintiff they were the only ones allowed to reprogram the WaveWriter Alpha system.

Boston Scientific and the U.S. Food and Drug Administration (FDA) face a lawsuit from a Louisiana man who says his WaveWriter Alpha spinal cord stimulator was defectively designed by the manufacturer and should never have been allowed to enter the market.

The complaint (PDF) was filed by Tone Silas in the U.S. District Court for the Central District of California on April 7, with Boston Scientific and the FDA listed as the defendants. It is one of an increasing number of complaints over the design and employment of spinal cord stimulator implants meant to relieve pain through the use of electrical pulses that have been linked to failures, worsening pain, electrical shocks and the need for revision surgery.

Spinal cord stimulators like the WaveWriter Alpha system are neuromodulation devices with electrical pulses that are supposed to interrupt pain signals before they reach the brain. They are typically implanted in individuals suffering from chronic back, leg or nerve pain after other treatments have failed.

SCS devices consist of a battery-powered pulse generator implanted under the skin, thin electrical leads positioned along the spinal cord and an external controller that allows doctors or patients to adjust stimulation levels. After implantation, they become a permanent part of the person’s body.

Silas’s claim joins other spinal cord stimulator lawsuits filed in recent months, alleging that the latest generation of these implants were not properly tested before being placed on the market. Each contains similar allegations that implants like the WaveWriter Alpha were approved by the FDA’s 510(k) fast-track approval program, which only requires devices be “substantially equivalent” to existing medical devices without the need for intensive testing.

Plaintiffs say the agency should have never approved these implants without more rigorous testing and failed in its duty to ensure that only safe medical devices are allowed on the market.

Boston Scientific WaveWriter Lawsuit

Silas’s lawsuit indicates he was implanted with a Boston Scientific WaveWriter Alpha system in January 2024 for the treatment of chronic pain. However, before receiving the permanent implant, , he underwent a trial period with a temporary unit intended to replicate its functionality and pain relief.

According to the lawsuit, the two devices were far more different than Silas was originally led to believe by Boston Scientific sales representatives. These representatives also insisted on reprogramming the device themselves to help maximize the effectiveness of the electrical pulses, despite lacking the needed medical training. They never told Silas that the device was approved without independent clinical testing, instead relying on data from older devices despite clearly making radical changes to how they function, Silas indicates.

Silas initially reported the expected level of pain relief following implantation. However, by April 2024, he began experiencing sharp, shooting pain in his hip and abdomen, while the device’s effectiveness steadily declined. Despite multiple reprogramming attempts by Boston Scientific representatives, the WaveWriter Alpha system was ultimately removed about a year later.

“During the time in which the SCS system was implanted in Plaintiff, Boston Scientific representatives, believed to be unlicensed in the State of Louisiana, or elsewhere for that matter, actively participated in implanting the WaveWriter Alpha, and programming and waveform selection post-operatively. 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.”

– Tone Silas v. Boston Scientific Inc. et al

Despite their lack of licensing, Silas indicates he was informed that only Boston Scientific sales representatives were allowed to program the WaveWriter Alpha system, instead of a trained medical doctor.

Silas presents claims of manufacturing defect, failure to warn, negligence, breach of warranty, fraudulent misrepresentation and concealment, negligent misrepresentation, violations of the Louisiana Unfair Trade Practices and Consumer Protection Law, negligent practicing medicine without a license, and violation of the Administrative Procedure Act by the FDA. He seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

Boston Scientific is not the only manufacturer facing spinal cord stimulator lawsuits, which have also been filed nationwide against Abbott Laboratories, Medtronic and other medical device manufacturers for the same problems.

In March a group of plaintiffs pursuing similar SCS claims against Boston Scientific and Abbott asked to centralize all of those federal cases before a single judge in the Northern District of Illinois, seeking to establish a multidistrict litigation (MDL) to coordinate the proceedings.

Both Boston Scientific and Abbott are urging the U.S. Judicial Panel on Multidistrict Litigation (JPML) to reject the motion for consolidation, claiming the cases involve different products and lack a common defect that would justify consolidation. They also indicate many of the lawsuits are fairly advanced and that consolidation would not offer any increase in efficiency. In addition, Boston Scientific claims the lawsuits will likely be dismissed because they are preempted by federal law.

The JPML is expected to schedule oral arguments on the issue sometime this summer.

As more claims are filed, spinal cord stimulator attorneys are continuing to evaluate potential lawsuits on behalf of individuals who experienced adverse outcomes following implantation of these kinds of devices.

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