Boston Scientific, a major manufacturer of medical devices, issued an Urgent Medical Device Advisory for certain WaveWriter Alpha™ spinal cord stimulator systems and is now named in product liability lawsuits brought by patients who allege they were harmed. Boston Scientific’s SCS systems, including the WaveWriter™ and Precision-series devices, are implanted in patients to help treat chronic pain conditions in the back and leg. They are designed to disrupt pain signals traveling to the brain. However, some patients have reported serious complications after having the device implanted, requiring additional treatment or even revision or removal surgery.
Wisner Baum has extensive experience handling medical device lawsuits and is currently accepting spinal cord stimulator lawsuits. Individuals who have experienced Boston Scientific spinal cord stimulator problems are encouraged to contact Wisner Baum at (310) 207-3233 to schedule a free case evaluation.
June 2026: The U.S. Judicial Panel on Multidistrict Litigation granted consolidation in part, creating a multidistrict litigation (MDL No. 3181) for Boston Scientific spinal cord stimulator cases. Per the JPML order, federal claims will be consolidated in the U.S. District Court for the Central District of California before Judge Josephine L. Staton. Pending and newly filed federal cases involving Boston Scientific systems may be transferred into the MDL for coordinated pretrial proceedings.
May 2026: The Judicial Panel on Multidistrict Litigation heard oral argument on the petition to consolidate the spinal cord stimulator cases. Boston Scientific and Abbott opposed consolidation, arguing that the claims involve different products and alleged defects that do not share enough common questions to warrant a single proceeding.
February 2026: Plaintiffs with lawsuits against spinal cord stimulator manufacturers—including Abbott and Boston Scientific—filed a motion asking the U.S. Judicial Panel on Multidistrict Litigation to consolidate their cases into a single Multidistrict Litigation (proposed MDL No. 3181) in the Northern District of Illinois. Consolidation would streamline pre-trial proceedings while allowing each case to remain independent. As of this writing, the panel has not ruled on the request, and the manufacturers are opposing consolidation.
January 2026: Lawsuits accuse Boston Scientific of using the FDA’s PMA supplemental process to make material modifications to its spinal cord stimulator systems without having to undergo more rigorous testing. Legal documents allege that an adequate disclosure was not made to patients and providers about the potential safety impact of these changes.
October 2025: A lawsuit was filed in the U.S. District Court in Central California alleging Boston Scientific failed to disclose material risks associated with its SCS devices and that its WaveWriter™ device contained a manufacturing defect that caused serious harm to a patient.
July 2024: Boston Scientific issued an “Urgent Medical Device Advisory” for certain lots of its WaveWriter Alpha™ SCS systems. According to the advisory, the company had received patient reports that the device would suffer a suspension of therapeutic benefit during charging. Boston Scientific noted that it was updating its firmware to help alleviate the problem.
Boston Scientific manufactures a wide range of medical devices for spinal cord stimulation, including the WaveWriter Alpha™, WaveWriter Alpha™ Prime™, and Spectra WaveWriter™ series. The company also continues to market the Precision Montage™ SCS system.
These devices are indicated to aid in the management of chronic, intractable pain in the back or legs. The device is implanted near the spinal cord and sends electrical stimulation designed to disrupt the nerve signals sent to the brain.
Boston Scientific spinal cord stimulation devices may be used for patients with:
In December 2020, Boston Scientific received FDA approval for its WaveWriter Alpha™ portfolio of spinal cord stimulation devices, nearly three years after receiving FDA approval for the Spectra WaveWriter™ system in January 2018. Since then, Boston Scientific has sought a number of PMA supplements which allow it to make changes to the device or indications for use without having to go through the rigorous premarket approval process again or clinical studies.
On February 5, 2024, the FDA issued a PMA supplement approval for Boston Scientific’s Spectra WaveWriter™ SCS System, WaveWriter Alpha™ SCS System, and WaveWriter Alpha Prime™ SCS System. This supplement expanded the indications for use to include treatment of chronic, intractable low back and leg pain without prior back surgery.
According to the approval, these devices are implanted into the body and generate electrical stimulation designed to block pain signals that are sent to the brain. The devices include sub-perception and multiwaveform modes that offer customized pain relief to patients.
Components of the WaveWriter SCS systems:
The WaveWriter SCS systems have recently been the subject of multiple lawsuits and an urgent safety advisory. Individuals who have experienced complications after having a Boston Scientific spinal cord stimulator implanted are encouraged to speak with an attorney at Wisner Baum to discuss the potential for taking legal action if they meet lawsuit qualifications.
According to a recent safety advisory, FDA adverse data, and legal documents, there have been a number of reported concerns with Boston Scientific spinal cord stimulators.
Alleged problems with Boston Scientific spinal cord stimulators (SCS):
In some instances, patients have reported having to undergo revision or removal surgery as a result of the complications.
Multiple legal claims have been filed against Boston Scientific alleging their spinal cord stimulators contained manufacturing defects. Lawsuits also accuse the company of failing to warn patients and providers about the potential safety risks associated with use of the device, negligent marketing, breach of warranty, and misrepresentation.
Another allegation made against the company is that it used regulatory loopholes to circumvent additional clinical testing through the PMA supplemental process of the FDA. After premarket approval, which is a rigorous approval process, companies may make minor modifications or changes to the indications for use of a device by filing a PMA supplement. Legal documents allege that Boston Scientific used this process to make material changes to the SCS devices without additional clinical testing, essentially depriving patients and providers of adequate safety information.
Individuals who suffered complications after having a Boston Scientific spinal cord stimulator implanted may be able to take legal action against the company. However, in order to file a lawsuit, individuals must meet certain qualifications.
Qualifying factors for a Boston Scientific spinal cord stimulator lawsuit:
Individuals are encouraged to contact Wisner Baum at (310) 207-3233 for a free case evaluation to determine if they qualify for a Boston Scientific spinal cord stimulator lawsuit.
When a medical device fails it can have a devastating impact on a person’s life. Whether it does not provide the intended relief or causes additional harm, its manufacturer should not only be made aware of the problem but also held accountable for any negligence or wrongdoing. Wisner Baum has decades of experience seeking justice for those injured by dangerous or defective medical devices.
Our lawyers are here to help you during these challenging times. If you or a loved one have been harmed by a Boston Scientific spinal cord stimulator, contact Wisner Baum at (310) 207-3233 for a free, confidential case review. Contacting the firm does not mean you have to file a lawsuit, it only provides you with clarity about your options and whether you may qualify to take legal action. Cases are handled on a contingency fee basis, meaning there are no fees unless compensation is recovered on your behalf.
"Wisner Baum gave exceptional attention to all aspects of the case, detailed inquiry, and tenacious overview of all the information submitted. The paralegals are efficient and diligent. I was completely surprised to find an empathic personal message to take care of my own health during the challenging time of being a full-time caretaker.*"
In May of 2019, the jury in the case of Pilliod et al. v, Monsanto Company ordered the agrochemical giant to pay $2.055 billion in damages to the plaintiffs, Alva and Alberta Pilliod, a Bay Area couple in their 70s. R. Brent Wisner served as co-lead trial attorney for the Pilliods, delivering the opening and closing statements and cross-examining several of Monsanto’s experts. Wisner Baum managing shareholder, Michael Baum and attorney Pedram Esfandiary also served on the trial team in the Pilliod case.
The judge later reduced their award to $87M. Monsanto appealed the Pilliod’s verdict which the California Court of Appeal for the First Appellate District denied on August 9, 2021. Monsanto then requested the California Supreme Court review the appeal’s court decision, which the court denied on Nov. 17, 2021. Monsanto (Bayer) then submitted a petition for a writ of certiorari with the U.S. Supreme Court which SCOTUS denied on June 27, 2022, allowing the final judgment of $87M to remain intact.
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Wisner Baum co-represented Dewayne “Lee” Johnson in the first Roundup cancer lawsuit to proceed to trial. On Aug. 10, 2018, a San Francisco jury ordered Monsanto to pay $39.25 million in compensatory damages and $250 million in punitive damages to Mr. Johnson, a former groundskeeper who alleged exposure to Monsanto’s herbicides caused him to develop terminal non-Hodgkin lymphoma.
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In 2016, Wisner Baum attorney Timothy A. Loranger and six other attorneys in the Plaintiffs’ Management Committee were able to secure a $265 million settlement for victims of the 2015 Amtrak 188 derailment in Philadelphia, one of the largest in the U.S. for 2016.
Yes, multiple problems have been alleged regarding Boston Scientific spinal cord stimulators, including the WaveWriter™ and Precision™ series. These problems may include lead migration, interruption to therapeutic benefit, lead fracture, device malfunction, battery depletion, and more.
While the Boston Scientific spinal cord stimulators have not been the subject of a full recall, patients and providers received an “Urgent Medical Device Advisory” about the potential for certain versions of the WaveWriter™ to suffer a disruption in therapy during charging.
Individuals who suffered complications related to a Boston Scientific spinal cord stimulator may be able to take legal action. Impacted patients are encouraged to speak with a Wisner Baum lawyer to determine if they meet the qualifications to file a lawsuit.
Individuals who file a successful Boston Scientific SCS lawsuit may be eligible for compensation, including recovery related to medical bills, lost wages, pain and suffering, impact on quality of life, and more.
While statutes of limitations are state-specific, patients generally have 1 to 3 years from the date of injury or date the injury was discovered to file a lawsuit against the manufacturer of a medical device.
Individuals seeking to file a claim against Boston Scientific related to the alleged failure of a spinal cord stimulation device must be able to prove that they suffered qualifying complications. This is generally done through medical records, including a diagnosis and treatment plan.
