Consolidated Lawsuit Over Boston Scientific Spinal Cord Stimulator Problems Filed in MDL

Plaintiffs allege the implants caused painful electrical shocks, nerve damage and worsening chronic pain, while questioning whether the devices were adequately tested before receiving FDA approval.

Two consolidated complaints have been filed in the growing federal litigation over Boston Scientific spinal cord stimulator (SCS) implants, outlining allegations that the devices are prone to failure, may worsen chronic pain and were marketed without adequate warnings about the risks.

The filings include a Master Personal Injury Complaint detailing allegations against Boston Scientific, as well as a separate complaint challenging the U.S. Food and Drug Administration’s (FDA) original approval of the company’s spinal cord stimulation technology.

Dozens of Boston Scientific spinal cord stimulator lawsuits have been filed by individuals who say the manufacturer failed to provide the promised pain relief, instead causing painful electrical shocks, nerve damage, worsening chronic pain and complications that sometimes required additional surgery to remove the devices.

Boston Scientific Spinal Cord Stimulator Failure Allegations

Spinal cord stimulators are medical implants designed to treat chronic pain by disrupting pain signals on the way to the brain. Consisting of a battery-powered pulse generator and electrodes placed near the spine, as well as an external remote control, the implants are supposed to be permanent.

However, numerous recipients have reported spinal cord stimulator implant problems that include components migrating out of position, sometimes re-emerging through the skin, total device failures and electrode lead fractures.

As the number of Boston Scientific SCS implant lawsuits continued to grow, all federal claims were consolidated in June into a multidistrict litigation (MDL) in the Central District of California before U.S. District Judge Josephine L. Staton, who is overseeing coordinated discovery and pretrial proceedings, likely in preparation for a series of bellwether trials.

Boston Scientific SCS implant bellwether trials would give counsel an opportunity to see how juries respond to evidence and testimony likely to be repeated throughout the litigation. They will be selected from cases most representative of the lawsuits as a whole, and the outcomes could help set parameters for eventual settlement negotiations.

Boston Scientific Master Personal Injury Complaint

On October 23, plaintiffs’ attorneys filed a Master Personal Injury Complaint (PDF), outlining common allegations involving several Boston Scientific spinal cord stimulator systems, including Precision, Precision Spectra, Precision Montage and WaveWriter devices.

The complaint alleges Boston Scientific failed to properly manufacture its implants, adequately warn patients and doctors about known complications, and accurately represent the devices’ ability to provide lasting pain relief.

Plaintiffs also claim company sales representatives played an unusually active role in patient treatment, including adjusting implanted devices and responding to complications without consulting physicians. According to the filing, representatives allegedly downplayed device failures, made misleading assurances and encouraged patients to delay reporting problems to their doctors.

“SCS devices are associated with significant complications and poor clinical results, including inadequate effectiveness in providing the pain relief their manufacturers promise.”

— Boston Scientific Master Personal Injury Complaint

In a separate Consolidated Master APA Complaint (PDF), plaintiffs also challenge the FDA’s original 2004 approval of the Precision Spinal Cord Stimulator System, which served as the regulatory foundation for subsequent generations of Boston Scientific implants.

The lawsuit alleges federal regulators relied primarily on clinical studies involving other manufacturers’ devices, rather than sufficient evidence demonstrating the Precision system’s own safety and effectiveness. According to the complaint, the limited clinical data involving the Precision system included only 26 implanted patients and did not report effectiveness results.

Plaintiffs further argue that the FDA subsequently authorized substantial changes to the implants without adequately establishing that the modified devices remained safe and effective. They are asking the court to set aside the challenged approvals and require the agency to reconsider its decisions.

The FDA approval claims are proceeding on a separate legal track from the personal injury allegations against Boston Scientific.

Boston Scientific SCS Lawsuits Expected to Grow

The consolidated complaints were filed following an October 20 pretrial order (PDF), in which Judge Staton established deadlines for preparing the master complaints and a proposed standardized short-form complaint.

The short-form complaint process is intended to simplify future filings by allowing plaintiffs to identify their specific devices, injuries and legal claims while incorporating relevant allegations from the Master Personal Injury Complaint.

According to an October 30 joint status report and proposed agenda (PDF), the litigation involved 72 cases representing 84 individuals at that time, with plaintiffs’ attorneys anticipating an increase in filings once the short-form complaint process is established and additional state statutes of limitations approach.

Judge Staton has set a November 20 deadline for motions to dismiss the consolidated complaints, which could determine whether certain claims are allowed to proceed as the litigation moves toward discovery and potential bellwether trials.

Spinal Cord Stimulator Lawsuits

In addition to coordinating all Boston Scientific spinal cord stimulator lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has separately consolidated federal Abbott spinal cord stimulator lawsuits and Nevro spinal cord stimulator lawsuits in the Northern District of Illinois and the Northern District of California, respectively.

As the litigation continues to evolve, spinal cord stimulator lawyers are investigating potential claims involving SCS system complications and failures, including:

Individuals who experienced complications that may be associated with a defective implant can request a free evaluation to determine whether they may be eligible to pursue a spinal cord stimulator lawsuit. Attorneys investigating these cases handle claims on a contingency fee basis, with no upfront legal fees and payment only if compensation is recovered.

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