Abbott Faces Spine Stimulator Lawsuit Brought Jointly by 17 Injured Patients

The case is one of a growing number of spinal cord stimulator lawsuits filed against various manufacturers in recent months, alleging defective devices failed or caused painful electrical shocks, requiring removal surgery.

Seventeen individuals from across the country have joined together to file a product liability lawsuit against Abbott Laboratories, alleging that the company sold defective and unreasonably dangerous spinal cord stimulator (SCS) systems that failed to relieve chronic pain, and instead caused severe neurological complications, worsening symptoms and other permanent injuries.

The complaint (PDF) was brought in the U.S. District Court for the Northern District of California on July 13 by Clive Mair and 16 other plaintiffs from California, Arizona, Florida, Oklahoma, Texas, Pennsylvania, Ohio, Georgia, Louisiana, Tennessee, Indiana and Illinois.

According to the lawsuit, each plaintiff underwent implantation of an Abbott spine stimulator to treat chronic pain after the company represented the devices as safe and effective.

However, the complaint alleges all of the implants malfunctioned or failed to provide adequate pain relief, leaving patients with complications that often required additional medical treatment or revision procedures.

Spinal Cord Stimulator Problems

Spinal cord stimulators are implanted medical devices designed to manage chronic pain by sending electrical impulses through electrodes placed near the spinal cord. The system includes an implanted pulse generator (IPG) powered by a battery. Patients can adjust stimulation levels using a handheld controller.

However, a number of reports in recent years have linked spinal cord stimulators from several manufacturers to device malfunctions and serious complications, with some patients requiring revision or removal surgery shortly after implantation. Alleged problems include battery depletion, unexpected device shutdowns, painful electrical shocks, burning sensations, worsening pain, neurological injuries and leads that fracture, migrate or erode through the skin.

Patients pursuing spine stimulator lawsuits claim manufacturers marketed defective devices without adequately disclosing the risks to physicians or consumers. The complaints seek damages for medical bills, lost wages, revision surgeries, pain and suffering, permanent injuries and other losses allegedly resulting from the failed implants.

Abbott Spinal Cord Stimulator Injury Allegations

The lawsuit indicates Abbott’s spinal cord stimulator systems originally received U.S. Food and Drug Administration approval in 2001. However, plaintiffs claim the company substantially altered the devices over the following years through dozens of premarket approval supplements that changed the battery chemistry, firmware, waveform controls, leads and user interface.

According to the complaint, those cumulative modifications fundamentally changed how the devices functioned without requiring a new premarket approval application or additional clinical testing to establish the safety and effectiveness of the redesigned systems.

Plaintiffs allege Abbott failed to disclose the extent of those changes to physicians, patients and regulators, leaving consumers implanted with devices that differed materially from the versions originally evaluated by the FDA.

The complaint contends the altered spinal cord stimulators were defectively designed and unreasonably dangerous, causing patients to suffer painful neurological symptoms, worsening chronic pain and potentially permanent injuries.

Plaintiffs further allege Abbott continued marketing the devices despite knowing about safety concerns and failed to adequately warn physicians and patients about the risks associated with the modified systems.

“Abbott’s conduct was knowing, deliberate, and reckless. It knowingly placed a materially altered medical device into the stream of commerce, misrepresented its safety and approval status, and failed to correct known defects through regulatory pathways available under federal law.”

— Clive Mair et al. v. Abbott Laboratories

The lawsuit raises allegations of manufacturing defect, failure to warn, negligence per se, breach of express warranty, breach of implied warranty of merchantability, negligence, negligent misrepresentation, fraudulent concealment, violation of consumer protection laws and unauthorized practice of medicine. It seeks compensatory, statutory, punitive and exemplary damages.

Spinal Cord Stimulator Lawsuits

The joint complaint is part of a broader wave of product liability lawsuits being pursued against Abbott and other spinal cord stimulator manufacturers over allegations that defective implants malfunctioned, delivered painful electrical shocks or failed to provide the promised pain relief.

As a growing number of claims have been filed throughout the federal court system over the past year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has been asked to establish several separate coordinated proceedings to help manage pretrial proceedings in the cases.

There is currently a pending motion seeking to centralize all Abbott Laboratories spinal cord stimulator lawsuits before one judge in the U.S. District Court for the Central District of California, to avoid duplicative discovery into common issues. The panel is expected to hear oral arguments on the motion this Fall.

A similar motion seeks to establish a separate consolidation for Nevro spinal cord stimulator lawsuits filed in U.S. Courts against that competing manufacturer.

In addition, dozens of Boston Scientific spinal cord stimulator lawsuits have already been consolidated in the Central District of California before U.S. District Judge Josephine L. Staton, who is expected to meet with the parties next month for an initial status conference.

As the litigation continues to move forward, spinal stimulator lawyers are reviewing hundreds of additional potential claims on behalf of individuals who experienced complications after receiving Abbott, Boston Scientific, Nevro or Medtronic spinal cord stimulators, including:

Individuals who believe they or a loved one suffered injuries caused by a defective spinal cord stimulator may qualify to pursue a spinal cord stimulator lawsuit for medical expenses, lost wages, pain and suffering and other damages. Attorneys are offering free case evaluations, and claims are handled on a contingency fee basis, meaning there are no legal fees unless compensation is recovered.

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