Abbott Proclaim SCS Lawsuit Alleges Stimulator Lead Migration Resulted in Multiple Surgeries

Lawsuit claims Abbott sales reps kept making programming adjustments to the spinal cord stimulator (SCS), which they said would provide relief. However, they were unaware the leads had moved out of position.

Instead of receiving pain relief from her Abbott Proclaim SCS (spinal cord stimulator), a North Carolina woman has filed a lawsuit against the manufacturer, indicating that she was forced to undergo numerous reprogramming sessions, only to discover the leads required to provide stimulation had migrated out of position.

The complaint (PDF) was brought by Brandie Melby in the U.S. District Court for the Northern District of Illinois on March 13, naming Abbott Laboratories and the U.S. Food and Drug Administration (FDA) as defendants.

Spinal cord stimulators are surgically implanted devices designed to help patients suffering from severe, chronic back pain. The implants are supposed to send small electrical pulses to the spinal cord, interrupting pain signals before they reach the brain.

The systems include 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. Once implanted, the device becomes a permanent part of the patient’s body.

Both Abbott and its competitors, Boston Scientific and Medtronic, have introduced various versions of spinal cord stimulators (SCS) over the last two decades. However, Melby and other plaintiffs are now pursuing litigation against the manufacturers, indicating that major design changes have been made during the past few years, even though the devices were approved through the FDA’s fast track 510(k) approval process.

Under these rules, manufacturers only have to show that their new devices are “substantially equivalent” to an existing, approved device, something Melby and other plaintiffs say the companies take advantage of to release untested products on the market. Because of the vague definition of “substantially equivalent,” those plaintiffs also say the FDA has failed in its duty to keep dangerous and defective medical devices off the market.

Individuals filing these spinal cord stimulator lawsuits now indicate that they have been left with various different problems, including sudden jolts of electricity, burning sensations and leads migrating out of position, often resulting in the need for multiple surgical procedures or attempts by company sales representatives to reprogram the devices.

According to Melby’s lawsuit, she was surgically implanted with an Abbott Proclaim XR5 spinal cord stimulator system in April 2022 for the treatment of chronic back pain. However, before agreeing to receive the SCS, which was supposed to be permanent, Melby underwent a trial period with a temporary device.

Once she agreed that the trial device had caused significant pain relief, Abbott sales representatives convinced her to undergo the full procedure. However, Melby indicates that after a short stint of pain relief, the device failed to work as advertised or expected.

This led to the Abbott sales representatives making several adjustment to the devices, the lawsuit notes, advising her that the device just needed to be dialed in to begin working. Those efforts failed, and in July 2023, Melby’s doctor discovered that the leads had migrated out of position. As a result, she was forced to undergo a complex revision surgery the next month.

Melby says the Abbott sales representatives told her they were the only ones who could reprogram the device and provided her with advice about the system, even though they were not qualified to provide medical treatment. She indicates the lead migration may have been found earlier if the device’s programming had been left in the hands of trained professionals.

“This medical advice was negligently given and was incorrect on several occasions. Further, this advice led Plaintiff to make medical decisions that were detrimental to her wellbeing and overall pain management treatment.”

– Brandie Melby v. Abbott Laboratories et al

The lawsuit presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, violation of the Administrative Procedure Act, and violations of North Carolina general statute laws.

Abbott Spinal Cord Stimulator Lawsuits

Melby’s complaint comes as a group of plaintiffs with similar spinal cord stimulator lawsuits against Abbott and Boston Scientific seek to have all federal claims filed nationwide consolidated before one judge as part of a multidistrict litigation (MDL) for coordinated pretrial proceedings in the Northern District of Illinois.

The plaintiffs say consolidation will serve the convenience of the parties, the court and witnesses involved in claims currently spread throughout the federal court system. Establishing an MDL will also help avoid contradictory rulings from different judges and the duplication of discovery efforts.

If the U.S. Judicial Panel on Multidistrict Litigation (JPML) grants the motion for transfer, it is expected that the judge appointed to preside over the litigation may prepare a small group of cases for early “bellwether” test trials, to see how juries respond to evidence and testimony likely to be repeated throughout the litigation.

While the outcome of such early test trials are not binding on other cases, they may help drive a potential spinal cord stimulator lawsuit settlement agreement, which could resolve the litigation without the need for hundreds, perhaps thousands, of individual trials.

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