Abbott Sales Reps Kept Trying to Reprogram Failed SCS Implant: Lawsuit

Spinal cord stimulator was surgically removed due to mechanical and therapeutic failure less than a year after being implanted.

A Texas man has filed a product liability lawsuit accusing a medical device manufacturer’s sales representatives of preventing him from receiving proper medical treatment when his spinal cord stimulator (SCS) implant failed.

The complaint (PDF) was brought by Homer Bailey in the U.S. District Court of the Northern District of Illinois on October 27. Abbott Laboratories Inc., the manufacturer of the Proclaim Spinal Cord Stimulator System, is named as the defendant.

Bailey, along with numerous other individuals filing lawsuits, claim that not only did Abbott design, manufacture and market a defective medical implant, but the company also deployed sales representatives who overpromised the beneficial effects of SCS implants, regularly assessed the effectiveness of the devices, and reprogramed them despite not being licensed physicians.

Spinal Cord Stimulator Failures

Abbott’s Proclaim is one of several spinal cord stimulation systems designed to treat chronic pain through electrical impulses. The devices consist of a battery-powered pulse generator implanted beneath the skin, electrodes positioned near the spinal cord and an external controller used to adjust stimulation settings.

These implants are intended to provide long-term pain relief by delivering electrical impulses that interfere with pain signals traveling through the spinal cord to the brain. They are generally used when other treatments have failed to provide adequate relief.

However, a growing number of recipients have reported problems involving spinal cord stimulator lead fractures and migration, which can cause the devices to malfunction or deliver stimulation to unintended areas. These complications may result in painful electrical shocks, worsening chronic pain, nerve injuries and the need for additional surgery to repair or remove the implants.

Individuals who experienced these and other complications are now pursuing spinal cord stimulator lawsuits against manufacturers including Abbott, Boston Scientific, Medtronic and Nevro.

The lawsuits raise allegations that manufacturers failed to adequately address known problems with their devices, including changes to stimulation technology, programming software and other components that plaintiffs claim increased the risk of serious complications without sufficient testing or warnings.

Abbott Spinal Cord Stimulator Reprogramming Allegations

According to the lawsuit, Bailey was implanted with the Abbott Proclaim XR5 SCS System in January 2024, for the treatment of chronic pain. Before the permanent implant, he was given an external SCS system for a short trial period to make sure the implant would be effective.

The lawsuit notes that during the process, Bailey met with several Abbott sales representatives, who did not have medical licenses. These individuals allegedly advised Bailey that the permanent implant would be just as effective as the trial device.

However, the lawsuit states it was not.

“On multiple occasions, Plaintiff reported to the Abbott sales representatives that he was experiencing ineffective pain relief and was experiencing unexpected and painful shocking from the SCS device. The representatives represented to him that the complications could be alleviated through programming adjustments, and that the pain relief would be increased through these adjustments.”

– Homer Bailey v. Abbott Laboratories Inc.

In addition to the lack of pain relief, Bailey reported worsening pain as time went on. He underwent additional surgery to have the device removed in October 2024 due to mechanical and therapeutic failure. In light of these conditions, Bailey claims there was no way the sales representatives could have programmed the device so that it was functioning properly. He also indicates they never suggested to him that the implant itself may have failed.

Bailey presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraud and fraudulent concealment, and unauthorized practice of medicine. He seeks both compensatory and punitive damages.

SCS Implant Lawsuits

The complaint will be consolidated with other Abbott SCS implant lawsuits in the Northern District of Illinois as part of a multidistrict litigation before U.S. District Judge Lindsay C. Jenkins, for coordinated discovery and pretrial proceedings. Similar MDLs have been formed for all Boston Scientific SCS implant lawsuits  and Nevro spinal cord stimulator lawsuits in the Central District of California and the Northern District of California, respectively.

The judges are expected to begin preparing for the selection of representative claims to serve as bellwether early test trials, the results of which could help in the negotiation of SCS implant lawsuit settlements.

Meanwhile, spinal cord stimulator lawyers continue to review claims of injuries caused by implant system problems, including:

Individuals who believe they may qualify for a spinal cord stimulator lawsuit can request a free case evaluation. Attorneys handling these claims work on a contingency fee basis, meaning there are no upfront costs and fees are only collected if compensation is recovered.

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