All three plaintiffs in this latest lawsuit experienced similar complications and injuries after being implanted with the Abbott Proclaim XR SCS, both related to the design of the implant and the actions of Abbott’s sales representatives. In addition, all three say the FDA should have prevented the device from hitting the market without adequate testing.

Electric Shocks and Bladder Incontinence

Furia was implanted with an Abbott Eterna SCS in 2024 after being told by Abbott sales representatives that the implant would relieve most of her back pain. 

Instead, she indicates the device not only gave minimal pain relief but also caused her to suffer bladder incontinence and electric shocks.

Revision Surgery After Leads Protrude Through Skin

In the case of Maroulis, she first underwent a routine trial implantation of an Abbott spinal cord stimulator in January 2023. These temporary test implants are commonly used to determine whether the therapy provides sufficient pain relief before surgeons proceed with a permanent device.

After the short trial period, the temporary device was removed and Maroulis received a permanent spinal cord stimulator implant in March. However, less than two months later she required revision surgery after discovering the device’s electrical leads were protruding through her skin. When the revision procedure failed to correct the problem, doctors ultimately removed the spinal cord stimulator entirely.

Nerve Damage, Electric Shocks and Worsening Pain

The third plaintiff, McClellan also says she was first implanted with a trial device before receiving the permanent version in June 2021. However, she indicates that the trial device was more effective at preventing pain than the permanent one.

McClellan suffered numbness, loss of feeling in extremities, bladder incontinence, electric shocks, burning sensations around the implant and worsening pain. While the device was removed due to health complications, McClellan reports still suffering pain and symptoms that may have been worsened by the failed device.

All three plaintiffs indicate that there was heavy involvement of Abbott sales representatives, who often met with patients outside of the presence of their doctors, and made adjustments to the programming of the devices without proper medical training.

The women present claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, violation of consumer protection laws, unauthorized practice of medicine, and a claim of violations of the Administrative Procedure Act against the FDA.

SCS Injury Lawsuits

Last month, a group of plaintiffs filed a motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for all SCS injury lawsuits to be consolidated into a multidistrict litigation, or MDL, in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

To date, spinal cord stimulator lawsuits have been filed against Abbott, Boston Scientific and Medtronic, who all have SCS models on the market. Litigation is expected to grow against those companies and other SCS manufacturers for individuals who suffered injuries such as:

• Lead wire fracture or migration
• Electrical shocks or overstimulation
• Sudden loss of pain relief
• Worsening chronic back or nerve pain
• Revision surgery or device removal
• Permanent nerve damage
• Long-term spinal cord complications

All spinal cord stimulator injury lawsuits are handled on a contingency-fee basis, meaning there are no upfront costs, and attorney fees are only paid if compensation is obtained through a settlement or trial verdict.

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