Lawsuit Alleges Spinal Cord Stimulator Shocks, Burns Caused by Manufacturing Defect

Man claims Abbott Laboratories failed to adequately disclose spinal cord stimular problems to federal regulators, patients and the medical community.

Abbott Laboratories faces a spinal cord stimulator lawsuit brought by a New Jersey man, who says he began experiencing serious complications that left him in more pain after the procedure than before.

The complaint (PDF) was filed by Luis A. Lebron Cruz in New Jersey federal court on May 29. It names Abbott Laboratories, the manufacturer, as the defendant, as well as numerous unnamed individuals and affiliated companies expected to be identified during the discovery process.

Lebron Cruz claims Abbott knew the spinal cord stimulator device implanted in him was associated with battery failures, loss of stimulation, lead migration and other complications through adverse event reports, yet failed to adequately warn physicians, patients and regulators.

Spinal Cord Stimulator Concerns

Several medical device manufacturers, including Abbott, Boston Scientific, Medtronic and Nevro make and sell spinal cord stimulators, which are implants designed to treat chronic pain. They consist of a small, battery-powered pulse generator that is placed under the skin, thin electrodes implanted near the spinal cord and connected to the generator, and a remote control for adjusting stimulation levels to maximize pain relief. 

While spinal cord stimulators are supposed to be permanent implants, a growing number of recipients like Lebron Cruz are now pursuing spinal cord stimulator lawsuits nationwide, indicating manufacturers designed and manufactured a defective implant that has resulted in numerous reports of shocks, burns, lead migrations and other complications that often result in the need for revision surgery to have the device surgically removed.

Spinal Cord Stimulator Pain Allegations

According to Lebron Cruz’s lawsuit, he was implanted with a Proclaim XR 5, Penta 3MM Paddle and NeuroSphere system for the treatment of chronic back pain.

However, about a year after the procedure, Lebron Cruz began experiencing problems, including intense burning sensations and electric shocks that appeared to emit from the battery implantation site. These shocks and burning sensations then radiated out through his lower extremities. Additionally, the plaintiff reports that his chronic pain has increased instead of being alleviated.

Lebron Cruz argues that Abbott knew the design was defective after receiving adverse event reports that included battery failures, painful shocks, loss of stimulation, leads migrating out of position and loss of effectiveness. However, it failed to address these problems and downplayed them to federal regulators.

“In many instances, adverse event descriptions were incomplete, delayed, or internally coded in a manner that obscured the true nature of the malfunction or injury. These omissions deprived the FDA, implanting physicians, and patients of material safety information that would have altered the risk-benefit analysis associated with use of the System.”

– Luis A. Lebron Cruz v. Abbott Laboratories et al.

The filing indicates the spinal cord stimulator remains implanted and continues to cause debilitating side effects.

As a result, Lebron Cruz presents claims of manufacturing defect, failure to warn, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, and violation of the New Jersey Consumer Fraud Act and the Illinois Consumer Fraud and Deceptive Business Practices Act. He seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

The lawsuit was filed just one day after the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments over whether to consolidate federal spinal cord stimulator lawsuits involving Abbott and Boston Scientific products.

At the time the complaint was filed, plaintiffs were asking the JPML to transfer all similar claims against both manufacturers to one judge in the U.S. District Court for the Northern District of Illinois, where the cases would undergo coordinated discovery and pretrial proceedings. However, the panel has since issued a transfer order that took a narrower approach.

Rather than creating a combined MDL for both manufacturers, the JPML centralized only the Boston Scientific spinal cord stimulator lawsuits, transferring those claims to the U.S. District Court for the Central District of California. The panel declined to include Abbott cases in the new proceeding, leaving those claims to move forward separately for now.

As more individuals come forward who have experienced problems caused by Abbott, Boston Scientific and other SCS devices, spinal cord stimulator injury attorneys continue evaluating claims for those suffering serious complications, including:

• Lead wire fractures or migration
• Painful electrical shocks or overstimulation
• Unexpected loss of pain relief
• Increased back pain or worsening nerve symptoms
• Revision procedures or surgical device removal
• Permanent nerve injuries
• Long-term spinal cord damage

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

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