Lawsuit Claims Abbott, Boston Scientific SCS Pre-Market Approval Supplements Caused Permanent Injuries

Woman alleges manufacturers altered SCS device batteries, firmware and stimulation features without new safety testing, leading her to suffer shocks, worsening pain and device failures that required surgical removal.

A Florida woman has filed a product liability lawsuit against Abbott Laboratories and Boston Scientific, alleging that spinal cord stimulator (SCS) devices implanted in her body were fundamentally altered after initial FDA approval, resulting in device failures that caused permanent injuries.

The complaint (PDF) was brought by Barbara Jarrett in the U.S. District Court for the Northern District of Florida on April 22. It names Abbott Laboratories, Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation as defendants.

Jarrett claims the manufacturers used hundreds of pre-market approval (PMA) supplements to change key aspects of their SCS devices, including battery systems, firmware and stimulation features, without undergoing new clinical testing or safety review.

As a result, she indicates that she experienced worsening pain, electrical shocks and multiple device malfunctions, ultimately requiring surgical removal of the implants. She goes on to say that fragments of the devices’ leads remain embedded in her body, preventing her from undergoing necessary MRI scans and contributing to long-term health complications.

Spinal Cord Stimulator Risks

Spinal cord stimulators are Class III medical devices designed to deliver electrical impulses to the spine to mask chronic pain signals. Because of their high-risk classification, they are subject to the FDA’s most stringent approval process, requiring manufacturers to demonstrate safety and effectiveness before marketing the products.

However, Jarrett alleges that after receiving initial PMA approval, both Abbott and Boston Scientific made sweeping changes to their SCS systems through more than 200 supplemental filings. These filings altered core features like waveform delivery, wireless programming and battery performance, which never required further FDA review.

Her case joins a growing number of spinal cord stimulator lawsuits filed in recent months. Many of the claims allege that Abbott Laboratories, Boston Scientific and other manufacturers introduced design modifications to their SCS devices without adequate testing or proper regulatory review, increasing the likelihood of failures. Complaints state that these changes have been associated with problems similar to those Jarrett suffered, such as lead migration or breakage, unexpected shocks, diminished pain relief and other neurological complications.

Spinal Cord Stimulator Failure Allegations

According to the lawsuit, Jarrett first received a Boston Scientific SCS implant in 2013, followed by additional surgeries due to complications such as lead migration. She later had an Abbott device implanted in 2021, yet alleges it also failed, causing burning sensations, ineffective pain relief and repeated malfunctions before it was ultimately removed.

During removal, doctors reportedly discovered fractured leads embedded in her spine and pelvis, leaving her unable to undergo MRI imaging needed to monitor her multiple sclerosis.

Jarrett claims the devices’ cumulative modifications significantly changed how they functioned and introduced new risks, yet the modified systems were never subjected to new clinical trials or publicly disclosed safety evaluations. As a result, she contends patients and physicians were misled into believing the implants were equivalent to the originally approved versions.

The complaint also points to a series of recalls, including multiple Class I recalls issued in 2023 for Abbott’s Proclaim SCS systems, which were linked to reports of painful shocks, sudden shutdowns and loss of therapy.

“As a direct and proximate result of the defective and misrepresented nature of the devices, Plaintiff suffered physical injury, worsening pain, emotional distress, and economic damages including medical expenses and loss of quality of life.”

— Barbara Jarrett v. Abbott Laboratories et al

Jarrett raises allegations of strict products liability, manufacturing defect, failure to warn, negligence, federal regulatory violations, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraudulent concealment, violation of consumer protection laws and unauthorized practice of medicine. 

She is seeking compensatory, statutory and punitive damages, alleging that the companies’ actions caused permanent physical injuries, emotional distress and significant medical expenses.

Spinal Cord Stimulator Lawsuits

Jarrett’s lawsuit joins a growing number of spinal cord stimulator claims being filed nationwide against several major medical device manufacturers.

In recent weeks, a group of plaintiffs pursuing cases against Abbott and Boston Scientific asked to have all federal SCS lawsuits involving those manufacturers consolidated before one judge in the Northern District of Illinois. They are seeking to establish a multidistrict litigation (MDL) to coordinate discovery and other pretrial proceedings in the litigation.

Both Abbott and Boston Scientific have pushed back against the proposal, maintaining that the cases involve different devices and do not center on a single, shared defect that would justify consolidation. They also argue that many lawsuits are already well into the litigation process and that centralization would offer little efficiency. Boston Scientific has further indicated that certain claims may be barred under federal preemption.

On April 16, the U.S. Judicial Panel on Multidistrict Litigation (JPML) announced it would hear arguments in late May over whether the Abbott and Boston Scientific SCS lawsuits should be consolidated.

Across the litigation, plaintiffs commonly allege that design and manufacturing flaws have left certain SCS systems prone to a range of complications, including devices failing to alleviate symptoms, while contributing to worsening pain, repeat surgeries and lasting health problems.

As more cases are filed, spinal cord stimulator injury lawyers continue to evaluate potential claims for individuals who experienced complications following implantation of these devices.

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