Boston Scientific Pacemaker Lawsuit Claims Recalled Device Caused Life-Threatening Situation

Lawsuit indicates Boston Scientific pacemaker was included in a Class I recall issued nearly a decade after implantation, which affected about 48,000 devices.

A Washington woman has filed a Boston Scientific pacemaker lawsuit alleging that a recalled cardiac device malfunctioned more than a decade after implantation, causing a life-threatening emergency that required urgent surgery.

The complaint (PDF) was brought by Sherri Walling and her husband, Cameron Walling, in Massachusetts Superior Court on February 20, naming Boston Scientific Corporation and other unidentified entities involved in the design, manufacture and distribution of the device as defendants. 

Pacemakers are small medical products implanted in the chest to help control abnormal heart rhythms by sending electrical signals to keep the heart beating at a normal, steady rate when it is too slow or irregular.

However, when a pacemaker malfunctions or contains design defects, life-threatening complications may occur. As a result, numerous pacemaker recalls and lawsuits have been brought in recent years.

Earlier this month, a Medtronic lawsuit was filed claiming that a defective Azure dual-chamber pacemaker caused dangerous heart rhythm problems and abnormal electrical signals for a Connecticut woman, ultimately requiring invasive surgery to remove and replace the device.

Similar manufacturing defect allegations have also been raised against Medtronic, Boston Scientific and other manufacturers in a growing number of spinal cord stimulator lawsuits. Like pacemakers, spinal cord stimulators are implantable medical devices that rely on electrical signals to regulate the body.  Plaintiffs in those complaints claim that manufacturing or design defects caused them to experience unnecessary shocks or burns from the lead wires.

According to the new lawsuit, Mrs. Walling was surgically implanted with a Boston Scientific Model K174 Pacemaker on February 21, 2013. She goes on to point out that nearly a decade later, on June 3, 2021, Boston Scientific, in conjunction with the U.S. Food and Drug Administration (FDA), issued a Class I recall for approximately 48,000 pacemakers, including the model implanted in Mrs. Walling.

A Class I recall is the most serious type of recall, issued when there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

The complaint indicates that the recalled pacemakers were prone to transitioning into a “safety mode,” which could cause the device to intermittently stop pacing a patient’s heart, creating a potentially life-threatening situation.

Mrs. Walling alleges that on February 24, 2023, her pacemaker catastrophically failed and intermittently stopped pacing her heart, forcing doctors to rely on the malfunctioning device until they could implant a temporary pacer and perform emergency replacement surgery at PeaceHealth Southwest Medical Center in Vancouver, Washington.

As a result of the surgery necessitated by the alleged device failure, Mrs. Walling reportedly suffered multiple post-operative infections, requiring prolonged hospitalizations and intravenous antibiotic treatment.

The complaint further claims that, before Mrs. Walling’s implantation surgery, Boston Scientific had received hundreds of reports of failures involving the Model K174 pacemaker. Those reports allegedly included devices that paused or stopped pacing entirely, resulting in injuries, deaths, and the need for surgical replacement.

However, she alleges that the company failed to adequately notify physicians and the medical community about the reported failures, and that Mrs. Walling’s doctors would not have selected the device had they been properly warned.

“Plaintiffs are informed and believe, and thereupon allege, that at all times herein mentioned, the Subject Pacemaker was defective and dangerous, both in manufacture and design, warnings and warranty, thereby rendering the subject product not reasonably safe for its intended use and that defects were a cause of injury to Mrs. Walling as described herein.”

— Sherri Walling et al v. Boston Scientific Corporation et al

The lawsuit raises allegations of negligence and strict liability. It is seeking damages for medical expenses, pain and suffering and emotional distress, as well as compensation for loss of earnings and loss of consortium on behalf of Cameron Walling as well.

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