ST. LOUIS — A St. Charles County man is suing Boston Scientific Corporation claiming an implantable cardioverter defibrillator pulse generator was defective.
Daniel Welz presented to SSM DePaul Hospital in St. Louis on Oct. 24, 2020, for implantation of a Boston Scientific A219 MRI compatible subcutaneous implantable cardioverter defibrillator (ICD) pulse generator, according to a complaint initially filed in St. Louis County Circuit Court and removed to U.S. District Court for the Eastern District of Missouri on June 12.
Welz claims shortly after that, he began having complications related to the device, including failure to provide a shock when necessary, failure to transmit and frequent error lights.
As a result of the complications he suffered with the defendant's medical device, the plaintiff required the removal of the device and the placement of a different device, the complaint states.
On Dec. 2, 2020, Boston Scientific issued a recall of certain models of the ICD for manufacturing defects, according to the suit. The plaintiff's medical device was one of the devices listed on the recall.
"The Subject ICD that is the subject of this Petition was, in fact, defective," the complaint states. "The defective condition of the Subject ICD existed when the product left the manufacturer—Defendant Boston Scientific."
Welz claims he was injured and suffered damages as a result of the defective device and required substantial medical care and will need additional medical care in the future.
The device was in a defective and unreasonably dangerous condition, as it failed to deliver shocks, delivered less shock than intended, failed to respond to a device check-in, failed to issue appropriate battery alerts and other defects, according to the suit.
Welz claims the device caused him injuries and to suffer damages, including injuries to his heart and cardiovascular system. He claims some of his injuries were permanent and resulted in disability.
Welz claims Boston Scientific had a duty to the public to use ordinary care to manufacture or design the product to be reasonably safe and breached that duty of care in one or more ways.
The defendant negligently designed the device, negligently manufactured the device, designed it in such a way that allowed it to short circuit and manufactured it in a way that caused it to fail.
"As a direct and proximate result of Defendant's negligence, Plaintiff was injured and suffered damages...and he required substantial medical care," the complaint states.
Welz is seeking compensatory damages and other relief. He is represented by Nathan W. Davis of The Davis Injury Law Firm in St. Louis.
Boston Scientific is represented by Christopher J. Kaufman and Katherine C. Bourk of Shook, Hardy & Bacon in Kansas City.
Attorneys for the parties declined to comment on the matter aside from the complaint.
Since December 2020, approximately 29,300 active devices have shown a malfunction rate of 11.6% at 5 years, with 99.4% of the affected 2,776 S-ICDs being replaced before full battery depletion, according to an advisory update by Boston Scientific.
U.S. District Court for the Eastern District of Missouri, St. Louis Division case number: 4:24-cv-00820