Indiana-based medical device company Cook Medical has been ordered to pay $1.2 million in compensation to a fireman who says he suffered severe injuries after being implanted with the brand’s Cook Celect IVC filter. A Texas state jury delivered the verdict on Thursday, May 24, 2018, ruling that Cook Medical should be held accountable for marketing a risky product without sufficient patient warnings.
Texas Jury Holds Cook Liable For IVC Filter Injuries
In his complaint, the plaintiff, a 35-year-old firefighter from Houston, says he received a Cook Celect IVC filter on March 3, 2015; the device is commonly implanted into the inferior vena cava, the body’s largest artery, to catch blood clots before they flow into the lungs or heart.
The 35-year-old firefighter underwent at least two procedures, including an open laparotomy, in hopes of having the medical device removed; Cook Medical markets the product as “retrievable.”
Vein Perforation Led To Multiple Surgeries
But the plaintiff says he had a far-different experience with the device, Law360 reports. Considering the Celect filter to be a temporary prophylactic against blood clots, the man’s surgeons scheduled a removal procedure seven weeks later. But when they attempted to remove the implant, it wouldn’t come out – pieces of the implant’s wire frame had split through the vein in which it was implanted and punctured his small intestine and aorta. And now, the device was pressing upon the patient’s spine.
Life-Long Risk Of Complications
Fearing severe and imminent harm, surgeons attempted to retrieve the “retrievable” IVC filter again, but their efforts were unsuccessful.
Today, the Cook-made Celect IVC filter remains embedded inside the man’s body. During court proceedings, he told jurors that he would require life-long health monitoring to guard against further injury. He lives at continual risk that the implant will break or move again, court documents report.
Cook Failed To Warn Patients, Attorneys Say
At trial, plaintiff’s attorneys argued that Cook Medical knew even before receiving FDA clearance that the Celect IVC filter created a serious risk of vein perforation. Resembling a metal spider, IVC filters sit inside the inferior vena cava, a major artery, anchored to the blood vessel’s walls by its cobalt-chromium struts.
Studies Find High Rate Of Perforation Side Effects
However, multiple medical studies have found that the struts of an IVC filter, after implantation, can perforate the vein, leading to internal bleeding, hematoma and chronic pain.
In fact, the Celect IVC filter appears to be one of the worst offenders; a 2015 study published by the Journal of Vascular and Interventional Radiology found that, compared to a main competitor filter, Celect filters caused vein perforation in up to 43% of patients after only 2 months of implantation. Argon Medical’s Option filter, the researchers wrote, wasn’t linked to a single perforation.
Conflicting Studies Aired In The Courtroom
A number of other studies have connected the Celect filter to even higher rates of vein perforation, up to 79% in some analyses. During closing statements, an attorney for the injured fireman also highlighted a study, sponsored by Cook Medical, that found an astounding perforation rate of 0%. The results of that paper were presented to the FDA in 2008, when Cook was seeking clearance to sell the Celect filter on the US market.
Why, the attorney asked, would we see such a wide divergence between independent studies and projects funded by Cook Medical? In response to this provocative query, by which the lawyer intended to suggest that Cook had gamed their study for favorable results, defense attorney John Mandler, who represented Cook Medical said, “they have their favorite studies and we have ours.”
Jury Says Celect IVC Filter Is Defective
Apparently, the Texas jury didn’t find Mandler’s explanation satisfying. After three weeks of trial, the 12-member jury ruled that Cook had failed to warn the public of its medical device’s risks, awarding the injured plaintiff a total of $1.2 million in damages. Jurors also held that the Celect IVC filter had been defectively designed and manufactured, presenting an unreasonable risk of harm to patients.