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Cook promoted its Celect IVC filter as retrievable, but the filter put into Jeff Pavlock's inferior vena cava tilted.
May 30, 2018
By: PR Newswire
Cook Medical must pay $1.2 million to compensate a man who was implanted with a Cook Celect IVC filter, said a Texas jury Thursday. Following a three-week trial, the jury of 12 ruled Cook must pay for injuries following a Celect filter’s implantation in Jeff Pavlock on March 3, 2015. A 35-year-old Houston-area firefighter, Pavlock sued Cook after its Celect inferior vena cava filter required open laparotomy surgery to remove. Cook promoted its Celect IVC filter as retrievable, but the filter put into Pavlock’s inferior vena cava tilted, perforated his IVC, duodenum and aorta, and was pressing against his spine and renal artery, making it impossible to remove without major surgery. Two previous removal procedures had failed. There was much conjecture from both sides about how much the results of the invasive surgery affected Pavlock now and could affect him in the future. Defense pounced on the Plaintiff side’s analysis that any spinal stenosis Pavlock may have is asymptomatic for now but could become symptomatic in the future. Nobody could say for certain whether or not Pavlock would suffer symptomatic stenosis in future or how much trauma he suffered from the surgery. Attorney David Matthews argued for the plaintiff in closing that Cook knew its Celect had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway. He showed the jury several independent studies that found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate. Matthews also reminded the jury that he had shown evidence that as few as one percent of adverse events are reported by doctors to a medical device maker. To explain or dismiss the large gap between independent and Cook-sponsored study findings, defense attorney John Mandler said, “They have their favorite studies and we have ours.” Cook’s attorneys had also refuted trial evidence of doctors reporting only 1-5 percent of actual adverse events related to medical devices. In closing, Mandler called the low-reporting evidentiary studies a “conspiracy theory.” Cook issued a press release the next day vowing to appeal the jury verdict. Freese & Goss and Matthews & Associates Law Firm represented the plaintiff. Faegre Baker Daniels represented Cook. The actual jury award was $1,240,500.
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