Cook Medical, Inc. has been in hot water lately over allegedly defective inferior vena cava (IVC) filters that have reportedly failed. More than 650 federal lawsuits are now pending in a multidistrict litigation (MDL) against the device manufacturing giant, and a judge has chosen the first bellwether case to go to trial in 2017.
The case involves Florida resident Elizabeth Jane Hill who was given a Celect IVC filter in November of 2010. The Celect model is a retrievable IVC filter that the FDA recommends removing within 29 to 54 days after implantation. If the filter remains longer than recommended, the patient is at increased risk for the filter to fracture, migrate, perforate, inflict organ damage or even lead to death.
Hill’s doctors attempted to remove the filter in March of 2011, but the attempt failed. During the three years that followed, Hill developed severe gastrointestinal symptoms such as diarrhea, inflammation, fatigue, and vomiting. It was during a colonoscopy that doctors discovered that the filter had migrated and embedded in her intestines. At another hospital, Hill underwent emergency surgery to remove the filter and was left with permanent narrowing at the site of excision.
In a study performed last year, researchers discovered that 43 percent of Celect filters perforated the vena cava within two months after implantation.
Marsha Lovejoy, Cook’s global manager of corporate content strategy, told the Indianapolis Business Journal that there is nothing wrong with the filters. “Cook’s IVC filters are not defective in design or manufacturing. We will vigorously defend against those claims.”