Product News and Recalls

Cook IVC Filter Trial Results in $1 Million Verdict

cook IVC filter trial leads to million dollar verdictA Houston jury awarded a plaintiff $1.2 million in a suit brought as a result of the failure of a Cook Medical “Celect” series IVC filter. This is the third trial the company has faced over allegations that the devices are prone to migration, breakage, and perforation of vital tissues and organs.

IVC filters are small, spider-like devices that are placed in the inferior vena cava. They are designed to catch blood clots traveling through the body’s blood vessels before they can reach the heart or lungs and cause a pulmonary embolism. Such an occurrence can be extremely dangerous for the patient and, in some cases, pulmonary embolisms can lead to death.

Thousands of lawsuits allege that design flaws in IVC filters, as well as a lack of focus on removing the devices once the threat of a blood clot has passed, have led to a number of debilitating injuries. In some cases, pieces of the IVC filter have broken off and traveled throughout the patient’s body via the bloodstream. In others, the devices have migrated away from the original implantation site and become embedded in other tissues and organs; some to the point of being irretrievable.

Cook filters have come under particular scrutiny as a study revealed that 43% of Cook Celect IVC filters perforated the patient’s vena cava within just two months of implantation. Many IVC filters are designed to be used only temporarily and, in most cases, the FDA recommends removal of the device no more than 54 days after initial placement. However, at present, less than a third of implanted IVC filters are ever retrieved.

For its part, Cook vigorously defended its IVC filters. “We are disappointed in this outcome and do not believe this verdict is supported by the facts or the law,” the company said in a press release. “This one case does not change our position on continually defending this important, life-saving technology.”

“Continually defending” is an interesting choice of words. If the device is such a critical component to saving people’s lives, why does it require a seemingly endless effort to defend it? No one is arguing that blood clots aren’t dangerous, but shouldn’t the device used to catch them pose as small a threat to the patient as possible?