A Houston firefighter was awarded $1.2 million on Thursday, after a Texas jury found Cook Medical responsible for injuries he suffered due to a malfunctioning inferior vena cava (IVC) filter.
The verdict marks the first such loss for the Indiana-based medical device maker, which currently faces more than 3,000 similar IVC filter lawsuits in courts throughout the country.
Plaintiff Jeff Pavlock, 35, received the Celect IVC filter in 2015. The filter subsequently tilted and migrated, perforating his aorta and duodenum. Pavlock’s doctors made two attempts to retrieve the device but were unable to do so because it was pressing against his spine and renal artery.
Pavlock was ultimately forced to undergo major surgery – an open laparotomy – in order to have the filter removed from his body.
At trial, Pavlock’s attorneys argued that Cook brought the Celect IVC filter to market even though it was aware of its issues with perforations. They also pointed to independent research that linked the Celect filter to a perforation rate greater than 79%. However, the Cook-sponsored study the company submitted to the U.S. Food & Drug Administration (FDA) prior to the filter’s 2008 510(k) approval reported a zero-rate of perforations.
Cook Medical has promised to appeal the Texas verdict.
IVC filters are designed to prevent pulmonary embolism in patients who are unable to use standard blood-thinning medications. Retrievable devices, including those at the center of the Cook Medical IVC filter litigation, are intended to be removed once a patient is no longer at risk for blood clots.
In 2010, the U.S. Food & Drug Administration (FDA) reported that it had received over 900 adverse event reports involving retrievable IVC filters, including:
The FDA issued a second alert just four years later, reminding healthcare providers to retrieve temporary blood clot filters within 29 to 54 days of their implantation in order to reduce the risk of patient harm.
The majority of IVC filter lawsuits filed against Cook Medical have been centralized in the U.S. District Court, Southern District of Indiana. That proceeding has already concluded two trials, both of which ended with defense verdicts.
Thousands of additional IVC filter lawsuits involving devices marketed by C.R. Bard, Inc. have been centralized in the U.S. District Court, District of Arizona. That litigation concluded its first trial in March, when Bard was ordered to pay $1.6 million in actual damages and $2 million in punitive damages to a woman who suffered complications related to the fracture and migration of the company’s G2 IVC filter.