A jury in Indianapolis federal court has ordered Cook Medical, Inc. to pay $3 million in compensatory damages to a woman who suffered serious injuries after a Celect IVC filter fractured and migrated to her spine.
The IVC filter verdict is the first awarded to a plaintiff in the multidistrict litigation now underway in the U.S. District Court, Southern District of Indiana, where Cook Medical faces over 5,100 similar claims involving its retrievable blood clot filters.
According to her complaint, Tonya Brand received the Cook Celect IVC filter in March 2009, in advance of spinal fusion surgery because of her history of deep vein thrombosis and other medical issues.
A little over two years later, she experienced pain in her right thigh. A subsequent ultrasound reveled something in her leg. A few weeks later, Brand noticed something protruding out of her thigh and pulled out a piece of the IVC filter.
A full body scan ultimately revealed that the blood clot filter had fractured and migrated to an area near her spine. An initial surgery failed to remove the device, and the IVC filter remained in her body until October 2015.
Last December, the judge overseeing her IVC filter lawsuit awarded Cook Medical summary judgment on Brand’s failure-to-warn, breach of warranty, negligent manufacturing, and loss of consortium claims. However, she was allowed to move forward with her other claims, including strict liability, negligent design defect, and punitive damages. (Case No. No. 1:14-cv-06018-RLY-TAB)
Brand’s case went to trial on January 14th, and the jury rendered its IVC filter verdict on January 31st.
The trial enters its second phase today, which will focus on punitive damages.
IVC filters are used to prevent pulmonary embolism in patients who can’t take standard blood-thinning medications. Once implanted in the inferior vena cava, the filters can intercept blood clots before they travel to the heart or lungs. Many of these devices, including the Cook Celect IVC filter, are designed to be retrieved once a patient is out of danger.
In 2010, the U.S. Food & Drug Administration (FDA) warned that IVC filters had been implicated in more than 900 adverse event reports, including migration, fracture, embolization, blood vessel perforation, and more. Among other things, the agency suggested the failure to remove retrievable devices was behind many of the reported injuries.
Just four years later, the FDA issued a new alert reminding doctors about the importance of IVC filter retrieval.
Sonya Brand’s IVC filter lawsuit was the third to go to trial in the federal litigation underway in Indiana.
Cook Medical won the proceeding’s first bellwether trial in November 2017, while the second bellwether case was dismissed 4 months later.
Last May, however, a Texas state court jury awarded a $1.2 million IVC filter verdict to a firefighter who’s Celect filter tilted, migrated, and perforated his aorta and duodenum.