Ongoing litigation over inferior vena cava (IVC) filters have had mixed results so far this year. In March, the first bellwether trial ended in a verdict for the plaintiff. A jury in Phoenix Arizona ordered medical device manufacturer C.R. Bard to pay a total of $3.6 million to a woman whose IVC fractured and migrated to her heart. The award included $1.6 million in compensatory damages and $2 million in punitive damages.
However, Bard prevailed in Round Two earlier this month. The case involved a Georgia woman who had an Eclipse IVC filter implanted in 2010. Five years later, she began suffering headaches and unusual pain in her arm. A medical scan revealed that the device had fractured and a shard had become lodged in her right pulmonary artery. Doctors were unable to remove that fragment, and it continues to be a potentially fatal risk. Nonetheless, the jury determined that Bard had “adequately warned” physicians of possible risks and complications of using the device.
Outcomes for Cook Medical have been similarly mixed. In November 2017, the company won its first bellwether trial. A second trial in March of this year ended in a summary judgment for the defendant. However, late last month, Cook Medical was ordered to pay $1.2 million to a 35-year-old fireman from Texas who underwent a laparotomy in order to have his Celect IVC filter removed.
Cook has claimed that the device was easily retrievable. However, the plaintiff's device had fallen out of place, perforating the artery and pressing against his spine. Two earlier attempts to remove the device had been unsuccessful. Plaintiff's counsel argued that Cook was aware of the perforation issue prior to seeking FDA approval, and pointed to independent studies demonstrating that the Celect IVC filter had a perforation rate of nearly 80 percent. These studies contradict Cook's own claims of no danger of perforation when it filed its 510(k) Clearance application in 2008.
IVC filters were designed as an alternative to anticoagulants, as some patients are unable to tolerate such medications. They are inserted into the inferior vena cava, the primary artery leading from the lower body to the heart and lungs, and are designed to trap blood clots that can cause an embolism, leading to cardiac arrest or stroke.
IVC filters are intended for temporary use. The FDA recommends they be removed no later than 54 days after they have been implanted. However, these devices have been known to come loose and migrate to other parts of the body as well as fragment altogether; small metal shards become lodged in artery walls and even internal organs causing serious, and even fatal complications.
As of last month, there were a total of 8,023 lawsuits pending against the two major manufacturers of IVC filters. Cases against Bard have been consolidated in Arizona, while those against Cook are being heard in Indiana.