Two women from Kentucky are the newest members of a massive litigation accusing Cook Medical and other device-makers of failing to warn about the risks of vena cava filters.
Cook is facing about 350 lawsuits in a centralized federal litigation in Indiana. Another 400 federal lawsuits are pending against C.R. Bard in Arizona.
Boston Scientific is only facing a handful of cases, but the number continues to grow. Katherine M., a woman from Kentucky, was severely injured when her Greenfield IVC filter became clogged with blood clots after remaining implanted for over a decade. The lawsuit was filed in the U.S. District Court for the Western District of Kentucky — Case No. 5:16-cv-65TBR.
Another lawsuit was filed by Olenda H., a woman from Graves County, Kentucky. Two years after she was implanted with the Cook Celect, it tilted and caused chronic pain and severe blood clots in her legs — Case No. 5:16-cv-00066.
According to the complaint:
“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”
The women are represented by Mark P. Bryant and Emily Ward Roark of Bryant Law Center PSC.
The FDA has received hundreds of complaints about intravenous filters, which catch blood clots in patients who can’t take blood-thinning medications. Recently, concerns have been raised about the serious dangers about these filters and what the company knew.
An IVC filter is a medical device that prevents pulmonary embolisms (blood clots in the lungs). It looks sort of like a spider with metal legs that anchor it inside the inferior vena cava (IVC), one of the largest blood vessels in the body. It catches blood clots traveling upward from the legs before they enter the lungs.
What manufacturers did was take a permanent filter with a sturdy design and weakened it to make it retrievable. In the 1990s, the popularity of “temporary” filters skyrocketed — but so did the number of complaints.
The weaker the design, the higher the risk of complications like migration, organ perforation, and broken pieces of the filter traveling to the heart or lungs. Patients may need emergency surgery to remove the filter. In some cases, broken pieces are too dangerous to remove.
Unfortunately, doctors frequently implant “temporary” filters and then never remove them. This is a problem because retrievable IVC filters were never designed to be permanent or studied for long-term use.
In 2010, the FDA reminded doctors about the importance of removing temporary filters as soon as possible. The agency had received over 900 complaints in the last five years. In 2014, the agency advised removing them between 29 and 54 days after implantation, if possible.