In a major step forward for the hundreds of plaintiffs lined up to take action against Cook Medical, the first bellwether IVC filter trials have been selected to begin in 2017.
Over 650 lawsuits have been filed against the medical device manufacturer over allegations that it knew about issues with its IVC filter line, yet continued to market and sell the devices to an unknowing public.
If such a deception did in fact occur, the results have been catastrophic. According to a multi-part story that aired in late 2015 on NBC Nightly News, nearly 30 people have died and over 300 have been injured by complications arising from faults with similar Bard IVC filters.
At issue is the propensity for the IVC filter to break, perforate the vena cava, or become dislodged and migrate once implanted in a patient.
In the case of the bellwether MDL set to start in 2017, one plaintiff was horrified to learn that her Cook Celect IVC filter had embedded itself in her intestines. She had been implanted with the filter in November of 2010. By March 2011, doctors were ready to remove it. Their attempts failed.
Over the next three years, the patient suffered incredible gastrointestinal distress. Vomiting, diarrhea, and fatigue set in and it wasn’t until she’d had a colonoscopy that doctors learned that her symptoms weren’t the result of disease or illness, but were actually the result of an IVC filter that was no longer in proper position and was, in fact, now in her intestines.
This plaintiff is joined by many others in her suffering. While numerous studies on IVC filter failures have been conducted, they universally show the same results: these devices fail in exceedingly high numbers. Once such study indicated that 43% of Celect IVC filters perforated the vena cava within two months of implantation.
The FDA now advises doctors to remove IVC filters from patients as soon as it is medically feasible to do so; generally within 29 to 54 days.
The case against Cook Medical; ranging from the marketing of unapproved devices to improper and faulty reporting, and virtually everything in between, has been building for years. Both sides will, no doubt, be watching this first trial incredibly carefully.