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A Philadelphia jury indicates that Rex Medical should be required to pay $33 million to a Georgia woman who suffered severe injuries linked to the Option Retrievable IVC filter, which they determined was defectively designed.
The verdict comes in a lawsuit that was one of more than 760 pending as part of a mass tort in Pennsylvania, each raising similar allegations that the spider-like blood clot filter was unreasonably dangerous and defective.
Known as an inferior vena cava filter, or IVC filter, the Option Retrievable Filter is designed to catch blood clots traveling through the vena cava, and prevent them from reaching the lungs and causing a pulmonary embolism. However, the design has been linked to problems where the retrievable IVC filter may move out of position, puncture the vena cava or fracture, causing small pieces to travel to the heart or lungs.
The trial began earlier this month in the Philadelphia Court of Common Pleas, involving claims brought by Tracy Reed-Brown, who claimed that an Option blood clot filter implanted in December 2016 perforated the wall of her vena cava, resulting in severe pain and a number of health complications.
The verdict includes $1,045,764 for future medical expenses, $2,322,650 for future pain and suffering, and also included $30,315,726 in punitive damages, which are designed to punish Rex Medical for recklessly endangering Reed-Brown and similar patients.
Various designs for retrievable blood clot filters sold by different manufacturers have been linked to a large number of problems in recent years, including allegations that the device may move, puncture the vein or fracture, sending small pieces to the heart or lungs.
Concerns about the potential overuse of IVC filters first emerged in 2010, when the FDA warned that it had received hundreds of adverse event reports involving problems with filters that had moved out of position, fractured or failed. At the time, the agency indicated that doctors should consider removing the filters when the risk of a blood clot passed, as the devices were often being left in place long-term.
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after an individual was no longer at risk of suffering a pulmonary embolism, since the risk of problems appeared to be greater the longer the filter was left in place. However, many manufacturers sold the devices for years without adequately informing physicians about the risks associated with leaving them in place.
The Option Retrievable filter litigation raises similar allegations to those presented in more than 15,000 Bard IVC filter lawsuits and Cook IVC filter lawsuits, which are pending in separate consolidated proceedings in the federal court system.