The lawsuit was filed by Jessica N., a woman who was implanted with the Option™ ELITE Retrievable Inferior Vena Cava (“IVC Filter”) on March 9, 2015 at Wellspan York Hospital in Pennsylvania.
Only 10 months later, she went back to the hospital to have the filter removed. That was when her doctor discovered that the filter was tilted and the retrieval hook was embedded in the wall of her blood vessel.
The filter remained in her body for another 8 months. In August 2016, another doctor tried to retrieve the filter. After multiple attempts, he finally snared the filter and removed it from her body.
The Option™ ELITE was approved in 2013 as a “new-and-improved” version of the Option, which had been on the market since 2009. However, lawyers say it is defective and unreasonably dangerous:
The implanted filter posed an unreasonable risk of causing thrombosis … perforation of surrounding vital organs … [and] an increased risk of fracturing, including the risk that fractured portions would travel to the plaintiff’s lungs or heart.”
The FDA has issued several warnings about IVC filters since 2010 — especially when temporary filters are not removed. In 2014, the agency recommended retrieving filters within 29-54 days, ideally. The risks increase the longer they remain implanted.
Rex Medical and Argon Medical Devices, the manufacturers of the Option™ ELITE, are accused of inadequately testing it for safety and failing to warn about the risk of severe, life-threatening side effects.
The lawsuit was filed on December 19, 2016 in the Philadelphia County Court of Common Pleas — Case No. 161202040.
There are now approximately 2,500 other IVC filter lawsuits now pending against Rex Medical, Cook Medical, and C.R. Bard. Most of these lawsuits have been centralized in Arizona and Illinois.
The plaintiff is represented by attorney Ben C. Martin of The Law Offices of Ben C. Martin in Dallas, Texas; and attorney Stephen A. Sheller of Sheller, P.C., in Philadelphia, Pennsylvania.