The lawsuit was filed by Dean S., a man from Florida who was implanted with the Option™ ELITE Retrievable Inferior Vena Cava Filter in September 2014 at a hospital in Columbus, Ohio.
Less than eight weeks later, he had another procedure to remove it. Unfortunately, doctors found that the filter was tilted and the retrieval hook was embedded in the wall of his vena cava. His doctor gave up after three failed attempts to retrieve it.
The filter is now permanently embedded in his body. It poses increasing long-term risks like blood clots and perforation of his vena cava, vital organs, or the spinal column. The embedded filter might also fracture and send broken pieces into his heart or lungs.
All of these side effects can result in immediate death, severe pain, and other life-threatening injuries.
Rex Medical and Argon Medical Devices are accused of selling a defective medical device and failing to warn about safety risks.
The Option ELITE is a retrievable blood clot filter that was approved in January 2014 with a 510(k) application, which means it did not go through clinical trials because it was “equivalent” to the Option IVC Filter.
Unfortunately, the Option was “equivalent” to several problematic filters. Two filters made by C.R. Bard — Recovery® and G2® — have been linked to high rates of filter fracture and embolization. Another “equivalent” filter — Günther Tulip® — was linked to a 43% risk of vena cava perforation and high rates of tilting in recent studies.
The lawsuit was filed on November 4, 2016 in the Philadelphia Court of Common Pleas — Case No. 161100002.
Over 2,000 other IVC filter lawsuits are now pending against various manufacturers, including C.R. Bard and Cook Medical.
The plaintiff is represented by Stephen A. Sheller of Sheller, P.C. in Philadelphia, Pennsylvania; and Ben C. Martin of The Law Offices of Ben C. Martin in Dallas, Texas.