The lawsuit was filed by Peggy F., a woman who was surgically implanted with the Option™ Retrievable Inferior Vena Cava Filter (“IVC Filter”) on February 2, 2014 at Yale New Haven Hospital in Connecticut.
The woman was implanted with the Option IVC filter before she had brain surgery. She did not have blood clots at the time. Instead, it was used as prophylaxis against complications of blood clots in the legs.
On June 17, 2016, she underwent a CT scan that showed the struts of the Option IVC filter perforated her inferior vena cava and were protruding through the wall of the vein. Her doctors also said the filter might be clogged (occluded), but they could not assess it at the time.
Her lawyers accuse Rex Medical of failing to conduct sufficient safety testing, such as animal studies, to determine how the Option IVC filter would perform in the body. According to the lawsuit:
Defendants knew and/or should have known that the Filter had a high rate of embedment, fracture, migration, excessive tilting, perforation of the vena cava wall, and thrombosis once implanted in the human body.”
The problem is that some hospitals routinely implant IVC filters before patients undergo surgery. These patients have a high risk of developing blood clots in the legs, a complication known as Deep Vein Thrombosis (DVT), because they are immobilized during recovery.
Surgery patients may not be able to take blood-thinning medications, which is the normal way to prevent blood clots during recovery, so hospitals implant a filter in the inferior vena cava to catch blood clots floating in the bloodstream before they end up in the lungs.
Unfortunately, IVC filters can cause far more serious side effects. One of the most common problems is a vein perforation when the filter legs (called “struts”) puncture through the wall of the inferior vena cava.
Another problem is occlusion, a complication in which the filter becomes clogged with blood clots. This can cause severe circulation problems in the entire body. It also increases the risk of developing blood clots, the same injury the filter was supposed to prevent.
Rex Medical is accused of downplaying these risks, failing to warn about side effects, and selling a dangerously defective medical device.
The lawsuit was filed on March 27, 2017 in the Philadelphia County Court of Common Pleas — Case ID. 170302884.
There are over 3,000 other IVC filter lawsuits currently pending against Rex Medical L.P., Argon Medical Devices Inc., Cook Medical, and C.R. Bard. Most lawsuits are 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.