The plaintiff, Amy R., was implanted with an IVC filter in December 2013. Six months later, she went to the hospital to have it removed.
Doctors discovered that it was tilted and embedded in her vena cava. They were unable to remove it and sent her to the emergency room because she had chest pain.
In November 2014, she developed blood clots in her legs — also known as IVC thrombosis. It causes chronic pain, swelling, vein damage, and permanent circulation problems. According to the lawsuit:
As long as the Option filter remains embedded in her vena cava, Plaintiff is at risk for further thrombosis and future filter fractures, migrations and perforations and tilting. She faces numerous health risks, including the risk of death.”
Rex Medical and Argon Medical Devices, the manufacturers of the Option IVC filter, are accused of selling a defective medical device and downplaying the risk of severe complications.
The Option was never tested for safety in clinical trials because it was approved with a 510(k) application. This allows new devices on the market if they are “equivalent” to another device.
Unfortunately, the “equivalent” devices include problematic filters like C.R. Bard’s Recovery, which was pulled off the market in 2005. Lawyers say the manufacturers should have known about the risks.
The lawsuit was filed on June 29, 2016 in the U.S. District Court for the Eastern District of Texas (Collin County) — Case No. 296-02801-2016.
The plaintiff is represented by Ben C. Martin, Thomas Wm. Arbon, and Jacob A. Boyd of the Law Offices of Ben C. Martin in Dallas, Texas.