June 30, 2016 — A woman who was left with an IVC filter permanently embedded in her body has filed a lawsuit against the manufacturer in Texas.
The lawsuit (PDF) was filed by Amy C. Rudy, a woman from Ohio. In December 2013, she was implanted with the Option Vena Cava Filter made by Rex Medical and Argon Medical Devices.
In June 2014, she went to the hospital to have the Option filter removed. During the retrieval procedure, doctors discovered that the Option had tilted and was embedded in her vena cava. They were unable to remove the filter and she was hospitalized with chest pain.
In November 2014, she developed recurrent blood clots in her lower legs. These recurrent clots have caused further pain, disability, and medical care. 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.”
Lawyers say Argon and Rex Medical knew or should have known the filter could fracture, tilt, migrate, and cause blood clots. The companies are accused of selling a defective device and downplaying the risk of severe, life-threatening side effects.
The Option did not go through rigorous safety studies because it was approved with a 510(k) application in 2009, which allows new devices on the market if they are “equivalent” to another device.
Unfortunately, the design is “equivalent” to filters with serious problems — the C.R. Bard Recovery (withdrawn from the market in 2005), Bard G2, Günther Tulip, Cordis OptEase, and Cordis TrapEase.
The lawsuit was filed on June 29 in the U.S. District Court for Collin County, Texas (Case No. 296-02801-2016).
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