Steven A. was implanted with the device in September 2011 at Baylor University Medical Center in Dallas.
In May 2016, he had back pain and visited Dr. Omar Colon to have an X-ray. Doctors discovered the filter was embedded in his inferior vena cava. Unfortunately, it was also impossible to remove without lacerating his vena cava and causing more problems.
He now requires ongoing medical monitoring and has a higher risk of severe complications and death. According to the lawsuit:
As long as the Option filter remains embedded in his vena cava, Plaintiff is at risk for future thrombosis, filter fractures, migrations, perforations, and tilting. He faces numerous health risks, including the risk of death.”
Option is a retrievable filter, but it remained in his body for nearly five years. The FDA recommends removing IVC filters between 29-54 days. The risk of complications increases the longer they remain in the body.
The long-term safety of the Option has never been studied. It was approved by the FDA with a 510(k) application, which allows new devices on the market without requiring new clinical trials so long as they are “equivalent” to another device.
The “equivalent” devices include the Recovery filter made by C.R. Bard, which was pulled off the market in 2005. As of mid-July, over 700 lawsuits have been filed by people who were injured by the Recovery and G2.
The defendants, Rex Medical and Argon Medical Devices, are accused of negligence for selling a defective and “unreasonably dangerous” medical device and failing to warn about side effects.
The case was filed on August 4 in Dallas County Civil Court — Case No. CC-16-03886-A.
The plaintiff is represented by Ben C. Martin, Jacob A. Boyd, and Thomas Wm. Arbon of The Law Offices of Ben C. Martin in Dallas, Texas.
Editor’s note: For more information about IVC Filter lawsuits and your legal rights, please contact The Law Offices of Ben C. Martin.