The lawsuit was filed by David T., a man who was implanted with the Option™ Retrievable Inferior Vena Cava Filter (“IVC Filter”) on December 11, 2011 at Holmes Regional Medical Center in Melbourne, Florida.
The filter was implanted because he had a history of pulmonary embolism, or blood clots in the lungs. He was also diagnosed with Deep Vein Thrombosis (DVT), or blood clots in the lower legs.
Exactly three years later, on December 11, 2015, he underwent an unsuccessful retrieval procedure. The filter could not be removed because it was tilted and the retrieval hook was embedded in the wall of his vena cava.
On January 5, 2016, he went back to the same doctor for a second attempt at removing the filter. Again, the procedure was unsuccessful.
On February 29, 2016, the same doctor made a third attempt to remove the filter. He failed again, despite a complex procedure to lasso the filter from above and below by using major veins in the neck and groin. According to the lawsuit:
This retrieval was a complex percutaneous attempt, utilizing both the jugular and femoral veins. The filter was unable to be retrieved, again due to the filter being tilted and embedment of the hook in the caval wall.”
The lawsuit highlights two of the most common side effects of IVC filters — tilting and embedment — and the challenge of removing the filter when these side effects occur.
Retrieving an IVC filter involves carefully “snaring” the hook, covering the filter to prevent parts breaking off, and pulling the filter out of the inferior vena cava through the jugular or femoral vein. The procedure is complex and carries significant safety risks.
The vena cava is the largest vein in the body, but it has extremely thin walls. If the filter is embedded, ripping it out can cause severe internal bleeding. If the filter breaks, metal pieces can travel in the bloodstream like missiles to the heart and cause sudden death.
There are also serious risks associated with leaving an embedded filter in place permanently. The main long-term complication is the development of blood clots, a condition known as IVC thrombosis. It occurs when the filter is clogged, or clots form on the exposed metal.
The risk increases over time, which is why the FDA recommends removing IVC filters as soon as the patient’s risk of blood clots subsides.
Rex Medical and Argon Medical Devices are accused of downplaying these serious side effects, manufacturing a defective medical device, and inadequately testing it for safety or retrievability.
The lawsuit was filed on March 27, 2017 in the Philadelphia County Court of Common Pleas — Case ID: 170302893.
There are now 3,000 other IVC filter lawsuits pending in state and federal courts nationwide against Rex Medical L.P., Argon Medical Devices Inc., Cook Medical, and C.R. Bard.
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.