I am reasonably sure that many of our readers have heard of the blood thinner Coumadin. Doctors prescribe Coumadin and similar blood thinners as a first line treatment for someone diagnosed with a blood clot, such as a deep vein thrombosis (DVT) or pulmonary embolism (PE). In some patients, blood thinners can’t be used. In cases of trauma, for example, where doctors are working to stop bleeding, Coumadin would only make matters worse. In those situations, the use of inferior vena cava (IVC) filters is the second-line treatment. IVC filters are small, cage-like devices inserted into the inferior vena cava to capture blood clots and prevent them from reaching the lungs. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart. (FDA Safety Communication, May 6, 2014.)
The original IVC filters were intended to be permanent filters and required surgical implant into the vein. Later versions of the permanent IVC filter were developed for percutaneous (non-surgical) placement using a catheter. More recently, manufacturers are marketing “removable” or “retrievable” IVC filters, in part due to an increased risk of DVTs seen with permanent IVC filters after being implanted for two years.
While removable IVC filters are approved for permanent use, product instructions for removable filters include a statement that the filter “may be retrieved in patients who no longer require a filter.” The use of IVC filters has increased exponentially since the late ‘70s, from 2,000 IVC filters placed in 1979 to approximately 260,000 IVC filters placed in 2012. Studies show that most retrievable IVC filters remain in place.
Numerous medical studies have revealed retrievable IVC filters are causing a significant number of injuries. A 2011 study revealed that 40 percent of the Bard Recovery© filters fractured after five and a half years, and a 2014 medical study revealed that 37.5 percent of Bard G2© filters fractured after five years. Other studies have shown that 100 percent of the Cook Tulip© and Celect© filters perforated the inferior vena cava after 71 days and 40 percent tilted.
In a 2010 FDA communication, the FDA reported that since 2005, it had received 921 adverse event reports involving IVC.
The injuries reported involved the IVC filter migrating (or moving) within the inferior vena cava (328 reports), the IVC filter completely detaching from the inferior vena cava wall and traveling to the heart or lungs (146 reports), the IVC filter tearing the wall of the inferior vena cava (70 reports), and the IVC filter fracturing or breaking into pieces (56 reports). A follow-up FDA communication in 2014 identified the following adverse outcomes:
device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. The FDA suggests the risks may be related to the length of time the IVC filter is in the body. The FDA suggests removing retrievable IVC filters as soon as protection from pulmonary embolism is no longer needed.
Evidence is mounting that manufacturers of retrievable IVC filters were aware of high failure rates with their IVC filters years ago, yet there has never been an official recall. As a result, many people have already been injured; and many more have a retrievable IVC filter in place with a high likelihood of failure in the future.
Beasley Allen lawyers are currently investigating a number cases involving injuries resulting from retrievable IVC filters. If you have been injured by a defective retrievable IVC filter, or if you currently have one of the retrievable IVC filters in place, or you just need information on this litigation, contact Roger Smith, a lawyer in our firm. If you need a list of the various products involved in the litigation, Roger will have them. You can contact Roger, who is in our firm’s Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com. He will be glad to talk with you.
