The U.S. Food and Drug Administration (FDA) approved the Cordis TrapEase in 2001; it is a permanent vena cava filter. The Cordis OptEase was introduced in 2003 which is a retrievable vena cava filter. The Cordis OptEase IVC filter is an egg-shaped wire device and Cordis TrapEase IVC filter is a star-shaped wire device. The IVC filters are used in those patients who may develop a PE and cannot be treated by using anticoagulant medication. This could be because they have allergies or because they are continuing to develop clots even though they have been treated with anticoagulants for a while. The inferior vena cava (IVC) filters sold by Cordis Corporation probably have design issues and have received hundreds of adverse event reports.
Cordis IVC filters were approved with a FDA 510(k) which allowed them to perform only minimal testing before selling the devices for use in patients nationwide. In November 2012, a study published by JAMA Internal Medicine linking Cordis TrapEase with a 50% risk of fracture. According to the study, 20 people were implanted with Cordis TrapEase between November 2002 and July 2006. After four years from implantation out of those 20 filters 10 filters (50%) were fractured. The patients who were with filters implanted for longer than four years, 64% suffered filter fractures.
The company has come under scrutiny after lawsuits reveal potential design defects. The Cordis OptEase and Cordis TrapEase lawsuits allegations are similar allegations to those presented against manufacturers of other IVC filters, including C.R. Bard and Cook Medical. The manufacturer have designed and sold defective devices and it’s also claimed that the IVC devices are subject to catastrophic failure, moving out of position, puncturing the vein or fracturing, potentially sending small metallic pieces to the heart or lungs. There are several serious potential risk associated with the device including:
- Filter Fracture
- Pulmonary Embolism or Thombosis
- Filter Migration or Tilting Out of Place
- Inability to Remove or Retrieve IVC Filter
- Organ damage (heart, lungs, kidneys, intestines)
- Internal hemorrhage (bleeding)
- Wrongful Death
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As of August 2016 more than 1,300 Bard, Cook and Cordis IVC filter lawsuits have been filed. The IVC filter lawsuits for Cordis have been centralized in Alameda County, California, the home of Cordis Corporation. Over 100 lawsuits have been filed in California at present. The lawsuits allege several claims, including negligence, failure to warn, liability for design defects, breach of implied warranty, failure to recall, fraudulent misrepresentation, and concealing evidence.