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Inferior vena cava filters, or IVC filters, are small, metal, cone-shaped devices that are inserted into the inferior vena cava to catch any blood clots that might free themselves from a patient’s veins and arteries to prevent them from reaching the heart and lungs. If clots do end up reaching the heart and lungs, they can lead to a pulmonary embolism (PE).
Between 2005 and 2010, the FDA received over 920 cases of adverse event reports involving IVC filters. In August 2010, an initial communication issued by the FDA announced that, among those cases, there were:
These problems exist for all IVC filters, but some manufacturers have come under additional fire for selling devices they knew to be less safe. One manufacturer put a new model on the market in 2002 and immediately saw death and injury reports rise. It wasn’t until 2010 that it was pulled from the market.
After various IVC filter studies began to roll out, the FDA issued an updated safety communication in 2014 warning doctors that they should be removing IVC filters as soon as they were no longer required. In addition to becoming less effective over time, the devices can move, break, puncture blood vessels, and actually contribute to the embolisms they are meant to prevent.
After hundreds of injuries and 27 confirmed deaths, thousands of lawsuits have now been filed over IVC filters, with a majority of them targeting two specific manufacturers: C. R. Bard and Cook Medical. Nearly 300 complaints have been combined from 11 districts in a multi-district litigation (MDL) against Cook, which is expected to begin in federal court in Indiana late in 2016. Another 200 or more suits against Bard are moving toward trial in a separate MDL action in Arizona. As of November 2016, there are over 1,000 pending IVC lawsuits in the MDL.
Allegations against filter manufacturers claim that Bard and Cook are responsible for negligence, knowingly manufacturing a defective product, and continuing to sell IVC filters without warning the public or the medical community of its risks. There are six devices in particular that stand at the focal point of IVC lawsuits across the country:
A major problem with IVC filters is that they were designed to be a temporary solution for at-risk patients (e.g., those who have just had a stroke or undergone surgery). The idea was that they would be inserted while the risk of PE to a patient was high and then removed a short time later.
In one study, researchers discovered that doctors made plans to remove the device from less than one-third of patients undergoing the procedure. Some of those plans were not followed through, and even for those with a planned removal, more than 25% of the devices could not be safely retrieved. This “temporary” device became permanent in more than 80% of the patients studied.
If you or a loved one received an IVC filter and developed complications, contact the Indianapolis Defective Medical Device Attorneys of Wilson Kehoe Winingham. The lawyers at WKW have experience helping victims pursue claims and can fight for the compensation you deserve. Call 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation.