Four years ago, lawsuits against Cook Medical for their IVC filters were filed without causing much of a stir. Today the company is facing over 500 lawsuits, making IVC filters a huge problem for Cook Medical. So what happened in these four short years?
Trouble Stirring in 2010
In August 2010 the Food and Drug Administration (FDA) released the first safety statement regarding IVC filters. The FDA stated they had received over 900 reports of adverse events and recommended the device be removed immediately after the threat of blood clots have passed. This initial statement prompted the first few IVC filter lawsuits against various manufacturers and by 2012 Cook Medical received its first lawsuits.
Over the next few years, the FDA continued to receive reports about defective IVC filters and in May 2014, they released a second safety statement with more specific instructions to doctors regarding the removal of the device. The FDA warned consumers the likelihood of device failure greatly increased with time in the body, and recommended the device be removed between 29 and 54 days after removal.
The FDA’s second statement prompted more lawsuits to be filed over the course of 2014 and 2015. However, by this time last year, Cook Medical was only facing 100 lawsuits over its IVC filters.
The nail in the coffin for Cook Medical was a study published in June 2015 in the Journal of Vascular Interventional Radiology. The study looked at patients who had received a Cook Medical IVC filter and discovered 43% of the patients had the device completely perforate the walls of the inferior vena cava. This study helped confirm what many patients already knew – Cook’s IVC filters are defective. Not only do they have a high rate of perforation, they have also been known to migrate through the body and fracture into pieces that can lodge themselves into other organs.
The study pushed the dangers of Cook’s IVC filters into the spotlight, and the company will now have to answer for its negligence. The first trials against Cook will begin in September, and they will be followed by many more lawsuits in the US and abroad.