Seattle, WAThe FDA recommended back in 2010 that IVC filters be removed as soon at the risk passed and in 2014 repeated this communication, adding that filter pieces could migrate within the body. And judging from the growing number of IVC Filter lawsuits, including two inferior vena cava (IVC) filter class actions in Canada, the device may soon be pulled from the market.
In recent years many manufacturers have designed these devices to be retrievable, while older models were meant to be permanent. The cage-like design is supposed to trap and break up blood clots and at the same time allow the rest of the blood to flow freely. But with the “rest” of the blood there could be minute pieces of the device breaking off from the cage structure and migrating to other parts of the body. Studies have shown that the longer the retrievable IVC filter stays in the body, the greater the chances of a serious risk. And in its second safety communication the FDA is also concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
In the US, most lawsuits have been filed against IVC filter manufacturers C.R. Bard, Cook Medical and Cordis. These three companies combined account for 75 percent of the IVC filter market. Bard was one of the first companies hit with a lawsuit: Lisa Davis was implanted with its G2 filter in 2006 and two years later it fractured and migrated to her heart. Davis chose not to have open heart surgery to remove the filter fragment; instead she opted to take blood thinners for the rest of her life. Davis is suing Bard for failing to warn her physician of the IVC filter’s risks and misrepresented the device as safe. She sued for physical trauma, anxiety and impaired ability to earn wages.
The Canadian class action lawsuits have been filed against Cook Medical. Last January Wendy Kopeck and her husband filed a $200-million class-action lawsuit against Cook Medical, alleging she was never warned of the potential risks. Wendy had the IVC filter implanted in August, 2013 and returned to the hospital in October to have it removed. According to CTVNews doctors determined it was too risky to remove the device. A PET scan revealed the filter had broken, with one leg piercing her internal jugular vein and the rest of the device migrating into her small intestines.
The second class action was filed by an Ontario man with similar complaints. Arie Kuiper told the news station that doctors have since made two unsuccessful attempts to remove the device and have been told it is likely they will not be able to extract it. The class action is asking for $500,000 for each person implanted with a Cook Medical IVC filter, as well as $20 million in damages.
In the US, between 350,000 and 600,000 people each year are affected by blood clots, and as many as 180,000 will die because the blockages travel to their lungs. According to Drugwatch.com by 2012, doctors inserted approximately 259,000 filters in patients. The FDA approved the device in 1979 for the prevention of pulmonary embolism (PE), but permanent filters have been on the market for more than 35 years. Recent complaints and complications involve temporary IVC filters that were approved under the 510(k) process. This means that the IVC filters were sent to market without full FDA approval and no clinical trials, as long as they are “substantially similar” to devices that are already on the market.
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