The inferior vena cava filter, known as the IVC filter, is used to prevent blood clots from traveling into the lungs or the heart, which can cause life-threatening blockages like a pulmonary embolism. This medical device is implanted in the inferior vena cava, the large, tube-like vein that brings blood from the legs and lower torso of the body into the chambers of the heart. Radiologists or surgeons implant the filters in patients after blood thinners or anticoagulants have not effectively reduced the patient’s risk of developing blood clots in the lower body.
However, certain types of product defects can make these filters dangerous instead of beneficial. Some IVC filters, such as those sold by Cook Medical, may break apart, causing internal damage to blood vessels and organs, which could result in wrongful death. Nevertheless, Cook has not issued any product recalls for these defective medical devices.
Cook IVC filters were developed to protect at-risk patients from serious complications related to blood clots. However, product defects in the filters can result in serious injuries instead. In many cases, the filter fails and migrates from the site of implantation. This migration causes serious problems, including:
The FDA's article, Removing Retrievable Inferior Vena Cava Filters warned doctors to be prompt in removing IVC filters from patients after their risk of clotting passed. According to the article, when left in the body for too long, the filters pose life-threatening risks to patients. The report included information from medical studies that found that prolonged use of these devices is not safe because they often erode.
Although Cook has issued no product recalls for IVC filters, several of their products are the subject of ongoing litigation. The affected Cook products are:
On February 1, 2019, the third and final Cook blood clot filter bellwether trial returned a $3 million verdict in favor of the plaintiff. This multidistrict litigation covers some 4,800 hundred cases.
On October 15, 2014, the Judicial Panel on Multidistrict Litigation (JPML) centralized 27 cases filed against Cook Medical in the U.S. District Court for the Southern District of Indiana. These cases allege that Cook’s IVC filter warnings are defective as well as the design.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE