On July 21, 2017, a Pennsylvania man filed a new IVC filter lawsuit against Cook Medical. He claims that after being implanted with the device, he suffered serious injuries. His case joins thousands of other federally filed cases currently consolidated in the Southern District of Indiana.
The FDA warned about all IVC filters back in May 2014, stating that they should be removed, if possible, within 29 to 54 days after implantation.
Plaintiff States that Cook IVC Filters Defectively Designed
According to his complaint, the plaintiff was implanted with a Gunther Tulip IVC Filter on December 26, 2005. These filters are used to trap and hold blood clots so they can’t travel on to cause problems in the heart and lungs. The filters are small, spider-like devices that are placed inside the inferior vena cava, which is the main vein traveling from the legs back to the heart.
In this case, the filter was placed to help the plaintiff avoid a pulmonary embolism (PE), which is a blood clot in the lungs. Unfortunately, over time, these devices can break, migrate to other locations, and even cause blood clots themselves.
The plaintiff claims that Cook Medical should be held liable for defective design and manufacturing, and for failing to warn doctors and patients of the real risks.
Studies Show Serious Risks with IVC Filters
A number of studies have revealed troubling problems with Cook and other IVC filters. In 2012, for example, researchers reported on their analysis of 50 patients who were implanted with Cook Gunther Tulip and Celect IVC filters between 2007 and 2009.
Results showed that all the filters, after 71 days, showed some degree of perforation into the vena cava, meaning they had actually punctured the vein. It also looked as if the perforation would only get worse. The scientists concluded that leaving the filters in the body for too long was likely to result in perforation. They suggested doctors remove them as soon as possible.
In a later 2015 study, researchers compared the Cook Celect with the Rex Medical Option filter, and found that the Celect had a 43 percent rate of strut perforation, whereas the Option had no incidences of perforation.
Other studies have suggested that the risks associated with these filters may outweigh any benefits. In a large study of in-hospital fatality rates, researchers showed that IVC filters did not reduce mortality rates for stable patients. In an editorial published in JAMA Internal Medicine, the author stated the benefits of the devices had never been validated by empirical studies.
Cook IVC Filter Lawsuits
On October 15, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Cook IVC filter lawsuits into the Southern District of Indiana. They assigned District Judge Richard L. Young to oversee the proceedings.
The first three bellwether lawsuit trials are scheduled to begin in late 2017.