Over the past few months, many lawsuits have been filed over the safety risks of IVC filters.

These retrievable medical devices were created to reduce an individual’s risk of pulmonary embolism but have been linked to several dangerous complications, including strut perforation.

According to recent reports, the risk of perforation may be even higher with certain brands of IVC filter products, such as the Cook Celect filter, manufactured by Cook Medical.

Concerns Over IVC Filters

IVC stands for inferior vena cava filter, because this spider-like device is implanted in a person’s lower part of the heart, the inferior vena cava, in order to capture blood clots with the many legs or struts before the clots can travel to the lung. Over the last few years, various different types and brands of IVC filters have been implanted in numerous patients, even though the safety and efficacy of the medical products has been questioned over the years. The expectation for IVC filters is that they will be implanted and then removed once the threat of pulmonary embolism entering a patient’s lungs has passed. However, some patients have filed reports concerning severe and painful IVC filter complications and injuries, especially events where the medical device tilts out of place and punctures the vena cava or other tissues and organs inside a patient. The Journal of Vascular and Interventional Radiology recently published a study performed by researchers from Northwestern University and the University of Colorado, which compared the ability to retrieve and remove two different brands of IVC filters, the Rex Option and the Cook Celect IVC filter. The research demonstrates that retrieval rates for the Cook Celect and Rex Option were about the same; however, there was one significant difference. The researchers found that the Cook IVC filters featured a 43 percent strut perforation rate, a figure significantly higher than the Rex Option. This IVC filter research took a close look at patients implanted with these medical devices over the course of a 33 month period; during this research period, the researchers reviewed the performance and safety of 99 Cook Celect IVC filters and 86 Rex Option filters. The results showed that the Rex Option had no incidences of IVC filter strut perforation, while the Cook medical device demonstrated a 43 percent perforation rate.

FDA IVC Filter Warnings

Because of the reports of IVC filter perforation and other complications associated with the temporary medical device, the FDA issued a May 2014 warning that strongly emphasized the importance of removing the retrievable medical device within one or two months of after it has been confirmed that the risk of blood clots has passed. Some personal injury reports that prompted this FDA IVC warning include complaints regarding perforation, migration, fracture, embolization, and difficulty removing the IVC filter device.As of August 2010, the FDA stated that it had received 900 adverse event reports, 328 of which specifically alleged injury from a migrated IVC filter and 70 more regarding IVC filter perforation.

IVC Filter Litigation

Over the past year, there have been several dozens of IVC filter lawsuits filed against Cook Medical in United States federal court. As of October 2014, many of these have been centralized in the Cook IVC filter multidistrict litigation (MDL) before U.S. District Judge Richard L. Young in Indiana federal court. Centralization of these cases into one Cook IVC MDL will hopefully reduce the risk of duplicative discovery, avoid conflicting rulings, and make court proceedings more convenient for all parties involved.