Cook Medical and C.R. Bard are now facing more than 3,700 lawsuits regarding injuries allegedly related to their IVC filters, Mass Tort Nexus reports.
An inferior vena cava (IVC) filter is a device implanted into the vena cava, the largest vein in the body, and is designed to catch blood clots in its spider-like legs. The purpose is to prevent pulmonary embolism (PE), a life-threatening condition in which blood clots enter the heart or lungs.
IVC filters designed for long-term use were used for years with few reported problems. However, when retrievable IVC filters were introduced into the market, the rate of reported failures and complications has risen significantly.
In two federal multidistrict litigations (MDLs), Cook Medical is a defendant in at least 1,918 cases involving its Gunther Tulip and Celect filters. Bard is facing at least 1,851 cases regarding its Recovery, G2, Meridian, and Denali filters. Both companies are being accused of hiding the risks associated with their devices, and failing to warn doctors of side effects. The lawsuits also claim the companies failed to instruct doctors when and how to remove the devices effectively.
When the FDA became aware of the high rate of failure reported in connection to retrievable IVC filters, it released an official recommendation that the retrievable filters be removed between 29 and 54 days after insertion. If the filter remains implanted any longer than recommended, the patient’s risk of failure or complication such as the filter fracturing, migrating, perforating and/or tilting becomes significantly higher, the agency warned.
In 2013, a paper published in JAMA Internal Medicine found that only 8.5 percent of retrievable IVC filters were actually being removed. That following year, the FDA issued a safety alert to remind doctors that retrievable IVC filter removal is of utmost importance.