High Failure Rates Lead to Surge in IVC Filter Lawsuits
IVC filter lawsuits have been on the rise lately, allegedly due to very high failure rates about which patients were never warned. Medical device manufacturers, Cook Medical and C.R. Bard, are on the defensive end as they handle numerous IVC filter lawsuits.
These medical devices have been associated with dozens of injuries and even some deaths. Many patients have come forward to share their concerns with their doctors about failure rates. The patients say they were never properly warned of the problems before implantation.
These devices are implanted into the inferior vena cava of a patient’s heart chambers and are intended to prevent blood clots traveling up the leg and into the pulmonary system. This can lead to catastrophic consequences such as an embolism. However, as IVC filter lawsuits allege, these filters have been falling out of place, fracturing and migrating, ultimately allowing small metal fragments to travel towards the heart and lungs.
This could be a fatal problem if not captured quickly. Patients and physicians are coming forward with claims of dangers due to the high failure rates of these filters.
One recent study put the risk of a Cook IVC filter fracturing and puncturing a critical blood vein at 43 percent but the real statistics may be more severe.
Medical experts currently believe that every IVC filter fails if it is left in place for too long a period of time.
The longer that the IVC filter is present in the patient, the higher the risk of injury and death. IVC filters were originally intended to be a temporary fix for patients at risk for embolism who could not be treated with blood-thinning medication.
When blood-thinning drugs are not an option, IVC filters are promoted as a safe way to minimize risk of life-threatening events.
However, in 2014, the U.S. FDA in response to numerous adverse event reports and IVC filter lawsuits said that these filters should be removed as soon as possible once the patient was no longer at critical risk for pulmonary embolism.
The Journal of the American Embolism Association recently reported that in eight percent of cases IVC filters were not effective in preventing pulmonary embolism. IVC filter lawsuits have also named other problems with the development and marketing of these devices such as a forged signature at CR Bard in 2005 when a regulatory employee would not sign-off on the FDA application.
IVC filters were approved through a 510(k) clearance program which allows them to avoid the more comprehensive requirements traditionally associated with FDA approval.
If you’ve been injured due to an IVC filter and are considering filing a lawsuit, consult with the attorneys at McDonald Worley today. The case review is free.