Our law firm recently filed a product liability lawsuit against C.R. Bard, which claims that one of the company’s IVC (inferior vena cava, is a major vein that runs the length of the body from the heart down to the leg) filters failed. The Bard IVC filter has cut into the walls of the woman’s vena cava and it cannot be removed without major invasive surgery.
Robin Arnold and her husband, Felix, filed her case in the U.S. District Court for the Western District of Texas. They filed claims against Bard for negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty, negligent misrepresentation and loss of consortium.
Plaintiff Suffered Severe Injuries from the Bard IVC Filter
Arnold received a Bard G2 filter in September 2007. The Bard G2 filter failed after it was implanted and the problems were not discovered until about July 2011. The spider-like filter arms have penetrated her inferior vena cava walls and can not be safely removed, without major invasive surgery.
Bard manufactures two IVC filters models. There has been several lawsuits filed, where plaintiffs claim that the device failed and that the filters legs have broken off and moved to other parts of the body (embolized). In some severe cases, plaintiffs claim that the embolized fragments punctured the inferior vena cava, the aorta, heart, lungs and the bowels.
The lawsuits allege that Bard knew or should have known about the high rate of fracture, migration and perforation of the vena cava wall that was occurring with the Bard Recovery and G2 filters, yet failed to warn consumers or the doctors.
What is the Bard IVC Filter?
Filters are used to prevent pulmonary embolism (blood clot in the lung), which can occur when there is a deep vein thrombosis (blood clot in the leg). Usually these patients cannot tolerate the traditional treatment of blood thinners, have side effects from blood thinners or blood thinners like Coumadin are contraindicated, for example in pregnancy.
The filter is a medical device, that is placed intravenously into a leg vein, to prevent the migration of a blood clot in the leg, in patients suffering a deep vein thrombosis. The G2 filter is an improved model of an earlier IVC filter, the Bard Recovery, which was removed from the market after reports of side effects.
The Bard Recovery and G2 filters were designed so that they can be removed once the risk of pulmonary embolism has been reduced.
Bard IVC Filter Side Effects, Migration and Fractures
The lawsuits have been brought after an FDA alert in August 2010, which warned about the risk of problems with removable IVC filters. The FDA had received more than 900 adverse event reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.
The FDA recommended that doctors remove the filters once the danger of the pulmonary embolism has passed, to reduce the risk of the filters breaking and embolizing through the body.
According to recent medical studies, there is a lack of evidence that the IVC filters are effective, and a lack of data on their proper use, resulting in doctors being unsure of how, when to implant them or remove them.
According to experts, there is approximately 100,000 of these filter devices that have been implanted in the United States.