After a year-long investigation, NBC News recently aired a shocking report that medical device manufacturer C.R. Bard was continuing to market and sell their inferior vena cava (IVC) filters even after the company became aware the filters were failing and causing serious injuries and even death.
The NBC expose linked at least 27 deaths and more than 300 injuries to failures associated with C.R. Bards Recovery Model IVC filters.
The IVC filter, or inferior vena cava filter, is a spider-like device that is inserted into the vena cava, the largest arterial, into which the filter deploys with thin, spider-like appendages spreading out to rest against the arterial wall, and designed to capture and trap blood clots passing through the artery and prevent them from reaching the lung.
In the course of their investigative report, NBC also uncovered that IVC devices made by C.R. Bard and Cook Medical have been linked to hundreds of adverse event reports where they puncture the vena cava, tilt out of position or migrate or break apart and cause metallic fragments to travel to the heart or lungs – a condition known as embolization. Even after C.R. Bard was warned about the problems, they continued to sell the devices, without warning the doctors of the defects and injuries.
Additionally troubling, it was also revealed that one of Bard’s IVC experts, Kay Fuller, a FDA regulatory specialist, quit the company after Bard would not address her concerns over the device’s health issues. She also accused the company of then forging her signature on the FDA approval application.
In 2010, after receiving thousands of adverse event reports, the FDA issued a warning citing the risk of retrievable filter injuries. Following that warning, in 2014 the FDA issued strong warnings to doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.
Lawsuits against the two major manufacturers of IVC filters, C.R. Bard and Cook Medical have begun to mount. On September 28, a wrongful death lawsuit was filed in Missouri against C.R. Bard over its allegedly defective Bard G2 IVC filter. The U.S. Judicial Panel on Multidistrict Litigation has also approved consolidated federal proceedings for Bard IVC filter lawsuits in Arizona, and consolidated MDL proceedings for all Cook Medical IVC filter lawsuits in Indiana.
An estimated 30,000 IVC filters have been implanted in the last 30 years. Patients need to be aware of the high failure rates associated with these devices and any patients who have suffered serious injuries after being implanted with C.R. Bard or Cook medical IVC devices may be able to recover damages.