A year-long investigation by NBC News has revealed that medical device manufacturer C.R. Bard, Inc. allegedly knew of defects in its Recovery IVC Blood Clot filters but continued to market the products anyway despite a more than 50% failure rate.
IVC filters are used to prevent blood clots from reaching a patient’s heart or lungs. The filter is implanted into the inferior vena cava of the heart, which carries oxygen-depleted blood from the body to the heart. It is estimated that approximately 250,000 Americans receive an IVC filter implant every year.
According to the NBC News investigation, the Bard Recovery IVC filter has been shown to have a failure rate of more than 50 percent, which typically occurs five years after implant. The consequences of IVC filter failure can include perforation of the inferior vena cava or surrounding organs as well as the breaking up of the device, which sends sharp fragments into a patient’s blood stream that may puncture the lungs or heart.
The investigation linked 27 deaths and more than 300 injuries to the Bard Recovery IVC filter, and charged that Bard continued to market the device despite knowledge of its high failure rate. NBC News obtained a company memo from December 2005 that noted that the Bard Recovery IVC filter had “an 11.5 times higher reporting rate for filter embolization deaths compared with all other vena cava filters.”
The Bard Recovery IVC filter was initially denied FDA approval and the company hired a regulatory consultant named Kay Fuller to help push the product to market. A subsequent application submitted by Bard included a legal document bearing Fuller’s signature that appeared to endorse the device.
However, Fuller later told MSNBC that the signature was forged and that she was so concerned about the safety of the Bard Recovery IVC filter that she secretly reported her concerns to the FDA.
There have been a number of lawsuits filed against Bard for its IVC filters. In August 2015, those suits were consolidated in the U.S. District Court, District of Arizona.
Showard Law Firm has represented numerous plaintiffs in medical device liability cases. Contact us today for your free consultation.