February 13, 2015 — Six days into a federal trial in Nevada, C.R. Bard has agreed to settle a lawsuit involving a man who was injured by an IVC filter.
Terms of the settlement were confidential, according to an order issued on February 9 by U.S. District Judge Robert C. Jones.
The lawsuit was filed by Kevin Phillips, a man who was implanted with a Bard Recovery IVC filter in August 2005. The device was supposed to catch blood clots traveling from the lower part of his body before they could enter his lungs and cause a pulmonary embolism.
Instead, the filter broke and one of its legs traveled to his heart in April 2010. During the trial, Phillips claimed the device was defective because it migrated instead of safely capturing the blood clot. Phillips had to undergo open heart surgery and suffered from a long recovery.
The lawsuit claims the Recovery is defective because it “has a high fracture and migration rate as compared to other IVC filters, and these defects can cause serious injury or death.”
The Recovery is a retrievable filter that is only meant for short-term protection against blood clots. In August 2011, the FDA published a Safety Communication to warn that retrievable filters should be removed as soon as the patient was no longer at risk of a pulmonary embolism.
It is not clear whether Phillips actually needed the Recovery for five years. The FDA has received hundreds of adverse event reports involving filters that were not removed. Out of 921 adverse events, 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture.
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