The fourth bellwether trial involving C.R. Bard’s retrievable IVC filters will soon get underway in the U.S. District, District of Arizona, where jury selection is scheduled to begin on Monday, May 13th.
More than 7,000 Bard IVC filter lawsuits are currently pending in the Arizona litigation. The proceeding’s bellwether trials are intended to test the strength of plaintiffs’ claims and provide insight into how other juries might decide similar cases.
The upcoming trial will involve a case filed on behalf of Debra Tinlin, a recipient of Bard’s Recovery blood clot filter. According to her complaint, pieces of the filter travelled to her heart after the device fractured, while some of its struts perforated her inferior vena cava. Filter fragments her doctors could not remove remain in Tinlin’s pulmonary artery and continue to endanger her life.
Because of her precarious health status, Tinlin will not be attending the trial. According to Preliminary Jury Instructions issued on August 29th, she well be viewing the proceedings on video-conference from her home in Wisconsin.
IVC filters are placed into the inferior vena cava to prevent pulmonary embolism in patients at risk for blood clots, but who are unable to use standard blood-thinning medications. Once in place, the tiny, wire devices can intercept clots before they travel to the lungs or heart. Retrievable filters, like Bard’s Recovery device, are intended to be removed once the patient is out danger.
The U.S. Food & Drug Administration (FDA) issued a warning for IVC filter complications in 2010, after its adverse event database received more than 900 adverse event reports involving devices, including 328 instances of filter migration, 146 reports of embolization, 70 cases of perforation, and 56 reports of blood clot filter fractures.
The FDA updated the alert in May 2014, warning that lower-limb deep vein thrombosis, migration, fracture, perforation, occlusion, and embolization were long-term risks associated with IVC blood clot filters.
“For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided,” the agency said. “The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
In 2015, NBC News reported that Bard’s Recovery IVC filter had been associated with more than 300 non-fatal injuries and 27 deaths before it was discontinued in 2005. The report also highlighted a confidential company study that linked the Recovery filter to higher rates of death, fracture and movement compared to its competitors.
The Bard IVC filter litigation has already convened three bellwether trials. The first concluded last March, when a recipient of the Bard G2 IVC filter was awarded $3.6 million in compensatory and punitive damages.
The second trial involved Bard’s Eclipse IVC filter, with the jury finding for the defense last May. Bard also prevailed in the third bellwether trial, which concluded in October and involved the G2X IVC filter.