The federal court overseeing hundreds of IVC filter lawsuits filed against C.R. Bard, Inc. has ruled that the company will not have to produce electronically stored foreign communications during discovery. According to a report from Bloomberg BNA, plaintiffs were seeking access to communications between overseas regulators and the foreign entities that market Bard’s retrievable blood clot filters overseas.
According to a decision issued in the U.S. District Court, District of Arizona, on September 16th, most of Bard’s regulatory communications, including those with overseas entities, were already subject to discovery, as they appeared to have been created in the U.S. And while some of the company’s overseas divisions do communicate with regulators independently, the Court found that those communications were minimally relevant for the purposes of e-discovery.
“First, there are no Plaintiffs in this MDL from foreign countries…. All plaintiffs received their Bard filters and allegedly were injured in the United States,” the Court’s opinion stated. “Second, Plaintiffs seek communications with foreign regulators for a narrow purpose—to determine if any of those communications have been inconsistent with Defendants’ communications with American regulators.”
More than 880 IVC filter lawsuits are currently pending in the federal multidistrict litigation underway in Arizona. All of the cases were filed on behalf of individuals who allegedly sustained serious injury due to the tilting, migration or fracture of Bard’s Recovery and G2 series retrievable blood clot filters.
Bard’s devices are intended to be implanted in the inferior vena cava of patients who are at risk for pulmonary embolism, and who cannot use standard blood-thinning medications. The small, wire, cage-like filters are implanted in the inferior vena cava, where the devices will be able to intercept blood clots before they can travel to the heart and lungs. Once a patient’s risk has subsided, the filters should be retrieved.
In 2010, the U.S. Food & Drug Administration disclosed that its adverse event database had received more than 900 reports of IVC filter complications linked to retrievable devices. Four years later, the agency issued a second advisory that urged doctors to remove temporary blood clot filters within 29 to 54 days of their implantation in order to reduce the risk of patient harm.
According to reports that aired on NBC Nightly News in 2015, the Bard Recovery filter was associated with more than 300 non-fatal injuries and 27 deaths before it was replaced with the G2 series in 2005. However, the G2 filters were also linked to about a dozen deaths during the five years they were on the market. Among other things, the report disclosed a confidential study commissioned by Bard in 2004 which linked the Recovery IVC filter to higher rates of death, fracture and movement compared to its competitors. Another document that included data through 2010 indicated that G2 IVC filters were also associated with more fractures, migrations and reported problems than other brands of retrievable IVC filters.