The second bellwether trial involving C.R. Bard Inc.’s retrievable inferior vena cava (IVC) filters got underway yesterday in the U.S. District Court, District of Arizona.
The case selected for trial was filed on behalf of a Georgia woman who received Bard’s Eclipse IVC filter in 2010. The filter fractured in April 2015 and became embolized in her pulmonary artery.
As a bellwether trial, the verdict in this case could provide insight into how other juries might decide similar lawsuits involving Bard’s retrievable IVC filters.
As previously reported, the trial will consist of two phases, the first of which will determine liability, compensatory damages and whether punitive damages are appropriate. The second – if needed – will determine the amount of punitive damages to be awarded.
A Witness List issued by the Court indicates that 76 people could be called to testify during the trial.
There are currently more than 3,800 IVC filter lawsuits pending in the District of Arizona, all of which were filed on behalf of patients who allegedly suffered life-threatening complications due to the fracture, migration, or tilting of Bard’s retrievable blood clot filters, including the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali devices.
The litigation’s first bellwether trial concluded in March when C.R. Bard was ordered to pay $3.6 million (including $1.6 million in actual damages and $2 million in punitive damages) to a woman who suffered complications related to the fracture and migration of the company’s G2 IVC filter.
IVC filters are indicated for use in patients at risk for pulmonary embolism, but who are unable to use standard blood-thinning medications. Retrievable devices, including those at the center of the Bard IVC filter litigation, are intended to be removed from the patient’s body once they are no longer at risk for pulmonary embolism.
In 2010, the U.S. Food & Drug Administration (FDA) reported that it had received over 900 reports of IVC filter complications, including:
“Some of these events led to adverse clinical outcomes in patients,” the agency noted. “These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism has subsided.”
The FDA issued a second alert just four years later reminding healthcare providers to retrieve temporary blood clot filters within 29 to 54 days of their implantation in order to reduce the risk of patient harm.