A woman who suffered serious injuries allegedly caused by C.R. Bard, Inc.’s G2 inferior vena cava (IVC) filter will be allowed to present evidence pertaining to the performance of a predicate device when her case goes to trial later this month.
C.R. Bard is currently named a defendant in more than 3,000 lawsuits involving its Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali IVC filters, all of which have been consolidated in the U.S. District Court, District of Arizona, for the purpose of coordinated pretrial proceedings.
Opening statements in the litigation’s first trial are scheduled to begin on March 14th. The IVC filter lawsuit selected to go before a jury was filed on behalf of Sherr-Una Booker’s, who claims to have suffered life-threatening complications because of a G2 filter she received in 2007.
As a bellwether trial, the outcome of Booker’s lawsuit is expected to provide some insight into how juries might decide similar cases in the future.
Bard had been seeking to prevent Booker from presenting evidence associated with its Recovery IVC filter, asserting that its alleged problems were not “substantially equivalent” to those purportedly associated the filter she received.
However, in an Order issued on March 1st to address several of the company’s motions in limine, the Court pointed out that Bard had identified the Recovery IVC filter as the predicate device for the G2 when it moved to have the new filter cleared by the U.S. Food & Drug Administration (FDA). Among other things, the Order notes that Bard told the FDA that the G2 ‘s “design, material, components, fundamental technology (mode of device function/operation) and intended use featured” were “substantially equivalent to those featured with the predecessor Recovery Filter System.”
The Court also pointed out that Bard had indicated that it developed the G2 with the intention of, among other things, “reducing the number of incidents of filter fracture and migration that Bard had observed with the Recovery Filter.”
“Given these facts, Bard’s knowledge of problems with the Recovery filter is relevant to central issues in this case – whether Bard properly designed the G2 to correct those problems, whether Bard failed to warn physicians and patients about problems shared by the Recovery and G2, and whether Bard’s alleged failure to correct or warn about known problems justifies an award of punitive damages,” the Order states.
C.R. Bard’s IVC filters are indicated for use in patients who cannot take standard blood-thinning medications, but who are at risk for pulmonary embolism. Once inserted into the inferior vena cava, the filters intercept blood clots before they can make their way to the heart or lungs. The devices at the center of this litigation are retrievable and are designed to be removed once a patient is out of danger.
In 2015, NBC News reported that the Recovery device had been linked to more than 300 non-fatal IVC filter complications and 27 deaths before it was replaced with the G2 in 2005. The NBC News report also highlighted a confidential company study that linked the Recovery IVC filter to higher rates of death, fracture and movement compared to its competitors.
An internal memo uncovered by NBC News also suggested that C.R. Bard had concerns about the G2 filter, while another document that included data through 2010 indicated that the new device had been associated with more fractures, migrations and reported problems than competitors’ filters. The supposedly improved product had also been linked to at least a dozen deaths.