Plaintiffs pursuing IVC filter lawsuits against C.R. Bard, Inc. in Arizona federal court are seeking to block the company’s attempts to seal certain internal documents pertaining to those claims.
According to Reuters, plaintiffs filed a brief with the U.S. District Court, District of Arizona. last Friday, asserting that the medical device maker had not presented any “compelling reasons” for withholding the documents from the public record. They further maintained that unsealing the documents would not reveal any trade secrets.
C.R. Bard is named a defendant in more than 3,000 product liability claims involving the company’s retrievable IVC filters, most of which have been centralized in Arizona federal court for coordinated pretrial proceedings.
The IVC filters at issue in this litigation 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 are retrievable and designed to be removed once a patient is out of danger.
Plaintiffs pursuing these cases claim that C.R. Bard’s devices are defective and prone to fracture, migration, and other malfunctions that can result in life-threatening IVC filter injuries and complications. They further claim that the company has been aware of these problems for years, but has failed to correct the alleged design defects or warn doctors and patients about the risks associated with the filters.
Many of the pending complaints involve Bard’s Recovery and G2 IVC filter product lines. In 2015, NBC News reported that the Recovery blood clot filter had been linked to more than 300 non-fatal injuries and 27 deaths before it was replaced with the G2 IVC filters series in 2005. The NBC News also highlighted a confidential company study that linked the Recovery IVC filter to higher rates of death, fracture and movement compared to its competitors.
While G2 filters were supposed to be more resistant to fractures and migration than the Recovery design, an internal memo uncovered by NBC News suggested that C.R. Bard also had concerns about its performance. A second document that included data through 2010 indicated that the G2 device was associated with more fractures, migrations and reported problems than other brands of retrievable blood clot filters. G2 filter malfunctions were tied to at least a dozen deaths.
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.