The federal judge overseeing thousands of lawsuits involving C.R. Bard, Inc.’s inferior vena cava (IVC) filters has denied the company’s bid to keep certain documents under seal.
According to Reuters, the documents in question were admitted into evidence but only partially disclosed during previous IVC filter lawsuit trials.
On Tuesday, however U.S. District Judge David Campbell of the District of Arizona ruled that the admission of the evidence waived an earlier protective order, even if the documents were not presented in court.
Bard is named a defendant in more than 5,700 IVC filter lawsuits centralized before Judge Campbell. While the majority of these claims involve the company’s retrievable blood clot filters, including the Recovery, G2, and Eclipse models, more than 80 involve the Simon Nitinol filter intended for permanent placement.
Plaintiffs pursuing these cases allegedly suffered blood vessel perforation, embolization, and other serious injuries due to a defectively designed IVC filter that tilted out of place, fractured, migrated or otherwise malfunctioned. T
hey further assert that Bard knew its blood clot filters were defective, but failed to warn patients and doctors about these risks.
The litigation’s first bellwether trial concluded last March, when a patient implanted with the Bard G2 filter was awarded $3.6 million in compensatory and punitive damages.
The second trial involved an Eclipse IVC filter lawsuit and concluded last May with a win for Bard.
A third Eclipse cases was to go to trial last August. However, the case was dismissed when the Court found it had been filed outside the governing statute of limitations.
Bard also won the fourth bellwether trial, which concluded in October and involved the G2X IVC filter.
Bard’s IVC filters are used to treat patients at risk for pulmonary embolism when they can’t use coumadin or other blood-thinning drugs. The devices look like small wire cages and are implanted in the inferior vena cava. One in place, the filters catch blood clots before they can reach the heart or lungs.
In 2010, the U.S. Food & Drug Administration (FDA) warned that IVC filters had been implicated in more than 900 adverse event reports, including migration, fracture, embolization, blood vessel perforation, and more.
Among other things, the FDA suggested the failure to remove retrievable devices was behind many of the reported injuries.
Just four years later, the FDA issued a new alert reminding doctors about the importance of IVC filter retrieval.
“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.”