The federal court overseeing hundreds of product liability lawsuits involving C.R. Bard Inc.’s allegedly defective IVC filters will allow a plaintiff to present evidence pertaining to a predicate device during the litigation’s second bellwether trial, which is slated to begin next month.
According to court documents pending in the U.S. District Court, District of Arizona, the case soon to go before a jury was filed on behalf of a Georgia woman who received C.R. Bard’s Eclipse blood clot filter in 2010 to treat recurrent deep vein thrombosis. Five years later, a scan revealed that one of the filter’s limbs had fractured and become embolized in her right pulmonary artery. Though doctors removed the filter, the fractured limb remains in her body.
The Eclipse IVC filter came to market under the U.S. Food & Drug Administration’s 510(k) program, which allows device manufacturers to avoid conducting human clinical trials when a new device is shown to be “substantially equivalent” to a “predicate device” that had already gone through the agency’s strict premarket approval device.
The predicate device for the Eclipse IVC filter was C.R. Bard’s Recovery filter. In an Order dated April 18th, Judge David G. Campbell ruled that the plaintiff would be able to present evidence pertaining to the testing, development and design of the Recovery blood clot filter, finding that it is relevant to her case.
“The history of the Recovery and how it led to the G2 tends to make a fact in dispute — the allegedly defective design of the Eclipse — more probable,” Judge Campbell wrote. “The Court cannot conclude that evidence of the Recovery’s complications, testing, and design should be precluded under Rule 403. The Court does not find such evidence to be unfairly prejudicial – it is a relevant part of the Eclipse filter’s design history
IVC (inferior vena cava) filters are indicated for use in patients at risk for pulmonary embolism, a life-threatening type of blood clot that occurs when a clot elsewhere in the body breaks free and travels through the bloodstream to the lungs. IVC filters are inserted into the inferior vena cava to prevent any such clots from making their way to the heart or lungs.
In 2010, the U.S. Food & Drug Administration reported that its adverse event database had received more than 900 reports in relation to IVC filters, including:
Four years later, the agency issued a second advisory urging 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.
Court records indicate that there are more than 3,700 IVC filter lawsuits pending in the multidistrict litigation now underway in the District of Arizona.
All of the cases were filed on behalf of individuals who suffered life-threatening injuries and complications allegedly due to the malfunction of C.R. Bard’s retrievable blood clot filters, including Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali devices.
The litigation’s first bellwether trial concluded in March, when the company 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 G2 IVC filter.
The Eclipse IVC filter lawsuits will head to trial on May 15th.
As bellwether trials, the verdicts in these cases are intended to provide insight into how other juries might decide similar IVC filter lawsuits.