The $3.6 million verdict awarded to a woman who suffered life-threatening complications following the fracture and migration of C.R. Bard, Inc.’ G2 IVC filter will stand, after an Arizona federal judge rejected the company’s bid for a new trial.
Plaintiff Sherr-Una Booker received the G2 filter in 2007. According to her lawsuit, the device subsequently fractured, tilted and migrated, causing one or more of its components to perforate her inferior vena cava. Though she underwent surgery to remove the IVC filter, a fragment remains in her body to this day.
Booker was awarded $1.6 million in actual damages and $2 million in punitive damages in March, after a jury in the U.S. District Court, District of Arizona, found that C.R. Bard was negligent in failing to warn her doctors about the risks potentially associated with the G2 IVC filter. The company was found 80% liable for Booker’s suffering.
C.R. Bard subsequently filed motions for a new trial and a judgment as a matter of law on April 23rd. Among other things, the company asserted that Booker had “utterly failed to present any evidence at the trial on the fundamental premise” of negligent failure to warn. In requesting a retrial, C.R. Bard maintained that the jury’s verdict was “irreconcilably inconsistent” because it did not find the company liable for strict liability failure-to-warn.
U.S. District Judge David Campbell rejected both arguments in an Order dated June 19th, ruling that the evidence supported the jury’s finding on Booker’s negligent failure-to-warn claim. He also disagreed that the verdict was inconsistent because the “focus in negligence is on the manufacturer’s conduct, while in strict liability it is on the product and the user’s expectations.”
The Booker case is one of more than 4,000 IVC filter lawsuits pending against C.R. Bard in the District of Arizona, where all such federally-filed product liability claims involving the company’s products have been centralized for coordinated pretrial proceedings.
As a bellwether trial – the litigation’s first – the verdict was expected to provide some insight into how other juries might rule in similar IVC filter lawsuits.
The litigation’s second bellwether trial concluded in May, with a win for C.R. Bard. That case involved the company’s Eclipse 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. The small, wire, cage-like devices are implanted into the inferior vena cave to intercept blood clots before they can make their way to the heart and lungs.
The C.R. Bard litigation focuses on retrievable IVC filters, which 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.