An Arizona federal jury has ordered medical device manufacturer C.R. Bard to pay nearly $4 million in damages to a woman who suffered severe injuries when one of the company's IVC filters broke apart inside her body, Law360 reports.
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The jury concluded that Bard was responsible for 80% of the $2 million in compensatory damages to which the plaintiff is entitled; the remaining 20%, jurors held, should be borne by her implanting physician, who was not party to the case.
An additional $2 million in punitive damages has also been assessed against Bard, bringing the woman's total compensation award to $3.6 million. The trial lasted just under two weeks, with District Judge David G. Campbell presiding.
This is the first of 2 bellwether trials to be held in the US District Court of Arizona, where nearly 4,000 IVC filter cases are now pending against C.R. Bard. As members of a Multi-District Litigation, the lawsuits have proceed through pre-trial proceedings as a group. The legal strategy has allowed plaintiffs to pool their resources for common benefit, while increasing the efficiency of litigation for Bard as well.
In their product liability claims, thousands of IVC filter patients claim to have suffered severe injuries after their implants broke apart or migrated inside the body. Several studies suggest that up to 50% of IVC filters will fracture after implantation, a result that buttresses the arguments posed by plaintiffs, who say the technology is inherently defective.
And a blockbuster investigation from NBC News has found evidence that, in the case of at least one IVC filter, officials at Bard forged the signature of a medical device expert to gain FDA clearance. At the same time, plaintiffs accuse the company of failing to warn the public and medical care community about the risks of IVC filters.
The lawsuit of Sherr-Una Booker, however, was the first case to test these arguments out in front of a real jury. In her product liability lawsuit, one among thousands filed against Bard over similar allegations, Booker said she received a Bard-made IVC filter in 2007.
Surgeons hoped that the device, she writes, would block any blood clots from reaching her lungs or heart; she received the device in anticipation of an invasive procedure to remove a cancerous tumor. In court documents, the woman describes the horrific complications that she says soon followed.
After implantation, Booker claims, her G2 Vena Cava Filter began to break apart, piercing her inferior vena cava (IVC), one of the body's largest veins. In 2014, she returned to the hospital, where surgeons discovered that a strut from the medical device had snapped off and traveled into her heart.
She underwent open heart surgery to remove fragments of the fractured implant, but according to her attorney, a piece of the filter remains embedded in her IVC wall. Booker lives in constant fear, the lawyer says, that this remaining piece will break away and threaten her vital organs.
In their findings, the Arizona jury concluded, based on the evidence presented at trial, that C.R. Bard had failed to adequately warn Booker of the G2 IVC filter's risks. Bard's wrongdoing, the jury found, went beyond negligence, which accounts for the $2 million in additional punitive damages.
20% of the fault for Booker's injuries, however, were imputed to her physician, on the basis of evidence showing that an early X-ray had been misread.
The next Bard IVC filter trial is scheduled to begin on May 15, 2018 in the US District Court of Arizona.
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