U.S. Court of Appeals for the Ninth Circuit upheld damages awarded to a patient who suffered heart damage from C.R. Bard’s clot-stopping vein filter. The court ruled that the U.S. Food and Drug Administration’s edicts did not pre-empt Georgia’s state law underscoring a duty to warn.
In 2007, patient Sherr-Una Booker underwent a surgical procedure to place a Bard’s G2 model inferior vena cava (IVC) filter near her heart. When fragments of the filter became detached, Booker was forced to under heart revision surgery.
In 2018 a Phoenix federal jury awarded Booker $3.6 million, including $2 million in punitive damages. The jury found device maker Bard to be 80 percent responsible for the plaintiff’s damages. Although the jury did not hold the company liable for strict product liability design defect, strict product liability failure to warn, or negligent design, they did find the defendant was liable for negligent failure to warn.
Twenty percent of the liability was assigned to a radiologist who neglected to detect a detached fragment of the filter in a 2009 X-ray.
Bard attorneys argued to the appeals court that the FDA’s guidance pre-empted any requirements to warn patients about the device’s tendency to migrate, perforate veins, and cast metal shards into patients’ heart.
The plaintiff’s attorney counter-argued that the FDA did not issue requirements related to the device’s design, leaving interpretation of rules up to states. Although the FDA imposed three requirements, the court ruled that they were too broad to pre-empt state law.
Georgia law mandates that product manufacturers warn consumers about potential hazards involved in using their products. Labeling on the G2 did note potential for breaking, migrating, and perforating veins, but it did not reveal the fact that the G2s had a much greater risk of these outcomes than competitors in the IVC filter market.