The last witness took the stand in a bellwether trial accusing C.R. Bard Inc., of selling a blood clot-catching medical device it knew was defective and capable of seriously injuring people.
Chad Modra, a former quality-assurance exective at Bard Peripheral Vascular (BPV) and current Staff Vice President of Operations at Bard, defended his company’s internal complaint-receiving procedures and agreed with defense attorneys that Bard’s methods for handling safety data were “highly regulated by the FDA.” But when plaintiffs attorneys asked about a warning letter BPV received in July 2015, Modra said his team considered the issues raised in the letter were resolved.
The trial involves the case of plaintiff Sherr-Una Booker, who claims that after being implanted with Bard’s G2 IVC filter, the device pierced her aorta and spine and, as a result, she had to undergo open-heart surgery.
IVC filters are tiny cage-like devices that are implanted in the inferior vena cava, a large vein that delivers deoxygenated blood from the lower extremities. They are designed to capture blood clots before they reach the heart and lungs. The devices have been linked to serious complications including migration and fracturing, which can cause the metal struts to puncture and embed in the inferior vena cava or other parts of the body.
According to Booker’s attorneys, records show that of the 130,000 Bard G2 devices implanted in patients, there were 207 repots of migrations, 316 repots of perforations, and 320 reports of tilting. To make matters worse, the system for reporting device failures is voluntary, which suggests the failure rate is much higher than the data shows.
Bard, and another IVC filter manufacturer, Cook Medical, are facing thousands of lawsuits alleging they marketed their blood clot catching devices knowing they were prone to failure and could cause patients serious injuries.