A U.S. judicial panel this week consolidated a group of product liability lawsuits filed over C.R. Bard (NYSE:BCR) inferior vena cava filters under a single court in Arizona.
The U.S. Judicial Panel on Multi-District Litigation pulled together 22 lawsuits filed in federal courts around the country and assigned them to the U.S. District Court for Arizona, under Judge David Campbell.
Another 16 cases could potentially tag along, the panel noted, according to court documents.
“After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the District of Arizona will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation,” the panel wrote in the August 17 ruling. “All actions involve common factual questions arising from allegations that defects in the design of Bard’s retrievable inferior vena cava filters … make them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.”
Last month Bard revealed an FDA warning letter issued over problems found at a pair of plants that make devices to retrieve IVCs.
The July 12 warning letter from the watchdog agency’s Los Angeles office cited quality system and medical device reporting problems found during inspections at Bard plants in Glens Falls, N.Y., and Tempe, Ariz., the company said. The FDA letter affects 2 models of Bard’s recovery cone removal system, Bard said.
In August 2010, the FDA warned that IVC filters could fracture, causing pieces of the device to travel through the bloodstream to other parts of the body. The agency recommended that physicians consider removing retrievable inferior vena cava filters after logging 921 reports of “adverse events” related to the devices.
Doctors place the device in the inferior vena cava, the main vein that brings blood back to the heart from the lower half of the body, to keep blood clots from traveling to the lungs and causing pulmonary embolisms. The implant treats patients with venous thromboembolism who have not responded to or cannot take anti-clotting medications.
There are two types of IVC filters, a permanent implant and a “retrievable” device meant for temporary use. The FDA said many of the 921 events reported appeared to be related to “a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of [PE] has subsided.” The reports involved device movement within the body, detachment of device parts, filter fracture and perforation of the IVC. The agency said doctors should remove the filter once the risk of pulmonary embolism has passed.
The filters are made by 10 companies, including units of New Jersey-based C.R. Bard Inc. (NYSE:BCR) and Johnson & Johnson (NYSE:JNJ); Vancouver, B.C.-based Angiotech Pharmaceuticals Inc. (NSDQ:ANPI); and Conshohocken, Pa.-based Rex Medical LP. The FDA did not specify the number of adverse event reports per manufacturer.
A separate article published online Monday in the Archives of Internal Medicine found problems associated with two types of filter made by C.R. Bard. Doctors commenced the study that the article is based on after a patient suffered a perforation of the heart three years after receiving an IVC device.
The study looked at 80 patients who received either of the two devices between April 2004 and January 2009. Of 28 patients who received the Bard Recovery filter, the older of the two models, 25 percent experienced a fracture. Twelve percent of the patients who received the Bard G2 filter, the model which replaced the Recovery filter to reduce the risk of fracture, experienced a fractured device. The patients implanted with the Recovery filter had the device inside them for twice as long.
The FDA said about 167,000 filters were implanted in 2007, with projections of 259,000 implantations by 2012.
