A year-long investigation by NBC Nightly News raises questions about the C.R. Bard’s handling of the Recovery IVC filter product, a device implanted in the inferior vena cava to block blood clots from traveling to the lungs.
In the first part of the series, aired on September 2, NBC News reported that more than 300 adverse events, including at least 27 fatalities, have been associated with the Recovery device.A confidential study commissioned by C.R. Bard in 2004 linked the Recovery IVC filter to higher rates of death, fracture and movement compared to its competitors. The author of the report said that further investigation was “urgently warranted,” but C.R. Bard did not recall the device. NBC News reports that the company sold roughly 34,000 Recovery filters over about three years before replacing it with a modified version sold under a different name (G2 IVC Filter System).
IVC filters like the Bard’s Recovery device are implanted in the inferior vena cava in order to block blood clots from traveling to the patient’s lungs. Some of the devices are permanent, others, like the Recovery device, are retrievable, intended to be removed once the danger of blood clots has passed, NBC News explains.
Retrievable IVC filters have been associated with reports of fracturing and migration. Fractured portions of the device can migrate to the heart and lungs or other organs, where the metal fragments can cause bleeding, severe pain, further embolus and other complications.
In 2010, the Food and Drug Administration (FDA) disclosed that retrievable IVC filters had been associated with more than 900 adverse events, including incidents of migration, fracture and embolization, and perforation of the inferior vena cava. In 2014, the agency issued a new advisory to alert doctors that retrievable IVC filters should be removed within 29 to 54 days of implantation, according to NBC News. However, a study that appeared in JAMA Internal Medicine in 2013 suggested that successful IVC retrieval occurred in only 10 percent of patients. Bard removed the Recovery IVC from the market in 2005, but it is believed that there are still devices implanted in people. The G2, which was the replacement for the Recovery, is still being used.
Court documents show that C.R. Bard has been named in dozens of IVC filter lawsuits, all of which claim that the Recovery and G2 products are prone to fracture, or they migrate, tilt, or perforate the inferior vena cava, resulting in serious injury to patients. On August 17, the U.S. Judicial Panel on Multidistrict Litigation transferred all federally filed C.R. Bard IVC filter cases to the U.S. District Court, District of Arizona for the purposes of coordinated pretrial proceedings, NBC News reports