More than 500 personal injury and wrongful death lawsuits have been filed against manufacturers of small wire devices called retrievable IVC filters. The devices were implanted in about 250,000 people annually who are at risk for dangerous blood clots, raising serious safety concerns.
Retrievable IVC filters are wire devices that are placed in the vena cava, the largest vein in the body. They are designed to stop blood clots from reaching the heart and lungs, and are recommended for patients who cannot take blood thinners.
The devices are made by 11 manufacturers, including C.R. Bard, Cook Colect and Johnson & Johnson. Permanent IVC filters have been used successfully in patients since the 1960s. Retrievable IVC filters were introduced in 2003 and promoted for use in patients undergoing bariatric, trauma and orthopedic surgery.
Since the retrievable IVC filters hit the market, hundreds of complications have been reported including migration, fracture and perforation leading to embolism, organ damage and death. In some cases, pieces of the device or the entire device have punctured the heart or migrated into the spine. As a result, lawsuits are mounting against manufacturers of these devices.
More than 400 lawsuits against Bard involving its retrievable IVC filter, marketed as the Recovery filter, are pending in U.S. District Court in Arizona. That device has been associated with at least 27 deaths and another 300 non-fatal problems. The lawsuits allege failure to warn, design and manufacturing defects, consumer fraud and wrongful death.
Despite reports of injuries and deaths linked to the Recovery filter, Bard did not issue a recall or stop selling its IVC filter. Instead, Bard continued to sell an additional 34,000 of the devices over the next three years. The company later replaced the Recovery filter with a modified version, marketed under the name G2.
About 120 lawsuits have been filed against retrievable IVC filter maker Cook Celect. Those lawsuits are pending in U.S. District Court in Indiana.