October 1, 2015, Trial News
More cases filed alleging defective Bard IVC filters in wake of MDL centralization
Litigation is ramping up against C.R. Bard as more information comes to light about the company’s allegedly defective IVC blood clot filters. Twenty-two cases pending across the country were centralized into a MDL in the District of Arizona under Judge David G. Campbell on Aug. 17. As of Sept. 24, that number has more than doubled.
Litigation is ramping up against C.R. Bard as more information comes to light about the company’s allegedly defective IVC blood clot filters. Twenty-two cases pending nationwide were centralized into an MDL in the District of Arizona under Judge David G. Campbell on Aug. 17. As of Sept. 24, that number has more than doubled. The devices also were the subject of a recent NBC News investigation and have been on the FDA’s radar since at least 2010.
The JPML noted in its transfer order that all the cases involved common factual allegations “that defects in the design of Bard’s retrievable filters make them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.” (Transfer Order, In re Bard IVC Filters Prods. Liab. Litig., MDL No. 2641 (J.P.M.L. Aug. 17, 2015).)
The complaints against Bard involve two iterations of a device—the G2 filter and its predecessor, the Recovery filter—intended to prevent a pulmonary embolism by capturing blood clots. The small device is implanted in the inferior vena cava, a vein in the heart, and is meant to be removed after the danger of blood clots has passed. However, they are not always removed in a timely manner, and the filters can move, break, and perforate the vein.
The FDA issued a safety alert in August 2010, stating that the filters should be removed as soon as patients are no longer at risk for blood clots, and that leaving the filters in beyond the necessary time to prevent a pulmonary embolism increases the risk of the device malfunctioning and injuring the patient. The FDA revealed at the time that since 2005, it had “received 921 device adverse event reports” including “70 [that] involved perforation of the IVC.”
The agency noted that this type of device has been around for decades but that its use has increased significantly—from 2,000 implanted in 1979 to 167,000 implanted in 2007. The FDA revisited the issue in May 2014, reiterating its recommendation that the filters be removed as soon as possible, and reported that its initial analysis indicated that the optimal time frame for removal of the filters is between 29 and 54 days after they are implanted.
A complaint filed in early September detailed typical allegations against Bard—that the manufacturer knew or should have known about the dangers associated with the devices but continued to market the filters and failed to adequately warn consumers of the risks. The plaintiff in that case, Mary Duffie, received a Bard G2 filter in 2008 and discovered in 2014 that part of the device had broken off and perforated her heart muscle. She underwent open heart surgery to retrieve the filter, but part of the device could not be located and is believed to still be in her body. She asserted negligence, strict liability for failure to warn, strict liability for design defects and manufacturing defects, breach of implied warranty, and negligent misrepresentation.
The claims against Bard have received national exposure from an NBC News investigation highlighting the deaths and injuries associated with the device. The two-part story alleged that Bard had been aware of the risk for complications from an internal study it commissioned, but did not disclose those risks outside the company. NBC News also raised questions about the Recovery device’s FDA-approval process.
An initial status conference for the MDL is scheduled for Oct. 29.