Cordis Corp. is the latest medical device maker caught up in the litigation involving allegedly defective IVC (inferior vena cava) filters.
According to a report recently published by Law.com, the company has been named a defendant in three IVC filter lawsuits currently pending in Florida’s Palm Beach County Circuit Court. At least 21 additional cases have been filed in California state court.
Cordis manufactures the TrapEase Vena Cava Filter, a nickel titanium alloy device indicated for use in patients at risk for pulmonary embolism. Like other blood clot filters involved in the growing products liability litigation over IVC filters, the TrapEase is implanted in the inferior vena cava to intercept blood clots before they can travel to the heart and lungs. The TrapEase is intended for permanent placement.
Plaintiffs who have filed TrapEase IVC Filter lawsuits claim that its anchoring mechanism is defective and can fail over time. Should this occur, the device may become dislodged, migrate and/or fracture the body, leading to punctured blood vessels, restricted blood flow, blood clots and pulmonary embolism, and other life-threatening IVC filter complications.
Plaintiffs are seeking compensation for Cordis’ alleged defective design and manufacture, deceptive marketing and failure to warn of the product’s risks.
Court documents indicate that C.R. Bard, Inc. has been named a defendant in at least 3,400 product liability claims involving its Recovery and G2 retrievable IVC filters, all of which have been centralized in a federal multidistrict litigation now underway in the U.S. District Court, District of Arizona.
An additional 3,636 claims involving Cook Medical, Inc.’s Celect and Gunther Tulip retrievable IVC filters have been filed in a second multidistrict litigation now underway in the U.S. District Court, Southern District of Indiana.
In August 2010, the U.S. Food & Drug Administration (FDA) warned that its medical device database had received hundreds of reports detailing IVC filter complications associated with retrievable devices, including cases of device fracture and migration, as well as incidents involving organ and blood vessel perforation.
“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides,” the agency stated. “Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”