Some lawsuits allege that IVC, a device that traps blood clots to keep them from moving through the body, has not lived up to its promise. Plaintiffs who have filed suit claim that IVC may cause blood vessel damage and death. IVC patients have been compensated damages of greater than $41 million with one state having around 15,000 pending cases in addition to two federal mass torts.
Manufacturers Cordis, Bard, Rex Medical and Cook Medical are among the defendants named in the lawsuit. Several claimants say that IVC cannot easily be removed, and the risk of removal caused them to live in mental distress or to get injured. Some injuries that have been reported with IVC include broken parts trapped in the body, perforated veins, death and migrating devices.
Lawsuits allege that the makers of IVC didn’t warn doctors and patients of the possible risks. In 2016, one patient claimed that their IVC tilted, which caused the device to fracture, and they won $3.6 million in compensation. In spite of several operations to dislodge struts, one strut remained attached to the inferior vena cava.
Four recalls have been linked to IVC, but a device recall isn’t required to file a lawsuit. In 2015, the FDA sent warning to manufacturer Bard for neglecting to inform patients of defects and misfiling consumer complaints. The FDA also claimed that Bard produced a removal device that the agency had not approved.
Bard still has over 7,800 pending cases against it with negotiations underway. Other personal cases have been dismissed or combined with the Bard and Cook Medical mass tort lawsuit. Rex Medical’s device had over 800 claims merge with the mass tort.
The FDA advises patients to have IVC filters removed 29 to 54 days after insertion. Patients who think they have been injured by their IVC may still be able to file with a mass tort.
