The manufacturers of the Option Retrievable Inferior Vena Cava (IVC) Filter have been named in a trio of lawsuits filed late last month in Pennsylvania’s Philadelphia Court of Common Pleas. All three complaints accuse the defendants of negligently manufacturing an unsafe product that may result in serious patient injury. (Case Nos. 170104248, 170104277 & 170104244)
IVC filters are implanted in the inferior vena cava of patients at risk for pulmonary embolism and who are unable to use standard blood-thinning medications. Once in place, the cage-like devices trap any blood clots that have broken loose from other areas of the body, preventing them from traveling to the heart or lungs. Products like the Option Retrievable IVC filter are intended to be removed once a patient is no longer at risk for blood clots. However, a 2013 study published in JAMA: Internal Medicine suggested that retrieval occurs in fewer than 10% of cases.
In 2010, the U.S. Food & Drug Administration (FDA) disclosed that it had received more than 900 reports of complications associated with retrievable IVC filters, warning that the incidents may have been related to filters that had been allowed to remain in the body for long periods of time. Four years later, the agency issued a second advisory that urged doctors to remove temporary blood clot filters within 29 to 54 days of their implantation in order to reduce the risk of patient harm.
One of the three complaints filed last month in Philadelphia involves the alleged wrongful death of a Pennsylvania man who received an Option Retrievable IVC filter on January 22, 2013. He suffered a fatal pulmonary embolism on February 2, 2015, with the filter still in place. The two remaining plaintiffs are both residents of Tennessee, and claim to have experienced life-threatening IVC filter complications that “require extensive medical care and treatment” due to malfunctioning Option devices. All three complaints charge that Option blood clot filters suffer from flaws that may result in “severe health side effects, including, but not limited to: hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; perforations of tissue, vessels and organs; and other severe personal injuries and diseases.”
The manufacturers of the Option products are not the only companies facing litigation over allegedly defective IVC filters. Court documents indicate that nearly 3,000 IVC filter lawsuits have been filed in U.S. courts over injuries allegedly related to retrievable devices marketed by C.R. Bard, Inc. and Cook Medical, Inc. Federal claims involving Bard’s Recovery and G2 IVC filter lines have been consolidated in the U.S. District Court, District of Arizona. A second consolidated litigation is underway in the U.S. District Court, Southern District of Indiana, for cases involving Cook Medical’s Gunther Tulip and Celect products.