COOK IVC FILTER
An inferior vena cava (“IVC”) filter is a small, cage-like device that is implanted in the IVC, which is the main vein that returns blood from the lower half of the body to the heart and lungs. The filter is designed to capture migrating blood clots that have broken loose from the arterial wall in an individual’s legs and that is moving toward the heart and lungs, allowing blood to continue to flow around the trapped blood clot.
IVC filters are placed in patients who are at risk for a pulmonary embolism, a blockage of one or both pulmonary arteries, which could result in difficulty breathing, chest pain, and/or death. The devices were first made available to the medical community in the 1960s, and are meant to be used in situations when anticoagulant therapy fails or cannot be used to treat pulmonary thromboembolism or during emergency treatment following a massive pulmonary embolism where the anticipated benefits of conventional therapy are reduced.
On August 9, 2010, the U.S. Food and Drug Administration (“FDA”) issued a safety warning regarding the risks associated with long-term use of IVC filters, which included lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization (movement of the entire filter or fracture fragments to the heart or lungs) and IVC perforation. The FDA had received 921 adverse event reports on the devices since 2005.
In March 2013, the Journal of the American Medical Association’s published a study that examined the management and complications of IVC filters in 952 patients. Of the 952 patients, 680 received retrievable filters, but only 58 of 680 patients had their IVC filters successfully removed. The study further found that the IVC filter failed to protect eight percent of patients with the device from a pulmonary embolism.
On May 6, 2014, the FDA updated their 2010 safety communication by stating that IVC occlusion was a long-term risk of IVC filter implantation. Further, through quantitative decision analysis, the FDA determined that the ideal window for retrieval of the IVC filter is between 29 and 54 days after implantation in order to minimize complications. However, the organization stated that additional clinical data will be collected to address unanswered safety questions regarding both permanent and retrievable IVC filters.
In Spring 2015, the PRESERVE Study (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters), which directly addressed the FDA’s 2010 safety alert, enrolled its first patient. Around 2,100 total patients were enrolled in the study, with at least 300 patients enrolled for each of the seven participating filter manufacturers. “The manufacturers and devices included in the study were ALN Implants Chirurgicaux (ALN Vena Cava Filters); Argon Medical Devices, Inc. (Option Elite Retrievable Vena Cava Filter designed and manufactured by Rex Medical); B. Braun Interventional Systems Inc. (VenaTech LP Vena Cava Filter); Bard Peripheral Vascular, Inc. (Denali Vena Cava Filter System); Cook Incorporated (Cook Günther Tulip Vena Cava Filter); Cordis Corporation (Cordis OptEase Retrievable Vena Cava Filter/Cordis TrapEase Vena Cava Filter); and Volcano Corporation (Crux Vena Cava Filter System).” The study will last for five years, but it has been estimated that the FDA’s final decision as to how to appropriately respond to the results may not be known for at least a decade.
In October 2015, the Annals of Surgery published an article that concluded the IVC filters not only failed to effectively prevent pulmonary emboli from occurring in trauma patients, but also caused thrombi to occur. After examining the results of over 30,000 trauma patients who received filters to those who did not, researchers discovered that almost twice as many patients who had an IVC filter implanted died, five times as many developed DVTs, four times as many developed thromboemboli, and twice as many developed pulmonary embolus.
Cook was founded in 1963 and “is a leading designer manufacturer and global distributor of medical products, tissue engineered biomaterials and interventional devices for radiology, cardiology, radiation, oncology, neurology, general surgery, gastroenterology, vascular access, wound care, urology, obstetrics and gynecology, critical care, endovascular and veterinary medical procedures.” Cook, which brings in about $1.8 billion in annual sales, consists of 42 companies that serve 13 hospital chains in 135 countries; the company is a global supplier of about 16,000 medical products.
Cook develops, manufactures, sells and distributes the Günther Tulip Vena Cava Filter, Günther Tulip Mreye, Cook Celect Vena Cava Filter and Cook Celect Platinum (together, the “Cook IVC Filters”), medical devices that are placed in the vena cava to prevent recurrent pulmonary embolism. The FDA approved the Günther Tulip Vena Cava Filter and the Günther Tulip Mreye for retrievable use under the Section 510(k) program in October 2003. The Cook Celect Vena Cava Filter and Cook Celect Platinum were approved under the same program in March 2008 and July 2012, respectively.
The Cook IVC Filters are retrievable, umbrella-shaped filters that are made of a cobalt-chromium alloy and have four primary legs, a second set of stabilizing wires and a hook at the top. Hundreds of thousands of patients worldwide have been implanted with the Cook IVC Filters, which are the subject of the MDL in the Southern District of Indiana. Plaintiffs claim that Cook’s IVC filters are defectively designed, making them “more likely to fracture, migrate, tilt or perforate the inferior vena cava, causing injury.
Plaintiffs in the litigation have filed suit against Cook concerning injuries caused by the manufacturer’s devices alleging that the retrievable IVC filters are generally defectively designed, that Cook made misrepresentations in its marketing, and that the company failed to warn doctors and patients of the risks associated with the device.