BARD 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.
Bard, a medical manufacturer with estimated annual revenue of about $3 billion, introduced the Bard Recovery IVC Filter (“Recovery”) to the market in 2003 as the first retrievable IVC filter to be approved by the FDA. The FDA approved the Recovery under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, which forgoes formal review of a medical device if it is substantially equivalent to other approved devices; this, according to Plaintiffs, allowed approval to occur without adequate testimony on the safety and efficacy of the device.
The Recovery is made up of six short struts, or “arms”, and six long struts, or “legs”, each of which is held together by a single connection to the cap at the top of the filter. The device is made from the memory-shaping alloy, nitinol, which changes shape to allow for insertion via catheter by placing the device in saline, and then returns to it’s prior shape when warmed to body temperature. The Recovery’s “Instructions for Use” state that the Recovery can only be retrieved by the Recovery Cone System, which Bard marketed and sold without seeking or obtaining FDA approval.
In August 2005, the FDA approved the G2 for non-retrievable use, and Bard launched the product in September 2005. Bard marketed and sold the G2 at the same time as the non-retrievable Simon Nitinol Filter (“SNF”), which had been sold since 1992, was used for the same indication and had nearly zero adverse events. For that very reason, in December 2005, Bard’s Medical Affairs Director allegedly questioned why Bard was even selling the G2. It wasn’t until January 2008 that the G2 was given clearance to be used as a retrievable filter. Although Bard marketed the device as having “enhanced fracture resistance,” “improved centering” and “increased migration resistance,” Plaintiffs claim that the G2 had the same manufacturing and design defects as the Recovery. In addition to suffering from the same adverse events as patients with the Recovery, some patients who had the G2 implanted also suffered from caudal migration (migration against blood flow) of the device toward the groin. At least 65,000 people have had the G2 implanted.
On January 15, 2008, the FDA approved the G2 Express filter (the “G2X”) as a retrievable IVC filter. The G2X was identical to the G2 other than an added hook at the top of the filter to facilitate retrieval
On August 9, 2010, the same day the FDA issued its safety warning about IVC filters, the Archives of Internal Medicine published a study that examined the prevalence of fracture and embolization of the Recovery and the G2. Of the 80 participants in the study, 28 with the Recovery and 52 with the G2, 13 experienced at least one strut fracture. In five of the seven Recovery cases, patients had at least one fragment embolize to the heart, with three of those patients experiencing life-threatening symptoms of ventricular tachycardia and/or tamponade and one patient experiencing sudden death. G2 had a fracture rate of 12%, with two of the six patients who experienced filter fractures also experiencing asymptomatic end-organ fragment embolization.
The FDA approved the Eclipse Vena Cava Filter (the “Eclipse”) on January 14, 2010 as the next generation retrievable IVC filter. However, the only difference from the previous filter was that the Eclipse was electropolished, and the design change failed to prevent the same complications that were associated with the Recovery and G2. Subsequently, the FDA approved the Meridian filter in August 2011, which added a caudal anchoring system in an attempt to reduce caudal migration. The Meridian, too, exhibited the same manufacturing and design defects alleged against its predecessors. On May 15, 2013, the FDA approved the Denali filter. The Denali added cranial anchoring systems and penetration limiters, but again, failed to address the other shortfalls of the previous filters.
On July 13, 2015, the FDA issued a letter to Bard warning that the Recovery Cone Removal System, Model RC-15 was never approved for commercial distribution and was currently being marketed without FDA clearance or approval in violation of the Federal Food, Drug and Cosmetic Act. The letter also stated that Bard failed to report information it received about device malfunctions and failed “to establish and maintain procedures for receiving, reviewing, and evaluating complaints” regarding the G2, G2 Express, Eclipse and Denali. A review of the FDA’s Adverse Event Reports for IVC filters from years 2004 to 2008 established that Bard IVC Filters were responsible for 50% of all adverse events, 64% of all filter migrations, 69% of all vena cava wall perforations and 70% of all filter fractures.
Plaintiffs in the litigation have filed suit against Bard concerning injuries caused by the manufacturer’s devices alleging that the retrievable IVC filters are generally defectively designed, that Bard made misrepresentations in its marketing, and that the company failed to warn doctors and patients of the risks associated with the device.