Have you been seriously injured by an IVC filter?
IVC filters are medical devices that are implanted into the inferior vena cava. The inferior vena cava is a large vein that carries blood returning from the legs to the heart. The IVC filter is implanted below the renal branches with the intention of catching potentially life-threatening blood clots, such as pulmonary emboli, that can travel from the lower extremities to other parts of the body, including the heart, lungs and brain.
IVC filters are manufactured by a number of medical device companies, including C.R. Bard (Recovery, G2, G2X, Eclipse, Meridian, and Denali), Cook Medical (Gunther Tulip and Celect), Johnson & Johnson (Cordis OptEase and TrapEase), Boston Scientific (Greenfield SS and Ti-Permanent), B. Braun Medical (Convertible, Vena Tech and LP), ALN (ALN), Rex Medical (Option), and Rafael Medical (SafeFlo). C.R. Bard and Cook Medical currently own approximately 80% of the market share for IVC filters.
The United States Food and Drug Administration (FDA) has received thousands of reports of serious adverse effects related to IVC filters, including migration, fracture and perforation of the device. These complications are potentially life-threatening.
Migration of the device through the venous system can result in the IVC filter being less effective in preventing clots. Migration can also lead to fracture of the “arms” or “legs” off the device. When pieces fracture off of the device, they can travel throughout the body and perforate veins or vital organs. The fractured pieces can also be impossible to safely remove. A fracture can also result in device failure, allowing clots to bypass the filter and travel to the heart, lungs, liver and kidney. In cases where the IVC filter perforates a blood vessel or organ, there is increased strain on the device, which can lead to fracturing of additional pieces off the device.
Once an IVC filter fails, a patient must undergo surgery to remove the device and any pieces that have fractured off of the filter. This can include open heart surgery and other serious procedures. In some cases, doctors may determine that it is too dangerous to remove the IVC filter due to the risk of other injuries, including possible death.
In August 2010, the FDA issued a safety advisory regarding the risks and adverse events associated with the use of IVC filters. The FDA identified over 900 adverse events associated with IVC filters over a 5-year period. There were over 300 cases involving migration of the device through the blood stream, nearly 150 embolisms due to the detachment of pieces off the filter, and 70 cases where the device perforated an organ, such as the heart or lungs. The FDA recommended that doctors remove IVC filters as soon as the risk ends for a patient developing a blood clot.
In May 2014, the FDA updated its safety advisory to include information on the most recently published research and post-market surveillance studies. The FDA created a mathematical model to assess whether there was a time period during which the risk of having an IVC filter is expected to outweigh any benefits. Based on its analysis, the FDA recommended the removal of IVC Filters within 29 to 54 days after implantation. For many years, the manufacturers of IVC filters have marketed these devices as appropriate for permanent implantation.
Numerous studies have shown the magnitude of the problems associated with IVC filters. One study focusing on devices manufactured by Cook Medical (“Cook”) found that 100% of the IVC filters studied perforated after 71 days in the body. Another study, published in 2011 in the Journal of Vascular and Interventional Radiology, found that 40% of C.R. Bard’s Recovery filters fractured after 5 ½ years. A 2014 study from the same publication similarly found that 37.5% of C.R. Bard’s G2 filters fractured after 5 years.
Studies have also demonstrated that in addition to the numerous serious risks associated with IVC Filters, there is also a lack of efficacy for these devices. An article appearing as far back as 1998 in the New England Journal of Medicine raised the lack of efficacy in IVC Filters. Following other articles reviewing the efficacy of the devices in 2005 and 2007, the Journal of the American Medical Association finally published an editorial in 2013 entitled, “The Inferior Vena Cava Filter, ‘How Could a Medical Device Be So Well Accepted Without Any Evidence of Efficacy?’” The medical literature suggests that for patients receiving anticoagulation therapy, IVC filters do not improve mortality and may actually increase the risk of suffering a deep vein thrombosis. It is also unclear from the literature that IVC filters reduce the risk of new pulmonary emboli.
Despite these risks, manufacturers of IVC filters, including C.R. Bard and Cook Medical, have been able to increase their annual sales from $100 million to $300 million as the number of IVC filters implanted each year has grown from 49,000 in 2004 to 260,000 in 2012. More recently, the devices have been marketed as appropriate for patients undergoing bariatric, orthopedic and trauma surgeries further increasing the sales of IVC filters.
IVC filters manufactured by C.R. Bard, including the Recovery, G2, and G2 Express filters, have been implicated in causing numerous serious adverse events. The Recovery filter was approved by the FDA in 2003 and was shown to have a high failure rate from the time it was first introduced on the market. Studies have demonstrated that the Recovery filter is prone to fracture and migration.
It is alleged that C.R. Bard conducted its own research that revealed the unreasonable danger posed by its IVC filters as early as 2003. These findings were not shared with the FDA, and no warning was provided to patients and doctors. Instead, C.R. Bard continued to sell the Recovery filter until the company could bring a replacement model to market. The Recovery filter was only removed from the market once its new filter, the G2, was ready for sale in 2005. Unfortunately, the G2 filter has been shown to have the same problems as the Recovery filter, including device fracture and migration.
More recently, on July 13, 2015, the FDA issued a warning letter to the Chairman and Chief Executive Officer of C.R. Bard regarding numerous violations and deficiencies related to Bard’s IVC filter systems. The warning letter stated that C.R. Bard failed to properly file adverse event complaints it received with the FDA, including one death, related to its IVC filters. Additionally, the warning letter stated that the device that C.R. Bard designed to remove IVC filters was never approved for sale by the FDA and that the company was selling the retrieval device without FDA approval.
IVC Filter Litigation Update
Lawsuits against C.R. Bard, Cook Medical and other IVC filter manufactures have been filed in courts across the country alleging that the devices are defective and causing life-threatening injuries to plaintiffs.
Over 100 cases filed against Cook Medical are currently consolidated in a multi-district litigation that has been established in the United States District Court (“USDC”) for the Southern District of Indiana in Indianapolis (MDL No. 2570, In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation).
On July 30, 2015, a hearing was held in San Francisco, California to determine whether a similar multi-district litigation should be established for IVC filter cases filed against C.R. Bard. Plaintiffs are seeking the consolidation in the USDC for the Northern District of Texas, or alternatively, in the USDC for the District of Nevada.
If you or a loved one have suffered complications related to an IVC filter, you may be entitled to pursue a claim against the manufacturers for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.