Patients at risk for blood clots and pulmonary embolism who receive an IVC filter implant may face an increased risk of severe complications, including inability or difficulty in removing the devices, implant failure, device migration, tilting, perforation, deep vein thrombosis and injury to internal organs.
A number of product liability lawsuits have already been brought against the makers of IVC filters, over injuries allegedly caused by the controversial medical devices.
If you believe you have been adversely affected by side effects of the Bard Recovery device, the Bard G2 device, or another potentially dangerous inferior vena cava filter on the market, contact a reputable product liability lawyer today for legal help. With a qualified IVC filter injury lawyer on your side, you can ensure that your legal rights are protected, and pursue the financial compensation you and your family deserve for your injuries, medical expenses, and emotional trauma.
An inferior vena cava (IVC) filter is a small cone-shaped medical device implanted in the inferior vena cava, which is the largest vein in the body and is responsible for carrying deoxygenated blood from the lower extremities of the body to the right atrium of the heart and the lungs. IVC filters are designed to capture an embolism, a blood clot that has broken loose from one of the deep veins in the legs, and prevent it from traveling to the heart and lungs, thereby reducing the risk of stroke, pulmonary embolism, and other blood clot-related injuries. The filter is designed to trap clots and allow blood to continue to flow around the clot, which over time, will be broken down by natural anticoagulants in the blood.
Inferior vena cava filters are commonly used in patients who are at a high risk for blood clots and pulmonary embolism, but who are unable to take blood thinner medications, or for whom anticoagulant therapy is inappropriate. Without the IVC filter in place, these patients may suffer a pulmonary embolism, which occurs when an embolism (blood clot, gas bubble, fat globule or foreign material in the bloodstream) blocks one or both pulmonary arteries, preventing deoxygenated blood from being transported to the lungs. However, recent studies have indicated that IVC filters may actually pose a risk of serious side effects for patients, possibly caused by the medical device fracturing, perforating the IVC, and traveling to other parts of the body, or otherwise malfunctioning.
Even though they are marketed as “retrievable” devices, reports of removable IVC filters migrating out of position and causing serious injuries or even death, have been on the rise in recent years. According to recent IVC filter side effect studies and reports of adverse events in consumers, patients who receive an IVC filter to reduce their risk of blood clots and pulmonary embolism may be at risk for the following complications:
In most cases of IVC filter failure, the tiny metal device fractures, and fragments of the device embolize, or migrate to the heart, lungs, kidneys, liver or other organs. Once the fractured pieces of the filter have embedded themselves in the organ, patients may begin to experience complications like severe pain, bleeding, perforation of the organ, and other potentially life-threatening injuries.
Several product liability lawsuits have already been brought against C.R. Bard and other IVC filter manufacturers, on behalf of consumers who believe they have suffered serious injuries caused by the controversial medical devices. Lawsuits brought against the makers of retrievable IVC filters all involve similar allegations, including claims that the manufacturing company: developed and sold a defective and unreasonably dangerous medical device; failed to adequately research the long-term risks of IVC filters; knew or should have known about the potential for the filters to cause serious injuries; failed to provide FDA and the public with adequate warnings about IVC filter complications; continued to market IVC filters as safe and effective, despite the risk of complications; and withheld information about the risk of IVC filter side effects from consumers and the medical community.
In a study published in the Archives of Internal Medicine in 2010, researchers found that fractures and device embolization were common complications affecting patients who received retrievable IVC filters manufactured by C.R. Bard. According to the study findings, 13 of the 80 patients implanted with the first-generation Bard Recovery and second-generation Bard G2 filters experienced at least one strut fracture. The older Recovery implant fractured and embolized in 25% of the 28 patients who received the filter, with embolization to the heart occurring in five out of the seven cases. There was also one case of sudden death and two cases of ventricular tachycardia and/or tamponade. In patients who received the Bard Recovery filter, 12% of the 52 implants fractured, with two patients experiencing embolization of the device.
Another study published in the Journal of the American Medical Association in 2013, analyzed the management and complications of blood clot filters in 952 patients. According to the researchers involved in the study, approximately 680 patients were implanted with retrievable IVC filters, but doctors were only able to successfully remove the implants in 58 of the patients. There were reportedly 13 unsuccessful removal attempts made by doctors, 11 of which occurred in patients who had their filter for more than 85 days. Of the 11 unsuccessful removal attempts, eight of the implants were embedded, three had protruded through a blood vessel, two had migrated out of position, and one had a blood clot inside of it.
Perhaps the most disturbing finding of the ongoing IVC filter litigation is the fact that C.R. Bard likely knew about the problems with its Recovery blood clot filter as early as 2004, yet failed to report these concerns to the public or the FDA. In December 2004, a report compiled by an independent consultant named Dr. John Lehmann, who was hired by Bard to compare the fracture and migration rates of new Bard filters to older models, indicated that the Recovery filter had significantly higher complication rates than its competitors. Bard’s lawyers reportedly distributed copies of the so-called Lehmann report to company employees, but chose not to go public with the information.
In August 2010, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning the public about the potential risk of side effects from IVC filters, after receiving more than 900 adverse event reports associated with the medical devices. Reported complications allegedly linked to IVC filter use included 328 device migrations, 146 embolisms, 70 filter perforations and 56 filter fractures. At the time of this warning, the FDA indicated that such complications could be related to the filters remaining in place for long periods of time, and therefore recommended that retrievable blood clot filters be removed as soon as the risk of blood clots and pulmonary embolism had subsided.
In 2014, the FDA updated this safety announcement, stating that IVC filters should be retrieved within 29-54 days after being implanted, as long as the patient’s risk of pulmonary embolism has subsided at that time. Unfortunately, hundreds, if not thousands, of IVC filter recipients had already suffered alleged IVC filter side effects at that time, and many have since pursued legal action against C.R. Bard and other IVC filter manufacturers. In a 2015 NBC News investigation, it was discovered that Bard may have forged a signature on an application submitted to the FDA for the approval of the Recovery filter, when a regulatory specialist hired by Bard refused to support the company’s request for FDA clearance to market the device, due to concerns about its safety.
Medical device makers C.R. Bard and Cook Medical are at the center of the IVC filter litigation, and former recipients of IVC filters have filed legal claims against the manufacturing companies, for defective design, poor manufacturing, and failure to provide adequate warnings about the risk of side effects from the blood clot filters. The five blood clot filters that stand out in current lawsuits as the source of serious problems include the following:
Bard’s G2 inferior vena cava filter was introduced in 2005, replacing the company’s controversial Recovery filter, which was removed from the market after studies showed the device was associated with an unexpectedly high rate of failure. The first IVC filter lawsuits against C.R. Bard were filed in Pennsylvania and California state courts in 2012, and so many claims have been brought against Bard and Cook Medical in the years since, that two multidistrict litigations (MDLs) have been created for all Bard and Cook filter lawsuits brought in federal courts across the country.
In one product liability lawsuit filed against C.R. Bard in early 2015, plaintiff Kevin Philips sought damages for injuries caused by his IVC filter, which fractured inside his body after it was implanted. According to the complaint, one of the filter’s small metal legs traveled to his heart, perforating it, and he ultimately required open heart surgery to repair the tear. Bard settled the case for an undisclosed amount in February 2015, compensating Philips for his injuries, medical expenses, and pain and suffering, which included a lengthy recovery from the surgery.
As more information comes to light about the alleged risk of injuries from IVC filters like C.R. Bard’s Recovery and G2 filters, consumers across the country are filing legal claims against the companies that make and sell the medical devices, accusing them of manufacturing defective and dangerous products, and downplaying the risks of the blood clot filters. If you or a loved one underwent surgery to receive an IVC filter implant, and you have since suffered complications like implant fracture, organ perforation, device embolization, or migration of the device to other parts of the body, consult a knowledgeable IVC filter attorney today to explore your possible compensation options. You may have grounds to file an IVC filter lawsuit against the device manufacturing company, in order to seek fair and timely reimbursement for your losses.