Inferior vena cava (IVC) filters have traditionally been used in patients who suffer from pulmonary embolism or venous thromboembolism to prevent another blood clotting event by supposedly trapping blood clots in the inferior vena cava and preventing emboli from reaching the lungs. These filters are typically placed in patients only when anticoagulant therapy (i.e. taking blood thinner medication) has either been ineffective or cannot be used for one reason or another, and the patient faces a risk of pulmonary embolism. Still, unfortunately, IVC filters can break apart, erode, and puncture organs and tissue, causing serious damage.
Recent Studies Released In December 2018 Show a Risk of Mortality
Shocking studies recently released and published in JAMA Internal Medicine revealed that patients are more likely to die after getting IVC filters, especially seniors (aged 65 and older) hospitalized for an acute pulmonary embolism. According to experts, complications associated with the placement of the filter could explain the increased risk of mortality. The results of this new study are consistent with findings of previous studies assessing mortality associated with the use of the filters in patients with venous thromboembolism. Concerns about these filters began to surface in 2010, when the Food and Drug Administration (FDA) received more than 900 reports of adverse events and issued an alert informing operators to remove them as soon as possible.
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Medical Experts Express Serious Concerns over IVC Filter Overuse in the United States
Still, according to reports, more than 13 percent of (i.e. one in six) elderly Medicare fee-for-services beneficiaries with an average age of almost 78 years old who have been hospitalized for acute pulmonary embolism currently receive these filters, even though cardiac perforation and death led to the 2010 FDA safety advisory (which was then updated in 2014). This is harrowing, given that medical experts who have specifically studied IVC filters have said that, until the medical community obtains additional, high-quality data from studies, they caution against the overuse of these filters in patients at risk of venous thromboembolism.
Other doctors have also explicitly come out and made statements that IVC filters are just blatantly overused in the U.S., in spite of an overall lack of data. According to these experts, even in patients who suffer from acute pulmonary embolism and/or proximal deep vein thrombosis who cannot initially rely on anticoagulation therapy, everything should be done to resolve that contraindication and ensure that anticoagulant therapy is used, instead, once the filter is removed. According to these experts, warnings from the FDA were simply insufficient in producing a real decrease in IVC filter use, and did not fully address the problem.
Concerns Also Escalate Over Device Removal
One study suggested that sending automatic reminders to doctors telling them to consider removing a patient’s IVC filter may cut down on complications. This is based on the assumption that some of the device’s complications and adverse impacts could be related to how long the filters remain in the patient. There is no question at this point that these filters should be removed as soon as they are no longer absolutely necessary; however, unfortunately, retrieval rates remain dangerously low.
According to medical reports, concerns also remain about how to address issues in patients with chronically-implanted IVC filters, as proactive removal may, in some circumstances, end up having negative consequences for a patient. In sum, it appears that additional data is necessary before filters that have been in place for many years and in patients who are not experiencing negative symptoms are removed en masse because the current, highly-involved removal procedures can put patients at risk without providing any significant benefits.
Cook Inc. Prevails In “Bellwether Trial,” But the Battle Is Far From Over
In December 2018, a decision came in the in the IVC filter multidistrict litigation in the Southern District of Indiana brought against Cook Medical’s IVC filters granting summary judgment to the defendants under the claim that the plaintiff in the case failed to raise a genuine issue of material fact and sustain her burden of proof on the proximate causation element of the case. The case was brought by a plaintiff who alleged that several years after having the filter inserted, she experienced pain and a portion of the filter actually protruding from her skin, causing her to have to undergo surgery to remove the rest of the filter. The lawsuit not only alleged that the filters are defective and cause harm, but that the labeling and instructions accompanying the product did not adequately warn doctors and patients about the risks associated with it.
The plaintiff specifically argued that, under Georgia’s intermediary doctrine, she could prevail on her warnings claims because the product’s warnings were inadequate and they caused her injuries and defendant manufacturers breached Georgia’s “post-sale duty” to warn physicians of the filter’s risks of fracturing and perforating. However, the judge decided that the plaintiff failed to establish causation in her negligent failure to warn and strict liability claims, where testimony from her surgeon who had implanted the device and who reported that, regardless of whether there had been additional, specific instructions, he would not have done anything different as a result, was key to the judge’s decision.
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If you or a loved one has been harmed by an IVC filter, it is crucial that you work with an experienced attorney who knows how to bring the right claims into court and knows how to litigate these claims properly so that you and your loved ones can obtain the recovery you deserve. A significant part of this knowledge also involves working with the right medical experts in order to establish that negligence caused the plaintiff harm. Contact our Georgia defective medical product attorneys today to find out more.