An inferior vena cava filter or IVC filter is a small umbrella-shaped device that is implanted in the largest vein in the body, called the inferior vena cava, just below the kidneys. The filter is designed to capture blood clots from the legs before they go to the heart and lungs and cause a heart attack or pulmonary embolism. The IVC filter captures the blood clot and blood flows normally around the trapped clot. Over time, natural anticoagulants in the blood break it down.
When certain IVC filters entered the market, the U.S. Food and Drug Administration (FDA) began receiving reports of problems caused by the filters breaking, fracturing and moving to different parts of the body, resulting in punctured organs or blood vessels.
A broken IVC filter can cause a wide range of symptoms and problems, including:
Not all IVC Filters are created equal. While many IVC filters are safe, certain filters produced by two manufacturers, C.R. Bard and Cook Medical, are believed to have caused hundreds of injuries in patients who had the devices implanted. It is those implants that are the focus of ongoing litigation.
The FDA first gave clearance for the Bard Recovery Filter in 2002, and soon thereafter the manufacturer, C.R. Bard, began receiving reports of deaths and injuries associated with the device moving and breaking. In addition to outside reports, Bard commissioned a confidential study that showed that the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all of its competitors. A doctor that Bard had hired to conduct the study warned the company that “further investigation…is urgently warranted.”
In 2005, after the Bard Recovery filter had been on the market for three years, Bard replaced it with a G2 series filter. However, the G2 proved to be no better than the Recovery filter. Within four months of the G2 series being cleared to sell by the FDA, Bard again began receiving reports of failure. In December 2005, a Bard vice president wrote about his concerns about “problems with…migration,” “tilting” and “perforation” of the G2 series. He knew that Bard had another filter on the market that posed none of the problems identified in the G2 series. He wrote, “Why shouldn’t doctors be using that one rather than the G2?” he asked.
It was clear that concern around the G2 series was growing both inside and outside the company, but instead of recalling the device, Bard kept it on the market for five years until 2010, selling more than 160,000 units. At least 12 deaths and hundreds of other adverse events are now believed to have been caused G2 series filters.
“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications. The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
Dr. William Kuo, interventional radiologist, Stanford University Health Care’s IVC Filter Clinic
Similarly, Cook Medical initially manufactured the Günther Tulip IVC filter, which was approved by the FDA in the 1990s, and later replaced it with the Celect Vena Cava Filter. One June 2015 study linked Cook Medical’s Celect IVC filter with a 43% rate of vena cava perforation, compared to a 0% rate for a competitor. Another study published by the journal of Cardiovascular and Interventional Radiology in 2012 revealed that 86% of Celect IVC filters perforated the vena cava and 40% tilted into the vena cava.
In 2010, the FDA warned the retrievable filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as protection from blood clots is no longer needed. If the filter is not removed, warned the FDA, the risk of complication increased significantly. In May 2014, the FDA recommended in safety alerts that should remove IVC filters between 29 and 54 days after implantation. However, most physicians were not aware of this warning and missed the advised time frame.
Both In 2014 and 2015, the Journal of the American Medical Association published studies finding that IVC filters were not as effective as blood thinners, and that the long term risks of these devices may counteract any health benefits they provide. More recently, in July 2015, the FDA issued a warning letter to Bard for illegal practices and problems with certain of its devices.
The FDA recommends that all patients with IVC filters get them surgically removed as soon as protection from blood clots is no longer necessary. The FDA also encourages all physicians who still perform the surgery to properly inform their patients regarding the above risks and that they will need to have the device removed at some point. Unfortunately, many physicians are not aware of the risk factors, and few surgeons are aware of the post-surgical long-term care required after IVC filter implantation.
For many people, the warning signs came too late. Hundreds of patients across the United States had IVC filters implanted without proper knowledge that they were being placed at risk of severe medical complications, including death in some cases. These patients and their families know that companies like Bard and Cook Medical need to be held accountable for their negligence, be forced to inform doctors and patients of the risks associated with the filters, and ultimately take their defective products off the market entirely.
Plaintiffs began filing lawsuits across the country, claiming the filters caused harm and death, alleging manufacturer negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation on the part of the companies and their subsidiaries.
Please call us so we can begin to investigate your claim and determine whether you are owed damages. Call us now at (800) 337-4002.
If you are a loved one had an IVC filter implanted and suffered because of it, please call us now for a FREE REVIEW of your medical records with a Kentucky IVC filter lawsuit attorney. You may be entitled to recover money for your injuries. Please be aware that there are time limitations for filing any kind of lawsuit. If you fail to file your case within the required time window, you will be unable to recover any money for your damages. Please contact us now so we can devote proper time and attention to your case. If you qualify, we want to represent you and help you get all you deserve.
Attorney Gary C. Johnson has been representing people who have been harmed by the negligence of others in eastern and central Kentucky for more than 40 years. Gary has won several multimillion-dollar jury verdicts and settlements over his long and distinguished career, including the eighth-largest verdict in the United States in 2002. He has the largest personal injury jury verdict of any lawyer in Kentucky.
Our attorneys are devoted to protecting the rights of our clients with integrity and honesty. We will work hard to ensure that your case receives the care and attention it deserves and that you receive the money and benefits to which you’re entitled. Coping with problems related to an IVC filter implant is hard enough without additional legal stress. Let us take the burden off your shoulders and navigate the legal system on your behalf.
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