The surgical implantation of IVC (inferior vena cava) filters has steadily increased over the past decade. According to an investigation conducted by NBC News, during this period, millions of people have been surgically implanted with these medical device filters. Unfortunately, several medical device manufacturers sold faulty devices, which have led to numerous IVC filter lawsuits.
An IVC filter is meant to stop blood clots from entering the hearts, lungs, kidneys, and brain and to help break said clots down. The filter is designed to trap the blood clot in the inferior vena cava, the largest vein in the body. The vena cava, located in the abdomen, returns deoxygenated blood to the heart. Typically, an interventional radiologist uses advanced imaging systems to guide IVC filter placement.
Once a clot is captured and contained within the spider-like legs of the filter, it naturally breaks down over time. This medical device was designed for patients who are not able to take blood thinners and anti-clotting medications, as well as for those who are on these medications, but continue to experience problems with new blood clots forming.
Without this filter, blood clots could enter major and vital organs within the body and lead to heart attack, stroke, pulmonary embolisms, and other life-threatening conditions.
Some of the IVC filters sold on the market over the past few decades, however, are not performing correctly. When left inside the vein long-term, some of these implants are causing serious risks to the body.
A number of medical professionals have testified that IVC filters are not safe. The failure rate is too high and the complications are too severe. For one, the filters can break apart. When they do, metal parts travel through the bloodstream and puncture the vein, heart, or other organs. If IVC filter removal is not performed on a defective device before breakage occurs, the result can be deadly.
Certain IVC filters, manufactured by four particular medical device companies are failing. These failures involve:
Due to these failures, it increases risks in people who have the device implanted within their veins since the small parts can move through the blood stream, get lodged in major organs, and even puncture the inferior vena cava wall.
Furthermore, since the placement of the filter is often close to the heart, pieces of the device can be drawn into and get stuck in the heart or puncture the chambers within the heart, creating life-threatening conditions. Pieces have also passed through the heart and ended up lodged in the lungs.
Unfortunately, depending on the location of the device, IVC filter removal techniques can be rather complex. Some surgeons consider the remove in certain patients very risky and tend to refer patients to specialists that deal specifically with the removal of the devices.
The FDA (Food and Drug Administration) has issued two separate blood clot filter implant alert safety communications about the use of IVC filters—one in 2010 and another in 2014.
Between 2005 and 2010, the agency received more than 900 adverse event reports about IVCs from Bard and Cook that included several problems:
* Device migrating out of the vena cava
* Detaching parts that caused an embolization (the very problem they are supposed to prevent)
* Perforation of body parts by the filter
* Filter breaks
While the FDA is fully aware the use of the filters in patients at risk for pulmonary embolisms (PEs) often requires long-term implantation, in other patients, where the risks of blood clots have subsided, the FDA has warned the devices should be removed.
In its 2010 safety communication, the FDA stated, “The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides.” The FDA went on to recommend the physicians that implanted the IVC filters remove them once there were no longer needed.
Again, in its 2014 safety communication, the FDA restated and stressed the importance of removing the devices when they were no longer required. Yet, even with these safety warnings, many patients who no longer require the filters still have them implanted.
Lawsuits have been filed against four medical device manufacturers because of their defective IVC filters. These manufacturers are:
In September 2015, NBC reported on a year-long investigation into Bard’s IVC filters. It concluded the manufacturer continued to sell and market the device even after it became aware it caused serious injury and death. NBC uncovered at least 27 deaths and more than 300 injuries associated with Bard’s devices.
In the investigation, NBC News uncovered that several of their IVC filter brands had resulted in deaths and hundreds of complications. Bard’s Recovery filter first started experiencing problems like those previously mentioned above in the “Risks” section.
In an attempt to address these issues, Bard developed a replacement filter, called the G2. However, the company was equally concerned over the failure of the G2 filters, which also includes the G2 Express filters. These new filters were released in 2005, and the company continued selling them, despite known problems, until 2010.
Between the Recovery, G2, and G2 Express, as of 2010, there have been at least 37 deaths, along with hundreds of complaints of device failures and complications by people who had Bard’s filters implanted.
In addition, internal reports show that the G2 filters were experiencing more failures than any other filter brand on the market from data the company collected through 2010. Furthermore, one of Bard’s FDA regulatory specialists, Kay Fuller, quit the company after it refused to address her concerns about Recovery’s safety. Fuller also accused Bard of forging her signature on an application to the FDA for a redesigned IVC filter she refused to endorse.
There have been thousands of lawsuits filed against C.R. Bard over the Recovery, G2, and G2 Express IVC filters. There are almost 1,600 pending cases still open against the company as of spring 2017. In other cases, individuals have sued Bard directly, and others have joined one of several different class action lawsuits or the federal multidistrict lawsuit through the federal court district in Arizona.
Cook Medical has also had a large number of lawsuits filed against them for defective IVC filters—namely, their Celect and Gunther Tulip brands. As of 2014, there were initially 27 lawsuits filed in 11 different districts throughout the country. The federal courts decided then to centralize the cases into a single federal multidistrict ligation at the federal court district in Southern Indiana.
Since that time, there has been a growing number of new lawsuits being filed against Cook Medical, exceeding 1,900 cases at one point, with well over 1,600 cases still pending in court as of spring 2017. The cases allege the company’s IVC filters failed to perform as designed and created additional risks for patients, which have resulted in personal injuries and deaths, very similar to the “Risks” mentioned above and the cases being filed against C.R. Bard.
It’s estimated that about 30,000 patients have been fitted with IVC devices from Bard and Cook Medical over the past 30 years. Reports culled from medical journals indicate:
Patients and their families who believe they suffered injuries from the devices are now fighting back.
A wrongful death lawsuit against Bard was filed in Missouri in September 2015. In addition, a U.S. Judicial Panel approved consolidated federal proceedings in Arizona against Bard and in Indiana against Cook. This allows patients to band together into a single lawsuit and share damages that may be recovered.
Though Bard and Cook have stopped selling the IVC filters mentioned, there are still people out using the faulty devices.
You may have grounds for a lawsuit if you have one of the following brands of filters implanted in your body and meet certain other requirements:
These other requirements could include experiencing complications due to device failure where parts of the legs have broken off, the device has migrated inside the body, or the device has failed to function for its intended purpose—i.e., to stop blood clots.
Even if you have not experienced any complications from having one of these brands of IVC filters installed, it is in your best interests to consult with your physician and consider having the device removed for your own safety or, at a minimum, to check its condition to ensure it is still intact and has not migrated.
Many people think the only way to be compensated for the harm they’ve experienced is to join an IVC filter class action lawsuit against Bard, a medical manufacturer, for having knowingly sold and marketed a defective product. However, the lawyers at Saunders & Walker P.A. are taking action by filing individual lawsuits for those negatively affected by an IVC filter. If you or a loved one has experienced complications or died as a result of a faulty IVC filter, you may have grounds for filing a personal injury case against the manufacturer of the device.
Fill out this form to contact Joe Saunders for a free evaluation, or call 1-800-748-7115.
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