What is the role of the IVC filter?
As well as preventing the flow of blood clots into the heart, brain, lungs and kidneys, this filter is used to trap any blood clot inside the IVC, which is the body’s biggest vein. The vena cava, which can be found in the abdomen, will return the deoxygenated blood back into the heart. In order to put the IVC filter in the correct place, a specialist radiologist guides it by using advanced imaging. When the clot has been trapped and enclosed within the filter’s spidery legs, it breaks down naturally. This particular type of medical product was for patients who can’t use a blood thinner and anti-clot medication, and for anyone who is already on those medications, but still experiences a problem with the forming of a new blood clot.
Without these filters, blood clots may enter vital and major organs in the body and lead to the possibility of a heart attack, pulmonary embolisms, stroke, and other possible life-threatening events.
Despite what seems to be a novel intervention, some IVC filters aren’t performing to expectations. What happens is that when left within the vein for extended periods of time some implants are putting the body under risk. One of the risks encountered was the filter falling apart allowing its metal parts to find themselves travelling through the bloodstream and in some cases puncturing the vein, heart, or another organ. It was even discovered that if the IVC filter is defective and it is not removed there could be deadly results.
Not all IVC filters are the same
There are only some types of IVC filters which have been manufactured by 4 medical device businesses that are failing.
The failures of the IVC filters are as follows:
- the spidery-like arms attached to the filter break off;
- the filter following implantation becomes hard or just about impossible to completely remove.
- the spidery-like arms become fractured;
- the device doesn’t prevent a blood clot from entering major organs.
- the IVC Filter isn’t able to prevent blood clots.
Because of the failures, it elevates the risks for individuals who have had a device implanted into their veins because the smallest parts are able to move along the blood stream and can end up stuck in one of the major organs. It could even puncture the wall of the IVC.
In addition, because the filter is positioned not that far from the heart bits of the device can find themselves drawn inside and getting stuck within the heart and even worse puncturing the chambers located in the heart. This situation could turn out to be life threatening. Bits have also been known to pass throughout the heart ending up wedged in the lungs.
Removing an IVC filter is not an easy task
Trying to remove an IVC filter takes an experienced specialist because as it hasn’t been out on the market for that long few physicians in such a short period of time have become sufficiently conversant with the IVC filter to understand the best and safest removal techniques.
Were potential patients and medical professionals aware of the IVC filters’ shortcomings?
The Foods and Drug Administration (FDA) hasn’t remained silent about the potential dangers of these IVC filters. In 2010, 2014, it issued alerts for the product stating that IVC filters were not completely safe to use. In that same period the FDA were in receipt of no less than 900 reports of adverse events taking place in IVC filters from Baird and Cooks.
The problems reported were as follows:
- the device finding its way out of the VC;
- parts that had become detached causing an embolization, even though that is one of things that should not take place;
- the filter perforating certain body parts;
- the filter breaking.
In the FDA’s 2010 safety communications it stated that the FDA was concerned that the removable IVC filters, which were in general short term placements only, aren’t always removed when the risk to the patient of PE has dropped. The only useful message the FDA announced was that the physician who was responsible for the implant should remove it as soon as it is no longer required.
Later in 2014 the FDA reiterated what it had said previously and stressed how important it was to remove the device when it wasn’t needed any longer. Yet, despite these ongoing safety announcements there are still some patients who don’t need the filters but have them in place.
As a result of discovering the defects in the IVC filter litigation has been filed against the 4 manufacturers. The names of the manufacturers are:
- C.R. Bard;
- Boston Scientific;
- Cordis.
C.R. Bard lawsuit
In September of 2015, there was a report published by NBC on a 12 month investigation into JVC filters manufactured by Bard’s. The conclusion drawn was that the manufacturer failed to stop selling and marketing the device despite knowing it could cause severe injury and even death. In fact, NBC found out that there were more than three hundred injuries and at least 27 fatalities that could be attributed to the use of Bard’s devices.
Bard responded to the revelation by developing a filter replacement which the company called G2 filters and G2 express. These as with the first Bard IVC filter encountered problems too that Bard was fully aware of after their release in 2005 but didn’t attempt to stop selling them until 2010. Up to 2010 37 deaths were due to the implanted devices as well as numerous complaints. In fact, G2 filters experienced more malfunctions than other available brands of filters. Bard took little action and one of its regulatory specialists from the FDA called Kay Fuller gave up her job with the company because it flatly refused to take up her concerns regarding the filter’s failings. Fuller also lodged a complaint that Bard misrepresented when using her signature for an FDA application for a new style IVC filter.
C.R. Bard has been the subject of lawsuits reaching into the thousands to do with the shortcomings and failings of the Recovery and G2 Express and G2 IVC filters. In the spring of 2017, there were 1,600 cases pending and still running against this company. Bard has also been sued directly, and there are others who have joined up with other class action litigation or have gone as far as federal multidistrict lawsuits using the Arizona federal court district.
Cook Medical lawsuits
Cook Medical experienced similar problems to Bard and has currently several lawsuits being filed against it for defects in IVC filters, which are their Celect Gunther Tulip brand. In 2014, 27 lawsuits were being filed in eleven distinct districts within the U.S. The federal court made the decision to centralize all the cases into one federal multi district ligation in south Indiana in the federal court.
Since then an increase in lawsuits are being filed against the Cook Medical company. At one time there were more than 1,900, with 1,600 in the spring of 2017 pending at the court level. The cases claimed the Cook Medical’s IVC filters did not perform as described and brought about risks to patients which resulted in a range of personal injuries as well as some fatalities and the risks were very similar to the cases that were filed as lawsuits against Bard.
IVC devices produced by Bard & Cook Medical are thought to have been fitted into 30,000 patients in the last thirty years.
The reports published in medical journals reveal:
- 40 percent of patients who have IVC implants endured filter fracture within 5 ½ years of the implant procedure;
- Nearly ten percent of patients in Boston Medical Centers who received retrievable IVC implants got blood clots.
Patients and family members who believed injuries they had suffered were a result of these devices are fighting to get the justice they deserve.
In September 2015 wrongful death lawsuits were filed against Bard in Missouri. Also patients were offered the chance to come together and file one lawsuit and therefore share any damages that could be gained.
What is required for filing IVC lawsuits?
As many people still have IVC implants more injuries are likely to come to light. You may be able to file a lawsuit if you have any of several types of IVC filters implanted into your body. These include the following:
- Bard’s G2 IVC;
- Bard’s Recovery IVC;
- Bards G2 Express IVC;
- Cook Celect IVC;
- Boston Scientific’s Greenfield IVC;
- Cook Gunther’s IVC.
Just having one of these implants present isn’t necessarily sufficient to file a lawsuit. To be eligible you should be experiencing complications because of device failure such as the breaking off of parts of the legs, the device managed to move while inside your body, or the device hasn’t achieved what it was supposed to do and that is to prevent the forming and moving of blood clots. If you haven’t as yet experienced any side-effects from use of the device, it is time now to see your physician to either have the device extracted from your body before it starts moving on its own accord or at the minimum have it checked so you can be sure it is doing what you want to do.
If you have experienced side effects from the use of any IVC filter you don’t have to join a class action to get compensation, but you can file an individual lawsuit based on the grounds that the IVC filter implanted in you is faulty.
