Tittle & Perlmuter is currently investigating inferior vena cava (IVC) filter claims that resulted in serious personal injuries to recipients, including organ perforation, punctured veins, migrated filters, and death. Since these injuries have occurred in the thousands, lawsuits have been filed against the manufacturers of the IVC filters claiming that the medical device was defective due to negligent design and inadequate warnings.
If you or a loved one have been injured as a result of an IVC filter, give our experienced defective product lawyers a call – we can help you get the compensation you deserve!
Current lawsuits against the manufacturers of the IVC filters claim that the medical device was defective and that the warnings provided to patients and physicians were inadequate as there were no warnings relating to the risks of the filter breaking, along with failure to warn about the risks of metal fragments moving through the blood, which could damage an organ.
The lawsuits also allege that the manufacturer of the IVC filter hid the results of its own research, which indicated that the filter was dangerous. In fact, the allegations go as far as to state that the manufacturer forged an employee’s signature on the FDA application in order to get approval.
The products most often involved in IVC lawsuits are as follows:
Other filters causing problems include the Bard Eclipse, Bard Merdian, and Bard Denali.
Imagine your doctor tells you that you have a high chance of a blood clot, which could travel to your lungs and cause pain or death. They recommend you have a medical device implanted in your body to prevent this from happening. Then, years later, you find out that the filter you still have implanted now gives you an increased risk of blood clots – the very condition you were hoping to avoid. This situation has happened to several people who have had Inferior Vena Cava (IVC) Filters implanted.
IVC filters are small and cage-like devices that are inserted into the largest blood vessel in the body (the inferior vena cava). The inferior vena cava is the main blood vessel that returns blood from the lower half of the body to the heart and eventually reaches the lungs. These IVC filters are implanted in the vein located right below the kidneys. They are designed to capture blood clots in order to prevent clots from reaching the lungs, which can be fatal.
IVC filters can either be permanent implants or more recently, are made to be removable devices. IVC filters are used to reduce the risk of blood clots, pulmonary embolisms, and deep vein thrombosis.
Approximately 50,000 IVC filter placements are implanted each year in the U.S. The number has increased due to the creation of retrievable IVC filters, meaning that the device can be removed after the risk of an embolism subsides. However, one study demonstrated that the devices are only removed a third of the time.
Despite the benefits of an IVC filter, the FDA received reports of “adverse events and problems with the product.” These included:
The device risks don’t end there. Long-term risks include:
IVC filters are placed in patients who are at risk of developing blood clots in their legs. People who have an increased chance of developing blood clots are those:
IVC filters were created with the intention of preventing pulmonary embolisms, amongst other issues. However, in some cases, the device risked the health of the patient rather than helped. Two filter devices that caused issues were the Bard Peripheral Vascular Recovery and its G2 filter system, created by the company C.R. Bard.
A study from 2010 evaluated this brand of IVC filters from the years 2004 to 2009. Even though the company tried to fix the complications associated with the device, a multitude of issues continued to occur. The study found that 12% of the devices had filter fractures; 16% of the devices had strut fractures; 25% of the filters embolized.
The FDA was concerned that the devices meant for short-term placement were not removed once the risk for a pulmonary embolism diminished.
In 2015, the FDA also sent a warning letter to C.R. Bard for not following quality regulations. The company was manufacturing two cone removal systems, which are used to remove IVC filters. The FDA found that these removal devices did not have the required clearances or premarket approval.
Another company facing critical issues with their IVC filters is Cook Medical. Both the designs of the Günther Tulip and Celect IVC filters were found to have an increased risk for filter tilting and migration, as well as the possibility of penetrating the vein. It was found that the longer the device was in the body, the higher the risk of perforation.
A study from 2014, found additional perforation statistics for the Celect IVC filters. The results showed that 39% of filters in the study penetrated the vein within 30 days. 80% of the filters penetrated the vein within 90 days. A shockingly 13% of the devices were found to have punctured one of the following: intestines, aorta, muscle, spine, pancreas, adrenal gland, liver, kidney, lymph node, or diaphragm.
This led one lawsuit to claim that “Cook IVC Filters were insufficiently tested and caused harmful adverse events that outweighed potential utility.”
If you or a loved one had an IVC filter implanted and that filter has now migrated, or you (or a loved one) have suffered an organ perforation, punctured veins, and/or death as a result of the filter, contact our firm today. Call today or fill out an online form for a free consultation. Our Cleveland defective product attorneys are ready to hear your case and advise you on your next steps. We can also arrange weekend and evening appointments, and we can come to you.