There are countless numbers of people that have had an IVC filter fitted. Out of these people, some were unfortunate to have a device manufactured by a few select companies that have resulted in extreme complications.
Today’s post is going to look at IVC filters, the issues that have been caused, and whether or not you could be one of the thousands that should be considering an IVC lawsuit.
What Is An IVC Filter Placement?
First and foremost, let’s start by explaining that IVC stands for inferior vena cava. The IVC is a tiny device that can aid in restricting blood clots access to the lungs. The inferior vena cava is a centrally located large vein, and the device is inserted into it during a short surgery.
If you aren’t overly familiar with physiology, then let’s get a little more acquainted with the hows and whys. Veins are blood vessels that carry oxygen-poor blood and waste into the cardiovascular system. Arteries are the vessels that contain oxy-rich blood and nutrients.
There are cases when a blood clot can form in a vein quite deep into the body; this is known as a DVT (deep vein thrombosis). These generally occur when there’s a thickening and clumping in the blood. More often than not, these clots form in the legs.
One of the most dangerous effects of DVT is that it can cause a blockage in the vessel in the lung. This type of blockage is called a pulmonary embolism. PEs can cause a wheezing breath and in certain circumstances, even death.
An IVC filter can be a method of preventing a pulmonary embolism. The IVC filter, when placed in the inferior vena cava, will catch the blood clots and stop them from moving towards the lungs and heart.
Benefits Of An IVC Filter
When searching for the evidence that offers support to the benefit of using IVC filters, unfortunately, based on studies, evidential support is pretty low. From the two major studies that were performed in 1998 and 2015, neither has successfully shown a mortality reduction.
The 1998 study and its eight years follow up did show a reduction in pulmonary embolisms, but unfortunately showed a significant increase in DVTs. The main contribution of the study was to confirm that the placement of IVC filters was not a good idea. Based on this study, almost every one of the IVC filters that are fitted today are retrievable.
Risks Of IVC Filters
While most IVC filters today are marked as retrievable, they generally become a permanent fixture in the body. The failure to remove the IVC filter is possibly due to inadequate communication and care coordination among medical professionals.
The official risks of IVC filters are unknown; this is due to a lack of comprehensive study. There have, however, been some notable side effects from specific protects. These effects were so noteworthy that the FDA advised doctors to remove the IVC filters within two months for the benefits of public safety.
While IVC filters are primarily there to reduce the risk of blood clots, there are claims, however, that the listed complications are:
- Device migration
- Blood clots
- Filter fracture
- Organ damage
- Organ perforation
- Impossibility of filter removal
IVC filters are tiny devices that are generally inserted into the patient’s groin or neck. When inserted, small leg like spindles are deployed inside the inferior vena cava vein.
There have been lawsuits filed in federal court that are alleging that IVC filter designs by Bard and Cook are extremely likely to experience fracture, tilt, migrate, and even perforate the inferior vena cava. If one of the devices were to break, it could travel through the body and damage the heart or lungs.
All people who have suffered injuries of this scale are confident the companies were aware of the dangers their products presented but failed to warn either the doctors or the patients.
Unfortunately, the FDA was delayed in its action when it came to arising problems with IVC filters. The FDA did, however, eventually issue two notices of safety on retrievable IVC filters. The FDA has stated that they had received 921 complaints in regards to IVC filter defects.
When we look at the precise nature of the defects, we are struck by a small familiarity. The defects reported were perforation, fracture, and migration.
In 2014 the FDA issued further communication, which added an additional update to their primary concerns. The FDA stated concern that IVC filters were not being removed after the risk of a pulmonary embolism had subsided.
The involvement of the FDA and their lack of commitment to investigating the issues with IVC filters could have played a considerable role in the issue.
In July 2015, the FDA distributed a warning letter to Bard Medical in regards to its IVC filter. The letter stated that the company had failed to report knowledge of malfunction with the device. Malfunctions with the device that were said to contribute to serious injury and death.
Current IVC Filter Lawsuits
To this day, there are over 10,000 IVC filter cases filed across the United States, both in state and federal courts. The main bulk of these cases are filed against Bard Medical and Cook Medical.
The Bard multidistrict litigation is venued in Arizona, while the Cook multidistrict litigation is in the Southern District of Indiana. In addition to these lawsuits, there are also cases being filed against Boston Scientific, Argon Medical, and Rex Medical.
Recently, A jury in Indiana has awarded $3 million to a plaintiff after findings that a Cook Celect IVC filter was defective. This was the third of the bellwether trials and the first in which the jury found for the defendant.
While the judge dismissed the second of the bellwether trials as the case was time-barred, there was a significant $1.2 million payout to a plaintiff in a failure to warn case. As things stand, there are more than 5000 ongoing cases against Cook Medical.
In the first of the Bard bellwether trials of 2018, a plaintiff was awarded $3.6 million, and Bard is still facing a further 3500 cases that are filed against them.
In 2015 there was an investigation carried out by NBC news that connected Bard Medical IVC filters to 39 deaths. The investigation unveiled that Bard Medical had been aware of the risks for many years, but did nothing. During the study, NBC acquired one of Bard’s 2004 commissioned studies. The study clearly showed that in comparison to competing devices, its failure rate was significant.
The claims against Cook Medical and Bard Medical include:
- The IVC filter presents a risk of perforation to the organs of the patient, and the manufacturer was aware of potential risk.
- The IVC filter device carries a large risk of fracture.
- The IVC filter has a high probability of migration into the body of the patient; the manufacturer was aware and did not issue a warning.
- The IVC filter was of poor quality and lacked sufficient strength to withstand placement in the body.
- The IVC filter could not withstand the cardiac and respiratory stresses of the body.
Another name briefly touched upon was Boston Scientific, there may be no MDL involving them or their Greenfield IVC filters, but there are many individual lawsuits filed against them.
Back in 2005, Boston Scientific had to recall 18000 of their Greenfield filters. The company had warned there was potential for part detachment that could potentially cause a lung or heart embolism. Later in 2005, Boston Scientific put out a second recall due to reports that the filters could also cause vessel damage.
In a 2016 study by the JCDT (journal Cardiovascular and Therapy) looked closely at IVC filters and their complications. These complications, of course, included perforation, migration, and fractures. The authors of the study cited an earlier study of the Boston Scientific Greenfield filter deployment issues. This early study was published in the Journal of Vascular and Interventional Radiology. The study reported that 71% of the placements of the Greenfield filter presented poor filter leg distribution.
The FDA has now noted that the ideal time for removal of IVC filters is between 29 and 54 days after implantation. So it may be worth visiting a doctor if this is not the case for you.
If you have found yourself at the mercy of any of the above companies, or if you feel that you may be entitled to a settlement in regards to an IVC filter you may have had in the past, you should get legal advice as soon as possible.