There are countless people who have had an IVC filter installed. Some of these people were unlucky enough to have a device made by a select few companies, which has resulted in extreme complications.
Today’s post looks at IVC filters, the problems they cause, and whether you might be one of the thousands who should be considering an IVC lawsuit.
What is IVC Filter Placement?
First, let’s explain that IVC stands for inferior vena cava. The IVC is a tiny device that can help restrict blood clots from entering the lungs. The inferior vena cava is a centrally located large vein into which the device is inserted during a brief operation.
If you are not too familiar with physiology, it is a good idea to familiarize yourself a little with the how and why. Veins are blood vessels that carry deoxygenated blood and waste into the cardiovascular system. Arteries are the vessels that contain oxygenated blood and nutrients.
There are cases when a blood clot can form in a vein deep in the body. This is known as DVT (deep vein thrombosis). These generally occur when the blood thickens and clumps. Most of the time, these clots form in the legs.
One of the most dangerous effects of DVT is that it can cause a blockage of the blood vessel in the lungs. This type of blockage is called a pulmonary embolism. PEs can cause wheezing and, in certain circumstances, death.
An IVC filter can be a method of preventing pulmonary embolism. When the IVC filter is placed in the inferior vena cava, it catches the blood clots and prevents them from moving towards the lungs and heart.
Advantages of an IVC filter
Unfortunately, when looking for evidence to support the use of IVC filters, the evidence support is quite limited due to studies. Of the two main studies, conducted in 1998 and 2015, neither successfully demonstrated a reduction in mortality.
The 1998 study and its eight-year follow-up showed a decrease in pulmonary embolism, but unfortunately showed a significant increase in DVTs. The main contribution of the study was to confirm that IVC filter placement was not a good idea. Based on this study, almost every IVC filter installed today is available.
Risks of IVC filters
While most IVC filters these days are marked as retrievable, they generally become an integral part of the body. Failure to remove the IVC filter may be due to poor communication and care coordination between health professionals.
The official risks of IVC filters are unknown. This is due to a lack of comprehensive studies. However, there were some notable side effects from certain protective measures. So remarkable were these effects that the FDA advised doctors to remove the IVC filters within two months for public safety reasons.
While IVC filters are primarily used to reduce the risk of blood clots, it is claimed that the complications listed are:
- Device migration
- Blood clots
- Filter breakage
- Organ damage
- Organ perforation
- Impossibility of filter removal
IVC filters are tiny devices that are generally inserted into the patient’s groin or neck. Small, leg-like spindles are inserted into the inferior vena cava during insertion.
Lawsuits have been filed in federal court alleging that Bard and Cook IVC filter designs are most likely to rupture, tilt, migrate, and even perforate the inferior vena cava. If one of the devices breaks, it can migrate through the body and damage the heart or lungs.
All people who have suffered injuries of this magnitude are confident that the companies were aware of the dangers of their products but did not warn the doctors or the patients.
Unfortunately, the FDA has been delayed on issues with IVC filters. However, the FDA eventually issued two precautionary statements for on-demand IVC filters. The FDA has stated that it has received 921 complaints regarding IVC filter defects.
When we look at the exact nature of the flaws, we notice a little familiarity. The defects reported were perforation, rupture, and migration.
In 2014, the FDA released another notice adding an additional update to its main concerns. The FDA raised concerns that IVC filters were not removed after the risk of pulmonary embolism subsided.
The involvement of the FDA and its lack of commitment to investigating problems with IVC filters could have played a significant role in this problem.
In July 2015, the FDA distributed a warning letter to Bard Medical regarding its IVC filter. The letter stated that the company had no knowledge of any malfunction of the device. Device malfunctions that are believed to result in serious injury or death.
Current IVC filter lawsuits
To date, over 10,000 IVC filter cases have been filed in state and federal courts in the United States. The majority of these cases are filed against Bard Medical and Cook Medical.
The Bard multiple district litigation is taking place in Arizona while the Cook multiple district litigation is taking place in the southern district of Indiana. In addition to these lawsuits, cases are also being filed against Boston Scientific, Argon Medical, and Rex Medical.
Recently, an Indiana jury awarded a plaintiff $ 3 million after a Cook Celect IVC filter was found to be defective. This was the third of the Bellwether trials and the first in which the jury found the defendant.
While the judge dismissed the second of the Bellwether trials as statute-barred, there was a substantial $ 1.2 million payout to a plaintiff if the case was not warned. There are currently more than 5000 pending cases against Cook Medical.
In the first Bard Bellwether trial in 2018, a plaintiff was awarded $ 3.6 million, and Bard faces another 3,500 cases filed against him.
In 2015, there was an investigation by NBC News that linked Bard Medical IVC filters to 39 deaths. The investigation found that Bard Medical had been aware of the risks for many years but did nothing. During the study, NBC acquired a study commissioned by Bards in 2004. The study clearly showed that the failure rate was significant compared to competing devices.
The claims against Cook Medical and Bard Medical include:
- The IVC filter carries the risk of perforating the patient’s organs and the manufacturer was aware of the potential risk.
- The IVC filter device carries a high risk of breakage.
- The IVC filter has a high probability of migration into the patient’s body; The manufacturer was aware of this and did not issue a warning.
- The IVC filter was of poor quality and did not have sufficient strength to withstand placement in the body.
- The IVC filter could not withstand the stresses of the heart and breathing.
Another name that came up briefly was Boston Scientific. There may not be an MDL that you or your Greenfield IVC Filters are involved in, but there are many individual lawsuits against you.
As early as 2005, Boston Scientific had to recall 18,000 of its greenfield filters. The company had warned that there was a possibility of parts becoming detached, which could potentially cause a pulmonary or cardiac embolism. Later in 2005, Boston Scientific issued a second recall based on reports that the filters could also cause vascular damage.
A 2016 study by JCDT (Journal Cardiovascular and Therapy) examined IVC filters and their complications in detail. These complications naturally included perforation, migration, and fractures. The study’s authors cited an earlier study on greenfield filter deployment problems by Boston Scientific. This early study was published in the Journal of Vascular and Interventional Radiology. The study reported that 71% of the greenfield filter placements had poor filter leg distribution.
The FDA has now determined that the ideal time to remove IVC filters is between 29 and 54 days after implantation. So it may be worthwhile to see a doctor if this isn’t the case for you.
If you are at the mercy of any of the above companies, or feel that you are entitled to an agreement regarding an IVC filter that you may have had in the past, you should seek legal advice ASAP.