There are countless people who have an IVC filter installed. Some of these people were unlucky enough to have a device made by a select few companies, which led to extreme complications.
Today's post looks at IVC filters, the problems they are causing, and whether you could be one of the thousands that should consider 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 clot access to the lungs. The inferior vena cava is a centrally located large vein into which the device is inserted during a short operation.
If you are not too familiar with physiology, you should familiarize yourself a little with the how and why. Veins are blood vessels that carry oxygen-poor blood and waste into the cardiovascular system. Arteries are the vessels that contain oxygenated blood and nutrients.
There are cases when a blood clot in a vein can form very deep in the body. This is known as DVT (Deep Vein Thrombosis). These generally occur when the blood thickens and clumps. Most often, these clots form in the legs.
One of the most dangerous effects of DVT is that it can cause blockage of the vessel in the lungs. This type of blockage is called pulmonary embolism. PEs can cause a wheezing breath and, in certain circumstances, even death.
An IVC filter can be a method of preventing pulmonary embolism. When inserted into the inferior vena cava, the IVC filter catches the blood clots and prevents them from moving towards the lungs and heart.
Advantages of an IVC filter
Unfortunately, based on studies, the level of evidence support when searching for evidence to support using IVC filters is rather low. Of the two main studies that were conducted in 1998 and 2015, none successfully showed a reduction in mortality.
The 1998 study and its eight-year follow-up showed a reduction in pulmonary embolism, but unfortunately showed a significant increase in DVTs. The main contribution of the study was to confirm that placing IVC filters was not a good idea. Based on this study, almost every IVC filter installed today can be called up.
Risks of IVC filters
While most IVC filters are now labeled as available, 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 medical professionals.
The official risks of IVC filters are unknown. This is due to a lack of extensive studies. However, there have been some notable side effects from certain protective measures. These effects were so remarkable 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, the complications listed are said to be:
- Device migration
- Blood clot
- Filter breakage
- Organ damage
- Organ perforation
- Impossibility of filter removal
IVC filters are tiny devices that are generally inserted into the groin or neck of the patient. When inserting, small leg-like spindles are inserted in the inferior vena cava.
Lawsuits have been brought before a federal court claiming that Bard and Cook's IVC filter designs are likely to break, 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 companies were aware of the dangers of their products, but did not warn the doctors or the patients.
Unfortunately, the FDA has delayed problems with IVC filters. However, the FDA finally issued two safety instructions for available IVC filters. The FDA said it received 921 complaints about IVC filter defects.
When we look at the exact nature of the defects, we notice a little familiarity. The reported defects were perforation, breakage and migration.
In 2014, the FDA released another release that expanded its main concerns with an additional update. The FDA expressed concerns that IVC filters would not be removed after the risk of pulmonary embolism subsided.
The participation of the FDA and its lack of commitment to investigate problems with IVC filters could have played a significant role in this problem.
In July 2015, the FDA issued a warning letter to Bard Medical regarding its IVC filter. The letter said that the company had reported no knowledge of device malfunction. Device malfunctions that are said to result in serious injury and 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 multidistrict litigation is in Arizona, while the Cook multidistrict litigation is in the southern district of Indiana. In addition to these lawsuits, cases against Boston Scientific, Argon Medical and Rex Medical are also being filed.
A Indiana jury recently awarded a claimant $ 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 accused.
While the judge dismissed the second of Bellwether's lawsuits 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 5,000 ongoing cases against Cook Medical.
In the first of the Bard Bellwether trials 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.
Claims against Cook Medical and Bard Medical include:
- The IVC filter carries the risk of perforation of 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 gave no warning.
- The IVC filter was of poor quality and not strong enough to withstand placement in the body.
- The IVC filter was unable to withstand the heart and respiratory strain on the body.
Another name that was briefly mentioned was Boston Scientific. There may not be an MDL in which she or her Greenfield IVC filters are involved, but there are many individual lawsuits against her.
As early as 2005, Boston Scientific had to recall 18,000 of its greenfield filters. The company had warned that there is a possibility of parts detachment that could potentially cause pulmonary or cardiac embolism. Later in 2005, Boston Scientific released a second recall based on reports that the filters could also cause vascular damage.
A 2016 study by the JCDT (Journal Cardiovascular and Therapy) examined IVC filters and their complications in detail. Of course, these complications included perforation, migration and fractures. The study authors cited a previous study by Boston Scientific on the problem of providing filters in the green field. 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 you don't.
If you are at the mercy of one of the companies listed above, or if you feel you are entitled to an IVC filter agreement that you may have had in the past, you should seek legal advice as soon as possible.