IVC Filter Settlements
Legally Reviewed and Edited by: Terry Cochran
The Inferior Vena Cava Filter (IVC Filter) is a metal device placed in the Inferior Vena Cava vein to stop the movement of blood clots from the lower extremities of the body to the heart and lungs. Since its introduction in 1998, until recently there have been a few lawsuits due to the placement and fracturing of this device causing permanent injury and even death to patients. Lately, however, IVC filter lawyers at Cochran, Kroll & Associates, P.C. have been increasingly busy because more of these lawsuits are surfacing in the courts. Some of this increased legal activity is due to the malfunction of the device itself, and some are due to the more common use of the apparatus.
There are currently 7 manufacturers of IVC filters that are used to be placed in the vein to prevent blood clot movement. Of these 7, the three companies sued most often are Bard Medical in Covington, Georgia; Cook Medical in Bloomington, Indiana; and Boston Scientific located in Marlborough, Massachusetts. Lawsuits have been won and lost by these companies, but the trend has been in favor of the plaintiffs’ winning the suits.
Why Use an IVC Filter?
The IVC is an acronym for the Inferior Vena Cava, which is the primary vein that carries deoxygenated blood from the lower body to the heart and lungs. This important vein moves the blood to the right atrium of the heart where it is supplied with oxygen and returns to the rest of the body. If there is any blockage or interference with the flow of blood, it can be life-threatening.
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) are two serious conditions that can occur as a result of blood clots moving through the Inferior Vena Cava to the heart or lungs. Blood clots are formed in the legs or lower body when a person may be immobilized for a long period. This could be due to a long car ride or plane ride where the person cannot stand up and walk around. It can also be due to a long surgery where the patient is lying still. Blood clots can also develop if a person was shot or seriously injured in a car accident, causing trauma to the body and blood flow.
Deep Vein Thrombosis (DVT) is a condition where there is noticeable swelling in the legs caused by a blood clot that has formed. If not monitored and treated, this blood clot can dislodge from the walls of the vein and move to the heart and lungs, causing blockage of the normal blood flow. If the blood clot reaches the lungs and causes an artery to be blocked this is known as a Pulmonary Embolism (PE) and can lead to death. If death is avoided, this condition can damage the lungs, and because there is reduced oxygen flowing to other parts of the body, other organs can be injured as well.
When this condition exists, the doctors usually recommend the use of a blood thinner or another anticoagulant to break up the blood clots. When the patient might be allergic to the blood thinner, doctors have devised the IVC filter to do the same thing without the medication.
What is IVC Placement?
The IVC filter is recommended for patients who are at risk of developing blood clots due to a heart condition, immobility, or a traumatic situation. The original purpose of inventing the IVC Filter was to have an option to treat patients who could not take blood thinners or anticoagulants to break down blood clots and prevent them from moving to the heart and lungs.
The IVC filter comes in many shapes and sizes, but the general concept is the same for all the models. The filter is made of metal, usually stainless steel. It is in the shape of a cone and has metal legs that align with the walls of the vein to stay within the blood flow for the purpose of intercepting blood clots. Once the filter is in place, the blood clots are gathered within the cone shape and hopefully dissipate over time without moving towards the heart and lungs.
The procedure to place the IVC filter in the vein is a simple and non-invasive surgery. The surgeon cuts a small wound in the vein in the neck or thigh and inserts the filter using a catheter. The patient is immobile, but many times, the only anesthesia needed is to numb the area where the wound was created. They also use x-rays and other imaging to place the IVC filter in the correct location. Every patient is different, so some of this is based on the experience and knowledge of the person performing the insertion of the filter.
Once the filter is in place, the patient can resume regular activity after 24 hours, but the doctor will monitor the patient’s reaction over the next few days. Most practitioners recommend the removal of the IVC filter as soon as the patient can begin to use blood thinners, which is usually within two months of the operation. Unfortunately, many times the IVC filter is left in for longer periods, or never removed, and that is when problems and complications begin to appear. The physician should always follow up with the patient within six weeks of the placement.
Complications of the IVC Filter
In August of 2010, the FDA reviewed several cases where there were claims against the complications of IVC filters. The FDA documented that they had received over 921 reports since 2005, where the IVC filter device had migrated, detached, or fractured causing injury to patients. In 2014 the FDA issued a recommendation that the IVC filters be removed as soon as possible to avoid these problems.
Some of the short term complications with the insertion of the IVC filter include a reaction to the dye used to highlight the vein, hemothorax and the collection of blood in the chest, bleeding at the site of insertion, and unexpected clotting at the insertion. Others can be related to the placement of the filter if it is tilted or attached incorrectly, or if there is a situation where the vein is blocked by the device causing a severe restriction of blood flow and even death.
Over the long term, the IVC filter can fracture, and pieces of the apparatus can migrate through the bloodstream lodging in the heart and lungs or even piercing other organs causing patient discomfort, permanent injury, or death. There can also be an increased risk of deep venous thrombosis (DVT).
What are Lawsuits Based On?
When an IVC filter migrates through the blood stream there are several things that can happen. Some of the more common occurrences are chest pains, confusion, lightheadedness, neck pain, or shortness of breath. More severe issues can lead to hemorrhaging, pulmonary embolism, stroke, or death.
If you have had an IVC filter inserted into your bloodstream for the purpose of preventing blood clots from entering your heart and lungs, and you have experienced any of these symptoms, contact your physician immediately. In addition, seek out the guidance of an IVC filter lawyer at Cochran, Kroll & Associates, P.C. who is very much aware of the history surrounding the use and litigation of these IVC filters. It is best to cover all of your bases because of the seriousness of possible complications.
IVC Filter Settlements
There have been over 14,000 lawsuits filed against major manufacturers of IVC filters as of July 2019. Cook Medical faced 5,627 lawsuits in Indiana, and Bard Medical faced 8,423 in Arizona. In some cases, the federal courts combined these cases into class action suits to be able to move the process along more quickly. Bellwether trials, trials conducted to test the range of possible settlements, have been conducted and the results have been documented.
In November of 2017, Cook Medical won the first Bellwether trial, and in March of 2018 the judge ruled that the plaintiff had waited too long to file the suit and the case was dismissed. On March 30, 2018, a jury awarded the plaintiff, Sherr-Una Booker, a total of 3.6 million dollars when she claimed that the device fractured and injured other parts of her body. This case was against Bard Medical. The jury awarded the plaintiff 1.6 million for the damages and then awarded her an additional 2 million because Bard had known of injuries to patients before use of the IVC filter by the plaintiff, and they did not make it known to the doctors. This award was a punishment, and it was clear the jury was angry at the manufacturer for withholding this information from the public.
A second verdict for the plaintiff was in May of 2018 when the courts awarded a firefighter from Texas of 1.2 million dollars when the plaintiff proved that the manufacturer, Cook Medical, did not give the patient’s doctor sufficient information about the risks of the procedure.
In February of 2019, a woman won a 3-million-dollar lawsuit against Cook Medical when it was proven that the IVC filter device used was defective. This was a landmark case, and it has opened the door for more cases to follow.
The string of lawsuits developed against Bard, Cook and Boston Scientific began in 2012 and continues until today. Because there are so many cases, the federal courts have consolidated 11 state districts in Indiana and in October 2014 began litigation. In August of 2015, the Arizona courts combined several cases against Bard and Cook, and currently, 50 of those cases are still pending. There are also several individual federal cases in process against Bard, Cook, and Boston Scientific. These also include suits against the other 4 manufacturers.
The nature of this type of litigation is that it sometimes takes a while for the science to catch up to the cases being brought to the courts. The IVC filter lawyers have gone through a learning curve as more cases are tried and more expert medical witnesses have testified as to what medical issues surface as a result of these implants. When the FDA recommended in 2015 that these implants into the vein should be temporary and removed as soon as practicable, it opened up many more cases where patients had earlier implants and had begun to exhibit symptoms related to the fracturing of the devices as well as the ineffectiveness of tilting and blockage.
In general, the trend is that there will be more large settlements because, as in the settlement in 2108, Bard was found negligent in not announcing the defects in the Bard IVC filter that they knew existed. This failure on their part is a manufacturing mistake that will not go unpunished by those patients who have been harmed. If you, or anyone you know, has been treated with an IVC filter, then you should contact an IVC filter lawyer as soon as possible.
It is challenging to sum up the extent of the settlements that are related to the medical issues caused by malfunctioning and product defects of IVC filters. These filters were designed as a mechanical option to assist doctors in treating patients who have a problem with blood clots developing in the body with the possibility of moving to the heart and lungs.
This was initially an honest attempt by the scientific community to create something to benefit the larger community. However, there are many reasons why these devices have come under scrutiny due to side effects and general failure of the devices to work properly.
At the law offices of Cochran, Kroll & Associates, P.C. we have a great deal of knowledge and experience investigating and keeping abreast of the changes in litigation that involves the IVC filter. If you have a concern that you may be a victim of this treatment, contact us immediately at Cochranlaw.com or call us at 866-MICH-LAW for a free consultation. We never charge a fee unless we win your case.
Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.