Over the last 20 years, the number of IVC filters implanted in patients has skyrocketed. In 1999, there were only about 49,000 IVC filters placed in the United States. By 2012, that number had reached well over 250,000.
Although IVC filters were considered a viable treatment option for those with a high risk of developing pulmonary embolism, concerns over the safety and effectiveness of the medical devices have increased.
As a result, thousands of patients have come forward to file lawsuits against the makers of IVC filters over claims of negligence and defective designs.
An IVC filter, which stands for inferior vena cava filter, is a small medical device implanted in the largest vein of the body just below the kidneys. Its purpose is to capture blood clots that break loose from one of the deep veins in the legs.
Blood clots are normally meant to stop blood from flowing out of the body, but sometimes a clot may inappropriately develop within an artery or vein. This could cause a heart attack, stroke, or other life-threatening medical condition.
When an IVC filter is implanted, it catches the clot and allows blood to freely flow around the blockage. Over time, the body’s natural anticoagulant functions will break it down.
If a blood clot filter is not implanted, the embolism may cause blockage of the pulmonary artery, resulting in chest pain, difficulty breathing, and even death.
IVC filters are not for everyone. Doctors will sometimes recommend IVC filters to those at risk of developing deep vein thrombosis (DVT). This is a condition in which blood clots develop in the deep veins.
The filters may also be implanted in those who are at risk of pulmonary embolism but can’t undergo anticoagulation therapy.
Finally, patients who already have large clots in the inferior vena cava or iliac veins are also candidates for these filters.
There are two types of IVC filters: permanent and retrievable.
Permanent IVC filters are surgically implanted in patients and designed to stay there. This is an option for patients in need of long-term protection from blood clots. The rate of complications is higher, however.
Retrievable, also called optional or convertible, filters are the more popular of the two. They are designed to be removed after the risk of pulmonary embolism has passed. Just a few of the most well-known retrievable IVC filters include Cook Medical Celect, C.R. Bard Denali, Rex Option Elite, and Cordis Optease.
The issue with identifying complications related to IVC filters is that they can go undetected, occur away from the implant area, or happen long after implantation.
As time progresses, implants can cause damage in different ways:
A filter may move or change position over time. The blood clot filter could migrate to a different part of the inferior vena cava or the heart. This complicates retrieval.
Despite being designed to reduce pulmonary embolism, IVC filters may increase the risk of blood clots forming in the deep veins of the body, such as the legs. In one study, 44% of patients developed deep venous thrombosis after filter implants.
Perforation of the IVC is another risk. Lacerations caused by the filter can result in significant bleeding.
Other major complications from IVC filters include:
As a result of the unexpected side effects and complications associated with IVC filters, patients have filed thousands of lawsuits against the makers of the devices, including Cook and Bard.
In one case, Kelly Vlasvich and her husband Chris sued Bard for negligence and breach of implied warranty.
Kelly had a Bard G2 filter implanted in 2009. It wasn’t until 2011 did she begin experiencing complications. Doctors eventually discovered that the IVC filter had fractured and a strut had become lodged in the right ventricle of her heart. Kelly claims this resulted in “significant medical expenses and has endured extreme pain and suffering, loss of enjoyment of life, disability, disfigurement and other losses, which are permanent in nature.”
Vlasvich’s case is similar to many other cases pending in court. Thousands claim that the devices have broken, fractured, or migrated. Some say the IVC filters have even been responsible for serious injury and death.
With the rise in reports of complications, the U.S. Food and Drug Administration has taken some action against IVC filters.
In 2010, the FDA issued a safety communication warning of potential complications in retrievable IVC filters. That communication was later updated in 2014.
Along with the safety communications to healthcare professionals and patients, recalls have also been issued for several IVC filters. In 2005, the Greenfield Vena Cava Filter was recalled for manufacturing defects. Most recently in 2016, a class 2 recall was issued for the Bard Denali IVC filter for missing warnings.
Despite the thousands of lawsuits still pending against Bard and Cook, neither has announced a global settlement.
Settlements typically only occur after several individual cases have been tried in court. These bellwether cases allow both sides to determine the terms of a settlement.
Three cases have already gone to trial against Bard over its G2 and Recovery filters.
Many of the thousands of pending lawsuits are waiting for the outcome of bellwether trials. Although one bellwether trial resulted in a victory for Cook Medical in 2017, two more were slated for trial in 2018. The outcomes of these trials will provide more information to determine the terms of a settlement.
Groups of plaintiffs have also tried to file class-action lawsuits against Bard. A judge refused to grant the class certification in 2017 after concluding the claims lacked cohesiveness.
With the continued use of IVC filters by patients around the country, it is expected that more lawsuits will keep being filed in the coming months. Those who have been implanted with an IVC filter and suffered from complications are encouraged to contact a qualified attorney.
Fill out this form for a FREE, immediate, Case Evaluation
Please read these Terms and Conditions ("Terms", "Terms and Conditions") carefully before using the https://www.kbaattorneys.com/ website (the "Service") operated by KBA Attorneys ("us", "we", or "our").
Your access to and use of the Service is conditioned on your acceptance of and compliance with these Terms. These Terms apply to all visitors, users and others who access or use the Service.
By accessing or using the Service you agree to be bound by these Terms. If you disagree with any part of the terms then you may not access the Service. The materials contained in this web site are protected by applicable copyright and trade mark law.
The materials and information contained within the Service is of a general, informational nature but does not constitute legal or professional advice and should not be constituted as such. Use of the Service in any way, does not establish an attorney-client relationship.
Except as required by law, neither KBA Attorneys nor its affiliated firms or businesses accept any responsibility and shall not be liable for any damages (direct, indirect, incidental, special, consequential or exemplary), resulting from the use of this Service. This includes, but is not limited to, damages (for loss of profits, goodwill, use, data or other intangible losses) resulting from the use of or inability to use the Service or its contents or from any interruption or delay in access to the Service for whatever reason.
Note also that sending an e-mail to our office does not create a lawyer-client relationship, and none will be formed unless there is an expressed agreement between the firm and the client. Therefore, we strongly advise you against sending confidential or privileged information to us until you can establish such a relationship.
Our Service may contain links to third-party websites or services that are not owned or controlled by KBA Attorneys
KBA Attorneys has no control over, and assumes no responsibility for, the content, privacy policies, or practices of any third party websites or services. You further acknowledge and agree that KBA Attorneys shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content, goods or services available on or through any such websites or services.
We strongly advise you to read the terms and conditions and privacy policies of any third-party websites or services that you visit.
These Terms shall be governed and construed in accordance with the laws of Maryland and Virgina, United States, without regard to its conflict of law provisions.
Our failure to enforce any right or provision of these Terms will not be considered a waiver of those rights. If any provision of these Terms is held to be invalid or unenforceable by a court, the remaining provisions of these Terms will remain in effect. These Terms constitute the entire agreement between us regarding our Service, and supersede and replace any prior agreements we might have between us regarding the Service.
We reserve the right, at our sole discretion, to modify or replace these Terms at any time. If a revision is material we will try to provide at least 30 days notice prior to any new terms taking effect. What constitutes a material change will be determined at our sole discretion.
By continuing to access or use our Service after those revisions become effective, you agree to be bound by the revised terms. If you do not agree to the new terms, please stop using the Service.
If you have any questions about these Terms, please contact us.