ivc filters,fda recall,blood clots,inferior vena cava,class action lawsuit,defective device,product liability
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.
What are IVC Filters?
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.
When are IVC Filters Needed?
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.
Types of IVC 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.
IVC Filter Complications
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:
- Device migration
- Filter Fracture
- IVC Perforation
- Pulmonary Embolism
- Device Infection
Patients Claim IVC Filters Defectively Designed
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.
FDA Issues Warnings & Recalls
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.
IVC Filter Lawsuit Settlement Amounts
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.
- In 2013, patient Lisa Davis reached a settlement with Bard after claiming her G2 filter had migrated to her heart. She sued Bard for failing to warn her physicians of risks and a misrepresentation of the device as safe.
- Kelly Vlasvich and Bard reached an agreement in January 2015 over her accusations of negligence and a breach of warranty against Bard.
- Another settlement against Bard took place in February 2015 shortly after Kevin Phillips went to trial in Nevada. He claimed his IVC filter fractured and a piece of the device perforated his heart.
More IVC Filter Lawsuits Expected
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.