Causing Internal Bleeding and Heart & Lung Damage
An IVC filter is kind of small strainer used to filter out blood clots or keep them from forming and becoming pulmonary embolisms (blood clots traveling to the lungs). The IVF or inferior vena cava is a large vein entering the right atrium (upper chamber) of the heart. It delivers oxygen-depleted blood from the legs, the pelvis, and the abdomen back to the heart.
A pulmonary embolism can damage lung tissue by preventing blood from flowing to part of the lungs, diminish oxygen levels in the blood, damage other body organs because they receive too little oxygen, lead to pulmonary hypertension (too much blood pressure in the pulmonary arteries), and cause death if a blood clot is large or if there are too many clots. The IVC filter looks like an umbrella minus the shaft. The spokes of the filter pierce blood clots, breaking them up or preventing them from passing through the inferior vena cava.
IVC Filter Lawsuits
Inferior vena cava (IVC) filter lawsuits claim that C.R. Bard, the manufacturers of the device, failed to warn patients of risks like device movement and fracture, embolization and tissue/organ perforation. At least 10,900 IVC filter lawsuits have been filed against various manufacturers, but none have settled to date.
IVC filter lawsuits typically claim the adverse events associated with the devices are due to one or more of the following reasons:
- Design and manufacturing defects
- Failure to warn consumers of known risks
- Breach of implied warranty on the medical device
- Negligence on the part of the manufacturing and/or marketing company
Patients have experienced a number of complications from alleged defects in the design of a variety of retrievable IVC filters. Complications including organ damage or perforation, blood clots (such as from deep-vein thrombosis), device migration, and device fracture have been commonly named in these lawsuits.
Several manufacturers and brands of IVC filters have been subject to individual and class-action lawsuits because of the devices’ failure or complications. According to court documents, each of these companies knew their products were defective but continued to sell them without informing doctors and patients of the risks.
IVC Filter Risks and Side Effects
There have been reports of the IVC blood clot filter falling out of place or breaking apart. The metal device, or pieces from it, can then move through the blood, working their way through a vein wall and puncturing an internal organ.
There are also reports of blood clots occurring at the location where the device was inserted – the same clotting the device is supposed to prevent.
Among many problems, side effects can lead to the following adverse events:
- Death
- Pulmonary embolism
- Compromised respiration
- Blood clot filter migration
- Filter fracture
- Perforation of the IVC
- Difficulty removing the filter
Warning Signs of a Defective IVC Filter
Abrupt pain in the chest or shortness of breath are warning signs that device is failing. A diagnosis may be confirmed by a CT scan and other diagnostic tests.
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IVC Filter Warnings and Recalls
The Food and Drug Administration (FDA) issued a
warning against leaving the filter in place for extended periods of time, claiming the devices tend to cause life-threatening problems..
In an August 2010 “initial communication,” the FDA listed adverse event reports concerning IVC filters. Of a total of 921 adverse events reported:
The FDA recommended:
- Physicians and others responsible for caring for IVC retrievable filter patients consider removing them as soon as protection from a pulmonary embolism is not needed.
- Doctors involved in treating and follow-up of IVC filter patients should consider the risks versus the benefits of placing a filter
IVC Filter Lawsuit Settlements
As of this time, there have been no large mass tort settlements involving IVC filters. Generally, however, large groups of settlements do not occur until such time as a few lawsuits are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
There have been some reported settlements in individual cases:
In March 2013, Bard settled an IVC filter case brought by plaintiff Lisa Davis, who received a G2 filter in 2006. The device fractured in 2008, migrating to her heart, resulting in ongoing health problems and making it necessary for her to take anticoagulant medications for the remainder of her life. Davis filed her complaint in 2011 in the U.S. District Court for the Eastern District of Michigan.
In January 2015, Bard settled a lawsuit brought by Kelly Vlasvich, alleging her IVC filter had fragmented. One of the twelve struts of the device lodged in her heart and two in her lungs. As a result, Mrs. Vlasvich suffered “permanent and extensive disfigurement.”
In February 2015, Bard reached a settlement with plaintiff Kevin Phillips for an undisclosed amount. Phillips filed the case in June 2012, alleging that the device, which had been implanted in 2005, fractured after five years. As a result, a fragment of the filter pierced and injured his heart. The case was tried in the U.S. District Court for the District of Nevada. Bard reached the settlement ten days after the opening of the trial.
There are several more
bellwether trial dates currently set for 2018.
The Russo Firm and IVC Lawsuits
The Russo firm is currently investigating claims of complications such as migration, fractures, embolization or perforation from use of an IVC Filter
If you or a loved one have suffered complications from an IVC Filter,
call The Russo Firm at 844-847-8300 or contact us online to talk with an experienced lawyer about your injuries. If you can’t travel to our office, we will come to you, or we can work by phone, fax, email or other methods of communication. Remember, you pay no fee unless we obtain compensation for you