IVC filters are supposed to prevent blood clots from entering the heart, lungs, kidneys, or brain by intercepting the clots in the bloodstream and allowing them time to break down. Tragically, the filters can break or dislodge, launching metal fragments into a vein and damaging organs.
Trauma, disease, and other conditions put people at risk for potentially fatal blood clots, but for many patients, anticoagulants and other medications aren’t an option, so they rely on mechanical devices instead – believing those devices have been thoroughly researched and tested and that they will function as promised.
In the case of IVC filters, however, the device manufacturers may have broken that promise.
What Is an IVC Filter?
The inferior vena cava (IVC) is a major vein that carries blood to the heart from other parts of the body. To guard against the danger of a pulmonary embolism in the lungs and other blood clots, an IVC filter – consisting of several small wires that look like a spider – is inserted into the vein to prevent a blockage.
IVC filters were initially intended to be permanently implanted, but a growing number of “adverse events,” a 2010 U.S. Food & Drug Administration (FDA) warning, and recent medical studies show that IVC filters may actually increase the risk of blood clots and death when kept in the body for an extended period.
Frequent injuries reported when IVC blood clot filters malfunction include:
- Tissue punctures in the heart, lungs, vena cava, or other organs
- Blood clots occurring at the location where the device is inserted
- Filter migration to different parts of the body
- Persistent chest pain or shortness of breath
- Hemorrhage (severe bleeding)
- Pulmonary Embolism
The FDA updated its 2010 warning in 2014, stating that most IVC filters should be removed within a certain time after implantation (usually 29-54 days).
Boston Scientific, C.R. Bard, and Cook Medical are the leading IVC filter manufacturers, and the following products are at the center of pending litigation:
- Bard Recovery® filter
- Bard G2® filter
- Bard G2® Express filter
- Cook Günther Tulip® filter
- Cook Celect® filter
- Boston Scientific Greenfield™ filter
According to an investigation by NBC News into 27 deaths associated with IVC filters, Bard may have known about the risk of its Recovery device as early as 2002. After an initial application for FDA clearance was denied that year, the company retained a regulatory specialist to assist with a subsequent application. Concerned about the results of clinical trials and patient safety, the specialist refused to sign the later application, yet her name and signature appear on the filing.
Take Action to Protect Yourself
The very real danger posed by IVC filters has prompted many patients implanted with the devices to file suit against the manufacturers for negligence, misrepresentation, and fraudulent concealment of data. While some plaintiffs have sought damages for actual injuries caused by the defective filters, others who have not yet experienced problems are also seeking compensation for the cost of medical monitoring and ongoing care.
If you or a loved one has an IVC filter, don’t wait for the device to fail to pursue a claim. The attorneys in Sommers Schwartz’s Complex Litigation Group are currently interviewing patients across the country about their rights to recover damages. Please contact us today for a free consultation!