Volcano Corporation manufactures the Crux inferior vena cava (IVC) filter to prevent pulmonary embolisms. It is a temporary filter and the longer it remains in a patient, the higher the risk of complications.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Overview
The Crux Vena Cava Filter is one of the most unique IVC filters on the market. It has a double-helix shape, which is intended to reduce the risk of fracture, migration, and perforation of the vena cava. It is also the first-ever bidirectionally retrievable filter, which means it can be removed through the jugular or femoral veins. It was approved by the FDA in July 2012.
What is the problem?
Vena cava filters are supposed to reduce a patient’s risk of death from blood clots in the lungs (pulmonary embolism). Unfortunately, there is growing concern that the risks of implanting a filter may outweigh the benefits in many cases.
Crux IVC Filter Risks Investigated in PRESERVE Study
In early 2015, researchers began enrolling patients for the PRESERVE trial, the first large-scale real-world study of IVC filter safety and effectiveness. The study will include seven different types of filters and 2,100 patients — including about 300 patients implanted with the Crux filter — over the next five years.
FDA Safety Warnings
In the meantime, hundreds of lawsuits have been filed by people who were injured by IVC filters. The FDA has already issued several warnings, beginning in August 2010 when the agency reported nearly 1,000 serious injuries since 2005.
The FDA is concerned that retrievable filters, which are meant only for temporary protection against blood clots, are not always removed. In fact, studies estimate that only 30-50% of retrievable filters are ever removed. This is concerning because long-term safety risks have never been studied.
What Are Safety Risks?
- Filter fracture
- Perforation through the vena cava wall
- Organ damage (heart, lungs, etc.)
- Internal bleeding (hemorrhagic, hematoma, etc.)
- Embolization of broken pieces of the filter in the bloodstream
- Migration of the filter to other parts of the body
- Obstruction of circulation if filter is clogged with blood clots
- Impossible to retrieve broken filter
- And more
Crux IVC Filter Lawsuits
Hundreds of lawsuits have been filed by people who were injured by IVC filters, but not as part of a class action. Instead, individual lawsuits against C.R. Bard and Cook Medical have been centralized in a “mass-tort” or Multi-District Litigation (MDL) in federal court. Members of this litigation accuse manufacturers of selling dangerous medical devices while failing to warn about potential risks.
Do I have an IVC Filter Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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