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Former recipients of retrievable IVC filters, which are devices designed to capture blood clots before they enter the lungs, filed legal claims against manufacturers for poor design, manufacturing and failing to warn of risks. Faulty filters punctured veins, fractured and migrated to other parts of the body causing complications.
Surgeons implant retrievable inferior vena cava filters in the veins of patients who are unable to take anticoagulants, or blood thinners, in order to prevent blood clots from moving to the lungs. IVCs catch the clots in the blood stream and, over time, the clots dissipate. But the U.S. Food & Drug Administration received hundreds of adverse reports about the retrievable filters. Reported complications included punctured organs, blood vessels and filter migration to different parts of the body.
FDA Warning on IVC
In 2010, the FDA warned the retrievable filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsided. The FDA updated safety communication in 2014, stating most devices should be removed between the 29th and 54th day after implantation. But the warning signs came too late for some. Plaintiffs began filing lawsuits across the country claiming the filters caused harm and death.
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
Various lawsuits claim negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation on the part the companies and their subsidiaries.
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