Cook IVC Filters Injury claims are on the rise, the personal injury and product liability lawsuits continue to pile up, with no end in sight. Injured folks allege that the Cook company’s blood-clot filters failed catastrophically puncturing vital organs and blood vessels, requiring emergency surgery to remove them.
Cook Celect, Gunther Tulip IVC Filters
The Cook Gunther Tulip IVC Filter System was approved by the FDA in 2003. The Cook Celect IVC Filter System was approved by the FDA in 2008.
Cook Medical’s IVC filters were approved via the controversial FDA 510(k) fast track approval process, which allowed the company to perform only minimal testing before selling the devices for use in patients nationwide. FDA 510(k) fast track approval process allows medical device manufacturers to sell devices with minimal testing “as long as they are substantially similar” to devices already approved under the more rigorous premarket approval process.
Cook IVC Filters Injury-FDA IVC Warnings
In May 2014, the FDA issued a safety alert in response to hundreds of reports involving IVC filters breaking inside patients and causing damage to the heart, lungs and other organs. As a result, the federal regulators warned that retrievable IVC filters should be removed within about one to two months after the risk of a pulmonary embolism has passed.
Cook IVC Filters Injury-Bellwether trials set
All of the federally filed cases against Cook have been consolidated and centralized in the U.S. District Court in Indianapolis. The first bellwether case is headed for trial in Indianapolis, and the stage is set for over 2,000 injury lawsuits that have amassed against Cook.
Bellwether cases are tried first and serve as a marker for how the remaining cases might be tried or settled.
The first case, set to begin October 2, involves a Florida woman who had a temporary filter known as the Celect Cava implanted in 2010. Shortly after the implantation, the woman tried to have the filter removed. All initial attempts to remove the filter were unsuccessful, and upon further investigation it was discovered that the filter had pierced a large blood vessel and small intestine. Finally the device was removed.
Settlement Mediation talks underway
Three settlement conferences have been scheduled starting July 26. The lawsuits have been consolidated in U.S. District Court in Indianapolis.
What are IVC Filters?
Inferior vena cava filters, or IVC filters are cage-like devices inserted into inferior vena cava to prevent blood clots from the leg reaching the lungs, causing a pulmonary embolism, or blockage of an artery in the lungs. About 200,000 inferior vena cava filters,are implanted nationwide each year.
If you think you may have Cook Celect, Gunther Tulip IVC Filter implanted and have suffered IVC filter failure requiring emergency care, please call Dr. Shezad Malik Law Firm at 214-390-3189.