The device is known as an IVC filter, and it is used to prevent pulmonary embolisms. About 200,000 filters are implanted in patients every year. Products made by Cook include the Günther Tulip and Celect.
Unfortunately, Cook’s IVC filters have been linked to rare but serious side effects. Lawsuits claim the wire legs (“struts”) of the filter can break off, perforate internal organs, travel to parts of the body where they are impossible to remove, and cause deadly complications.
Many of those lawsuits have been filed by Ben Martin, a Dallas-based attorney who told the International Business Times:
“There are probably tens of thousands of people that are walking around with a perforated vena cava and have absolutely no idea,” Martin said. “You’ve got a massive public health risk in the United States.”
The lawsuits have been centralized under U.S. District Judge Richard L. Young in one federal court in the Southern District of Indiana (MDL No. 2570). The plaintiffs claim the design is defective and Cook failed to adequately warn about potential risks.
Problems for Cook have been growing for years. In August 2010, the FDA issued a safety alert after receiving more than 900 reports of adverse events involving temporary IVC filters that were not removed as soon as the patient was not at risk of a pulmonary embolism.
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