The first bellwether case against Cook Medical over its inferior vena cava (IVC) filter is going to trial. The case is one among about 2,000 suits that have stacked up against Cook, from patients who claim their “life-saving” blood clot filters actually threatened their lives.
IVC filters are cage-like devices inserted into the largest vein in the body to catch blood clots before they can reach the heart or lungs. Formerly, the filters were designed to be permanent, but the temporary versions have been found to be of a much more fragile design. As a result, the FDA recommends that retrievable IVC filters be removed between 29 and 54 days after insertion.
Retrievable IVC filters, such as the Gunther Tulip, have been known to impale organs, puncture blood vessels, tilt, fracture and migrate, resulting in revision surgeries to either fix or remove the filter. In many cases, the failed filter has been blamed for the patient’s death.
Cook has refused any settlement offer for any of the cases, maintaining that the filters are safe. Cook says it will “vigorously defend these products because we believe in their ability to save lives.”
“Cook has no present plans to resolve the claims,” spokeswoman Marsha Lovejoy wrote to Indianapolis Business Journal in an email.
“These are pretty simple cases to understand,” said plaintiffs’ attorney Randy Roberts. “I don’t think a jury will have much trouble following the facts.”
Thousands of lawsuits are now pending against medical device manufacturing companies such as Cook Medical, Rex Medical, B. Braun Medical, and C.R. Bard alleging failed IVC filters resulted in patient injury.