A Phoenix woman was awarded $3.6 million in damages when a jury found C.R. Bard Inc. 80 percent responsible when her clot-stopping, Inferior Vena Cava (IVC) filter device broke apart in her body. However, the jury found that Bard was not liable for the product liability design defect, strict product liability failure to warn, or negligent design.
The plaintiff, who was 37 at the time she received the IVC filter broke and resulted in injuries that led to the need for open-heart surgery. The jury assigned the other 20 percent of the fault to the radiologist who failed to flag a visibly separated filter piece on an x-ray. During the surgery, only some of the pieces of the device were able to be removed. She worries that the remaining pieces of the IVC filter could migrate and cause more health issues.
What is an IVC filter?
IVC filters are placed within the Inferior Vena Cava vein in the abdomen that takes blood from the lower body to the heart. Blood clots often form in the legs and pelvis which then travel up to the heart or lungs. IVC filters can help reduce the risk of pulmonary embolism by trapping blood clots before they reach the heart or lungs.
FDA Approval
The device that was involved in the lawsuit was a second-generation model that was not tested by the FDA as a new device. It was approved by the FDA under a 510(k) program which allows the manufacturer to certify a new product that is similar to one already approved.
Sources:
https://www.drugwatch.com/2018/03/30/3-6-million-awarded-first-bard-ivc-filter-case/
https://www.law360.com/articles/1028298/bard-owes-injured-woman-3-6m-in-ivc-bellwether-jury-finds
