Cook Inferior Vena Cava (IVC) filters have been found to be ineffective at stopping blood clots in many cases. Cook IVC filters are designed to stop blood clots traveling to the lungs through a small device inserted into the vein.
The filters are used in patients at risk of having the veins or arteries in their lungs blocked by blood clots, a condition known as a pulmonary embolism. Companies that produce products that cause consumers serious injury or death are held responsible for product liability, the legal responsibility the company incurs for producing or selling a faulty product.
The Cook IVC filter is the oldest filter approved for use and designed to be removed after 12 weeks or the risk of a pulmonary embolism has passed. An investigation into the filters found that serious complications could arise from use or prolonged use of IVC filters, including:
- Pulmonary embolism;
- Infection or hematoma at the filter site;
- Pieces of the filter breaking free and traveling to the lungs;
- Becoming tilted and out of place;
- Filter fracture in the Vena Cava; or
- Perforation of the Vena Cava.
In a 2010 report, the Food and Drug Administration (FDA) had received over 900 adverse reports from consumers, doctors, and hospitals relating to use of IVC filters. They issued a warning stating the IVC filters should be removed after the risk of a pulmonary embolism has passed. Keeping IVC filters in longer than needed can lead to a higher risk of complications.
The FDA introduced new IVC approval requirements in 2003 and 2004. Previously approved designs for IVC filters were exempt from having to get approval through the current requirements. The companies only had to claim they were the same or better designs as the filters having to go through the approval process. Claims that the IVC filters were the same as new designs were left to an honor system by the companies.
The previously designed IVC filters should have been tested through the same requirements as new designs. Technology changes and the designs used may not have actually been updated to meet standards. Companies should be held to product liability standards on defective products.
If you or a family member has been affected or passed away from the placement and use of a Cook Inferior Vena Cava device, contact a Chicago product liability attorney today. Call the law office of [[title]], at [[phone]] to schedule a free consultation.