Inferior vena cava (IVC) filters are blood-filtering devices that are often implanted in people recovering from accidents and surgeries by preventing blood clots from traveling to the lungs. These devices can be temporary or permanent and are inserted into the largest vein in the body where they trap clots. By 2012, about 259,000 IVC filters had been inserted into patients. Doctors typically recommend IVC filters to patients who have recently suffered serious injury or undergone surgery, because they are at an increased risk of blood clots, but cannot take blood thinners. Those who have just had surgery or a serious injury often cannot take blood thinners because they are at a risk of uncontrollable bleeding, so doctors recommend IVC as an alternative. Common cases in which doctors might recommend the use of an IVC filter include car accidents, voluntary or emergency surgeries, gunshot or stabbing injuries, dialysis treatment, spinal cord injury, cancer diagnosis or treatment, and serious falls.
The inferior vena cava is the largest vein in the body. The vein moves deoxygenated blood from the lower legs to the heart and then to the lungs. IVC filters are specifically used to prevent blood clots from traveling to the lungs, which could result in a pulmonary embolism, a blockage in the lung. The two types of IVC filters are permanent and optional, or retrievable. Retrievable IVC filters are often associated with complications including blood vessel and organ perforation, as well as filter migration. Because of these known potential risks, the U.S. Food and Drug Administration announced a safety alert regarding retrievable IVC filters in 2010. This report was prompted by 921 reports of adverse events that occurred from 2005 to 2010 as a result of retrievable IVC filters. Some of these events included device migration, filter perforation, filter fracture, and detached device components. The most common adverse incident was device migration, accounting for 35 percent of total adverse incidents. Another problem with retrievable filters is that they are not often removed when they should be. Follow up studies on retrievable IVC filters performed by the Journal of the American Medical Association (JAMA) found that only 58 of 679 filters that were inserted were actually removed. Five specific brands of filter prone to failure were Bard’s Recovery, Bard’s G2, Bard’s G2 Express, Cook’s Gunther Tulip, and Cook’s Celect.
The various findings by the FDA and JAMA have provided ample evidence for those filing lawsuits claiming negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation on the part of the companies and their subsidiaries. The first lawsuits were filed against Bard in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated numerous lawsuits against Cook from 11 districts to one MDL in the Southern District of Indiana. To date, there are over 100 lawsuits against Cook. The U.S. Judicial Panel on MDL also consolidated lawsuits against Bard to the U.S. District Court District of Arizona in 2015. Over 50 of these lawsuits are still pending, as well as many other lawsuits in other state and federal courts.
If you or a family member has suffered as a result of a faulty IVC Filter, call the drug injury law firm of Altman & Altman, LLP for a free case consultation. 617-492-3000.
“IVC Filters: Complications & DVT Risks from Vena Cava Device.” DrugWatch. N.p., n.d. Web. 18 July 2016.