New Jersey based company C.R. Bard Inc. is facing nationwide litigation including an estimated 400 cases accusing it of marketing a defective product. The IVC Filter MDL is an intra-veinous filter designed to catch blood clots in patients who can’t take blood thinning medication. This particular device has the potential to break off and travel to other parts of the body with a risk of piercing and embedding in tissue. Between 2005-2010, the FDA has received about 920 complaints, prompting them to issue several warnings, including one saying that the filters need to be removed within 29-54 days after implantation. Over 325 reports involved device migration, with 145 instances claiming broken pieces traveled to vessels which provide the lungs and heart with blood; 70 reports claimed perforation, or piercing of organ tissue, and 56 involved the entire filter completely breaking down. According to NBC News, and earlier model of the device caused 27 deaths, and hundreds of injuries, prompting C.R. Bard to replace it with a modified version that apparently did little to fix the problem. Company records show that it had received failure reports, and was highly aware of health risks within months of being cleared to sell the product by the FDA. Instead of issuing a recall, the company kept the device on the market for five years, selling more than 160,000 IVC filters. At least 12 deaths have been associated with the current version. “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” said Dr. William Kuo, an interventional radiologist at the Stanford Health Care’s IVC Filter Clinic, which specialized in removing failed blood clot filters. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.” An estimated 250,000 people in the U.S. each year are implanted with blood clot filters, with millions implanted in the last ten years. C.R. Bard is one of 11 manufacturers that make these devices.
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