Medical device manufacturer, C.R. Bard, Inc., is back in the news and back in Federal Court. On August 18, 2015, the Judicial Panel on Multidistrict Litigation (JPMDL) announced that the lawsuits pending currently against C.R. Bard, Inc. and Bard Peripheral Vascular involving the IVC filter will be consolidated and transferred to the U.S. District Court for the District of Arizona. More than 200 pending cases will be transferred immediately, and it is believed that many more will follow.
An inferior vena cava (IVC) filter is a small medical device that is surgically implanted inside the body to capture blood clots before they migrate to other areas of the body, causing serious conditions such as a pulmonary embolism or stroke. However, a number of studies have shown that pieces can break away from the filter and migrate to other areas of the body, causing serious injuries and deaths. The New England Society for Vascular Surgery conducted a study, which concluded that the IVC filters fractured in 31% of the cases. These shards or splinters often migrated to the patients’ right ventricles of the heart. Another study found that in 25% of the patients studied, there were splinters that broke off, many of which migrated to the heart, lungs and the hepatic vein.
Before introducing these filters on the medical market, Bard knew that IVC filters were associated with serious side effects. However, this information was not conveyed to doctors. Bard knew the filters were prone to fracture, which could lead to perforations of the vena cava, surrounding vessels and organs, necessitating serious and life-threatening open surgical procedures. On July 13, 2015, the U.S. Food and Drug Administration (FDA) cited Bard for failing to report adverse events associated with the IVC filters and for illegally selling a device that was designed to retrieve the filters. It is believed that Bard has sold more than 500,000 IVC filters. With failure rates approaching 40% after five years of implantation, there are far too many patients with IVC filters who are at risk.