According to documents from the Judicial Panel on Multidistrict Litigation (JPML), as of December 15, 2015, Cook Medical faced 172 consolidated lawsuits in MDL 2570 (In re: Cook Medical, Inc., IVC Filter Marketing, Sales Practices and Product Liability Litigation). By the same date, Bard faced 72 lawsuits in MDL 2641 (In Re: Bard IVC Filter Products Liability Litigation). Both MDLs have grown since the November numbers were released, although not drastically. As of November 16, Cook faced 156 consolidated lawsuits while Bard faced 66 consolidated lawsuits. Those numbers do not include lawsuits that have been filed but have not yet been consolidated.
Inferior vena cava filters were designed to prevent pulmonary embolism in patients who cannot use anticoagulant medications. The filters are implanted in the patient’s inferior vena cava, and struts trap any blood clots that may be headed to the patient’s lung. But lawsuits allege some filters are prone to metallic failure, allowing a strut to break off and perforate a major blood vessel. This puts the patient at risk of internal bleeding or stroke.
As of August 2010, the US Food and Drug Administration (FDA) had reportedly received 921 reports of adverse events linked to the filters, including more than 300 reports of device migration, almost 150 reports of the device or its components moving to the heart or lungs, and more than 50 reports of perforation. In its communication, the FDA noted that part of the problem could be linked to the temporary devices being left implanted for too long.
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NBC (9/3/15) reports that at least 27 deaths have been linked to the Recovery filter, with another 300 reports of non-fatal injuries. According to NBC, Bard, maker of the Recovery filter, had at least some warning in the form of a report from a consultant that the Recovery filter had unusually high failure rates but the company did not issue a timely recall. The device maker now faces lawsuits alleging its device caused serious harm to patients.