More than 20 suits alleging injury resulting from the use of C.R. Bard Inc.’s inferior vena cava (IVC) filter have been consolidated before a federal judge in Phoenix, Ariz.
The filter, a spider-like wire device, is inserted into the vena cava of a cardiac patient at high risk of pulmonary embolism. It is meant to be a temporary solution until the risk of an embolism has been mitigated.
The suits allege that Bard failed to warn patients and their physicians of the risk of fractures in the device which can result in the release of metal fragments into a patient’s vascular system. Five separate products are implicated in the litigation: The Bard Recovery Filter, the Bard G2 filter, the Bard G2 Express filter, the Cook Gunther Tulip filter and the Cook Celect filter.
As many as 30 deaths and 300 non-fatal injuries have been linked to the device.
The federal Food and Drug Administration has issued two warnings, one in 2010 alerting the public about 921 reports of complications related to use of the device, and the second in 2014 recommending that the device be removed between 29 and 54 days after implantation.
The device is also the subject of allegations by a former regulatory specialist at the company that her signature was forged on an application seeking approval from the FDA for the Bard Recovery filter.
In its Aug 17 order, the federal Judicial Panel on Multidistrict Litigation assigned the 22 suits to U.S. Judge David G. Campbell of the District of Arizona. Judge Campbell will preside over pretrial proceedings in the existing cases and any additional federal actions arising from use of the IVC filter.
The 22 suits are pending in 16 different federal courts. There are at least an additional 16 suits pending in 13 federal courts.
The panel found that the suits involve common issues of fact and that consolidation in Phoenix will be convenient for the parties and ensure judicial efficiency.
Bard opposed the consolidation.
Information about the IVC litigation is available on the Levin Papantonio IVC Blood Clot Filter web site.