A new MDL (multidistrict lawsuit) has been established in the U.S. District Court, District of Arizona, for all federal Bard IVC filter lawsuits filed by or on behalf of patients who allege to have been injured by the Recovery and G2 inferior vena cava (IVC) filters manufactured by C.R. Bard, Inc.
Pursuant to an order of August 17, 2015 almost two dozen Bard IVC filter cases were transferred to the District of Arizona by the U.S. Judicial Panel on Multidistrict Litigation (JPML) after it was determined that centralization will help avoid duplicative discovery and promote a quicker resolution of the cases. According to court documents, the lawsuits share common questions of fact and similar allegations, including design defects that make Bard IVC filters more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing serious injury to patients.
Problems with IVC Filters
C.R. Bard’s Recovery and G2 IVC filters are designed to catch blood clots and prevent them from making their way to the lungs where they could potentially cause a pulmonary embolism. But problems with the filters prompted hundreds of adverse reports to the U.S. Food and Drug Administration (FDA). In August 2010, the FDA announced a warning about the risks surrounding IVC filters, particularly when the devices broke apart and traveled to other areas of the body and caused perforations and other serious injuries.
Most IVC filters are never removed because insufficient clinical follow-up, failed retrieval procedures, or because patients are not offered the opportunity for filter removal. In May 2014, the FDA recommended that doctors remove IVC filters within a month or two after the risk of pulmonary embolism had passed, and not leave them in place indefinitely, noting that many doctors were not adequately warned about the importance of retrieving the devices. The FDA further stated:
Recommendations/Actions:
The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.The FDA encourages all physicians involved in the treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.
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