The final Bard IVC Bellwether Group 1 cases will be selected in the latter part of April 2017, according to an Order issued December 22 by U.S. District Judge David G. Campbell. The Bard IVC lawsuits have been centralized into multidistrict litigation (MDL) in the District of Arizona.
Case Management Order No. 20 issued by Judge Campbell establishes dates for case-specific fact discovery that will begin on January 5, 2017:
• February 16, 2017 – Deadline to depose all of the Discovery Group 1 plaintiffs.
• April 17, 2017 – Deadline for each side of Discovery Group 1 to exchange a list of six proposed plaintiffs for bellwether group 1 and the proposed order of the trials.
• April 28, 2017 – Briefing deadline after which Judge Campbell will select the trial group if the parties cannot agree.
• Fall of 2017 – First Bard IVC bellwether trials will begin.
What are IVC Filters?
IVC filters are medical devices placed between the proximal vessels of the lower extremities and the right side of the heart to help prevent pulmonary embolism by catching blood clots and preventing them from traveling to the lungs.
Since 2005, the U.S. Food and Drug Administration (FDA) has received more than 900 reports of adverse events connected to IVC filters. Common complications associated with IVC filters that have been left in the body for long periods of time include:
• The progression of DVT
• Recurrent PE
• Filter migration
• Tilt, break, or embolism
• IVC perforation or occlusion
In 2010, the FDA warned that retrievable filter posed risks of filter fracture, device migration, and organ perforation, and should be removed as soon as the patient’s risk for blood clots had subsided. In 2014, the FDA updated this safety communication, stating that most devices should be removed between the 29th and 54th day after implantation. However, the majority of IVC filters implanted are not retrieved, and their benefits continue to make them a frequent choice for doctors and patients, despite the risk of serious side effects including fracture, embolism, and IVC wall penetration.