The lawsuit was filed by Violet C., a woman from Pennsylvania who was injured by the G2® Inferior Vena Cava Filter (“IVC Filter”) manufactured by C.R. Bard and Bard Peripheral Vascular Inc.
The IVC filter was surgically implanted in her body at a hospital in Pennsylvania in 2009 to prevent side effects of blood clots.
One year later, the FDA reported nearly 1,000 adverse events with IVC filters since 2005 and reminded doctors to remove temporary IVC filters as soon as safely possible.
In August 2010, a study published in the Archives of Internal Medicine associated the G2 with a 12% fracture-rate. Bard pulled the G2 off the market by the end of 2010, but did not recall it. Approximately 160,000 G2 filters had been sold since 2005.
In 2014, the FDA issued another Safety Communication to suggest removing IVC filters within 29-54 days, or as soon as the risk of blood clots subsides.
That same year, a study published in the Journal of Vascular Interventional Radiology of 892 patients who received a G2 IVC filter estimated that 38% would fracture within five years.
The risk was nearly identical to the 40% 5.5-year fracture-risk associated with Bard’s Recovery® IVC Filter.
Fractured fragments of the G2 were identified in the pulmonary arteries, right ventricle, pericardium, iliac vein, and kidney. Four fracture limbs stayed by the filter, but three could not be located.
The most serious complication of a broken IVC filter is that fractured fragments will be carried in the bloodstream until they hit the heart and cause heart attack-like symptoms, irregular heart rhythm, or death. The authors of the study warned:
The prevalence of fracture would be identical to that observed for the Bard Recovery filter, thus challenging the hypothesis that the Bard G2 filter represents an improvement in fracture resistance.”
Lawyers accuse C.R. Bard of negligence for selling a defective medical device and downplaying the risk of severe side effects. In a recent investigation by NBC News, the G2 filter was linked to at least 12 deaths and hundreds of non-fatal injuries.
The lawsuit was filed on April 19, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-01166-DGC.
C.R. Bard is now facing 1,750 other IVC filter lawsuits nationwide. Most of the lawsuits are centralized in Multi-District Litigation (MDL No. 2641) In Re: Bard IVC Filters Products Liability Litigation.
The plaintiff is represented by Ben C. Martin of The Law Offices of Ben C. Martin in Dallas, Texas. He a trial attorney who serves as plaintiffs’ co-lead counsel in the Cook IVC Filter MDL and is on the plaintiffs’ steering committee of the Bard IVC Filter MDL.