The lawsuit was filed by Deborah K., a woman from Nebraska who was implanted with the C.R. Bard G2® Vena Cava Filter on December 30, 2009.
The G2 is a 2nd-generation filter made by C.R. Bard that was introduced in 2005. It did not go through clinical trials because it was “equivalent” to Bard’s 1st-generation Recovery® Vena Cava Filter.
G2 and Recovery are identical except slight differences in size. They have the same materials, components, and manufacturing process.
They also have the same problems. Recovery was introduced in 2003. In 2004, a study linked it to higher rates of fracture and migration than its competitors. In 2005, it was withdrawn and replaced by the G2.
Bard sold 160,000 G2 filters before pulling it off the market in 2010. That same year, independent studies began confirming what Bard already knew — both the Recovery and G2 had high rates of fracture.
In 2010, a study of 80 patients found a 25% fracture-risk, with 70% of broken fragments traveling to the heart. The study concluded:
The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.”
Even more concerning was a study of 684 patients in 2014 that estimated 38% of G2 filters would fracture within 5 years. The broken fragments were discovered in patients’ lungs, heart, pericardium, iliac vein, and kidneys. Early fractures were rare, but the risk increased over time.
In August 2010, the FDA issued a Safety Warning after 921 injuries were reported since 2005. The FDA warned about long-term risks like Deep Vein Thrombosis (DVT), filter fracture, migration, embolization, and perforations through the vein.
C.R. Bard is accused of aggressively marketing “short-term” IVC filters like the Recovery and G2 without providing adequate safety warnings. As a result, very few of the filters were removed in a timely manner.
The FDA has received at least 12 reports of death and hundreds of injuries associated with the G2, according to NBC News. The Recovery has been linked to 27 deaths and over 300 injury reports to the FDA.
Lawyers say C.R. Bard downplayed side effects and continued selling dangerously defective medical implants after discovering safety risks.
The lawsuit was filed on March 4, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-00654.
It will be centralized with around 1,470 other IVC filter lawsuits now pending against C.R. Bard 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 on the plaintiffs’ steering committee of the Bard IVC Filter MDL.