The lawsuit was filed by Diane C., a woman who was implanted with the C.R. Bard Recovery® Vena Cava Filter in September 2003 at a hospital in Oklahoma.
C.R. Bard is accused of negligence for selling a defective medical device and failing to warn about safety risks.
The FDA recommends removing temporary vena cava filters within 29-54 days of implantation, but most filters remain implanted for years or indefinitely.
Recovery is a temporary inferior vena cava (IVC) filter that was approved in 2003 through a 510(k) clearance, which means it did not go through clinical trials before it was allowed on the market.
Unfortunately, it was soon linked to safety concerns. Without issuing a recall, C.R. Bard pulled the Recovery off the market in 2005 after a study by Dr. John Lehmann found higher risks than its competitors.
In February 2012, a study of 363 patients with the Recovery estimated that 40% would fracture within 5.5 years. Only 97 were removed during 3-year study. In a smaller study published in 2010, fracture and embolization occurred in 7 out of 28 patients (25%) with the Recovery. In five cases, broken pieces of the filter got stuck in the patient’s heart.
The lawsuit was filed on October 18, 2016 in the U.S. District Court for the District of Arizona — Case No. 2:16-cv-03595.
It will be centralized with over 1,000 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.