The lawsuit was filed by Kyler K., a man from Alabama who was implanted with the C.R. Bard Meridian® Vena Cava Filter on April 23, 2013.
Meridian is a 5th-generation Bard IVC filter that was approved in 2011. It was modified from the 4th-generation Eclipse filter with a more highly-polished surface to reduce fractures and barbs on the legs to prevent migration.
Despite these significant design changes, Bard did not update the materials or manufacturing process for Meridian filters. Like previous generations, Meridian was also linked to reports of fracture.
There were 38 reported cases of spontaneous fractures involving Meridian filters in 2013 alone. Some of the broken fragments traveled in the bloodstream until they hit the kidney vein, lungs, or heart.
These reports are concerning because Bard’s 1st-generation and 2nd-generation filters — the Recovery and G2 — are estimated to fracture in about 40% of patients within 5 years. Like these older IVC filters, Meridian was pulled off the market without a recall after a few years.
The only filter Bard still sells is the 6th-generation Denali, which was approved in 2013. Unlike the Meridian and all previous generations, the Denali filter was made with completely new materials and single-piece laser-cutting technology to address fracture and migration.
Fractures are an extremely serious risk. In one case report, a Meridian filter fractured inside a 74 year-old woman’s body within 8-12 months. She did not have symptoms because the broken piece got stuck near the filter, but the long-term risks include sudden death.
Severe complications like these are why the FDA recommends removing “short-term” IVC filters like the Meridian within 29-54 days, ideally. Even so, studies show that only about 30% are ever removed.
Lawyers accuse C.R. Bard of selling defective medical devices, failing to study them for safety, and inadequately warning about side effects.
The lawsuit was filed on March 3, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-00636.
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 serves on the plaintiffs’ steering committee of the Bard IVC Filter MDL.