The lawsuit was filed by Stacy M., a woman currently living in Ohio who was implanted with an inferior vena cava (IVC) filter made by C.R. Bard at a hospital in Kentucky in 2004.

Bard’s only filter on the market in 2004 was the Recovery® Vena Cava Filter. It was actually the first FDA-approved “temporary” filter when it hit the market in 2003, designed with a hook to facilitate retrieval.

The popularity of temporary IVC filters skyrocketed in the mid-2000s, largely due to their perceived safety advantages over older permanent filters like the Greenfield or Simon Nitinol.

Bard Recovery® IVC Filter

This perception has been contradicted by recent studies showing no difference in survival rates of trauma patients who were implanted with IVC filters to catch blood clots.

The indiscriminate use of “temporary” IVC filters is also controversial because less than 30% are ever actually removed. Studies also show that a large percentage of Recovery filters eventually cause injuries.

For example, a small study in 2009 involving 14 patients found that all Recovery filters punctured through the vena cava within 2.5 years.

In 2012, a study involving 363 patients predicted a fracture-rate of 40% at 5.5 years and reported several cases in which the broken pieces of the filter floated in the bloodstream and got stuck in the heart or lungs.

Lawyers say C.R. Bard knew the Recovery was problematic because an internal report found higher rates of fracture and migration compared to other retrievable IVC filters on the market. The author of that report, Dr. John Lehmann, concluded:

This data and analysis provides two significant signals … that further investigation of the Recovery VCF filter performance in relation to migration and fracture is urgently warranted.”

The report was finalized in December 2004. In 2005, Bard withdrew the Recovery from the market without issuing a recall and replaced it with a nearly identical 2nd-generation model called the G2. It was soon linked to a fracture-rate of 38% at 5 years, which is nearly identical to the Recovery’s estimated fracture-rate.

The G2 was pulled off the market in 2010, the same year the FDA issued its first warning about IVC filters and reported nearly 1,000 injuries. In November 2010, a study also concluded that Recovery and G2 had “high prevalences of fracture and embolization, with potentially life-threatening sequelae.”

C.R. Bard is accused of selling defective medical devices, failing to warn about safety risks, and inadequately testing IVC filters for safety.

The lawsuit was filed on February 7, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv00395.

It will be centralized with over 1,360 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.

Editor’s note: For more information about IVC Filter lawsuits, please visit the IVC Filter Lawsuit Guide: An In-Depth Report.

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Posted by Daily Hornet

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