IVC Filter Wrongful Death Lawsuit Filed Over Bard G2 Filter Failure

One of the latest lawsuits filed against C.R. Bard involves a wrongful death complaint filed by a St. Louis woman, who alleges that her husband was killed due to complications with a Bard G2 inferior vena cava (IVC) filter.

The complaint (PDF) was filed by Catherine Rowden on September 28, in the U.S. District Court for the Eastern District of Missouri, over the death of her husband, Johnny Rowden.

According to the wrongful death lawsuit, Johnny Rowden had the small, retrievable filter implanted into his vena cava in November 2006, to “catch” blood clots that may break free from the deep veins and prevent them from causing a pulmonary embolism. However, Catherine Rowden alleges that the Bard G2 filter failed after it was implanted, tilting out of position and perforating the vein. As a result, the device was ineffective at preventing a deadly clot from moving to the heart or lungs.

The case joins a growing number of IVC filter lawsuits filed on behalf of individuals nationwide who have experienced similar problems, alleging that design problems with the Bard G2 and other retrievable filters make them prone to move out of position, fracture or ultimately fail.

“Due to Bard’s lack of understanding of caval anatomy and the forces the device would be exposed to once implanted, Bard set design specifications that were not clinically relevant and did not account for the forces these devices would actually see when implanted in the human body,” the lawsuit states. “Bard also failed to test the device under reasonably foreseeable conditions that the device could be exposed to when used in an intended and expected manner.”

The G2 filter is the second generation version of the Bard Recovery filter, which was itself known to have problems with fracturing and migration and had a very high failure rate. According to this and other recent lawsuits, Bard knew the design had problems, had seen reports of filter fractures and migration, but continued selling it anyway, before making minor changes and repackaging it as the G2 filter.

A recent investigative report by NBC news also delved into the development of the devices. According to the report, officials in C.R. Bard were warned about the problems by adverse event reports and their own employees, but continued to sell the devices, without warning the medical community of the problems.

One employee, Kay Fuller, a regulatory specialist who worked for Bard on getting the Recovery approved, said she quit when the company would not address her concerns over the device’s health issues, and then forged her signature on the FDA approval application, according to NBC.

IVC Filter Lawsuits

The litigation over IVC filters emerged following an FDA statement issued in August 2010, which warned about the risk of retrievable filter problems, indicating that the agency had received hundreds of adverse event reports where filters broke free and travelled to other areas of the body or caused other injury.

In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.

In August 2015, the U.S. Judicial Panel on Multidistrict Litigation established consolidated federal proceedings for Bard IVC filter lawsuits, centralizing the cases before U.S. District Judge David G. Campbell in the District of Arizona as part of a MDL, or multidistrict litigation.

Another consolidated MDL proceeding has been established for all Cook Medical IVC filter lawsuits, which raise similar allegations of problems associated with other retrievable devices, including the Cook Celect and Gunther Tulip filters. Those cases are centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.