Lawsuit Filed After Bard IVC Filter Fails, Penetrates Vena Cava Wall

C.R. Bard faces yet another product liability lawsuit that alleges one of the company’s IVC filters failed, penetrating the walls of a Texas woman’s vena cava and leaving her doctors unable to remove the device.  

The complaint (PDF) was filed by Robin Arnold and her husband, Felix, in the U.S. District Court for the Western District of Texas on July 11, pursuing claims against Bard for negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty, negligent misrepresentation and loss of consortium.

Arnold received a Bard G2 filter in September 2007, which is one of two two IVC (inferior vena cava) filters marketed by C.R. Bard that have been the subject of a number of similar lawsuits in recent years, where plaintiffs allege that the device failed and that the legs have either broken off and moved to other parts of the body, or pierced the inferior vena cava or vital organs. The G2 filter is an upgraded version an earlier IVC filter, the Bard Recovery, which was removed from the market amid reports of problems.

Unlike traditional IVC filters, the Bard Recovery and G2 filters were designed so that they can be removed once the threat of a pulmonary embolism has passed.  However, in many cases physicians have allowed the devices to remain in place, which may increase the risk of complications.

According to allegations raised in Arnold’s Bard IVC filter lawsuit, her G2 filter failed after it was implanted and the problems were not discovered until about July 2011. The arms of the spider-like filter have allegedly penetrated her inferior vena cava (IVC) walls and can not be safely removed, which has left her suffering extreme pain and loss of enjoyment of life.

Problems with Bard IVC Filter Failures and Fractures

Arnold’s complaint joins a growing number of Bard G2 filter lawsuits and Bard Recovery filter lawsuits, which have been brought in courts throughout the country by individuals who have experienced similar problems where the device fractured or failed.

Most of the complaints have been brought following an FDA alert issued in August 2010, which warned about the risk of problems with removable IVC filters, indicating that the agency had received more than 900 adverse event reports. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved  components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.

The FDA recommended that doctors remove the filters once the danger of the clot has passed, to reduce the risk of the filters breaking free and traveling through the body.

According to allegations raised in many of the lawsuits filed against Bard, the medical device manufacturer knew or should have known about the unreasonably high rate of fracture, migration and perforation of the vena cava wall that was occurring with the Bard Recovery and G2 filters, yet failed to warn consumers or the medical community.

Several studies published earlier this year raised further concerns about the products, indicating that there is a lack of evidence that the IVC filters are effective, as well as a lack of data on their proper use, resulting in doctors being unsure of how and when to implant them or remove them.

A number of Bard IVC filter class action lawsuits have also been filed on behalf of individuals who received the Bard Recovery or G2 filters, seeking to force the manufacturer to pay for the medical monitoring that patients will need to ensure that the filters have not failed. An estimated 100,000 of the devices have been implanted in patients in the United States.