Lawsuit Filed Over Bard G2 IVC Filter Failure and Surgical Removal

A New York woman has filed a product liability lawsuit against C.R. Bard, alleging that the company’s G2 inferior vena cava (IVC) filter failed multiple times, requiring surgery to remove it.  

The complaint (PDF) was filed by Sarah Bednarek in U.S. District Court for the Eastern District of New York on April 16, claiming that Bard sold a defective and unreasonably dangerous IVC filter, which the manufacturer knew or should have known had a high rate of fracture, migration and failure.

The Bard G2 is an inferior vena cava (IVC) filter used for individuals who may be at risk for a pulmonary embolism, but for whom an anticoagulant has been ineffective or is contraindicated. The small, spider-like device contains a number of legs or struts that extend out to catch blood clots that may break free elsewhere in the body, such as the deep veins of the legs.

According to Bednarek’s Bard G2 IVC filter lawsuit, her doctors implanted the device in May 2009. Subsequently, the IVC filter failed and fractured at multiple locations, perforating her inferior vena cava and migrating to other organs.

As a result of the Bard IVC filter failure, Bednarek indicates that she suffered severe injury and internal damage, requiring surgical removal of the IVC filter in March 2012. She claims that she has been left with extreme pain and suffering, medical expenses, disability and loss of enjoyment of life.

Problems with Bard IVC Filters

In recent years, a number of similar lawsuits over the Bard G2 filter have been filed, as well as Bard Recovery IVC filter lawsuits, involving an earlier version of the device. The Bard Recovery and G2 feature a similar design and both have been linked to an alarming number of reports involving fractures and failure of the IVC filter.

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 allow the devices to remain in place, which may increase the risk of complications with the IVC filter, where the struts may fracture, perforate the vena cava or allow the device to migrate to other areas of the body, such as the heart or lungs.

According to allegations raised in Bednarek’s complaint, a review of the FDA’s medical device adverse event database reveals that Bard IVC filters, including the G2 Filter, were responsible for the majority of all reported problems with IVC filters in the United States between 2004 and 2008.

In August 2010, the FDA issued an alert about the risk of problems with IVC filters, indicating that the agency had received more than 900 adverse event reports associated with the products. 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 indicated that doctors should 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.

Two studies published earlier this year raised further concerns about IVC filters, 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.

Several Bard IVC filter class action lawsuits have ben 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.