Lawsuit Filed After Bard G2 IVC Filter Breaks, Sends Fragments into Lungs

The number of Bard IVC filter lawsuits pending throughout the country continues to increase, as an Illinois women recently brought a complaint alleging that a G2 inferior vena cava (IVC) filter broke inside her body, causing small fragments of dangerous debris to enter her heart and lungs.  

The complaint (PDF) was filed in the U.S. District Court for the Northern District of Illinois on October 31, by Kelly Vlasvich and her husband, Chris Vlasvich.

According to allegations raised in the lawsuit, Kelly Vlasvich had a Bard G2 filter implanted in February 2009. Nearly three years later, in December 2011, Vlasvich began suffering moderate chest pain and discomfort, which eventually led to difficulty breathing, nausea, vomiting, sweating, coughing, dizziness and weakness. She was admitted to the hospital and CT scan revealed that the IVC filter had broken into pieces, with metallic fragments in her heart and lungs.

The fragments were determined to be spokes from the Bard G2 IVC filter that broke off. When the filter itself was scanned, it only had nine spokes, when it should have had 12. The product liability lawsuit claims that the Bard filter was defective.

Bard IVC Filter Lawsuits

The Bard G2 IVC filter is one of two controversial IVC filters marketed by C.R. Bard, which have been the subject of a number of similar lawsuits in recent years. All of the complaints involve allegations that the filter failed and that the legs either broken off of that the filter moved to other parts of the body, piercing the inferior vena cava or other vital organs.

Bard introduced the G2 filter as an upgraded version of the Bard Recovery IVC filter, which was removed from the market only a few years after it was introduced, amid reports of a high rate of the implant splintering and breaking.

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 Vlasvich’s lawsuit, the G2 carries many of the same problems as the Bard Recovery IVC filter. Both are covered in a substance called Nitinol, a metal that changes shape when the temperature changes and returns to that shape when again exposed to the initial temperature. The lawsuit notes that the Recovery was removed from the market after it was found to have a 21% to 31% failure rate.

“The Recovery Filter System had manufacturing defects, including lack of preparation of the exterior surface of the device so as to eliminate gouges in the Nitinol struts of the device. These gouges caused the Recovery Filter System to fail/fracture,” the lawsuit claims. “The G2 Filter continues to have manufacturing defects in the form of ‘draw marks’ on the exterior of the device.”

The lawsuit suggests that G2 filter defects also pose a risk of potentially fatal complications including hemorrhage, perforation of tissue, vessels and organs, and a condition known as cardiac/pericardial tamponade, which is pressure on the heart caused by blood collecting around it.

Vlasvich’s lawsuit charges C.R. Bard with negligence, breach of implied warranty, negligent misrepresentation, and strict liability. Her husband is suing the company for loss of consortium.

In August 2010, the FDA issued an alert warning about the risk of problems with removable IVC filters. At that time, the FDA had received more than 900 adverse event reports regarding the IVC filters. 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.