Bard faces a lawsuit from a married couple alleging that IVC filter complications caused serious health problems for the husband.

Plaintiffs William K. and Paula K. filed their lawsuit against CR Bard Inc. and other subsidiaries in late October. William had the Bard G2 Filter placed in February 2010 and later allegedly suffered from a variety of IVC filter complications including tilt, migration, and perforation of the vena cava.

IVC filters such as the G2 Filter are small metal devices which are placed into the inferior vena cava to trap and break up clots. Clots often form in the deep veins of the leg, where they can travel up the vena cava into the lungs. Once in the lungs, these clots are considered pulmonary emboli. Pulmonary emboli can cause serious health problems and can result in death if left untreated.

IVC filters provide a mode of prevention for pulmonary emboli and are often placed in patients with a high clotting risk or a history of pulmonary emboli. However, not all filters are made equal and some may be subject to IVC filter complications.

In their lawsuit, William and Paula allege that the Bard G2 Filter was defective, which caused William to experience IVC filter complications.

According to the IVC filter complications lawsuit, the G2 filter is poorly designed and cannot withstand the pressure exerted by blood flowing through the vena cava.  This allegedly causes the filters to tilt and shift in the blood vessel which, in turn, increases the chances of migration and perforation.

A variety of IVC filter complications have allegedly been reported with the G2 filter including, but not limited to, death, hemorrhage, cardiac tamponade, cardiac arrhythmia, severe pain, and perforation of tissues, vessels, and organs.

The IVC filter lawsuit also claims that Bard knew or should have known about the risks associated with the G2 filter but chose not to warn patients or recall the device.

The defective nature of Bard IVC filters allegedly began with the company’s first iteration of the product, the Recovery filter. The Recovery filter was released in 2003 but was soon the subject of numerous adverse event reports. In late 2004 to early 2005, Bard withdrew the Recovery filter from the market due to adverse events, but did not recall the device.

In 2005, Bard released the G2 Filter, claiming that it was as safe or better than the Recovery filter. The device was allegedly intended to be a safer, newer version of the Recovery filter. In 2008, the company released the G2 X Filter which was the same as the G2 filter but was designed to be retrieved.

The IVC filter complications lawsuit claims that the G2 and G2 X filters have the same risks as the Recovery filter and that all three devices are defective and dangerous.

“Defendants knew or reasonably should have known that the Recovery, G2 and G2 X filters were dangerous or were likely to be dangerous when used in its indented or reasonably foreseeable manner,” the IVC filter complications lawsuit argues.

Plaintiffs accuse the defendants of negligence, failure to warn, design defect, manufacturing defect, breach of warranties, fraudulent concealment, negligent misrepresentation, fraudulent misrepresentation, violation of New York consumer protection laws, and loss of consortium.

William and Paula seek economic damages, compensatory damages, punitive damages, court costs, and attorneys’ fees.

The IVC Filter Complications Lawsuit is Case No. 1:18-cv-01173 in the U.S. District Court for the Western Division of New York.