A woman from Texas is suing C.R. Bard Inc. and Bard Peripheral Vascular Inc. over her alleged IVC filter complications following the implantation of the device in October 2007.

Plaintiff Janice B. claims in the IVC filter lawsuit that when her doctor tried to remove the filter in May 2008, it was discovered that two of the filter’s struts had broken. One of the fragments was able to be removed, but the second fragment had lodged in her right lung. The rest of the filter could not be removed.

A couple days later, she underwent a second attempt at IVC filter removal. That attempt also failed.

In her IVC filter lawsuit against Bard, Janice is raising claims based on theories of fraud, negligence, failure to warn, failure to recall, defective design and manufacture, breach of warranty, and violation of state consumer protection laws.

Janice’s claim is part of the Bard IVC filter multidistrict litigation, or MDL, now going on in a federal court in Arizona. An MDL is a consolidation of similar lawsuits into a single court so that pretrial processes can be conducted more efficiently.

The Bard IVC Filter MDL is MDL No. 2641 in the U.S. District Court for the District of Arizona.

What Is an IVC Filter?

The Bard IVC filter Janice is suing over is a surgically implanted device used to prevent clot-related complications in persons for whom anticoagulant medication is not an option. It consists of a tiny wire basket that is placed in position inside the inferior vena cava.

The basket catches clots and holds them so that they cannot continue traveling to the heart and lungs, where they might cause pulmonary embolism. While the filter holds the clot, natural anticoagulants in the blood dissolve the clot and flush it away.

IVC Filter Complications

According to the master complaint for the Bard IVC filter MDL, plaintiffs hope to hold Bard accountable for different types of problems, some of which have allegedly been fatal. They say that Bard IVC filters have an unreasonably high rate of fracture. The G2 filter that Janice received has a fracture rate of 37.5 percent within five years from the date of implant, the plaintiffs say.

Filter fracture creates the risk that filter fragments or the entire filter can travel to the heart. The plaintiffs say that these fragments can then cause conditions like cardiac tamponade, perforation of the atrial wall, myocardial infarction, and possibly death.

The plaintiffs argue that these complications make the Bard IVC Filter “not safe, fit, and effective for human use in their intended and reasonably foreseeable manner.”

Reports of IVC filter complications led the FDA to issue a safety communication addressing the issue in May 2014. The agency said it had received reports of various adverse events including fracture of the filter and difficulty with IVC filter removal, as Janice experienced.

Other complications the FDA mentioned included device migration, perforation of the blood vessel, and movement of either the entire filter or its fragments to the heart or lungs.

The FDA encouraged physicians to consider IVC filter removal once the patient is no longer at risk for pulmonary embolism.