While the FDA continues to monitor reports of IVC filter complications, an Arizona federal court will conduct pretrial procedures for several federal IVC filter lawsuits.

An IVC filter is a device that blocks blood clots from the legs or pelvis from traveling through the circulatory system up to the lungs, where they may cause a pulmonary embolism – a potentially fatal condition.

It’s an alternative treatment for patients who are at risk for such blood clots but for whom anticoagulant medication is not a good option.

The filter itself is like a basket made of metal wire. Placement of the filter is done on an outpatient basis. It can be inserted through a small incision in the neck or the groin, then maneuvered into place inside the inferior vena cava.

But in hundreds of cases, IVC complications have created significant problems. Some filters have broken, allowing fragments of the filter to migrate through the body and sometimes find their way to the heart or lungs, potentially causing an embolism. Other filters have moved out of place or punctured the wall of the inferior vena cava.

Some IVC filters are designed to be removed later, and others are designed to be in place permanently. However, in August 2010, the FDA issued a communication recommending that physicians remove retrievable IVC filters as soon as they are no longer needed to avoid the possibility of IVC complications.

In making that recommendation, the FDA cited 921 reports of adverse events associated with IVC filters received over the previous five years. These events included migration of the filter away from where it had been positioned, detachment of filter parts resulting in embolization, perforation of the inferior vena cava, and fracture of the filter.

Research and studies conducted since the FDA’s 2010 communication have also called into question the effectiveness and safety of IVC filters in general.

In March 2013, an opinion piece in the journal JAMA Internal Medicine questioned the very efficacy of IVC filters. The authors noted that eight percent of the patients in a study developed pulmonary embolism despite having an IVC filter in place.

In May 2014, the FDA followed up on its 2010 recommendation in the wake of even more IVC filter research and studies. The agency specifically recommended removal of retrievable IVC filters between 29 and 54 days after implantation once the risk of pulmonary embolism has passed.

The agency based this recommendation on a decision analysis published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013.

The FDA noted that manufacturers of IVC filters are participating in ongoing studies, the PRESERVE study and the 522 Studies, that the agency anticipates will yield more useful information when they are completed.

IVC Filter Lawsuits

Cook Medical and C.R. Bard are both manufacturers of IVC filters. Both companies have been implicated in recent IVC filter lawsuits.

In August 2015, the federal Judicial Panel on Multidistrict Litigation ordered 22 IVC lawsuits against Bard to be consolidated into a single multidistrict litigation, or MDL, in federal court in Arizona.

Generally, an MDL is used for consistent and efficient administration of pretrial procedures in cases where several different individual claims have much in common, such as with medical products liability litigation. Future IVC filter lawsuits against Bard will likely be transferred into the same MDL.

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