A new wave of products liability litigation is developing over the tendency of a certain type of blood filter to fail, potentially causing the embolism it was meant to prevent.

An inferior vena cava filter, or IVC filter, is a medical device used to capture blood clots and prevent them from traveling from the legs to the heart. It’s a metal filter that gets positioned in the inferior vena cava, which is the major vein that carries blood returning to the heart.

Implantation of the IVC filter is done via catheterization, and only a small incision and some mild anesthetic is required. These filters are used to prevent pulmonary embolism in patients who for one reason or another cannot use anticoagulant medication, or for whom such medication is ineffective. Some of these filters are intended to be left in place permanently, while others – so-called “retrievable filters” – are designed to be removed after the risk of pulmonary embolism has subsided.

Unfortunately, these devices have earned a reputation for developing dangerous complications. The FDA has collected many adverse event reports of IVC filters breaking apart or dislodging from their proper positions. Fragments of the filters and sometimes the filters themselves may migrate to the heart or lungs, potentially causing an embolism. Other patients have reported embolisms in the lower limbs, perforation of the vein wall, or occlusion of the inferior vena cava itself.

In August 2010, the FDA issued a safety communication advising physicians to remove retrievable IVC filters as soon as they are no longer needed to prevent pulmonary embolism, in order to prevent IVC filter complications. The agency expressed concern that many instances of IVC filter complications were related to leaving retrievable filters in place after they were no longer needed. Following further research, the agency confirmed and reiterated this warning in a second communication issued in May 2014.

IVC Filter Lawsuits

Several IVC filter lawsuits are now pending throughout the United States. In the fall of 2014, the U.S. Judicial Panel on Multidistrict Litigation transferred 27 IVC filter lawsuits against Cook Medical Inc. into a single multidistrict litigation, or MDL, to be handled in an Indiana federal court. An MDL is a procedural device used in the federal court system when a large number of individual lawsuits share common issues, as is common in large-scale products liability litigation.

Cook Medical manufactures the Celect and Gunther Tulip IVC filters. Plaintiffs in the MDL generally allege that in its design and manufacture of their IVC filters, Cook Medical engaged in defective design, misrepresentation, and failure to warn doctors and patients about IVC filter complications.

The Cook Medical MDL now consists of over 60 individual IVC filter lawsuits. It’s pending in the U.S. District Court for the Southern District of Indiana.

Other IVC filters manufactured by C.R. Bard have drawn similar claims. Bard has so far faced an estimated 200 IVC filter lawsuits over its Recovery and G2 IVC filters. The company has agreed to confidential settlements of many of these claims before they went to trial. No MDL for the Bard IVC filter lawsuits has been established yet.

The Cook Medical IVC Filter MDL is In re: Cook Medical Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation, MDL No. 2570, in the U.S. District Court for the Southern District of Indiana.