Cook Celect, Gunther Tulip IVC Filters Lawsuits Heading to MDL

Recently many IVC filter lawsuits have been filed against Cook Medical, and the U.S. Judicial Panel on Multidistrict Litigation (JPML) is reviewing the federal cases for coordinated pretrial proceedings. If approved, then the lawsuits will be centralized before one judge as part of an MDL, or multidistrict litigation.

Cook Celect IVC Filter Litigation

There are at least 27 Cook Celect IVC filter or Cook Gunther Tulip IVC filter lawsuits that are filed in different U.S. District Courts across the country. The plaintiffs allege that the medical devices were defectively designed and caused patients to be injured after receiving the filters. The filters are designed to reduce the risk of pulmonary embolism (blood clot in the lung) following a deep vein thrombosis or blood clot in the legs.

Inferior vena cava filters (IVC), are implantable medical devices used in patients who are at high risk of pulmonary embolism. The devices are used when anticoagulant medication is contraindicated, usually because of bleeding problems.

The metallic devices are implanted in the inferior vena cava, with a number of struts that extend out to trap blood clots before they can travel up to the lung. Some IVC filters are associated with metallic failure, where the struts break off, causing perforation of major blood vessels, strokes and deadly bleeding if the struts puncture blood vessels.

Medical Adverse Studies

According to a study published in the Cardiovascular Interventional Radiology in April 2012, 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal caval wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.

A study published in the JAMA Internal Medicine in March 2013 demonstrated that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

Benefits of MDL

The establishment of multidistrict litigation for all Cook IVC filter lawsuits is designed to reduce discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and courts.

The MDL motion requests that the Cook IVC filter litigation be transferred to the U.S. District Court for the Southern District of Indiana. Cook Medical’s world headquarters located in that district, and more than 50% of the lawsuits are already filed there.

FDA IVC Filter Warnings

In August 2010, the FDA issued a warning about the risk of IVC filter complications, stressing that they had received more than 900 adverse events, where the filter failed, travelled to other areas of the body and caused severe injuries.

The FDA recommended that doctors remove retrievable IVC filters and urged caution in implanting IVC filters.

Bard IVC Filter Lawsuits

Similar IVC filter injury claims have been filed against C.R. Bard, the manufacturer of the Bard Recovery IVC Filter and Bard G2 IVC Filters. According to plaintiff allegations, Bard knew for years that their IVC filters were prone to fracture, which can cause severe complications, including death, but failed to warn doctors and patients.