Cook Medical manufactures the Celect Vena Cava Filter. It was approved in 2008 under the FDA 510(k) approval process. This process is a short cut to getting approval for medical devices.
Manufacturers of new devices do not have to present new safety studies so long as the device is similar to another device on the market. Cook introduced the Celect as an improved version of the Günther Tulip IVC filter, which was approved in the 1990s.
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.
Cook Celect IVC Filter Litigation
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.
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.