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Amid a growing number if IVC filter lawsuits filed against Cook Medical, a request has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish coordinated pretrial proceedings for the cases, centralizing the lawsuits before one judge as part of an MDL, or multidistrict litigation.
There are currently at least 27 Cook Celect IVC filter lawsuits or Cook Gunther Tulip IVC filter lawsuits that are pending in 11 different U.S. District Courts nationwide. All of the complaints involve similar allegations that the medical devices were defectively designed and caused users to experience complications after receiving the filters to reduce the risk of pulmonary embolism.
IVC filters, or inferior vena cava filters, are a treatment alternative used for patients who carry a risk of blood clots breaking off and travelling to the lung, which are often used when an anticoagulant is contraindicated or if such medications have not been effective.
The spider-like devices are inserted into the inferior vena cava, with a number of legs or struts that extend out to “catch” blood clots before they enter the lung. However, some IVC filters have been linked a risk of complications, where the legs or struts break off, or cause internal injury.
According to allegations raised in the lawsuits over the Cook IVC filters, a study was published in the medical journal Cardiovascular Interventional Radiology in April 2012, which found that 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.
In a motion (PDF) filed on July 21, attorneys for plaintiffs Lara and Keith Adams asked that an MDL be established for all Cook IVC filter lawsuits to reduce duplicative discovery across the growing number of similar cases, avoid conflicting rulings from different judges in different courts and to serve the convenience of the parties, witnesses and courts.
The Adams have asked that the Cook IVC filter litigation be transferred to the U.S. District Court for the Southern District of Indiana. The motion points out that not only is Cook Medical’s world headquarters located in that district, but that more than half of the related actions are already filed in that district as well.
IVC Filter Concerns
In August 2010, the FDA the FDA issued a warning about the risk of IVC filter complications, indicating that the agency had received more than 900 adverse events at that time involving problems where the filter broke free and travelled to other areas of the body or caused other injury.
The agency recommended that physicians consider removing retrievable IVC filters once the threat of a pulmonary embolism has passed, and urged caution in considering the benefits and health risks of IVC filters.
A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating 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.
In addition to lawsuits against Cook Medical, similar claims have been filed against C.R. Bard in recent years involving problems with the Bard Recovery IVC Filter and Bard G2 IVC Filters. According to allegations raised in the complaints, 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.