October 15, 2014 — Federal judges have issued an order (PDF) to centralize 27 lawsuits involving the Cook Medical IVC Filter into a Multi-District Litigation (MDL).
The U.S. Judicial Panel on Multi-District Litigation (JPML) has selected the U.S. District Court for the Southern District of Indiana. Cook Medical is headquartered in Indiana and more than half of the actions are already pending in the state.
Most of the lawsuits allege that the Günther Tulip and Celect filters are defectively designed:
“The subject actions share factual issues arising from allegations that defects in the design of Cook’s inferior vena cava (“IVC”) filters makes them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.”
Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel, and the judiciary.
Cook Medical opposed the MDL, arguing that “perforation and fracture are extremely rare occurrences” and the creation of an MDL will encourage a proliferation of meritless claims. Lawyers have also vowed to seek dismissal of claims based on the “learned intermediary doctrine,” arguing that doctors were adequately warned about the risks.
In 2012, a study involving 50 Günther Tulip and Celect IVC filters that were placed between July 2007 and May 2009 found that 86% perforated the inferior vena cava. All filters showed some degree of perforation after 71 days. In addition, 40% of filters tilted and perforated the vena cava.
In 2010, the FDA published a safety warning after receiving more than 900 adverse event reports involving temporary IVC filters that were not removed after a patient was not at risk of a pulmonary embolism.
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