Court Overseeing Cook Medical Blood Clot Filter Lawsuits Issues Protocol for Independent Medical Exams

Published on June 8, 2017 by Sandy Liebhard

IVC (inferior vena cava) filter lawsuits involving products manufactured by Cook Medical, Inc. continue to move forward in the U.S. District Court, Southern District of Indiana. According to a Case Management Order issued on June 7th, the parties have agreed on protocols governing independent medical exams for bellwether plaintiffs.

The Order indicates that the medical exams were requested by Cook Medical defendants. The Court agreed after finding that bellwether plaintiffs had put certain aspects of their physical condition at issue in their lawsuits. Among other things, the protocol stipulates that:

  • Cook Medical is entitled to two exams of each plaintiff, to be conducted by licensed health care professionals in an appropriate office and/or examination room.
  • The health care professionals are entitled to ask any questions that relate to plaintiffs’ prior medical histories, personal or family histories and any other conversation or investigation that they would normally engage in during their examinations.
  • They may conduct examinations of the plaintiffs related to their general health, cardiovascular system, gastrointestinal system, psychiatric state, etc.
  • No representative of Cook will be present at the exam. However, plaintiffs may bring one non-lawyer representative who can be present before, during, and after the examinations.

Cook Medical Bellwether Trials to Begin in October

Court documents indicate that 1,900 lawsuits are pending in the Southern District of Indiana, all of which were filed on behalf of individuals who suffered serious complications allegedly due to malfunction of Cook Medical’s Celect and Gunther Tulip IVC filters. The proceeding’s first bellwether trial is scheduled to begin on October 2, 2017, and is expected to provide some insight into how juries might rule in similar cases involving Cook Medical’s blood clot filters.

IVC filters are implanted in the inferior vena cava, where they are able to catch blood clots before they can travel to the heart and lungs. They are indicated for use in patients who are at risk for pulmonary embolism, but who are unable to use standard blood-thinning drugs. Both the Celect and Gunther Tulip filters are retrievable, and are designed to be removed once a patient is no longer at risk or blood clots.

Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. The first was issued in August 2010, and disclosed that the agency’s medical device database had logged hundreds of adverse event reports of involving serious IVC filter complications, including filter fracture, migration, and embolization.

In May 2014, the FDA reminded doctors to remove the blood clot filters as soon a patient no longer requires protection from blood clots.

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