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A Master Consolidated Complaint for Individual Claims has been filed in the Cook Medical federal multidistrict litigation (MDL) court in Indianapolis. The Master Complaint will potentially increase efficiency in handling the cases, which make similar allegations.

The consolidated complaint filed for Cook IVC Filter cases makes the following allegations:

• Cook IVC Filters are associated with an increased risk for serious injury and death resulting from filter tilting, perforation, fracture, breakage, and migration.
• Cook Medical failed to act regarding the known failures and injuries associated with these devices, and failed to warn, concealed, suppressed, omitted, or misrepresented the risks, dangers, defects, and disadvantages of its IVC filters.
• Cook was negligent in its advertising, labeling, promotion, marketing, sales, and distribution of IVC filters, presenting them as safe when the company had reason to know or did know that the devices caused serious injury and death.
• Cook is strictly liable for injuries caused by its IVC filters because the devices are unreasonably dangerous and not accompanied by adequate warnings.

What are IVC Filters?

Inferior vena cava (IVC) filters are used to avert pulmonary embolism (PE), a potentially preventable cause of death in hospitalized and other high-risk patients. The probability of PE increases with the development of deep vein thrombosis (DVT), and the treatment for both PE and DVT is anticoagulation, but in circumstances when blood thinners are not appropriate, an IVC filter is used instead.

The first IVC filters were permanent stainless steel versions, followed by temporary filters fastened to the skin to allow for direct removal without ensnaring. These filters were used in hospitalized patients for a short period of time before they had to be removed.

Currently, the U.S. Food and Drug Administration (FDA) has approved eight optionally retrievable filters, including The Cook Celect and Günther Tulip. Unlike previous temporary filters, optional filters do not need to be tethered to the skin and have a lower rate of infection. They do not have to be removed within a few days, and may be left in place indefinitely, removed when they are no longer needed.