Cook Group, Inc., one of the industry leading manufacturers of inferior vena cava (IVC) filters, has come under fire over the company’s Celect and Gunther Tulip filters, which plaintiffs allege are defective and responsible for causing severe injuries.
Over a hundred Cook IVC filter lawsuits filed in the federal court system have been consolidated as part of a multidistrict litigation (MDL) centralized in the Southern District of Indiana before U.S. District Court Judge Richard L. Young. The lawsuits all raise similar allegations, which claim that design defects in the metal filters led to premature fracture, migration, or perforation of internal organs and blood vessels. For its part, Cook says that problems with its IVC filters are extremely rare and even when issues do occur, the company is not at fault. We disagree and seek to hold culpable defendants accountable for the injuries and damages they have caused.
What are IVC Filters?
IVC filters are a treatment option for patients who have a risk of blood clots developing in the veins of the leg or pelvis and large pieces breaking off and traveling to the lung, but for whom an anticoagulant is contraindicated or has not been effective.
The spider-like IVC filters are inserted into the inferior vena cava, where the legs or “struts” extend out to catch blood clots before they can enter the lung. However, IVC filters have been linked to a number of complications when the struts break off or cause internal injury, requiring medical procedures to remove the filters.
Warnings Regarding IVC Filter Complications
In August 2010, the U.S. Food and Drug Administration (FDA) issued a warning about the risks of IVC filter complications after the agency received more than 900 adverse event reports regarding instances where the filter broke free, travelled to other areas of the body, and caused injury:
- 328 reports involved the filter breaking free and migrating through the body.
- 146 reports involved components breaking loose.
- 70 reports involved the IVC being perforated.
- 56 reports detailed the fracturing of the filters.
The FDA recommended that physicians consider removing retrievable IVC filters once the threat of pulmonary embolism had passed, and urged medical practitioners to consider the risks and benefits of IVC filters when recommending their use.