A year-and-a-half ago, Cook Medical faced approximately 100 IVC filter lawsuits, but as of now, more than 1,000 defective product cases have been filed against the company, and at least one will go to trial in the coming year.
The lawsuits against Cook Medical have been consolidated in the U.S. District Court in the Southern District of Indiana, MDL 2570, and three bellwether cases have been selected for trial. Two of these cases involve allegations concerning the Celect IVC filter, and the other relates to the Günther Tulip IVC filter.
What are IVC Filters?
IVC filters are medical devices placed between the proximal vessels of the lower extremities and the right side of the heart to help prevent pulmonary embolism by catching blood clots and preventing them from traveling to the lungs. Over the past 30 years, the use of the IVC filter has steadily increased. While around 2,000 filters were implanted in patients in the U.S. in 1979, by 1990, over 120,000 IVC filters had been placed, and at the end of the decade, nearly 50,000 IVC filters were being implanted each year.
Since 2005, the U.S. Food and Drug Administration (FDA) has received hundreds of reports of adverse events connected to IVC filters. Common complications associated with IVC filters that have been left in the body for long periods of time include:
• The progression of DVT
• Recurrent PE
• Filter migration
• Tilt, break, or embolism
• IVC perforation or occlusion
In 2010, the FDA warned that retrievable filter posed risks of filter fracture, device migration, and organ perforation, and should be removed as soon as the patient’s risk for blood clots had subsided. In 2014, the FDA updated this safety communication, stating that most devices should be removed between the 29th and 54th day after implantation, but according to the agency, the majority of IVC filters are not retrieved, and their benefits continue to make them a frequent choice for doctors and patients, despite the risk of increased fracture, embolism, and IVC wall penetration.