Cook IVC Filter Litigation
The first inferior vena cava (IVC) filter lawsuits against Cook Medical will be tried as bellwether cases next month, and may set the tone for similar cases filed against C.R. Bard that will begin in mid-2017.
The Cook IVC multidistrict litigation (MDL) was established in October 2014 in the Southern District of Indiana. The lawsuits consolidated into the MDL make similar allegations:
- Cook Medical failed to inform patients that IVC filters are prone to breakage, tilting, and migration from the initial insertion position.
- Filters that migrate may puncture the lungs, heart, or inferior vena cava, and cause serious and even fatal injuries.
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. They 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 approximately 2,000 filters were implanted in patients in the U.S. in 1979, by 1990, over 120,000 IVC filters had been placed. At the end of the decade, nearly 50,000 IVC filters were being implanted each year.
Adverse Event Reports Lead to IVC Filter Lawsuits
Since 2005, the U.S. Food and Drug Administration (FDA) has received more than 900 reports of adverse events connected to IVC filters. According to the FDA, the majority of IVC filters are not retrieved despite the risk of increased fracture, embolism, and IVC wall penetration.
Common complications associated with IVC filters 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
A 2013 JAMA Internal Medicine report noted that an attempt is made to remove only about 10.5 percent of all IVC filters implanted, and concluded that this low retrieval rate, combined with other factors, resulted in less-than-optimal outcomes due to high rates of venous thromboembolism (VTE).