Cook manufactures two types of retrievable IVC filters that have come under lots of scrutiny: the Gunther Tulip and the Cook Celect. Part of the problem is that while these filters are, in theory, retrievable, it’s not that easy in practice. Also, the longer the filter remains in place, the harder it is to remove.
This can lead to complications. The Gunther Tulip, which was introduced in 1992, features four legs and 12 filter wires designed to catch blood clots. The FDA approved the Cook Celect in 2008. Its hooks sometimes get embedded in the vena cava, inhibiting removal. After being in place for three to four months, the risks of complications from retrievable IVC filters increase. These complications can include:
- Filter migration
- Fractured filter (increasing difficulty of removal)
- Cardiac tamponade (pressure from heart from buildup of blood or other fluids)
- Chest pain
- Damage to organs
At the time of posting, at least 27 lawsuits involving IVC filters had been lodged against Cook Medical in 11 different districts. Plaintiffs hope to transfer all the litigation to one place, the U.S. District Court for the Southern District of Indiana. Cook Medical is based in Bloomington, Indiana. The company started in 1963 in the spare bedroom of founder Bill Cook. It focused on manufacturing devices for minimally invasive medicine. By the 1990s, Cook had become the biggest privately owned medical device manufacturer in the world. In 2008, Forbes ranked Cook as number 324 of America’s largest private companies.