On October 15, 2014, with the Judicial Panel on Multidistrict Litigation (JPML) centralized 27 cases filed against Cook Medical centralized in the U.S. District Court for the Southern District of Indiana. These cases allege that Bard’s IVC filter design and warnings are defective.
The inferior vena cava filter (IVC filter) is a medical device that is surgically implanted into the inferior vena cava, which is a larger blood vessel that runs from the abdomen into the heart and returns blood from the lower half of the body. The device prevents blood clots, or thombi, from traveling to the heart and lungs by filtering the clots from the blood. Interventional radiologists or vascular surgeons implant the devices in patients when anti-coagulant and blood-thinning drugs do not effectively reduce the patients’ risk of developing blood clots in the lower body. During the IVC filter procedure, the radiologists or surgeons insert a catheter into the blood vessel located in the neck or groin. They then guide the catheter into the IVC using an ultrasound or fluoroscope. The catheter inserts the filter into the IVC by attaching it to the walls of the vein.
For some patients, the device fails to work properly and migrates from the site where it was implanted. This migration causes serious problems, including:
- Perforations, meaning holes in the vena cava and sometimes the aorta,
- Movement of the metal device to the heart, which usually requires that patients undergo open heart surgery, and
- Embolization, meaning the spread of filter pieces throughout the body, which embed themselves in organs, usually the heart.
The target products are:
- Cook Celect IVC filters
- Cook Tulip IVC filters
- Cook Platinum IVC filters
The FDA issued a warning on August 9, 2010 entitled, “Removing Retrievable Inferior Vena Cava Filters: Initial Communication.” The FDA warned patients to avoid leaving IVC filters in their bodies for extended periods of time, because the devices tend to cause life threatening problems. Recent medical studies have found that the device is not safe because it often erodes and pierces the vena cava.
Defendant Cook Group Incorporated is a privately held company based in Bloomington, Indiana, which primarily manufactures medical devices.
Patients have currently filed at least 32 complaints against Cook Medical nationwide. On October 15, 2014, the Judicial Panel on Multidistrict Litigation (JPML) consolidated these cases before Judge Richard Young of the Southern District of Indiana.