On October 15, 2014, the Judicial Panel on Multidistrict Litigation (JPML) centralized 27 cases filed against Cook Medical 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, known as the IVC filter, is used to prevent blood clots from traveling into the lungs or the heart causing life-threatening blockages like pulmonary embolus. This medical device is implanted either surgically, or via a catheter through the blood vessels and is installed in the Inferior Vena Cava. The Inferior Vena Cava, or IVC, is the large, tube-like vein that brings blood from the patient’s legs and lower torso of the body into the chambers of the heart. Radiologists or surgeons implant the filters in patients after blood thinners or anticoagulants have not effectively reduced the patients’ risk of developing blood clots in the lower body.
During the procedure to implant the IVC filter, the radiologists or surgeons insert a catheter into either the internal jugular vein or the large femoral vein, depending on whether the neck or the groin allows easier placement. They then guide the catheter and filter through the blood vessels to the IVC using x-rays or an ultrasound. The catheter inserts the filter into the walls of the IVC
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, tears or holes in the vena cava and sometimes the aorta
- Movement of the metal device to the heart, which ultimately requires that patients undergo open heart surgery
- Embolization, the spread of filter pieces throughout the body, which embed themselves in the intestines, abdominal organs, or even the heart.
The affected products are:
- Cook Celect IVC filters
- Cook Tulip IVC filters
- Cook Platinum IVC filters
On August 9, 2010, the FDA released the article, “Removing Retrievable Inferior Vena Cava Filters: Initial Communication.” This release warned patients to be prompt in having their IVC filters removed from their bodies after their risk of clotting passed. When left in the body for too long, the filters pose life-threatening risks to patients. Recent medical studies have found that prolonged use of 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.
If you or a loved one may have been injured by an IVC filter, please contact our office today. All consultations are free of charge.