The two biggest players in the inferior vena cava device manufacturers include CR Bard and Cook Medical. As the number of inferior vena cava (IVC) filter lawsuits continue to climb, new research points to the Cook Celect filter for the high rate of strut perforations.
What are IVC Filters?
IVC filters are small metal devices inserted into the inferior vena cava, (a major vein) to prevent pulmonary embolism, a blood clot to the lung, after developing a blood clot in the leg or a deep vein thrombosis.
These spider-like devices have a number of legs or struts that trap blood clots and prevent them from moving to the lungs.
These retrievable IVC filters are designed to be removed once the risk of a pulmonary embolism has passed. Unfortunately many patients have reported severe side effects and perforations with IVC filters, where the devices puncture the vena cava or cause other serious or catastrophic injuries.
What is the Cook Celect Filter Perforation Problem?
Recently, researchers from Northwestern University and the University of Colorado compared the retrievability of two types of inferior vena cava filters, the Cook Celect and Rex Option filters.
The researchers found that the Cook Celect IVC filter perforation rate was higher, with a 43% incidence of strut perforation. In this latest study, researchers looked at IVC filters implanted in patients over a 33-month period, with 99 Celect and 86 Option filters reviewed.
Medical Studies: 100% Perforation
A 2012 study, in the medical journal Cardiovascular Interventional Radiology, reported that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall in less than 3 months of implantation. The study also reported that 40% of the filters became tilted and out of position.
A 2013 study, in the medical journal JAMA Internal Medicine questioned the effectiveness of IVC filters. JAMA reported that less than 10% of filters in the study were successfully removed and 8% of IVC filter patients suffered a pulmonary embolism while having the device.
In May 2014, the FDA announced a warning about removing IVC filters within one or two months after the blood clot risk has passed. The recommendations came hot on the heels of adverse event reports involving IVC filter perforation, migration, fracture, embolization, and difficulty removing the device.
In August 2010, the FDA first announced an alert about the risk of problems with IVC filters. According to the FDA, it had received more than 900 adverse event reports, including 328 where the IVC filter broke free and migrating through the body, 146 where components broke loose, 70 involving perforation of the inferior vena cava and 56 involved the filter fracturing.
IVC Filter Litigation
There are 102 Cook IVC filter lawsuits pending throughout the federal court system as of July 15, involving folks who have been injured by a Cook Celect or Gunther Tulip filter.
Similar personal injury claims have also been filed against C.R. Bard over two of their retrievable IVC filters, including the Bard G2 filter and Bard Recovery filter. The litigation raises similar allegations of design defects to those brought in Bard Recovery IVC filter lawsuits and Bard G2 IVC filter lawsuits, which have also been linked to reports of problems where the devices may fracture, migrate or perforate internal organs.
Since October 2014, the Cook IVC filter litigation has been centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana, as part of an MDL or multidistrict litigation.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) is currently considering whether to establish similar centralized proceedings for the Bard IVC filter litigation.
In recent trial in February, C.R. Bard reached a settlement agreement to resolve a personal injury and product liability lawsuit that claimed the plaintiff suffered severe heart injuries because of a Bard Recovery Inferior Vena Cava filter.
The trial took place in the U.S. District Court for the District of Nevada, in a lawsuit brought by Kevin Phillips, in which he blamed the IVC filter for breaking apart and puncturing his heart.
Details of the settlement agreement were not released and remains confidential. Bard has been quietly settling several Bard IVC Recovery and G2 lawsuits as they have been on the verge of trial. There are about 200 lawsuits filed over the Bard devices and many more are on the way as these devices continue to fail with alarming frequency.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.