Cook Medical is exposed to a personal injury and product liability claim by a Michigan man, who blames the Celect Inferior Vena Cava filter for causing severe injury when it broke apart and punctured his heart.
Larry and Brenda Johnson recently filed a lawsuit in the U.S. District Court for the Eastern District of Michigan, claiming that the filter used to prevent blood clots traveling from the legs to the lungs damaged his heart.
Johnson was implanted with the retrievable IVC filter to prevent blood clots from traveling to his lungs and causing a pulmonary embolism.
According to Johnson, he had to undergo four emergency heart surgeries before doctors discovered a thin wire had punctured his heart.
There are two major manufacturers of the Inferior Vena Cava (IVC) filters that have recently come under fire over their allegedly defective medical devices. The two big players in the device manufacturers include CR Bard and Cook Medical.
There are about 60 Cook IVC filter lawsuits filed throughout the federal court system, alleging problems with the Celect and Gunther Tulip filters.
In the fall of 2014, all Cook Celect and Cook Gunther Tulip lawsuits have been consolidated in the federal court system as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.
This Cook Celect litigation is similar to the design defects claimed in Bard Recovery IVC filter and Bard G2 IVC filter lawsuits. These IVC filters are made of fragile metal, which leads to premature fracture, migration or perforation of vital internal organs and blood vessels.
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.
Currently there is no federal MDL consolidation and centralization for the Bard IVC litigation, but according to sources an application for MDL status for pretrial discovery maybe forthcoming in the next few weeks, because of a lack of progress in a global settlement.
What’s the Problem with IVC Filters?
IVC filters, are inserted into the vena cava and act as an umbrella to prevent leg blood clots from travelling to the lungs when anticoagulant therapy is contraindicated because of bleeding or when the therapy has failed.
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.
The FDA issued a warning in 2010, about the risk of IVC filter devices, reporting that it had received hundreds of adverse event reports where filters broke free and migrated and caused perforation injuries.
In a stronger worded warning bulletin in May 2014, the FDA recommended doctors to remove IVC filters after the risk of a pulmonary embolism has passed.