A Pennsylvania man has filed a lawsuit against Cook Medical claiming the company concealed the risks of IVC filters and falsely advertised its devices as safe. The man had one of Cook Medical’s IVC filters implanted in June 2012, but when doctors tried to remove the device, they discovered the device had tilted from its original position and completely perforated the inferior vena cava wall.
To make matters worse, the IVC filter had broken, causing small pieces of the device to travel into the man’s heart. Surgery to remove the pieces in the heart was unsuccessful and the man now suffers serious health problems.
This is one of thousands of reports of adverse events related to defective IVC filters. Cook Medical, C.R. Bard, Cordis Corporation, and Boston Scientific are all facing hundreds of lawsuits alleging the companies failed to adequately warn patients of the risks of IVC filters.
A study published in Cardiovascular and Interventional Radiology in 2012 found Cook’s IVC filters had tilted out of position in 40% of patients. The study also found full perforation of the inferior vena cava wall occurred in 86% of the patients and 100% of patients experienced some degree of perforation just 71 days after implantation.
Cook received approval for its IVC filters through the controversial 510(k) fast track approval process. This allowed the company to rely on clinical data from similar IVC filters trials to aid in approval. This approval process only required minimal testing of Cook’s devices before receiving approval.
Defective IVC filters have become a huge problem for Cook, who has seen a huge spike in lawsuits in the past year. The company is also facing lawsuits in Canada alleging similar allegations. The first of the lawsuits to come to trial will take place this September, and could help predict the outcome of lawsuits against other IVC filter manufacturers.