The lawsuit was filed by Peggy R., a woman who was implanted with the Cook Celect® Vena Cava Filter on May 24, 2010 at Bethesda TriHealth Good Samaritan Hospital in Cincinnati, Ohio.
In December 2012, doctors in Ohio published one of the most interesting studies of Celect IVC filter retrievals in the Journal of Vascular and Interventional Radiology.
The study highlighted a number of safety concerns — low retrieval rates, high rates of vein penetration with the risk increasing over time, penetrations causing serious complications, and failed retrievals.
There were 620 patients implanted with a Celect filter at the Cleveland Clinic in Ohio between September 2007 and January 2012. Only 120 patients (19.3%) came back to have it removed. Of those filters, 12% could not be removed after being implanted for 5 months, on average.
The study found a remarkably high rate of vein penetration — 86% of Celect filters had at least one needle-like leg puncturing through the wall of the inferior vena cava. Nine patients had filter legs penetrating into nearby organs like the intestines, aorta, or kidney. The researchers concluded:
This study showed a high penetration rate for Celect IVC filters. … Penetration appears to correlate with indwelling time, suggesting that the filter should be removed as soon as [Pulmonary Embolism] protection is no longer indicated.”
The study also found that 77% of Celect filters migrated out of position. Migration was often associated with vein penetration. Vein penetration is a well-recognized side effect of cone-shaped filters — and especially the Celect. In another study, researchers blamed a stiff leg in the Celect filter for frequent vein penetrations.
The problem is that the walls of the inferior vena cava are incredibly thin because it carries blood under very low blood pressure. The vein also flexes as it pulsates with blood, which is why it is so common for perforations to occur as the filter’s legs dig into the vein.
Filter tilt is another well-recognized risk of Celect IVC filters. The legs create a relatively stable base, but the hook at the tip floats freely without support. Over time, IVC filters tend to move to a more stable position — often tilting with the hook digging into the wall of the vein. It is a common reason for failed retrievals.
Cook Medical is accused of selling a defective medical device with “unreasonably dangerous” side effects. Lawyers also accuse the company of failing to warn patients and doctors about safety risks.
The lawsuit was filed on January 26, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00267.
It will be centralized with over 1,370 other IVC filter lawsuits now pending in Multi-District Litigation (MDL No. 2570)— In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices, and Products Liability Litigation.
The plaintiff is represented by Ben C. Martin and Thomas Wm. Arbon of The Law Offices of Ben C. Martin.
Ben C. Martin is a trial attorney based in Dallas, Texas who serves as the plaintiffs’ co-lead counsel in the Cook IVC Filter MDL.