The lawsuit was filed by Susan P., a woman who was implanted with the Cook Celect® Vena Cava Filter on August 17, 2015 at Mount Nittany Medical Center in State College, Pennsylvania.
Celect is one of two types of Inferior Vena Cava (IVC) filters manufactured by Cook Medical. The other is the Günther Tulip® IVC filter, which has been linked to high rates of tilting in the vein. A study in 2008 showed that 91% were tilted during retrieval attempts.
Cook tried to fix these issues on the Celect by adding 4 more sharp wire legs called “struts” to dig into the vein and prevent tilting. The problem is that these unprotected struts significantly increased the risk of Celect filters puncturing through the vein and into nearby organs.
In 2015, a study found that 43% of Celect filters punctured the vein in 2 months, on average, compared to 0% of Option IVC filters.
In 2012, another study of 120 Celect filters, 86% punctured the vein within 5 months, on average. Nine patients had at least one filter strut puncture their aorta, kidney, or duodenum. The researchers warned:
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 risk of side effects increases over time, which is why the FDA recommends removing “short-term” IVC filters as soon as the risk of blood clots subsides — ideally within 29-54 days. Even so, studies show that fewer than 30% are ever removed. Retrieval rates are higher at hospitals that follow up with patients to remove the filters.
Lawyers accuse Cook Medical of downplaying side effects, selling an unreasonably dangerous device, and failing to study it for safety.
The lawsuit was filed on March 11, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00762.
It will be centralized with around 1,500 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.