The lawsuit was filed by Joanna B., a woman from Florida who was implanted with the Cook Celect® Vena Cava Filter on December 13, 2014 at Physicians Regional Hospital in Naples, FL.
Celect is an intravenous medical device. It is implanted in the largest vein in the body to catch blood clots before they end up in the lungs.
The FDA approved Celect in April 2007 without requiring clinical trials. Cook Medical said Celect was “equivalent” to the Gunther Tulip, when in fact there were major design differences between the two devices.
The Gunther Tulip was plagued by high rates of tilting because it only had four “struts” anchoring it inside the vein. Cook Medical tried to fix tilting problems by adding four more unprotected struts on the Celect.
The trade-off for lowering tilting rates on the Celect was dramatically increasing rates of vein perforations, often within days of placement. Evidence of this serious design flaw was published in November 2007, just a few months after Celect was approved.
Doctors reported a Celect IVC filter that punctured through the vein into the patient’s pancreas within 9 days of placement. They compared it to the Gunther Tulip, and warned:
The new filter, unlike the older one, has unprotected primary struts. Only filters with an unprotected primary strut design have been associated with penetration injuries such as the one described in this case.”
Another recent study of 265 patients found that 39% of Celect filters punctured the vein within 30 days. By 90 days, 80% punctured the vein. Remarkably, 13% also punctured nearby organs (e.g., duodenum, aorta, muscle).
Tilting and vein perforations are usually asymptomatic, so patients may have no idea until their doctor is unable to remove the filter because it is stuck in the vein.
Unfortunately, there are many long-term risks of leaving short-term IVC filters implanted permanently. One of the most serious complications occurs when the entire filter or broken pieces travel to the heart or lungs and cause sudden death.
Lawyers accuse Cook Medical of selling a defectively-designed medical device with unreasonable risks. Cook is also accused of downplaying risks and inadequately studying Celect for safety.
The lawsuit was filed on March 15, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00795.
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.