The lawsuit was filed by Caitlin G., a woman who was implanted with the Cook Günther Tulip® Vena Cava Filter on June 21, 2012 at Lehigh Valley Hospital (Cedar Crest) in Allentown, Pennsylvania.
The filter that was implanted in her body is one of the oldest on the market. Europe approved it as a permanent implant in 1992, about two decades after the first stainless steel IVC filters were invented.
Unlike older filters, Günther Tulip was made of Conichrome® and it had a hook at the tip to facilitate removal. Cook Medical saw an opportunity to sell it as both a permanent and “short-term” IVC filter.
In the United States, Tulip was approved as a permanent filter in October 2000. The FDA initially refused to approve it for retrieval, so Cook completed a 41-person study to assess retrieval within 14 days.
Only 26 (63%) were actually retrieved, one filter migrated to the patient’s heart, and 9 (21%) tilted in the vein after an average of 11 days. Based on that study, Tulip was approved for retrieval in October 2003.
Many of the same safety issues in that 41-person study have been identified in recent studies. Tilting is one of the most common hazards because the Tulip has only four wire “legs” anchoring it in the vein.
In 2008, a study found that 91% of Tulip filters were tilted during retrieval in 175 patients. The researchers warned that tilting “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing.”
Tilting also increases the risk of perforations through the vein. Tilting can allow the hook to become embedded in the vein and make retrieval impossible. In 2013, a study found that 69 of 160 Tulip filters (43%) perforated through the vein. The researchers noted that stainless steel Greenfield filters “had a significantly lower rate of IVC perforation.”
Cook Medical is accused of selling defective medical devices, downplaying side effects, and inadequately studying Tulip for safety. The lawsuit was filed on March 9, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00731.
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.