Pharmaceutical

Pennsylvania Woman Files Lawsuit Over Cook Medical IVC Filter

IVC filter 294x210 Pennsylvania Woman Files Lawsuit Over Cook Medical IVC FilterPennsylvania resident Caitlin G. was implanted with an inferior vena cava (IVC) filter on June 21, 2012, when she was found to be at risk for a blood clot. At Lehigh Valley Hospital in Allentown, the Günther Tulip, made by Cook Medical, was implanted. However, Caitlin was left with injuries that led her to file a lawsuit against Cook on March 9, 2017, alleging the filter failed and resulted in her injuries. Her lawsuit has been added to 1,500 similar lawsuits pending in a multi-district litigation.

The Günther Tulip is one of the oldest IVC filter models still on the market. Different from other filters on the market during that time because of its Conichrome construction, the Günther Tulip was approved in Europe as a permanent filter in 1992. It was also one of the first filters to include a hook at the top for removal.

When the Günther Tulip first made its way into the United States, it was rejected by the FDA as a retrievable filter. Cook Medical conducted a study with 41 patients to prove that it was safely removable. But after a period of 11 days, only 63 percent were able to be retrieved successfully. One filter migrated to the patient’s heart, and nine of the filters tilted into a position that rendered it irretrievable.

Although the Günther Tulip was approved as a permanent filter, issues still continue to be reported, including tilting and perforating. A 2008 study of 175 Günther Tulip recipients found that 91 percent of filters were tilted. According to researchers, tilting “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing.”

Tilting also increases the risk of perforation. When the filter doesn’t remain in its upright position, the filter legs can become embedded in the vein, and even puncture the vein, impaling nearby veins or organs. A 2013 study found that 43 percent of implanted Günther Tulip filters perforated completely through the vein. Researchers compared the Conichrome design to a Greenfield filter made of stainless steel, concluding that the Greenfields “had a significantly lower rate of IVC perforation.”

Source: Daily Hornet