The federal court overseeing thousands of IVC filter lawsuits filed against Cook Medical, Inc. will allow plaintiffs to depose the company’s former president.
Plaintiffs had requested to depose Kem Hawkins in early 2017. He had been with Cook Medical for 34 years, and was president from 2001 until his retirement in 2015. In their filing, plaintiffs indicated that they wanted to question Hawkins about certain documents, including personal emails, that they assert show he was deeply involved in decisions regarding the testing, design, marketing, and production of the Gunther Tulip and Celect IVC filters.
Cook Medical’s attorneys filed a Motion for a Protective Order in April that sought to block the deposition. However, a Magistrate Judge in the U.S. District Court, Southern District of Indiana, denied the motion on June 30th, prompting the defendants to file an appeal with U.S. District Judge Richard L. Young on July 14th.
Judge Young rejected Cook Medical’s appeal in an Order dated September 13, 2017, writing that a review of the sealed documents showed that Hawkins was involved in “strategic decisions regarding the enhancement of the Tulip filter and the development of the Celect filter to increase market share. He was aware of the timetable for the Celect clinical trials and sought to speed up the process to get Celect on the market. Most importantly, the documents reflect that he was aware of the risk that both IVC filters could perforate the wall of the vena cava.”
Cook Medical’s Celect and Gunther Tulip IVC filters are implanted in the inferior vena cava, where they intercept blood clots before they can travel to the heart and lungs. They are indicated for use in patients who are at risk for pulmonary embolism, but who are unable to use standard blood-thinning medications. Both the Celect and Gunther Tulip filters are retrievable, and are designed to be removed once a patient is no longer at risk or blood clots.
More than 2,000 product liability lawsuits have been filed in the Southern District of Indiana by Plaintiffs who claim that Cook Medical’s Gunther and Celect devices are defectively designed and place recipients at risk for serious and potentially deadly IVC filter complications, including:
Among other things, the lawsuits cite a 2012 study which found that the Celect and Gunther Tulip filters exhibited some degree of inferior vena cava perforation in 100% of patients within 71 days of implantation. Full perforation occurred in 86% of observed cases. In 40% of patients, the filters tilted out of position.
Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. The first was issued in August 2010, and disclosed that the agency’s medical device database had logged more than 900 adverse event reports involving retrievable IVC filters, including reports of filter fracture, migration, and embolization.
In May 2014, the FDA reminded doctors to retrieve IVC filters as soon as medically possible to reduce the risk of patient harm.