Cook Medical, a division of Cook Group, Inc., is one of the world’s largest privately-held medical device companies. Its products include transvaginal mesh for use in the surgical repair of pelvic organ prolapse and stress urinary incontinence, as well as retrievable IVC filters for patients at risk for pulmonary embolism.
Cook Medical was founded in 1963 by Bill Cook, an inventor of medical devices, and his wife, Gayle, in the spare bedroom of the Bloomington, Indiana, apartment they shared. The company was the first to market the three primary components for percutaneous catheterization— needles, wire guides, and catheters —in a single convenient set. By the end of the 1970s, Cook Medical had shipped enough catheters to allow doctors to perform 2,000 cardiovascular catheterizations per day.
In the 1980s, Cook established a research and development facility called the MED Institute in response to the growing demand for medical devices, especially in underserved practices areas like gastrointestinal endoscopy, urology and women’s health. In the 1990s, the company introduced the world’s first intravascular coronary stent. During that decade, Cook Medical also gained distinction as the world’s largest privately-held medical device manufacturer.
Today, Cook Medical boasts more than 2,470 employees, and reported over $1 billion in sales in 2014. Bill Cook died in 2011. His son, Carl, currently serves as CEO of Cook Group.
In 2011, the U.S. Food & Drug Administration (FDA) issued a warning regarding the high rate of complications associated with transvaginal mesh devices used to treat pelvic organ prolapse and stress urinary incontinence. Since then, tens of thousands of lawsuits have been filed against the manufacturers of these products, including hundreds that name Cook Medical as a defendant. In 2013, it was reported that Cook was engaged in talks to settle these claims.
Cook Medical currently faces hundreds of lawsuits involving its Celect and Gunther Tulip retrievable IVC filter products. Such devices are implanted into the inferior vena cava of patients who are at risk for pulmonary embolism. However, plaintiffs claim that Cook’s blood clot filters are prone to fracture, migration and tilting, which may lead to punctures of the inferior vena cava and other potentially deadly complications.
Since 2010, the FDA has issued two alerts regarding the importance of timely IVC filter retrieval, warning that failure to do so once the threat of pulmonary embolism has passed increases the risk for serious complications. Several studies have also suggested that the Cook IVC filters are associated with high rates of malfunction.
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