Cook Medical is a manufacturer of medical devices and one division of the larger Cook Group, which also includes Allied Manufacturing and Affiliates. Cook is headquartered in Bloomington, Indiana and was founded in 1963 to make devices like catheters and needles. Today the company makes thousands of different medical devices and provides these to over 100 countries around the world.
Among its many successful products Cook has made a few that have been problematic. The transvaginal mesh and graft products used to treat urinary incontinence and pelvic organ prolapse as well as inferior vena cava (IVC) filters for catching blood clots before they cause harm, have caused serious complications in some patients. Cook has faced expensive lawsuits over these issues.
Cook Medical – Overview
Cook Medical has been around since 1963 and has spawned the huge Cook Group with several different products, property development services, polymer manufacturing, and other products and industries, amounting to 42 different companies. The entire group of companies was founded in Bloomington, Indiana, and the headquarters remain there today. The main offices in Bloomington employ nearly 2,500 people and the over 16,000 medical products are sold to facilities in over 135 countries.
Cook states that it is focused on developing and making medical products that are simpler and less invasive. As a private, family-owned company, Cook has the freedom to design the kinds of products it wants to provide to doctors and patients. Cook specializes in devices and products for gynecology, surgery, and interventional radiology, but makes products for many other areas of medicine and health care as well.
Some of the company’s problematic products have included transvaginal mesh, catheters, and IVC filters. The former has been found to cause erosion, organ perforation, infection, bleeding, pain, and other complications. The IVC filters and catheter tips have also caused perforation after migrating out of position. All three types of devices cause complications serious enough that surgery is typically needed to correct the damage.
Cook Medical’s founding happened in 1963 in the small apartment of Bill Cook. He used his spare bedroom to design and make medical devices including a brand new design for a catheter. Cook’s wife kept the books in her spare time, while he invented and constructed his new designs. From these humble beginnings grew the mega company that today is Cook Group and Cook Medical.
Cook’s products proved successful quickly and the company rapidly expanded throughout the U.S. and to other countries. By the 1970s the catheters were the company’s biggest success and were a part of thousands of surgeries every day. In the 1980s Cook started a research and development facility to further expand its product line. The company quickly added gynecological products, urology devices, and endoscopes to its line of catheters.
By the 1990s Cook had become the world’s largest private medical device company. It continued to grow, acquiring smaller companies and inventing more new devices. Not only is Cook today the largest private medical device maker in the world, it is one of the largest private companies in the U.S., worth billions of dollars. The current CEO is Carl Cook, the son of founder Bill Cook.
Transvaginal Mesh and Grafts
Transvaginal mesh is a product made by several different medical device companies. It is a surgical mesh that is sized to be inserted through the vagina and into the pelvic region to support the uterus, bladder, or bladder neck. This extra support is needed in some women with pelvic organ prolapse or stress urinary incontinence. With both conditions, tissues in the pelvic area have become too weak to support organs or hold urine in the bladder. The extra support from mesh helps to treat the conditions.
Using transvaginal mesh is a relatively new procedure. In the past these conditions were treated with mesh or bladder slings surgically inserted through abdominal incisions. The transvaginal procedure has been found to cause serious problems including bleeding, pain, infection, worsening of the original condition, erosion trough tissues, and perforation of tissues and organs. Follow up surgery is usually needed to correct these problems.
Cook Medical’s transvaginal mesh and graft products, unlike most made by other companies, are made from biomaterials, usually tissue from pigs. While the U.S. Food and Drug Administration issued a warning about all transvaginal mesh, Cook argued that their biomaterials were safer. According to those who have received them, though, Cook’s products have still caused cases of erosion and may be even more prone to infection and weakness than synthetic meshes.
IVC filters are medical devices inserted into the inferior vena cava, a vein in the leg that brings blood to the heart, to catch and filter out blood clots. Blood clots can be deadly. Although they form in the legs most often, they can travel through blood vessels to the lungs, heart, or brain, where they cause fatal blockages. People at risk for blood clots, such as those having surgery, often are given blood thinners to prevent the formation of clots.
For people who cannot take blood thinners, an IVC filter can be implanted to catch any clots that form before they move from the leg to the lungs or elsewhere. The problem with the filters is that certain brands, including those made by Cook, have been found to fail. These failed devices may come loose, puncture the vein, or even travel through the vein to another part of the body.
Two of Cook’s IVC filters were specifically mentioned in warning statements from the FDA: the Celect and the Gunther Tulip. These were designed to be removed from patients once the risk of blood clot formation had passed, but they have been found to cause a lot of perforations compared to other filters.
Beacon Tip Catheters
Catheters, long thin tubes used threaded through blood vessels, were the original Cook Medical devices. One particular product, the Beacon Tip Catheters for coronary angiography, have been found to be faulty. These catheters are threaded through blood vessels to the heart to inject die that allows X-rays to image the heart and surrounding blood vessels.
The problem with the catheters is that the tip can split and fracture. Most of the defective catheters were found and recalled before reaching patients, but 14 made it through and caused adverse events in patients. A broken tip from a catheter can travel through the blood vessels and cause a dangerous blockage. In the best case scenario, the tip has to be retrieved with an additional procedure or surgery.
Cook has faced a number of lawsuits for its faulty or dangerous products. Transvaginal mesh, which is now classified by the FDA as a high-risk medical product, has been the source of hundreds of lawsuits against Cook. The company is expected to settle these and is also facing multidistrict litigation and several lawsuits in state courts.
The IVC filters have also led to a number of lawsuits against Cook. Over 100 of these were collected together in multidistrict legislation to more efficiently settle them. Plaintiffs are accusing Cook of marketing and selling defective devices and failing to warn patients and doctors of risks. Negotiations are expected to be settled in September of 2016.