Cook Medical manufactures medical devices for a number of medical needs, including gynecology. A number of women filed lawsuits against the company over its transvaginal mesh products, and people are starting to accuse the company's retrievable IVC filters of causing injuries.
Cook Medical is the world’s largest private medical device manufacturer and one of three divisions that form Cook Group Incorporated, a 42-company conglomerate. Each of Cook Group’s divisions, which also include Allied Manufacturing and Cook Group Affiliates, owns several subsidiary companies.
Cook Medical develops and manufactures minimally invasive medical devices for a variety of specialties, including surgery, gynecology and interventional radiology. It is a global supplier of approximately 16,000 products, including heart stents, living-tissue transplants and urological equipment. The company serves 13 hospital chains in 135 countries and brings in $1.8 billion in annual sales.
One type of product Cook Medical manufactures is the pelvic floor graft, which doctors implant in women who suffer from stress urinary incontinence or pelvic organ prolapse. Several of Cook’s graft devices have been added to multidistrict litigation (MDL) involving more than 70,000 personal injury claims related to transvaginal mesh and similar products.
Inferior vena cava (IVC) filters manufactured by Cook are also giving people problems. The devices are designed to prevent blood clots from reaching the lungs, but they can fracture or migrate inside the body. Fractures and migrations can cause serious health problems, leading a number of people to file lawsuits against Cook.
Cook Medical has also made headlines as a highly vocal opponent of a provision in the Affordable Care Act. The company fought to repeal a newly imposed tax on medical devices that would help pay for the law, saying that it would stop expansion and force American jobs overseas.
History of Cook Medical
From all accounts, Cook Medical had humble beginnings. The business started out in the early 1960s in the small apartment of medical device inventor Bill Cook. In a spare bedroom, Cook developed a new catheter design during the day while his wife, Gayle, performed quality control and bookkeeping at night.
|Fast Facts about Cook Medical|
|Founder: Bill Cook|
|CEO: Carl Cook|
|Headquarters: Bloomington, Ind.|
|Size: 2,478 employees|
|2014 Sales: Approximately $1.8 billion|
In the 1970s, Cook Medical experienced startling growth. The business expanded to Asia and Europe, and by the end of the decade shipped enough products for doctors to perform 2,000 cardiovascular catheterizations per day.
Cook Medical established MED Institute, a research and development facility, in the 1980s. It allowed the company to meet the growing demand for products in various other specialties, including urology, endoscopy and women’s health.
In the 1990s, Cook Medical earned the distinction of world’s largest privately held medical device manufacturer. It added numerous other companies to its family and introduced the world’s first intravascular coronary stent.
After building a highly successful medical empire, Bill and Gayle Cook became well-known billionaires and Indiana-area celebrities. In 2002, the Cooks nearly sold Cook Medical to Guidant, a manufacturer of cardiovascular devices. However, the deal fell apart and they decided to keep the company privately owned. Guidant was later acquired by another device manufacturer, Boston Scientific.
Forbes Magazine has listed the Cook Group as one of the largest private companies in the United States. Bill Cook died in 2011 from congestive heart failure, leaving behind a $3.1 billion fortune. His son Carl Cook is the current CEO of Cook Group.
Cook Medical Transvaginal Graft Products
Unlike most transvaginal products used to treat pelvic organ prolapse and stress urinary incontinence, Cook Medical’s devices are made with biologic rather than synthetic materials. Cook developed a dermis-based device made with biomaterials derived from the small intestine of pigs.
|Transvaginal Graft Products Made By Cook Medical|
|Biodesign Urethral Sling||Surgisis Urethral Sling|
|Biodesign Tension-Free Urethral Sling||Surgisis Tension-Free Urethral Sling|
|Biodesign Anterior Pelvic Floor Graft||Surgisis Anterior Pelvic Floor Graft|
|Biodesign Posterior Pelvic Floor Graft||Surgisis Posterior Pelvic Floor Graft|
|Biodesign 1-Layer Tissue Graft||Surgisis 1-Layer Tissue Graft|
|Biodesign 4-Layer Tissue Graft||Surgisis 4-Layer Tissue Graft|
|Biodesign 8-Layer Tissue Graft||Surgisis 8-Layer Tissue Graft|
|Biodesign Vaginal Erosion Repair Graft||Surgisis Vaginal Erosion Repair Graft|
|Biodesign Peyronie’s Repair Graft||Surgisis Peyronie’s Repair Graft|
|Stratasis Urethral Sling|
In 2011, the U.S. Food and Drug Administration (FDA) issued a health alert warning over potential complications with some surgical mesh procedures. Cook even issued a press release expressing support for the FDA — with a caveat. The manufacturer urged the FDA to perform additional analysis of its products compared with synthetic mesh devices made by its competitors. Cook asserted that its devices were biologic, and therefore safer than synthetic devices.
But according to affected patients and some doctors, Cook’s biologics have been found to be weaker and more infection-prone than synthetic mesh. Women filing lawsuits against Cook Medical have reported many of the same devastating complications of transvaginal mesh, like severe pain, vaginal erosion and infection in the pelvic region.
Transvaginal Mesh Lawsuits
Cook Medical currently faces about 300 lawsuits from women who claim they suffered injuries because of the company’s tissue graft products. In late 2013, Cook was named among five other vaginal device manufacturers said to be negotiating settlements for personal injury claims filed against them.
About 75,000 federal lawsuits have been consolidated before a single judge in West Virginia for more efficient handling, including hundreds against Cook Medical. Analysts predict the total number of claims in the multidistrict litigation could continue to climb as more claimants come forward with hopes of receiving a settlement. Cook Medical also faces hundreds of claims in state courts.
Cook’s IVC Filters
When patients at risk for developing blood clots can’t take anticoagulants (blood-thinners), doctors may resort to medical devices to keep clots away from the heart or lungs. Doctors insert IVC filters into a vein between the legs and heart. The filters are supposed to block a clot from reaching the vital organs.
Cook manufactured and marketed two devices that were meant to be retrievable: the Gunther Tulip and the Celect filter. The FDA warned retrievable filters posed risks to patients and should be removed as soon as necessary.
A study also found the Cook devices had high rates of perforation in which they pierced the wall of the vein they were implanted in. They also migrated from their original position at high rates.
People harmed by the devices accused Cook of negligence, failing to warn of risks and designing faulty devices. In 2014, more than 100 lawsuits against Cook Medical were consolidated into a multidistrict litigation court.
The Future of Cook Medical
In late 2013, Cook Medical made headlines for fighting a provision in the Affordable Care Act that places excise taxes on medical devices. The 2.3 percent tax on device purchases was projected to raise nearly $30 billion over the next decade to pay for the health care plan.
However, Cook Medical was one of many device makers arguing that the tax will hurt them. The company claims the tax will cost the company roughly $20 million per year that will put expansion plans in the Midwest United States on hold. Cook says it will focus on growth overseas and continue fighting to have the tax repealed.