Cook Medical Company Information
Cook Medical had a humble beginning. It started as Bill Cook designed an
innovative catheter in his apartment during the 1960s. By the 1970s, the
company grew to international levels and expanded its product offerings
to satisfy urological and women’s health needs. As the century turned,
Cook Medical established itself as the largest privately held medical
manufacturer in the country.
Besides its financial successes as a medical empire, the company has made
waves by publicly opposing the Affordable Care Act, which imposes a tax
on medical devices. Other problems facing Cook include lawsuits against
its transvaginal mesh devices.
Recalls Against Cook Medical Company
Like most major manufacturers in the medical industry, Cook Medical has
had to overcome a few recalls. On March 2011, the FDA issued the strongest
“Class I” recall for its central venous catheter instrument.
This product was used to monitor a patient’s venous pressure, collect
blood samples, and administer fluids and medication. According to documentation,
certain catheter trays and kits contained liquids that could cause the
devices to become desterilized.
More recently, the FDA issued a recall of Cook’s Zilver PTX Drug-Eluting
Stent. There were a number of complaints the unit’s delivering port
separated at the tip of the inner catheter. Under these circumstances,
it was necessary for a person to undergo surgery to have the tip removed.
Thrombosis and cardiac arrest were possible side effects as well. Cook’s
own investigation uncovered a part of the injection system used for implanting
the stent did not meet established design criteria.
Lawsuits Facing Cook Medical Company
Lawsuits have been filed against Zilver PTX stents. Multiple complaints
emerged stating the tips could separate before exiting the body. The company
admitted the problems stemmed from a defect in the delivery system. The
side effects of the faulty devices can be tragic. To receive compensation
for pain, suffering, and wrongful death, numerous victims filed claims
against Cook Medical.
A growing number of IVC filter lawsuits are mounting against Cook Medical
as well. These devices are treatment alternatives used in patients who
are at risk to have blood clots break off and head to the lungs. The spider-like
devices enter the inferior vena cava, and legs extend to “catch”
clots before they cause damage to other organs. Cook’s IVC filters
have been associated with numerous complications. It is alleged the devices’
legs break and cause internal injuries. A study published in “Cardiovascular
International Radiology” stated 100 percent of Cook’s IVC
filters caused perforations within 71 days of implantation. Another 40
percent tilted out of position. Victims claim Cook new about the faults
but never warned doctors. Many individuals underwent corrective surgeries
to remove the devices and are fighting for adequate compensation to cover
pain and suffering.
More serious lawsuits are emerging against Cook’s vaginal mesh products.
Over 40 cases have been filed against the manufacturer’s Surgisis
and Stratasis devices. Effected women fight these items are defective
and cause dangerous complications. One of the first lawsuits came from
a woman in Georgia claiming she suffered numerous infections and permanent
nerve damage from this mesh device and required corrective surgery.
The biggest difference between Cook’s transvaginal mesh devices and
similar offerings from other manufacturers is the material makeup. Cook’s
mesh slings are crafted from pig intestines, which the company touts as
safe and effective. However, numerous patients receiving these products
are at high risk of developing inflammation and adhesions. Plaintiffs
allege Cook misrepresented its products to the public. There were no warnings
about the potential dangers that come from using these devices.
Verdicts Against Cook Medical Company
Cook Medical faces over 100 lawsuits against women who suffered injuries
from the company’s vaginal mesh products. It is one of many major
manufacturers being sued over these type of devices. These mesh makers
have paid out millions of dollars to settle these kinds of cases, and
Cook is expected to experience the same fate. More than 50,000 claimants
against Cook are taking legal action.
FDA Sanctions Against Cook Medical Company
The FDA has issued sanctions against many manufacturers of transvaginal
mesh products. In 2011, the federal agency presented a health warning
about potential complications associated with surgical mesh procedures.
Cook expressed support for this ruling but urged the organization to perform
further examinations into its products and how they differ from the competition.
Cook explained its devices are biologic, which makes them safer than synthetic
products. However, certain doctors believe Cook’s devices are weaker
and cause more infections than synthetic products.
In October 2014, the FDA sent a warning letter to Cook Medical over problems
discovered during routine facility inspections. Its Bloomington, Indiana
plant manufactures vascular devices. Inspectors uncovered issues concerning
Cook’s corrective and preventative action procedures. Besides failing
to perform adequate quality tests on a representative sample size, it
did not use correct procedures to test materials received from an outsourced
company. Further inspections raised eyebrows as well. These forced Cook
Medical to push back anticipated complete dates for new plants.
The problems are just beginning to mount against Cook Medical. As more
and more victims come forward and claim injuries from the manufacturer’s
transvaginal mesh products, Cook is sure to be paying a high sum of money
for its negligent product. It appears this is not the end of financial
woes for the company. To fund the Affordable Care Act, Cook may be forced
to pay $20 million in taxes each year. This places its United States expansion
on hold. Its immediate plans are to focus on overseas growth.