Endo International has been providing health products for over a century.
Today, its global headquarters are located in Ireland, and its U.S. headquarters
remain in Pennsylvania. This manufacturer is divided into four major divisions;
American Medical Systems, Endo Pharmaceuticals, Paladin Labs, and Qualitest.
American Medical Systems deals with pelvic related devices, Endo Pharmaceuticals
provides branded drugs, Paladin Labs creates pharmaceutical products to
Canada and other emerging markets, and Qualitest produces generic and
Although the company is best known for Percocet, its narcotics painkiller,
it has manufactured a number of items, including testosterone therapy
products and vaginal mesh devices. In 2014, Endo acquired Paladin Labs
to accelerate its transformation into the leading specialty healthcare
company of the world. Despite these plans, the company continues to be
plagued by complaints and lawsuits.
Drugs or Devices Recalled by Endo
Through the years, Endo has faced a few product recalls. In 2012, they
involuntarily recalled their generic version of Vicoin. Certain bottles
were believed to contain extra high levels of painkillers that could be
hazardous to some patients’ health. The same year, it recalled its
GIA stapler system. Reports surfaced that surgeons had difficulties using
the devices during procedures, which could lead to patient injury or death.
Although many concerns have been expressed over Endo’s transvaginal
mesh and testosterone products, no recalls have been made to date.
Lawsuits Facing Endo International
In 2011, Endo Pharmaceuticals acquired American Medical Systems and became
responsible for all of its product liability. This has become a nightmare
for Endo, especially since AMS is a primary producer of transvaginal mesh
devices. Recently, the manufacturer has been pressed with questions about
the safety of these products, and a high number of lawsuits have followed.
The details of the cases are different, but most plaintiffs tell similar
stories. Women claim these products caused pain, organ damage, incontinence,
and sexual dysfunction. Many victims have had to undergo numerous corrective
surgeries to repair damage. Endo faced allegations it did not properly
design or test the safety of its mesh products. Also, the company failed
to warn doctors and patients about the accompanying health risks.
Thanks to the numerous lawsuits over its transvaginal mesh items, Endo
has lost a great deal of financial backing. It has been forced to cut
its workforce and place high hopes in recovering some revenue with its
testosterone products. However, this may be a questionable path. Unfortunately,
Endo International has been faced with actions against Fortesta, its testosterone
therapy gel. In 2014, a product liability lawsuit was filed claiming the
manufacturer failed to disclose dangerous side effects of the therapy.
Fortesta has been linked to a number of life-threatening side effects.
Males being treated may have an increased risk of developing a heart attack,
stroke, or blood clots. Plaintiffs allege the company aggressively marketed
its product for a nonexistent disease and used ads suggesting symptoms
associated with other conditions may be caused by low testosterone, which
prompt men to discuss this drug with doctors. However, side effects are
Despite the growing concerns surrounding Fortesta, Endo has recently been
approved to market another controversial testosterone drug. Aveed, one
of the latest drugs added to Endo’s offerings, brings concerns from
the public as well. The FDA responded with a statement that the organization
is constantly reviewing testosterone products, and there is no evidence
that proves Aveed brings greater risks than products already available.
However, labeling includes instructions Aveed can only be prescribed to
men who have been diagnosed with hypogonadism, a condition of low testosterone
caused by illness or injury.
In 2013, Endo Pharmaceuticals was part of a civil lawsuit over its Lidoderm
pain patch. Drogueria Betances Inc. claimed Endo violated federal antitrust
regulations for excluding generic competition of its patch. To battle
back, Endo filed a lawsuit against Actavis, a company awaiting approval
for a Lidoderm generic equivalent. Endo accused Actavis of infringing
on its patent. In the end, both companies agreed to stop competing for
a set amount of time. Also, Endo provided $96 million of Lidoderm for
free and an additional $240 million to be sold by Actavis and its subsidiaries.
Verdicts Against Endo International
Numerous pharmaceutical giants have been forced to pay billions of dollars
to victims over vaginal mesh products. American Medical Systems Inc.,
Endo’s offshoot, agreed to settle first claims against its mesh
products for $54.4 million. By May 2014, another $830 million agreement
was reached to settle over 20,000 more cases. In September 2014, Endo
stated it would release $1.6 billion to complete the payout and settle
the remaining litigation claims in this country. However, the manufacturer
never admitted liability.
FDA Sanctions Against Endo International
In 2014, the FDA issued a warning letter to Endo after an inspection was
performed at its Minnesota facility. The federal agency claimed the drug
manufacturer violated three regulations regarding the way it produces
some of its urological devices. In response, Endo explained its plan to
correct actions through 2015. The FDA accepted the terms but warned a
new inspection would be performed.
The first violation occurred as Endo did not adequately validate its manufacturing
processes and tests for certain devices. The second violation concerned
the way Endo designed its products. The FDA requires all manufacturers
to establish processes that validate product designs so that they conform
to how consumers use them. Endo failed to perform satisfactory risk analysis.
The last violation claimed Endo did not take corrective or preventative
measures concerning quality issues. The FDA accused the company of not
investigating the cause for the rising number of complaints related to
the problems caused by its products.
Upon the heels of the numerous lawsuits against vaginal mesh devices, the
FDA announced it would begin the process of reclassifying these products
as high risk class III. Back in 2010, over 265,000 units were placed in
women to treat prolapse and incontinence. The reclassification would require
manufacturers to submit proof of safety before placing products on the
market. As of now, manufacturers are only required to furnish proof that
similar devices are already being sold.