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Endo International

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 OTC products.

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 never mentioned.

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.

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