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Endo’s AMS Unit Settles 20,000 Vaginal Mesh Cases for $830M

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Endo International announced it will pay roughly $830 million to resolve a large number of lawsuits filed by women claiming injury from its vaginal mesh implants.

Last year, Endo already agreed to pay $54 million to settle an unspecified number of cases. At the time, the company told Law 360, “The company and AMS intend to continue to vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”

Endo and its American Medical Systems (AMS) unit face over 25,000 lawsuits, but this settlement should cover most of these, Bloomberg reported.

“The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” company officials said in a statement. Though the company offered to settle, it did not admit liability or fault.

Women across the country received Endo’s mesh devices, including its Perigee, Apogee and Elevate, to treat stress urinary incontinence (SUI), pelvic organ prolapse (POP) and after hysterectomies. Lawsuits filed by injured women state that they suffered complications such as pelvic pain, device erosion, bleeding and painful intercourse.

In order to finalize the settlement, plaintiffs must fulfill certain requirements and are subject to verification of the implant and a medical records review.

Under the current terms, each woman included in the settlement will received about $40,000. However, women may seek more damages if they faced multiple surgeries for device removal, according to plaintiffs’ attorneys.

Additional Federal Lawsuits Still Pending

Additional lawsuits against Endo are still pending in a West Virginia federal court, under Judge Joseph Goodwin.

Other manufacturers also face tens of thousands of mesh lawsuits in federal court. As of April 15, the total number of federal mesh cases totaled over 49,000, while thousands remain unresolved in state courts.

C.R. Bard, Boston Scientific and Coloplast are among the companies in settlement talks. Coloplast already agreed to pay $16 million to settle about 400 of its claims in March. Under this agreement, each woman would receive $40,000.

Johnson & Johnson has yet to participate in settlement talks, though in April a Texas jury ordered it to pay $1.2 million to Linda Batiste, a woman injured by its TVT-O mesh sling. Batiste

The New Jersey-based company is under scrutiny for destroying internal documents pertaining to these products. At the April 2014 Johnsons & Johnsons shareholder meeting, women injured by the company’s Ethicon division mesh products appealed to J&J executives to investigate the case of the missing documents and resolve a number of injury claims.

FDA to Reclassify Mesh Devices

The Endo settlement comes hot on the heels of the U.S. Food and Drug Administration (FDA) announcement that it is seeking to reclassify many mesh devices from a class II device to a high risk class III.

In 2010 alone, U.S. doctors implanted about 70,000 vaginal mesh devices for prolapse and 195,000 for incontinence. If approved, the reclassification would require mesh manufacturers to submit proof of the safety and efficacy of their prolapse repair devices before selling them.

Currently, manufacturers only have to prove that a similar device is already on the market before gaining approval.

Previously, the agency ordered mesh manufacturers to conduct studies on the rates of complications linked to their products after lawsuits flooded in. J&J pulled four of its products from market in 2013 after it faced an increasing number of claims.

The announcement by the FDA that it will tighten regulations on devices may spur more settlement talks, according to Bloomberg.

Last modified: May 3, 2017

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Author

Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.

View Sources
  1. Dye, J. (2014, April 30). UPDATE 1 – Endo agrees to $830 mln settlement of vaginal-mesh cases. Reuters. Retrieved from http://www.reuters.com/article/2014/04/30/endo-mesh-settlement-idUSL2N0NM2V820140430
  2. Feeley, J. (2014, April 30). Endo pays $830 Million to Resolve Vaginal-Mesh Suits. Bloomberg. Retrieved from http://www.bloomberg.com/news/2014-04-30/endo-pays-830-million-to-resolve-vaginal-mesh-suits.html
  3. FDA. (2014, April 29). FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm
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