March 2, 2016 ~ Facing billions in defective product lawsuits, Endo International will shut down its pelvic organ mesh unit, Astora Women’s Health, after a search for a buyer was unsuccessful.
Based in Eden Prarie, Minnesota, Astora will close March 31 to “reduce the potential for product liability related to future mesh implants." the company says. Endo is based in Dublin, Ireland where it enjoys a lower tax-base than it had in Pennsylvania, reports the Wall Street Journal.
Endo Health Solutions acquired women's urology products when it took over American Medical Systems (AMS) in 2011 for $2.9 billion. In doing so, it also acquired more than 22,000 lawsuits that claimed the polypropylene mesh was defective and doctors were not adequately warned about the complications associated with the mesh. Last year Endo sold the men’s health division to Boston Scientific for $1.6 billion, reports Fierce Medical Devices here.
By closing Astora, the company will limit its exposure to expensive lawsuits filed by women who were implanted with the AMS meshes.
AMS makes the Perigee, Elevate and Apogee transvaginal mesh (TVM) used to treat pelvic organ prolapse (POP), a common condition in women following pregnancy, due to weak collagen or as a result of aging. Apogee and Perigee are no longer for sale in the U.S. according to the AMS website.
AMS also makes the Sparc and Monarc slings to treat urinary incontinence, using a narrow strip or sling to support the urethra.
According to the company’s website the Apogee Vaginal Vault Prolapse Repair System and the Perigee Transobturator Anterior Prolapse Repair System are “not available for sale in the U.S.”
The company won the CE approval in Europe for a fecal incontinence mesh implant which recently won approval by an FDA expert panel.
In the company’s Securities and Exchange Commission filing in 2013, AMS said it plans to “vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”
The FDA recently announced that it would tighten regulations and required more stringent proof of safety and efficacy before mesh for pelvic organ prolapse could enter the market. The FDA gave mesh makers 30 months before it imposed the more stringent premarket approval or PMA, which is required of drugs. Currently mesh is classified as a moderate risk or class II device. The change will reclassify them as class III or higher risk.
Was On The Settlement Track
In June 2013, Endo Health Solutions Inc. agreed to pay $54.5 million to settle some outstanding lawsuits that have been filed by women who were implanted with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.
In March of the same year, the company announced it had put aside $520 million to cover the cost of litigation or settlement. Endo also recorded a pretax charge off about $316 million at the end of 2013 which brought its product liability fund to about $520 million.
In its SEC filing, Endo Health Solutions Inc. said that an estimated 500 million women worldwide may suffer from urinary or fecal incontinence and around 400,000 surgeries are performed around the world annually to correct some form of pelvic organ floor prolapse.
Endo Under Investigation by AG Office
Also in March 2013, in the Endo annual report released by the Securities and Exchange Commission, Endo admitted it had received subpoenas from several states investigating the overpayment for its pelvic mesh products. The California Attorney General’s office is one of those states which issued a subpoena to Endo.
Post-Approval Monitoring Ordered
In January 2012, the U.S. Food and Drug Administration ordered pelvic mesh makers of mesh for pelvic organ prolapse, to conduct post-approval monitoring on the rates of organ damage and complications among the women implanted with its transvaginal meshes used for pelvic organ prolapse.
AMS received 19 orders but had honed that down to sixteen “for various commercial reasons” it said in an SEC filing. The company then took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market and in doing so it relieved the company of the post-market monitoring. Ethicon, a division of Johnson & Johnson removed four meshes from the market in 2012 as well to obtain relief from the 522 orders as they are known within the FDA. #
Philadelphia Business Journal February 29, 2016 Endo shutting down its women’s health division, here
Moody’s Investors Service Feb 29, 2016 here
Mesh News Desk, March 2014, Endo Under Investigation, See background story here.
Mesh News Desk, Endo Offers $830 Million to Settle 20k AMS Pelvic Mesh Lawsuits, here
Reuters, Endo Agrees to $830 million to Settle Vaginal Mesh Cases, April 30, 2014 here
Mesh News Desk– Endo/ AMS set aside $520 Million to Settle, February 2014 here
Master Settlement, SEC filing, $54.5 Million, Freese & Goss, Matthews & Associates and AMS here
Mesh News Desk, June 21, 2013, Endo Agrees to Settle Some AMS Vaginal Mesh cases for $55 Million here