Monday, April 21, 2014
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A bad day for vaginal mesh implants

Thursday was a bad day for vaginal mesh implants and at least two of the many health-care companies that rely on the revenue from those devices.

A bad day for vaginal mesh implants

Thursday was a bad day for vaginal mesh implants and at least two of the companies that rely on the revenue from those devices - Johnson & Johnson and Endo Health Solutions.

A jury in Atlantic City ordered J&J to pay $7.8 million in punitive damages to a former hospice nurse for the pain and suffering she endured after using a vaginal mesh implant sold by J&J's Ethicon subsidiary. The verdict follows a $3.35 million award for compensatory damages, delivered Monday. J&J said it would appeal.

A link to the Inquirer story on that is here.

Meanwhile, Endo Health Solutions of Malvern announced Thursday it incurred big losses, due in part to a $640 million write down on the value of its American Medical Systems device division. A link to an Inquirer article on that is here.

AMS is focused on pelvic health problems, including vaginal mesh implants.

On April 11, 2011, Endo announced that it agreed to spend $2.9 billion to acquire AMS, including debt.

Endo suggested on its web site that 34 million women suffer from what is called prolapse, a condition in which organs near the pelvis sag and surrounding muscle weaken, often in the years after giving birth. Vaginal mesh implants were intended provide support.

J&J's Ethicon division introduced its Gynecare Prolift implant in 2005, but withdrew it from the market in 2012 amid reports of problems and lawsuits.

J&J faces about 1,800 lawsuits in New Jersey state courts alone. There are tens of thousands of lawsuits against multiple manufacturers of vaginal mesh implants in state and federal courts around the country. Endo was facing more than 2900 as of last fall.

The Food and Drug Administration issued warnings about vaginal mesh implants in October of 2008.

But in July of 2011, just a few months after Endo bought AMS, the FDA ramped up the concern. In January of 2012, the FDA ordered post-marketing surveys of vaginal mesh implant use to assess the problems, which is rarely a good sign for patients or companies.

The passage below is from the legal proceedings section of Endo's third-quarter 2012 financial report to the Securities and Exchange Commission. It explains the corporate woes for the AMS acquisition and Endo as a whole. The passage starts on page 40 and a link to the SEC filing is here.

Vaginal Mesh Cases

On October 20, 2008, the FDA issued a Public Health Notification regarding potential complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The notification provides recommendations and encourages physicians to seek specialized training in mesh procedures, to advise their patients about the risks associated with these procedures and to be diligent in diagnosing and reporting complications.

In July 2011, FDA issued an update to the October 2008 Public Health Notification regarding mesh to further advise the public and the medical community of the potential complications associated with transvaginal placement of surgical mesh to treat POP and SUI. In this July 2011 update, the FDA maintained that adverse events are not rare, as previously reported, and questioned the relative effectiveness of transvaginal mesh as a treatment for POP as compared to non-mesh surgical repair. The July 2011 notification continued to encourage physicians to seek specialized training in mesh procedures, to consider and to advise their patients about the risks associated with these procedures and to be diligent in diagnosing and reporting complications. FDA also convened an advisory panel which met on September 8-9, 2011 to further address the safety and effectiveness of transvaginal surgical mesh used to treat POP and SUI. At the conclusion of the meetings, the advisory panel recommended reclassifying transvaginal mesh products used to treat POP to Class III devices (premarket approval) and recommended that manufacturers of these products be required to conduct additional post-market surveillance studies. The advisory panel recommended that transvaginal surgical mesh products used to treat SUI remain as Class II devices. Regarding retropubic and transobturator (TOT) slings, the advisory panel recommended that no additional post-market surveillance studies are necessary. Regarding mini-slings, the advisory panel recommended premarket study for new devices and additional post-market surveillance studies. The advisory panel’s recommendations are now under consideration by FDA.

On January 3, 2012, the FDA ordered manufacturers of transvaginal surgical mesh used for pelvic organ prolapse and of single incision mini-slings for urinary incontinence, such as AMS, to conduct post-market safety studies and to monitor adverse event rates relating to the use of these products. These class-wide post-market study orders apply to eighteen AMS pelvic floor repair and mini-sling products. AMS is in the process of complying with these orders. In these orders, the FDA also noted that it is still considering the recommendation of the September 9, 2011 advisory committee that urogynecological surgical mesh for transvaginal repair of pelvic organ prolapse be reclassified from Class II to Class III.

Since 2008, AMS, and more recently, in certain cases the company or certain of its subsidiaries, have been named as defendants in multiple lawsuits in various federal and state courts, as well as in Canada, alleging personal injury resulting from use of transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs in these suits allege various personal injuries including chronic pain, incontinence and inability to control bowel function, and permanent deformities. On February 7, 2012, a multidistrict litigation (MDL) was formed, and cases pending in federal courts are now consolidated in the Southern District of West Virginia as part of MDL No. 2325. Similar cases in various state courts around the country are also currently pending. More specifically, as of October 30, 2012, approximately 2,960 mesh cases are currently pending against AMS and/or the Company or certain of its subsidiaries. Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. The majority of the currently pending cases are in the MDL.

In addition, we have been contacted regarding a civil investigation that has been initiated by a number of state attorneys general into mesh products, including transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence. We have not yet received a subpoena relating to this investigation, and at this time, we cannot predict or determine the outcome of this investigation or reasonably estimate the amount or range of amounts of fines or penalties, if any, that might result from a settlement or an adverse outcome from this investigation.

AMS and the Company intend to vigorously contest all currently pending cases and any future cases that may be brought, if any, and to explore other options as appropriate in the best interests of AMS and the Company. Nevertheless, we believe it is reasonably possible that the outcomes of such cases could result in losses in excess of insurance reimbursement levels that could have a material adverse effect on our business, financial condition, results of operations and cash flows. However, we are unable to estimate an amount of possible loss or range of possible loss in excess of the insurance reimbursement levels.

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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