At 29,000 and Counting, When Will TVM Lawsuits End?

Charleston, WVThe number of women who have filed an AMS transvaginal mesh lawsuit against manufacturer American Medical Systems Inc. (AMS) and its parent company Endo Health Solutions (ENDP) Inc. (Endo), is now above 5,000. However, that’s just a drop in the bucket compared to the over 29,000 lawsuits filed against various manufacturers of transvaginal mesh products.

According to Bloomberg News (6/20/13), lawsuits alleging erosion and other complications with regard to TVM mesh - including AMS mesh - have been consolidated before US District Judge Joseph Goodwin in Charleston, West Virginia. Given the vast number of lawsuits (29,000), consolidation is a natural response to such a high number of cases.

However, it is also interesting to note that of the more than 30 manufacturers that were actively churning out TVM mesh products at the time the US Food and Drug Administration (FDA) ordered manufacturers to conduct post-market studies of their products, only four are at the center of the 29,000 lawsuits consolidated in multidistrict litigation.

AMS transvaginal mesh, through its parent company Endo, is one of those four. Earlier this year, AMS agreed to create a $54.5 million fund in order to settle a collection of AMS tvm lawsuits. The settlement, announced as part of an AMS securities filing released June 20, 2013, relates to plaintiffs who alleged complications from AMS transvaginal mesh products Perigree, Apogee and Elevate mesh implants.

The settlement, according to Bloomberg News, does not include the majority of the 5,000 lawsuits currently consolidated in multidistrict litigation.

In its filing with the US Securities and Exchange Commission (SEC) in June, AMS noted that the first AMS case to go to trial in federal court is scheduled for December. Beyond that, AMS would only say that the company intends “to vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise,” with the AMS lawyers.

The AMS legal situation surrounding allegations of AMS transvaginal mesh injury is proving to put performance pressure on the company and its parent, Endo. The latter acquired AMS for $2.9 billion in 2011. Since the purchase, Moody’s Investors Service lowered its outlook this past spring on Endo due to the company’s increasing exposure to AMS transvaginal mesh lawsuits.

There could be more coming, given the number of women who have been treated with TVM mesh for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

According to market data filed with the FDA for the year 2010, 260,000 women in the US suffering from SUI underwent surgery. Of those, surgeons in 80 percent of the cases employed transvaginal mesh. That same year, some 300,000 women underwent surgical treatment for POP. Of those, about a third received TVM mesh from various manufacturers.

Historically, POP and SUI were treated by way of major surgical procedures using a patient’s own tissue to stitch a sling into place to help yield wayward pelvic organs. In recent years, however, the use of TVM mesh has fulfilled more recent trends toward less-invasive surgery that speeds healing and frees up hospital beds, by the insertion of TVM mesh through a small incision to shore up sagging organs.

However, the number of women who have encountered serious complications from mesh eroding, migrating, becoming intertwined with vital organs and even piercing the vaginal canal have numbered in the thousands, prompting the FDA in August 2011 to identify mesh products as carrying a high risk for complication and adverse reaction, and that the use of transvaginal mesh for the treatment of SUI and POP is no longer, in the view of the FDA, the safest option.

According to a report from Reuters (6/20/13), AMS estimated its potential liability from all current and future AMS transvaginal mesh lawsuits to be at least $160 million as at March 31 of this year.