Monthly Archives: October 2013

Endo Health offers $54.5 million to settle some vaginal mesh cases

Endo Health offers $54.5 million to settle some vaginal mesh cases

(Reuters) – A unit of Endo Pharmaceuticals Inc said it has agreed to pay $54.5 million to settle some of the thousands of lawsuits in North America that it is facing over injury claims stemming from the use of transvaginal surgical mesh products.

Endo unit American Medical Systems Inc announced the settlement in a regulatory filing with the U.S. Securities and Exchange Commission on Thursday. The company did not disclose how many cases would be resolved by the agreement, in which the company did not admit any liability or fault.

AMS estimated its potential liability as of March 31 from all current and future vaginal mesh cases to be at least $160 million, according to another SEC filing. Settlement details were not disclosed.

AMS is one of several companies facing thousands of lawsuits over transvaginal mesh devices in U.S. state and federal courts, as well as Canada. The devices are designed to treat pelvic organ prolapse and stress urinary incontinence.

Market data submitted to the FDA showed that in 2010, approximately 300,000 women underwent surgery for pelvic organ prolapse, and roughly one in three of those used mesh. That same year, about 260,000 women underwent surgery for stress urinary incontinence, 80 percent of which involved transvaginal mesh.

Plaintiffs in the lawsuits have alleged a variety of injuries stemming from the devices, including chronic pain and incontinence.

In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other transvaginal device makers to conduct post-market safety studies and monitor the rate at which adverse events were reported.

AMS said it has been hit with thousands of lawsuits since 2008 and expects the number to climb, according to a regulatory filing from May. As of April 26, there were approximately 7,700 mesh cases pending against AMS, Endo and certain subsidiaries,  an SEC filing said.

A spokesman for Endo did not immediately return a request for comment Friday.

Shares in Endo were down .32 percent or 12 cents to $37.38 in late afternoon trade.

NaturaLyte and GranuFlo

FMC says U.S. wrongful death lawsuits to be consolidated

Reuters | Thu Dec 13, 2012 1:57am EST

Dec 13 (Reuters) – Fresenius Medical Care , the world’s largest dialysis group, said a group of plaintiffs in the United States had moved to consolidate wrongful death lawsuits against the company over its NaturaLyte and GranuFlo products.

The suits generally allege that the two products carried inadequate labeling and warnings, causing harm to patients, FMC said, adding that it considered the suits to be without merit and was vigorously defending against them.

The company’s chief executive Ben Lipps said in a statement that FMC’s actions related to the products were appropriate and responsible.

“Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago,” he said.

“I am confident of our position on this medical issue,” he said.

FMC’s North American subsidiary received a subpoena from the Massachusetts district attorney on Dec. 7 requesting documents in the case and was cooperating fully, the company said.