Earlier
this month, Endo International announced it had reached agreements to settle up
to 20,000 legal claims from women who said they were harmed by transvaginal
mesh devices, ending nearly all of the U.S. cases against it and its American
Medical Systems unit. The proposed settlement is valued at $400 Million.
Endo,
which did not admit liability, said it would increase the amount of money it
had set aside to cover vaginal mesh claims from $1.2 billion to approximately
$1.6 billion in connection with the latest agreements.
Earlier this year
in April, Endo announced it reached agreements to settle up to approximately
21,700 additional mesh claims. Last year, it settled an undisclosed number of
cases for $54.5 million. See my previous blog posts for more on those
settlements.
Transvaginal mesh manufacturers have faced a wave of litigation in the last few years over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The women suing the companies have accused the companies of selling subpar devices that caused injuries such as chronic pain, incontinence, bleeding and infection. Besides Endo, C.R. Bard Inc., and Johnson & Johnson's Ethicon are facing tens of thousands of lawsuits over similar products, with several trials scheduled for the fall.
Many of those cases have been
consolidated before U.S. District Judge Joseph Goodwin in the Southern District
of West Virginia, who is overseeing more than 60,000 mesh cases against seven
manufacturers.
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 manufacturers to conduct post-market safety
studies and monitor the rate at which adverse events were reported. The FDA
announced earlier this year it is considering a proposal to tighten safety
standards for mesh used to treat pelvic organ prolapse.
