To date, more than 87,000 transvaginal mesh lawsuits have been filed in the U.S., making pelvic mesh litigation the largest and most complicated mass tort action in history. In fact, one of four civil cases in the U.S. today deals with pelvic mesh.
The cases involve seven different manufacturers, and have been consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia under Judge Joseph Goodwin.
Lawsuits against mesh manufacturers began cropping up more than 10 years ago. Almost 4,000 injuries were reported to the U.S. Food and Drug Administration between 2005 and 2010. These complaints involved complications from mesh inserts used in pelvic organ prolapse (POP) surgery, including pelvic pain, bleeding, organ damage, infection and urinary problems. In January 2012, the FDA ordered mesh manufacturers to perform safety studies on their products.
In January 2016, the FDA reclassified transvaginal mesh as a high-risk medical device and ordered manufacturers to address safety concerns by submitting new applications that demonstrate their products are safe and effective. These new requirements apply only to mesh products used to repair POP in women.
Following a number of verdicts in favor of plaintiffs in pelvic mesh suits, Judge Goodwin urged manufacturers to cut their losses and settle claims. To date, the following settlements have been announced:
American Medical Systems — announced a settlement of $54.4 million for an unspecific number of claims in June 2013 and another settlement of $830 million to settle approximately 20,000 claims in May 2014.
C.R. Bard — after losing individual mesh lawsuits in 2012 and 2013, the company announced its first major settlement of $21 million to resolve 500 suits. In 2015, Bard announced a $200 million settlement to settle 3,000 lawsuits.
Boston Scientific — announced that it would pay $119 million to settle approximately 3,000 cases in April 2015.
Coloplast — paid $16 million in 2014 to settle 400 lawsuits.
Ethicon (Johnson & Johnson) — one of the last defendants to settle, the company announced it would pay $120 million to settle up to 3,000 suits in January 2016. A recent regulatory filing with the Securities and Exchange Commission notes that J&J has set aside an undisclosed reserve for additional claims.
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