It has been reported that Johnson and Johnson has agreed to pay $120 million to settle between 2,000 and 3,000 transvaginal mesh lawsuits filed by women who alleged that their mesh implants that were intended to treat pelvic organ prolapse and/or incontinence shrunk after being implanted in them, causing internal organ damage and leaving them in constant pain. Prior to the reported agreement to settle these mesh lawsuits, Johnson and Johnson, and its subsidiary Ethicon, had settled only a small number of the mesh lawsuits filed against them.
In response to reports of problems with transvaginal mesh implants, Johnson and Johnson had removed some of its mesh products from the market in June 2012. Johnson and Johnson has reported in regulatory filings that it faces approximately 42,400 additional mesh lawsuits; however, analysts believe that the recent agreement to settle several thousand mesh lawsuits is a significant step forward for Johnson and Johnson to resolve the remaining mesh claims (Johnson and Johnson reportedly paid $2.2 billion in total litigation expenses in 2013, $1.2 billion in 2014, and $141 million in 2015).
There are over six manufacturers of transvaginal mesh products that have faced lawsuits, including Johnson and Johnson (along with its Ethicon subsidiary), Boston Scientific Corporation, and C.R. Bard, Inc. Some of these other mesh manufacturers have settled their mesh claims, setting aside over $1 billion related to such claims.
While Johnson and Johnson and Ethicon have won some transvaginal mesh lawsuits filed against them, including a West Virginia mesh lawsuit in 2014, a jury in Philadelphia recently ordered Johnson and Johnson to pay the plaintiff $12.5 million in damages regarding her claim that her Prolift mesh that was manufactured by Ethicon injured her bladder. Juries in California, New Jersey, and Texas have also found against Johnson and Johnson and Ethicon in mesh lawsuits.
Other Mesh Manufacturers Have Also Settled Mesh Lawsuits
Boston Scientific Corporation agreed in April 2015 to pay $119 million to settle nearly 3,000 mesh claims but still faces 30,000 mesh lawsuits, as it reported in November 2015.
C. R. Bard, Inc. reportedly agreed in August 2015 to pay in excess of $200 million to settle at least 3,000 mesh claims filed against it, but reported in October 2015 that it still faces approximately 6,400 mesh lawsuits.
The FDA Continues To Respond To Transvaginal Mesh Concerns
On January 4, 2016, the FDA issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally. In one order, the FDA reclassified these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices. The second FDA order requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The FDA orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP and do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
If you or a family member were implanted with transvaginal mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your surgical mesh claim for you and represent you in a claim against the manufacturer, distributor, and/or supplier of the surgical mesh, if appropriate.
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