Endo Pharmaceuticals Reaches Settlement Agreement with Transvaginal Mesh Victims
On Tuesday, September 30th, Endo International Plc stated that the medical device manufacturer had agreed to a settlement involving 20,000 transvaginal mesh personal injury claims, ending all of the cases against its American Medical Systems unit, which were going to trial in a multidistrict litigation (MDL).
As part of the settlement terms, Endo does not admit liability for the transvaginal mesh damages, and said it would increase the amount of money that the company had set aside for victims – from $1.2 billion to $1.6 billion.
In April, Endo announced that it had reached agreements to settle 21,700 additional transvaginal mesh personal injury cases with separate plaintiffs’ law firms, for $830 million. In 2013, the company settled an undisclosed number of transvaginal mesh cases for $54.5 million.
The deal resolves the transvaginal mesh lawsuits for upwards of $48,000 per claimant.
“We believe these settlements will allow the AMS business to continue its return to growth and enhance focus on operations and profitability,” Chief Executive Officer Rajiv De Silva said in in the statement.
Transvaginal mesh was originally developed in 1996 and approved by the FDA for organ prolapse that caused vaginal pain and stress urinary incontinence. The original transvaginal mesh, Boston Scientific’s ProtoGen, was recalled in 1999, but due to an FDA approval loophole called 510(k) – which fast-tracks approval of devices similar to previously-approved devices – many other medical manufacturing companies began developing transvaginal mesh devices of their own.
Because of numerous complaints about the transvaginal mesh devices eroding, which can cause organ perforation, bleeding, infection, severe pain, and continued organ prolapse, the FDA ordered major transvaginal mesh manufacturers like Boston Scientific and Johnson & Johnson to study the devices’ effectiveness more in depth. Recently, the regulatory agency stated that it would not allow any more transvaginal mesh devices to use the 510(k) process, which allows medical devices substantially similar to previously-approved devices to get a “quick approval.” Transvaginal mesh devices today are based on one original device, the Gynecare ProLift, which was approved in 1996 but then recalled in 1999 because of the side effects.
Last fall, five of the six transvaginal mesh manufacturers agreed to begin settlement talks with plaintiffs. The only company so far that has not gone into settlement negotiations for its transvaginal mesh devices is Johnson & Johnson and its subsidiary, Ethicon. “Ethicon is now focusing on trying to efficiently manage thousands of unverified and possibly unfounded complaints,” Sheri Woodruff, a spokeswoman for the Ethicon unit of New Brunswick, New Jersey-based J&J, said in an e-mail. The company will “request dismissal of meritless claims, including claims with no compensable injury, claims barred by the statute of limitations, misfiled claims, and improperly filed claims.”
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, Transvaginal Mesh Injury can arise from vaginal mesh slings, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800