Transvaginal mesh device manufacturer Endo International PLC has agreed to pay $830 million to settle thousands of lawsuits alleging that its devices caused pain and bleeding in women.
The agreement in principle, announced on Wednesday, resolves “a substantial majority” of the transvaginal mesh claims against its Minneapolis subsidiary, American Medical Systems Inc. (AMS). The company estimated the settlement would resolve 20,000 claims, although it was unclear whether that is the number of lawsuits filed.
Endo, which previously reserved $520 million for vaginal mesh claims, anticipated taking a $625 million pretax, noncash charge during its first quarter 2014. Its financials are due out on Thursday.
In a written statement, Endo said the settlement was “subject to final documentation” and “not in any way an admission of liability or fault.” Plaintiffs firms must verify that their clients had an AMS vaginal mesh product implanted and confirm certain medical records.
Joseph Rice, founding member of Motley Rice in Mount Pleasant, S.C., who negotiated with AMS on behalf of the plaintiffs, said the settlement could be available to 6,000 women.
“This settlement has been the result of adversarial but respectful and professional negotiation on the part of all of the parties,” he said in a prepared statement.
Endo is one of seven companies facing litigation alleging that its transvaginal mesh products, inserted into women to treat urinary incontinence and pelvic organ prolapse, caused bleeding and pain and, in some cases, subsequent removal surgeries.
Including those that just settled, more than 40,000 cases are pending, most before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia in Charleston.
On Tuesday, the last of a series of four bellwether cases against another defendant, C.R. Bard Inc., settled.
The settlement, which was referenced in a court order on Tuesday, came in a case brought by Carolyn Jones, a Mississippi woman who had one of Bard’s Avaulta line of products implanted. The case, which was filed in 2010 and sought punitive damages, was scheduled to go to trial on May 19.
“The court has been advised by counsel of the pending settlement of this action,” Goodwin wrote in an order asking the parties to file for dismissal within 60 days.
Plaintiffs attorney Henry Garrard III of Burlingame Burch Garrard & Ashley in Athens, Ga., did not respond to a request for comment, nor did a Bard spokeswoman or the company’s attorney, Lori Cohen, chairwoman of the pharmaceutical, medical device & health care practice at Greenberg Traurig in Atlanta.
More than 40,000 cases are pending, most before Goodwin.
Last year, a jury in the first federal court bellwether trial against Bard awarded $2 million. Bard settled the second case. The plaintiff voluntarily dismissed the third.
In the case of Jones, Garrard sought a continuance of a planned Jan. 10 trial after the wife of a witness was “urgently hospitalized.” Bard, meanwhile, has been fighting subpoenas against a former supplier of monofilaments used in its mesh products.
Goodwin has called for a new bellwether process that could resolve hundreds of cases at a time. Bard and lead plaintiffs attorneys are selecting 200 cases for bellwether trials that could begin next year.
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