(John Disney/Daily Report)
An agreement with Endo International PLC to resolve thousands of lawsuits over transvaginal mesh devices is unlikely to sway other manufacturers to immediately settle, according to lawyers involved in the litigation.
The deal, estimated to be worth about $830 million, resolves 20,000 claims against Endo’s Minneapolis subsidiary, American Medical Systems Inc., the company said on April 30. The deal is the largest to come out of the mesh litigation—but that doesn’t mean other manufacturers are scrambling to craft their own agreements. In fact, two of the largest defendants—Johnson & Johnson and Boston Scientific Corp.—are preparing for trials this year.
“It’s going to be a busy year,” said Harry Bell of The Bell Law Firm in Charleston, W.Va., liaison co-counsel for the plaintiffs in the mesh litigation. “The landscape of TVM [transvaginal mesh] is going to be drastically different at the end of the year. We’ve already seen one huge change.” He referred to the AMS settlement.
AMS isn’t the first defendant to settle mesh cases. Coloplast Corp., which faces more than 1,200 lawsuits, announced on March 4 that it had “reached a settlement agreement in principle with a group of lawyers.”
But the AMS deal resolves the largest volume of cases. More than 40,000 lawsuits have targeted seven manufacturers alleging that mesh implants, designed to treat urinary incontinence and pelvic organ prolapse, have caused pain and bleeding and in, some cases, required additional surgeries to remove them.
On April 29, the U.S. Food and Drug Administration issued two proposed orders that would reclassify transvaginal mesh devices as “high risk.”
The AMS agreement aside, most of the manufacturers have taken a hard line.
“The official position of the other defendants—we’re talking about Bard, Ethicon, and Boston Scientific—is they are prepared to fight this,” Bell said. “They think their products, there’s nothing wrong with them, and they’re aggressively fighting and continuing to do so.”
Johnson & Johnson, whose Ethicon Inc. unit is named in more than 15,000 lawsuits, faces mounting pressure in mesh litigation. On Feb. 4, U.S. Magistrate Judge Cheryl Eifert in the Southern District of West Virginia sanctioned Ethicon for having lost or destroyed some documents and ordered that juries should be told about it—but she also concluded the actions weren’t negligent.
Consumer groups, taking up the sanctions order, have called upon the Justice Department and Congress to investigate. The Corporate Action Network, which has launched a campaign called www.JohnsonandJohnsonHurtsWomen.org, has called on chief executive officer Alex Gorsky, who previously headed the Ethicon unit, to stop making the implants.
Johnson & Johnson is scheduled to go to trial on July 7 in New Jersey state courts—although the date could be pushed back, given Atlantic County Superior Court Judge Carol Higbee’s temporary assignment to the appellate division.
Lead plaintiffs attorney Adam Slater, a partner at Mazie Slater Katz & Freeman in Roseland, N.J., said Johnson & Johnson has been among the most aggressive opponents. “The litigation has been much more contentious,” he said. “It’s hard fought litigation.”
On April 3, a jury in Dallas issued a $1.2 million verdict against Johnson & Johnson. . On Feb. 19, U.S. District Judge Joseph Goodwin, overseeing most of the mesh cases in the Southern District of West Virginia, tossed out the first federal trial over one of its mesh devices. A second trial is set for Aug. 25.
Boston Scientific, which faces more than 10,000 lawsuits, also has trials coming up. In federal court, Goodwin has scheduled a Sept. 29 trial for five women in Florida and an Oct. 14 trial involving 10 women in West Virginia.
“Until they come in with a serious substantial offer for my clients, we’re going to be prepared to go to trial,” Bell said.
It’s not just the defendants who are up for a fight. Although steering committees lead the litigation, plaintiffs attorneys have pursued cases independently. About a dozen firms with a combined 10,000 claims didn’t participate in the AMS agreement, said Joseph Rice, founding member of Motley Rice in Mount Pleasant, S.C., who led negotiations over the deal.
“This is not a global settlement,” he said. “This settlement probably resolves 80 percent of the cases that have been filed in the courthouse.”
Some attorneys, he said, just weren’t ready to settle. After all, AMS isn’t just writing blank checks. Under the agreement, the women must prove that it was AMS’s device—not another defendant’s—that caused their injuries.
That process could take at least nine months, Rice said. He acknowledged that many women could have trouble proving their pain is related to the mesh devices inside them.
“I’m certain the defendants feel there are a number of claims filed that have not suffered a present injury,” he said. “And I believe they’re right.”
Contact Amanda Bronstad at email@example.com.