By Jef Feeley & David Voreacos - Sep 30, 2013 9:41 AM MT
Inc. and four other makers of vaginal-mesh implants accused of injuring women are in talks to settle thousands of lawsuits, people familiar with the discussions said.
Lawyers for Bard, Endo Health Solutions Inc. (ENDP), Boston Scientific Corp. (BSX) and two other companies making vaginal inserts to support women’s pelvic muscles and treat incontinence have begun talks about settling all suits over their products, the people familiar with the matter said. Johnson & Johnson, which also faces suits over the inserts, isn’t involved in the talks, said the people, who asked not to be identified because they weren’t authorized to speak publicly.
Patients’ lawyers want U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing federal suits targeting the implants, to appoint a settlement committee, the people said. The group would include plaintiffs’ lawyers Henry Garrard, lead counsel on the Bard cases, and Joe Rice, a lawyer who helped negotiate a $246 billion tobacco-litigation accord on behalf of state attorneys general, the people said.
“I know you all are considering settlement protocols and the possibility of resolutions,” Goodwin said at a Sept. 18 court hearing. He noted the talks were going on “behind the scenes.”
The discussions are aimed at resolving more than 30,000 implant suits already filed that have been consolidated before Goodwin for pre-trial information exchanges, the people said. The talks also include insert makers Coloplast A/S (COLOB) and Cook Medical Inc., they said.
The total number of suits could swell to more than 50,000 as more claimants seek to join the potential settlement, the people said.
“The liability seems pretty clear on these cases, so settlement makes sense,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in an interview. “Given how serious the injuries are and the number of cases, when you do the math, you can easily come up with a multibillion-dollar settlement.”
Scott Lowry, a spokesman for Murray Hill, New Jersey-based Bard, didn’t return a call and an e-mail seeking comment on the settlement talks. Ulla Lunhus, a Coloplast spokeswoman, said she couldn’t comment on the talks.
“We are following a process that is in accordance with U.S. law,” she said in a phone interview. “As long as that process is ongoing, we are not able to make any comment about it.”
Marsha Lovejoy, a spokeswoman for Bloomington, Indiana-based Cook; Peter Lucht, a spokesman for Natick, Massachusetts-based Boston Scientific; and Blaine Davis, a spokesman for Malvern, Pennsylvania-based Endo declined to comment on the talks.
Bard’s implants have been targeted in more than 12,000 cases while Boston Scientific said in an August regulatory filing it faces more than 12,000 suits over its vaginal devices.
Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, Davis said in an interview. Coloplast and Cook face about 1,000 claims combined, the people added.
J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing. Sheri Woodruff, a spokeswoman for the Ethicon unit of New Brunswick, New Jersey-based J&J, said it would be “inappropriate” to discuss litigation involving other manufacturers.
“Ethicon is now focusing on trying to efficiently manage thousands of unverified and possibly unfounded complaints,” Woodruff 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.”
Some manufacturers, such as Bard and Endo, already have settled some suits over the devices. Earlier this year, Endo officials paid $54.5 million to settle an unspecified number of cases alleging the company’s vaginal-mesh inserts were defective.
Coloplast, based in Humlebaek, Denmark, is the furthest along with talks to settle all of the more than 600 cases it faces over its vaginal implants, the people said. The company is aiming to resolve all litigation over the devices by the end of the year, they added.
Bard officials also have settled some vaginal-mesh cases after losing two trials over the devices. A California state court jury last year found Bard liable for a woman’s injuries related to an Avaulta implant in the first case to go trial in a U.S. court. Jurors said the company should pay $5.5 million in damages. Bard is liable for $3.6 million under that state’s law.
Goodwin presided at the first federal trial of claims over Bard’s Avaulta Plus vaginal mesh in August. A jury ordered the company to pay a total of $2 million in damages to a Georgia woman who said the device damaged her organs.
Bard officials pulled the Avaulta implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and pain during sex linked to their products.
Bard faces more than 8,000 federal claims over Avaulta, which women allege can cause organ damage and make sexual intercourse painful when the devices erode.
J&J, which opted out of settlement talks, has battled court claims against its withdrawn line of vaginal implants. A New Jersey jury ruled in February the company must pay $11.1 million in damages to a woman who blamed J&J’s Gynecare Prolift for her injuries. It was the first case over the devices to go to trial.
Officials of J&J’s Ethicon unit told Goodwin last year they would stop selling some vaginal implants after suits over the devices. The company’s executives have declined to participate in settlement talks, the people said.
“I expect Johnson & Johnson (JNJ) to discuss settlement when they think the time is right,” Adam Slater, a New Jersey lawyer who won the February verdict against the company over vaginal devices, said in an interview. Slater said he is preparing for his next trial in March 2014.
Goodwin said in the September hearing that he’s struggling to find ways to move the “mountain” of vaginal-mesh cases through the federal courts and is considering combining multiple plaintiffs’ claims for trial.
“I’m going to keep the bulldozer moving to deal with these cases,” he said.
Lawyers for women suing over the inserts have recommended that Goodwin tap plaintiff lawyers Garrard, Rice, Bryan Aylstock of Florida and Clayton Clark, a Texas-based litigator, for a settlement committee empowered to conduct talks with all mesh manufacturers, the people said.
Rice, one of the architects of the 1998 tobacco settlement, is known for his ability to put together accords in high-profile cases. Last year, the 59-year-old lawyer helped negotiate a now $9.6 billion settlement of suits against BP Plc (BP/) over the 2010 oil spill in the Gulf of Mexico. He declined to comment on his role in the vaginal-mesh talks.
The vaginal-mesh litigation poses a challenge for Rice and other settlement negotiators because they are faced with cases over more than 50 different implants manufactured by six different companies, the people said. Some of those products have been pulled from the market while others are still being implanted, they added.
Rice is focusing his attention first on cases involving American Medical Systems’ inserts, the people said. Ellen Reisman, a Los Angeles-based lawyer representing the device maker, was one of BP’s lawyers in Gulf oil spill settlement announced last year, they noted. Reisman was at the Sept. 18 hearing in West Virginia.
Coloplast rose 1.5 percent to 314 kroner ($56.98) in Copenhagen on news of the vaginal-mesh litigation settlement talks. The company’s shares have climbed 13.8 percent this year.
Boston Scientific also rose 1.4 percent to $11.68 in New York trading at 11:36 a.m. JNJ fell 4 cents to $86.69 while Bard fell 81 cents to $114.93. Endo rose 4 cents to $45.65 in Nasdaq trading.
The Bard consolidated cases are In re C.R. Bard Inc. (BCR) Pelvic Repair System Products Liability Litigation, 10-md-02187, U.S. District Court, Southern District of West Virginia (Charleston). The J&J consolidated cases are: In re Ethicon Pelvic Repair System Products Liability Litigation, 12-md-2327 U.S. District Court, Southern District of West Virginia (Charleston).