Vaginal Mesh Manufacturers May Resolve All Claims– Great News for Women Who Had These Products Implanted

From Bloomberg News:

C.R. Bard 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.

Boston Scientific said in an August regulatory filing it faces more than 12,000 suits over its vaginal devices. Photographer: JB Reed/Bloomberg News

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.

50,000 Claims

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.

Following Process

“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.

‘Possibly Unfounded’

“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.

Trial Losses

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.

J&J Sales

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.

Settlement Architect

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.

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).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware atjfeeley@bloomberg.net; David Voreacos in Newark at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

 

Protecting Your Criminal History In A World of Misinformation

By Tab E. Lawhorn

Last year, I authored an article on how criminal background checks are used and what you can do to make sure yours is as clean as possible. One of the aspects of that article mentioned how third party data collection companies are profiting from selling background checks on individuals to employers, apartment managers, dating sites, and even schools.

Recently, I challenged an old arrest for a client of mine that was unique for one reason: even after getting a signed order from a judge removing the arrest, the old arrest still continued to appear on her criminal history. Not to be defeated, I challenged the Texas Department of Public Safety to properly remove the arrest according to the judge’s order. To my surprise, the TDPS explained that the arrest, in fact, was properly removed from the records of TDPS.

So why was the employer background check still showing an old arrest on my client’s criminal history? The results of my investigation were quite shocking.

The Texas Department of Public Safety, along with many other states, actually sell your information to third party data collection companies. These companies pay a hefty premium to offer “name” based background searches to anyone willing to pay their fee. No new news here. The problem is that if the database that was purchased is an old one, that is, if it doesn’t reflect any new changes to your criminal history, the third party company only has the rights to publish the old criminal history (unless they pay TDPS another fee for an updated database).

TDPS does send orders that expunge or make old arrests/convictions non-disclosable to these third party companies, but it usually takes months or even years for the companies to update their records on their own.

Even more alarming is that if these companies have sold their databases to other companies, there is no guarantee that they have forwarded any orders from the court or DPS to those purchasing companies.

The best way to ensure that an old arrest or conviction is removed from these subsequent third party data collection agencies is to send them each a certified copy of the court’s order directly, either from the clerk’s office or from your attorney’s office. Although it is time consuming and a little more costly, it is the most effective way to clean up your criminal history.

Tab Lawhorn is a criminal lawyer and partner at Derryberry Zips Wade Lawhorn, PLLC.  He lives in Tyler, Texas with his wife Zoe, his two loving dogs, Noodle and Fathead, and Mancat, his not-so-loving cat.  For a decade, he has fought for the rights of those individuals who have needed to clear up their past from criminal arrests and convictions.  He has carried his briefcase into courts from Los Angeles, California to Ben Wheeler, Texas (Population-400)–ensuring that people have clean records so they can live their lives accordingly.  He has founded YOURENOTGUILTY.COM and has been an active donor and community volunteer in East Texas ever since.

Bard Settles Second Bellweather Vaginal Mesh Case

Bard settles second bellwether mesh case after plaintiff verdict in first trial

Female-Patient-Doctor

By Courtney L. Davenport

Following a plaintiff verdict in the first transvaginal mesh bellwether trial in a federal MDL against C.R. Bard, Inc., the device maker settled the second bellwether case shortly after jury selection. About 4,400 suits are pending in that MDL, and about 25,400 federal suits are pending in MDLs against other mesh manufacturers. (In re C.R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187 (S.D. W. Va. Aug. 23, 2013).)

Last month, a jury awarded Donna Cisson and her husband $2 million, including $1.75 million in punitive damages, against Bard after transvaginal mesh implanted to treat pelvic organ prolapse (POP) eroded, causing bleeding, pain during intercourse, and bladder spasms and requiring additional surgeries. The Cissons alleged Bard defectively designed the mesh and failed to warn doctors when it learned of the risks.

Less than two weeks later, Bard settled with Wanda Queen and her husband for an undisclosed amount. Queen’s specific injuries were not disclosed in the complaint, but attorneys said that despite six corrective surgeries, her injuries are permanent.

Harry Bell of Charleston, W. Va., coliaison counsel in the MDLs, said the Cisson verdict may have prompted Bard to settle with the Queens because Queen’s case was even more egregious. But he does not know what impact the positive resolutions will have on the two remaining bellwether suits or the other MDL plaintiffs.

“From the perspective of the manufacturer, how’s it going to look to the public to have two adverse verdicts back to back and with the verdict amounts increasing? They made the decision they couldn’t take that risk,” he said. “Whether Bard makes the decision to settle [the others], one never knows. Bard has to be considering settlement considering the cases it is losing.”

Transvaginal mesh is surgically implanted in the vagina or abdomen to treat POP—in which the bladder, bowel, or other pelvic organs protrude into the vagina—and stress urinary incontinence. But shortly after it became popular in the late 2000s—in 2010 alone, mesh was implanted in 300,000 women—the FDA started receiving reports of serious injury when the mesh eroded, scraping tissue and protruding into the vagina or other organs, causing chronic pain, incontinence, infection, pain during intercourse, and other problems. Sufferers often require multiple surgeries to remove all of it. In 2011, the FDA warned that serious complications are “not rare” and advised that transvaginal mesh should not be used to treat POP, because it had not proved to be more effective than safer alternatives.

Thousands of mesh recipients and their families sued Bard; Johnson & Johnson subsidiary Ethicon, Inc.; American Medical Systems, Inc.; Boston Scientific Corp.; Coloplast Corp.; and Cook Medical, Inc. The suits allege the manufacturers did not test the defectively designed mesh before putting it on the market, nor did they properly train physicians. Federal MDLs were established against each defendant. State lawsuits are also pending against many of them, and at least two plaintiffs have obtained jury verdicts.

In July 2012, a California state court jury awarded Christine Scott—who suffers fecal incontinence and chronic pain and cannot have sexual relations after mesh eroded into her colon and vagina—and her husband $3.61 million against Bard. (Scott v. C.R. Bard, Inc., No. S-1500-CV-266034 (Cal., Kern Co. Super. July 24, 2012).) Earlier this year, a New Jersey court jury awarded Linda Gross and her husband $11.11 million against Ethicon. Gross underwent 18 surgeries to remove eroded mesh and permanently suffers such severe pain in her legs and pelvis that she cannot sit comfortably, be active for more than a few minutes, or have sexual intercourse. (Gross v. Ethicon, Inc., No. Atla-L-6966-10 (N.J., Atlantic Co. Super. Feb. 25, 2013).)

Bard asked that the court stay the other bellwether trials or certify an interlocutory appeal of an order in Cisson that excluded evidence of the FDA 510(k) device-approval process and the FDA’s decision not to recall Bard’s mesh devices. The judge has denied the request, holding that “I remain unconvinced that Bard is likely to succeed on the merits of any appeal related to the 510(k) issue” and that Bard will not be irreparably injured by waiting for the outcome of the remaining bellwether trials, the first of which is set to begin Oct. 8.

Derryberry Zips Wade Lawhorn, PLLC Announces the Settlement of Two Drunk Driving Cases

We obtained a settlement for a man and his 14 year old son who were hit by a drunk driver. The drunk driver’s insurance company paid the maximum policy limits that were available to settle the case. The drunk driver attempted to flee the scene of the wreck but our client, and a good Samaritan who witnessed the wreck, followed the drunk driver until the police could pull him over and arrest him. The drunk driver pled guilty to DWI, his second DWI.

We obtained another settlement for a man who was hit by a drunk driver. Our client’s vehicle was hit head on by the drunk driver and our client’s vehicle rolled over several times. The drunk driver’s insurance company paid the maximum policy limits that were available to settle the case. The drunk driver pled guilty to DWI.

Derryberry Zips Wade Lawhorn, PLLC continues to work each day to protect members of the community by holding responsible and accountable those individuals and corporations that violate safety rules that are designed to protect all members of a community.

Derryberry Zips Wade Lawhorn, PLLC Announces the Settlement of a Wrongful Death Case in May, 2013

Type of Case: Wrongful Death- Hospital Medical Negligence-Malpractice

A 28 year old young lady died as a result of the negligence of a hospital and its employees, including the nurses and hospital administrators. We were able to obtain a substantial confidential settlement for the young lady’s 4 year old son and her parents. The young lady suffocated to death because the nurses and hospital administrators ignored the doctor’s orders that a sitter be at her bedside at all times. Instead, she was left alone, rolled onto her stomach and was unable to turn back over onto her back. A hospital employee found the young lady lying face down and non-responsive. Autopsy results confirmed that she suffocated to death, an event which would not have occurred if the doctor’s orders had been followed by the nurses and hospital administrators.

We will continue to serve our clients and pursue those individuals and businesses that needlessly endanger all members of the community by violating basic safety rules that are designed to prevent harm to all members of the community.

Fosamax Fracture Trial Begins

Merck Knew of Fosamax Bone Risk in ’90, Lawyer Tells Jury
By Erik Larson – Apr 9, 2013 1:18 PM CT

Merck & Co. (MRK) was aware its Fosamax osteoporosis treatment might cause brittle bones and increase fracture risks years before the drug was made available to the public, a lawyer told a jury at the start of a lawsuit trial.

Starting in 1990, five years before Fosamax won approval by U.S. regulators, consultants began warning Merck that the drug could lead to spontaneous fractures in some users by preventing bones’ natural daily repair of so-called micro-fractures, Paul Pennock, the lawyer for plaintiff Bernadette Glynn, said today in federal court in Trenton, New Jersey.

“This company should have warned of the problems that they saw coming,” Pennock said in his opening statements to the jury, while holding a life-size replica of a thigh bone. “The company should have warned of the problems they learned actually were happening — that’s an obligation of the company.”

Merck, based in Whitehouse Station, New Jersey, faces about 3,300 femur-fracture suits. Glynn, 58, may the first such claimant to get a jury verdict, after an earlier lawsuit ended in mistrial last month. The case may be a bellwether revealing litigation strategy and potential damages awards.

The trial before the jury of three men and five women chosen yesterday is scheduled to last three weeks and will hear from medical experts on both sides of the dispute.

‘Theoretical’ Warnings
The second-biggest U.S. drugmaker denies the claims. Its lawyer, Chilton Varner, said the consultants’ early warnings were “theoretical” and that early studies showed people who took Fosamax instead of a placebo had fewer fractures.

Glynn, an elementary school worker from Cohoes, New York, who regularly takes long bike rides and yoga classes, claims Fosamax weakened her femur over a seven-year period, causing the leg bone to snap in April 2009, when she bent over in her garage to pick up a frog-shaped lawn ornament while gardening.

Glynn’s leg was repaired with surgery and the use of rods, according to her complaint. She and her husband, who sued in September 2011, appeared in court today with their children. She has never had osteoporosis and was prescribed the drug due to low bone-mass density, her lawyer said.

Merck claims Glynn’s fracture was the result of her bone condition, and that tests showed Fosamax had helped. Merck also claims Glynn broke her leg after tripping over a chain saw in her garage and falling down — a description Merck says she gave to emergency workers on the day of the accident.

‘Spontaneous Fractures’
“You might think from what you’ve heard this morning that Fosamax causes these spontaneous fractures,” Varner said in her opening statements. “Such fractures occur in people who have never taken Fosamax as well as people who have — such fractures have occurred long before Fosamax.”

Merck also denies claims that doctors and patients weren’t properly warned when the company learned of reports that Fosamax could cause so-called atypical femur fractures in some people — a warning that went on the drug’s label in 2009.

Merck also says that regardless of what was on the label and when, Glynn’s fracture wasn’t atypical, because the break was spiral in nature instead of straight across, the bone broke into more than two pieces, and the wound healed quickly. Varner also said that Fosamax doesn’t accumulate in the part of the bone that fractured in Glynn’s case.

Strongest Bones
Pennock said femurs, as the strongest bones in the body, usually only break in high-force incidents, such as car accidents, and not from falling down. Because Fosamax is designed to repair daily bone damage by stopping the natural clearing of old bone, the process results in micro-fractures building up instead of being naturally replaced, he said.

“The evidence is going to show you that it wasn’t a surprise — it wasn’t coming out of the blue,” he said of Merck’s discovery of Fosamax’s possible fracture risks. “They looked for it and studied it — when all the information starting coming in, they did nothing about it.”

The company faces another 1,230 cases alleging Fosamax caused similar fractures in jaws.

The case is Glynn v. Merck Sharp & Dohme Corp., 3:11- cv-05304, U.S. District Court, District of New Jersey (Trenton)

To contact the reporter on this story: Erik Larson in federal court in Trenton, New Jersey, at elarson4@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Jury finds for Plaintiff in J&J vaginal mesh trial

J&J Failed to Warn of Vaginal Mesh Risks, N.J. Jury Rules

By David Voreacos – Feb 25, 2013 10:28 AM CT.

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled.
Jurors ordered J&J to pay $3.35 million to Linda Gross, the nurse, and her husband. Linda Gross, 47, had 18 operations after the device was implanted.
The jury ruled that J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor.
The verdict in state court in Atlantic City came in the first of more than 2,100 lawsuits to go to trial over claims that Ethicon’s Gynecare Prolift injured women.
Gross claimed that J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations to her. Her lawyers said company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. She blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.
“We’ve established during this trial that this is something that never should have been sold,” Gross attorney Adam Slater told jurors in his summation on Feb. 15. “You had the words of the people at the company saying it shouldn’t have been sold. You saw them talking about that before it ever went on the market, that it was unreasonably dangerous.”
J&J claims the Prolift is safe and effective and it warned of the risks.
“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments.
Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.
The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).
To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net