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

 

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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.

What can I do when my child has been arrested or is in trouble at school?

By Tab Lawhorn, Member of Derryberry Zips Wade Lawhorn, PLLC

As my flight left the slick run way headed for home, I couldn’t help but notice that the woman next to me was in severe distress.  It has been raining for days, and the beads of water were glistening off the tiny window next to her in such a way that it made it impossible to clearly see the wing of the 727.  I kindly offered a few words of encouragement about the safety of flying and the weather, when she explained that she wasn’t afraid to fly.  Ten thousand feet later, she started to tell me that her son was arrested at school and she didn’t know what to do.

When a child is in trouble at school, parents often think that their child has all the same rights as a criminal defendant.  They don’t.  Often times, kids will have punishment and disciplinary records that will follow them until they graduate.  Even a simple accusation by another student can turn a reprimand by a teacher into a police investigation.  Whether your child is only facing administrative punishment from the school, or if they are facing criminal charges from the State, you can arm yourself with these important steps to greatly increase your chances of helping your child both legally and administratively.

1. Call your attorney.

  If you don’t have an attorney, then call me.  My initial consultation for you and your child is free.  If you don’t call me, then at least call a lawyer who has experience in juvenile law and has worked with school administrations and their policies.  Many parents I’ve talked to, including the one on the plane that day, all have a sense of helplessness simply because they just don’t have the vital information that a competent lawyer can provide.  I’ve seen a parent’s anger towards their child turn into embarrassment and frustration right before my eyes, and many times, these emotions are unnecessary once they get the information they need about the rights of their child.

2.  Read your child’s student handbook.

Sounds crazy right?  Believe me, there is a reason that schools are required to have one and issue it to their students.  If your child wasn’t handed an actual printed book, then you can always find a copy on your school district’s website.  For example, the Tyler ISD student handbook can be found here.  The most important parts of the handbook address punishment.  For example, the administrative rules regarding punishment that are in place by your school district have different appeal procedures depending on who administered the punishment.  Let’s say your child was wrongfully accused by a teacher, the handbook would give a deadline by which you could appeal that punishment and accusation to the vice principal.  There may even be additional levels of appealing punishment all the way to the school board–which acts like the supreme court on all decisions of discipline.  Many school districts divide up punishment by levels and this information would be contained in your child’s handbook.  I once had a case where my client, a 9 year old girl who was wrongfully accused of stealing a cell phone, had her punishment upheld at every level until we finally had the school board vote to remove her punishment and restore her school records.  It was a hard fought victory indeed, but one that would not have been possible if the parents had not read the handbook and complied with the deadlines for appealing the punishment.

3.  Listen to your child.

When you first confront your child about a discipline violation at school, don’t be the one that does all the talking.  Sometimes the best information I gather about an incident at school comes from me just simply letting a child tell her side of the story.

Kids will often retreat into silence or not be truthful when they feel threatened about an incident at school. Remember to listen to your child about an incident at school.

We often assume that children do not share the same sense of right and wrong that adults do and that can lead us to discredit their version of an incident, even if they are trying to tell the truth.  This is a terrible mistake.  That doesn’t mean that we leave our common sense at the door and believe everything a child says, but if your child knows that you are willing to listen to them, then they will often times shoot you straight.  If you scream at them, they will say almost anything to get you to stop, including admitting to something they didn’t do.  School officials make this mistake all the time.

4.  Don’t assume that school officials are on your side.  Many times, a school rule violation can also be a crime.  If your child takes a gun to school, you will quickly realize the distinction.  Any statement you or your child makes to school officials can be used against him or her in a criminal investigation later. If your child is being asked questions that could subject her or him to a crime, then you seriously need legal counsel.

In one of my more serious juvenile cases, a young man in highschool admitted to his coach that he did something he didn’t actually do because he thought that he would merely be doing extra laps around the track as punishment.  Four days later, he was brought before a judge after being arrested, and it took six months to get the charges dismissed.  The criminal charges were gone, but the experience of being arrested, sitting in jail, and missing his family will be with him forever.  If he had known that his statements to his coach that day could have led to his eventual arrest, then he would have taken the situation much more seriously.

I’m not saying that school administrators are always out to get your child.  In fact, I think that most of the time, they get it right when it comes to enforcing their rules and doing the right thing.  But we humans have a tendency to occasionally get things wrong, even when we mean well.

5. The criminal juvenile system is no joke.

  If circumstances are completely out of your control with your child and his or her situation at school, then you will be visiting them at the local juvenile justice center.

Juveniles await a detention hearing in hopes of getting to go home with their parents.

Your child can be taken to jail and detained there if the judge determines detention is needed.  However, your child can be released into your custody with special conditions.  Kids don’t bond out of juvenile detention like adults do in jail.  If your child is released to you pending the trial of their case, then you are responsible for seeing that they appear timely in court.  If your child is facing assault, theft, drug charges, or another type of charge, and you don’t know what to do, then remember tip #1 and give me a call.

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 been wrongfully accused of a crime whose ages range from 8 years old to 80.  He has lectured school boards on punishment statistics from the U.S. Department of Education and represented hundreds of kids in juvenile court.  He has founded YOURENOTGUILTY.COM and has been an active donor and community volunteer in East Texas ever since.