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J&J's Ethicon Settles Bellwether Mesh Case Mid-Trial in West Virginia
Mar 9, 2015 | Reuters
By Jessica Dye
Four days into a bellwether trial in West Virginia federal court, Johnson & Johnson's Ethicon Inc has reached a settlement in a lawsuit... -
J&J Wins Appeal, Loses Civil Case Over Pelvic Mesh Implant
Mar 9, 2015 | Med Device Online
By Suzanne Hodsden
Two new court decisions leave Johnson & Johnson subsidiary Ethicon with a win and a setback in its ongoing nationwide pelvic mesh litigation -
Women Describe Horrific Life with Vaginal Mesh
Mar 7, 2015 | The Palm Beach Post
By Jane Musgrave
...Mesh-makers — Boston Scientific, American Medical Systems and C.R. Bard — didn’t respond to requests for comment. Johnson & Johnson is also being sued for its vaginal mesh... -
Ethicon, J&J Settle Bellwether Prolift Transvaginal Mesh Case 4 Days Into Trial
Mar 9, 2015 | Harris Martin Publishing
Ethicon Inc. and Johnson & Johnson have settled a federal bellwether Prolift transvaginal mesh case four days into trial, according to a court filing. -
Hello March ~ A Year of Settlements and Immunity
Mar 9, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Then just yesterday, a settlement was offered by Ethicon in the Dianne Bellew case, the specifics of which are not disclosed...
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J&J's Ethicon Settles Bellwether Mesh Case Mid-Trial in West Virginia
Mar 9, 2015 | Reuters
By Jessica Dye
Four days into a bellwether trial in West Virginia federal court, Johnson & Johnson's Ethicon Inc has reached a settlement in a lawsuit from a woman who said she was injured by one of its transvaginal mesh devices.
Jurors in the U.S. District Court for the Southern District of West Virginia were dismissed Friday morning after being informed that the case had concluded, according to minutes from court proceedings. A spokesman for Ethicon, Matthew Johnson, said Monday the parties had agreed to resolve the case, but declined to comment further.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1GzbEsw
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J&J Wins Appeal, Loses Civil Case Over Pelvic Mesh Implant
Mar 9, 2015 | Med Device Online
By Suzanne Hodsden
Two new court decisions leave Johnson & Johnson subsidiary Ethicon with a win and a setback in its ongoing nationwide pelvic mesh litigation. Though a U.S. Court of Appeals for the 4th Circuit upheld Ethicon’s win from a year ago, a California jury has awarded $5.7 million in damages the court says were caused by Ethicon’s Gynecare TVT Abbrevo (Abbrevo) device.
Abbrevo, a newer pelvic mesh product developed by Ethicon, was approved by the FDA in 2010 to treat stress urinary incontinence and pelvic organ prolapse.
According to the California court’s decision, Abbrevo has serious design defects and Ethicon failed to warn doctors about the implant’s problems, according to The National Law Journal. Reuters reports that a Kern County Superior Court jury awarded the plaintiff, Coleen Perry, $700,000 in compensatory damages and $5 million in punitive damages.
According to Perry’s lawyers, she began experiencing pain almost immediately following her surgery, as the device began to erode inside her body. The verdict, said the lawyers, “sent a clear message to Ethicon” about its “improper conduct in designing and marketing Abbrevo,” reported Reuters.
Ethicon spokesman Matthew Johnson told Bloomberg that his company stands by the safety of Abbrevo and feels there is enough evidence to support an appeal.
“The evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research development and marketing of the product,” Johnson told Bloomberg.
Despite its loss in California, Ethicon did manage to hold onto its win in West Virginia, Reuters reports.
Last week, the Fourth Circuit upheld a decision from January of 2014 that plaintiff Carolyn Lewis did not have enough evidence to support her claim that a sufficient warning would have prevented her doctor from prescribing the device, Law360 reports.
“When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury,” the appeals judges said.
Abbrevo is one of numerous similar devices from multiple high-profile device makers fighting and settling court battles over the past few years. Boston Scientific, Endo, C.R. Bard, and Covidien have all been in court to resolve pelvic mesh lawsuits.
Danish medical device manufacturer Coloplast recently agreed to a $16 million dollar settlement for 400 cases against its vaginal mesh insert, Bloomberg reported.
“It appears that momentum is building for some type of global resolution as more of these vaginal-mesh cases settle,” said Carl Tobias, product liability law professor at the University of Richmond, told Bloomberg.
Bloomberg projects that despite litigation the market for pelvic mesh devices is expected to exceed $1.7 billion by 2017.
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Women Describe Horrific Life with Vaginal Mesh
Mar 7, 2015 | The Palm Beach Post
By Jane Musgrave
Having finished three Ironman triathlons, Michelle Nelson is used to pushing through pain.
But, the 43-year-old West Palm Beach mother of three was unprepared for the unrelenting aching she experienced after having what was supposed to be a simple operation to resolve an embarrassing, annoying and not uncommon side effect of giving birth to whopper babies.+LANNIS WATERSMichelle Nelson talks about her problems with vaginal mesh.
Her complaints of stabbing pain — which increased during intercourse — went unheeded by doctors until one night her husband was cut while the couple was having sex.
Mesh that was implanted to shore up sagging parts of her urinary tract had penetrated her vaginal wall.
“He has a scar,” Nelson said. “It was an incredible.”
But for Nelson and thousands of women the effects of the mesh are far worse than a simple scar caused by what has been disturbingly dubbed the “barbed wire effect.” While Nelson has had two operations to remove the mesh, much of it remains. “I’ll be dealing with this for the rest of my life,” she said.
And the urinary incontinence, the “leaking,” that prompted her to get the surgery? It, too, remains.
Nelson is one of nearly 70,000 women nationwide who have sued the makers of the mesh, claiming they didn’t properly test it before putting it on the market. Then, when their own consultants warned of life-altering problems that could result, they hid that information from the public, according to federal lawsuits filed around the country that are being considered by a West Virginia judge.
West Palm Beach attorney Joseph Osborne, who in November won a $26.7 million verdict against Boston Scientific for West Palm Beach resident Amal Eghnayem and three other South Florida women, said the complications are horrific. And because the polypropylene mesh becomes brittle and breaks into tiny pieces once it’s implanted, it’s impossible to completely remove.
“It’s a retained foreign body in your vagina for the rest of your life,” said Osborne, who is representing roughly 3,000 women, including about 200 in Palm Beach County, who are suing mesh manufacturers. “I have a lady now who has mesh embedded in her colon. The doctors said they can’t go in and get it because it could create a catastrophe. They told her, ‘All we can do is hope it doesn’t penetrate the colon.’ It’s a ticking time bomb.”
For 80-year-old Helen Morales the time bomb exploded. The suburban Lake Worth mother of three has had five surgeries, including a temporary colostomy, since doctors in 2009 implanted mesh to shore up her urinary tract when she had a hysterectomy. The mesh had penetrated her colon. Doctors had to take skin grafts from her leg to repair the holes.
Not one to question doctors, Morales said she didn’t even know doctors implanted the mesh. Plagued by repeated infections and nasty discharges after the hysterectomy, she went to various doctors before one finally discovered the reason for her discomfort.
“You have mesh growing all over like a spider web,” the suburban Lake Worth woman recalled the doctor saying.
“What are you talking about? What mesh?” she responded. “I didn’t know there was mesh inside of me.”
How much the women knew about the mesh before it was implanted in them is a key part of the lawsuits.
Mesh-makers — Boston Scientific, American Medical Systems and C.R. Bard — didn’t respond to requests for comment. Johnson & Johnson is also being sued for its vaginal mesh.
In the November trial in federal court in Miami, attorneys representing Boston Scientific insisted the women were warned of the risks.
“No product is perfect. No surgery is perfect,” Boston Scientific attorney Hildy Sastre told the jury during closing arguments. “There is no such thing as risk-free surgery. It’s unheard of. It doesn’t exist.”
Further, she said, the four women had serious medical problems before the mesh was implanted. They had debilitating pelvic prolapses, causing their organs, such as their bladder, rectum, bowel or uterus, to droop so low they could feel them when they walked. The women were in pain. They had bleeding and discomfort during sex. They needed help.
The mesh was developed because there was a high failure rate when natural tissue was used. Further, Boston Scientific lawyer Molly Craig, told the jury that the mesh was tested and found to be safe. “Mesh has been used in human bodies for decades,” she said.
However, Osborne said, Boston Scientific’s own documents dispute Craig’s claims. In 2008, about five years after vaginal mesh was placed on the market, Louisiana urologist Dr. Joseph Macaluso warned the company of its dangers.
“Use mesh only as needed AND IF REALLY necessary,” he wrote in a report solicited by the company. “Less use is better.”
Osborne said the use of the mesh was okayed by the U.S. Food and Drug Administration through an abbreviated process that allows companies to piggyback onto approvals given to other products. “We don’t need to do all the testing because this product is the substantial equivalent to something you’ve already blessed,” Osborne said, describing the pitch companies make to the FDA.
In the case of mesh, it had already been approved for use in the abdomen to treat hernias. “If it behaved this way in the abdomen, why not the vagina?” he said the companies argued in getting approval to essentially use women as human guinea pigs.
A Boca Raton urogynecologist testified that compared to the abdomen, a vagina is a hotbed for bacteria. That increases the risk for infection, erosion and other complications.
Dr. Linda Kiley testified that she never implants mesh in the vagina but has removed it from many women. She opted not to use vaginal mesh after watching one operation. “I was somewhat horrified with the way that it went in - the extent of the mesh. There was a large amount of it,” she testified. “I didn’t find that it was an elegant repair.”
The removal process, she testified, is agonizing. Pieces that have broken apart are small and brittle. She has to take great care not to injure a nearby organ. “I have to do a lot of scrapping away using my fingers. I have to actually manually dissect the tissue from the mesh and that can take several hours,” she testified. “It’s like scrapping against sandpaper.”
And, some of the women said, the cure is almost as bad as living with the mesh.
Patricia Keefe, 58, of Riviera Beach, said she still hasn’t fully recovered since having mesh removed in April. She’s nauseous, has no sex drive, becomes drained of energy easily and is now seeing doctors for gastrointenstenial problems. “It just never ends,” she said.
Like Nelson, the triathlete, Keefe decided to have mesh implanted to take care of “leaking” that began after she gave birth at 40 to a third son, who weighed nearly 11 pounds. It was supposed to be an easy fix so she wouldn’t have to wear pads for the rest of her life.
Instead, about a year after the mesh was implanted in 2007, she was doubled-over in pain. “I thought I was going to die,” she said of the night she was taken to St. Mary’s Medical Center where the source of her months-long leg, back and pelvic pain was finally discovered.
Tammy Gigele, 57, of Jupiter, said she feels better since the mesh she had implanted in 2006 was removed in separate operations in December 2012 and March 2013. But, she said, she tempers her activities, is a less enthusiastic about sex and worries about the future. “Who knows what it will bring me for the rest of my life?” she said.
None of the women is looking for a big payout, they say. Nelson said she could have taken care of her urinary incontinence by taking a pill daily but opted for the mesh because she was assured it was safe. Now she just wants the companies to acknowledge what they did to thousands of women. Morales says she wants to make certain what happened to her doesn’t happen to anyone else. Gigele said she is angry.
“I’m mad at these big companies leading these doctors to believe that this was a safe product,” she said. “That’s the only way to get these big companies to say, let’s take another look at this product.”
In 2012, the FDA ordered the mesh manufacturers to conduct clinical studies to track potential side effects. But, Osborne said, vaginal mesh remains on the market although its use has plummeted.
Exactly how long it will take to resolve the lawsuits is unclear. American Medical Systems in May announced it would pay $830 million to settle the 25,000 lawsuits it and its parent company, Endo International, face. Johnson & Johnson also recently settled more than 100 suits filed by women. U.S. District Judge Joseph Goodwin, the West Virginia judge who is overseeing the cases, has recommended that C.R. Bard follow suit, Bloomberg reported.
His recommendation was based on the lopsided track record of companies that have gone to trial. More than $100 million worth of damages have been awarded to women by nine juries across the country. In three trials, juries declined to find the companies at fault.
The companies are still fighting. Boston Scientific promised to appeal the $26.7 million verdict Osborne and that legal team won in November.
Keefe said women whose lives have been forever changed deserve compensation. “We’re all looking to be OK,” she said. “That’s all we want.”
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Ethicon, J&J Settle Bellwether Prolift Transvaginal Mesh Case 4 Days Into Trial
Mar 9, 2015 | Harris Martin Publishing
Ethicon Inc. and Johnson & Johnson have settled a federal bellwether Prolift transvaginal mesh case four days into trial, according to a court filing.
Trial began on March 2 in the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin and settled on March 6, the daybook entry stated.
Arizona resident Dianne M. Bellew alleged she was injured after being surgically implanted with Ethicon Inc.’s Prolift Anterior Pelvic Floor Repair System, which had been prescribed to treat her pelvic organ prolapse and stress urinary incontinence.
Bellew claimed that following her ...
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Hello March ~ A Year of Settlements and Immunity
Mar 9, 2015 | Mesh Medical Device News Desk
By Jane Akre
Hello March ~
At this writing, we have just heard the result of two pelvic mesh defective product trials – The Coleen Perry case resulted in a defective product conclusion by the jurors, defective instructions to the end user (doctor), $5 million in punitive damages and $700,000 in compensatory. The jury took nearly four days to come to that conclusion. Then just yesterday, a settlement was offered by Ethicon in the Dianne Bellew case, the specifics of which are not disclosed.
Both of these actions name Ethicon, a division of Johnson & Johnson. Settling a case not only avoids a “defective” designation but it also allows the company to skirt any liability. Settling the higher cost cases (presuming a settlement is in the seven-figure range) also lowers the “average” pelvic mesh case value, perhaps laying the groundwork on what is ahead in the near future – settlements to put behind the company this dark chapter of defective medical devices.
One advantage of a settlement is that the woman receives her jury award sooner. By comparison, Linda Gross who won a case against Ethicon over the Prolift prolapse mesh in February 2013, is still waiting for an appeal by Ethicon to wind through the courts.
With the exception of a few cases won by Boston Scientific, plaintiffs are finally having their day in court and the wins are almost exclusively on the side of the plaintiff. Just how many more losses can defendant mesh manufacturers take without finally agreeing to settlements? It will happen, and probably soon but again, it will never be enough to not only restore health but to send a message to the companies to discourage their reckless rush to profits at any cost.
Mesh News Desk (MND or MMDND) has been covering the issues surrounding pelvic and hernia mesh for nearly four years now. If you are new to the issues surrounding the controversy, please visit the search bar or click on the topics. You will find a world of coverage. You may want to start with Resources and our Facebook page.
There are now more than 72,000 lawsuits filed in Charleston, West Virginia, consolidated in multidistrict litigation (MDL). These are transvaginally placed pelvic mesh affecting women, not hernia mesh, though it is the same mesh and often the adverse events are similar. Both meshes are made from polypropylene, a petroleum-based product that is not inert and continues to change in the body. Many doctors feel that there is no time line on when a complication can occur. Mesh has been called a ticking time bomb for that reason. Mesh placement has been called “experimental” because it never went through any clinical trials to assure safety. That was not required by the Food and Drug Administration.
The longer these manufacturers wait, the more evidence is coming forward about the dangers of polypropylene mesh. Right now, the autoimmune issues, so common in many after their implants, are being explored. That will add another injury to the plaintiff’s long list and will not spell well for the mesh makers.
Even as U.S. manufacturers take some of their most troubling pelvic meshes off the market, they export them. Mesh News Desk is hearing from women in Ireland, Scotland, Israel, So. Africa, among other places, who are the recipients of these U.S. rejects.
Many wonder why that is not criminal negligence.
If you are new to the mesh issue, or suspect those symptoms you’ve been having for some time may have started after your implant, you are not alone. Besides pelvic pain from mesh shrinkage and scar formation, many women feel a burning and pulling sensation, experience ongoing infections, develop rashes, dental problems, joint aches, even fibromyalgia and lupus.
If you suspect your implant may be negatively affecting your life, it’s important to go to a mesh expert. The established medical community does not offer them on every corner. You must seek them out. Look up our doctor directory and please avoid the doctors who have been involved in implanting mesh that has gone wrong. Most experts now believe that partial removals may leave the patient in worse shape, so it’s important to have as few removal surgeries as possible to get as much as is humanly possible, if removal is warranted at all.
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Thanks to Courtroom View Network for access to trial video feeds. I encourage mesh injured and their families to attend one of these trials in person if you can. Even for one day. It is amazing how much information must be carefully explained to a jury. One comes to appreciate the U.S. jury trials. If you ever are a juror, consider it an honor to listen to the evidence in a case and be asked to issue an opinion.
GoFundMe – Your donations are appreciated to allow court coverage, even in the form of mileage for hotels and air. Also much appreciated are your thoughts shared with the website. For those wanting to donate – there is a GoFundMe page to contribute to journalism in the public interest. Indy journalism is a challenging road, to say the least, but the need is there, and I believe the support is as well. (Please if you are mesh injured and suffering financially as well, you do not need to contribute).
Bruiser -PS Bruiser, your editorial assistant, who was born with a compromised liver, is doing well. He is stable with meds. In May he will be 5 years old. It’s amazing how the body can compromise when it needs to!
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