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Ethicon 23/12
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J&J Tagged With $7M Punitives In Pa. Pelvic Mesh Case
Dec 22, 2015 | Law360
By Dan Packel
Jurors on Tuesday hit a Johnson & Johnson unit with $7 million in punitive damages, on top of $5.5 million in compensatory damages, in the first case over the company’s Prolift pelvic mesh product to be tried in Philadelphia’s mass tort program. -
J&J hit w/additional $7m in punitive damages in 1st pelvic mesh case
Dec 22, 2015 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) must pay $7 million in punitive damages on top of $5.5 million in compensatory damages it was ordered to pay yesterday in the 1st of a series of pelvic mesh lawsuits. -
Phila. jury awards $12.5M in vaginal mesh case
Dec 23, 2015 | The Philadelphia Inquirer
By Chris Mondics
A Philadelphia jury awarded $12.5 million Tuesday to a woman who alleged that a vaginal mesh implant made by Johnson & Johnson caused her to have extreme pain during sex and required multiple corrective surgeries. -
Philadelphia Jury Adds $7 Million in Punitive Damages to $5 Million Compensatory Verdict At Conclusion of Prolift Mesh Trial
Dec 23, 2015 | HarrisMartin Publishing
A Pennsylvania jury has awarded a Prolift pelvic mesh plaintiff $7 million in punitive damages in the second phase of a Prolift transvaginal mesh device trial, sources tell HarrisMartin Publishing. -
Ethicon hit with $12.5 mln verdict in Philadelphia mesh trial
Dec 22, 2015 | Reuters
By Jessica Dye
Johnson & Johnson subsidiary Ethicon Inc has been hit with a $12.5 million verdict in a lawsuit from a woman who said she was injured by transvaginal mesh, a device that is the subject of tens of thousands of lawsuits in state and federal courts. -
$7M in Punitives Awarded in Pelvic Mesh Case
Dec 22, 2015 | The Legal Intelligencer
By max Mitchell
A Philadelphia jury has hit Johnson & Johnson with a $7 million punitive damages verdict over conduct in the design and marketing of its pelvic mesh implant device. -
The hidden medical epidemic few women have been willing to talk about, until now
Dec 22, 2015 | Washington Post
By Tara Bahrampour
When Carmel Price’s mother had an operation six years ago, Price helped her in the hospital but never really knew what the procedure was for. “I heard that she was having ‘reconstructive surgery,’ like that her organs had moved around and they were putting them back where they belonged,” said Price, a sociology professor at the University of Michigan in Dearborn. -
Vaginal Mesh Use for Prolapse Repair Drops After 2011 Warning
Dec 22, 2015 | Medscape
By Marcia Frellick
Since the US Food and Drug Administration (FDA) issued a second warning in 2011 against surgically implanting mesh for treating pelvic organ prolapse (POP), use of the vaginal mesh decreased in New York from 30% to 23% in 2013, new data show. -
Philadelphia Prolift Mesh Case Yields $12.5 Million Verdict for Plaintiff
Dec 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
After negotiating for less than 24 hours, the 12 jurors in the case of a woman implanted with a Prolift pelvic mesh made by Johnson & Johnson (J&J), added to her $5.5 million compensatory award with $7 million in punitive damages bringing her total jury award to $12.5 million.
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J&J Tagged With $7M Punitives In Pa. Pelvic Mesh Case
Dec 22, 2015 | Law360
By Dan Packel
Jurors on Tuesday hit a Johnson & Johnson unit with $7 million in punitive damages, on top of $5.5 million in compensatory damages, in the first case over the company’s Prolift pelvic mesh product to be tried in Philadelphia’s mass tort program.
After the jurors concluded their second set of deliberations, Johnson & Johnson and its Ethicon unit immediately said that they would appeal the verdict from the three-week trial of a case brought by Indiana woman Patricia Hammons.
“We believe the evidence showed Ethicon’s Prolift pelvic organ prolapse repair kit was properly designed; Ethicon acted appropriately and responsibly in the research, development and marketing of the product; and Prolift was not the cause of the plaintiff’s continuing medical problems. We have always made patient safety a top priority and will continue to do so,” Matthew Johnson, director of communications of Ethicon, said in a statement.
Hammons’ May 2013 suit alleged that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, became implanted in her bladder. She accused Ethicon scientists and officials of overlooking negative side effects associated with Prolift and hiding the risks from her implanting surgeon.
Ultimately, 10 of 12 jurors concluded that the company failed to warn her implanting surgeon of the risks of the product, and that its negligence in designing the implant resulted in her inability to have sex. They also found that the company should be subject to punitive damages.
After hearing arguments on Thursday afternoon about the appropriate size of these damages, the jurors deliberated for roughly two hours before settling on the $7 million figure on Friday.
The case is the first of 180 in Philadelphia’s mass tort program over pelvic mesh products.
“We have to take them one at a time,” Hammons’ attorney Shanin Specter said Thursday.
There are also approximately 8,000 pelvic mesh suits pending in New Jersey state court and 35,000 in federal court.
Hammons is represented by Shanin Specter, Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter PC and Adam Slater of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Ellis LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
J&J hit w/additional $7m in punitive damages in 1st pelvic mesh case
Dec 22, 2015 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) must pay $7 million in punitive damages on top of $5.5 million in compensatory damages it was ordered to pay yesterday in the 1st of a series of pelvic mesh lawsuits.
Jurors took 2 hours of deliberation before they reached the $7 million figure, according to Law360.com.
Johnson & Johnson and its Ethicon division said they will appeal the verdict in the trial, brought against it by Patricia Hammons over her inability to have sex after being implanted with the company’s pelvic mesh.
“We believe the evidence showed Ethicon’s Prolift pelvic organ prolapse repair kit was properly designed; Ethicon acted appropriately and responsibly in the research, development and marketing of the product; and Prolift was not the cause of the plaintiff’s continuing medical problems. We have always made patient safety a top priority and will continue to do so,” Ethicon communications director said according to Law360.com.
A total of 10 of 12 jurors agreed the company failed to warn the implanting surgeon of risks associated with the product and found J&J to be negligent in their design of the implant which resulted in Hammons inability to have sex.
Hammons’ case is one of many challenging pelvic mesh makers, including J&J and Boston Scientific (NYSE:BSX).
The pelvic mesh makers will have to challenge more than 860 product liability lawsuits on a case-by-case basis, a Pennsylvania state judge ruled in 2014 in a growing mass tort action in Philadelphia.
Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, on Sept. 2 dismissed joint motions by J&J subsidiary Ethicon, Boston Scientific, C.R. Bard (NYSE:BCR) and Endo Health Solutions (NSDQ:ENDP) unit American Medical Systems Holdings to toss all of the lawsuits en masse, according to court documents.
The defendants had argued that Pennsylvania law bars the bulk of the claims lodge in a master complaint covering some 863 product liability lawsuits filed with the Philly court.
“The preliminary objections are overruled without prejudice to raise as a choice-of-law issue via summary judgment on a case-by-case basis,” New wrote, according to court documents.
Earlier in 2014 New dismissed a 5th defendant, Secant Medical, from the mass tort. Keystone State law shields Secant from the lawsuits because the company only made a component of the larger companies’ transvaginal mesh products, New wrote.
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Phila. jury awards $12.5M in vaginal mesh case
Dec 23, 2015 | The Philadelphia Inquirer
By Chris Mondics
A Philadelphia jury awarded $12.5 million Tuesday to a woman who alleged that a vaginal mesh implant made by Johnson & Johnson caused her to have extreme pain during sex and required multiple corrective surgeries.
Even after the surgeries, Patricia Hammons, 65, a Wal-Mart shelf stocker from Indiana, claimed in her lawsuit, she could no longer have sex and suffered from other health problems.
The Common Pleas Court jury awarded $5.5 million in compensatory damages for her ongoing health problems and inability to have sex. The jury also awarded $7 million in damages to punish the health-care-products giant for having marketed an unsafe product.
Hammons is "gratified" by the jury's verdict, said her lawyer, Shanin Specter of the Center City law firm Kline & Specter.
"Every American depends on Johnson & Johnson to put safety ahead of selling," Specter said. "They aren't doing that, and they need to engage in some honest soul-searching."
A spokesman for Ethicon, the J&J subsidiary that made the product, said the company would appeal.
"We believe the evidence showed Ethicon's ... pelvic organ prolapse repair kit was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and the [mesh] was not the cause of the plaintiff's continuing medical problems. We have always made patient safety a top priority and will continue to do so," the spokesman said in a statement.
The 21/2 week trial pitted experts for Hammons against those of J&J, and focused on the testimony of J&J managers, physicians, and others who worked on development of the implant, known as Prolift.
In a pivotal moment in the trial, Hammons' lawyers elicited damaging testimony from a product engineer for Ethicon on the lack of a backup plan if the implant failed. Although removal of the implants is a hugely complex surgical procedure, Scott Ciarrocca said the company had never given any thought to how to remove the mesh if it caused problems. In earlier testimony, a plaintiff's expert described such procedures as exceedingly difficult and tantamount to a surgical "train wreck."
Moreover, while the company knew before its product launch in 2005 that vaginal mesh implants had been associated with pain during sex, that was not included on the product warning label.
During the portion of the trial devoted to determining whether the company should be subject to punitive damages - hurt financially for acting recklessly in selling Prolift - a company official testified the company had $108 million in Prolift sales from the time the product was launched in 2005 until it took it off the market in 2012, following complaints from women who had the implants.
Pelvic mesh implants came into wide use a decade ago for treatment of a condition when the bladder and other organs, weakened by childbirth, sag over time into the vagina, causing urinary incontinence, pain during intercourse, and other maladies.
Hammons had implant surgery in 2009, when she was 58. Although she underwent corrective surgery, the pain persisted, as did other problems, including incontinence. In subsequent surgeries to remove the mesh, her physician noted that the mesh was "bunched up" along the undersurface of her bladder and that the movement likely caused the perforation of her bladder.
About 180 women who alleged that failed pelvic mesh implants have caused them ongoing health problems and interfered with their ability to have sex have filed suit against J&J in Philadelphia courts. The company faces tens of thousands of additional lawsuits in courts around the country.
During his arguments in the punitive damage phase of the trial, Specter argued that J&J acted recklessly by placing the product on the market before it fully understood how it would work, and then by delaying its withdrawal even as evidence mounted that it was severely injuring some of the women who had the implant.
J&J's lawyer, Tarek Ismael, acknowledged that J&J made mistakes in the development of Prolift. But he said that the company never intended to do harm and that J&J employees were devoted to improving public health.
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Dec 23, 2015 | HarrisMartin Publishing
A Pennsylvania jury has awarded a Prolift pelvic mesh plaintiff $7 million in punitive damages in the second phase of a Prolift transvaginal mesh device trial, sources tell HarrisMartin Publishing.
The verdict was rendered on Dec. 22, one day after the jury awarded the plaintiff $5.5 million in compensatory damages following a two-week trial and one day of deliberation. Judge Mark I. Bernstein of the Philadelphia Court of Common Pleas presided over the trial.
The plaintiff alleged that the product was negligently designed and that Ethicon and its parent, Johnson & Johnson, negligently failed to warn consumers and ...
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Ethicon hit with $12.5 mln verdict in Philadelphia mesh trial
Dec 22, 2015 | Reuters
By Jessica Dye
Johnson & Johnson subsidiary Ethicon Inc has been hit with a $12.5 million verdict in a lawsuit from a woman who said she was injured by transvaginal mesh, a device that is the subject of tens of thousands of lawsuits in state and federal courts.
Following a three-week trial, jurors in the Philadelphia County Court of Common Pleas awarded plaintiff Patricia Hammons $5.5 million in compensatory damages on Monday, and an additional $7 million in punitive damages on Tuesday.
To read the full story on WestlawNext Practitioner Insights (subscription required), see here: bit.ly/1QK0FBW
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$7M in Punitives Awarded in Pelvic Mesh Case
Dec 22, 2015 | The Legal Intelligencer
By max Mitchell
A Philadelphia jury has hit Johnson & Johnson with a $7 million punitive damages verdict over conduct in the design and marketing of its pelvic mesh implant device.
The punitive damages award in Hammons v. Ethicon on Tuesday morning came one day after the same jury awarded plaintiff Patricia Hammons $5.5 million in compensatory damages. Hammons had alleged the product was negligently designed, and J&J subsidiary Ethicon failed to properly warn health professionals about the risks of the Gynecare Prolift device.
Hammons' attorney, Shanin Specter of Kline & Specter, called the award "a great victory."
"The jury worked very hard on the case throughout," he said. "I hope this sends a message to Johnson & Johnson that they need to exercise care in the development and marketing of their products."
A spokesman for Ethicon said the company plans to appeal the verdict.
"We believe the evidence showed Ethicon's Prolift pelvic organ prolapse repair kit was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and Prolift was not the cause of the plaintiff's continuing medical problems. We have always made patient safety a top priority and will continue to do so," spokesman Matthew Johnson said in an emailed statement. "Studies demonstrated that Prolift was efficacious and had a low rate of post-operative complications when used with appropriate patient selection and proper surgical technique."
The Hammons case was the first out of Philadelphia's pelvic-mesh mass tort program to hit trial. Judge Mark I. Bernstein presided over the case.
According to Stanley Thompson, director of the Complex Litigation Center, there are 181 pending cases in the pelvic-mesh mass tort, with the last case being filed in October.
In 2009, the Prolift device had been implanted into Hammons, an Indiana resident who worked as a stocker for Wal-Mart, to address a prolapsed bladder.
Her counsel had argued, among other things, that the density of the mesh caused scar tissue to build up and contract, which eventually led to erosion of Hammons' bladder and "excruciating" pain during sex.
After the device failed, she had to have numerous surgeries, but will not be able to completely remove portions of the mesh that eventually adhered to the bladder, according to Specter.
During the compensatory phase, Ethicon's attorney, Susan M. Robinson of Thomas Combs & Spann, said development of the device was led by doctors, not Ethicon, and the risks of using pelvic mesh were well known throughout the medical community.
According to Robinson, despite the later complications, the mesh worked and properly supported Hammons' bladder.
Robinson also noted that, along with Hammons' bladder, her uterus was also prolapsed, and, after she underwent a hysterectomy in 2009, her small bowel also began to prolapse into her vaginal canal. She argued that this can also lead to pain during sex.
After the jury of seven women and five men awarded Hammons $5.5 million in compensatory damages Monday afternoon, the case went directly into the punitive damages phase. The jury had voted during its deliberations in the compensatory phase that the case should also include the consideration of punitive damages.
Specter kept his opening statement in the punitive phase to J&J's net worth, which is more than $69.7 billion.
J&J then called accountant Mark Schneider to testify about the finances of Ethicon and J&J. Among other things, Schneider said that Ethicon made only $4.2 million from selling the Prolift product between 2005 and 2012, when the device was taken off the market.
On cross-examination, Specter questioned the claimed amount of profits from the device, and told jurors that the company had at least $44.1 billion in liquid assets that could easily be converted to cash.
During his subsequent closing argument in the punitive phase, Specter told jurors the company needed to be sent a message that its conduct after learning of the safety risks of the product was wrong.
According to Specter, the company had been told the device had problems before and after it went to market, but the product was sold for another seven years. He said the company knew the mesh was causing pain during sex in about 20 percent of the women using the device.
"That same 20 percent number, they knew it from the beginning. ... It was all designed simply to sell as many of these things as they could," Specter said. "You have to be heard from."
In his closing argument during the punitive phase, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum, who also represented Ethicon, told the jurors that, even less than 90 minutes after the initial verdict came down, top company officials had already heard their message.
He also noted that the headquarters for J&J is close to Philadelphia.
"It stings to be told by members of our community that we didn't meet their expectations," he said.
Ismail additionally noted that the Prolift product has been off the market since 2012, and said the company acted appropriately in the wake of learning of the risks of the product.
"That corrective action has already been taken," Ismail said. "That decision was made over three years ago."
Specter tried the case with Kline & Specter attorney Kila Baldwin and Mazie Slater Katz & Freeman attorney Adam M. Slater.
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The hidden medical epidemic few women have been willing to talk about, until now
Dec 22, 2015 | Washington Post
By Tara Bahrampour
When Carmel Price’s mother had an operation six years ago, Price helped her in the hospital but never really knew what the procedure was for. “I heard that she was having ‘reconstructive surgery,’ like that her organs had moved around and they were putting them back where they belonged,” said Price, a sociology professor at the University of Michigan in Dearborn.
Then Price had two babies of her own and suddenly she understood — and unlike earlier generations of women, she is talking about it
“My bladder was bulging outside of my body, and if I was on my feet for any significant length of time, like if I was giving a three-hour lecture, or running or jumping, it would fall out even further.” Her mother confirmed that it was the same thing she’d had.
Pelvic organ prolapse – when a woman’s bladder, uterus, or rectum falls down through the vaginal canal – affects millions of women in America, and becomes more likely the older they get. The average age women start to notice pelvic floor disorders, which include prolapse as well as urinary and fecal incontinence, is 56; by 80, half of all women have one or more symptoms. One in ten end up in surgery – and associated costs are soaring as the population ages -from an estimated $66 billion a year in 2007 to a projected $83 billion in 2020.
And yet for years, few women talked about it. Gynecologists often do not notice it in routine exams, and many have lived with the condition for years or even decades without realizing anything would be done.
“This is a stigmatized condition,” said John DeLancey, a Univeristy of Michigan professor of gynecology and urology who pioneered the use of MRIs and biomechanical analysis to diagnose pelvic floor damage. “It’s nothing people would talk about in polite company.... And because nobody talks about it, everyone thinks they’re the only one.”
Recently, however, the conversation has opened up ever so slightly. Last month the actress Kate Winslet spoke publicly about her urinary incontinence since having babies. The FDA recently approved several versions of a pelvic floor muscle trainer, which provide feedback via a smartphone app. And new internal devices for incontinence and prolapse, which advocates say work better than earlier versions, are just hitting the U.S. market.
“There has definitely been a sea change starting this calendar year,” said Missy Lavender, founder and executive director of the Women’s Health Foundation, which does education and advocacy on the issue. “We suddenly have people looking at women’s pelvic health, going, ‘Why don’t we do more?’”
An ancient problem
References to pelvic organ prolapse appear in Egyptian hieroglyphics, Medieval woodcuts, and the Bible (which says it is a sign a wife has been unfaithful). Treatments throughout the ages included fumigating the lower abdomen with herbs; tying a woman upside-down to a ladder and shaking it; or menacing the wayward organ with a hot poker to frighten it into place.
In reality, pelvic floor prolapse is similar to a hernia where the organs and vaginal walls are pushed out through an opening in the muscles of the pelvic floor. The condition is most common among women who have given birth. In 10 to 15 percent of vaginal deliveries, the attachment of the muscles to the side walls tears, weakening the ability of the muscles to support the organs. Most women have no idea there is a problem until years later: when the muscles weaken with age and are no longer able to hold the organs in place.
“It’s not painful so much as uncomfortable,” DeLancey said. “ ....They feel this intense pressure. Often they say they have a backache.”
Pelvic floor problems run in families; other risk factors include obesity, routine heavy lifting, older maternal age at first birth, and the use of forceps during delivery.
Treatments include the use of a pessary, an internal support device that women can insert to hold the organs in place, or surgery using the patient’s own tissue or a mesh to lift and repair the fallen organs. There are 320,000 surgeries a year for pelvic floor disorder, 200,000 of which are for prolapse. For less advanced cases, physical therapy can help reduce symptoms.
Left untreated, the prolapse can grow to the size of a grapefruit or larger, and it can become painful if the organs pull on the ligaments that connect to the sacrum. It can become dangerous if the prolapse causes blockage in the tubes that attach kidney to bladder, And it can put older women at risk of reduced activity and social isolation.
“Urinary incontinence is one of the top reasons people end up in nursing homes - people don’t want to deal with the smell,” said Cheryl Iglesia, director of MedStar Washington Hospital Center’s Section of Female Pelvic Medicine and Reconstructive Surgery and a professor of gynecology and urology at the Georgetown University School of Medicine, noting that it is often the last straw for caregivers.
In the U.S., more pads are sold for incontinence than menstruation, Iglesia said. “It is a problem because we don’t have enough trained experts [in pelvic floor issues] to handle the aging population.”
Even when it is not dangerous, it erodes enjoyment of life. Women stop exercising because physical activity tends to worsen the condition – especially running or jumping, or activities involving weights, sit-ups or squats. Some avoid intimacy, fearing that prolapse or incontinence will repel their partners.
New attention to the problem is driven in part by differing expectations of the Baby Boom generation as they age, Lavender said. “We’re the generation of ‘Our Bodies, Ourselves.’ We grew up wanting to know more than our moms did.”
That thick tome did not include a section on pelvic floor disorders; rather, the information tends to spread by word of mouth. Urogynecologists joke that when one member of a bridge club, mah jong group, or neighborhood coffee klatch comes for treatment, the other members are sure to follow. “I did a whole cul-de-sac, one woman in the cul-de-sac after the other,” Iglesia said.
Ethel Potts, 90, a potter and city government volunteer in Ann Arbor, heard about the surgery from a woman in her craft co-op, and had an operation a couple of years ago.
“The surgery was like a miracle” said Potts, whose uterine prolapse had worsened over eight years and was not alleviated by a pessary. “…I didn’t have to worry about if I went out of the house for a few hours was I going to need more pads or have difficulties.”
But even when women do speak up, they can hit a gender bias.
“My ob-gyn said, ‘Oh, your body just changes after having a baby’ and it’s just life. ...It felt really dismissive,” said Price, 38, who since her diagnosis has shifted her research to study the issue. “It made it seem like my surgery was elective, as if I was having cosmetic surgery, In other words, if I was willing to be sedentary and just live with it, it wasn’t necessary. My dad has had shoulder surgery and I never heard the term quality of life, like if he’s just willing to stop playing golf then his shoulder is not a problem.
Pelvic floor physical therapy can help reduce the tension on the ligaments by strengthening the surrounding area, but the service can be hard to find. Julie Janes, a pelvic floor physical therapist in Arlington, Va, has patients who drive more than 100 miles to see her, and she has colleagues in the Midwest whose patients drive much farther.
“It’s a very new field in the US,” she said. “In France, women receive ten sessions [with a physical therapist] starting in the hospital after every vaginal delivery. One of my old colleagues was coming from France and her biggest culture shock when she moved to the U.S. were the aisles of Depends and incontinence products.”
An upcoming article in the Journal of Biomechanical Engineering proposes measuring a pregnant woman’s anatomy and the size of her baby’s head to predict the likelihood of an injury.
If such diagnostics had been available to Jeanne McMahon when she delivered a nine-and-a-half pound baby in 1988, she would have considered a Caesarian section.
Her doctor used a suction device to deliver her son, and afterward told her to expect problems with a prolapsed uterus.
“They used to just say it was a ‘female problem,’” said McMahon, 58, who had two more children and lived with bladder and uterine prolapse for over 20 years. She finally got surgery in October, and has since been able to resume activities such as tennis and hiking.
“I actually feel younger, which is a nice side effect,” she said. “Truly, I do wish I had done it sooner.”
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Vaginal Mesh Use for Prolapse Repair Drops After 2011 Warning
Dec 22, 2015 | Medscape
By Marcia Frellick
Since the US Food and Drug Administration (FDA) issued a second warning in 2011 against surgically implanting mesh for treating pelvic organ prolapse (POP), use of the vaginal mesh decreased in New York from 30% to 23% in 2013, new data show.
Findings from the study by Art Sedrakyan, MD, PhD, from the Department of Healthcare Policy and Research, Weill Medical College of Cornell University in New York City, and colleagues were published online December 21 in JAMA Internal Medicine.
Prior research showed that after the first FDA mesh warning in 2008, use of the mesh actually went up from 21% in 2008 to 30% in 2011.
The difference is likely a result of the wording of the warnings, the authors suspect. In the first warning, physicians were asked to get extra training in using the mesh and to be aware of the risks. In the second warning, in 2011, the FDA questioned the benefit of the mesh over traditional POP repair and said complications were "not rare," noting that there had been 1503 mesh-related events recorded by the end of 2010, an increase of five times the number recorded on January 1, 2008.
"Although other explanations are possible," the authors write, "we believe that the stronger language in the 2011 [US Food and Drug Administration] warning is at least partly related to the decline in mesh use and has implications for future risk-communications policy, suggesting that stronger regulatory warnings can influence physicians' use of potentially unsafe medical devices."
The researchers used data from the New York Statewide Planning and Research Cooperative System, which contains records of all surgeries in the state.
They found that the annual number of repairs for pelvic organ prolapse decreased from 6960 in 2011 to 5757 in 2013. The use of mesh after the 2011 FDA warning declined from 30% (95% confidence interval [CI], 29% - 31%) to 23% (95% CI, 22% - 24%) in 2013.
They also found that most of the decline after the 2011 warning occurred in low-volume centers compared with high-volume centers (from 25% [95% CI, 23% - 27%] to 15% [95% CI, 13% - 16%] vs from 37% [95% CI, 35% - 39%] to 34% [95% CI, 32% - 36%]; P < .01), as well as in nonacademic centers (from 29% [95% CI, 27% - 30%] to 20% [95% CI, 18% - 21%] vs from 32% [95% CI, 31% - 34%] to 27% [95% CI, 25% - 29.0%];P < .01 for academic centers).
Higher-volume and academic centers may have more procedures with higher severity and may also be more comfortable because of physicians' experience with using mesh, the authors speculate. The greater decline in the low-volume, nonacademic centers may also be related to lower tolerance for litigation as the number of lawsuits and amount of awards increases.
FDA's 510(k) Approval Pathway Flawed, Experts Say
In an accompanying commentary, Vanessa L. Jacoby, MD, from the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, and colleagues say the study findings add to the evidence that the FDA's 510(k) pathway to approve moderate-risk medical advices is flawed.
Under this process, the manufacturers do not have to go through clinical trials, but must demonstrate "substantial equivalence" of the structure and function to an existing, legally marketed device.
The FDA approved vaginal mesh for POP because it was substantially equivalent to mesh for abdominal hernia repair, "an entirely different surgery performed on tissues with characteristics disparate from those in POP repair," the commentary authors write.
They add that the study highlights that substantial use of mesh persists "despite serious risks and the initiation of 49,000 federal lawsuits against manufacturers," adding that gynecologists began reporting complications to the FDA soon after the 2002 approval, including erosion into the vagina, severe pain, and dyspareunia.
The authors advocate for the FDA requiring evidence from comparative clinical trials before an implantable device is used in surgical practice, rather than relying on postmarket voluntary reporting to determine safety.
The study was funded in part by the National Institutes of Health and the US Food and Drug Administration. The authors have disclosed no relevant financial relationships. One commentary coauthor reports funding from Astellas Pharma US via contracts with the University of California, San Francisco, to conduct research unrelated to transvaginal mesh. The other commentators have disclosed no relevant financial relationships.
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Philadelphia Prolift Mesh Case Yields $12.5 Million Verdict for Plaintiff
Dec 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
After negotiating for less than 24 hours, the 12 jurors in the case of a woman implanted with a Prolift pelvic mesh made by Johnson & Johnson (J&J), added to her $5.5 million compensatory award with $7 million in punitive damages bringing her total jury award to $12.5 million.
According to a report in Philly.com (here), the seven women and five male jurors made that award to Patricia Hammons, 65, a store stocker at Walmart from Indiana.
Punitive damages are intended to send a message to a company to stop its behavior.
Hammons claimed that her pelvic damages are permanent and the Prolift cannot be removed causing her chronic infection, pain, repeated surgeries and an inability engage in sex. The polypropylene implant is implanted to treat incontinence or pelvic organ prolapse.
Tarek Ismail, attny for J&J
During closing arguments, attorney for Ethicon, a subsidiary of J&J, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum told the jury, “It stings to be told by members of our community that we didn’t meet their expectations,” referring to Philadelphia’s proximity to J&J headquarters in New Brunswick, New Jersey.
In a turn of events, Ismail said the Prolift was taken off the market three years ago indicating the company acted appropriately after it learned of the risks.
“The corrective action has already been taken,” Ismail is quoted by The Legal Intelligencer.
Ironically when Prolift and three other meshes were removed from the market, Matthew Johnson a spokesman for J&J (no relation), cited financial reasons for the product removal, not safety or efficacy.
Matthew Johnson, J&J Corporate Communications
Johnson told Pharmalot that “This is not a product recall. We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”
During punitive phase deliberations, the financial worth and size of the company was presented.
Johnson & Johnson earns about $70 billion a year, but Prolift reportedly made only $4.2 million in sales between 2005 and 2012, according to an accountant with J&J. The $5.5 compensatory award given to Ms. Hammons Monday exceeds company profits for the medical device, he said.
Judge Mark Bernstein presided over the case in the Philadelphia Court of Common where 181 other pelvic mesh cases are pending. Adam Slater of Mazie Slater and Shanin Specter of Kline& Specter represented Ms. Hammons.
A CASE OF FIRSTS
This was the first pelvic mesh case to be heard in this court. It is also the first time the Prolift Pelvic Floor Repair System has been found defectively designed and that J&J failed to warn doctors about the dangers it understood were inherent with the product.
This jury trial marks the first time in Johnson & Johnson pelvic mesh litigation that there has been any mention of document destruction by the company to jurors. J&J destroyed thousands of pages of documents that were on a litigation hold to help plaintiffs prepare for litigation, according to a conclusion by West Virginia Magistrate Judge Cheryl Eifert. So far that fact was never allowed to be mentioned before a jury.
During the two-and-a half week trial, J&J research and development engineer Scott Ciarrocca said the company had not considered how to remove the mesh if there were any complications.
Prolift was marketed in June 2005 bypassing any notification to the U.S. Food and Drug Administration (FDA). It wasn’t until three years later when the company wanted to put Prolift M+ on the market that the FDA had any awareness of the Prolift mesh kit. There were no sanctions imposed for bypassing the FDA approval process.
This marks the second time Prolift mesh has been the subject of a product liability trial. In 2013, the case of Linda Gross led to $11.1 million in compensatory damages for Ms. Gross. The couple from South Dakota has not seen their compensation since their case is still on appeal.
The Prolift trial of the late Joan Budke ended with a settlement last January after her 91-year-old husband took the stand weeping over his lost “bride.” Ms. Budke, 77, died of a systemic infection that originated at the site of the pelvic mesh implant.
Ethicon has failed to return repeated email requests for a comment by Mesh News Desk.
Product liability litigation over Johnson & Johnson/Ethicon pelvic mesh implants are scheduled in rapid succession during the first four months of 2016.#
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