Preview Newsletter
Ethicon 12/22
-
J&J Found Liable In 1st Philly Pelvic Mesh Case
Dec 21, 2015 | Law360
By Dan Packel
A Philadelphia jury returned a $5.5 million verdict against a Johnson & Johnson unit on Monday after agreeing that the negligence of scientists regarding pelvic mesh implant Prolift was the root cause of an Indiana woman’s inability to have sex after having the product implanted. -
Johnson & Johnson lose 1st Philly mesh case
Dec 21, 2015 | MassDevice
By Fink Densford
A jury in Philadelphia ruled today that Johnson & Johnson (NYSE:JNJ) must pay $5.5 million in the 1st in a series of pelvic mesh lawsuits. -
Philadelphia Jury Awards Prolift Transvaginal Mesh Plaintiff $5.5 Million in Compensatory Damages
Dec 21, 2015 | HarrisMartin Publishing
A Pennsylvania jury has awarded a Prolift pelvic mesh plaintiff $5.5 million in compensatory damages following a two-week trial and one day of deliberations in the bifurcated proceedings, sources confirmed to HarrisMartin. -
First Phila. pelvic-mesh trial goes to jury
Dec 21, 2015 | Philadelphia Inquirer
By Chris Mondics
What is the value of a lawsuit against the maker of a surgical implant that causes some women such excruciating pain during sexual intercourse they are forced into celibacy? -
Jury Awards $5.5M in Pelvic Mesh Case, Calls for Punitives
Dec 21, 2015 | Legal Intelligencer
By Max Mitchell
The jury hearing the first pelvic mesh case in Philadelphia handed up a $5.5 million verdict Monday, and sent the case to a second phase on punitive damages. -
Prolift Pelvic Mesh Found Defectively Designed, Plantiff Awarded $5.5 Million, Punitives to be Determined
Dec 21, 2015 | Mesh Medical Device News Desk
By Jane Akre
A Philadelphia jury today ruled Johnson & Johnson (J&J) must pay a mesh-injured woman $5.5 million in compensatory damages for its negligence over the defectively designed Prolift pelvic mesh. The jury will return for deliberations Tuesday over punitive damages which could add millions to the verdict in a damaging blow to the company. -
Yes, You Need To Exercise Your Pelvic Floor Muscles
Dec 22, 2015 | Elle Australia
By Sara McLean
Gwyneth Paltrow is concerned you might be peeing your pants. The Goop founder recently used her website to highlight the un-conscious uncoupling between women and their pelvic floor – and for good reason
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
J&J Found Liable In 1st Philly Pelvic Mesh Case
Dec 21, 2015 | Law360
By Dan Packel
A Philadelphia jury returned a $5.5 million verdict against a Johnson & Johnson unit on Monday after agreeing that the negligence of scientists regarding pelvic mesh implant Prolift was the root cause of an Indiana woman’s inability to have sex after having the product implanted.
The jury took almost two days to find that Ethicon Inc. was responsible for Patricia Hammons’ contracting the condition known as dyspareunia, in the first of 180 cases in the mass tort program to go to trial.
The jury also granted Hammons’ bid for punitive damages against the company, opening the door for additional arguments and evidence.
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.
The trial extended over two weeks, during which jurors heard Hammons’ attorneys argue that Prolift’s design was irredeemably flawed. They said the product incorporated far too much mesh with far too few holes, making it harder for healthy tissue to grow around it when implanted. Instead, the construction of the mesh prompted the growth of scar tissue, which contracts over time, pulling the mesh with it, and ultimately causes the vagina to shrink.
Ethicon’s attorneys, however, alleged that Hammons’ complaints were likely traceable to several other surgeries aimed at treating her condition, including a vaginal hysterectomy. And they said that pelvic implants made of polypropylene — the material in Prolift — had been evaluated and observed for years since gynecologists began using mesh designed for abdominal hernias in surgeries.
They also argued that Hammons waited too long to launch her lawsuit, and that she was aware of the connection between the mesh and her condition well in advance of two years before the May 2013 filing date.
Jurors in the case were subjected to a steady stream of deposition videos — more than 25, by the count of defense attorney Tarek Ismail.
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.
-
Johnson & Johnson lose 1st Philly mesh case
Dec 21, 2015 | MassDevice
By Fink Densford
A jury in Philadelphia ruled today that Johnson & Johnson (NYSE:JNJ) must pay $5.5 million in the 1st in a series of pelvic mesh lawsuits.
The jury found J&J liable, based on the negligence of its scientists in relation to its Prolift pelvic mesh implant, citing it as the root cause of defendant Patricia Hammons’ inability to have sex after it was implanted.
After 2 days of deliberation, the jury ruled in Hammons’ favor and granted their bid for punitive damages, which allows for additional arguments and evidence.
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.
-
Philadelphia Jury Awards Prolift Transvaginal Mesh Plaintiff $5.5 Million in Compensatory Damages
Dec 21, 2015 | HarrisMartin Publishing
A Pennsylvania jury has awarded a Prolift pelvic mesh plaintiff $5.5 million in compensatory damages following a two-week trial and one day of deliberations in the bifurcated proceedings, sources confirmed to HarrisMartin.
The Pennsylvania Court of Common Pleas for Philadelphia County jury reached the verdict on Dec. 21. 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 doctors of the device’s risks. The jury also determined that punitive ...
Subscription required. For Full text please see: http://harrismartin.com/article/20232/philadelphia-jury-awards-prolift-transvaginal-mesh-plaintiff-55-million-in-compensatory-damages/
-
First Phila. pelvic-mesh trial goes to jury
Dec 21, 2015 | Philadelphia Inquirer
By Chris Mondics
What is the value of a lawsuit against the maker of a surgical implant that causes some women such excruciating pain during sexual intercourse they are forced into celibacy?
That is probably the most important question underlying a 21/2-week trial before Philadelphia Common Pleas Court Judge Mark Bernstein. Testimony concluded and on Thursday the jury began deliberations.
The trial involved allegations by Patricia Hammons, 65, a Walmart shelf stocker from Indiana, who underwent surgery in 2009 to correct a sagging bladder, a consequence of childbirth and a common problem in middle-aged women. It causes urinary incontinence and interferes with sex.
Her surgeon implanted a pelvic mesh barrier made by Ethicon, a subsidiary of global health-care products giant Johnson & Johnson, to shore up Hammons' bladder. But a short time later, Hammons complained sex had become so painful she had to cease relations with her boyfriend. In her lawsuit, Hammons claimed J&J's pelvic mesh implant was inherently unsafe, having a tendency to bunch up inside the pelvis while piercing her bladder. And she said that J&J knew about its safety problems but concealed them from doctors and patients.
Her lawsuit, the first to be tried in Philadelphia, is one of as many as 100,000 nationwide against makers of pelvic mesh implants. The outcome of a handful of cases like hers will decide how this overall legal battle will end. To say the stakes are enormous would be something of an understatement. Nationwide, there have been 16 verdicts in recent years against pelvic mesh manufacturers, including J&J, totaling $247 million. That includes a verdict in May in which a Wilmington jury awarded $100 million to a woman who said a pelvic implant made by Boston Scientific caused pain during sex.
Judging from the Hammons trial, it isn't a slam dunk for either side. Over the course of the trial, Hammons' lawyers, Shanin Specter of Kline & Specter in Philadelphia and Adam Slater of Roseland, N.J., who was assisting in the trial, elicited testimony from J&J executives that the company rushed to get the pelvic mesh product to the market in the face of competition from other companies.
Though use of pelvic mesh already had been associated with pain during sex - the medical term is dyspareunia - by the time J&J began selling it in 2005, no mention of this risk was made on the product label.
During the trial, one expert for the plaintiffs testified that removing the mesh completely was exceedingly difficult, if not impossible, and that doing so typically was a surgical "train wreck." Yet, in one particularly troubling bit of testimony, J&J product engineer Scott Ciarrocca said no one at the company had given any thought to how to remove the mesh if it failed.
One fact bolstering Hammons' case: J&J itself seems to have lost confidence in its mesh device named "Prolift." In 2012, the company pulled the product from the market.
J&J focused its defense on studies purporting to show the product was far more effective than earlier therapies, and testimony that the mesh was a safe and effective way to deal with pelvic organ prolapse - the sagging of organs into the vagina.
But J&J's defense wasn't entirely high road. While it argued that studies show the treatment was safe and effective, it also suggested Hammons' smoking habit may have played a role in her malady.
J&J lawyers also suggested the real reason Hammons wasn't having sex was that her boyfriend was impotent. In his concluding argument, Specter treated that assertion with contempt. Of Hammons' boyfriend, he said to the jury, "He was ready."
If I were sitting on the jury, I would likely decide that J&J knew too little about potential adverse outcomes and had brought the product to market prematurely, as one of the plaintiff's experts emphatically testified. The product had obviously failed in some patients and the company knew too little about how it would work in the real world.
But, for all the science bandied about in trials like these, verdicts often come down to judgment calls. The truth is no one can say with absolute certainty what caused Hammons' dyspareunia. Was it the vaginal mesh? Was it a hysterectomy she had undergone after the implant? Was it the natural atrophying of vaginal tissue that sometimes attends the aging process?
Evaluating the science is not an exact science. But juries usually are able to cut through conflicting data and claims and see through to the bottom line. What makes Hammons' lawsuit especially important, apart from her own claim to be compensated for a wrong she says was done to her, is that this case and a handful of others will help to form a legal consensus about J&J's conduct.
And that will shape the extent of J&J's liability in the tens of thousands of cases that remain.
-
Jury Awards $5.5M in Pelvic Mesh Case, Calls for Punitives
Dec 21, 2015 | Legal Intelligencer
By Max Mitchell
The jury hearing the first pelvic mesh case in Philadelphia handed up a $5.5 million verdict Monday, and sent the case to a second phase on punitive damages.
After more than two weeks of trial and one day of deliberation, the jury in Hammons v. Ethicon delivered its verdict Monday afternoon, finding the company that designed and manufactured the Gynecare Prolift had failed to properly warn about the risks of the product, and that the company’s negligence caused the plaintiff’s harm. The jury consisted of seven women and five men.
The plaintiff, Patricia Hammons, had alleged the product was negligently designed, and Ethicon and Johnson & Johnson failed to properly warn health professionals about the risks of the Prolift device.
The Prolift device, which was approved for use by the U.S. Food and Drug Administration in 2005, was implanted into Hammons in 2009 to address a prolapsed bladder. 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.
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 jury determined punitive damages were warranted in the case, the trial moved directly into opening statements on punitive damages.
A fuller version of this article will be posted later when the article is completed.
-
Dec 21, 2015 | Mesh Medical Device News Desk
By Jane Akre
Mesh News Desk, December 21, 2015 ~ A Philadelphia jury today ruled Johnson & Johnson (J&J) must pay a mesh-injured woman $5.5 million in compensatory damages for its negligence over the defectively designed Prolift pelvic mesh. The jury will return for deliberations Tuesday over punitive damages which could add millions to the verdict in a damaging blow to the company.
This was the second product liability trial over Prolift, one of the largest pelvic meshes ever produced used to treat pelvic organ prolapse and incontinence. The first Prolift trial of Linda Gross in 2013 resulted in a $11.1 million ruling for Ms. Gross but did not find the mesh was defective in its design. That verdict is still under appeal.
In the two-week trial of Patricia Hammons, 64, the jury found for the plaintiff on all three claims – defective design, a failure to warn doctors about its dangers and negligence in manufacturing and in bringing the Prolift to market.
Does this verdict bring J&J to the settlement table? Plaintiff attorney Adam Slater (Mazie Slater) says he is not settling his clients for cheap.
“We never made a settlement demand from Day One. We told them we intended to take this case to a verdict.”
Slater says high-level executives within Ethicon were watching the trial.
”J & J has displayed an attitude so far they don’t care what the jury says, they don’t care what the judge says, they’re bigger than everyone else. They do things on J&J’s terms. That’s my impression of them.”
This is the first case heard in the Philadelphia Court of Common Pleas with at least 181 other cases filed against Ethicon, a division of J&J, over its pelvic mesh to be heard in rapid succession beginning in January 2016. Additionally there are 8,000 pelvic mesh cases filed against Ethicon in New Jersey and 30,312 cases (as of today) filed in Charleston WV where federal consolidation of cases under multidistrict litigation.
Attorneys for Ms. Hammons were Shanin Specter of Kline & Specter and Adam Slater of Mazie Slater.
This marks the first time document destruction by J&J has been brought before a jury. See the MND background stories here and here.
Defense team included Matt Moriatiry of Tucker Ellis, Susan Robinson of Thomas Combs.
Attorney Shanin Specter (Kline & Specter) said the Prolift pelvic mesh implant has too much mesh which causes scar tissue, mesh contraction and erosion. The amount of mesh could stretch across two-and-a half football fields, he told jurors. Ms. Hammons suffers mesh erosion into her bladder and “excruciating” pain during sex or dyspareunia. The mesh was found to have folded under her bladder and repeated surgeries have caused a shortened vagina.
Patricia L. Hammons v Secant Medical, Ethicon, in the Philadelphia Court of Common Pleas, Case No. 2:13-cv-04086. Secant is the maker of a component of the polypropylene mesh implant.
The defense team blamed pain during sex on the plaintiff’s hysterectomy she underwent in 2009 and additional prolapsing of her small bowel and uterus. Prolift had nothing to do with the fact she later developed the bowel prolapse, she said.
Ethicon removed Prolift from the market three years ago after the U.S Food and Drug Administration required it to do three year post approval monitoring for its effects on woemen. Mesn Hews Desk has since found Prolift available online on ebay.
This trial has been limited to two weeks by Judge Mark I. Bernstein.
Expect defective product trials naming pelvic meshes made by Ethicon to be heard in New Jersey, Pennsylvania and Dallas all beginning in January 2016. #
-
Yes, You Need To Exercise Your Pelvic Floor Muscles
Dec 22, 2015 | Elle Australia
By Sara McLean
Gwyneth Paltrow is concerned you might be peeing your pants. The Goop founder recently used her website to highlight the un-conscious uncoupling between women and their pelvic floor – and for good reason. A study by the Agency for Healthcare Research and Quality found that up to 45 per cent of women suffer urinary incontinence (aka leakage), with up to 30 per cent of young women falling victim. Yet the negative side effects of a weak pelvic floor go beyond gradually replacing the tampons for Tena on your weekend shop.
“So many women suffer in silence, thinking it’s normal to have a low libido, lack of orgasm, an inability to lubricate properly, urinary incontinence and lower back pain,” says mother and self-taught intimacy expert Kim Anami. “But it’s not normal, and it can be reversed.” Bali-based Anami has spent 20 years studying tantra, herbal medicine and meditation, and now runs online “vaginal kung-fu” workouts, helping women become better acquainted with this mystifying muscle group.
5 WAYS TO BECOME A RUNNER (EVEN IF YOU HATE EXERCISE)
But a healthy pelvic floor influences more than just the bedroom and bathroom. This collection of muscles and tissues, which sits at the base of your pelvis, essentially holds your uterus, bladder and bowel in place. “As the pelvic floor is hidden from view it’s very hard for women to visualise or connect with,” explains Elizabeth Evans, a physiotherapist specialising in women’s health and pelvic conditions. “But weakness can cause pelvic organ prolapse – when the bladder, bowel or uterus descends towards or even out of the vagina, requiring extensive training, vaginal pessary support or surgery to fix.”
While pregnancy and age are clear contributors, any repeated strain on the area, whether through constipation, chronic respiratory conditions or high-impact sport, can lead to a weak pelvic floor. “There are also a group of women who have pelvic floor muscles that are actually too tight and they’re experiencing similar symptoms due to a dysfunction,” explains Evans, who recommends all women test their own inner strength by visiting a professional pelvic floor physiotherapist or a gynaecologist, who will prescribe an at-home program of exercises to follow. “The phrase ‘use it or lose it’ couldn’t be more true for the pelvic floor – the muscles need to be strong because they’re the only set we get,” she adds.
THE 8 GLASSES OF WATER A DAY RULE IS A MYTH
Think you’re a star student if you’re already practising kegels? Think again. “Most women know they should be doing pelvic floor exercises, but more than 50 per cent of females don’t know how to do a correct pelvic floor contraction and 25 per cent are actually doing them in a detrimental way,” says Evans (the correct technique is all about lifting up – see box below).
Of course, in this app-obsessed era, the tech-heads have created several new gadgets that act like personal (very personal) trainers for your vagina. There’s the egg-shaped Elvie, which is inserted into the vagina and uses sensors and bluetooth to send the results from the five-minute “clenching” workout to your smart phone via an app, and the kGoal, which gives you real-time feedback to make sure you get the moves right. There’s also the crowdfunded SKEA (Smart Kegel Exercise Aid), which basically sees you playing a video game with your vagina as the controller.
SITTING MIGHT NOT KILL YOU AFTER ALL SAYS NEW STUDY
Taking a more lo-fi approach, Anami’s vaginal kung-fu involves a jade egg being inserted into the vagina. A string is attached, from which she encourages her clients to weight train by carrying everything from household objects to free weights. She’s so convinced of this movement that she’s gone social, documenting her personal crusade on Instagram using the hashtag #thingsiliftwithmyvagina – and she says her clients have also experienced life-changing results thanks to her methods. “One client had a 20-year problem of urinary incontinence disappear after one week,” she says. “And I’ve had many women experience their first G-spot or cervical orgasm after only a few days of practice.”
Taboo topics aside, Anami is adamant a healthy pelvic floor keeps more than just the internal organs in place. “A strong pelvic floor creates lifting action in the body that results in a natural ‘facelift’. I’ve had clients stop using Botox after practising,” she insists. Another way to attack a sagging face? No wonder the ever-youthful anti-ageing guru Gwyneth is on board.
A GUIDE TO CORRECT KEGELS
Find the muscles
Those muscles that stop your pee mid-flow? That’s your pelvic floor.
Ease into the squeeze
Contract and release these muscles a few times to get used to the exercise. Avoid simply squeezing your butt and thighs – you want to squeeze and lift the base of your pelvis from within.
Build your strength
Start off by squeezing for a few seconds, building up to 10 seconds, and make sure you release slowly each time.
Keep it up
Just like weekly Pilates creates a stronger core, you have to continue with these exercises even after you’ve gained pelvic strength.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested