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Ethicon Media Monitoring 9/11/2017

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

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  1. 'The only reason I haven't committed suicide is because of my three cats': Grandmother, 61, slams scandal-hit vaginal mesh after a similar procedure left her disabled and in agony

    Sep 8, 2017 | The Daily Mail

    By Stephen Matthews And Alexandra Thompson

    A grandmother-of-two almost committed suicide after being left in agonising pain throughout her body from a controversial mesh implant.
  2. J&J Mesh Cases Belong In Philly, Out-Of-State Residents Say

    Sep 8, 2017 | Law 360

    By Matt Fair

    A group of out-of-state residents pursuing claims against a Johnson & Johnson unit in Pennsylvania over allegedly defective pelvic mesh products said Thursday that the company had sufficient ties to the state for the Philadelphia County Court of Common Pleas to retain jurisdiction over their cases.
  3. 'I never thought this day would come,' says York Co. woman awarded millions in pelvic mesh suit

    Sep 9, 2017 | York Daily Record/Sunday News

    By Gordon Rago

    A 51-year-old Conewago Township woman, awarded $57 million in a medical case involving pelvic mesh implants, said she will live with pain for the rest of her life.
  4. $57 Million Awarded in Vaginal Mesh Lawsuit

    Sep 8, 2017 | Daily Hornet

    The trial involved Ella Ebaugh, a woman who was injured by two vaginal mesh implants made by Ethicon Inc., a subsidiary of Johnson & Johnson.
  5. News of Note—Neurostimulation player ElectroCore bags $36M; Ethicon slammed with $57M pelvic mesh verdict

    Sep 8, 2017 | FierceBiotech

    By Amirah Al Idrus

    Johnson & Johnson’s Ethicon unit was ordered to pay $57.1 million in a pelvic mesh suit. Philadelphia Inquirer article
  6. $57.1M Ethicon TVT Secur Mesh Verdict Awarded

    Sep 8, 2017 | Lawyers And Settlements

    By Lucy Campbell

    Philadelphia, PAA $57.1 million verdict has been awarded against the makers of defective TVT Secur mesh, Johnson & Johnson and its subsidiary, Ethicon. The award breaks down as $50 million in punitive damages and $7.1 million in compensatory damages for plaintiff Ella Ebaugh, a Pennsylvania resident, according to court documents.
  7. Transvaginal Mesh Lawsuit Verdict: Johnson & Johnson, Ethicon Ordered to Pay $57.1 Million to Pennsylvania Woman Left Incontinent by TVT Mesh Implants

    Sep 8, 2017 | RX Injury Help

    By Laurie Villanueva

    Johnson & Johnson and Ethicon, Inc. have been ordered to pay a record $57.1 million to a Pennsylvania woman who was left incontinent after receiving the company’s TVT and TVT-Secure pelvic mesh implants.

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. 'The only reason I haven't committed suicide is because of my three cats': Grandmother, 61, slams scandal-hit vaginal mesh after a similar procedure left her disabled and in agony

    Sep 8, 2017 | The Daily Mail

    By Stephen Matthews And Alexandra Thompson

    ·  Sylvia Litchfield's problems stem from a rectopexy mesh that was fitted in 2014

    ·  Within days of undergoing the procedure, an 'incredible' discomfort started

    ·  The mesh even triggered a stroke and heart attack, Ms Litchfield believes

    ·  It is similar to the vaginal procedure which has left thousands of women in agony

    ·  The scandal came to light earlier this year, but its true extent is yet to be revealed



    A grandmother-of-two almost committed suicide after being left in agonising pain throughout her body from a controversial mesh implant.

     

    Sylvia Litchfield, 61, from Birmingham, claims the only reason she is still alive today is because of her three cats and grandchildren, who gave her a purpose to live.

     

    Her problems stem from a rectopexy mesh, similar to that of the vaginal procedure which has left thousands of other British women in agony.

     

    The scandal came to light earlier this year, but its true extent is yet to be uncovered - though mounting pressure is being placed on health officials to address concerns.

     

    Senior doctors now calling for a public inquiry into its usage say it could be akin to thalidomide, as the NHS has been accused of sweeping the matter under the carpet.

    Within days of undergoing the scandal-hit procedure, an 'incredible' discomfort started in Ms Litchfield's body - before it spread and left her disabled.

     

    The mesh, made of the same material as that used in the more common surgery, even triggered a stroke and heart attack, she claims.

     

    Not only was the pain so bad it forced the former charity worker to retire, but she is now completely dependent on crutches to move. 

     

    Speaking for the first time since having the mesh fitted, Ms Litchfield has revealed the devastating impact it has had on her life. 

     

    She told MailOnline: 'If it wasn't for the fact I have three cats, a granddaughter and grandson, I would have done it [committed suicide] a long time ago.

     

    'The pain just drains you.' Ms Litchfield described her discomfort as being like 'having your skin scrubbed with a wire brush all the time'.

     

    She added: 'All I can think of in the morning is getting through the day, not going anywhere has taken everything away from me except my existence. 

     

    'I was fine until the mesh. I'm still in incredible pain from my waist down to nearly my knees. I can't stand or walk properly, I can only do that with crutches.' 

     

    Ms Litchfield, who now lives in a warden-controlled flat, was originally fitted with the mesh at Walsgrave Hospital, Coventry in January 2014. 

     

    It was meant to only take 20 minutes, but the procedure to treat her collapsed rectum went wrong and instead lasted for nearly seven hours.

     

    She only found out something happened while under the knife when a concerned passerby asked why she was gone for so long. 

     

    After challenging nurses for more information, Ms Litchfield found out her blood pressure plummeted during the operation, before shooting back up.

     

    But no more details were given to her, despite her relentless pursuits to discover the complete truth about the surgery.

     

     

    Problems started just 10 days later, sparking her first visit to the doctor. But they said she was just recovering from her operation.

     

    When Ms Litchfield returned again two weeks later, she was told that it was just an infection, she claims, despite evidence linking such pain to the mesh. 

     

    But her attempts to have the mesh removed have been unsuccessful, as she is adamant the NHS is trying to cover-up the scandal. 

     

    No consultant will admit the mesh is causing her pain, meaning she is unable to claim the correct the right benefits. As a result, she said she is 'living on a pittance'.   

     

    She said: 'Getting a doctor to say that [the mesh is causing pain] is so difficult, I've got the same symptoms as hundreds, if not thousands, of other women. 

     

    'They wouldn't look, they wouldn't accept it could be the mesh, they just dismiss it every time you ask. It's a huge problem. 

     

    'Unless you can get doctors to acknowledge the damage it is doing, we will continue to be left in excruciating pain that keeps up all day, you can't escape it.'

     

    Ms Litchfield has since put her details forward to the MHRA for investigation and is in the process of getting records from the hospital to seek legal action.

     

    She has researched and found the damage that toxins in mesh can do, causing high blood pressure – partly responsible for her near-death cardiac events. 

     

    As a result of her heart attack and stroke, she is unable to take most painkillers - leaving her reliant on widely-ineffective paracetamol and aspirin. 

     

    Alarming studies show that mesh implants can trigger pain, erosion and perforation in up to 40 per cent of women. Others suggest it could be as high as 75 per cent.

     

    But English health officials have yet to acknowledge the risks of the brittle implants which can break into tiny fragments and cause nerve damage. 

     

    Currently, the NHS and MHRA state that as little as 1 per cent of women will go on to experience the life-changing complications such as pain.

     

    Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with officials accepting that up to 40 per cent of women may experience injury. 

     

    HOW MANY WOMEN SUFFER?

    According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.

    Yet, a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.

    Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.

    Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.

    Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life.

    According to Kath Samson, head of the Sling The Mesh campaign, surgeons often refuse to accept vaginal mesh implants are causing recipient's pain, and are not obligated to report such complications anyway.

    She said: 'Less than 40 per cent of surgeons report vaginal mesh implant side effects.

    'In last 10 years, 126,000 mesh and tape implants have been fitted in England alone.

    'In that period around 7,800 women have gone into hospital with a mesh complication, but the number reported to the MHRA is just over 1,000.

    'Many more women would have experienced pain but never gone to hospital.'

     

    http://www.dailymail.co.uk/health/article-4732908/Grandmother-61-slams-scandal-hit-vaginal-mesh-procedure.html

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  2. J&J Mesh Cases Belong In Philly, Out-Of-State Residents Say

    Sep 8, 2017 | Law 360

    By Matt Fair

    Law360, Philadelphia (September 8, 2017, 3:04 PM EDT) -- A group of out-of-state residents pursuing claims against a Johnson & Johnson unit in Pennsylvania over allegedly defective pelvic mesh products said Thursday that the company had sufficient ties to the state for the Philadelphia County Court of Common Pleas to retain jurisdiction over their cases.

    A judge agreed last month to rethink whether cases from out-of-state plaintiffs lodged as part of a mass tort program to deal with mesh-related claims could stay in Philadelphia in the wake of two recent U.S. Supreme Court decisions clarifying the law surrounding general and specific jurisdiction over nonresidents.

    While Ethicon Inc., which claims its base of operations in neighboring New Jersey, argues that it lacks a significant-enough business tie to Pennsylvania to allow the state to exercise jurisdiction over claims from nonresidents, the plaintiffs fired back on Thursday with evidence that the company’s allegedly defective mesh had been sourced from Pennsylvania.

    “The factual record shows that Ethicon acted extensively and regularly in Pennsylvania while designing, testing, and manufacturing the pelvic mesh products that were implanted into the plaintiffs,” the plaintiffs argued in a brief.

    Ethicon is looking to force the dismissal of nearly a hundred cases, or about two-thirds of the docket, it is facing in Philadelphia County over allegedly defective mesh products. The company argues that the Supreme Court’s ruling in Bristol-Myers Squibb v. Superior Court of California had limited the circumstances under which a state court is able to assert specific jurisdiction over nonresident companies.

    The BMS decision followed on the heels of another ruling, BNSF Railway Co. v. Tyrell, that limited the extent to which state courts can exercise general jurisdiction over nonresident companies.

    Ethicon noted in a brief last month that both it and J&J were incorporated and had their principal place of business in New Jersey and that neither had registered to do business as a foreign corporation in Pennsylvania. It argued that the nonresident plaintiffs had received their mesh implants and other relevant treatment outside of the state.

    But the plaintiffs countered on Thursday that Ethicon had contracted a Pennsylvania-based company, Secant Medical Inc., to manufacture the mesh that was eventually incorporated into the implants at the center of the litigation.

    “Based on their contractual relationship, under which Secant agreed to manufacture mesh as directed by Ethicon, Ethicon worked closely with Secant in Pennsylvania at all stages of the design, manufacturing, and quality control processes of the mesh that was implanted into the plaintiffs,” the plaintiffs argued.

    Ethicon, however, wrote off its contract with Secant in its brief last month.

    “Secant’s involvement ceases as soon as it sends the rolls to Ethicon,” the company argued. “Ethicon manufactures the mesh devices outside of Pennsylvania. … Ethicon, not Secant, conducts all testing and trials on the products; is responsible for all regulatory submissions; and develops and prepares packaging inserts, labels and marketing materials.”

    Six cases in the mass tort program have gone to trial so far in Philadelphia resulting in five verdicts in favor of plaintiffs against Ethicon and damages now totaling just over $105 million.

    The most recent verdict — a whopping $57.1 million — was returned on Thursday in case involving claims that a pair of allegedly defective mesh products had sawed into a woman’s urethra resulting in significant scarring and leaving her all but incontinent.

    A spokesperson for Ethicon did not immediately return a message seeking comment on Friday.

    The plaintiffs are represented by Thomas Kline, Shanin Specter, Lee Balefsky and Charles "Chip" Becker of Kline & Specter PC and Clayton Clark of Clark Love & Houston.

    Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLPand Julie Callsen of Tucker Ellis LLP.

    In Re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

    --Editing by Christine Chun.

    https://www.law360.com/articles/961982/j-j-mesh-cases-belong-in-philly-out-of-state-residents-say

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  3. 'I never thought this day would come,' says York Co. woman awarded millions in pelvic mesh suit

    Sep 9, 2017 | York Daily Record/Sunday News

    By Gordon Rago

    A 51-year-old Conewago Township woman, awarded $57 million in a medical case involving pelvic mesh implants, said she will live with pain for the rest of her life.

    "A lot of days, I can't get out of bed," said Ella Ebaugh, who in 2005 was diagnosed with stress urinary incontinence. "I struggle every day. I will struggle with that pain every day for the rest of my life."

    The implants -- made and created by Ethicon, a subsidiary of the medical manufacturing giant Johnson & Johnson -- eroded into Ebaugh's urethra, according to her attorney, Kila Baldwin.

    Ebaugh sought out the implants in 2007 after she began leaking urine while playing softball. Up until 2015, Ebaugh had worked at a Friendly's distribution center in York County, but had also traveled the country playing on a softball team.

    Stress urinary incontinence can be brought on by something like exercise, coughing or sneezing.

    The two implants, TVT-Secur and TVT, are Ethicon devices used to treat incontinence. But after a few years, Ebaugh started experiencing "excrucitating pain" in her pelvic area.

    It wasn't until she was at home, recovering from surgery to try to remove the mesh implants, that she saw a TV commercial about eroding pelvic mesh implants. She began researching on the internet and would later go on to file a lawsuit.

    On Thursday, after a one-month trial, a jury ordered Ethicon to pay Ebaugh $50 million in punitive damages and $7 million in compensatory damages, Baldwin said. The $7 million is for "negligent design and strict product liability design defect," according to Baldwin.

    "I never thought this day would come," Ebaugh said in an interview with the York Daily Record on Friday.

    Still, she and her lawyer said, it is unlikely Ebaugh will see any of that money soon. 

    Ethicon has already said it plans to appeal the Philadelphia jury's verdict.

    "We believe the evidence showed Ethicon's TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff's continuing medical problems," a company spokeswoman, Kristen Wallace, told Philly.com.

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    That newspaper reported that evidence presented during the trial showed that Johnson & Johnson intentionally manipulated the literature regarding problems with the products and withheld information about complications and injures from doctors.

    In an interview with the Daily Record, Baldwin pointed to the exhibition of internal company emails that swung the jury in favor of awarding her client money.

    But Ebaugh says she is still working on finding a new normal. The mother of four had the full support of her children and husband, Marvin. She kept them away from going to the trial because she didn't want them to see or hear the defense lawyers on the other side.

    Today, she said she is "chained to a bathroom." If she goes to see her 16-year-old son play baseball or football, she has to sit near a bathroom. She carries a diaper bag with her and sits in a special chair when she goes to visit her mother.

    "Yes, I will wear diapers the rest of my life. Yes, I can't be intimate with my husband," Ebaugh said. "Yes, I'm depressed. These are things I will carry with me for the rest of my life."

    For her, it's about finding the highlights right now, like Sunday family visits or her son's athletic games.

    The verdict this week was emotionally and physically exhausting for her, she said. 

    "I'm just glad Johnson & Johnson is finally getting their hand smacked when it should be," she said. "They're doing things seriously hurting and harming women everywhere."

    http://www.ydr.com/story/news/2017/09/09/york-co-woman-awarded-millions-lawsuit-live-pain-rest-my-life/647241001/

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  4. $57 Million Awarded in Vaginal Mesh Lawsuit

    Sep 8, 2017 | Daily Hornet

    The trial involved Ella Ebaugh, a woman who was injured by two vaginal mesh implants made by Ethicon Inc., a subsidiary of Johnson & Johnson.

    One was the TVT-Secur mesh, which is no longer on the market. The other was the company’s “standard” TVT mesh, which is still sold.

    Ebaugh was implanted with TVT-Secur mesh in May 2007 for the treatment of stress urinary incontinence. When the mesh failed to correct her condition, she was implanted with TVT mesh in 2008.

    Three years later, she was suffering from incontinence and chronic pain. Doctors found that her mesh implants eroded into her urethra. She required a series of surgeries, including one described as being “cut open from hip to hip” to remove as much of the mesh as possible.

    Despite multiple surgeries, Ebaugh still suffer from incontinence as a result of scar tissue and complications of her vaginal mesh implants.

    The jury unanimously agreed that Ethicon was responsible for selling a defective device that “mutilated” her urethra and left her incontinent. The $57 million verdict included a $50 million punitive damage award.

    The trial was the 5th vaginal mesh case to proceed in Philadelphia, with 4 out of 5 juries awarding nearly $50 million in total damages. The largest verdict before Ebaugh’s trial was a $20 million award in April.

    Ethicon is the last big holdout in the vaginal mesh litigation, which at its peak involved lawsuits from over 100,000 women who were injured. All of the other manufacturers have agreed to pay settlements in the vast majority of cases, but Ethicon still faces 30,000 lawsuits.

    The lawsuit was filed in the Philadelphia County Court of Common Pleas in Pennsylvania — Ella Ebaugh et al. v. Ethicon Inc. et al. — Case No. 130700866.

    https://dailyhornet.com/2017/57-million-awarded-in-vaginal-mesh-lawsuit/

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  5. News of Note—Neurostimulation player ElectroCore bags $36M; Ethicon slammed with $57M pelvic mesh verdict

    Sep 8, 2017 | FierceBiotech

    By Amirah Al Idrus

    > ElectroCore, which markets a noninvasive vagus nerve stimulation device that treats pain associated with episodic cluster headaches, raised $36 million. SEC filing

    > Johnson & Johnson’s Ethicon unit was ordered to pay $57.1 million in a pelvic mesh suit. Philadelphia Inquirer article

    > The FDA cleared MyndTec’s functional electric stimulation system for the treatment of patients with upper extremity paralysis. Release

    http://www.fiercebiotech.com/medtech/news-note-neurostimulation-player-electrocore-bags-36-million-ethicon-slammed-57m-pelvic

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  6. $57.1M Ethicon TVT Secur Mesh Verdict Awarded

    Sep 8, 2017 | Lawyers And Settlements

    By Lucy Campbell

    Philadelphia, PAA $57.1 million verdict has been awarded against the makers of defective TVT Secur mesh, Johnson & Johnson and its subsidiary, Ethicon. The award breaks down as $50 million in punitive damages and $7.1 million in compensatory damages for plaintiff Ella Ebaugh, a Pennsylvania resident, according to court documents.

    The award may well be the largest to date against Ethicon in a vaginal mesh personal injury complaint. There are over 100 more transvaginal mesh cases pending in Philadelphia's pelvic mesh mass tort program.

    In Ebaugh’s complaint, she alleged she was diagnosed with urinary incontinence in 2005 and had TVT-Secur mesh installed in 2007. However, the device didn’t provide any relief so she had a second device implanted about two months later. During the next few years, that device eroded through her urethra on three occasions, and she had to undergo three revision surgeries between 2011 and 2016.

    Ebaugh alleged that Ethicon and J&J failed to inform patients and physicians about the risks associated with the TVT products. She further claimed that the defendants withheld information about the complications from the medical community.

    Transvaginal mesh, also known as pelvic mesh or TVM bladder sling, have been implanted in tens of thousands of women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many of those women have suffered severe transvaginal mesh complications, resulting in more than 100,000 defective device lawsuits filed and possibly making the vaginal mesh one of the largest medical device mass torts ever.

    https://www.lawyersandsettlements.com/articles/personal_injury/57-million-ethicon-tvt-mesh-settlement-22559.html

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  7. Transvaginal Mesh Lawsuit Verdict: Johnson & Johnson, Ethicon Ordered to Pay $57.1 Million to Pennsylvania Woman Left Incontinent by TVT Mesh Implants

    Sep 8, 2017 | RX Injury Help

    By Laurie Villanueva

       Laurie Villanueva is an attorney with Bernstein Liebhard LLP

    Johnson & Johnson and Ethicon, Inc. have been ordered to pay a record $57.1 million to a Pennsylvania woman who was left incontinent after receiving the company’s TVT and TVT-Secure pelvic mesh implants.

    The verdict marks the fifth time a jury in the Philadelphia Court of Common Pleas has found for a plaintiff in an Ethicon transvaginal mesh lawsuit. The verdict is also the largest rendered so far in the consolidated pelvic mesh litigation underway Pennsylvania.

    According to her complaint, Ella Ebaugh was implanted with Ethicon’s TVT-Secur sling in 2007, at the age of 39, to treat stress urinary incontinence. In July 2007, she underwent corrective surgery due to mid-urethral erosion, at which time she was implanted with a different TVT product. (Case No. # 130700866)

    Ebaugh was forced to undergo another corrective surgery due to complications in June 2011. Ebaugh says she continued to experience complications, forcing her to undergo a fifth surgery just last year.

    Ebaugh claimed that Ethicon’s TVT devices were defective and accused the company of failing to properly disclose their risks to doctors and patients.Transvaginal Mesh Jury Awards $50 Million in Punitive Damages

    Yesterday’s verdict followed nearly a month of testimony and two days of deliberations. Ebaugh was awarded $7.1 million in compensatory and $50 million in punitive damages. Punitive damages are assessed when juries believe defendants engaged in wrongful conduct.

    Ebaugh’s transvaginal mesh lawyer told The Legal Intelligencer that Johnson & Johnson’s internal emails likely played a significant role in the jury’s decision.

    “It showed there were many attempts to manipulate the literature … and they continued to sell them knowing this information,” she said. “They made the case almost indefensible.”Ethicon Transvaginal Mesh Litigation

    Transvaginal mesh is indicated to treat women who suffer from pelvic organ prolapse and stress urinary incontinence. However, reports linking the implants to thousands of serious injuries and complications have prompted the U.S. Food & Drug Administration (FDA) to issue several warnings regarding their use. Last year, the agency reclassified transvaginal mesh intended for prolapse repair as a high-risk medical device.

    Ethicon and Johnson & Johnson have been named defendants in more than 55,000 pelvic mesh lawsuits pending in state and federal courts throughout the nation. Trials have been convened in various states, with plaintiffs and the defendants winning at various times, while a small number of cases have settled outside of court.

    A total of six Ethicon transvaginal mesh trials have concluded in the mass tort program currently underway in the Philadelphia Court of Common Pleas. Four other juries ordered Ethicon and Johnson & Johnson to pay plaintiffs’ damages ranging from $2.16 million to $20 million.

    The companies’ only win in the Pennsylvania litigation came in June, when another TVT-Secur plaintiff was denied damages after the jury hearing the case determined that the transvaginal mesh implant did not cause her injuries. However, they did find that TVT-Secur mesh was defectively designed.

    Last month, the court agreed to grant that plaintiff a new hearing on damages after she argued in a post-trial motion that the jury’s verdict was inconsistent with the evidence.

    https://www.rxinjuryhelp.com/news/2017/09/08/transvaginal-mesh-lawsuit-verdict-johnson-johnson-ethicon-ordered-to-pay-57-1-million-to-pennsylvania-woman-left-incontinent-by-tvt-mesh-implants/

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