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Ethicon Media Monitoring 10/3/2017
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Justices Let $3M Pelvic Mesh Verdict Against Ethicon Stand
Oct 2, 2017 | Law 360
By Daniel Siegal
The U.S. Supreme Court on Monday rejected Johnson & Johnson subsidiary Ethicon’s bid to overturn a Fourth Circuit decision upholding a $3.27 million jury verdict in a bellwether trial over the company's allegedly harmful pelvic mesh, declining to review the ruling. -
NJ Powerhouses Eclipse Competitors Amid Stagnant Demand
Oct 2, 2017 | Law 360
By Jeannie O'Sullivan
... And both Riker Danzig and Drinker Biddle have helped Johnson & Johnson navigate product liability issues. -
J&J pay out $57M in vaginal mesh case
Oct 3, 2017 | Medical Plastics News
By Reece Armstrong
It is the largest pay-out to date for a verdict relating to the mesh devices. Numerous cases have been launched since 2015 in the UK, US and Australia. -
Vaginal mesh problems in UK and USA for J&J
Oct 2, 2017 | News-Medical.net
By Dr Ananya Mandal
Vaginal meshes have been used surgically in over 75,000 women in England who undergo surgery to correct stress incontinence and vaginal prolapsed. -
More laughing, less leaking: Frederick Memorial Hospital event offers urinary incontinence solutions
Oct 3, 2017 | The Fredrick News-Post
By Imade Borha
Many of us know the feeling of needing to use the bathroom and being unsure if you’ll get there in time. But for the 1 in 4 women over 18 who experience moments of leaking urine involuntarily, according to the National Association for Continence, this occurrence can impact daily activities and bring unwanted embarrassment.
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Justices Let $3M Pelvic Mesh Verdict Against Ethicon Stand
Oct 2, 2017 | Law 360
By Daniel Siegal
Law360, Los Angeles (October 2, 2017, 10:13 PM EDT) -- The U.S. Supreme Court on Monday rejected Johnson & Johnson subsidiary Ethicon’s bid to overturn a Fourth Circuit decision upholding a $3.27 million jury verdict in a bellwether trial over the company's allegedly harmful pelvic mesh, declining to review the ruling.
In a single line entry contained in Monday’s order list, the high court denied the petition for a writ of certiorari filed by Ethicon, which had argued that an appellate court had misunderstood precedent in allowing the exclusion of certain product review evidence in the suit brought by Jo Huskey.
Huskey’s suit is one of the tens of thousands of cases involving J&J’s surgical mesh products and was the first bellwether case to go to trial in a massive multidistrict litigation against Ethicon.
Ethicon spokesperson Kristen Wallace said in a Monday statement that the company is disappointed the Supreme Court denied the review, because it believes the case presents “a recurring question of national importance.”
Ed Wallace of Wexler Wallace LLP, representing Huskey, told Law360 on Monday that the high court’s decision was a “victory for women everywhere” who have been injured by the pelvic mesh products.
“Jo Huskey has taken every punch Ethicon has thrown at her and she has persisted on behalf of women everywhere to achieve justice,” he said.
Huskey filed her suit in West Virginia federal court in 2012. She claimed the polypropylene mesh in her TVT-O sling eroded, causing her severe, ongoing pain as the mesh could not be entirely removed through surgery. Her husband, Allen, sued for loss of consortium.
A jury delivered its verdict in September 2014, which was solidified in August 2015 when U.S. District Judge Joseph Goodwin refused to toss the decision as a matter of law or grant a new trial.
The verdict was upheld by a Fourth Circuit panel in January with a ruling that, citing Huskey's expert testimony, said a reasonable juror could conclude that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect that caused Huskey’s pain.
The district court had prevented Ethicon from using the U.S. Food and Drug Administration’s 510(k) medical device clearance process as evidence during the trial, Ethicon said in its May 23 petition to the high court. In the petition Ethicon said the Fourth Circuit’s affirmation was based on a misunderstanding of 1996’s decision in Medtronic Inc. v. Lohr as holding that the 510(k) review has little to do with safety.
The result of misconstruing the Lohr decision is that the Fourth Circuit’s ruling now threatens companies’ ability to use FDA regulatory processes as evidence in defending the safety of their products, the petition said.
In seeking a grant of certiorari, Ethicon had hoped the court would correct the misunderstanding of the Lohr case and clarify that the 510(k) process includes safety and efficacy review. The petition had cited the issue's importance to other pelvic mesh and medical device cases.
Ethicon is represented by Charles C. Lifland, Walter Dellinger, Jonathan D. Hacker, Stephen D. Brody and Jason Zarrow of O’Melveny & Myers LLP, David B. Thomas and Philip J. Combs of Thomas Combs & Spann PLLC and Christy D. Jones and Luther T. Munford of Butler Snow LLP.
Jo Huskey and Allen Huskey were represented at the Fourth Circuit by Edward A. Wallace and Mark R. Miller of Wexler Wallace LLP, Fidelma L. Fitzpatrick of Motley Rice LLC and Jeffrey M. Kuntz and Adam S. Davis of Wagstaff & Cartmell LLP.
The case is Ethicon Inc. et al. v. Jo Huskey et al., case number 16-1399, in the Supreme Court of the United States.
--Additional reporting by Melissa Daniels. Editing by Bruce Goldman.https://www.law360.com/articles/970168/justices-let-3m-pelvic-mesh-verdict-against-ethicon-stand
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NJ Powerhouses Eclipse Competitors Amid Stagnant Demand
Oct 2, 2017 | Law 360
By Jeannie O'Sullivan
Law360, New York (October 2, 2017, 4:39 PM EDT) -- In the cutthroat legal landscape of New Jersey, where competition currently outpaces demand, four long-established firms have earned spots on Law360's list of 2017 New Jersey Powerhouses thanks to a combination of stellar reputations and victories in both courtrooms and the marketplace.
They range from a regional stalwart dating back to the 19th century to a national player that planted Garden State roots in the 1930s, and represent clientele from the thriving local industries of real estate, health care and pharmaceuticals, to name a few. The standout firms in this year's series are Cole Schotz PC, Gibbons PC, Drinker Biddle & Reath LLP and Riker Danzig Scherer Hyland & Perretti LLP.
Among the tasks that kept them busy in 2016 were fending off consumer contract class actions and product liability claims for high-profile clients, assisting in the financial stabilization of Atlantic City, steering major hospitals through mergers and sales, and overseeing millions in commercial real estate and financing transactions, including ones bringing major developments to fruition. They also took on government agencies as both clients and foes.
Riker Danzig in Newark and Trenton holds court as the oldest powerhouse, with its headquarters dating back to 1882, while the youngest, Philadelphia-based Drinker Biddle & Reath, made its New Jersey debut in the 1930s and has cemented its Princeton and Florham Park offices through acquisitions of other firms.
Gibbons emerged from a Newark office in 1926 and has since launched an outpost in Trenton, while Cole Schotz opened in the industrial boom town of Silk City, better known as Paterson, in 1928 and now operates in Hackensack. Collectively, the four firms boast a New Jersey roster of 475 attorneys who tackle bustling practice areas like litigation, product liability, class actions and real estate transactions with finesse.
The Powerhouse firms are "committed to New Jersey and well-established in the state," said legal recruiter David Garber of Princeton Legal Search Group LLC.
Those are key traits given the rising competition and falling demand for legal services that's shaping the current business law landscape, according to Garber.
"It's an increasingly competitive landscape where you have to be nimble and even creative in how you structure engagements with clients who are sophisticated and have access to information about how legal services are priced and how engagements are structured. It is a given that you have to provide exceptional service at a reasonable price," Garber said.
Maximizing New Jersey's Prime Locations
The state's industrial roots have proved fertile ground for lucrative redevelopment projects ranging from giant warehouses strategically situated near major highways to mixed-use high rises gracing the Manhattan skyline from across a river.
Drinker Biddle is bringing new life to old land on both ends of the state. The firm helped a developer obtain zoning approvals for a 1 million-square-foot former pipe foundry site that will house an e-commerce facility straddling the southern New Jersey towns of Burlington City and Burlington Township. To the north, the firm represents Toll Bros. in the development of two high-end residential high rises in Hoboken on sites of the former Maxwell House coffee and Hudson Tea plants.
Gibbons is helping to usher in the future Seton Hall-Hackensack Meridian School of Medicine, the state's first new private medical school in 40 years, with the closing of title for the sale of client Hoffmann-La Roche Inc.'s 16-acre campus in Nutley and Clifton to an affiliate of Prism Capital Partners.
On the state's busy retail front, Cole Schotz represented TopGolf in the opening of its first location in the Garden State. TopGolf Edison, 65,000-square-foot venue in Edison Towne Square on Route 1, opened in December after the firm helped secure land use and liquor license approvals.
And in what Riker Danzig says is the largest office lease transaction in New Jersey in 2016, the firm facilitated the $58 million lease of a new corporate headquarters in Madison for Allergan Sales from client Lincoln Equities Group.
Counseling and Crossing the Government
In 2016, the Garden State’s government agencies and entities came to consider these firms their go-to advocates for a wide range of legal needs, and, in other cases, courtroom adversaries who keep public bodies on their toes.
Gibbons represented New Jersey in its high-profile financial takeover of Atlantic City, which teetered on the brink of insolvency following a spate of poor gaming revenue and successful property tax appeals. The resulting Municipal Stabilization and Recovery Act has helped stave off bankruptcy for the town, which is also struggling to fill in revenue gaps caused by casino closures.
In another entertainment mecca, Gibbons is counsel to the New Jersey Sports and Exposition Authority in its role as landlord for the massive entertainment and retail project at the Meadowlands Sports Complex, known as American Dream. The firm's representation in the venture entails a wide array of tasks ranging from handling transactional real estate to addressing environmental issues to tackling related litigation.
The Middlesex County Utilities Authority met its match in Riker Danzig when the firm secured a $10 million settlement, including major spoliation sanctions, in a construction litigation case brought by its client Spectraserv. The state also endured a defeat in New Jersey Tax Court when Cole Schotz successfully challenged the taxation of a client’s $46 million lottery winnings.
Tackling New and Old Litigation Frontiers
New Jersey firms in the business of defending big names are accustomed to fending off product liability suits given the state's abundant pharmaceutical base, and are getting familiar with the new trend of class actions lodged on behalf of consumers.
The state's tough Truth In Consumer Contracts Warranties and Notices Act was the basis of a putative class action Riker Danzig helped defeat for Lumber Liquidators Inc., while a federal Telephone Consumer Protection Act claim against Buy Buy Baby was extinguished at the hands of Drinker Biddle.
"We've made a great focus of our efforts to really dig down and find issues facing retailers in this day and age," said Andrew B. Joseph, partner in charge of Drinker Biddle's Florham Park office.
And both Riker Danzig and Drinker Biddle have helped Johnson & Johnson navigate product liability issues. Riker Danzig represents the pharmaceutical titan in the ongoing multidistrict litigation over adverse health effects stemming from its pelvic mesh, and Drinker Biddle secured a victory for J&J in two products liability cases alleging a talc-based product caused ovarian cancer.
Riker Danzig's litigation prowess in 2016 also extended to the Third Circuit, where a panel handed down down a precedential decision ending a putative class action brought against its client, Fidelity National Title Insurance Co., and affiliated underwriters seeking in excess of $150 million.
Navigating Health Care Transformations
Hospital mergers are in vogue right now in New Jersey, where Camden-based Cooper University Health Care recently announced its plan to buy three Trinity Health facility to form the fourth-largest hospital system in the state and the largest in South Jersey.
Drinker Biddle got a piece of the trend last year when it advised Meridian Health System in its affiliation with Hackensack University Health Network, a merger that created a health network of 13 hospitals across seven New Jersey counties and that generates approximately $4.3 billion annually. The firm is also advising Hackensack Meridian Health in its acquisition of John F. Kennedy Health System.
Another key New Jersey player in the health care front, St. Michael's Medical Center in Newark, had Cole Schotz to thank for steering it through the Chapter 11 bankruptcy process and subsequent $62 million sale to Prime Healthcare.
Looking forward, Garber noted that competitive spirit, flexible thinking and smart pricing are what keeps attorneys firmly "outside the box." And these players embody those attributes.
"When clients perceive that they are receiving value, it allows law firms to attract new business and maintain business from valued clients. The firms that embrace alternative fee arrangements and value pricing of their services are able to compete for talent from larger national firms," Garber said.
--Editing by Katherine Rautenberg.https://www.law360.com/articles/968876/nj-powerhouses-eclipse-competitors-amid-stagnant-demand-
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J&J pay out $57M in vaginal mesh case
Oct 3, 2017 | Medical Plastics News
By Reece Armstrong
A US woman has received $57 million in damages from Johnson & Johnson for the injuries caused by the company’s vaginal mesh implant.
It is the largest pay-out to date for a verdict relating to the mesh devices. Numerous cases have been launched since 2015 in the UK, US and Australia.
The damages were awarded to 51-year-old Ella Ebaugh who had the TVT-Secur device implanted in 2007 after suffering from incontinence. After her condition didn’t improve she had a second TVT device implanted. The devices are made by Johnson & Johnson’s subsidiary Ethicon. Ebaugh suffered from a range of complications due to the TVT device such as pelvic pain and urethral erosion and had to undergo three corrective surgeries.
Ethicon was found liable for causing injury to Ebaugh due to the devices being negligently and defectively designed.
The court case revealed that the TVT-Secur was developed to address the issues seen by Ethicon’s previous mesh products. The product was pushed to market without trial to compete with existing products. By applying for a 510(k)-premarket notification, the TVT-Secur did not have to undergo clinical trials as it was similar to existing products on the market.
French gynaecologist professor Bernard Jacquetin, told The Guardian that Johnson & Johnson acted “irresponsibly” by launching the device without adequate evidence. A study was later done by Jacquetin on the TVT-Secur in 40 patients. The device had success rates of 77% two months after surgery. Ethicon’s original TVT mesh device had success rates of around 85-90%.
Documents provided during the trial show that Ethicon knew about the disappointing results. Ethicon’s director of sales Xavier Buchon suggested the company should withhold the results while it reviewed the patients to be included in the analysis. In an email, Buchon said: “No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion.” The TVT-Secur device was withdrawn from market in 2012.
About the verdict an Ethicon spokesperson said the company is planning to appeal. The spokesperson said: “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.
Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.”
Kila Baldwin, the attorney representing Ebaugh told Law360: “Hopefully they recognise that their conduct was reckless. I hope this sends a clear message that they did something wrong with these products and that they really think, going forward, about what they do.”
https://www.medicalplasticsnews.com/news/j-j-hit-with-57m-veri/
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Vaginal mesh problems in UK and USA for J&J
Oct 2, 2017 | News-Medical.net
By Dr Ananya Mandal
Meshes in the United Kingdom
Vaginal meshes have been used surgically in over 75,000 women in England who undergo surgery to correct stress incontinence and vaginal prolapsed. The surgeries between 2006 and 2016 have used this mesh according to data from the NHS. Experts believe that some of these meshes that have been used have never been clinically tested and this is a disaster waiting to happen.
Reports suggest that one in 15 of these meshes that have been surgically implanted have been removed due to complications. They had been used for a 20 minute surgery that is used to correct stress incontinence and prolapsed that results from childbirth. The basic principle of the surgery is insertion of a polypropylene mesh that would support the vagina and the bladder from sagging. In some women the insertion of this mesh is not successful leading to chronic pain that makes it difficult for them to walk or go about their regular day-to-day activities and also makes sexual intercourse painful. Evidence has shown that the mesh that is supposed to be flexible within the body does not always remain so. It hardens and stiffens and can cut into the neighboring organs such as the bladder causing internal injuries.
One manufacturer is Ethicon, a subsidiary of Johnson & Johnson. At present over 300 women from United Kingdom are moving towards legal action against Johnson & Johnson because of their dissatisfaction and complications that arose from this mesh. David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, called this a “significant medical case” claiming that there could be “billions of pounds” in settlements that could make this the “largest medical case in UK history”. On the other side, a spokesperson for Johnson & Johnson said that this mesh has been through rigorous years of clinical research and said that they are confident of their products and these pelvic mesh devices are being used worldwide without complications.
Johnson & Johnson loses a case to a woman in Pennsylvania
Johnson & Johnson must pay out $57 million in compensation to Ella Ebaugh, 51, who underwent vaginal mesh insertion. This insertion was followed by three surgeries that she had to undergo due to the complications. The mesh had cut into her urethra (tube that carries urine out of the body). This is a serious complication that necessitated a surgical correction.
Ms Ebaugh underwent a surgery to correct urinary incontinence that is seen commonly after childbirth. She had had five deliveries that led to her incontinence. She was fitted with Johnson & Johnson’s Ethicon vaginal mesh. Soon she started developing “excruciating pain” on standing, sitting or performing any activity. She had to undergo three surgeries after the initial one to correct the complications and the mesh had to be removed. Despite the surgeries, part of the mesh still remains within her. Ms Ebaugh was awarded her payout after a jury in Philadelphia voted in her favor stating that Johnson & Johnson had been negligent and the mesh was designed defectively.
There are more than 1,000 lawsuits at present around the world, including the US, the UK and Australia, against Johnson & Johnson from women who have developed complications.
Ethicon plans to appeal the court’s decision. They said in a statement, “We believe the evidence in the Ebaugh trial showed Ethicon’s devices were properly designed.”
https://www.news-medical.net/news/20171002/Vaginal-mesh-problems-in-UK-and-USA-for-JJ.aspx
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More laughing, less leaking: Frederick Memorial Hospital event offers urinary incontinence solutions
Oct 3, 2017 | The Fredrick News-Post
By Imade Borha
Many of us know the feeling of needing to use the bathroom and being unsure if you’ll get there in time. But for the 1 in 4 women over 18 who experience moments of leaking urine involuntarily, according to the National Association for Continence, this occurrence can impact daily activities and bring unwanted embarrassment.
At the “I Only Leak When I Laugh” event last week hosted by Frederick Memorial Hospital’s Women Center, women’s incontinence was discussed by Dr. Gary Ott and FMH Rehabilitation physical therapist Lynne Schill, MPT.
For a variety of reasons including stigma, Ott said his patients often deal with incontinence for about 6½ years before seeing Ott at Simmonds, Martin & Helmbrecht OB-GYN practice.
Though incontinence includes many frustrations, such as purchasing pads and waking up in the middle of the night, Ott also hears about the activities his patients can no longer do.
“Listen. I’m so mad. I can’t jump on a trampoline with my kids anymore,” Ott said of what he frequently hears from new patients.
Before deciding treatment options for his patients, Ott does an extensive evaluation to understand the incontinence that a person is experiencing. He explained at the “I Only Leak When I Laugh” event that there are four different types of incontinence: urge, stress, overflow and functional. Urge incontinence — popularized by the “Gotta go, gotta go right now” Detrol commercials — involves the urge to use the bathroom suddenly. Stress incontinence is leakage when stress or force is imposed on the bladder through laughing, coughing, sneezing or rising from sitting to standing. Overflow is a form of incontinence where a person is unable to empty their bladder. Functional incontinence is when someone cannot get to the bathroom in time for reasons of immobility.
The risk for incontinence can increase with constipation, being overweight and having a hysterectomy, along with pregnancy and childbirth.
“As much as we love these kids, they do a lot of damage,” Ott said. He added that childbirth can damage the connective tissue between the vagina and the bladder.
A prolapsed bladder can occur, where this connective tissue barrier becomes too damaged. As a result, the bladder lowers on top of the vagina, increasing the chance of pain and stress incontinence.
Ott explained possible medical interventions, including the insertion of a surgical mesh that strengthens the tissue between the vagina and bladder.
Surgical mesh has had a contentious history. It’s not unusual to view a vaginal mesh lawsuit commercial while watching a daytime court TV show. But Ott shared that after an influx of doctors performed surgical mesh procedures, there is now a lot less and among that number, many are often more qualified.
Ott’s own surgical approach is implanting a thin mesh called Desera with three insertions. Ott compared the procedure to placing a solid surface underneath an active garden hose. When a person steps on that garden hose, the water is incapable of flowing out because of the support beneath it, which is different when someone steps on an active garden hose that is on sand.
Ott said that a hospital stay for a surgical mesh procedure can be from two hours to overnight.
Lifestyle changes can also be made to reduce incontinence, including pelvic floor kegel exercises that Schill teaches to strengthen the pelvic muscles. She described these muscles as like a bowl at the bottom of the pelvis.
“Unfortunately, those muscles are really thin and really small,” Schill said. She added that a woman in her 20s can have pelvic muscles that are the thickness of five layers of tissue paper. “They get very thin as time moves on.”
Kegel exercises can strengthen the pelvic muscles, but Schill warned that most likely, you can do these exercises incorrectly because the pelvic muscles are so small, the feeling of the muscle contracting during exercises can be difficult to sense.
Another way of improving bladder health, Schill advised, is avoiding certain food and drinks that include citrus, caffeine and alcohol that can irritate the bladder. Schill’s list of “safe foods” for the bladder include pears, watermelon, apricots, papayas, non-citrus herbal teas and acid-free coffee.
Schill also warned that limiting drink consumption in hopes of less accidents can cause the urine to become more concentrated, which can irritate the bladder. Using the bathroom many times can also produce an unwarranted effect, Schill explained, because the bladder needs to learn to fully expand.
Rushing to the bathroom is also not encouraged by Schill, who recommends that when you have the urge to go, stand still or sit down, take deep breaths, contract your pelvic muscles and slowly proceed to the bathroom to keep your bladder calm.
When using the bathroom, Schill also said, sit on the toilet and don’t hover.
“The squatting position is the relaxing position for your pelvic floor,” Schill explained. She recommended that while using the toilet, to place your feet on a small stool like a squatty potty. This position, where the knees are higher than the hips, is the preferred way to use the toilet according to Schill.
Schill closed with a pep talk. She has seen the progress of her clients, and she wanted the audience to know they can progress in their journey toward continence as well.
“Tell your bladder who’s in charge,” said Schill, who believes in the power of positive thinking.
Schill’s last slide summed up the event’s purpose: “You should never stop laughing but you can stop leaking.”
https://www.fredericknewspost.com/news/health/more-laughing-less-leaking-frederick-memorial-hospital-event-offers-urinary/article_7f3eb05d-06a3-59f8-9889-2032b5be11c3.html
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