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Product Liability Group Of The Year: Shook Hardy
Feb 1, 2016 | Law360
By Steven Trader
After scoring victories on behalf of Philip Morris both overseas and domestically, as well as the continued success at trial representing Boston Scientific Corp. in its pelvic mesh litigation in 2015, the product liability team at Shook Hardy & Bacon LLP nabbed a spot among Law360's Product Liability Groups of the Year. -
Mostyn Law Calls On FDA, Boston Scientific To Stop The Use Of Counterfeit Surgical Mesh
Jan 29, 2016 | SE Texas Record
By David Yates
A federal judge in West Virginia urged a plaintiff in a lawsuit against Boston Scientific Corp. to ask the Food and Drug Administration to investigate the company's use of a plastic resin from China to make vaginal surgical mesh. The Jan. 26 decision by U.S. District Judge Joseph Goodwin in Charleston directed plaintiff Teresa Stevens to ask the FDA ... -
MP Owen Smith, Welsh Shadow Work And Pensions Secretary: ‘In Six Years This Is The Worst Medical Issue I Have Come Across’
Jan 29, 2016 | Cambs Times
By Kath Sansom
Real life stories of how women have gone from healthy and active to suffering terrible pain with some walking on sticks or in wheelchairs were outlined in the meeting, called to hear the devastating effects when a mesh sling operation goes wrong. MP Owen Smith, Welsh shadow work and pensions secretary... -
A Workout To Overcome Incontinence -- And Look Good
Feb 1, 2016 | TH Online
By Wendy Donahue
Forceps helped bring Cristin Taylor's first child into the world, a joy that outweighed the pain of the fourth-degree tear Taylor suffered in her perineum during the birth. The wounds closed, but Taylor struggled with urinary incontinence. She'd leak when she ran, coughed or brushed her teeth.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Full Text of Stories Below
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Product Liability Group Of The Year: Shook Hardy
Feb 1, 2016 | Law360
By Steven Trader
After scoring victories on behalf of Philip Morris both overseas and domestically, as well as the continued success at trial representing Boston Scientific Corp. in its pelvic mesh litigation in 2015, the product liability team at Shook Hardy & Bacon LLP nabbed a spot among Law360's Product Liability Groups of the Year.
In one of the first so-called Engle progeny trials of 2015, the team at Shook Hardy, acting as lead counsel, helped Philip Morris USA Inc. duck a $29 million liability suit brought by a former smoker claiming the cigarette maker’s product caused his laryngeal cancer. The firm’s success only continued from there, convincing a jury to side with the tobacco giant in two other trials, and limiting the amount of damages in at least one more.
Shook Hardy, whose product liability team of 329 is the largest in the world, also found success on behalf of Philip Morris overseas, convincing an Israeli district court judge to dismiss a proposed class action of “lights” smokers who claimed they were tricked into believing they were smoking healthier cigarettes. After the group appealed to Israel’s Supreme Court, Shook Hardy won that argument as well.
John Murphy, chairman of the firm, said the key to the firm’s success defending clients, whether it be Engle progeny or in the pharmaceutical or automotive fields, is being more prepared for cases as well or better than anyone else in the country.
“We’re trial lawyers first, and I also think that our ability to engage with jurors is very important and very critical, and I think makes us very successful,” Murphy said. “We’ve always been able to take complex cases, complex themes and make them simple for jurors. That’s always been a hallmark of ours.”
It can be a particular challenge when you’re on the corporate side and facing off in a courtroom against someone who’s been harmed by smoking or any other product, where the sympathies of the jury may first lie with a plaintiff, Murphy said.
“But I think we’ve always recognized that you have to humanize your corporate client, and that’s something I think we’ve done very well,” Murphy said. "I don’t know if it dates back to our Midwest beginnings, but there’s always been a certain attitude I think permeates our trial lawyers regardless what office they’re in, there’s not an arrogance there, and I think that comes across to jurors.”
In October, the Shook Hardy team helped Boston Scientific fend off a suit by a woman who claimed she was injured by one of the company’s vaginal mesh products. The firm convinced a North Carolina federal jury that Martha Carlson hadn’t proved her design defect or breach of warranty claims related to Boston Scientific’s Uphold Vaginal Support System, which was marketed as a thinner and lighter alternative to synthetic mesh devices.
The case had been remanded to North Carolina from the West Virginia federal court overseeing multidistrict litigation against the company. In late 2014, Shook Hardy won two similar jury verdicts. Of the 14 mesh cases tried to jury verdict, Shook Hardy has achieved three of the four defense wins, the firm said.
“I think those are cases where we’ve typically excelled,” Murphy said. “Products cases involving science, engineering and health issues have always been our strong point. And the fact that, of the defense cases that have been won there, we’ve been involved with 75 percent of them, I think that’s important.”
Murphy said one of the key factors that differentiates the firm is its team of 115 professionals with advanced degrees in biology, chemistry and biochemistry, among others, that make up what’s called its analyst program, which the firm started in the 1970s. That team helps litigators formulate discovery and trial theories, evaluate scientific and technical issues and identify and prepare experts — a godsend as part of a trial team, according to Murphy.
That bodes well for a firm that acts as national counsel for nine or 10 pharmaceutical and medical device companies. The national counsel role has allowed the firm to spot trends with respect to issues like food product liability, how plaintiffs’ lawyers may want to attack particular aspects of a company’s product, and has allowed them to be very proactive with clients in a counseling role, Murphy said.
“You want to be in a position where I think we are, where you have the trial lawyers that have the street credibility to be able to successfully try the case in a courtroom,” Murphy said. “But you also want to be in a position where you can proactively advise your client, work with them so that the courtroom never becomes a battleground, and we continue to do that.”
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Mostyn Law Calls On FDA, Boston Scientific To Stop The Use Of Counterfeit Surgical Mesh
Jan 29, 2016 | SE Texas Record
By David Yates
A federal judge in West Virginia urged a plaintiff in a lawsuit against Boston Scientific Corp. to ask the Food and Drug Administration to investigate the company's use of a plastic resin from China to make vaginal surgical mesh.
The Jan. 26 decision by U.S. District Judge Joseph Goodwin in Charleston directed plaintiff Teresa Stevens to ask the FDA for a determination on the safety of products made by Boston Scientific Corp.
As previously reported, the plaintiff recently filed a lawsuit claiming Boston Scientific used counterfeit resin smuggled from China.
Judge Goodwin said the regulatory agency should be given the first opportunity to decide whether Boston Scientific's mesh should be banned for use in vaginal implants under the doctrine of "primary jurisdiction."
The doctrine allows a judge to halt a case while a regulatory agency determines technical matters.
Judge Goodwin did not dismiss any of the claims made by Mostyn Law on Stevens' behalf but did halt action while the FDA investigates. The court also recognized that the FDA cannot resolve all of the claims by Stevens, retaining its jurisdiction over the case and ordering a status report on the FDA's investigation on May 1.
Houston-based Mostyn Law, headed by attorneys Amber and Steve Mostyn, sued Boston Scientific and three other companies under the Racketeering and Corrupt Organizations Act on behalf of Stevens and other women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems and other complications from the plastic mesh implants, which are used to treat urinary incontinence and shore up pelvic organs.
"Our efforts to get justice for women who have been harmed by Boston Scientific's dangerous surgical mesh are far from over,” said Amber Mostyn in a Jan. 27 press release.
“The court has given the FDA an opportunity to act, but retained jurisdiction over the lawsuit while the FDA investigates. Boston Scientific is making a product that harms tens of thousands of women with counterfeit plastic that contains high levels of toxic selenium. The company should take this product off the market immediately. And if Boston Scientific won't do the right thing, the FDA should make them do it without delay.
"In the meantime, Boston Scientific should release its documents to the FDA and the public. We won't stop until we get to the bottom of this and will continue to seek justice for women who have already suffered from Boston Scientific's reckless disregard for their health."
Goodwin's ruling was the latest development in a lawsuit that accuses Boston Scientific of engaging in an international conspiracy to import counterfeit plastic resin from China for its surgical mesh.
The lawsuit against Boston Scientific is based largely on internal company emails and other communications that remain confidential.
Mostyn Law obtained the internal Boston Scientific messages in connection with other civil suits against the mesh-maker. In its latest filing, the firm said Boston Scientific has fought to keep its internal communications private because it wants to "conceal serious misconduct."
Mostyn Law has asked Goodwin to publicly release all of the internal communications to protect "public health and safety."
The judge has not ruled that request. However, Goodwin agreed last week to release a court document filed by Mostyn Law that refers to "facts taken from internal documents and emails" obtained from Boston Scientific.
The internal company messages from 2011 to 2012 reveal that despite worries about the reliability of the Chinese resin supplier, Boston Scientific devised ways to smuggle from China 34,000 pounds of the material without verifying or fully testing it, the press release states.
According to the newly released court filing, a Boston Scientific employee worried, "God knows what grade, or even recycled material" was in the Chinese resin.
Boston Scientific has continuously blocked release of the internal emails and documents while maintaining that the suit has no merit, the press release states.
"If Boston Scientific thinks we're wrong, it could immediately release the documents and let the FDA and the public decide for themselves. Right now, we can't share our evidence with the FDA," said Amber Mostyn.
The unsealed Mostyn filing includes a detailed timeline describing how Boston Scientific turned to a known counterfeiter in China after a U.S. manufacturer warned that the plastic resin should not be used in the human body and stopped selling it for surgical mesh.
The federal court lawsuit is an unusual use of the RICO statute, which is typically used by the Justice Department to target criminal organizations but can also apply to civil lawsuits.
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Jan 29, 2016 | Cambs Times
By Kath Sansom
Real life stories of how women have gone from healthy and active to suffering terrible pain with some walking on sticks or in wheelchairs were outlined in the meeting, called to hear the devastating effects when a mesh sling operation goes wrong.
MP Owen Smith, Welsh shadow work and pensions secretary, who backs the campaign after hearing about a woman living locally to him suffering from the mesh operation, said: “In six years this is the worst medical issue I have come across.
“To hear of my constituent’s suffering and terrible pain because of an operation that was supposed to help is awful.”
Professor Keith Willett, director of acute episodes of care for the NHS, was among those handed dossiers of evidence giving accounts of how the mesh can erode, cut into organs, cause lifelong health problems like fibromyalgia or mean women lose their sex lives.
NE Cambs MP Steve Barclay said: “This is not about party politics this is about getting the right care for women.
“Kath deserves huge credit for the work she has done to raise awareness of the risks involved when vaginal mesh implants go wrong, and following my meeting with Professor Willet in the summer at the House of Commons it was great this time to have the benefit of Kath’s input and first hand experience.
“A number of actions were identified to better raise awareness, make it easier for women to report problems and improve the data collection of these reports.
“There is still much more to do to ensure women are aware of the risks of these implants, but is welcome that the NHS now recognises the seriousness of the problem and that it is taking steps to improve surgical procedures and patient information.”
Ten action points were outlined as part of a pledge to look at problems with the operation which inserts mesh as a permanent device.
A December 2015 study carried out by four Canadian clinicians shows that patients of less experienced surgeons have a 37 per cent higher risk of ing mesh complications and a study in 2013 into mesh used for pelvic organ prolapse repair was stopped early due to a 15.6 per cent complication rate.
But Scottish campaigner Olive McIlroy said: “It is not about the numbers, it is about the seriousness of complications when things go wrong, even for one patient.”
Surgeon Christine Landon writing in a medical journal The Expert Witness, said there were a number of factors leading to controversies around mesh implants and the complications some women have suffered.
“These seem to centre not only around the patient selection and possible lack of surgical experience, or inadequate training leading to poor technique and sub optimal surgical standards for some women, but also the inherent properties of plastic mesh and the human tissue response to it in some patients.
“Surgeons may be taking on procedures that appear to be straightforward and that are marketed to them and presented in handy kit form but that are in reality technically challenging to get absolutely right.”
Gosport MP Caroline Dinenage, minister for women and equalities, said: “The impact of mesh surgery to treat stress urinary incontinence has caused serious unintended medical problems for many women throughout the UK.
“That is why I am working alongside other MPs to see how we can tackle this complex issue and ensure that women who have suffered from complications associated with mesh surgery are listened to and supported.”
The meeting came shortly before news that prescription nerve blocker drugs gabapentin and pregabalin, used by many mesh injured women to control pain, could soon be more tightly regulated.
Government advisors called for them to become Class C, which would mean they cannot be repeat dispensed and prescriptions will only be valid for one month.
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A Workout To Overcome Incontinence -- And Look Good
Feb 1, 2016 | TH Online
By Wendy Donahue
Forceps helped bring Cristin Taylor's first child into the world, a joy that outweighed the pain of the fourth-degree tear Taylor suffered in her perineum during the birth. The wounds closed, but Taylor struggled with urinary incontinence. She'd leak when she ran, coughed or brushed her teeth.
A decade-long battle with her bladder raged through Kegel exercises, the birth of another daughter and physical therapy (not with a pelvic floor specialist). Taylor resorted to surgery to insert mesh support, in hopes of correcting what had been diagnosed as a tilt in her bladder neck. After six weeks of recovery, the incontinence continued -- now accompanied by numbness that dulled her sex life. "It was like a foot that had fallen asleep."
In 2011, Taylor and a friend tried a new fitness class at a gym near her home in Satellite Beach, Fla. Called Fluidity. The class uses an adjustable-height barre to strengthen all muscle groups, but particularly the lowest and innermost structures of the core, what Fluidity founder Michelle Austin calls "the inner unit."
"Michelle talked a lot about the pelvic floor and alignment awareness," Taylor said. "They had three classes a week, and I came every time I could. Within six months, I was noticing huge changes in my life, including a wonderful, more connected sex life with my husband."
Women like Taylor were the original target for Austin's Fluidity regimen, which has been taught at gyms and rehabilitation centers around the country for longer than decade. But, in the last year Fluidity has been noticed and recommended by Microgate USA, a company that specializes in movement analytics to help everyone from professional athletes to the elderly and Parkinson's patients.
Anyone can benefit from the regimen, Austin said, which revolves around a barre with a backboard that rises from the floor. The ability to adjust the Fluidity barre to hip height is key, Austin said, because it reduces the tendency to perform exercises in a posterior tilt, which compromises alignment and effectiveness of some barre workouts.
Fluidity's goal: To correct pelvic instability that can contribute to chronic complaints such as incontinence, back pain, sexual dysfunction and loss of balance as we age.
The concept emerged from Austin's resolve to rehabilitate herself after cancer and a full hysterectomy at age 42, combined with her training in the Lotte Berk barre method, which Austin taught in the 1990s in New York City.
"In hysterectomies, they're taking out an organ, if not several, and there's no rehab," Austin said. "It's ridiculous."
Fluidity classes now are held at rehabilitation centers and gyms around the country. An at-home counterpart includes a collapsible barre, DVDs, mat, ball and bands.
The pelvic-floor muscles often become dysfunctional after childbirth, gynecological surgery, illness such as urinary tract infections, or just from disuse, says Cindy Neville, a physical therapist specializing in women's health who is on clinical faculty at the University of Northern Florida.
That dysfunction can contribute to pelvic organ prolapse, where the vaginal walls or cervix drop, as well as incontinence, estimated to affect 30 to 40 percent of middle-aged women and 30 to 50 percent of elderly women.
Many women suffer in silence. If they seek treatment, doctors sometimes recommend a surgery like Taylor's. Of the 400,000 pelvic floor surgeries annually in the U.S., 120,000 of those are repeats, Neville said, suggesting that surgery isn't solving the problem.
"But, people are afraid to talk about the pelvic floor muscles; it's like breast cancer 20 years ago; to say the word breast was almost pornographic in our culture," she said.
Neville recommends Fluidity to some of her patients.
"In Fluidity there's not an emphasis on bending forward or rounding forward, it's more balanced with the front and back of the body, versus always being the front of the body, which so many things focus on," Neville said. "The neutral pelvis and engaging the deep core, including the pelvic floor, are very effective."
Peter Gorman, the president of Microgate USA who holds several patents on heart rate monitors, met Austin at a deli counter in Florida over Thanksgiving in 2014.
"I didn't know what Fluidity was, but she and I were speaking the same language," he said. "As you lose integrity in your core, especially your inner core, things happen; you can get physiological changes from anatomical deficiency."
He was curious enough about her method to observe her Fluidity class, where Austin guided participants into what she calls the "neutral pelvis" position: Wrap thumb and index finger around the right hip and around the left hip and tilt the pelvis all the way forward and all the way back. When you find the position where the wrist feels relaxed between those two places, that's neutral pelvis.
In that position, the muscles can contract and relax more effectively to not just tone the body but re-establish the stability of the inner core and pelvic floor.
Gorman thinks the Fluidity regimen has applications beyond fixing incontinence, which he views as an early warning sign for problems that become life-threatening as we age.
"As we march through life, we lose our balance control," Gorman said. "The average 53-year-old should be able to stand on one leg with eyes closed for 15 seconds. If she can't, she's at a higher risk (of deadly falls). So, what if we put her in a program where besides just feeling good and losing some pounds -- hey, let's all go to Ipanema together! -- but also, her balance, timing and coordination improved? By doing that she's basically learned to grow younger."
A year after starting Fluidity, Taylor visited a cranial sacral therapist who evaluated her muscle control.
"She reported I have 360 degrees of strength in my pelvic floor, which to her was phenomenal, regardless of what I recovered from," Taylor said.
Fluidity isn't a cheap or instant cure, she noted. When she is busy and goes on hiatus from her Fluidity workouts, she notices her bladder control starts to lapse. It's one reason she invested in the barre system for her home.
"I feel like I have this tool," Taylor said, "and I can always heal myself."
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