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Second June Rally of Pelvic Mesh-Injured Women and Families Planned for June in Charleston, WV
May 7, 2016 | Mesh Medical Device News Desk
...That day should mark the beginning of Edwards v. Ethicon in federal court before Judge Joseph Goodwin. he defendant corporation is Ethicon, a division of Johnson & Johnson, the manufacturer facing the largest number of mesh cases consolidated in this federal court among seven manufacturers. -
Australian mesh device manufacturer failed to show how benefits outweighed risks
May 7, 2016 | Newcastle Herald
By Joanne McCarthy
Australia’s peak health regulator cancelled an Australian-made mesh device implanted in thousands of women after the manufacturer failed to show how the benefits of mesh implants outweighed the risks, and questions about a “large discrepancy” in reported problems. -
A Scourge for Mothers: Pelvic Organ Prolapse
May 6, 2016 | The New York Times
By Rachel Nardos
In recent years, there has been growing awareness of the devastating effect of obstetric fistulas. But many women are at risk for a severe condition that affects even more people than fistulas: pelvic organ prolapse. -
Pharma and Medical Device Companies Paid Idaho Doctors $24 Million
May 8, 2016 | Magic Valley
By Bryan Clark
...Gynecologist Dr. Ty Erickson of Idaho Falls topped the list in eastern Idaho. Between mid-2013 and late-2014, he received more than $200,000 from medical device manufacturers. His biggest benefactor was Coloplast, a Danish company which manufactures devices called “transvaginal meshes” which are used to treat pelvic organ prolapse and stress urinary incontinence. -
CVN To Webcast $6M+ Boston Scientific Pelvic Mesh Trial In Massachusetts
May 6, 2016 | CVN
By David Siegel
Opening statements begin Monday in a Massachusetts state courtroom in a potentially $6 million product liability lawsuit against Boston Scientific Corp. claiming one of the company’s allegedly defective pelvic mesh implants caused a woman to suffer chronic pain and to need numerous additional surgeries. -
Endo endgame? Pharma trouble, employment hit stock averages
May 6, 2016 | Communities Digital News
By Terry Ponick
...But the drug sector’s issues pre-date the current problems being endured by Endo, which, among other things, is still busy trying to settle multiple millions of dollars’ worth of vaginal mesh lawsuits—you know, the ones the ambulance-chasing thieves lawyers pitch constantly on late night cable TV channels. -
Improving urinary incontinence through physical therapy
May 7, 2016 | WRVO
By Kaylyn Izzo
...This week on “Take Care,” Dr. Jenni Johnson Gabelsberg explains this problem, known as urinary incontinence, and how to fix it through physical therapy. Gabelsberg is a nationally prominent physical therapist whose focus is on pelvic floor rehabilitation. She has a doctor of physical therapy degree, and lectures widely on evaluation and treatment for female and male pelvic floor dysfunctions, such as urinary and fecal incontinence. -
AUA 2016:The truth behind transvaginal mesh litigation: Devices, timelines, and provider characteristics - Session Highlights
May 9, 2016 | Uro Today
By Lauren Wood, MD
Lauren Wood of Los Angeles, CA reported the results of study of a 1% random sample of the Bloomberg Law Database. The authors reported that 63% of the 710 claims for transvaginal mesh involved slings for stress incontinence, with retropubic slings being slightly more common than transobturator , 13.3% involved pelvic organ prolapse mesh and 23.2% involved both slings and prolapse mesh. -
AUA 2016: Role of uterine preserving surgery in mesh based pelvic organ prolapse repair. - Session Highlights
May 9, 2016 | Uro Today
By James Forde, MD
james Forde presented data on mesh prolapse repair in 10,339 women between 2008-2013 from a statewide research database in New York. -
AUA 2016: What is the role of preoperative urodynamics for women undergoing prolapse surgery? - Session Highlights
May 9, 2016 | Uro Today
By Dianne Glass, MD
Dianne Glass from New York University presented data from a retrospective study on the role of preoperative urodynamics in patients undergoing surgical correction of pelvic organ prolapse. -
AUA 2016: Pathophysiological relationship between pelvic organ prolapse and overactive bladder - Session Highlights
May 9, 2016 | Uro Today
By Steven Weissbart, MD
Steven Weissbart from the University of Pennsylvania presented the results of a prospective, cross-sectional study of risk factors for overactive bladder syndrome in women with pelvic organ prolapse. They evaluated the risk factors for overactive bladder syndrome in pelvic organ prolapse. -
Check Out Your Health In Your 50’s
May 9, 2016 | News 8 WTNH
By Ann Nyberg
...Nationally renowned Urogynecologist Dr. Mark Preston will be on-hand from 2 – 4 p.m. to privately provide women free advice and solutions to questions regarding pelvic health and incontinence issues. Dr. Preston is an expert in Urogynecology, specializing in the minimally-invasive treatment of pelvic organ prolapse and urinary incontinence.
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Second June Rally of Pelvic Mesh-Injured Women and Families Planned for June in Charleston, WV
May 7, 2016 | Mesh Medical Device News Desk
Just as they did last June, organizers of mesh-injured women want the public to know a rally is planned for Charleston, West Virginia on Friday, June 3, 2016.
That day should mark the beginning of Edwards v. Ethicon in federal court before Judge Joseph Goodwin.
The defendant corporation is Ethicon, a division of Johnson & Johnson, the manufacturer facing the largest number of mesh cases consolidated in this federal court among seven manufacturers.
Last June 2, Mesh Awareness Movement (MAM) brought women and their families from Kentucky, Ohio, Pennsylvania, Florida and beyond to join in solidarity and send a message that pelvic mesh should not be allowed to continue to injure unsuspecting women and that mesh manufacturers need to financially care for the women they’ve harmed.
A dinner is planned June 2, Thursday, with the rally beginning 8 am Friday morning in front of the Robert C. Byrd federal courthouse.
Pelvic mesh, used to shore up pelvic organs, was never approved for safety or efficacy by the U.S. Food and Drug Administration. Instead it was approved by the FDA 510(k) approval process that does not require any clinical trials. Assurances of safety rely on the integrity of the manufacturer.
Litigation was consolidated in federal court in Charleston by the Judicial Panel on Multidistrict Litigation in January 2012.
Since then, seven manufacturers now face more than 90,000 lawsuit alleging they sold defective transvaginal mesh which was promoted to doctors as part of an aggressive, yet deceptive campaign. The plaintiffs allege defective manufacturing instructions to doctors and a breach of warranty, negligence, fraud, and more. They are asking for punitive damages.
Only American Medical Systems (AMS) has offered mass settlements to women, though many women tell MND their settlement amount is as low as $5,000 after legal fees are paid and any existing liens.
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Australian mesh device manufacturer failed to show how benefits outweighed risks
May 7, 2016 | Newcastle Herald
By Joanne McCarthy
Australia’s peak health regulator cancelled an Australian-made mesh device implanted in thousands of women after the manufacturer failed to show how the benefits of mesh implants outweighed the risks, and questions about a “large discrepancy” in reported problems.
Former Australian champion basketballer and Newcastle Falcons player Paul Zadow is appealing the November 2014 cancellation after the Therapeutic Goods Administration (TGA) found his company, TFS Manufacturing, had failed to provide “sufficient evidence to establish the benefits to be gained from using this device”.
The Tissue Fixation System (TFS) was one of the first transvaginal mesh devices cancelled by the TGA following significant concerns in Australia and overseas about more than 60 different mesh devices, and mesh as a class of products. More than 13,000 TFS devices have been sold worldwide.
Details about the cancellation are made public for the first time after the cancellation report was obtained following a freedom of information application through the American Food and Drugs Administration (FDA).
The report adds to calls for a Senate inquiry into the registration of mesh devices in Australia by women implanted with one of more than 40 mesh devices, including the Tissue Fixation System device, available in Australia for a decade from 2005.
The cancellation review and report showed that nearly 10 years after the TGA registered the TFS device for use on the Australian market, the regulator had serious concerns about the reporting of adverse events experienced by women.
Mesh devices are used in women experiencing prolapse, or weakening of the pelvic muscles and ligaments, after pregnancy and childbirth.
TFS Manufacturing advised the TGA that between 2005 and May 2014 the company had had only two complaints, and one of those related to advertising. The TGA noted it was unclear if the complaints related to Australia, where 1938 devices were sold, or worldwide, but it raised “serious concerns”.
“This result is not consistent with the known complication rates associated with this type of device,” the TGA cancellation report said.
“This clear discrepancy between the expected complication rate and the rate presented by the (company) raises serious questions regarding the quality of the post market surveillance system utilised by the (company) and manufacturer.”
The TGA found TFS Manufacturing had failed to adequately address concerns about how it identified and managed risks including erosion of mesh devices in women, bleeding, voiding dysfunction, urinary retention and damage to the bladder and bowel during surgical procedures to implant the mesh devices.
The company had failed to provide adequate clinical evidence to meet TGA requirements for the device. The cancellation report noted one article referred to in a review of the clinical evidence related to an incontinence device specifically for males.
Mr Zadow did not respond to questions from the Newcastle Herald. In March Mr Zadow confirmed his company was seeking reinstatement of the TFS mesh device on the Australian Register of Therapeutic Goods and had an appeal before the Administrative Appeals Tribunal.
”While the review is in process, we cannot make any further comment about the TGA’s decision,” Mr Zadow said in March.
Australian Pelvic Mesh Support Group member Gai Thompson warned the TGA five years ago that mesh devices – including the Johnson and Johnson mesh device she received – had left women with permanent and serious complications.
The group will hold a rally in Canberra on May 25 and call for a Senate inquiry into the TGA’s registration of more than 40 mesh devices in Australia, and an investigation of how the TGA monitored their use.
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A Scourge for Mothers: Pelvic Organ Prolapse
May 6, 2016 | The New York Times
By Rachel Nardos
In recent years, there has been growing awareness of the devastating effect of obstetric fistulas. But many women are at risk for a severe condition that affects even more people than fistulas: pelvic organ prolapse.
Pelvic organ prolapse is primarily a childbirth-related injury, and leads to the bulging of pelvic organs like the uterus, bladder and sometimes bowel. Hadas Birhane is a 36-year-old Ethiopian woman who suffered from such a severe form of the condition that her womb hung eight centimeters outside of her vaginal opening.
I met Hadas on my recent surgical teaching trip to Mekelle, Ethiopia, on behalf of the Worldwide Fistula Fund and theFootsteps to Healing program at Oregon Health & Science University. Hadas is one of many rural Ethiopian women who silently suffer from this condition. A preliminary ongoing survey of three regions in Ethiopia estimates that 5,000 to 6,000 women have obstetric fistulas, while over 250,000 suffer from pelvic organ prolapse. Vaginal delivery, especially in the event of obstructed and prolonged labor, increases the chance that women will suffer from the condition.
Hadas acquired her prolapse after her first and only vaginal delivery 15 years ago. Like most women in rural Ethiopia, she labored for two days, unattended by a trained obstetric provider, before she had her baby at home.
When she noticed her organs bulging through her vaginal opening, she wasn’t sure what was going on.
“At first I thought it was a baby,” she said about the large tennis ball-sized vaginal protrusion. She went to a clinic where she was told she had prolapse. Hadas could not afford hospital fees and even if she could, it’s unlikely she would have found a doctor properly trained in pelvic medicine and reconstructive surgery to provide her with appropriate treatment.
“I stopped leaving my house. I couldn’t empty my bladder so I dribbled small amounts at a time, all day long. I felt like I was disabled,” Hadas told me, in tears. “I couldn’t tell anyone except my mother, who promised to take me to a doctor, but she died before she could. I couldn’t do what was expected of me. So I lived as an outcast.”
Her husband told her that if she sought care, doctors would remove her womb and that he would divorce her if she couldn’t bear him more children. Hadas did not want more children, but even if she did, her severe prolapse prevented sexual intimacy.
In Ethiopia, women are at very high risk for severe prolapse because of multiple factors: prolonged obstructed labor caused by lack of access to timely and skilled obstetric care; multiple vaginal deliveries starting at a young age; a lifetime of heavy lifting; and lack of access to properly trained healthcare providers who can provide early intervention for pelvic floor conditions. Women in the region with this condition often receive hysterectomies (the removal of the uterus) without a reattachment of the vagina to its normal supported position. This puts patients at higher risk for prolapse recurrence.
Until last year, there was no formal reconstructive surgery, or urogynecology, training program for healthcare providers in Ethiopia, despite the large burden of prolapse. But in 2015, the firsturogynecology fellowship program was launched in the country, a collaboration between several groups based in Ethiopia and overseas.
In January 2016, Hadas heard that a prolapse surgery team was coming to work with local doctors in her area. She tricked her husband into allowing her to travel to Mekelle and hitchhiked for two days to get to the hospital, hoping, finally, to regain her life. After 15 years of suffering, she was willing to risk losing her marriage and living a life of poverty as a divorced woman in rural Ethiopia. Hadas is now one of more than 100 women with severe pelvic organ prolapse to benefit from this collaborative fellowship program.
“I am thankful that I am cured,” said a beaming Hadas. “When I go back, I am going to tell others that there is help for this condition.”
As we look forward to celebrating all mothers this Mother’s Day, we are grateful that a unique model of global health collaboration gives mothers like Hadas a renewed sense of hope.
Dr. Rahel Nardos, originally from Ethiopia, is assistant professor of urogynecology at Oregon Health and Science University and a founder of OHSU’s Footsteps to Healing Global Women’s Health Initiative. She is also a board member of the Worldwide Fistula Fund.
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Pharma and Medical Device Companies Paid Idaho Doctors $24 Million
May 8, 2016 | Magic Valley
By Bryan Clark
Over a year-and a half, pharmaceutical companies and medical device manufacturers paid nearly $24 million to Idaho doctors.
They sent Idaho-licensed physicians to every state but Delaware and Maine, as well as to 15 foreign countries. Companies paid for more than 56,000 meals and more than 4,000 travel and lodging expenses.
Many physicians and experts say it’s important for doctors to have relationships with the companies that develop new health care products. As new drugs come on the market, physicians have to be kept informed in order to best treat their patients.
But experts say there are other, more worrisome effects of these relationships. There is strong evidence that speaking fees, free trips and other industry perks can influence the way physicians treat their patients, driving up the cost of care and industry profits without necessarily improving clinical outcomes.
Nothing is free.
“The idea that we can receive these kinds of gifts, no matter how small, and not be culturally programmed to reciprocate in some way is not realistic. We are influenced,” Dr. Rex Force said.
Force is the associate dean for clinical research at Idaho State University and an academic pharmacist.The Data
The Affordable Care Act requires pharmaceutical companies and medical device manufacturers to report such payments to the Centers for Medicare and Medicaid Services, with goals such as stopping “conflicts of interest that can harm patients and their care.” Nationwide data is available through the Open Payments platform. It covers payments from Aug. 1, 2013 and Dec. 31, 2014.
The Post Register used that data, which includes records of about 15 million individual payments, to hone in on payments to the roughly 3,800 physicians who were licensed to practice in Idaho at some point during that time.
The payments the Post Register examined do not include payments for conducting research such as clinical trials on medication or devices. Nor do they include doctors’ investment interests in pharmaceutical companies and device manufacturers.
The payments include transactions such as consulting and speaking fees, meals, travel expenses, free education and gifts.
Payments in those categories amounted to $24 million, about $6,300 per Idaho doctor.
But those dollars aren’t spread evenly. In eastern Idaho, most physicians got less than $1,000 from the industry, while a handful of doctors made tens of thousands of dollars.Dr. Ty Erickson
Gynecologist Dr. Ty Erickson of Idaho Falls topped the list in eastern Idaho. Between mid-2013 and late-2014, he received more than $200,000 from medical device manufacturers. His biggest benefactor was Coloplast, a Danish company which manufactures devices called “transvaginal meshes” which are used to treat pelvic organ prolapse and stress urinary incontinence.
Only three doctors in the country were paid more by Coloplast than Erickson, according to a related ProPublica database.
Coloplast paid travel and lodging expenses for Erickson in Minnesota, Washington, Illinois, Florida, California and Arizona, as well as Grand Cayman in the Cayman Islands, and Paris. In all, Erickson got about $190,000 from Coloplast.
Erickson said if people imagine he’s spending those trips on the golf course, they’re wrong. Often, he’s in a cadaver lab teaching other physicians how to perform surgical procedures with Coloplast devices.
“I’m a huge believer in training surgeons in all kinds of procedures,” he said.
And it’s fair that he’s compensated for those services, he added.
Erickson also has helped to develop new surgical products. He’s one of a group who invented a new implant to treat certain pelvic disorders.
Coloplast has faced legal problems in recent months.
According to a November news release (reprinted by PR Newswire) from MT Services LLC, a company that reports on lawsuit settlements, Coloplast has settled 400 lawsuits over transvaginal mesh products and has more than 2,000 lawsuits pending. It has set aside $727 million to deal with the lawsuits, according to the release.
Erickson said he believes such suits arise from a profit-driven lawsuit industry.Dr. Aaron Altenburg
Orthopedic Surgeon Dr. Aaron Altenburg of Pocatello was the second-highest recipient, pulling in about $130,000. Nearly all of that came from DePuy, a subsidiary of Johnson & Johnson which manufactures joint replacements.
DePuy paid for travel and lodging expenses for Altenburg in Georgia, Minnesota, Wisconsin, Illinois, California, Texas, Colorado, Nevada, Florida and Washington.
Altenburg said his relationship with DePuy is strictly educational.
“I assist with one of the largest orthopedic manufacturers in the world to help train surgeons around the country,” he said.PauseCurrent Time0:00/Duration Time0:00Loaded: 0%Progress: 0%0:00Fullscreen00:00Mute
Altenburg was trained in joint replacement surgery at the Mayo Clinic. He said in recent years the demand for joint replacements has risen faster than the number of surgeons who are qualified to perform the surgery. So he works to provide training on such procedures.
“I am giving up my time to do this because this is my passion,” he said. “My passion is teaching. My passion is helping others. If I were to stay in Pocatello and just run my clinic and run my operating room, I would make more income.”
Altenburg said all his patients are aware that he has a relationship with DePuy and that they employ him to train other surgeons.
“I think it should be championed,” he said. “Here we have a surgeon in eastern Idaho who is at the absolute pinnacle or top of his game. We have the insight, knowledge and skill in eastern Idaho that people travel from around the country (to learn) the latest skills and technology.”Dr. Sherwin D’Souza
Internist Dr. Sherwin D’Souza, who during the reporting period practiced in Pocatello but today practices in Meridian, got the third-most money at about $120,000. D’Souza received payments from a host of pharmaceutical companies including Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novo Nordisk, Pfizer, Sanofi and Genzyme and Takeda.
Many of D’Souza’s payments are for “services other than consulting,” which according to the Center for Medicare and Medicaid Studies generally means holding speaking or training events. Pharmaceutical companies paid travel and lodging expenses in Utah, California, Idaho, Nevada, New Jersey, Oregon, Florida and Texas.
D’Souza did not respond to repeated requests for comment.
Another 14 eastern Idaho physicians got more than $10,000 from pharmaceutical companies and medical device manufacturers. Another 98 got more than $1,000. The remaining 414 got less.Money and Influence
There is evidence that payments by the pharmaceutical and medical device industries influence doctors’ medical decisions. ProPublica found that doctors who get payments are more likely to prescribe brand-name drugs instead of generics. Generics are chemically identical to brand-name drugs but usually cost much less.
ProPublica found that internists who receive no payments from pharmaceutical companies prescribe brand-name drugs about 20 percent of the time, while those who are paid more than $5,000 prescribe them 30 percent of the time. And ophthalmologists who get nothing prescribe brand-name drugs 46 percent of the time while those who are paid more than $5,000 prescribe them 65 percent of the time.
“There is ample data that more interaction with industry leads to higher utilization of high-cost medications. The other place that it’s seen is in formulary requests. … Those things all increase health care costs,” Force said.
He’s intimately familiar with the ways the drug and medical device industries interact with physicians and other health care providers.
“I know how this works from both sides,” he said. “I’ve tried to manage its influence in our academic training clinic, and I have been on drug company-sponsored trips and received research funding from industry.”
In practice, such interactions range from a pharmaceutical rep showing up at a clinic with free food and literature about a new drug, to invitations to participate in “advisory boards” where physicians tell companies which pieces of clinical research they find most convincing.
The pitch goes something like this: “We’re having an advisory board this weekend in Sun Valley, and we’d like to get your opinion about how best to use medication. We would pay for your travel there. We’re going to have some meetings during the day, and we’re also going to have a golf tournament in the afternoon,” Force said.
Now Force teaches residents training to be family physicians about the ethics of dealing with drug companies.
“How do we manage these kinds of interaction with industry, which are necessary and common, in a way where we can feel good at the end of the day about the kind of care we provide and the cost of that care?” he said.“Key Opinion Leaders”
Force said one of the common strategies the pharmaceutical industry uses is to identify and fund what they call “KOLs,” which stands for “key opinion leaders.” Often, these are among the physicians paid the most by the industry.
“These key opinion leaders are utilized to influence the practice in a given community or medical specialty,” Force said.
Typically, these will be highly visible doctors within individual communities who the companies judge exert significant influence on the opinions and prescribing patterns of their colleagues.
There are big benefits to being identified as a key opinion leader — personal, professional and financial, Force said. First, there’s the “ego gratification” involved in being picked to lead talks as a national expert. Second, that reputation as an expert means that key opinion leaders are often top picks for referrals from other doctors. Finally, it means lucrative consulting and speaking fees from the industry itself.
Evidence presented by key opinion leaders often emphasizes positive clinical outcomes associated with the drug, while underplaying side effects, Force said. They will often emphasize evidence that a drug produces a positive intermediate outcome (say, lowering blood pressure) while underemphasizing the fact that there isn’t much evidence that it improves long-term outcomes (reducing heart attacks).
“Errors of omission are common,” Force said. “These key opinion leaders often don’t talk about some of the bad things, but they do talk about all of the good things.”
The use of key opinion leaders by industry, Force said, is an effective way of influencing medical decisions.
“Industry recognizes that having key opinion leaders in the community is even more effective than their traditional marketing efforts,” Force said. “Pharmaceutical companies monitor that based on the prescription volumes that come out of certain areas. They have full departments that delve into the data to see if their efforts are effective in changing behavior. And they generally are.”
Force said there is no question that health care providers need to hear from the industry about new medical products. But doctors need to keep in mind that the companies aren’t giving out perks for free.
“Sometimes it’s legitimate. And sometimes it’s a guise for marketing and promotion. And there is a big grey area in between,” Force said.
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CVN To Webcast $6M+ Boston Scientific Pelvic Mesh Trial In Massachusetts
May 6, 2016 | CVN
By David Siegel
Opening statements begin Monday in a Massachusetts state courtroom in a potentially $6 million product liability lawsuit against Boston Scientific Corp. claiming one of the company’s allegedly defective pelvic mesh implants caused a woman to suffer chronic pain and to need numerous additional surgeries.
Plaintiff Ronda Orozco’s lawsuit accuses Boston Scientific of using a type of polyurethane mesh in its Uphold-brand implant that her attorneys argue is not suitable for use in humans. They claim the mesh reacts to human bodily fluids and becomes stiff and brittle, which supposedly left Orozco suffering from bleeding, incontinence and pain during sexual intercourse.
She seeks up to $6 million in compensatory damages and an unspecified amount in punitive damages, according to court filings. The full trial will be webcast and recorded gavel-to-gavel by Courtroom View Network.
Mesh implants like the Uphold are used to treat a condition known as pelvic organ prolapse, which occurs when abdominal organs fall out of place. Tens of thousands of lawsuits against Boston Scientific and other pelvic mesh manufacturers are currently pending in state and federal courts throughout the country, and while a North Carolina federal jury in 2015 ruled in Boston Scientific’s favor at a trial involving the Uphold, Orozco’s lawsuit is the first time a state court jury will weigh in on the device.
State court juries in Texas and Delaware have hit Boston Scientific with verdicts as high as $100 million in mesh cases, but so far the company has a perfect winning record in its home state of Massachusetts. In 2014 two juriescleared the company in consecutive trials involving its Pinnacle and Obtryx-brand implants.
With far more mesh lawsuits pending than could ever actually make it to trial, each new jury verdict in the litigation could help shape the landscape for future mass settlements. Boston Scientific has already begun chipping away at its load of pending cases, having struck a $119 million deal in 2015 to resolve nearly 3,000 mesh-related claims.
Despite a number of jury losses Boston Scientific has put together back-to-back wins in its two most recent trials. In addition to the North Carolina verdict over the Uphold, a Missouri state court jury in February cleared the company following a lengthy trial that also included mesh manufacturer C.R. Bard Inc. as a defendant.
That trial, like Orozco’s case, was also webcast and recorded gavel-to-gavel by CVN.
The Massachusetts trial will take place before Justice Thomas H. Billings.
Attorneys for Orozco and representatives for Boston Scientific did not respond to requests for comment.
Orozco is represented by Motley Rice LLC.
Boston Scientific is represented by Eckert Seamans Cherin & Mellott LLC and by Murphy & Riley PC.
The case is Ronda Orozco, et al. v. Boston Scientific Corp., case number 1281CV03068 in Middlesex County Superior Court.
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Endo endgame? Pharma trouble, employment hit stock averages
May 6, 2016 | Communities Digital News
By Terry Ponick
Sell in May syndrome seems to be in full effect in Friday trading action. All major averages are modestly down as of the noon hour today, but the damage generally occurring in the utility and pharmaceutical sectors is major, driven today, apparently, by gloomy numbers from Dublin, Ireland headquartered Endo International PLC (symbol: ENDP), which is down some 40 percent as we write this article. Endo was one of the last of the formerly U.S.-based companies to successfully invert and decamp for the tax friendlier shores of the Oulde Sod.
But the drug sector’s issues pre-date the current problems being endured by Endo, which, among other things, is still busy trying to settle multiple millions of dollars’ worth of vaginal mesh lawsuits—you know, the ones the ambulance-chasing thieves lawyers pitch constantly on late night cable TV channels.
Relentless selling has been ongoing in the drug sector since rogue pharma Valeant (symbol: VRX) hit the skids, first with its unfriendly battle to take over fellow drug maker Allergan (AGN), and later for its involvement in the abrupt over-pricing of certain key proprietary drugs, including those about to go off-patent.
That game, as we’ve been discovering, was far from unique to VRX, leading to U.S. and international government scrutiny of the industry, thus putting those pharma stock prices under pressure.
Add to this the “lower than expected) 160,000 jobs the U.S. Department of Labor says were created in April, and you get general over all market unhappiness, which looks to extend this week’s losses further by Friday’s close.
CNBC tries to help the job-destroying Obama administration out by claiming
“On the bright side, wages rose during the month, with average hourly earnings up 8 cents an hour, representing a 2.5 percent annualized gain. The average work week edged higher to 34.5 hours, according to the Bureau of Labor Statistics, which issues the monthly jobs report.”
Golly gee, that “annualized” gain figure masks the pathetic 0.2 percent monthly figure, which is essentially zero in an economy the size of ours. And when was the last time the “average work week” managed to “edge up” to 34.5 hours. Color the Maven rapidly aging, but isn’t the work week supposed to be 40 hours, not “edging up” to 34.5? Anything to do with Obamacare “mandates,” hmmm? Amazing.
Oil did edge up a bit today, but the employment numbers are starting to make it clear that the Fed is going to have a hard time justifying any interest rate increases this year, which clouds the economic picture further.
But the mass dumping of pharmaceuticals is the real story today. A short piece today from ZeroHedge gives us the reason why. It seems that hedge funds have suffered the most damage from the current selling wave, which has also engulfed other sectors widely held in this community.
Endo is one of the biggest positions in hedge fund land, as evidenced by this Goldman chart of hedge fund current top holdings as it appears in ZeroHedge.
As the chart indicates, other big hedgie positions are in the battered energy and consumer discretionary sectors. With hedge fund bailouts and forced sales causing massive exits in these investments, now including pharma, is it any wonder why averages have been tanking since at least the beginning of May. This selling isn’t likely to end until all these smart-guy hedge funds have dumped all their shares while panicking their way out the tiny door that remains open for them.
Trading diary
Unfortunately for the Maven’s now mostly-successfully downsized portfolio, his favorite current investment, Allergan Preferred A shares (AGN/PRA) have been getting the blitzkrieg treatment Friday. They’ve been hammered all week but are getting pulverized even worse today, off some $35 per share at the moment, close to a 5 percent loss on the day.
Apparently, in their haste to exit all pharma, the hedgies can’t figure out the difference between Allergan’s common stock (AGN)—also clobbered today like most other pharmas—and its preferred, which pays a large, fixed dividend. Further, AGN/PRA is a “term preferred” that will expire in March 2018 and be redeemed at that time at par value, which, in this case, is a healthy $1,000 per share.
Now at or around its 52-week low of $752 per share, at least in today’s volatile and heavy trading action, just a buy and hold here is likely to be rewarded when buyers trade those shares back to the company for $1000 apiece in 2018. Plus, the stock goes ex-dividend next week, meaning that the morons who are stampeding for the exits are leaving a whopping $13.75 quarterly dividend on the table by panicking now.
We had been incrementally buying these shares at a considerably higher price when this got started. But we’re slowly averaging down as this nonsense continues. Frankly, the stock is likely to take an additional, at least modest hit next week when it goes ex-dividend—all dividend-paying stocks due, since on that day, new buyers won’t be entitled to the current dividend. But that move is likely to mark something close to the bottom in this issue, given that its redemption date is now less than two years from now.
That’s no guarantee, of course, that Allergan common, preferred, and for that matter any other drug stock won’t continue to get hammered. Mr. Market has rarely shown any deference to the Maven, and he doesn’t expect that to change any time soon. But this is one of those investments where patience is likely to be rewarded, at least as long as this pharmaceutical giant, famed for botox and other cosmetic and health remedies and drugs, remains in business.
What puzzles the Maven somewhat, however, is why Allergan’s preferred continues to take a beating, unless there’s something dark and sinister he hasn’t yet discovered. Preferred stocks don’t usually suffer a dividend cut unless the common dividend is cut first, and/or something terrible happens.
True, AGN pays no dividend at all. But it should recover in a quarter or two from its Washington-quashed attempt to join with Pfizer (PFE). (Backgrounder: Allergan, fleeing from a hostile takeover by the aforementioned Valeant, found a white knight in Dublin-based Actavis and merged while inversions were still working, with Actavis adopting its more famous acquisition’s name.)
But even if it eliminated the dividend next week for the duration, which could really kill this issue, the preferred still must be redeemed in 2018 at par. Given that AGN is a serious A-list big-cap company, it would take a lot to derail that redemption. So, we’ll hang in there no matter what happens, more or less. (When trading stocks, you can never say never.)
Otherwise, we’re sitting tight. We shouldn’t have dumped our small position in SGOL, the Swiss gold bullion ETF. It’s back up sharply today. But this also proves our point. May’s market action has gotten very, very treacherous. We’ve finally exceeded our breakeven point for 2016 after taking a serious drubbing in January and February. We’re about 70 percent cash right now. And we’re in no particular hurry to add much to the portfolio until the latest nonsense in the market—including panic selling by the hedge funds—finally runs its course.
Election 2016, however, is another matter entirely. But we’ll worry about that next week.
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Improving urinary incontinence through physical therapy
May 7, 2016 | WRVO
By Kaylyn Izzo
We’ve probably all seen a commercial at some point for medication to help a weak bladder, but it isn’t something we generally want to talk about if we have one.
This week on “Take Care,” Dr. Jenni Johnson Gabelsberg explains this problem, known as urinary incontinence, and how to fix it through physical therapy.Gabelsberg is a nationally prominent physical therapist whose focus is on pelvic floor rehabilitation. She has a doctor of physical therapy degree, and lectures widely on evaluation and treatment for female and male pelvic floor dysfunctions, such as urinary and fecal incontinence.
Urinary incontinence can be broken down into two categories:Stress urinary incontinenceUrge urinary incontinence
Gabelsberg says with stress urinary incontinence, the muscles of the pelvic floor aren’t doing their job of keeping the bladder shut. This can cause someone to leak urine due to something as simple as sneezing.
With urge urinary incontinence, the bladder is contracting too often and can cause a sudden, severe feeling of having to go to the bathroom right away. Gabelsberg says urge incontinence can even be a side effect from surgery designed to fix stress incontinence. She also says eating or drinking things that are bladder irritants in excess can be a cause.
But unfortunately for women, the biggest risk factors for developing urinary incontinence are vaginal child birth and menopause.
When a woman gives birth, the vaginal walls are stretched three and a half times their normal length, which can cause long-term damage, according to Gabelsberg. As a comparison, she says to imagine if your hamstring muscle were subject to this. The damage caused would not be easily fixed.
Since vaginal child birth can cause urinary incontinence, it can be seen in women as early as their 20s. These women often have trouble keeping their bladder shut or have pelvic organs, such as the uterus, which dropped lower in the vaginal canal from the stretching, says Gabelsberg.
In post-menopausal women, the reason for urinary incontinence stems from lower estrogen levels.
“Normally, when your estrogen levels are high, the urethra [the tube that excretes urine from your body] stays shut,” Gabelsberg said. “But after menopause, when our estrogen levels start to drop down, that urethra sits more widely open…it’s not able to close quite as well.”
Gabelsberg says about 35 percent of women suffer from urinary incontinence, but thinks this number is highly underestimated, due to women thinking it’s a normal side effect after having children.
Although Gabelsberg says urinary incontinence isn’t as common in men, it is possible for them to suffer from the problem after a prostate surgery.
So how do you get rid of a urinary incontinence?
Well, there are a few options, such as the medicine you may have seen advertised in commercials; or surgery, but Gabelsberg says the most effective way is through physical therapy.
Gabelsberg says the main goal of physical therapy for urinary incontinence is to strengthen the muscles of the pelvic floor, and lift pelvic organs through exercises.
In order to do this, muscles around the pelvic region also need to be strengthened, such as:Gluteal musclesInner and outer thighsDeep abdominals
“There are about five muscles that we consider making up the team that help keep the bladder shut,” Gabelsberg said. “Typically a treatment plan runs eight to 12 weeks.”
After a treatment plan is completed, Gabelsberg said improvement in patients is anywhere between 85 and 100 percent.
To find a specialist that will help with urinary incontinence, Gabelsberg says there are resources available on the American Physical Therapy Association website, under the 'Find a PT tab. She also mentions her DVD, which demonstrates exercises and behavioral techniques you can do at home.
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May 9, 2016 | Uro Today
By Lauren Wood, MD
Lauren Wood of Los Angeles, CA reported the results of study of a 1% random sample of the Bloomberg Law Database. The authors reported that 63% of the 710 claims for transvaginal mesh involved slings for stress incontinence, with retropubic slings being slightly more common than transobturator , 13.3% involved pelvic organ prolapse mesh and 23.2% involved both slings and prolapse mesh.
They reported that most claims were made around 5 years after implant and very few cases (4) named the implanting provider as a defendant. The vast majority of the mesh in the lawsuits was placed by a non-FPMRS surgeon.
The moderators and audience discussed the surgeon's experience as a factor in the cases that have been settled thus far.
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May 9, 2016 | Uro Today
By James Forde, MD
James Forde presented data on mesh prolapse repair in 10,339 women between 2008-2013 from a statewide research database in New York.
The authors reported that patients who had a concomitant hysterectomy at the time of prolapse repair had longer length of stay, more medical complications, more bleeding, but less bladder injuries and hospital readmissions within 90 days. There was no difference in reintervention rates, although mean follow up was only 48.3 weeks.
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May 9, 2016 | Uro Today
By Dianne Glass, MD
Dianne Glass from New York University presented data from a retrospective study on the role of preoperative urodynamics in patients undergoing surgical correction of pelvic organ prolapse.
In their series of 348 patients patients, urodynamics changed management in 27.3% of patients. The most frequent change in management was planning for a midurethral sling in patients with stress urinary incontinence.
The authors concluded that there may be better methods than urodynamics for evaluating lower urinary tract symptoms in patients with prolapse outside of questions of occult stress incontinence.
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May 9, 2016 | Uro Today
By Steven Weissbart, MD
Steven Weissbart from the University of Pennsylvania presented the results of a prospective, cross-sectional study of risk factors for overactive bladder syndrome in women with pelvic organ prolapse. They evaluated the risk factors for overactive bladder syndrome in pelvic organ prolapse.
The authors reported on 74 women with pelvic organ prolapse, and 50% of these had overactive bladder syndrome. Splinting to void and reporting stress urinary incontinence was associated with overactive bladder, while severity of prolapse (anterior POP-Q measurement) did not correlate with overactive bladder.
Audience discussion focused on correlating symptoms/the syndrome of OAB with prolapse versus using urodynamic parameters, the authors responded by encouraging further study in both areas.
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Check Out Your Health In Your 50’s
May 9, 2016 | News 8 WTNH
By Ann Nyberg
On Sat., May 14 from 10 a.m.- 4 p.m., EG Home at Chatfield Farms, 639 Skokorat Road in Beacon Falls, will open its doors to the public for its first-ever Health + Wellness Expo designed especially for active individuals over age 55.
Co-sponsored by Griffin Hospital in Derby, the Better After 55 Health + Wellness Expo will provide free preventative health screenings, doctor and pharmaceutical advice, lectures, giveaways, massages and yoga, and will feature products and services to enhance health and wellness after age 55.
Nationally renowned Urogynecologist Dr. Mark Preston will be on-hand from 2 – 4 p.m. to privately provide women free advice and solutions to questions regarding pelvic health and incontinence issues. Dr. Preston is an expert in Urogynecology, specializing in the minimally-invasive treatment of pelvic organ prolapse and urinary incontinence.
Lung cancer specialists and counselors from The Center for Cancer Care at Griffin Hospital will offer screenings and support for attendees. Eunice Lisk, Director of Griffin’s Cardiac Rehabilitation program, will answer cardiology questions, provide screenings and handouts.
Occupational therapists, breast wellness and mammography specialists, and sleep wellness professionals will provide consultation. There will be healthy cooking demonstrations during the day.
Dave Shapera, RPh, a pharmacist from CVS Pharmacy in Ansonia, will be on hand to answer questions about prescriptions and interactions between multiple medications.
CT Men’s Health, LLC, a specialized ED practice, will be there to expertly answer all Erectile Dysfunction questions and discuss solutions and the proprietary procedural strategies that sets them apart from other practitioners, evidenced by their patients’ success rates.
Dr. Beverley Marr and Dr. Chris Sova will demo a new posture device, PurePosture, which helps correct poor posture, thereby alleviating back and neck pain.
Licensed massage therapist Khristy Long will provide massages, and Tayna Sage, a Registered Yoga Teacher, will provide gentle therapeutic yoga demonstrations.
Aromatherapy practitioner and Reiki Master Lori Haggerty will stimulate attendees’ olfactory senses with essential oils, and provide guidance on using herbal oils for stress relief and a number of other maladies.
Chatfield Farms is an amenity-rich 140-Acre development of 231 luxury homes, which surround its crown jewel, the spectacular Fieldstone Club, a 10,000, 2-story clubhouse furnished with numerous patios, decks and entertainment areas, grills, gaming activities and stunning views.
Better After 55 Health + Wellness Expo takes place on Sat., May 14, 10 a.m. – 4 p.m: The Fieldstone Club at Chatfield Farms, 639 Skokorat Road, Beacon Falls, 06403: Phone: 203.714.6622. www.chatfieldfarms.com.
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