Preview Newsletter
Ethicon Media Monitoring 08/18/16
-
What Exactly is Pelvic Organ Prolapse?
Aug 17, 2016 | Mesh Medical Device Newsdesk
You’ve heard the term “pelvic organ prolapse” and may have seen the shortcut POP. But what does it mean and how likely are to be be affected by this condition? -
Kentucky Files Mesh Lawsuit Against Johnson & Johnson
Aug 17, 2016 | Drugwatch
By Michelle Llamas
Kentucky’s attorney general filed a civil lawsuit against Big Pharma giant Johnson & Johnson and its Ethicon division over its surgical mesh products. -
Kentucky AG accuses Johnson & Johnson of deceptive marketing of vaginal implants
Aug 17, 2016 | Becker's Hospital Review
By Kelly Gooch
Kentucky Attorney General Andy Beshear filed a civil lawsuit Monday against Johnson & Johnson and its medical device unit, Ethicon, alleging deceptive marketing of surgical mesh medical devices for women. -
Most Active Healthcare in Momentum Stocks- Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ)
Aug 17, 2016 | Seneca Globe
...Johnson & Johnson (NYSE:JNJ) [Trend Analysis] shows fluctuation in active trade, on Tuesday shares crashed down -1.62% to $120.33. The Kentucky Attorney General released that he’s looking for thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson and Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. -
Healthcare Hot Movers: Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), StemCells Inc. (NASDAQ:STEM), Johnson & Johnson (NYSE:JNJ), Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX)
Aug 17, 2016 | Benchmark Monitor
The Kentucky Attorney General announced Tuesday that he’s seeking thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson & Johnson (NYSE:JNJ) and its medical device unit, accusing the companies of conducting a deceptive marketing campaign.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
What Exactly is Pelvic Organ Prolapse?
Aug 17, 2016 | Mesh Medical Device Newsdesk
You’ve heard the term “pelvic organ prolapse” and may have seen the shortcut POP. But what does it mean and how likely are to be be affected by this condition?
What is Pelvic Organ Prolapse?
Many women are unaware of the medical condition known as pelvic organ prolapse or POP until it happens to them.
Pelvic organ prolapse was called the female version of a hernia. Prolapse refers to the dropping of the pelvic floor, the uterus or even part of the colon. The lowest part in the pelvic floor is the vagina so unfortunately gravity pushes the dropped organs down to and even outside of the body through the vagina. That bulge can be measured in degrees of prolapse called the POP-Q system.
Why does this happen?
Childbirth is one reason women experience POP. A difficult delivery or a very large child may compromise the pelvic floor, its muscles and ligaments. Some women may have inherited weaker collagen making organs less likely to stay in place for her lifetime. Smoking is also thought to weaken tissues since smoking deprives them of much-needed oxygen. Obesity puts more pressure on the entire abdomen as does pushing on the pelvic organs due to constipation.
Menopause can increase the likelihood of POP as can a hysterectomy. During that procedure, a woman’s uterus and ovaries may be removed leaving a large empty space where surrounding organs may prolapse or cave in due to gravity. That is one more thing to consider before agreeing to undergo a hysterectomy.
Pelvic mesh manufacturers, that predicted a multimillion dollar industry from creating pelvic mesh to treat POP, often refer to it in the literature as a disease” that needs “treatment.” This is an overstatement of the condition of POP.
The condition of prolapse is just that – a “condition” not a disease. It is often without symptoms or pain. Women may feel a slight pressure in the vagina. They may experience difficulty urinating or having a bowel movement.
Sometimes the woman is surprised to find something bulging out of her vagina and that is the first clue that she is experiencing pelvic organ prolapse.
Urologists estimate up to fifty percent of women will experience some degree of prolapse in their lifetime. With that many women affected, you would think this condition would be discussed more often than it is.
What are the treatments?
In the case of POP, a woman maybe fitted with a pessary, which is a small silicone device placed in the vagina to hold back fallen organs. A woman may have to undergo several different fittings to find the one that is right for her. A pessary can be removed to be cleaned and for sex.
Pelvic floor exercises may be recommended to strengthen the pelvic floor.
A suture repair may tack back into place fallen organs. Its success is very dependent on the condition of one’s tissues.
At one time, doctors recommended pelvic mesh as a first option for treatment but with more than 100,000 defective product lawsuits filed in the U.S. and the numbers growing, many doctors have decided to stop using polypropylene pelvic mesh. Those with surgical skills may opt instead to harvest a portion of a woman’s own fascia to create a biocompatible mesh that her body won’treject.
A repair using a fascia involves healing from the harvest surgery as well as the pelvic surgery, but a woman is far less likely to suffer pain and the repeated surgeries associated with a polypropylene pelvic mesh repair.
Even the conservative Food and Drug Administration (FDA) says mesh for pelvic organ prolapse repair has complications that are “not rare” and mesh should not be a first line treatment for the condition of prolapse.
Ask your doctor if he or she is well-versed in non-mesh repairs. If not, it may be time to seek new medical counsel for your condition of pelvic organ prolapse. ##
http://www.meshmedicaldevicenewsdesk.com/exactly-pelvic-organ-prolapse/
-
Kentucky Files Mesh Lawsuit Against Johnson & Johnson
Aug 17, 2016 | Drugwatch
By Michelle Llamas
Kentucky’s attorney general filed a civil lawsuit against Big Pharma giant Johnson & Johnson and its Ethicon division over its surgical mesh products.
Attorney General Andy Beshear announced that his office filed the lawsuit for deceptive marketing of the company’s transvaginal mesh products. The suit seeks “millions of dollars in civil penalties under Kentucky’s Consumer Protection Act that prohibits companies from false, misleading, deceptive or unfair acts or practice in trade or commerce,” according to a press release.
“The way this company clearly chose profits over people is outrageous,” Beshear said in a statement. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”
Transvaginal mesh is a net-like implant made of plastic. Doctors use it to treat incontinence and pelvic organ prolapse — a condition that causes organs to sag into the vagina. In Kentucky, more than 15,000 women received these implants, according to Beshear’s press release.
But Kentucky isn’t the only state facing large numbers of mesh victims. Lawsuits filed by women across the country say these implants caused them to suffer from a number of serious complications. These include debilitating pelvic pain, painful sexual intercourse, nerve damage, organ damage, autoimmune disorders and a host of other problems.
Nearly 33,000 federal lawsuits are pending against J&J’s Ethicon division in West Virginia. C.R. Bard, American Medical Systems, Boston Scientific, Coloplast and Cook Medical also face lawsuits. Altogether, about 75,000 lawsuits claim companies failed to warn doctors and women about the risks tied to the implants.
Companies paid millions in settlements, and juries hit them with millions in verdicts.Lawsuit: J&J ‘Concealed and Misrepresented’ Risks
Beshear’s complaint lists a number of health issues faced by women who say the implants took a toll on their lives. The lawsuit states J&J “concealed and misrepresented to doctor and patients many of the risks of adverse events associated with these devices.” Mesh crippled some women who had to undergo multiple surgeries to remove the implant.
According to the lawsuit, J&J “denied women the ability to make informed choices regarding their health and caused them to unknowingly take risks with their well-being.”
Several of these women met with Beshear in July. One Kentucky woman — who had to remain anonymous — told Drugwatch she and six other mesh-injured women personally spoke to the attorney general. Mesh ruined this former nurse’s life, and she underwent several surgeries and must have several more.
“We met with [Beshear] for a few hours to get this lawsuit filed,” she said. “I’m hoping to help remove mesh from the market and to stop J&J from harming more women. Big Pharma and doctors kept this quiet for a long time and put profit over lives. It’s ridiculous.”
J&J markets itself as a family company, and before mesh she trusted the medical field. This entire experience opened her eyes, she said.
“It is all about greed,” she told Drugwatch. She hopes this lawsuit spreads awareness.Women Plan to Rally at J&J Headquarters
For these women, it has always been about spreading awareness. To that end, they organized a rally and plan to take it directly to J&J’s doorstep at its headquarters in New Brunswick, New Jersey.
This is not the first time the group banded together to show support for women with mesh. It is very active on social media through Twitter and Facebook. The Mesh Awareness Movement (MAM) rally is set for Friday, Sept. 30 at 8 a.m.
“Even after the lawsuit is over, I’m not stopping the fight,” the Kentucky woman said. “I have a daughter, and I want to make sure mesh never hurts anyone again.”
Any women interested in learning more about the Kentucky lawsuit may contact Beshear’s office.
https://www.drugwatch.com/2016/08/17/civil-mesh-suit-filed-against-jj/
-
Kentucky AG accuses Johnson & Johnson of deceptive marketing of vaginal implants
Aug 17, 2016 | Becker's Hospital Review
By Kelly Gooch
Kentucky Attorney General Andy Beshear filed a civil lawsuit Monday against Johnson & Johnson and its medical device unit, Ethicon, alleging deceptive marketing of surgical mesh medical devices for women.
Mr. Beshear is accusing Johnson & Johnson of failing to follow recommendations by its own staff to include more complete disclosures of the risk for such devices. Transvaginal mesh is a synthetic woven fabric implanted through the vagina to treat common pelvic floor conditions that 30 to 50 percent of all women experience.
Mr. Beshear said in a statement that more than 15,000 women had transvaginal mesh implanted without Johnson & Johnson and Ethicon providing sufficient information about the known hazards so women and their physicians could make informed treatment decisions.
The lawsuit seeks millions of dollars in civil penalties under Kentucky's Consumer Protection Act.
In an emailed response to the Associated Press Tuesday, the Johnson & Johnson subsidiary Ethicon called the lawsuits "unjustified."
"The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," the company said according to an Associated Press report published by The Washington Post. "The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research."
Read the full lawsuit here.
http://www.beckershospitalreview.com/legal-regulatory-issues/kentucky-ag-accuses-johnson-johnson-of-deceptive-marketing-of-vaginal-implants.html
-
Most Active Healthcare in Momentum Stocks- Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ)
Aug 17, 2016 | Seneca Globe
Pfizer Inc. (NYSE:PFE) [Trend Analysis] tries to capture market sentiments, shares slightly down -0.91% to $34.79. ViiV Healthcare, a global specialist HIV firm established in November 2009 by GlaxoSmithKline (GSK.L) and Pfizer (PFE), released that start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir and lamivudine as a treatment for HIV-1 infection in adults who have not attained previous antiretroviral therapy.
The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada®). The studies together will include about 1,400 men and women living with HIV and are being conducted at research centres in Europe, Central and South America, North America, South Africa and Asia Pacific.
HIV care is a long-term prospect for those living with the disease, requiring life-long adherence to treatment. Since the introduction of highly active antiretroviral therapy 20 years ago, HIV treatment regimens have predominantly included three antiretroviral drugs.[1],[2] ViiV Healthcare is looking to the future and exploring how HIV treatment could evolve to reduce drug exposure and improve treatment adherence, while maintaining the level of efficacy achieved with three-drug regimens.
When calculating EPS anticipates for the current year from sell-side analysts, the Price to current year EPS stands at -21.50%. Investors looking additional ahead will note that the Price to next year’s EPS is 7.48%. (What Market Forces Produce Volatility in NYSE:PFE Share? Find Free Report Here)
As for as concerns shares volumes, in share of capital Pfizer Inc. (NYSE:PFE) has 6094.33 million outstanding shares among them 6062.99 million shares have been floated in market exchange. PFE institutional ownership remained 76.30% while insider ownership included 0.04%. The firm attains analyst recommendation of 2.20 with week’s performance of -0.83%
Johnson & Johnson (NYSE:JNJ) [Trend Analysis] shows fluctuation in active trade, on Tuesday shares crashed down -1.62% to $120.33. The Kentucky Attorney General released that he’s looking for thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson and Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign.
Attorney General Andy Beshear is accusing the firm of concealing and mispresenting to doctors and patients many of the associated risks. The plastic mesh is used to treat pelvic organ prolapse, a condition involving the shifting of organs such as the bladder, bowel and uterus, often following childbirth, a hysterectomy or menopause.
The implants have prompted tens of thousands of court cases across the nation. Beshear stated in a statement that over 15,000 women in Kentucky had transvaginal mesh implanted without being provided with sufficient information about complications that can lead to permanent disability. The court case seeks civil penalties of $2,000 per infringement of the state’s deceptive practices law, and $10,000 when targeted at consumers over age 60.
The 52-week high of the share price is -4.55% and 52-week low of the share price is 50.35%. Current stock price is in the upbeat territory taking into account of 20 days moving average with -3.24% and continued bullish run for 50 days moving average with -0.69%.
Moving toward technical analysis, the current ratio, or the liquidity ratio of a firm was calculated 3.10 as compared to its debt to equity ratio stands at 0.36. To take look on ration of tradable shares being shorted in market, float short ration was 0.85%, as compared to sentiment indicator; Short Ratio was 3.44. Taking notice in average true range, it was 1.02.
http://www.senecaglobe.com/most-active-healthcare-in-momentum-stocks-pfizer-inc-nysepfe-johnson-johnson-nysejnj/335510/
-
Aug 17, 2016 | Benchmark Monitor
Eleven Biotherapeutics, Inc. (NASDAQ:EBIO) traded 5.75 Million shares on last trading day with closing price of $5.41. Company return on investment (ROI) is -107.30%. Stock value has moved between $0.25 – 5.76 in last one year. Analyst’s mean target price for Eleven Biotherapeutics, Inc. (NASDAQ:EBIO) is $12.00 while analysts mean recommendation is 2.00. EBIO EPS growth this year and EPS growth next year is 25.60%.
Eleven Biotherapeutics, Inc. (NASDAQ:EBIO) announced the effectiveness of the exclusive licensing deal with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche). Eleven has granted Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. EBI-031 is a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling. EBI-031 is currently in development for the treatment of ocular diseases. Eleven is entitled to receive $30 million in payments from Roche, including a $7.5 million upfront payment in connection with the effectiveness of the license agreement, and a $22.5 million milestone payment based on the Investigational New Drug application (IND) for EBI-031 becoming effective.
StemCells Inc. (NASDAQ:STEM) shares moved to $2.60 after starting the day at $0.45 on Tuesday. STEM market capitalization is 30.43M with 74 employees. Analyst’s mean target price for StemCells Inc. (NASDAQ:STEM) is $22.00 while analysts mean recommendation is 2.30. Its weekly performance is 566.67% while year to date (YTD) performance is -48.41%.
The day that StemCells Inc. (NASDAQ:STEM) entered a merger that sent its stock rocketing up sevenfold (albeit to $2.36 per share), the company’s chief executive and chief financial officers effectively resigned, as did three members of the company’s board of directors. The reverse-merger with Israeli private company Microbot Medical Ltd. was “unanimously” approved by StemCells’ board of directors on Monday. Three of the members of the board resigned that day “in connection with the announcement of the merger agreement,” according to the SEC filing, leaving three other members that will continue to serve.
On last trading day Johnson & Johnson (NYSE:JNJ) traded 11.28 Million shares and was closed at 120.33. Analyst’s mean target price for JNJ is $126.72 while analysts mean recommendation is 2.40. Company is -4.55% away from its 52 week high and is moving 50.35% ahead of its 52 week low. JNJ Gross Margin is 69.60% and its return on assets is 14.20%. Johnson & Johnson (NYSE:JNJ) quarterly performance is 6.47% while its price to sale ratio is 4.67 and price to book ratio is 4.56.
The Kentucky Attorney General announced Tuesday that he’s seeking thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson & Johnson (NYSE:JNJ) and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. Attorney General Andy Beshear is accusing the company of concealing and mispresenting to doctors and patients many of the associated risks. The plastic mesh is used to treat pelvic organ prolapse, a condition involving the shifting of organs such as the bladder, bowel and uterus, often after childbirth, a hysterectomy or menopause.
Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX) traded 6.19 Million shares on last trading day with closing price of $0.65. Company gross margin stands at 70.40% whereas its return on investment (ROI) is -31.00%. Stock value has moved between $0.39 – 5 in last one year. Analyst’s mean target price for Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX) is $6.00 while analysts mean recommendation is 2.30. PTX EPS growth this year and EPS growth next year is -198.50%, 164.70% respectively.
On Aug. 11, Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX) announced financial results for the three and six months ended June 30, 2016. Net Revenue was $36.7 million, an increase of 13% over the first quarter and a decrease of 22% over the same period in the prior year. For the three months ended June 30, 2016, net revenue was $36.7 million compared to $32.5 million for the three months ended March 31, 2016, an increase of 13%.
http://www.benchmarkmonitor.com/healthcare-hot-movers-eleven-biotherapeutics-inc-nasdaqebio-stemcells-inc-nasdaqstem-johnson-johnson-nysejnj-pernix-therapeutics-holdings-inc-nasdaqptx/1883349/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested