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Kentucky AG Ethicon Lawsuit Morning Report 8/17/16

National Coverage

Kentucky AG: Johnson Co. didn’t warn of female implant risks
Aug 16, 2016 | Associated Press

The Kentucky Attorney General is suing Johnson and Johnson and its medical device unit for deceptive marketing practices of a vaginal mesh implant.
Yet another state sues J&J for allegedly hiding vaginal mesh risks
Aug 16, 2016 | STAT News

Kentucky has become the latest state to file a lawsuit accusing Johnson & Johnson of concealing severe risks and falsely marketing its vaginal mesh products. Earlier this year, California and Washington filed identical claims against the health care giant.
Kentucky AG sues Johnson & Johnson over transvaginal mesh marketing
Aug 17, 2016 | CNN
By Steve Almasy

Kentucky's attorney general is suing health-care giant Johnson & Johnson for millions of dollars, saying the company "concealed and misrepresented" the risk of its transvaginal mesh products to doctors and patients.
GM labeled faulty ignition switch a ‘customer satisfaction issue,’ not a safety concern
Aug 16, 2016 | Washington Post

Only Relevant Portions Included: Kentucky’s attorney general announced Tuesday that he is seeking thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson & Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. Attorney General Andy Beshear accuses the company of concealing and misrepresenting 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 that can occur after childbirth, a hysterectomy or menopause. The implants have prompted tens of thousands of lawsuits across the nation.

Local Coverage

(UPDATE) Kentucky Attorney General Sues Johnson & Johnson Over Surgical Mesh
Aug 16, 2016 | WFPL 89.3 NPR (Louisville, KY)
By Rick Howlett

Kentucky’s attorney general is suing health care and pharmaceutical giant Johnson & Johnson for allegedly failing to disclose the potential risks associated with one of its surgical products.
Beshear files lawsuit against Johnson & Johnson over surgical mesh
Aug 16, 2016 | WKYT-CBS (Lexington, KY):

Attorney General Andy Beshear announced on Tuesday a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon. The lawsuit claims the company used deceptive marketing for its surgical transvaginal mesh.
WATCH LIVE: AG Beshear files lawsuit against Johnson & Johnson for deceptive marketing of mesh
Aug 16, 2016 | WHAS-ABC (Louisville, KY)

Attorney General Andy Beshear today announced a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, for its deceptive marketing of surgical transvaginal mesh.
Beshear Sues Johnson & Johnson Alleging Deceptive Marketing of Surgical Mesh for Women
Aug 16, 2016 | WKMS NPR
By Matt Markgraf

Kentucky Attorney General Andy Beshear is suing Johnson and Johnson alleging deceptive marketing of a surgical mesh for women.
AG: Johnson & Johnson used deceptive marketing
Aug 16, 2016 | Courier Journal (Lousiville, KY)
By Morgan Watkins

In a new lawsuit, Attorney General Andy Beshear has accused Johnson & Johnson, a major pharmaceutical company, of marketing a surgical implant to women without sufficiently disclosing the risks associated with it.

Broadcast Video Coverage

WKYT News at 12:30 PM
Aug 16, 2016 | WKYT-CBS

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WHAS11 News at Noon
Aug 16, 2016 | WHAS-ABC

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WHAS11 News at 4P
Aug 16, 2016 | WHAS-ABC (Louisville, KY)

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News at 9 on FOX23
Aug 16, 2016 | KBSI-FOX (Paducah, KY)

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44News at 10
Aug 16, 2016 | WEVV-CBS (Evansville, IN)

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LEX 18 News at 11
Aug 17, 2016 | WLEX-NBC (Lexington, KY)

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LEX 18 News at Sunrise at 5am
Aug 17, 2016 | WLEX-NBC (Lexington, KY)

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Good Morning Kentuckiana
Aug 17, 2016 | WHAS-ABC (Louisville, KY)

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WDRB Morning News at 5
Aug 17, 2016 | WDRB-FOX

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LEX 18 News at Sunrise at 6am
Aug 17, 2016 | WLEX-NBC (Lexington, KY)

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WLKY News at 6:00AM
Aug 17, 2016 | WLKY-CBS (Louisville, KY)

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44News This Morning at 6
Aug 17, 2016 | WEVV-CBS (Evansville, IN)

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WDRB in the Morning
Aug 17, 2016 | WDRB-FOX (Louisville, KY)

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Full Text of Stories Below

Trade Coverage

(UPDATE) Ky. AG Hits J&J With Pelvic Mesh Deceptive Marketing Suit
Aug 16, 2016 | Law360
By Emily Field

The Kentucky Attorney General on Monday hit Johnson & Johnson and its Ethicon Inc. unit with a suit in state court accusing them of deceptively marketing transvaginal mesh devices and hiding from women and their doctors risks such as chronic pelvic pain.
U.S. stocks retreat from record territory, as Fed rate hike odds improve
Aug 16, 2016 | Investing.com

Only Relevant Portions Included: The top performer on the Dow was Intel Corporation (NASDAQ:INTC), which added 0.22 or 0.62% to 35.13. It came one day after the Philadelphia Semiconductor Index rose sharply to hit its highest level in 16 years. The worst performer was Johnson & Johnson (NYSE:JNJ), which fell 1.90 or 1.55% to 120.41. It came after Kentucky attorney general Andy Beshear announced that the state is filing a civil lawsuit against the company's Ethicon medical device unit for its alleged deceptive marketing of its transvaginal mesh device. Beshear alleged in the suit that approximately 15,000 patients in the state received the implant without getting proper disclosures from Ethicon on the hazards associated with the treatment.

National Coverage

Kentucky AG: Johnson Co. didn’t warn of female implant risks

Aug 16, 2016 | Associated Press

The Kentucky Attorney General is suing Johnson and Johnson and its medical device unit for deceptive marketing practices of a vaginal mesh implant.
The lawsuit is seeking thousands of dollars for each patient who had the procedure.
Attorney General Andy Beshear alleges in the lawsuit that the company concealed and mispresented to doctors and patients many of the risks associated with the devices.
The devices, which are intended to treat common pelvic floor issues, are the subject of tens of thousands of lawsuits in the U.S.
Beshear says in a news release that more than 15,000 women in Kentucky had transvaginal mesh implanted without being provided with sufficient information about the hazards.

Johnson and Johnson said after Washington and California filed similar actions in May that the lawsuits were “unjustified.”

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Yet another state sues J&J for allegedly hiding vaginal mesh risks

Aug 16, 2016 | STAT News

Kentucky has become the latest state to file a lawsuit accusing Johnson & Johnson of concealing severe risks and falsely marketing its vaginal mesh products. Earlier this year, California and Washington filed identical claims against the health care giant.
As in the earlier lawsuits, Kentucky claims Johnson & Johnson failed to disclose various problems caused by its devices, which were marketed to combat stress urinary incontinence and pelvic organ prolapse. Among the side effects cited were permanent pain with intercourse; a loss of sexual function; chronic inflammation; and permanent urinary or defecation dysfunction.
“The way this company clearly chose profits over people is outrageous,” Kentucky Attorney General Andy Beshear said in a statement. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices.”
The lawsuit, filed on Monday, largely contains nearly identical language as the other suits, such as a quote from an unnamed woman who said she had “all kinds of problems with chronic pain, bleeding, dyspareunia (painful sex) … The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought of living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent miserable sex, and marital problems was almost more than I could bear.”
The interchangeable language is not surprising, given that a multistate investigation has been under way for a few years. In fact, Johnson & Johnson and its Ethicon unit, which sold the devices, signed tolling agreements with 47 states and the District of Columbia, which means the states still have the opportunity to decide whether to pursue litigation. This suggests still more state lawsuits may be filed.
As we noted previously, Ethicon sold more 787,200 devices nationally between 2008 and 2014. Worldwide, more than 2 million women have been implanted with the devices, according to the states. And the lawsuits point to thousands of alleged violations that may expose the company to potentially tens of millions of dollars in penalties. Ethicon agreed in 2012 to pull some devices off the market.
An Ethicon spokeswoman wrote us that the lawsuit is “unjustified, and the company plans to vigorously defend itself against the allegations. The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products.
“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 … Ethicon is concerned that this lawsuit will keep women from obtaining treatment for the often debilitating symptoms of stress urinary incontinence.”
To date, Johnson & Johnson has lost six cases at trial, including two earlier this year in which juries awarded $13.5 million to one woman and $12.5 million to another. The company reversed an earlier verdict on appeal. Several months ago, the company reportedly began talks to pay more than $120 million to resolve up to 3,000 lawsuits, although the status of the talks is unclear. About 50,100 lawsuits are filed in the US and about 500 overseas.
Meanwhile, the US Food and Drug Administration reclassified the devices as high-risk rather than moderate-risk, and required all device makers to submit data to support safety and effectiveness before they can market their products. The agency noted it had seen a “significant increase” in the number of reported adverse events associated with the mesh devices.

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Kentucky AG sues Johnson & Johnson over transvaginal mesh marketing

Aug 17, 2016 | CNN

By Steve Almasy

Kentucky’s attorney general is suing health-care giant Johnson & Johnson for millions of dollars, saying the company “concealed and misrepresented” the risk of its transvaginal mesh products to doctors and patients.
Johnson & Johnson called the lawsuit unjustified.
Attorney General Andy Beshear said more than 15,000 women in Kentucky had transvaginal mesh implanted but Johnson & Johnson, through its medical device company, Ethicon, didn’t provide enough information about adverse effects.
The lawsuit says women have reported chronic pelvic pain, pain associated with intercourse and/or the loss sexual function, and other health problems.
“The way this company clearly chose profits over people is outrageous,” Beshear said in a written 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.”
The lawsuit says one of the misrepresentations the company made was that it said its products were approved by the Food and Drug Administration. It adds the surgical mesh devices were FDA cleared, not approved.
Johnson & Johnson denied it was deceitful.
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” It said. “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.”
The company, which is headquartered in New Jersey, said it was concerned that women will be deterred by the lawsuit and not get treatment for stress urinary incontinence.
Johnson & Johnson sold $6.4 billion worth of medical devices worldwide in the second quarter of 2016, according to a company report posted online.
Just two months ago, California and Washington became the first two states to sue Johnson & Johnson over the marketing of transvaginal mesh products. A statement announcing California’s lawsuit said more than 780,000 devices were sold by Johnson & Johnson between 2008 and 2014. It also said there are more than 35,000 personal lawsuits against the company.
According to the FDA, surgical mesh has been used in the transvaginal repair of pelvic organ prolapse since the 1990s. In 2002, the FDA cleared mesh devices as a moderate-risk device. In January, the FDA reclassified the devices into the high-risk category and gave companies 30 months to submit applications for premarket approval.
Five manufacturers sell such products.

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GM labeled faulty ignition switch a ‘customer satisfaction issue,’ not a safety concern

Aug 16, 2016 | Washington Post

Only Relevant Portions Included: Kentucky’s attorney general announced Tuesday that he is seeking thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson & Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. Attorney General Andy Beshear accuses the company of concealing and misrepresenting 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 that can occur after childbirth, a hysterectomy or menopause. The implants have prompted tens of thousands of lawsuits across the nation.

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Local Coverage

(UPDATE) Kentucky Attorney General Sues Johnson & Johnson Over Surgical Mesh

Aug 16, 2016 | WFPL 89.3 NPR (Louisville, KY)

By Rick Howlett

Kentucky’s attorney general is suing health care and pharmaceutical giant Johnson & Johnson for allegedly failing to disclose the potential risks associated with one of its surgical products.
Beshear’s office has filed a civil suit against the company and its medical supply unit, Ethicon for what it says was deceptive marketing of a vaginal mesh implant. The surgical mesh is a synthetic fabric used to treat common pelvic conditions experienced by women.
During a news conference Tuesday, Beshear said the company failed to disclose the potential risks and side effects associated with the product, including chronic pain and loss of urinary or sexual function.
“It’s chronic pain that they experience that prevents the most basic functions: using the restroom — and we’re not talking about discomfort, we’re talking about serious, searing pain — sexual relations, difficulty sleeping, sitting, working, moving,” Beshear said.
He said more than 15,000 women in Kentucky have received a mesh implant and some have experienced severe complications.
“They were put at risk by a company that put their own profits over the quality of their potential patients’ lives,” he said. “While this lawsuit doesn’t seek direct restitution for the individuals, it seeks to hold the company accountable.”
Beshear said his suit seeks millions of dollars in civil penalties. He said women seeking individual restitution who don’t have representation should call his office.
Ethicon has settled some of the thousands of lawsuits filed over the product nationwide.
The Associated Press reports Johnson and Johnson said after Washington and California filed similar actions in May that the lawsuits were “unjustified.”

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Beshear files lawsuit against Johnson & Johnson over surgical mesh

Aug 16, 2016 | WKYT-CBS (Lexington, KY):

Attorney General Andy Beshear announced on Tuesday a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon. The lawsuit claims the company used deceptive marketing for its surgical transvaginal mesh.
Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women. The product design and implantation technique can cause serious complications, such as erosion and organ perforation.
In Kentucky, 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 doctors could make informed treatment decisions, according to the lawsuit.
“The way this company clearly chose profits over people is outrageous,” Beshear said. “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.”

The lawsuit seeks millions of dollars in civil penalties under Kentucky’s Consumer Protection Act. While the lawsuit doesn’t seek restitution for individuals, Beshear is asking women not already represented in litigation to contact his office at 502-696-5389.

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WATCH LIVE: AG Beshear files lawsuit against Johnson & Johnson for deceptive marketing of mesh

Aug 16, 2016 | WHAS-ABC (Louisville, KY)

Attorney General Andy Beshear today announced a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, for its deceptive marketing of surgical transvaginal mesh.
The lawsuit 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.
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.
In Kentucky, 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 doctors could make informed treatment decisions, according to the lawsuit.
“The way this company clearly chose profits over people is outrageous,” Beshear said. “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.”
Beshear said Johnson & Johnson failed to follow recommendations by its own staff to include more complete disclosures of the risk.
According to the lawsuit, in 2005 Johnson & Johnson’s medical director emailed the company to propose stronger warnings on the product for doctors and patients.
The email from the medical director proposed the following disclosure: “WARNING: Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse.”
Another of the company’s medical directors noted in 2006 that post-operative patients were reporting that they did not believe they were provided adequate information prior to surgery on the possible adverse complications and that additional disclosures might be needed “…reflecting the current knowledge of the manufacturer…”
Johnson & Johnson failed to fully incorporate this information into any of its marketing or promotional materials, according to the lawsuit.
In fact, Beshear said the company purposely concealed and mispresented to doctors and patients many of the risks of adverse events associated with the devices, which include chronic pelvic pain, urinary and/or defecatory dysfunction, pain with sexual intercourse or total loss of sexual function.
The company also represented to doctors that the products were “FDA approved” when in fact they were only “FDA cleared” – a significantly different, and less rigorous evaluation.
While the lawsuit doesn’t seek restitution for individuals, Beshear is asking women not already represented in litigation to contact his office at 502-696-5389.
Beshear filed his lawsuit this week in Franklin Circuit Court

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Beshear Sues Johnson & Johnson Alleging Deceptive Marketing of Surgical Mesh for Women

Aug 16, 2016 | WKMS NPR

By Matt Markgraf

Kentucky Attorney General Andy Beshear is suing Johnson and Johnson alleging deceptive marketing of a surgical mesh for women.
Beshear said Tuesday the company and its medical device unit Ethicon failed to provide sufficient information about risks associated with transvaginal mesh.
The lawsuit seeks ‘millions of dollars’ in civil penalties. According to Drugwatch.com, transvaginal mesh is an implanted synthetic woven fabric used to treat pelvic organ prolapse and stress urinary incontinence that can occur after a hysterectomy, menopause or childbirth. The product can cause serious complications like erosion and organ perforation.
According to the lawsuit, more than 15,000 women in Kentucky had the transvaginal mesh implanted. Beshear said Johnson & Johnson failed to follow recommendations by staff to include more disclosures, citing an email by the company’s medical director proposing stronger warnings for doctors and patients.
The lawsuit does not seek restitution for individuals. Beshear asks women not already represented to contact his office at 502-696-5389.
The suit was filed in the Franklin Circuit Court.
Nearly 70,000 lawsuits have been filed by women injured by the mesh.
Update with Response from Ethicon:
“The lawsuit against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations. The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products. 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. Synthetic midurethral slings are the worldwide standard of care for surgical treatment of stress urinary incontinence. The American Urogynecologic Society (AUGS), the nation's leading association of urogynecology doctors, in a statement supported by six other leading medical associations, has noted that ‘the polypropylene midurethral sling has helped millions of women with [stress urinary incontinence] regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly.’ Ethicon is concerned that this lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence. “ – Samantha Lucas, spokesperson for Ethicon

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AG: Johnson & Johnson used deceptive marketing

Aug 16, 2016 | Courier Journal (Lousiville, KY)

By Morgan Watkins

In a new lawsuit, Attorney General Andy Beshear has accused Johnson & Johnson, a major pharmaceutical company, of marketing a surgical implant to women without sufficiently disclosing the risks associated with it.
On Tuesday, Beshear announced the lawsuit against Johnson & Johnson as well as Ethicon, its subsidiary, for deceptively marketing a transvaginal mesh product. The mesh is a synthetic fabric that is implanted to treat pelvic conditions that many women experience, according to an Attorney General's Office news release. More than 15,000 women in Kentucky who got the implant did not receive sufficient information from Johnson & Johnson and Ethicon regarding the treatment's potential risks.
Beshear contends in his lawsuit, which is seeking millions in civil penalties but doesn't request restitution for specific individuals, that Johnson & Johnson's lack of appropriate disclosure prevented those women and their physicians from making informed medical decisions.
“The way this company clearly chose profits over people is outrageous,” he said in the news release.
He accused the company of purposely concealing and misrepresenting many health risks associated with the mesh, such as chronic pelvic pain and "total loss of sexual function," according to the news release. He said Johnson & Johnson also represented these implants as being "FDA approved" to physicians when they were actually only "FDA cleared," which involves a less rigorous evaluation process.
Beshear isn't the first attorney general to challenge Johnson & Johnson in court over its mesh implants. The attorneys general in California and Washington state sued the company in May, citing similar concerns, according to The Associated Press. At the time, Ethicon said those lawsuits were unjustified.

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Broadcast Video Coverage

WKYT News at 12:30 PM

Aug 16, 2016 | WKYT-CBS

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Rough Transcript: attorney general andy beshear has filed lawsuit against Johnson and Johnson... claiming they didn't tell the truth about a product used by many women. the lawsuit is asking for 'millions' of dollars in civil penalties under kentucky's consumer protection act. wkyt's andrea walkers has more 12:34 PM walker has more on the lawsuit... in a story that's new at 12-30. :46 andrea in the lawsuit centers around a surgical transvaginal mesh . used to treat common pelvic floor conditions which affects 30 to 50-percent of all women take vo according to the lawsuit, in 2005 Johnson and Johnson’s medical director emailed the company to propose stronger warnings on the product. the email proposed the following disclosure ... quote "warning: early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse." Johnson and Johnson failed to fully incorporate this information into any of its marketing or promotional materials, according to the lawsuit . "frankly dangerous is not a strong enough word for what has happened here. the known but undisclosed complications have ruined lives. women have suffer chronic pai and horrible outcomes and in many situations the complications are irreversible." more v the company also led doctors toelieve the products were "fd approved" when in fact they were only "fda cleared" significantly different, and less rigorous evaluation. andrea out according to the suit... more than 15- thousand women have had the mesh implanted inside their bodies in kentucky alone. in frankfort, aw wkyt. while the lawsuit isn't seeking restitution for individuals. beshear is asking women not already represented in litigation to contact his office

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WHAS11 News at Noon

Aug 16, 2016 | WHAS-ABC

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Rough Transcript: attorney general andy beshear behind a new lawsuit this afternoon against a new lawsuit this afternoon against johnson and johnson... accusing the company of using deceptive marketing for surgical mesh for women. transvaginal mesh is a synthetic fabric implanted to treat common pelvic conditions. according to the lawsuit... johnson and johnson and ethicon did not provide enough information on the dangers of the mesh. political editor chris williams is in frankfort right now looking at the high price the ag wants to get from johnson and johnson. look for his report at 4 and updates throughout the day on whas 11 dot and the whas 11 mobile app.

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WHAS11 News at 4P

Aug 16, 2016 | WHAS-ABC (Louisville, KY)

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Rough Transcript: And now to a lawsuit filed today on behalf of 15- thousand kentucky women who've had transvaginal mesh implants. they're used to treat common pelvic conditions -- but the state's attorney general says Johnson and Johnson chose profits over people. political editor chris williams 4:08 PMwith the new details from frankfort. general andy beshear claims. the women who fell victim were deceived by Johnson and Johnson and their medical device unit ethicon. he claims 15- thousand of them across the commonwealth underwent transvaginal mesh surgery using a product that was far from advertised. attorney general of kentucky i do not tolerate those who would profit by misrepresenting their products and by lying or lying by omission to kentuckians :11 the f-da explains that surgical mesh "can be used for urogynecologic procedures, including repair of pelvic organ prolapse and stress urinary incontinence. it is permanently implanted to reinforce the weakened vaginal wall." the lawsuit filed in franklin circuit court seeks millions from the surgical mesh manufacturer claiming it failed to disclose dangerous complications. and stated that the product was "fd approved" when it was instead only "fda cleared" beshear argued Johnson and Johnson and ethicon were guilty of "outrageous" deception t doctors and patients because the 4:09 PMdifference is 11- hundred hours of testing. attorney general of kentucky frankly, dangerous is not a strong enough word for what has happened here.. :05 the known but undisclosed complications have ruined lives. women have suffered chronic pain and horrible outcomes and in many situations the complications are irreversible :19 " a spokesperson for ethicon called the lawsuit "unjustified" in statement that reads, in part; "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." the statement goes on to explain: "ethicon is concerned that this lawsuit will keep women from obtaing treatment for the often- debilitating symptoms of stress urinary incontinence." you can read the full statement at whas11 dot com. general beshear said any monetary victory would go into state funds. he'll urge lawmakers to put those monies to consumer protection. but he's asking anyone who may be impacted to contact his office so they can be made aware of possible lawsuits to from which they could benefit. in frankfort. chris williams. whas 11 news.

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News at 9 on FOX23

Aug 16, 2016 | KBSI-FOX (Paducah, KY)

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Rough Transcript: kentucky attorney general andy beshear -- suing johnson and johnson for what he calls deceptive marketing. the item at stake -- something caled trans- vaginal mesh. thousands of kentucky women had the mesh implanted -- allegedly without being told of the hazards. the lawsuit is seeking millions of dollars in civil penalties under kentucky's consumer protection act. according to the lawsuit -- in 20-15 johnson and johnson's own medical director proposed stronger warnings on the product. "johnson and johnso refused to provide adequate information and never incorporated these concerns from their own staff in their marketing or promotional material." beshear says johnson and johnson also promoted the product as "fda approved" when it was actually only "fda cleared.

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44News at 10

Aug 16, 2016 | WEVV-CBS (Evansville, IN)

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Rough Transcript: a lawsuit is filed against johnson and johnson and its medical device unit for deceptive marketing practices of a vaginal mesh implant. the lawsuit was filed by the kentucky attorney general. andy beshear's lawsuit is seeking thousands of dollars for each patient who had the procedure. he says the company concealed and misrepresented many of the risks associated with the devices. the devices are intended to treat common pelvic floor issues - and right now - they are the subject of tens of thousands of lawsuits in the u.s. beshear says more than 15-thousand women in kentuckyhad transvaginal mesh implanted without being given sufficient information about the hazards.

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LEX 18 News at 11

Aug 17, 2016 | WLEX-NBC (Lexington, KY)

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Rough Transcript: kentucky's attorney general, andy beshear, is filing a civil lawsuit against johnson and johnson... as well as the companies medical device unit "ethicon".. this after what the attorney general calls "deceptiv marketing" of the surgical "trans vaginal mesh" the lawsuit seeks millions odollars in civil penalties under keucky's consumer protection act. the act prohibits companies from false, misleading, deceptive or unfair actor practices in trade or commerce.

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LEX 18 News at Sunrise at 5am

Aug 17, 2016 | WLEX-NBC (Lexington, KY)

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Rough Transcript: kentucky's attorney general, andy beshear, is filing a civil lawsuit against johnson and johnson... as well as the companies medical device unit "ethicon".. th after what the attorney general calls "deceptiv marketing" of the surgical rans- vaginal mesh" the lawsuit seeks millions of dollars in civil penalties under kentucky's consumer protection act. thect prohibits companies from false, misleading, decepte or unfair acts or praices in trade or commerce.

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Good Morning Kentuckiana

Aug 17, 2016 | WHAS-ABC (Louisville, KY)

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Rough Transcript: attorney general andy beshear is suing johnson and johnson on behalf of more than 10- thousand kentucky women. the suit claims the company did not disclose dangerous complications of transvaginal mesh implants. those implants are used to treat common pelvic conditions. the lawsuit is seeking millions in damages. " i do not tolerate those who would profit by misrepresenting their products and by lying or lying by omission to kentuckians" a spokesperson for the manufacturer called the lawsuit "unjustified". beshear said an monetary victory would go into state funds.

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WDRB Morning News at 5

Aug 17, 2016 | WDRB-FOX

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Rough Transcript: kentucky attorney general andy beshear is suing johnson and johnson over a medical device for women. beshear announced the civil lawsuit yesterday.it seeks thousands of dollars for each patient who used a feminine meshimplant product.beshear claims the company used deceptive marketing.the suit claims more than 15-thousand kentucky women used the product.

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LEX 18 News at Sunrise at 6am

Aug 17, 2016 | WLEX-NBC (Lexington, KY)

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Rough Transcript: attorney general, andy beshear, is filing a civil lawsuit agast johnson and johnson... as well as theompanies medical device unit "ethicon".. this after what the attorney general calls "deceptiv marketing" of the surgical "trans vaginal mesh" the lawsuit seeks millions of dollars in civ penalties underkentucky's consumer protection act. the acprohibits companies from false, misleading, deceptive or unfair acts or practices in trade or commerce. hayley

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WLKY News at 6:00AM

Aug 17, 2016 | WLKY-CBS (Louisville, KY)

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Rough Transcript: kentucky files a lawsuit against one of the country's most well-known health care companies. attorney general andy beshear accuses johnson and johnson of conducting a deceptive marketing campaign. he says more than 15-thousand women had trans-vaginal mesh implanted without being provided sufficient information about potential health risks. the device is intended to treat common pelvic conditions. >>frankly dangerous is not a strong enough word for what has happened here. the known but undisclosed complications have ruined lives, women have suffered chronic pain and horrible outcomes, and in many tuations the complications are reversible. jennifer: the lawsuit seeks thousands of dollars in civil penalties,

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44News This Morning at 6

Aug 17, 2016 | WEVV-CBS (Evansville, IN)

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Rough Transcript: ketucky attorney general andy beshear files a lawsuit against johnson and johnson and its medical device unit for deceptive marketing practices of a vaginal mesh implant. the lawsuit seeks thousands of dollars for each patient who had the procedure. beshear says the company concealed and misrepresented many of the risks associated with the devices. the devices are intended to treat common pelvic floor issues...

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WDRB in the Morning

Aug 17, 2016 | WDRB-FOX (Louisville, KY)

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Rough Transcript: kentucky attorney general andy beshear is suing a john son and johnson over a medical device for women. >> they failed to disclose a host of dangerous complications that have irreversibly alterede lawsuit seeks thousands of dollars for each patient who used a femine mesh implant product.beshear claims the company used deceptive marketing. the lawsuit claims more than 15,000 kentucky women used the product without being told about the risks.

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(UPDATE) Ky. AG Hits J&J With Pelvic Mesh Deceptive Marketing Suit

Aug 16, 2016 | Law360

By Emily Field

The Kentucky Attorney General on Monday hit Johnson & Johnson and its Ethicon Inc. unit with a suit in state court accusing them of deceptively marketing transvaginal mesh devices and hiding from women and their doctors risks such as chronic pelvic pain.
Attorney General Andy Beshear said in the complaint, which seeks millions of dollars in civil penalties under the state’s Consumer Protection Act, that J&J misrepresented that its products were approved by the U.S. Food and Drug Administration, when in fact they had only been cleared by the agency under its 510(k) process, which evaluates whether a product is substantially equivalent to one already on the market.
That’s a significant difference, Beshear said in the complaint. FDA-approved products undergo about 1,200 hours of review for their safety and efficacy, whereas the review for an FDA-cleared device only takes about 20 hours, according to Beshear.
J&J knew that that representing that a device received FDA approval leads doctors and patients to believe that the product has been well-studied and scrutinized, the state attorney general said.
“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.”
More than 15,000 women in Kentucky had transvaginal mesh implanted, but J&J and Ethicon failed to provide sufficient information about known risks so they and their doctors could make informed medical choices, the suit said.
In addition to chronic pelvic pain, those risks include include urinary dysfunction, pain from sexual intercourse and the loss of sexual function entirely, according to the state attorney general.
J&J’s own staff urged the company to include more complete disclosures of the risks of the transvaginal mesh, but the company failed to do so, according to the suit.
In 2005, Axel Arnaud, J&J’s medical director, proposed stronger warnings on the device in an email, the attorney general said.
According to the suit, Arnaud proposed including this disclosure: “WARNING: Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction, which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse.”
But the company never included that disclosure in its marketing or promotional materials, the suit said.
A year later, another J&J medical director noted that patients after their surgeries were reporting that they didn’t believe they had been provided adequate information before surgery on the possible complications, and that additional disclosures might be needed, the suit said.
But the company continued to conceal risks of those possible complications, according to the suit.
Seven separate MDLs comprising 70,000 cases against J&J and other companies are pending in West Virginia over the allegedly defective products. The FDA recently reclassified pelvic mesh devices such as those at issue in the suits as high-risk devices that must undergo the agency's most stringent safety evaluation before hitting the market.
“The lawsuit against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations," an Ethicon spokeswoman told Law360 on Tuesday. "The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products."

Case information was not immediately available on Tuesday.

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U.S. stocks retreat from record territory, as Fed rate hike odds improve

Aug 16, 2016 | Investing.com

Only Relevant Portions Included: The top performer on the Dow was Intel Corporation (NASDAQ:INTC), which added 0.22 or 0.62% to 35.13. It came one day after the Philadelphia Semiconductor Index rose sharply to hit its highest level in 16 years. The worst performer was Johnson & Johnson (NYSE:JNJ), which fell 1.90 or 1.55% to 120.41. It came after Kentucky attorney general Andy Beshear announced that the state is filing a civil lawsuit against the company's Ethicon medical device unit for its alleged deceptive marketing of its transvaginal mesh device. Beshear alleged in the suit that approximately 15,000 patients in the state received the implant without getting proper disclosures from Ethicon on the hazards associated with the treatment.

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