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Ethicon Media Monitoring 08/17/16
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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. -
Kentucky AG sues Johnson & Johnson over vaginal mesh implants
Aug 17, 2016 | Fox News Health
By Associated Press
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 and Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. -
Ky. AG Hits J&J With Pelvic Mesh Deceptive Marketing Suit
Aug 16, 2016 | Law 360
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. -
Just In !* Kentucky AG Files Deceptive Marketing Lawsuit Against Johnson & Johnson Over Surgical Mesh
Aug 16, 2016 | Mesh Medical Device Newsdesk
Kentucky becomes the latest state to filed a civil lawsuit naming Johnson & Johnson and its medical device unit, Ethicon, for deceptively marketing surgical transvaginal mesh. -
GM labeled faulty ignition switch a ‘customer satisfaction issue,’ not a safety concern
Aug 16, 2016 | The Washington Post
...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. -
Ky. AG urges women to come forward as he files Johnson & Johnson lawsuit
Aug 16, 2016 | WHAS11
By Chris Williams,
The Kentucky Attorney General is urging thousands of woman to come forward as he files suit against one of the nation’s largest medical companies. -
Yet another state sues J&J for allegedly hiding vaginal mesh risks
Aug 17, 2016 | Stat
By Ed Silverman
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 Attorney General Sues Johnson & Johnson Over Surgical Mesh
Aug 16, 2016 | WFPL
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. -
Kentucky AG sues Johnson & Johnson over vaginal implants
Aug 16, 2016 | Medical Xpress
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 and Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. -
Beshear files lawsuit against Johnson & Johnson over surgical mesh
Aug 17, 2016 | WKYT
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. -
U.S. stocks retreat from record territory, as Fed rate hike odds improve
Aug 16, 2016 | Investing.com
.... 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. -
AG: Johnson & Johnson used deceptive marketing
Aug 16, 2016 | Courier-Journal
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.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Full Text of Stories Below
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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.
http://edition.cnn.com/2016/08/16/health/kentucky-sues-johnson--johnson/
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Kentucky AG sues Johnson & Johnson over vaginal mesh implants
Aug 17, 2016 | Fox News Health
By Associated Press
FRANKFORT, Ky. – 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 and Johnson 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.
The implants have prompted tens of thousands of lawsuits across the nation.
Beshear said in a statement that more than 15,000 women in Kentucky had transvaginal mesh implanted without being provided with sufficient information about complications that can lead to permanent disability.
The lawsuit seeks civil penalties of $2,000 per violation of the state's deceptive practices law, and $10,000 when targeted at consumers over age 60.
The U.S. Food and Drug Administration this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for them.
In an emailed response Tuesday, the Johnson & Johnson subsidiary Ethicon Inc. 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. "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."
http://www.foxnews.com/health/2016/08/17/kentucky-ag-sues-johnson-johnson-over-vaginal-mesh-implants.html
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Ky. AG Hits J&J With Pelvic Mesh Deceptive Marketing Suit
Aug 16, 2016 | Law 360
By Emily Field
Law360, New York (August 16, 2016, 5:10 PM ET) -- 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.http://www.law360.com/articles/829068/ky-ag-hits-j-j-with-pelvic-mesh-deceptive-marketing-suit
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Aug 16, 2016 | Mesh Medical Device Newsdesk
Kentucky becomes the latest state to filed a civil lawsuit naming Johnson & Johnson and its medical device unit, Ethicon, for deceptively marketing surgical transvaginal mesh.
AG Andy Beshear’s office announced the lawsuit today. The state seeks millions of dollars in civil penalties from the healthcare giant.
The state alleges J&J violated Kentucky’s Consumer Protection Act that prohibits companies from introducing products into the marketplace using false, misleading deceptive or unfair acts.
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.”
“I do not tolerate those who misrepresent their product by lying or lying by omission to Kentuckians.” Just In !* Kentucky AG Files Deceptive Marketing Lawsuit Against Johnson & Johnson Over Surgical Mesh
Mesh Medical Device News Desk, August 16, 2016 ~ Kentucky Joins Washington State and California in filing civil action against J&J for deceptively marketing its pelvic surgical mesh to consumers.
Seeks millions in restitution.
Kentucky becomes the latest state to filed a civil lawsuit naming Johnson & Johnson and its medical device unit, Ethicon, for deceptively marketing surgical transvaginal mesh.
Disintegrating J&J mesh, Sling the Mesh campaign, photo T Rogers
AG Andy Beshear’s office announced the lawsuit today. The state seeks millions of dollars in civil penalties from the healthcare giant.
The state alleges J&J violated Kentucky’s Consumer Protection Act that prohibits companies from introducing products into the marketplace using false, misleading deceptive or unfair acts.
“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.”
“I do not tolerate those who misrepresent their product by lying or lying by omission to Kentuckians.”
It took a number of readers of Mesh News Desk to meet secretly with the AG’s office staff in Frankfurt to tell them their personal stories of life after a pelvic mesh product.
They are just six of the more than 15,000 women implanted with J&J mesh without sufficient information about the known hazards so they could make true informed consent, according to the lawsuit. Many have done so even though they were threatened by their law firms not to go forward or they would be dropped as clients.
The company ignored J&J insiders who wanted to add more risks to the warnings, says the action.
“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.”
See the rest of AG Beshear’s press conference here.
The company intentionally and purposely concealed and misrepresented to doctors many of the risks and adverse events of the permanent implants which include chronic pain, infection, urinary and defecatory dysfunction, pain with sexual intercourse or loss of sexual function. Ethicon also called its pelvic mesh implants FDA approved, then it was only FDA cleared, says the lawsuit.
The Attorneys General of both Washington State and California has also filed similar Consumer Protection Act civil lawsuits against Johnson & Johnson and Ethicon.
Johnson & Johnson/Ethicon has the greatest number of product liability lawsuits filed in the U.S. with 35,000 filed on the consolidated proceedings in West Virginia, and another 15,000 or so filed in individual state court. Additionally, J&J is facing civil lawsuits in Australia, Israel, Canada, Scotland, among other countries.
Women from Kentucky who are not represented in litigation but are asked to call the AG’s office at 502-696-5389.
The lawsuit was filed August 15, 2016 in Franklin Circuit Court, KY.
Here is the lawsuit:
http://ag.ky.gov/pdf_news/20160815_Complaint.pdf -
GM labeled faulty ignition switch a ‘customer satisfaction issue,’ not a safety concern
Aug 16, 2016 | The Washington Post
AUTO INDUSTRYGM didn’t label faulty switch as safety issueGeneral Motors failed to designate a flawed ignition switch linked to multiple deaths as a safety concern, chief executive Mary Barra told jurors at a Texas trial.
GM engineers in 2004 and 2005 “misdiagnosed it as a customer satisfaction issue and not a safety issue,” Barra said in a video deposition taken last year and played at trial Monday by attorneys for the plaintiff.
“A series of mistakes were made over a period of time that caused the ignition-switch defect,’’ Barra testified. “This had tragic consequences.’’
Barra’s testimony, from a previously unseen deposition taken for multiple lawsuits, is the CEO’s first to jurors weighing the company’s liability to accident victims allegedly harmed by faulty ignition switches GM knowingly put in cars for years.
GM recalled 2.6 million vehicles with the flawed switches, which, if jostled, can unexpectedly shift into the off position, stalling engines. The defect has been linked to at least 124 deaths and 275 injuries.
The video was shown in a case brought by a Houston family that claims a defective switch caused a fatal car crash in 2011, which resulted in Zachary Stevens, then 19, being charged with manslaughter. That charge was dismissed because the accident involved a recalled car. Stevens is seeking compensation for brain injuries and the cost of defending his criminal case.
When pressed on whether GM intentionally hid a deadly flaw from regulators and customers, Barra said the defect “could cause frontal air bag non-deployment, and certainly if the air bag doesn’t work, it could cause a problem that could cause a fatality.”
— Bloomberg NewsEARNINGSHome Depot’s profit up in second quarter
Home Depot, the world’s largest home-improvement retailer, posted second-quarter profit that rose 9.3 percent and boosted its earnings forecast for the year as Americans continued spending on their houses.
Net income rose to $1.97 a share in the quarter, which ended July 31, the company said Tuesday in a statement. That matched analysts’ average estimate.
The results showed that consumers are still willing to splurge to fix up their homes, spurred by rising home values.
“We are fortunate in that we are in a space where the customer is willing to spend,” Home Depot chief executive Craig Menear said in a conference call with analysts. “That’s clearly being driven by the dynamics that exist in the housing market.”
Home Depot said profit this year will be $6.31 a share, up from its previous forecast of $6.27. The company reaffirmed its projection that sales will rise about 6.3 percent.
Home Depot’s second-quarter sales rose 6.6 percent, to $26.5 billion, in line with analysts’ projections. Sales at Home Depot stores open for more than a year increased 4.7 percent, down from 6.5 percent in the previous quarter.
— Bloomberg NewsALSO IN BUSINESS
● U.S. consumer prices were unchanged in July as a big drop in gasoline and other energy prices kept inflation under control. The Labor Department says the flat reading for overall inflation followed a 0.2 percent gain in June. Energy prices fell by the largest amount in five months. Core inflation, which excludes the volatile energy and food categories, edged up 0.1 percent in July.
● Apartment construction in the Northeast fueled a jump in building in July. The Commerce Department said housing starts rose 2.1 percent, to a seasonally adjusted annual rate of 1.21 million, the highest level since February. Most of the gains came from an 8.3 percent acceleration in the construction of multi-family buildings. Construction of single-family houses edged up 0.3 percent. Home construction climbed 15.3 percent in the Northeast. The Midwest and South reported smaller gains, while starts slipped in the West.
● U.S. factories cranked out more autos, machinery and chemicals in July, lifting production by the most in a year. The Federal Reserve said factory output grew 0.5 percent in July, after a 0.3 percent gain in June. Overall industrial production, which includes utilities and mining, expanded 0.7 percent, the biggest increase since November 2014. Utilities’ output jumped 2.1 percent as hotter weather boosted air conditioning use. Mining activity rose 0.7 percent, its third straight gain.
● Mississippi Secretary of State Delbert Hosemann says Morgan Stanley will pay up to $4.2 million to partially reimburse customers who suffered “inordinate losses” because a portfolio manager allegedly used high-risk investments for people who hadn’t agreed to them. Hosemann says the investment firm agreed to resolve a probe by the securities division of his office. In a consent order released Tuesday, the firm neither admitted nor denied the allegations about Steven Wyatt, who worked as portfolio manager in its Ridgeland, Miss., office, starting in 2007. Hosemann says 259 accounts from 15 states were affected.
● 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.
https://www.washingtonpost.com/business/economy/gm-labeled-faulty-ignition-switch-a-customer-satisfaction-issue-not-a-safety-concern/2016/08/16/20a7c0c6-63d8-11e6-96c0-37533479f3f5_story.html
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Ky. AG urges women to come forward as he files Johnson & Johnson lawsuit
Aug 16, 2016 | WHAS11
By Chris Williams,
LOUISVILLE (WHAS11) -- The Kentucky Attorney General is urging thousands of woman to come forward as he files suit against one of the nation’s largest medical companies.
Attorney General Andy Beshear claims the women who fell victim were deceived by Johnson and Johnson and their medical device unit Ethicon.
He claims 15,000 of them across the Commonwealth underwent Transvaginal Mesh surgery using a product that was far from advertised.
“I do not tolerate those who would profit by misrepresenting their products and by lying or lying by omission to Kentuckians,’ Beshear (D) said.
The FDA 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 “FDA Approved” when it was instead only “FDA cleared”.
Beshear argued Johnson and Johnson and Ethicon were guilty of “outrageous” deception to doctors and patients because the difference is 1,100 hours of testing.
“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 situations the complications are irreversible,” Beshear said.
A spokesperson for Ethicon called the lawsuit "unjustified" in a 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 obtaining treatment for the often-debilitating symptoms of stress urinary incontinence."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.
The following is the full Ethicon statement:
“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.”
http://www.whas11.com/news/local/ky-ag-urges-women-to-come-forward-as-he-files-johnson-johnson-lawsuit/299722320
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Yet another state sues J&J for allegedly hiding vaginal mesh risks
Aug 17, 2016 | Stat
By Ed Silverman
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.
https://www.statnews.com/pharmalot/2016/08/16/johnson-and-johnson-vaginal-mesh-lawsuit/
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Kentucky Attorney General Sues Johnson & Johnson Over Surgical Mesh
Aug 16, 2016 | WFPL
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.”
Ethicon has settled some of the thousands of lawsuits filed over the product nationwide. In an emailed statement, the company said Beshear’s suit was unwarranted.
“The lawsuit against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations,” spokesperson Samantha Lucas said in a statement. “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.”
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.
http://wfpl.org/kentucky-attorney-general-sues-johnson-johnson-surgical-mesh/
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Kentucky AG sues Johnson & Johnson over vaginal implants
Aug 16, 2016 | Medical Xpress
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 and Johnson 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.
The implants have prompted tens of thousands of lawsuits across the nation.
Beshear said in a statement that more than 15,000 women in Kentucky had transvaginal mesh implanted without being provided with sufficient information about complications that can lead to permanent disability.
The lawsuit seeks civil penalties of $2,000 per violation of the state's deceptive practices law, and $10,000 when targeted at consumers over age 60.
The U.S. Food and Drug Administration this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for them.
In an emailed response Tuesday, the Johnson & Johnson subsidiary Ethicon Inc. 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. "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."
http://medicalxpress.com/news/2016-08-kentucky-ag-sues-johnson-vaginal.html
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Beshear files lawsuit against Johnson & Johnson over surgical mesh
Aug 17, 2016 | WKYT
FRANKFORT, Ky. (WKYT) - 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.
http://www.wkyt.com/content/news/Beshear-files-lawsuit-against-Johnson--Johnson-over-surgical-mesh----390310202.html
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U.S. stocks retreat from record territory, as Fed rate hike odds improve
Aug 16, 2016 | Investing.com
Investing.com -- U.S. stocks fell out of record territory on Tuesday, as investors eyed the release of the minutes from the Federal Reserve's July meeting, while a key policymaker hinted that it could be appropriate to raise interest rates in the coming months as the economy demonstrates continued improvement.
The Dow Jones Industrial Average fell 84.03 or 0.45% to 18,552.02, while theNASDAQ Composite index lost 34.91 or 0.66% to 5,227.11, each moving off record intraday and closing highs from the previous day. The S&P 500 Composite index, meanwhile, fell 12.00 or 0.55% to 2,178.15. On the S&P 500, nine of 10 sectors closed in the red, as stocks in the Telecom and Utilities industries lagged. Stocks in the interest rate sensitive, defensive industries performed poorly in Tuesday's session, each falling by more than 1%. Stocks in the Energy sector led, closing the session as the only industry in the green.
On Monday, all three major indices on Wall Street closed at all-time record highs for the second time in three sessions. When the Dow, NASDAQ and S&P 500 all closed at a previous record high last Thursday, it marked the first time the occurrence transpired in 17 years.
Stocks in the beaten down banking sector received a boost on Tuesday morning when New York Fed president William Dudley jolted markets with hawkish comments on the likelihood that that the U.S. central bank could lift interest rates before the end of the year. Speaking exclusively with Fox Business, Dudley said the Fed is "getting closer" to that point when it "will be appropriate" to actually raise short-term rates. A rate hike by the Fed this year is viewed as bullish for leading Wall Street banks, as higher interest rates help financial institutions increase their net interest margins.
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.
The biggest gainer on the NASDAQ was American Airlines Group (NASDAQ:AAL), which added 0.87 or 2.41% to 36.74. Shares in American Airlines continued to rebound amid heavy profit taking, after the airlines giants reported subdued July traffic and lowered its third-quarter outlook late last week. American Airlines shares are still down more than 18% over the last year. The worst performer was Activision Blizzard Inc (NASDAQ:ATVI), which fell 2.03 or 4.89% to 39.45. Shares in Activision Blizzard (NASDAQ:ATVI) plunged on Tuesday, one day after hedge fund manager John Paulson disclosed in an SEC filing that he is reducing his stake in the video game manufacturer by 68%.
On the New York Stock Exchange, declining issues outnumbered advancing ones by a 2,056-899 margin.
http://www.investing.com/news/stock-market-news/u.s.-stocks-retreat-from-record-territory,-as-fed-rate-hike-odds-improve-420699
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AG: Johnson & Johnson used deceptive marketing
Aug 16, 2016 | Courier-Journal
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.
http://www.courier-journal.com/story/life/wellness/health/2016/08/16/beshear-sues-johnson-johnson-over-surgical-mesh-women/88836694/
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