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Ethicon 5/27
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State Attorneys General Sue J&J Over Allegedly Deceptive Vaginal Mesh Marketing
May 26, 2016 | Fierce Medical Devices
By Emily Wasserman
Johnson & Johnson ($JNJ) has been wading through vaginal mesh litigation, sometimes to no avail. Now the company is facing pushback from Washington and California law officials who sued J&J over its allegedly faulty implants. -
Washington, California, Sue J&J, Ethicon for Misrepresenting Risks of Pelvic Mesh Devices
May 26, 2016 | Harris Martin Publishing
Washington State has sued Johnson & Johnson and its subsidiary, Ethicon Inc., accusing them of misrepresenting the allegedly severe and irreversible risks of their pelvic mesh devices designed to treat pelvic organ prolapse and stress urinary incontinence. -
Two states sue Johnson & Johnson over vaginal mesh device problems
May 26, 2016 | BioPharma Dive
By Nicole Gray
Johnson & Johnson is being sued by the states of California and Washington for failure to disclose risk associated with its vaginal mesh device, reports Stat. -
State Charges Johnson & Johnson Hid Risks of Pelvic Mesh
May 26, 2016 | Seattle Pi
By Rita R. Robison
In a consumer protection lawsuit filed Tuesday, the state is accusing Johnson & Johnson of concealing the risks of a surgical mesh designed to treat pelvic floor conditions in women. -
California Sues Johnson & Johnson for Women
May 26, 2016 | Couthouse News Service
By Philip A. Janquart
Stepping in after more than 1,500 civil lawsuits, California's attorney general sued Johnson & Johnson and Ethicon on Tuesday, claiming they sold pelvic mesh implants knowing that the devices lead to severe complications and injuries in women.
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State Attorneys General Sue J&J Over Allegedly Deceptive Vaginal Mesh Marketing
May 26, 2016 | Fierce Medical Devices
By Emily Wasserman
Johnson & Johnson ($JNJ) has been wading through vaginal mesh litigation, sometimes to no avail. Now the company is facing pushback from Washington and California law officials who sued J&J over its allegedly faulty implants.
The Washington and California state attorneys general accused the New Jersey-based med tech giant of not telling patients and doctors about serious problems linked to the devices, including urinary dysfunction, loss of sexual function and severe pain, The Wall Street Journal reports.
"For many victims, their health and their quality of life were forever changed as a result of this deception. Sitting upright, lying on their side, walking all became incredibly painful. … These women were robbed of their ability to live and work in the way they once did," Washington State AG Bob Ferguson said at a news conference, as quoted by the WSJ.
California's suit claims that J&J's Ethicon unit used false advertising and deceptive marketing for its vaginal mesh products. The company sold about 790,000 devices in the U.S. between 2008 and 2014, including more than 42,000 in California, California State AG Kamala Harris said in a statement seen by the WSJ.
The suit in Washington alleges that J&J violated the state's consumer protection law by selling 12,000 devices but never telling patients that the mesh can erode and cause complications. The state is seeking millions of dollars in penalties, according to the WSJ story.
J&J is not owning up to any wrongdoing. "The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," the company told the newspaper in an emailed statement. J&J is "concerned that the attorney general's decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence," it said.
Meanwhile, J&J is facing upwards of 35,000 lawsuits over its vaginal mesh products. Earlier this year, the company said that it would shell out more than $120 million to settle thousands of suits from women who claim that J&J's vaginal mesh implants caused them pain and injury. The move marked the first time J&J agreed to a settlement, but the word is still out on whether J&J will agree to resolve more suits.
"From time to time we have appropriately agreed to resolve some cases. We will not discuss the terms, nor discuss our ongoing litigation strategy," J&J spokesman Ernie Knewitz said at the time.
http://www.fiercemedicaldevices.com/story/state-attorneys-general-sue-jj-over-allegedly-deceptive-vaginal-mesh-market/2016-05-26
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Washington, California, Sue J&J, Ethicon for Misrepresenting Risks of Pelvic Mesh Devices
May 26, 2016 | Harris Martin Publishing
Washington State has sued Johnson & Johnson and its subsidiary, Ethicon Inc., accusing them of misrepresenting the allegedly severe and irreversible risks of their pelvic mesh devices designed to treat pelvic organ prolapse and stress urinary incontinence.
The May 24 complaint filed by Washington Attorney General Robert W. Ferguson in the King County Superior Court says J&J and Ethicon marketed their products to doctors as a “new and revolutionary” product that would reduce time in the operating room and increase profits, without disclosing the serious complications the devices can cause. Defendants also touted the devices as improvements over ...
Subscription required, full story at: http://harrismartin.com/article/20867/washington-california-sue-jj-ethicon-for-misrepresenting-risks-of-pelvic-mesh-devices/
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Two states sue Johnson & Johnson over vaginal mesh device problems
May 26, 2016 | BioPharma Dive
By Nicole Gray
Dive Brief:
Johnson & Johnson is being sued by the states of California and Washington for failure to disclose risk associated with its vaginal mesh device, reports Stat. The company already faces 35,000 personal-injury suits from consumers in the U.S. over its surgical mesh products.
The implanted pelvic mesh device is intended to shore up weakened pelvic muscles and control urinary incontinence. However, plaintiffs against J&J claim the device was defectively designed and manufactured, which has led to numerous injuries.
Women have complained of numerous serious adverse events, including organ perforation, chronic pain and inflammation, urinary dysfunction, and loss of sexual function.
Dive Insight:
Between 2008 and 2014, J&J's Ethicon unit sold roughly 787,232 pelvic mesh devices, according to the California Attorney General's office. Globally, the company has sold two million devices, and also faces lawsuits from women in a number of other countries.
"They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials," said Washington Attorney General Bob Ferguson.
J&J recently lost two jury verdicts, after juries determined its failure to disclose risk led to serious harm for two women. The first woman was awarded $13.5 million in damages, while the other received $12.5 million, according to Stat.
These lawsuits come as J&J is handling legal challenges related to its talcum powder. J&J is facing 1,200 suits which contend the company knew of an alleged link between talcum-based products such as Johnson's Baby Powder and an increased risk of ovarian cancer, yet failed to warn consumers about the risk.
Earlier this month, a judge in South Dakota ordered J&J to pay $55 million to a woman who said the company's talcum powder caused her ovarian cancer.
http://www.biopharmadive.com/news/two-states-sue-johnson-johnson-over-vaginal-mesh-device-problems/419885/
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State Charges Johnson & Johnson Hid Risks of Pelvic Mesh
May 26, 2016 | Seattle Pi
By Rita R. Robison
In a consumer protection lawsuit filed Tuesday, the state is accusing Johnson & Johnson of concealing the risks of a surgical mesh designed to treat pelvic floor conditions in women.
As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and bowl movement dysfunctions, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection, the Washington State Attorney General’s Office charged in the lawsuit.
These complications can crop up years after the surgery and are in many cases irreversible, Attorney General Bob Ferguson said, adding removal of the mesh is nearly impossible.
“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials.”
The state is alleging tens of thousands of violations of the state consumer laws, with the potential of millions of dollars of penalties.
Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the United States. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.
The mesh is made of woven polypropylene threads and is marketed to doctors and patients as a way to treat pelvic organ prolapse, when organs shift from their normal position, and bladder issues.
The mesh is inserted surgically. It’s put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and permanently anchored in the body to hold up falling organs.
The mesh can shift position and cut through the vaginal wall or into other organs.
A doctor described in a 2009 email to Johnson & Johnson: “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician. She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere. … This patient will have a permanently destroyed vagina.”
The agency said the company never told consumers that:The mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body fights to rid itself of the foreign material.The mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.The mesh can cause severe erosion or a complication where the mesh moves and protrudes into an organ or through the vaginal wall, causing chronic pain and painful intercourse.This risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.
Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at a consumer protection lawsuit, MarybethH@atg.wa.gov, or contact the agency’s Consumer Resource Center at 800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.
The U.S. Food and Drug Administration hasn’t banned the pelvic mesh, but early this year it did reclassified vaginal mesh implants for pelvic organ prolapse as a class III, or high-risk, medical devices requiring premarket approval application. Vaginal mesh implants were previously classified as class II, or moderate risk, devices.
http://blog.seattlepi.com/boomerconsumer/2016/05/26/state-charges-johnson-johnson-hid-risks-of-pelvic-mesh/
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California Sues Johnson & Johnson for Women
May 26, 2016 | Couthouse News Service
By Philip A. Janquart
Stepping in after more than 1,500 civil lawsuits, California's attorney general sued Johnson & Johnson and Ethicon on Tuesday, claiming they sold pelvic mesh implants knowing that the devices lead to severe complications and injuries in women.
The attorney general cites one woman's story, from 2008, as "illustrative of the toll that surgical mesh has taken on people's lives."
"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."
Pelvic mesh implants are used to treat pelvic floor conditions such as stress urinary incontinence and pelvic organ prolapse. Stress urinary incontinence occurs when muscles that control urine flow are weakened or damaged, causing unintended leakage, especially when laughing, coughing or exercising. Pelvic organ prolapse occurs when muscles of the pelvic floor cannot support pelvic organs, causing them to drop down or even bulge out the vagina, according to the Mayo Clinic.
Johnson & Johnson manufactures medical devices to treat the conditions. The devices are made with polypropylene threads derived from crude oil — chemicals used in a tremendous number of products, from rugs to car parts.
Women who get the implants have reported a variety of complications, ranging from sexual dysfunction to permanent disfigurement. The Courthouse News database contains more than 1,500 civil lawsuits involving the devices.
"Complications associated with the use of synthetic mesh in transvaginal repair include the following: erosion, exposure and intrusion ...; a chronic foreign body response to the mesh and resulting chronic inflammation; bacterial colonization of mesh and mesh infections; and mesh contracture or shrinkage inside the body," Attorney General Kamala Harris says in the May 24 lawsuit in Superior Court. "These mesh-related complications can lead to further problems for women, including severe, chronic pain, permanent dyspareunia and sexual, urinary and defecatory dysfunction. The risk of these mesh-related complications is lifelong; mesh complications can arise years - or even decades - after insertion."
Complete mesh removal is difficult and in many cases impossible. The complaint compares it to trying to get gum out of hair or "trying to remove rebar from concrete without damaging the overall structure."
There are non-surgical options to treat the conditions, including mesh devices and non-mesh surgical alternatives that "do not pose the same risks that surgical mesh does," the attorney general says.
She says Johnson & Johnson marketed though it knew of the risks, and touted them as "FDA approved," though the Food and Drug Administration had only "cleared" the product, meaning the devices "need only demonstrate that they are 'substantially equivalent' to a device already on the market."
FDA "approval," however, requires "rigorous" evaluation, involving about 1,200 hours of intense FDA review.
"Johnson & Johnson made these misrepresentations understanding that the 'FDA approved' designation leads doctors and patients to believe that a medical product has been well studied and scrutinized," the complaint states.
The state also claims that Johnson & Johnson hid the risks and complications associated with the devices, "which would have been material information in considering treatment options."
"Johnson and Johnson deceptively marketed its surgical mesh devices as safe with minimal risk when in fact these devices exposed women to a host of dangerous complications," the complaint states. "By concealing this information, Johnson & Johnson took away doctors' ability to accurately counsel patients and women's ability to make informed choices about whether or not to have this risky device permanently implanted in their bodies."
Deputy Attorney General Jinsook Ohta could not be reached for comment after hours Wednesday.
An Ethicon spokeswoman called the lawsuit "unjustified."
"The decision by the attorneys general to file suit against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations," Ethicon's Samantha Lucas said in an email. "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."
Lucas said the mesh slings are "the worldwide standard of care for surgical treatment of stress urinary incontinence," and noted that the American Urogynecologic Society has said "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."
She added, "Ethicon is concerned that the attorneys general's decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence."
The state seeks an injunction, damages for unfair competition and false advertising, and civil penalties of $2,500 against each defendant for each violation of California's Business and Professions Code 17200 and 17500, and another $2,500 against each defendant for each violation of section 17200 "perpetrated against a senior citizen or disabled person."http://www.courthousenews.com/2016/05/26/california-sues-johnson-johnson-for-women.htm
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