Preview Newsletter
Mesh Media Monitoring 5/24/16
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(UPDATE 2) California AG sues Johnson & Johnson over marketing for pelvic mesh
May 24, 2016 | Reuters
By Jessica Dye
California has accused Johnson & Johnson of failing to warn doctors and patients about the severity and frequency of complications associated with its pelvic mesh devices. -
(UPDATE 2) Washington, California sue over pelvic mesh implants
May 24, 2016 | Associated Press
By Gene Johnson
Washington state and California sued Johnson & Johnson on Tuesday, saying that for years the company misrepresented the risks of vaginal mesh implants it sold to repair pelvic collapse. -
State AG files lawsuit against Johnson & Johnson for pelvic mesh
May 24, 2016 | KIRO-TV (Seattle, WA)
State Attorney General Bob Ferguson has announced a consumer protection lawsuit against Johnson & Johnson regarding its marketing of a surgical mesh used to treat pelvic floor conditions in women. -
State AG files lawsuit against Johnson & Johnson over surgical mesh
May 24, 2016 | KING-NBC (Seattle, WA)
Washington State Attorney General Bob Ferguson filed a consumer lawsuit against Johnson & Johnson on Tuesday, accusing the company of knowingly concealing the risk associated with a surgical mesh designed to treat pelvic floor conditions in women. -
State sues Johnson & Johnson over pelvic mesh, seeks millions in fines
May 24, 2016 | KOMO-TV (Seattle, WA)
Washington state is suing Johnson & Johnson, saying that for more than a decade the company misrepresented the risks of vaginal mesh implants it sold. -
(PRESS RELEASE) Attorney General Kamala D. Harris Files Lawsuit Against Johnson & Johnson for Deceptive Marketing of Surgical Mesh Products
May 24, 2016 | CA Office of the Attorney General
Attorney General Kamala D. Harris today filed a lawsuit against Johnson & Johnson (J&J) for false advertising and deceptive marketing of its surgical mesh products for women. The complaint alleges that J&J neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks.
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(UPDATE 2) California AG sues Johnson & Johnson over marketing for pelvic mesh
May 24, 2016 | Reuters
By Jessica Dye
California has accused Johnson & Johnson of failing to warn doctors and patients about the severity and frequency of complications associated with its pelvic mesh devices.
According to the lawsuit filed by the state's attorney general on Tuesday, J&J and its Ethicon unit falsely marketed the devices as a safe and superior option to non-mesh treatments for pelvic floor disorders, when it was aware that they could cause pain, bleeding, loss of sexual function and other side effects.
"Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products," California Attorney General Kamala Harris said in a statement. Her office led a multi-state investigation into J&J's mesh products, which included 46 states and the District of Columbia.
The lawsuit seeks monetary penalties and an order halting any unfair advertising for mesh.
J&J said in a statement that the lawsuit was "unjustified" and could discourage women from seeking treatment for incontinence symptoms.
"The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," said spokeswoman Samantha Lucas.
J&J is one of several manufacturers that sold the devices to treat conditions like stress urinary incontinence and pelvic organ prolapse in women. Those companies are facing tens of thousands of individual lawsuits from plaintiffs who said they were injured by the mesh's poor design and substandard materials, which plaintiffs say led to serious complications that require surgery to repair.
According to California's attorney general, J&J sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California.
Also on Tuesday, Washington state's attorney general, Bob Ferguson, filed a similar consumer-protection lawsuit against J&J over its marketing of pelvic mesh devices.
Over the past several years, the devices have come under increasing scrutiny by regulators as well as private litigants. The U.S. Food and Drug Administration says it has received thousands of reports of complications in connection with mesh used to treat pelvic organ prolapse.
Earlier this year, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse transvaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices' safety.
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(UPDATE 2) Washington, California sue over pelvic mesh implants
May 24, 2016 | Associated Press
By Gene Johnson
Washington state and California sued Johnson & Johnson on Tuesday, saying that for years the company misrepresented the risks of vaginal mesh implants it sold to repair pelvic collapse.
In the latest legal actions over the problem-prone devices, Attorneys General Bob Ferguson of Washington and Kamala Harris of California accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain.
"For many victims, their health and their quality of life were forever changed as a result of this deception," Ferguson told a news conference. "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."
Patients have already filed tens of thousands of lawsuits against mesh manufacturers, including New Jersey-based Johnson & Johnson, Massachusetts-based Boston Scientific and Ireland-based Endo International. In 2014, Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits. Johnson & Johnson faces more than 35,000 lawsuits, Harris said.
The plastic mesh is used to treat pelvic organ prolapse, a condition that involves organs such as the bladder, bowel and uterus shifting, often after childbirth, a hysterectomy or menopause. In response to thousands of injuries from the mesh, the U.S. Food and Drug Administration early this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for them. The agency had already concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches.
In an emailed statement, Johnson & Johnson subsidiary Ethicon Inc., which marketed the mesh, 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.
"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."
California and Washington led a group of 46 states and the District of Columbia in investigating the company's practices. California's lawsuit alleges false advertising and deceptive marketing. In a news release, Harris noted that Johnson & Johnson sold nearly 790,000 of the devices nationwide from 2008 to 2014, including more than 42,000 in California.
Washington's lawsuit alleges tens of thousands of violations of the state's consumer protection law and seeks penalties that could reach well into the millions of dollars. Ferguson said Johnson & Johnson sold 12,000 of the devices in Washington, but it never told patients the mesh can cause chronic inflammation as their body rejects the foreign material; that the mesh harbors infections that can live indefinitely in its small weave; or that the mesh frequently protrudes into an organ or through the vaginal wall.
He noted a 2009 email that one doctor sent to Johnson & Johnson just before operating on a woman. "She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere," the doctor wrote. "This patient will have a permanently destroyed vagina."
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State AG files lawsuit against Johnson & Johnson for pelvic mesh
May 24, 2016 | KIRO-TV (Seattle, WA)
State Attorney General Bob Ferguson has announced a consumer protection lawsuit against Johnson & Johnson regarding its marketing of a surgical mesh used to treat pelvic floor conditions in women.
The lawsuit alleges thousands of violations of the Washington Consumer Protection Act by deceptive informational and marketing materials distributed to consumers and doctors.
Some patients who received the medical devices suffered serious and sometimes lifelong complications, including chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction, according to Ferguson.
These risks were minimized or omitted in materials distributed by the company.
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State AG files lawsuit against Johnson & Johnson over surgical mesh
May 24, 2016 | KING-NBC (Seattle, WA)
Washington State Attorney General Bob Ferguson filed a consumer lawsuit against Johnson & Johnson on Tuesday, accusing the company of knowingly concealing the risk associated with a surgical mesh designed to treat pelvic floor conditions in women.
Ferguson says thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.
“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. This is an unacceptable way of doing business, and I will hold the company accountable.”
The state alleges tens of thousands of violations of the Washington Consumer Protection Act, potentially placing penalties well into the millions of dollars.
The company sold nearly 12,000 mesh devices in Washington.
The mesh is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.
The state says the mesh has caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The suit alleges that the mesh can shift position and cut through the vaginal wall or into other organs.
Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.
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State sues Johnson & Johnson over pelvic mesh, seeks millions in fines
May 24, 2016 | KOMO-TV (Seattle, WA)
Washington state is suing Johnson & Johnson, saying that for more than a decade the company misrepresented the risks of vaginal mesh implants it sold.
Attorney General Bob Ferguson said Tuesday his office filed the consumer protection lawsuit in King County Superior Court. He said the company sold nearly 12,000 of the devices in Washington, and thousands of women in the state have faced complications that include urinary dysfunction, constipation, vaginal disfigurement, loss of sexual function and chronic infection.
The complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible, Ferguson said.
One patient described her ordeal: "I experienced excruciating pain from day one. I felt as though my urethra was being strangled, I couldn't pee, walking was out of the question, sitting was agony, (and) I couldn't lie on my left side due to severe pain and numbness at my left groin area. Over the course of the next 14 weeks I visited/was admitted to the (hospital) 10 times.
I had no quality of life. My consultant likened the mesh removal as to 'trying to remove chewing gum from hair.' "
"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."
The devices are used to treat pelvic organ prolapse, a condition that involves organs such as the bladder, bowel and uterus shifting, often after childbirth, a hysterectomy or menopause. Early this year the U.S. Food and Drug Administration re-labeled the mesh high risk instead of moderate.
The lawsuit alleges thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors.
The attorney general will ask the court to prohibit Johnson & Johnson from misleading marketing, find the company violated the Consumer Protection Act and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.
The state alleges tens of thousands of violations, potentially placing penalties well into the millions of dollars.
Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.
Johnson & Johnson did not immediately respond to an email seeking comment.
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May 24, 2016 | CA Office of the Attorney General
Attorney General Kamala D. Harris today filed a lawsuit against Johnson & Johnson (J&J) for false advertising and deceptive marketing of its surgical mesh products for women. The complaint alleges that J&J neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks.
California co-led a multistate investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women, and is seeking injunctive relief and monetary penalties to ensure that J&J stops its deceptive practices.
“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” said Attorney General Harris. “Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being. My office will continue to hold companies accountable for misleading consumers and patients for financial gain.”
The surgical mesh device is designed to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse. The lawsuit alleges that J&J misrepresented the safety of these devices by concealing the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and potentially devastating impact on overall quality of life.
J&J also misrepresented the severity and frequency of common complications, and failed to disclose that its surgical mesh devices presented risks not present in alternative treatment options.
The suit further claims that J&J knew about potential risks and side effects prior to the launch of their mesh products, yet omitted that information from educational and marketing materials provided to doctors and patients.
J&J sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California for that same time period. Worldwide, more than 2 million women had been implanted with these mesh products.
In addition to the lawsuit filed today, J&J faces over 35,000 personal injury lawsuits in state and federal court related to its surgical mesh products.
A copy of the complaint is attached to the online version of this news release at www.oag.ca.gov/news.
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Online Sources
Full Text of Stories Below
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