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Kentucky AG Ethicon Lawsuit EOD Media Report 8/18/16
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Kentucky joins Calif., Wash. state in suing J&J’s Ethicon over pelvic mesh
Aug 18, 2016 | Mass Device
By Brad Perriello
Kentucky joined California and Washington state in suing Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon over its pelvic mesh products, accusing the company of deceptively marketing its treatments for female urinary incontinence and pelvic organ prolapse. -
Johnson & Johnson now being sued by 3 states over vaginal mesh implants
Aug 18, 2016 | Clinical Innovation + Technology
By John Gregory
Kentucky has filed a lawsuit against Johnson & Johnson’s medical device unit, Ethicon, alleging it concealed and purposely misrepresented the risks involved in its surgical transvaginal mesh products to physicians and patients. -
(UPDATE) J&J faces yet another marketing suit, this time from the state of Kentucky
Aug 17, 2016 | FierceBiotech
By Alyssa Huntley
Attorney General Andy Beshear filed a lawsuit this week in Franklin Circuit Court in Kentucky against Johnson & Johnson and its medical device unit Ethicon. The suit claims deceptive marking of surgical transvaginal mesh under the Kentucky Consumer Protection Act. -
Greater Cincinnati firm faces lawsuit over deceptive marketing allegations
Aug 18, 2016 | Cincinnati Business Courier
By Barrett J. Brunsman
Ethicon, which makes medical tools used for surgery, is facing a lawsuit that could cost the Blue Ash firm millions of dollars if it’s found to have engaged in deceptive marketing of surgical mesh devices for women.
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Kentucky joins Calif., Wash. state in suing J&J’s Ethicon over pelvic mesh
Aug 18, 2016 | Mass Device
By Brad Perriello
Kentucky joined California and Washington state in suing Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon over its pelvic mesh products, accusing the company of deceptively marketing its treatments for female urinary incontinence and pelvic organ prolapse.
Ethicon is already facing tens of thousands of product liability lawsuits over the pelvic mesh devices; in Kentucky, more than 15,000 women were 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 a press release from Kentucky attorney general Andy Beshear.
“The way this company clearly chose profits over people is outrageous,” Beshear said in prepared remarks. “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 against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations,” spokeswoman Samantha Lucas told FierceBiotech. “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.”
In May, California AG Kamala Harris and Washington AG Bob Ferguson sued Ethicon on similar grounds.
“For many victims, their health and their quality of life were forever changed as a result of this deception,” Ferguson said at the time, according to the Wall Street Journal. “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.”
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Johnson & Johnson now being sued by 3 states over vaginal mesh implants
Aug 18, 2016 | Clinical Innovation + Technology
By John Gregory
Kentucky has filed a lawsuit against Johnson & Johnson’s medical device unit, Ethicon, alleging it concealed and purposely misrepresented the risks involved in its surgical transvaginal mesh products to physicians and patients.
California and Washington filed similar lawsuits earlier this year, accusing the large company of conducting a deceptive marketing campaign for the synthetic fabric implants, marketed under the names TVT and Prolift, which are supposed to treat conditions like stress urinary incontinence and pelvic organ prolapse.
Kentucky Attorney General Andy Beshear said more than 15,000 women in the state had transvaginal mesh implanted without being aware of the potential complications, including chronic pelvic pain, urinary dysfunction, painful sexual intercourse or total loss of sexual function.
“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 alleges J &J ignored the advice of its own medical directors to include stronger warnings about potential complications, and did the same when physicians complained. One pelvic surgeon is quoted as saying of a patient: “She will likely lose any coital function as her vaginal length is now 3 cm. ... This patient will have a permanently destroyed vagina.”
The damage goes beyond sexual complications, according to the suit, saying patients have become permanently disabled or unable to work with accommodations. Others have said they’ve undergone multiple corrective surgeries that don’t eliminate pain because the complications may be irreversible or the mesh can’t be fully removed.
“I had no quality of life,” said one August 2011 complaint, according to the suit. “My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’ He had to shave the mesh from my urethra because it was so badly eroded.”
The lawsuit says J &J was aware of the complications, but marketed the mesh beginning in 1997 as a minimal risk surgical option, with the product’s brochures not mentioning many of the major complications the lawsuit lists.
Additionally, the suit alleges J &J told doctors the mesh was FDA approved when it had only been “cleared” under the far less rigorous 510(k) process.
In an emailed statement, company spokeswoman Samantha Lucas called the lawsuits “unjustified.”
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” Lucas 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.”
Beshear said the suit will be seeking “millions” in damages for violations of Kentucky law on deceptive marketing practices.
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(UPDATE) J&J faces yet another marketing suit, this time from the state of Kentucky
Aug 17, 2016 | FierceBiotech
By Alyssa Huntley
Attorney General Andy Beshear filed a lawsuit this week in Franklin Circuit Court in Kentucky against Johnson & Johnson and its medical device unit Ethicon. The suit claims deceptive marking of surgical transvaginal mesh under the Kentucky Consumer Protection Act.
According to the suit, the synthetic woven fabric--which is implanted through the vagina to treat pelvic floor conditions--was used to treat more than 15,000 women in Kentucky. However, Johnson & Johnson and Ethicon did not provide sufficient information on the hazards and risks associated with the mesh, which is necessary for women and their healthcare providers to make the most informed decision. Recommendations were made by Johnson & Johnson’s own staff to include more complete disclosures, which were ignored by the company, Beshear said.
According to the suit, this warning came first in 2005 through an email from Johnson & Johnson’s medical director asking for stronger disclosures on the product. “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,” the email read.
“The way this company clearly chose profits over people is outrageous,” Beshear said in the announcement. “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.”
In 2006 an additional medical director made note of post-operative patients who were concerned that they had not, prior to surgery, been given adequate information regarding possible complications.
Beshear said in the suit that not only did the company fail to incorporate any of this information in its marketing, the company purposely concealed and misrepresented to doctors and patients many risks and complications that could come along with the device. Those risks include chronic pelvic pain, urinary and/or defacatory dysfunction, pain with sexual intercourse or total loss of sexual function.
In addition, Johnson & Johnson allegedly told doctors the products were FDA approved, while they were only FDA cleared.
Samantha Lucas, a spokesperson for Ethicon, shared the following statement withFierceMedicalDevices: "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."
This is far from the first time Johnson & Johnson has had problems with the marketing of their vaginal mesh products. Just this past May, the states of Washington and California filed suits against the device maker for similar reasons.
"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,” said Washington State Attorney General Bob Ferguson at a conference. “These women were robbed of their ability to live and work in the way they once did."
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Greater Cincinnati firm faces lawsuit over deceptive marketing allegations
Aug 18, 2016 | Cincinnati Business Courier
By Barrett J. Brunsman
Ethicon, which makes medical tools used for surgery, is facing a lawsuit that could cost the Blue Ash firm millions of dollars if it’s found to have engaged in deceptive marketing of surgical mesh devices for women.
More than 15,000 women in Kentucky had transvaginal mesh implanted without Ethicon or its parent company, Johnson & Johnson, providing sufficient warning about the known hazards, according to the suit filed by Kentucky Attorney General Andy Beshear.
The lawsuit against Ethicon and Johnson & Johnson is unjustified, and the company (NYSE: JNJ) plans to vigorously defend itself against the allegations, spokeswoman Samatha Lucas told me.
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” Lucas 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 this lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence,” Lucas said.
Ethicon is one of the largest employers in Blue Ash. The company had a workforce of 824 people in 2015.
Beshear said women and their doctors needed sufficient warning of possible complications from Ethicon so they could make informed decisions about medical treatment with transvaginal mesh.
The suit filed in Franklin Circuit Court described transvaginal mesh as “a synthetic woven fabric implanted through the vagina to treat common pelvic floor conditions that 30 to 50 percent of all women will face in their lifetime.”
Beshear’s office is seeking civil penalties of $2,000 for each violation and $10,000 for each violation targeted to consumers 60 or older under the state’s Consumer Protection Act, which prohibits companies from false, misleading, deceptive or unfair practice in trade or commerce.
The suit didn’t specify what the total cost to Ethicon and New Jersey-based J&J might be but noted it would be millions of dollars.
“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.”
California and the state of Washington filed similar suits against J&J earlier this year.
The surgical mesh was marketed to doctors and patients as minimally invasive with minimal risks, according to the Kentucky suit.
“J&J concealed and misrepresented to doctors and patients many of the risks of adverse events associated with these devices, such as chronic pelvic pain, urinary and/or defecatory dysfunction, pain with sexual intercourse and or loss of sexual function, and the potentially irreversible nature of these complications,” the suit stated.
Also known as synthetic midurethral slings, the devices “are the worldwide standard of care for surgical treatment of stress urinary incontinence,” said Lucas, the spokeswoman for Ethicon and J&J.
“The American Urogynecologic Society, 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,’” Lucas said.
The Kentucky attorney general said J&J failed to follow recommendations by its own staff to include more complete disclosures of the risk of using the Ethicon product.
In 2005, J&J’s medical director emailed the company to propose stronger warnings on the product for doctors and patients, the lawsuit stated.
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.”
J&J persisted in misrepresenting the risks of the devices after receiving complaints from doctors and patients about severe complications, the suit stated.
One surgeon complained, “This patient will have a permanently destroyed vagina,” the suit stated.
A woman complained, “I experienced excruciating pain from Day One,” the suit stated. “I felt as though my urethra was being strangled. I couldn’t pee, walking was out of the question, sitting was agony. … Over the course of the next 14 weeks I visited/was admitted to the (hospital) 10 times … My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’ He had to shave the mesh from my urethra as it was so badly eroded.”
The suit stated that mesh removal surgery is required to treat complications but it is extremely difficult and often impossible to remove all of it – “akin to trying to remove rebar from concrete without damaging the overall structure.”
Beshear requested a jury trial and attorney fees as well as an order that Ethicon and J&J disclose clinically significant risk information in the future.
The lawsuit doesn’t seek restitution for individuals, but Beshear requested that women not already represented in litigation call his office at 502-696-5389.
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