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Ethicon 26/5
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California Attorney General Sues Johnson & Johnson Over Transvaginal Mesh
May 25, 2016 | NBC
By Vicky Nguyen, Kevin Nious and Jeremy Carroll
The complaints allege J&J “neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks” from surgical mesh. -
Here’s Why Johnson & Johnson’s Brand Reputation is Getting Slammed
May 25, 2016 | Money
By Martha C. White
It’s been a rough month for Johnson & Johnson: A Missouri court ordered the company to pay $55 million a few weeks ago, following a lawsuit brought by a woman who said the company’s talcum powder gave her ovarian cancer. Then on Tuesday, California’s attorney general suedthe company for failure to disclose the risks of its pelvic mesh devices. -
J&J sued by two states, alleging hidden vaginal mesh risks
May 25, 2016 | Stat
By Ed Silverman
Johnson & Johnson faces fresh legal problems over its vaginal mesh products as two state attorneys general on Tuesday filed lawsuits accusing the health care giant of concealing severe risks and falsely marketing the products to doctors and women. -
Study: FDA needs tougher device rules to protect women
May 25, 2016 | Philadelphia Local News
By Marie McCullough
Over the last 15 years, the Food and Drug Administration has approved numerous high-risk women's health devices based on weak clinical studies, including some that showed no effectiveness, according to an analysis by Northwestern University researchers.
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California Attorney General Sues Johnson & Johnson Over Transvaginal Mesh
May 25, 2016 | NBC
By Vicky Nguyen, Kevin Nious and Jeremy Carroll
Attorney General Kamala Harris and Washington State Attorney General Bob Ferguson filed two separate consumer lawsuits against Johnson & Johnson. The complaints allege J&J “neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks” from surgical mesh.
The mesh, also known as transvaginal mesh or pelvic sling, is commonly used to treat women for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). 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.
As the NBC Bay Area Investigative Unit reported in February, more than 3,000 women have filed complaints with the Food and Drug Administration about serious health concerns related to mesh.
“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,” Attorney General Harris said. “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.”
California co-led a multistate investigation that included 45 other states and the District of Columbia. The investigation looked into J&J’s surgical mesh products for women. The lawsuit seeks injunctive relief and monetary penalties.
The suit claims J&J misrepresented the severity and frequency of common complications, and 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.”
According to Harris’ office, 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 a statement Johnson and Johnson said:
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. 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, has stated “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 the Attorneys General’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.
http://www.nbcbayarea.com/investigations/California-Attorney-General-Sues-Johnson--Johnson-Over-Transvaginal-Mesh-380891931.html
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Here’s Why Johnson & Johnson’s Brand Reputation is Getting Slammed
May 25, 2016 | Money
By Martha C. White
Pharma company, heal thyselfIt’s been a rough month for Johnson & Johnson: A Missouri court ordered the company to pay $55 million a few weeks ago, following a lawsuit brought by a woman who said the company’s talcum powder gave her ovarian cancer. Then on Tuesday, California’s attorney general suedthe company for failure to disclose the risks of its pelvic mesh devices.
Now, a new survey shows that the bad press is affecting Americans’ views of the company: According to YouGov BrandIndex, consumer perception of J&J just hit a three-and-a-half year low. “Since February 8th, Johnson & Johnson’s perception levels have dropped by two-thirds,” it said, using a metric it calls a “Buzz Index” that measures positive and negative sentiment.
The Missouri verdict came on the heels of another, similar decision against the company: In February, it was ordered to pay $72 million to the family of a woman who used its talcum powder and died of ovarian cancer. Aside from the talcum powder-cancer news, YouGov also said J&J’s reputation was suffering because of defects in replacement hips, over which the company was ordered to pay $502 million by a federal court back in March.
There are indications that all this could be hurting J&J’s bottom line as well as its brand image: YouGov found that purchase intention — that is, whether a consumer who planned to buy a product in that category would purchase J&J or another brand’s product — fell six percentage points to 46% over the course of about a year.
http://time.com/money/4348268/heres-why-johnson-johnsons-brand-reputation-is-getting-slammed/
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J&J sued by two states, alleging hidden vaginal mesh risks
May 25, 2016 | Stat
By Ed Silverman
Johnson & Johnson faces fresh legal problems over its vaginal mesh products as two state attorneys general on Tuesday filed lawsuits accusing the health care giant of concealing severe risks and falsely marketing the products to doctors and women.
The lawsuits, which were filed in California and Washington state, allege thatJohnson & Johnson failed to disclose a host of problems caused by the devices, which are designed to treat the conditions stress urinary incontinence and pelvic organ prolapse. Among the side effects cited: permanent pain with intercourse; a loss of sexual function; chronic inflammation; and permanent urinary or defecation dysfunction.
“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,” Washington State Attorney General Bob Ferguson said in a statement.
“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.”
In the lawsuit filed by California Attorney General Kamala Harris, one woman is quoted as saying 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.”
Harris, who led an investigation that involved 46 states and the District of Columbia, noted that Johnson & Johnson’s Ethicon unit sold more 787,200 devices nationally between 2008 and 2014. Worldwide, more than 2 million women have been implanted with the devices. The state lawsuits cite thousands of violations that may expose the company to potentially tens of millions of dollars in penalties.
A Johnson & Johnson spokeswoman wrote us that the lawsuits are “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 company is concerned the lawsuits will “keep women from obtaining treatment for the often debilitating symptoms of stress urinary incontinence.”
The health care giant already faces an estimated 35,000 personal-injury lawsuits that have been filed by consumers across the country over the devices. Still more lawsuits have been filed in at least nine other countries, including Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, and Venezuela, according to a filing with the US Securities and Exchange Commission.
And in recent months, the company lost two consecutive jury verdicts in the first two cases to go to trial. One verdict awarded a woman $13.5 million, and the other ordered the company to pay a woman $12.5 million. Both verdicts included punitive damages. Around the same time, Johnson & Johnson reportedly began talks to pay more than $120 million to resolve between 2,000 and 3,000 lawsuits
Earlier this year, the US Food and Drug Administration tightened regulations. The devices were reclassified as high-risk rather than moderate-risk, and all device makers must now submit data to support the 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 devices.
https://www.statnews.com/pharmalot/2016/05/25/johnson-johnsonj-vaginal-mesh-product-safety/
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Study: FDA needs tougher device rules to protect women
May 25, 2016 | Philadelphia Local News
By Marie McCullough
Over the last 15 years, the Food and Drug Administration has approved numerous high-risk women's health devices based on weak clinical studies, including some that showed no effectiveness, according to an analysis by Northwestern University researchers.
Using the FDA's database, the researchers looked at all 18 high-risk devices approved between 2000 and 2015, including products for fetal monitoring, contraception, and reducing abnormal uterine bleeding. Of the 18, four devices did not demonstrate effectiveness, six were not required to conduct postmarketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.
Another device - Essure sterilization coils - has been hit by lawsuits and a petition to remove it from the market. Earlier this year, the FDA responded by requiring label warnings that the coils can cause persistent pain, organ perforation, and allergic reactions.
The FDA has long been faulted for relatively lax approval standards for medical devices in general. This review focused on high-risk obstetrical and gynecological devices because, researchers wrote, recent controversies have pointed to regulatory shortcomings. In addition to reconsidering Essure, the FDA has issued warnings that transvaginal mesh can cause pelvic organ injury and that electric surgical tools called morcellators can spread undetected uterine cancer.
Under FDA rules, devices posing the highest potential risk to patients, such as pacemakers, must submit enough clinical data to show safety and effectiveness. (Transvaginal mesh and morcellators were approved under less rigorous pathways.)
Even with this most stringent approval pathway, the FDA does not require that clinical data come from randomized trials, which are the gold standard in clinical research. Nor do the data have to be evaluated by the FDA's expert advisory committee or bolstered by postmarketing safety studies.
"Device regulation is just so much weaker than drug regulation, and it doesn't make any sense," said Steve Xu, a Northwestern physician and health-policy researcher, who coauthored the analysis in the June issue of Obstetrics and Gynecology. "The argument is that more rigorous regulation would decrease innovation. But I would say that has not been demonstrated."
In response, an FDA representative said: "As a general policy, we do not comment on individual studies."
Among the findings in the analysis:
Intergel, a goo that aimed to prevent postoperative internal scarring called adhesions, failed to do that in clinical testing. Although the FDA's advisory committee recommended against approval, the agency gave its OK in 2001 and did not require any postmarketing studies. In 2003, the maker yanked Intergel from the worldwide market amid reports of adhesions, pain, and foreign body reactions.
OxiFirst, a fetal oxygen saturation monitor, failed in its stated aim of reducing cesarean deliveries. Not only was the device approved, but a similar system by another firm, Corometrics 120F Maternal/Fetal Monitor, was not required to show any clinical benefit - just that it was equivalent to OxiFirst. Yet another system, the Stan S31 Fetal Heart Monitor, was approved even though the expert advisory committee gave it thumbs down.
The LUMA Cervical Imaging device was intended to enhance existing technology for biopsying cervical tissue containing precancerous or cancerous cells. While the device improved detection of abnormalities, it also increased "false positives." The FDA approved it after an advisory committee rejected it.
Xu and his four coauthors are concerned that the 21st Century Cures Act - legislation that has passed the House and is being considered in the Senate - would make device regulation even weaker by broadening the definition of "valid scientific evidence."
"We believe both government and organizations representing obstetrician-gynecologists should require more rigorous regulatory standards," they wrote.
http://www.philly.com/philly/health/20160526_Study__Some_FDA-approved_devices_harm_women.html
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