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Ethicon Media Monitoring 4/23/2019
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Washington state to take J&J to trial over pelvic mesh marketing
Apr 23, 2019 | Reuters
By Nate Raymond
The state of Washington is set on Monday to become the first state to take Johnson & Johnson to trial over allegations that it misrepresented the risks of serious conditions that women using its pelvic mesh devices could develop. -
J&J settles Washington state's case over mesh marketing for $9.9 million
Apr 23, 2019 | Reuters
By Nate Raymond
Johnson & Johnson on Monday said it had agreed to pay $9.9 million to resolve a lawsuit by the state of Washington accusing the company of misrepresenting key information about the risks its pelvic mesh devices posed to women. -
J&J Settles Wash. AG's Pelvic Mesh Case Just Before Trial
Apr 22, 2019 | Law 360
By Daniel Siegal
Johnson & Johnson has agreed to pay $9.9 million to settle the state of Washington’s allegations that its Ethicon subsidiary downplayed the risks of its surgical mesh devices in its marketing, avoiding a Seattle trial that was about to begin Monday. -
Washington State Settles with Johnson & Johnson Over the Cost of Pelvic Mesh Injuries
Apr 22, 2019 | Mesh Medical Device News Desk
By Jane Akre
Trial was supposed to begin this morning as Washington State sued Johnson & Johnson over failing to warn women about pelvic mesh complications. At the eleventh hour it settled. Now three more states will take their turn. -
Johnson & Johnson Will Pay $9.9M to Settle Pelvic Mesh Case (1)
Apr 22, 2019 | Bloomnberg Law
By Paul Shukovsky
Johnson & Johnson will pay $9.9 million to settle allegations that it concealed risks associated with pelvic mesh devices implanted into thousands of women in Washington, the state’s attorney general announced April 22. -
Eve of trial: Johnson & Johnson pays $9.9 million to settle state's lawsuit
Apr 22, 2019 | Seattle Post Intelligencer
By Joel Connelly
Johnson & Johnson will pay $9.9 million to settle a lawsuit by the State of Washington that claimed the pharmaceutical giant misrepresented and failed to include risks in its marketing of surgical mesh devices. -
Johnson & Johnson settles Washington surgical mesh lawsuit for $9.9 million
Apr 22, 2019 | MyNorthwest
In an effort to avoid going to trial, Johnson & Johnson will pay $9.9 million for failing to disclose the serious risks linked with their surgical mesh devices, which impacted numerous Washington patients, nurses, and doctors. -
Johnson & Johnson pays $9.9M to settle Washington state pelvic mesh lawsuit
Apr 22, 2019 | AP (In The Seattle Times)
On the eve of trial, Johnson & Johnson has agreed to pay $9.9 million to settle a lawsuit brought by Washington state accusing the health-care giant of misrepresenting the risks of pelvic mesh implants. -
J&J Pays $9.9M to Settle Pelvic Mesh Case Brought by Washington AG
Apr 22, 2019 | Law.com
By Amanda Bronstad
Johnson & Johnson’s Ethicon Inc. unit has agreed to pay nearly $10 million to Washington Attorney General Bob Ferguson to settle the first lawsuit brought by a state over its transvaginal mesh devices. -
Just before trial, Washington AG Ferguson's Ethicon case against Johnson & Johnson settles
Apr 22, 2019 | Legal Newsline
By John Sammon
A lawsuit launched by Washington Attorney General Bob Ferguson against Johnson & Johnson for a pelvic mesh implant sold by its subsidiary Ethicon has been settled out of court, according to a report from Courtroom View Network (CVN). -
Johnson & Johnson to pay $9.9 million for failing to disclose risk of surgical mesh devices
Apr 22, 2019 | KIRO 7
Johnson & Johnson will pay $9.9 million to Washington women who were harmed by the company’s failure to disclose the risk of its surgical mesh devices, Attorney General Bob Ferguson announced Monday. -
Johnson & Johnson settles lawsuit with Washington state over pelvic mesh implants
Apr 22, 2019 | KNKX
By Paula Wissel
The health care giant Johnson & Johnson will pay nearly $10 million to Washington state to settle a lawsuit over the marketing of pelvic mesh implants. The mesh implants are designed to repair pelvic collapse that sometimes happens after a woman gives birth or has a hysterectomy. -
FDA Says to Stop Selling Vaginal Mesh
Apr 22, 2019 | Health Care Packaging
By Tim Hayes
For the past few years, the FDA has been investigating the safety of surgical mesh used for repairing a condition called pelvic organ prolapse -
Why This High-Growth Medtech Stock Might Cut Its 2019 Outlook
Apr 22, 2019 | Investor's Business Daily
By Allison Gatlin
Boston Scientific (BSX) will likely cut its 2019 outlook, an analyst said Monday after the Food and Drug Administration dealt the medical device company a pair of setbacks. -
Health-care earnings: ‘Medicare for all’ expected to loom large
Apr 22, 2019 | MarketWatch
By Sarah Toy
Health-care earnings begin in earnest this week, starting with government insurance giant Centene Corp. reporting on Tuesday, followed by Anthem Inc., Biogen Inc., Boston Scientific Corp. and Swiss drugmaker Novartis AG reporting Wednesday.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Washington state to take J&J to trial over pelvic mesh marketing
Apr 23, 2019 | Reuters
By Nate Raymond
The state of Washington is set on Monday to become the first state to take Johnson & Johnson to trial over allegations that it misrepresented the risks of serious conditions that women using its pelvic mesh devices could develop.
King County Superior Judge Suzanne Parisien in Seattle will preside over the non-jury trial in the lawsuit by Washington Attorney General Bob Ferguson, who wants J&J to pay millions of dollars in penalties for violating a state consumer protection law.
To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2PponX4
https://www.reuters.com/article/health-johnsonjohnson/washington-state-to-take-jj-to-trial-over-pelvic-mesh-marketing-idUSL1N22404V
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J&J settles Washington state's case over mesh marketing for $9.9 million
Apr 23, 2019 | Reuters
By Nate Raymond
Johnson & Johnson on Monday said it had agreed to pay $9.9 million to resolve a lawsuit by the state of Washington accusing the company of misrepresenting key information about the risks its pelvic mesh devices posed to women.
The settlement with Washington Attorney General Bob Ferguson came on the eve of what was to be the first trial for J&J in lawsuits by state attorneys general alleging the company concealed severe risks associated with the devices, which are used to treat pelvic organ prolapse, a condition in which organs shift from their normal positions, and various bladder issues.
To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2XwHVvC
https://www.reuters.com/article/health-johnsonjohnson/jj-settles-washington-states-case-over-mesh-marketing-for-99-million-idUSL1N22419E
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J&J Settles Wash. AG's Pelvic Mesh Case Just Before Trial
Apr 22, 2019 | Law 360
By Daniel Siegal
Johnson & Johnson has agreed to pay $9.9 million to settle the state of Washington’s allegations that its Ethicon subsidiary downplayed the risks of its surgical mesh devices in its marketing, avoiding a Seattle trial that was about to begin Monday.
Hours after the trial was scheduled to start before King County Superior Court Judge Suzanne R. Parisien, Washington Attorney General Bob Ferguson announced the deal.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” Ferguson said in a statement. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct — and look forward to providing millions of dollars in relief to assist those who were harmed.”
Roughly 14,000 women in the state have had J&J surgical mesh devices implanted in them, and hundreds of those women have been harmed by the devices, according to the Washington attorney general’s office. Those harms range from having to undergo an additional medical procedure to having their “quality of life impacted dramatically.”
Ferguson’s announcement said the $9.9 million paid by J&J would be used to assist women who received pelvic mesh implants, and it would come on top of what they might win in their own lawsuits. A formal claims process will be unveiled at a later date, according to the attorney general.
Ethicon released a statement Monday confirming the settlement and saying the company was “pleased” to have resolved the lawsuit.
“Ethicon’s devices for treatment of incontinence are recognized as the standard of care by surgeons and medical professional societies in Washington and around the world,” the company added. “Any contrary allegations are at odds with the views of leading doctors and medical groups, as well as the FDA.”
Ethicon also thanked the medical community of Washington in its statement, saying many of its members had publicly disagreed with the lawsuit’s allegations.
Ferguson filed suit in May 2016, alleging J&J and Ethicon knowingly concealed the risks associated with their product, which is designed to treat common conditions in women such as stress urinary incontinence and pelvic organ prolapse. The mesh devices can lead to serious complications including loss of sexual function, chronic pain and infection, permanent urinary or defecatory dysfunction and a “devastating” impact on women’s quality of life, according to the complaint.
These complications can crop up years after the surgery and are in many cases irreversible, as removal of the mesh is nearly impossible, Ferguson said in a statement when the suit was filed.
Ferguson alleged “tens of thousands of violations” of Washington’s consumer protection laws.
Ferguson’s suit was filed the same day that then-California Attorney General Kamala D. Harris filed her own suit in California state court accusing J&J and Ethicon of violating the state’s false advertising laws. That suit is pending and is slated for trial on July 12, according to the case docket.
Monday’s settlement comes less than a week after a Philadelphia jury sided with Ethicon in a trial over an allegedly defective pelvic mesh implant.
Despite agreeing that Ethicon had negligently designed, marketed and sold its TVT-Secur mesh implant, the jury found that the negligence was not a cause of any of the injuries that Philadelphia-area resident Malgorzata Krolikowski said she suffered from the device.
Washington state is represented by Daniel Allen, Breena Roos, Katharine Barach, Heidi Anderson, Beth Howe, Patricia Bower and Jeffrey Grant of Washington’s Office of the Attorney General.
J&J is represented by O’Melveny & Myers LLP, Covington & Burling LLP, Calfo Eakes & Ostrovsky PLLC and Butler Snow LLP.
The case is State of Washington v. Johnson & Johnson et al., case number 16-2-12186-1 in the King County Superior Court in the State of Washington.
--Additional reporting by Steven Trader and Matt Fair. Editing by Kelly Duncan.
https://www.law360.com/articles/1152253/j-j-settles-wash-ag-s-pelvic-mesh-case-just-before-trial?copied=1 -
Washington State Settles with Johnson & Johnson Over the Cost of Pelvic Mesh Injuries
Apr 22, 2019 | Mesh Medical Device News Desk
By Jane Akre
Trial was supposed to begin this morning as Washington State sued Johnson & Johnson over failing to warn women about pelvic mesh complications. At the eleventh hour it settled. Now three more states will take their turn.
The trial was set to begin this morning in Seattle.
See: State of Washington v. Johnson & Johnson, et al., case number 16-2-12186-1 SEA in King County Superior Court.
Attorney General Bob Ferguson sued the healthcare giant to recoup the costs the state advanced to care for women injured by Johnson & Johnson’s Ethicon division pelvic meshes. The company violated Washington’s consumer protection division by failing to acknowledge or by misrepresenting the serious life-altering risks of the pelvic (vaginal) mesh it sold in the state.
It was estimated that J&J sold more than 12,000 of its pelvic mesh medical devices in Washington State between 2002 and 2015.
The state was seeking the maximum penalty of $2,000 per violation along with costs, fees, restitution and other relief which could amount to $24 million.
J&J updated its instructions for use in late 2015.
Details of the settlement are not available.
Globally, more than 40,000 women have filed product liability actions against the healthcare giant. Complications filed by thousands of women include chronic pain and infection, mesh erosion and shrinkage, nerve damage and loss of sexual function.
Kentucky, California and Mississippi have also filed similar suits but this is the first AG action to go to trial. Former California AG Kamala Harris filed the California case which is set to go to trial in July in San Diego.
https://www.meshmedicaldevicenewsdesk.com/washington-state-settles-with-johnson-johnson-over-the-cost-of-pelvic-mesh-injuries/
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Johnson & Johnson Will Pay $9.9M to Settle Pelvic Mesh Case (1)
Apr 22, 2019 | Bloomnberg Law
By Paul Shukovsky
Johnson & Johnson will pay $9.9 million to settle allegations that it concealed risks associated with pelvic mesh devices implanted into thousands of women in Washington, the state’s attorney general announced April 22.
The lawsuit was brought under the state Consumer Protection Act, which does not provide compensation for pain and suffering. Attorney General Bob Ferguson (D) encouraged women damaged by the mesh to contact the AG’s office about seeking a share of the settlement.
About 14,000 Washington women have...
§ Access to full text unavailable – subscription required. Story can be found here: https://news.bloomberglaw.com/health-law-and-business/j-j-settles-vaginal-mesh-lawsuit-with-washington-state-a-g
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Eve of trial: Johnson & Johnson pays $9.9 million to settle state's lawsuit
Apr 22, 2019 | Seattle Post Intelligencer
By Joel Connelly
Johnson & Johnson will pay $9.9 million to settle a lawsuit by the State of Washington that claimed the pharmaceutical giant misrepresented and failed to include risks in its marketing of surgical mesh devices.
The suit had been scheduled to go on trial Monday.On day trial was supposed to start, Johnson & Johnson agrees to pay $9.9 million to settle suit brought by state over concealing risks in its surgical mesh devices, inserted in an estimated 14,000 Washington women.
Johnson & Johnson will pay $9.9 million to settle a lawsuit by the State of Washington that claimed the pharmaceutical giant misrepresented and failed to include risks in its marketing of surgical mesh devices.
The suit had been scheduled to go on trial Monday. Recommended Video
Attorney General Bob Ferguson, at a morning briefing, estimated that 14,000 of the devices were implanted in Washington women, and that for "hundreds of women" -- he could not give an exact number -- the devices adversely impacted their health.
"Johnson & Johnson knew about the risks and did not disclose them," said Ferguson.
During depositions for the case, John & John global medical director Piet Hinoul admitted that the company knew "from day one" about potential hazards in the mesh implants.
The devices, made of polypropylene, are implanted through the vagina to treat two conditions -- pelvic organ prolapse and urinary issues such as incontinence.
Washington became, in 2016, the first state to sue Johnson & Johnson. The AG's office charged the company with violating the Washington Consumer Protection Act by not mentioning serious and in some cases life-altering risks in its surgical mesh devices in materials furnished to physicians and patients.
The risks, Ferguson outlined Monday, were chronic pain, pain during sexual intercourse, and urinary issues.
The $9.9 million will be used to assist women who received pelvic mesh implants, in addition to any personal injury awards they have received.
The Washington AG's suit is only one of Johnson & Johnson's legal worries. The U.S. Justice Department and Securities & Exchange Commission have sought internal company documents on possible asbestos contamination in its baby power and other talc-based products.
The company faces 13,000 lawsuits in which baby power is blamed for causing ovarian cancer or mesothelioma.
Last July, a Missouri jury told J & J to pay $4.69 billion to 22 women who claimed its talc products caused ovarian cancer. The company has appealed the verdict.
J & J has won some cases, but suffered big verdicts. In three other suits, juries have awarded $110 million, $72 million and $55 million in suits related to talc products.
Sen. Patty Murray, D-Wash., has also asked Johnson & Johnson for information. Murray is ranking Democrat on the Senate Health Education Labor & Pensions Committee.
The New York Times and Reuters last fall revealed internal company documents in which health risks from baby powder were discussed, and which information was withheld from the public.
The resolution agreement with Washington prohibits Johnson & Johnson from making deceptive or untrue statements about its surgical mesh products. If any future health risk is discovered, the state must disclose it.
https://www.seattlepi.com/local/politics/article/Johnson-Johnson-pays-9-9-million-to-settle-13785941.php
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Johnson & Johnson settles Washington surgical mesh lawsuit for $9.9 million
Apr 22, 2019 | MyNorthwest
In an effort to avoid going to trial, Johnson & Johnson will pay $9.9 million for failing to disclose the serious risks linked with their surgical mesh devices, which impacted numerous Washington patients, nurses, and doctors.
Originally filed in 2016, the lawsuit brought by Attorney General Bob Ferguson contended that Johnson & Johnson violated Washington’s Consumer Protection Act when they didn’t indicate the life-altering risks of their mesh on instructions and marketing materials.
As a result of using them, Washington women experienced chronic pain, urinary issues, pain during sex, and the devices were found to be very difficult and painful to remove. The mesh devices are normally used for urinary issues, as well as pelvic organ prolapse, when organs shift from their normal position.
Johnson & Johnson’s foreknowledge was confirmed when Global Head of Medical Affairs Piet Hinoul admitted they knew of the risks “from day 1,” and did not make the decision to inform patients.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” said Ferguson. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct — and look forward to providing millions of dollars in relief to assist those who were harmed.”
Approximately 14,000 Washington women had these devices implanted, and the Attorney General’s Office believes hundreds have been impacted, with several suffering lifelong pain.
https://mynorthwest.com/1355920/johnson-johnson-patient/
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Johnson & Johnson pays $9.9M to settle Washington state pelvic mesh lawsuit
Apr 22, 2019 | AP (In The Seattle Times)
On the eve of trial, Johnson & Johnson has agreed to pay $9.9 million to settle a lawsuit brought by Washington state accusing the health-care giant of misrepresenting the risks of pelvic mesh implants.
Attorney General Bob Ferguson sued the New Jersey-based company in 2016, saying it and its subsidiary Ethicon Inc. violated the state’s Consumer Protection Act by failing 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. Surgical mesh is intended to provide extra support when repairing weakened or damaged tissue.
Johnson & Johnson did not admit wrongdoing. Trial was to start Monday in King County Superior Court.
Tens of thousands of patients have sued Johnson & Johnson and other companies over the products. Ferguson said the settlement money would be used to help Washington women who had mesh implanted.
About 14,000 Washington women had the devices implanted, according to Ferguson’s office. The office said in a press release it believes hundreds of women have been adversely impacted, ranging from having to go back for another procedure, to having their quality of life affected.
The Attorney General’s Office will announce a formal claims process in the future. Privacy protections have kept the Attorney General’s Office from knowing the names of the women implanted with surgical mesh in the state. Women who want a claims administrator to contact them should notify Ferguson’s office.
https://www.seattletimes.com/seattle-news/johnson-johnson-settles-washington-pelvic-mesh-lawsuit-for-nearly-10-million/
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J&J Pays $9.9M to Settle Pelvic Mesh Case Brought by Washington AG
Apr 22, 2019 | Law.com
By Amanda Bronstad
Johnson & Johnson’s Ethicon Inc. unit has agreed to pay nearly $10 million to Washington Attorney General Bob Ferguson to settle the first lawsuit brought by a state over its transvaginal mesh devices.
The $9.9 million settlement, announced just as the trial was set to begin Monday in Seattle, sets up a claims process that compensates women who had pelvic mesh devices surgically implanted in them. It also prohibits Johnson & Johnson from making false or deceptive statements about the risks of its mesh products.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” Ferguson said in a press release Monday. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct—and look forward to providing millions of dollars in relief to assist those who were harmed.”
Ethicon has faced numerous trials and settled thousands of cases brought by women alleging that the devices, which treat incontinence and pelvic organ prolapse, caused pain during sex and urinary problems that, in most cases, required surgical removal. Verdicts have reached as high as $57.1 million, but Ethicon also has won some trials.
Washington is one of four states that have sued over transvaginal mesh devices. Another case, brought against Ethicon by California Attorney General Xavier Becerra, starts July 12 in San Diego County Superior Court. The states of Mississippi and Kentucky also have sued.
Monday’s trial was expected to last five weeks.
According to a trial brief filed in King County Superior Court, lawyers for the state had planned to argue that Ethicon’s product brochures misrepresented the safety of the devices to doctors. Ethicon also allegedly promoted sales of the devices through marketing to patients.
Ferguson’s office, which handled the case without outside counsel, had asked for disgorgement of at least $16.7 million in net revenues that Ethicon earned from the sale of the devices to 14,000 women in Washington, plus statutory damages of up to $2,000 per violation under Washington’s Consumer Protection Act.
Ethicon had brought in Seattle’s Calfo Eakes & Ostrovsky—in particular, Patty Eakes and Angelo Calfo—as well as Butler Snow’s William Gage, a partner in Jacksonville, Mississippi; Carolyn Kubota, a partner at Covington & Burling in Los Angeles; and Steve Brody, head of the product liability and mass torts practice at O’Melveny & Myers, where he is a partner in Washington, D.C.
“Ethicon is pleased to have reached a settlement with the Washington state attorney general to resolve the pending litigation,” wrote Johnson & Johnson spokeswoman Mindy Tinsley. “Ethicon’s devices for treatment of incontinence are recognized as the standard of care by surgeons and medical professional societies in Washington and around the world. Any contrary allegations are at odds with the views of leading doctors and medical groups, as well as the FDA.”
In its trial brief, Ethicon had insisted that doctors were aware of the risks of the products, and, furthermore, relied on their own medical judgment, not just product brochures, to determine whether to recommend them to their patients.
Ethicon had received support from an unusual group: doctors. On Dec. 9, Ferguson received a letter from 63 surgeons in the state of Washington, including three retained by Ethicon in the case, insisting that he drop the lawsuit. The letter said doctors do not look at just the “instructions for use” on pamphlets to determine the risks associated with medical devices.
“It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group,” they wrote.
Tinsley, in her statement about today’s settlement, recognized their support.
“We appreciate the advocacy of the Washington State medical community, many of whom publicly disagreed with the allegations in this lawsuit and supported maintaining options for patients who suffer with the debilitating effects of stress urinary incontinence and pelvic organ prolapse,” she wrote.
https://www.law.com/2019/04/22/jj-pays-9-9m-to-settle-pelvic-mesh-case-brought-by-washington-ag/?slreturn=20190323040542
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Just before trial, Washington AG Ferguson's Ethicon case against Johnson & Johnson settles
Apr 22, 2019 | Legal Newsline
By John Sammon
A lawsuit launched by Washington Attorney General Bob Ferguson against Johnson & Johnson for a pelvic mesh implant sold by its subsidiary Ethicon has been settled out of court, according to a report from Courtroom View Network (CVN).
The agreement is worth $9.9 million, Ferguson's office said. The trial was to have begun on April 22.
The pelvic mesh implant manufactured by Ethicon is supposed to support a prolapsed or sagging bladder. The case would have featured attorneys for the state in King County Superior Court arguing that the implants sold to women violated the state’s consumer protection laws and caused medical problems or extinguished sexual function.
Nearly 14,000 Ethicon implants were sold to women in Washington state, according to Ferguson. He was the first AG to file this kind of suit.
Ethicon is part of the medical devices arm of Johnson & Johnson, a New Jersey-based conglomerate well known recently for court battles over its talcum baby power, which in recent years has generated lawsuits filed by women who claimed the powder was tainted with asbestos, causing them to develop ovarian cancer. Men and women also allege it caused mesothelioma.
The implant device is a clear plastic-looking polypropylene mesh with connecting arms. Critics of the device say it is too large and causes the body to form scar tissue in efforts to reject it and that it also constricts, causing intense pain.
More than 100,000 lawsuits filed by women against the manufacturers of pelvic mesh implant devices have been launched in courts across the country.
The lawsuits have alleged that makers of pelvic mesh devices continued to manufacture, market and sell the products, while also continuing to inadequately warn, label, instruct and disseminate information regarding the product, both prior to and after the marketing and sale of the products implanted into the plaintiffs.
The U.S. District Court for the Northern District of Indiana last year awarded a woman $10 million in damages and $25 million in punitive damages after a jury said Johnson & Johnson and Ethicon had misled the public about the risks of the mesh implant. The verdict said the companies failed to establish proper safety procedures for removal of the mesh in case of failure and failed to perform adequate research and pre-testing of the device.
Allegations in that case included claims that Johnson & Johnson provided incomplete, insufficient and misleading training and information on the implantation of the devices to doctors who would install them, to increase sales of the mesh devices.
Former California Attorney General Kamala Harris filed a lawsuit against Ethicon that is set to go to trial in July in San Diego and could result in a greater compensation award as more mesh implant devices have been sold in that state, approximately 42,000 between 2008 and 2014, a CVN report noted.
The case launched by Washington's AG, if held, had been projected to last for five weeks.
The Washington Attorney General's Office had planned to use its own in-house attorneys. The representation of J&J and Ethicon was to be handled by attorneys from O’Melveny & Meyers based in the firm’s Washington, D.C. office, Los Angeles-based Covington & Burling, and Calfo Eakes & Ostrovsky in Seattle.
Judge Suzanne Parisien of the Washington State Superior Court for King County would have presided.
https://legalnewsline.com/stories/512449050-just-before-trial-washington-ag-ferguson-s-ethicon-case-against-johnson-johnson-settles
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Johnson & Johnson to pay $9.9 million for failing to disclose risk of surgical mesh devices
Apr 22, 2019 | KIRO 7
Johnson & Johnson will pay $9.9 million to Washington women who were harmed by the company’s failure to disclose the risk of its surgical mesh devices, Attorney General Bob Ferguson announced Monday.
In 2016, Ferguson was the first state attorney general to file a lawsuit against Johnson & Johnson over the mesh devices.
In the lawsuit, Ferguson asserted Johnson & Johnson violated Washington’s Consumer Protection Act by “failing to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors.”
We had testimony admitting that they did know of these various serious risks from the start of the launch of the very first device,” said Assistant Attorney General Breena Roos.
About 14,000 women in Washington had the surgical mesh devices implanted and Ferguson says he believes hundreds of those women have had to go back for another procedure or have had their quality of life impacted dramatically.
Ferguson explained some of the women with the mesh devices experienced chronic pain, pain with sexual intercourse and numerous urinary issues.
The mesh devices, made of polypropylene, are implanted into a woman’s body to hold up failing organs.
“Removing the mesh is extremely difficult, and in some instances, impossible,” Ferguson said.Among those willing to testify was Diana Iund.
She told KIRO 7 by phone she had four additional surgeries trying to repair the effect of her implants.
“Within just a few months I began to have excruciating pain and had some bleeding instances that turned into hemorrhaging. It curtailed all of my activities. I was a hiker and a fast walker. That has all changed, I now have hobbies where they keep me in my house and I'm right here by the restroom. It was life altering and not for the better. It was life altering,” she said.
Investigators heard many similar stories.
“There were very frustrated and they spent a lot of money and time going from doctor to doctor to doctor to find out what was wrong with them,” said senior investigator Mary Beth Haggerty-Shaw who spent hours speaking with many of the women.
A trial with Johnson & Johnson was scheduled to being Monday.
"Johnson & Johnson's knowing deception caused Washington women to suffer in deeply personal ways," said Ferguson. "I'm proud of my team for holding a powerful interest accountable for its egregious conduct -- and look forward to providing millions of dollars in relief to assist those who were harmed."
The $9.9 million will be used to assist women who received the pelvic mesh implants in addition to any recovery they receive in personal injury lawsuits, Ferguson said.
Ferguson explained that one Washington woman has suffered chronic urinary tract infections, constant lower back pain and cramps in the back of her leg as a result of Johnson & Johnson’s mesh device.
Another woman in Washington underwent three surgeries to partially remove the mesh to treat her incontinence and frequent pain, Ferguson said.
Ferguson said his office will unveil a formal claims process in the future, but due to privacy protections, his office does not know the names of the women in Washington who had a had a surgical mesh implanted and the office cannot reach out to women directly.
He said in addition to paying the $9.9 million, Johnson & Johnson is prohibited from making “unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices.”
“If the company learns about new, significant risks associated with its surgical mesh, it must disclose those risks. Johnson & Johnson's promotional material must be truthful, accurate, and presented in a balanced way. Further, if Johnson & Johnson sponsors a study or research and cites that study or research in promotional materials, it must disclose its sponsorship,” Ferguson wrote in a news release.
Ferguson said that during a deposition, Piet Hinoul, Johnson & Johnson’s head of medical affairs, admitted the company knew of the serious risks “from day 1” but failed to inform patients.
“One woman shared that her consultant likened the mesh removal as to ‘trying to remove chewing gum from hair,” Ferguson said.
Ferguson said Johnson & Johnson continues to sell four of the surgical mesh devices in Washington state.
The Attorney General’s Office estimates 14,000 Washington women may have had mesh implants. Anyone who would like a claims administrator to contact them can provide their contact information here.
https://www.kiro7.com/news/local/johnson-johnson-to-pay-99-million-for-failing-to-disclose-risk-of-surgical-mesh-devices/942421490
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Johnson & Johnson settles lawsuit with Washington state over pelvic mesh implants
Apr 22, 2019 | KNKX
By Paula Wissel
The health care giant Johnson & Johnson will pay nearly $10 million to Washington state to settle a lawsuit over the marketing of pelvic mesh implants. The mesh implants are designed to repair pelvic collapse that sometimes happens after a woman gives birth or has a hysterectomy.
Johnson & Johnson and other companies that manufacture mesh implants have been sued by tens of thousands of patients, who claim lingering complications from the devices, including chronic pelvic pain, pain with sexual intercourse and ongoing urinary tract infections. Removing the mesh can be difficult, if not impossible, described as the equivalent to having chewing gum removed from your hair.
Washington state's lawsuit against Johnson & Johnson, filed in May 2016, was over misrepresentation of risks associated with the implants. Washington Attorney General Bob Ferguson said the company violated the state's Consumer Protection Act by not adequately warning patients and doctors of the risks.
In announcing the settlement, Ferguson said going forward the company will be required to spell out those risks. “Our resolution is sending a clear message, that you cannot sell medical devices in Washington state and fail to adequately disclose the risks associated with those products,” Ferguson said.
At a news conference, Ferguson read a letter from Jean Giallombardo of Rochester, Washington, who said her life has been "a nightmare" since she had surgery in 2006. She wrote that the pelvic mesh implant has caused such pain and ongoing complications that she rarely leaves her house. "I was injured and my life was completely altered due to that surgery," she wrote.
Ferguson said the $9.9 million will go to affected consumers. However, due to privacy protections, the state doesn't know the names of women who've had mesh implants. So, the attorney general is urging anyone with an implant to contact his office. He also encouraged them to contact an attorney and consider suing the company as an individual. He pointed out that the settlement reached by the state does not prevent individuals from filing personal injury claims.
As for banning the devices outright, Ferguson said that is beyond the reach of Washington’s Consumer Protection Act because pelvic mesh implants have been approved for use by the Food and Drug Administration.
https://www.knkx.org/post/johnson-johnson-settles-lawsuit-washington-state-over-pelvic-mesh-implants
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FDA Says to Stop Selling Vaginal Mesh
Apr 22, 2019 | Health Care Packaging
By Tim Hayes
For the past few years, the FDA has been investigating the safety of surgical mesh used for repairing a condition called pelvic organ prolapse. A recent article from The Washington Post contained the latest development stating that the FDA has ordered manufacturers to immediately stop selling the products. This includes Boston Scientific and Coloplast, neither of which has demonstrated a “reasonable assurance” of safety and effectiveness for long-term use of the devices. The companies have 10 days to submit plans for withdrawing them from the market.
https://www.healthcarepackaging.com/article/fda-says-stop-selling-vaginal-mesh
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Why This High-Growth Medtech Stock Might Cut Its 2019 Outlook
Apr 22, 2019 | Investor's Business Daily
By Allison Gatlin
Boston Scientific (BSX) will likely cut its 2019 outlook, an analyst said Monday after the Food and Drug Administration dealt the medical device company a pair of setbacks.
Earlier this month, the FDA ordered Boston Scientific and Danish company Coloplast to stop selling repair devices for pelvic organ prolapse in women. Last month, the FDA said some heart disease devices coated in a drug called paclitaxel could have led to an increase in patient deaths.
Boston Scientific stock slipped on both pieces of news. Still, Boston Scientific stock remains one of the higher-growth issues in the medical device sector, RBC Capital Markets analyst Brandon Henry said in a note to clients. He expects Boston Scientific to meet its first-quarter outlook.
"Based on results from Johnson & Johnson (JNJ) and Abbott Laboratories (ABT), we expect that several Boston Scientific product categories including electrophysiology, defibrillators/cardiac resynchronization therapy devices and neuromodulation had a strong first quarter," he said.Boston Scientific Earnings On Deck
Boston Scientific plans to report its first-quarter earnings on Wednesday. Analysts polled by Zacks Investment Research expect the medical device company to post adjusted income of 36 cents per share on $2.54 billion in sales.
On a year-over-year basis, Boston Scientific earnings would rise 9.1% and sales would jump 6.6%. The first quarter is expected to be Boston Scientific's slowest earnings growth in nearly two years.
But Henry expects the first quarter to be in line for Boston Scientific. The medical device company called for 7%-8% organic sales growth and adjusted earnings of 35-36 cents per share. Several heart disease devices and medical-surgical sales "have done consistently well for several quarters," he said.
Further, the worry over paclitaxel-coated medical devices isn't likely to hurt Boston Scientific in the first quarter, he said. The medical device company remains in the early innings of its U.S. launch of Eluvia, a stent that uses paclitaxel.
"Since the U.S. Eluvia launch is in early stages, we expect negligible impact from the FDA advisory on first-quarter revenues," Henry said. He noted the FDA will discuss the paclitaxel-coated devices matter further during a panel meeting in June.
Is Boston Scientific Stock Under Pressure?
However, the FDA news still pressures Boston Scientific's full-year revenue by 75 basis points, he said. The medical device company has guided to 7%-8.5% organic growth for 2019, or 8.1%-9.6% growth including the impact of acquisitions.
Boston Scientific has estimated a $25 million impact from the FDA's order on pelvic organ prolapse repair devices. Henry cut his 2019 estimates for paclitaxel-coated device Eluvia by $40 million to $50 million.
"It is worth remembering that Boston Scientific overcame a similar setback in 2017, when it withdrew Lotus (a heart-valve replacement device) three weeks after issuing guidance for the year," he said. "Boston Scientific still exceeded the upper end of its initial organic growth forecast by 30 basis points."
The medical device company could be prepping for a repeat in 2019, Henry said.
"We think Boston Scientific has an even stronger product portfolio at present," he said.
On the stock market today, Boston Scientific stock dipped 0.5%, to 34.93.
https://www.investors.com/news/technology/medical-device-company-boston-scientific-2019-outlook/
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Health-care earnings: ‘Medicare for all’ expected to loom large
Apr 22, 2019 | MarketWatch
By Sarah Toy
Health-care earnings begin in earnest this week, starting with government insurance giant Centene Corp. reporting on Tuesday, followed by Anthem Inc., Biogen Inc., Boston Scientific Corp. and Swiss drugmaker Novartis AG reporting Wednesday.
The past week has been a difficult one for health companies. Health-care stocks are lagging the broader market by their largest margin since 2006, sparked by murmurs of a single-payer health system and proposals to tighten regulations around drug pricing. Shares of UnitedHealth Group Inc. tumbled last week despite the company reporting first-quarter earnings and revenue that beat expectations — a sign of investors’ growing anxiety over the health-care regulatory climate.
With that in mind, here’s what to watch out for during the next couple of days as health-care companies announce earnings.
Centene CNC, -0.25% is set to announce first-quarter earnings on Tuesday before the market opens. Analysts polled by FactSet expect the Medicaid-focused health insurer to report first-quarter earnings of $1.35 per share, up from $1.09 a year ago. Revenue is expected to come in at $17.462 billion, compared with $13.194 billion in the year-earlier quarter.
Last month, Centene agreed to buy competitor WellCare Health Plans Inc. WCG, +0.57% for $15.3 billion, creating a managed-care giant in the business of government health programs and boosting Centene’s Medicare market share. The deal, which dropped as health-policy threats came from both the left and the right, was seen by some as a bet on the future of the Affordable Care Act (ACA), also known as Obamacare. Whether the bet pays off will depend on what changes, if any, are made to the ACA.
Centene executives will likely get questions on Tuesday’s earnings call with analysts about the future of the ACA. The company, whose stock has fallen 16% so far this year, is the largest provider of plans through both the Medicaid program and the ACA marketplaces.
Health insurer Anthem ANTM, +1.83% will report first-quarter earnings on Wednesday before the opening bell. The company is expected to report earnings of $5.89 per share, up from $5.41 in the year-earlier quarter, according to analysts polled by FactSet. Revenue is expected to come in at $24.426 billion, higher than $22.342 billion a year ago.
Shares of Anthem are down 8.4% so far this year, reflecting the recent sell-off in health insurance stocks.
In 2017, Anthem announced it would launch its own pharmacy-benefit manager, which the insurer said should generate around $4 billion in savings each year. The PBM, called IngenioRx, was initially slated to launch in 2020, but then Anthem said in January the rollout would be pushed up to March, resulting in a boost in projected earnings for the year. Management will likely give an update on the rollout on Wednesday during its earnings call with analysts, so investors should keep their ears open.
Biogen BIIB, +1.07% is set to report first-quarter earnings on Wednesday before the market opens. The drugmaker, whose shares are down 24% in the year to date, was dealt a severe blow this past quarter when it was forced to discontinue Phase 3 trials of aducanumab, an investigational Alzheimer’s drug whose mechanism of action was based on the so-called amyloid hypothesis. Shares plunged 28% at the time, and Biogen said it would take a closer look at the data.
Investors will want answers from management on Wednesday about what went wrong with aducanumab, which analysts once thought would be the company’s next big blockbuster drug. They will also want to hear an update on the drugmaker’s collaboration with Eisai Co. Ltd. ESALY, +0.89% on another amyloid-based treatment for Alzheimer’s.
Biogen is expected to report earnings of $6.83 per share, up from $6.05 a year ago, according to analysts surveyed by FactSet. Revenue is expected to come to $3.385 billion, up from $3.131 billion in the year-earlier quarter.
Medical device maker Boston Scientific Corp. BSX, -0.51% which will also announce earnings on Wednesday morning, should report earnings of 36 cents per share, according to FactSet, higher than 33 cents in the year-earlier quarter. Revenue should be $2.535 billion, up from $2.379 billion a year ago.
Last week, the Food and Drug Administration ordered Boston Scientific and Coloplast Corp. CLPBY, -0.10% to remove their transvaginal mesh products, used to treat pelvic organ prolapse, from the market. Shares of Boston Scientific fell more than 7% at the time, though shares are only down 1.8% for the year. Investors will want to hear from management how the removal of the vaginal mesh products, a part of Boston Scientific’s urology and pelvic health business and the subject of years of litigation against the company, will affect the bottom line.
Finally, Swiss drugmaker Novartis AG NVS, -1.32% will be reporting earnings on Wednesday, as well. Analysts polled by FactSet expect earnings of $1.10 per share, down from $1.13 a year ago. Revenue is expected to be $11.356 billion, down from $12.694 billion in the year-earlier quarter.
In March, the Food and Drug Administration approved the company's new multiple sclerosis drug, Mayzent. Novartis priced the treatment at $88,000 annually, something that probably won’t invite objections from investors but could draw scrutiny from payers and lawmakers. Management will likely give an update on the drug launch during the company's Wednesday earnings call with analysts.
Management will also likely address its Friday disclosure of an investigation looking into the death of a second baby involved in a clinical trial of experimental multiple sclerosis treatment Zolgensma. A six-month-old patient with type 1 spinal muscular atrophy had recently died in Europe after undergoing the treatment, but an investigator and independent monitor deemed that death unrelated to the therapy. Zolgensma, whose FDA submission was based on data from a trial of 15 babies, is expected to be approved by the FDA within weeks.
Shares of the drugmaker, which spun off eye-care business Alcon Inc. ALC, -0.60% earlier this month, are down 0.8% so far this year.
https://www.marketwatch.com/story/health-care-earnings-what-to-look-out-for-on-tuesday-and-wednesday-2019-04-22
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