2023: Johnson & Johnson to pay $302 million for cheating in vaginal implant ads
On February 21, 2023, the US Supreme Court rejected the appeal of Johnson & Johnson (J&J), upholding the previous decision to pay the company $302 million in compensation for inappropriate advertising of vaginal implants.
We are talking about pelvic nets designed to treat urinary incontinence and organ prolapse. However, many patients who used such products complained of pain, urinary problems, bleeding and other serious complications.
In 2016, a lawsuit was filed against J&J in California with allegations that the company did not inform patients and doctors about potentially serious risks and distorted information when advertising vaginal implants. In 2019, the U.S. Food and Drug Administration banned the sale of all pelvic mesh devices. In early 2020, a $343.99 million judgment was issued against J&J and an Ethicon subsidiary. But in 2021, the Fourth Circuit Court of Appeals in California reduced the size of the administrative fine by $42 million.
J&J requested a retrial, saying it had not been notified of the fines and that California state lawyers had not proven that doctors or patients had been misled in any way. The U.S. Supreme Court, however, upheld the penalty order, citing no grounds for refusing to hear J&J's appeal.
 | For years, Johnson & Johnson has refused to take responsibility for misleading patients and their doctors about the risks of using implants. Now these victims can sleep calmer, knowing that the $302 million judgment that we have achieved against the company is final, "said California Attorney General Rob Bonta[1] |  |
2022: Johnson & Johnson to pay $205 million to sell defective implants for pelvic diseases
In mid-September 2022, Johnson & Johnson settled a pelvic mesh class action lawsuit in Australia for about $205 million. This followed numerous lawsuits involving more than 11 thousand plaintiffs, the pharmaceutical giant and its subsidiary Ethicon. Shine Lawyers, which handled the lawsuit, confirmed the settlement.
In its latest quarterly report, Johnson & Johnson revealed how Australia's Federal Court ruled in favor of the top three plaintiffs in a class action in March 2020. A federal court judge previously found that Ethicon sold implants to treat urinary incontinence and pelvic organ prolapse without alerting women and surgeons to the risks, and rushed to bring the products to market before proper testing. Since then, the pharmaceutical and medical giant has largely exhausted its appeals process.
In a statement shared with MassDevice, a Johnson & Johnson spokesperson and its Ethicon subsidiary said that pending approval from the Federal Court, they are pleased to conclude a settlement agreement that provides certainty and a way forward for relevant Australian patients. Ethicon sympathizes with all women who experience medical complications related to drooping pelvic organs or stress incontinence, the statement added. These are extremely complex medical conditions, and Ethicon is committed to maintaining the availability of treatment options for women with such conditions.
According to Form 10-Q filed with the Securities and Exchange Commission, Johnson & Johnson recorded litigation expenses of $205 million for the first half of 2022. Expenses were mainly related to pelvic nets. These products are arguably one of the biggest failures of the medical device industry in the 21st century, dragging many large medical companies into costly lawsuits.
Mesh products were intended to treat the weakening of muscles and ligaments that support the woman's pelvic organs. But the FDA in 2019 ordered Boston Scientific and Coloplast to stop spreading pelvic nets. By that point, there were already thousands of lawsuits and millions of dollars for the settlement, as women reported pain, heavy bleeding and loss of sexual function.
From 2008 to 2014, Johnson & Johnson sold more than 470,000 pelvic mesh products nationally through its subsidiary Ethicon. In its annual report released in February 2022, the company said there are 10,100 plaintiffs in the U.S. with claims directly related to mesh products. In April, a California appeals court largely agreed with a lower court's decision that Johnson & Johnson should pay the state $205 million in connection with claims that the company engaged in misleading marketing of pelvic nets.[2]
2021: Boston Scientific to pay $188.6 million fine for defective vaginal implants
At the end of March 2021, Boston Scientific agreed to pay a fine of $188.6 million to 47 states and the District of Columbia to resolve claims for the sale of defective transvaginal nets. Read more here.
2020
Becton Dickinson to pay $60m to sell defective vaginal implants
At the end of September 2020, it became known that Becton Dickinson will pay $60 million for the sale of defective vaginal implants to a subsidiary of C.R. Bard. The implants were intended to treat weakened muscles and pelvic floor ligaments, but caused thousands of lawsuits. Read more here.
Johnson & Johnson to pay U.S. authorities millions to sell defective vaginal implants
In early May 2020, Johnson & Johnson entered into an agreement to regulate the lawsuit with the authorities of the state of West Virginia. By court order, the company will pay a $3.9 million fine to the state for the sale of defective vaginal implants.
In September 2019, state Attorney General Patrick Morrisey took up a lawsuit against a company that provided inaccurate data on the risks and effectiveness of these implants. Johnson & Johnson, like a number of other major companies, had already stopped manufacturing implants by that point because the regulator recognized them as dangerous to women's health.
The lawsuit, filed in a West Virginia court, accused Johnson & Johnson and its subsidiaries of not only selling defective implants but also sending misleading information. According to the plaintiffs, the company paid for reviews of consultants and provided inaccurate data to medical professionals.
| | Incorrect marketing of drugs can jeopardize the health of consumers, "said Morrisey. - The agreement shows that the state authorities are ready to hold accountable all corporations that ignore the potential risks and side effects of their goods and deliberately hide important information when sending materials. | |
BJohnson & Johnson said the settlement provides for no admission of liability or misconduct.
| | We still consider it our main task to help medical professionals and patients, "said spokeswoman Mindy Tinsley. | |
The court also settled a West Virginia lawsuit against Johnson & Johnson regarding deceptive marketing practices in the distribution of defective hip implants.[3]
$2.6M payment to three women who were fitted with defective Johnson & Johnson vaginal implants
In early March 2020, the US Federal Court ruled that the pharmaceutical company Johnson & Johnson must pay compensation in the amount of $2.6 million to three women who were fitted with defective vaginal implants.
In 2019, Judge Anna Katzmann ruled that Johnson & Johnson and its two subsidiaries were negligent in assessing defective vaginal implants. Now the company must reimburse the losses, as well as all treatment costs, to the three main plaintiffs, Ann Sanders, Kathryn Gill and Diane Dawson.
| | We are pleased and encouraged by the court's decision, the plaintiffs note. - This is an important step forward, but we still have a lot to overcome before all women affected by substandard products can be compensated. | |
Johnson & Johnson marketed mesh implants as a safe method to strengthen the pelvic floor and eliminate stress incontinence or pelvic organ prolapse. However, poor-quality products have caused many cases of chronic pain, damage to surrounding organs and other symptoms.
Judge Katzmann specializes in lawsuits against large companies that hide the true extent of complications and bring products to market without rigorous clinical trials. Some companies do not conduct clinical studies, others only sponsor trials with small groups of patients. Johnson & Johnson vaginal implants have not been compared with other therapies or evaluated in randomized controlled trials.
By March 2020, 1,350 women had filed a class action lawsuit against Johnson & Johnson. The court is expected to issue a final ruling within weeks.[4]
Johnson & Johnson to pay $344m to sell defective vaginal implants
In mid-February 2020, a judge from San Diego ruled that Johnson & Johnson must pay $344 million in fines for unfair advertising of defective vaginal implants. The lawsuit was brought by the California Department of Justice back in 2016.
| | Johnson & Johnson was aware of the side effects of its products but put profits ahead of the health of millions of women, California's attorney general said. | |
These vaginal implants, also called transvaginal mesh, are synthetic devices that are installed in minimally invasive surgeries for women with drooping pelvic floor or incontinence. It is estimated that 3% to 17% of women are affected by such problems, especially after the age of 70. Many women sued the company, claiming the implant installed caused severe pain, bleeding, infections and discomfort during intercourse.
A spokeswoman for Johnson & Johnson said the company would appeal the court's decision. Prosecutors did not provide enough evidence, according to Johnson & Johnson, and Ethicon's surgical products division "communicated in advance all the risks and benefits of its transvaginal implants to all physicians and patients." Johnson & Johnson also says millions of women have benefited from vaginal implants in an undeniable way.
The company is also appealing to a decision by the International Association of Urogynecologists, which is working to improve outcomes for women with incontinence and other pelvic floor disorders. This organization argues that pelvic mesh is a safer option than previous surgical procedures, which are more invasive, carry a higher risk of complications, and require a much longer time to repair.[5]
2019
Johnson & Johnson to pay $117 million to sell defective vaginal nets
On October 17, 2019, Johnson & Johnson agreed to pay $117 million to settle the trial, the initiators of which accused the company of unfair advertising of vaginal mesh implants.
According to Reuters, citing US Attorney General William Barr, the agreement concludes proceedings over the company's violation of consumer protection laws. The manufacturer distorted information about the safety and effectiveness of its devices and hid all risks associated with their use.
The settlement applies to 41 states and counties in Columbia but does not apply to lawsuits in California, West Virginia, Kentucky and Mississippi.
Thousands of women have sued Johnson & Johnson and an Ethicon subsidiary, alleging they suffered injuries from the use of vaginal mesh implants. The latter were positioned by the manufacturer as a means of treating bladder problems and drooping pelvic organs. According to the victims, these devices in practice damage organs and cause constant pain.
Earlier, the California State Attorney's Office said that Johnson & Johnson sold more than 787 thousand mesh implants for women in the United States from 2008 to 2014.
Johnson & Johnson says the current agreement with states to settle the claims does not mean admitting improper marketing activities.
Meanwhile , Johnson & Johnson is recalling a batch of 33,000 Baby Powder baby powder bottles due to the discovery of a small proportion of chrysotile asbestos in one of them, which has carcinogenic properties.
Johnson & Johnson shares on the New York Stock Exchange after the publication of the message decreased by $7.66 (5.62%), reaching $128.52.[6]
Vaginal mesh prostheses completely banned due to complications and infections in women
In mid-April 2019, the Food and Drug Administration (FDA) banned the sale of vaginal mesh prostheses used in pelvic floor repair operations due to a variety of complications, including infectious ones. The regulator justified its decision by the fact that products involved in thousands of lawsuits are unlikely to be considered safe and effective.
Vaginal mesh prostheses have been used for minimally invasive surgery for pelvic organ prolapse, a condition common among women that develops when pelvic floor muscles that hold the bladder and uterus weaken. The prescription affected the only remaining manufacturers on the market - Boston Scientific and the Danish company Coloplast A/S. Previously, 31 companies were involved in the production of vaginal nets, including Johnson & Johnson (J&J), C.R. Bard and Endo International. However, since mesh prostheses entered the market in 2002, lawsuits have rained down on manufacturers for numerous complications - painful sensations, infection, and in some cases even death were noted.
In 2016, U.S. regulators classified a vaginal mesh prosthesis as a high-risk device and required companies to prove the benefits of the product to keep it on the market. However, data from Boston Scientific and Coloplast did not satisfy regulators - according to an FDA statement released in April 2019, the companies did not provide reasonable guarantees for the safety and effectiveness of these devices.
According to the analyst, Wells Fargo the production of vaginal mesh prostheses brings Boston Scientific $25 million per year, which makes up only 0.003% of the company's total revenues. According to Coloplast spokeswoman Lina Danstrup, sales of vaginal mesh prostheses account for about 0.2% of the company's revenue and will not affect its overall condition. It is known that in 2018, sales brought the company $2.6 billion. The spokeswoman declined to comment further.
However, after the news, shares of Boston Scientific fell by 4%, and the value of Coloplast securities on the American stock exchange - by 3.9%. In addition, Boston Scientific will have to settle lawsuits brought against it by dissatisfied patients. The company has allocated more than $900 million for legal proceedings, most of which are related to legal costs. Unlike Boston Scientific, Coloplast has already settled all claims.
The regulator gave the companies 10 days to submit plans to take their devices off the market. Boston Scientific openly condemned the decision and said it wished to discuss further steps with regulators more thoroughly. Company spokeswoman Kelly Leadem noted that the company's management is deeply disappointed with the decision of the regulatory authorities, since the refusal to use vaginal nets will seriously limit the treatment of many women with pelvic organ prolapse.
Although Coloplast has settled all cases involving vaginal nets, Boston Scientific still has to come forward over 18,000 lawsuits. Most of these cases are under negotiation, company officials said in February 2019. Other device makers, such as J&J, still have to deal with thousands of claims from affected patients. Unlike Boston Scientific and Endo, J&J did not pursue a common settlement program - instead, the company deals with claims on a case-by-case basis.[7]
Johnson & Johnson fined $41m for selling defective vaginal implants
In early February 2019, Johnson & Johnson was fined $41 million for selling defective vaginal implants manufactured by an Ethicon subsidiary.
The lawsuit against the manufacturer was filed in November 2018 in Pennsylvania State Court. According to a report by Mesh News Desk, Suzanne Emmett, who argued the case, had Prolift vaginal mesh for pelvic organ prolapse, TVT-O mesh for incontinence therapy and a Gynemesh implant. The woman claims that after implantation, her condition deteriorated significantly: she constantly experiences pain, including with intimate contacts, and also makes complaints about frequent exacerbations of urinary tract infections.
The jury agreed with the report of experts who found that the quality of the Gynemesh, Prolift and TVT-O vaginal nets produced by Ethicon did not meet the standard, and the company itself was negligent in the production of implants. The court sentenced Ethicon to a fine of $25 million and compensation of $15 million to Mrs. Emmett and $1 million to her husband.
An Ethicon spokesman said the company disagreed with the court's decision and was confident that the implants in question met all regulations and surgeons were adequately informed of the known risks. Although pelvic organ prolapse and stress urinary incontinence are serious conditions in which vaginal meshes can become an effective treatment, the risk of side effects cannot be ruled out, an Ethicon spokesperson noted.
However, despite the company's assurances, Suzanne Emmett's case is no exception - when analyzing two complaints, the defective design of the TVT-O implant was proved, and the Prolift defect was identified in a clinical trial. Plaintiffs complaining of vaginal implant quality won $105.16 million overall [8]
2018: Becton Dickinson's' daughter 'to pay $3.6 million to sell defective vaginal implants
In April 2018, the court convicted C.R. Bard (part of Becton, Dickinson). The company will pay $3.6 million for the sale of defective vaginal implants.
The court was won by Sherr-Una Booker, who claimed to have suffered health damage as a result of installing a kava filter. This medical device is implanted into the lumen of the inferior vena cava in order to catch blood clots that are carried by the blood current. The device ensures the free passage of red blood cells and other cells through the filter, but delays large blood clots. It is recommended to remove the cava filter 29-45 days after the operation.
According to Sherra-Una Booker, the G2 kava filter made by C.R. Bard broke inside the body and created a perforation in the inferior genital vein. Then a piece of the device reached the heart through the bloodstream. In 2014, the woman underwent open heart surgery, during which the cava filter was removed, but the doctors failed to remove all parts of the implant.
A federal jury in Arizona sided with the plaintiff and ordered the manufacturer to pay her $3.6 million in moral and health damages. C.R. Bard denies the existence of defects in its devices and blames the surgeon.
The court found C.R. Bard guilty by 80%. The remaining 20% of the blame lies with the radiologist, who did not report the problem with the device. He was fined $400 thousand.
Over the years, more than 3500 thousand lawsuits related to defective vaginal implants have been filed against C.R. Bard. All complaints were combined into one collective. Sherra-Una Booker's victory in court could serve as the basis for resolving the rest of the cases, in which other manufacturers of kava filters, such as Cook Medical and Cordis, are also defendants.[9]
2017
700 women sue Johnson & Johnson over substandard vaginal implants
In early July 2017, a trial began in Australia, which is considering a case on a collective charge by Johnson & Johnson of selling substandard vaginal implants that left women in excruciating pain.
The class action lawsuit against Johnson & Johnson, which is being filed in a Sydney court, was joined by more than 700 women affected by the use of implants created to treat intrauterine pathologies and pelvic diseases.
According to the prosecution, Johnson & Johnson did not sufficiently test its vaginal nets before the start of sales and did not warn patients and doctors about the risk of using these products. At the same time, the consultants who sold them knew about possible complications, but preferred to be silent in order to sell as many goods as possible.
The plaintiffs allege they had to endure terrible pains, infections, sexual dysfunction, and in some cases internal organ displacement after implants began destroying surrounding tissue and organs. Even after further operations, they were left with chronic pain.
| | This cannot continue. Too many women who have gone through pain now have complications for life, "said Joanne Maninon, one of the women who filed the lawsuit. | |
According to The Telegraph, about 100 thousand women around the world used Johnson & Johnson band vaginal nets. In Australia, there are 8 thousand such people. The devices are intended primarily for those who have developed weakness of the pelvic floor and incontinence after childbirth.
According to the manufacturer, the use of implants helped millions of women, and its development "was carried out in compliance with all regulatory requirements and is supported by years of clinical research."[10]
Notes
- ↑ Supreme Court denies J&J appeal of $302M vaginal mesh ruling
- ↑ J&J settles big Australian pelvic mesh case
- ↑ Johnson & Johnsons settles West Virginia pelvic mesh lawsuit
- ↑ Johnson & Johnson ordered to pay $2.6m in damages over vaginal mesh implants
- ↑ Johnson & Johnson ordered to pay $344M in pelvic mesh case
- ↑ Johnson & Johnson agrees to pay about $117 million to settle U.S. states' mesh probe
- ↑ FDA Halts Vaginal Mesh Sales; Boston Scientific Shares Fall
- ↑ UPDATE: Philly jury hits J&J's Ethicon with $41m judgment in pelvic mesh case
- ↑ Bard hit for $4M in first IVC Filter Injury Trial
- ↑ Vaginal mesh risks downplayed by Johnson & Johnson, court told
| The site content is translated by machine translation software powered by PROMT. The machine-translated articles are not always perfect and may contain errors in vocabulary, syntax or grammar. Read original article If you find inaccuracies or errors in the results of machine translation, please write to editor@tadviser.ru. We will make every effort to correct them as soon as possible. |