The 'Texas two-step' is back as J&J tries to shed talc lawsuits for a third time


Alexis Keenan · Senior Legal Reporter
Sun, October 20, 2024 at 9:00 AM MDT 6 min read

Johnson & Johnson (JNJ) is taking a controversial legal argument to court for a third time in hopes of containing a barrage of lawsuits alleging its baby powder caused cancer.

Judges have denied J&J’s previous attempts to resolve such claims using a maneuver known as the "Texas two-step," where a company tries to use the bankruptcy of an affiliate or subsidiary to settle mass liabilities.

J&J's third attempt at bankruptcy protection involves a subsidiary called Red River Talc that would cap settlement damages at $8 billion. The company maintains that none of the talc-related claims against it have merit.

J&J’s CFO Joseph Wolk told Yahoo Finance this time the bankruptcy court result should be different, in part because a large majority of talc claimants signed on to the company's settlement offer.

“The difference this time … I'd say, is 83% of the claimants actually support the current offer that's on the table,” Wolk said. “So we think that's something that was not present in the prior filings.”

The current proposal seeks to resolve all current and future claims related to ovarian cancer alleged to be caused by the company's cosmetic talc.

But a plaintiffs' lawyer who represents 11,434 of approximately J&J's roughly 100,000 talc claimants said the company's figure is inflated, and its latest bankruptcy petition is "fraught with problems."

The lawyer, Andy Birchfield of Beasley Allen, said J&J "stuffed the ballot box" in a tally held to determine the percentage of plaintiffs on board with J&J's latest settlement proposal.

A container of Johnson & Johnson baby powder is displayed in 2023 in San Anselmo, Calif. (Justin Sullivan/Getty Images) · Justin Sullivan via Getty Images

Birchfield said in addition to counting no votes as votes in support of the deal, J&J counted votes from claimants who should not have been included because they have not been diagnosed with disease and therefore have only non-compensable claims.

The lawyer said 69 of his clients voted in favor, and his firm has asked the court for a re-tabulation.

"We're confident that J&J’s 83% number that it floated … that that's wrong," Birchfield said. "Once those [inaccurate votes] are sifted out, I don't know where it will be, but it'll be significantly less than 70%."


The claims being made by both sides set up a new legal battle that will now unfold inside a Houston bankruptcy court.

J&J's worldwide vice president of litigation Erik Haas told Yahoo Finance that Beasley Allen "misstates the record in a failed attempt to explain away the blatantly false certification submitted by its partner Andy Birchfield."


Haas said Birchfield falsely certified under oath that he contacted and secured informed consent to oppose the plan from claimants who affirmatively voted in favor of the deal that was certified by an independent claims administrator.

"We look forward to the full discovery of this malfeasance before the Bankruptcy Court in Houston,” Hass said.

Earning the support of at least 75% of claimants may be an important threshold for J&J.

Bankruptcy courts have permitted companies to move forward with resolving large numbers of injury claims through bankruptcy when at least 75% of the outstanding creditors, including claimants, agree to the deal.
How it works

The "Texas two-step" strategy takes advantage of state laws that allow for the transfer of liabilities through a so-called divisive merger, which is a way to separate a company's operations into discreet business entities.

Texas was the first state to allow this, in 2006, which helps explain why the strategy came to be known as the "Texas two-step."

The first step is the division. The second is that the liability-retaining entity gets limited funding from its solvent parent, files for bankruptcy, and then manages mass tort litigation with the limited funds.


The benefits are that further litigation is paused, capping costs, and the assets of the solvent company are walled off from the reach of plaintiffs. The hope is that the solvent parent can also absolve itself of secondary liability for the claims.

But critics of the strategy see it as a subversion of the US Bankruptcy Code. Courts have become increasingly skeptical of attempts by companies to use bankruptcy court law to protect assets from plaintiffs.

Aden McCracken Tyrone of Pennsylvania holds a sign in honor of his parents outside of the Supreme Court in December as the Supreme Court heard arguments regarding a nationwide settlement with Purdue Pharma, the manufacturer of OxyContin. (Michael A. McCoy/For The Washington Post via Getty Images) · The Washington Post via Getty Images

In June, the US Supreme Court took a step that will make it more difficult for companies to do so in the future.

In a 5-4 decision, the court held that billionaire members of the Sackler family, longtime owners of the now-bankrupt opioid maker Purdue Pharma, could not shield their personal assets from opioid claims using the corporation's bankruptcy proceedings.

The Sacklers, the court said, engaged in a "milking program" by withdrawing from Purdue approximately $11 billion — roughly 75% of the firm’s total assets.


The court said that no provision within the US Bankruptcy Code permits the type of agreement that the Sacklers and the company tried to reach by limiting plaintiff recoveries to a $6 billion settlement fund.

Other attempts by companies like 3M, Avon, and Georgia Pacific to use the two-step strategy have had varying outcomes. Those inconsistent court decisions are leading some legal experts to predict that the US Supreme Court may review the tactic's legality.
'No financial distress'

In J&J's latest attempt at the two-step, it is asking for the latest vote from claimants to support a “channeling injunction.”

That would cap its liability for all existing and future talc claims at the $8 billion it agreed to place in a settlement trust. J&J agreed to fund the proposed settlement trust over 25 years.

Birchfield expects J&J's latest bankruptcy attempt could run into roadblocks no matter how many claimants vote in favor of a broad settlement because the two-step would strip especially future claimants from their constitutional rights to demand that J&J face jury trials.

"Our view is J&J isn’t entitled to bankruptcy relief because there is no financial distress,” he said. “They’re a $400 billion company."


“If they would pay reasonable compensation and do it on reasonable terms, they could put this behind them,” Birchfield added.

J&J's Wolk said its proposed bankruptcy would provide more recourse to claimants and more quickly resolve cases that would take years to be adjudicated.

Juries have handed down multimillion-dollar awards related to talc litigation risks.

On Tuesday, a Connecticut jury returned a $15 million verdict in favor of a man who said the company's talc-based powder caused him to develop mesothelioma, a cancer that impacts lung and other tissue.

The jury also held that J&J should pay punitive damages to punish it for including talc in its products.

Yahoo Finance Senior healthcare reporter Anjalee Khemlani contributed to this report.

Alexis Keenan is a legal reporter for Yahoo Finance. Follow Alexis on X @alexiskweed.

Biden, Harris hail lower Medicare drug prices and each other

President Joe Biden and Vice President Kamala Harris appeared together in Maryland, touting changes to Medicare's drug purchasing system and each other's credentials, as the pair settle into their new campaign roles.

President Joe Biden and Vice President Kamala Harris made a joint appearance in Maryland, not so far from Washington and the White House, on Thursday.

Nominally, it was to announce changes to the way Medicare acquires prescription drugs, with the government saying it drastically reduces the prices they're paying.

But the event also morphed into mutual praise and campaign rhetoric, as the pair shared a stage just a few weeks after Biden's decision to withdraw from the race and Harris emerging in his place.

"She can make one hell of a president," Biden said of his 2020 running mate, saying the goal for the November 5 vote was to "beat the hell out of" the Republican opponent.

Biden, Harris hold first event since candidate switch 05:01

Harris, meanwhile, delivered more brief remarks in a show of deference to the president, saying it had been her honor to serve under the "most extraordinary human being."

"There's a lot of love in this room for our president," Harris, set to be formally confirmed at the Democrats' party convention next week in Chicago, said.

US says Medicare can now source key drugs far more cheaply

Biden and Harris presented negotiated lower prices for 10 of the most commonly purchased prescription drugs used by Medicare—in one case, for what the US government claims to be a 79% savings.

The change was a part of the far-reaching "Inflation Reduction Act," signed into law in 2022, and the new prices should go into effect starting next year.

The US government estimates savings of approximately $6 billion (roughly €5.5 billion) in the first year alone.

Although the event in Largo, Maryland was formally meant to introduce new policy coming into effect, developments of the past few weeks in the campaign also featuredImage: Elizabeth Frantz/REUTERS

Chants of "thank you, Joe" could be heard as Biden addressed the community college crowd in the city of Largo.

"We finally beat Big Pharma," Biden said at the event.
Industry, Republicans had resisted the changes

"My entire career, I have worked to hold bad actors accountable and lower the cost of prescription drugs," Harris said. "Medicare can use that [collective bargaining] power to go toe-to-toe with Big Pharma and negotiate lower drug prices."

Harris had to cast the Vice President's special 101st vote in the Senate — the last-resort tie-breaking mechanism if a Senate vote is locked at 50-50 — in order for the changes to come into effect, after no Republican Senators supported it.

She stressed this in Largo on Thursday, as Democrats seek to portray themselves as the party trying to keep people's medical bills down.

Republicans alleged that the changes amounted more to "price-fixing," arguing it could ultimately drive prices higher, and supporting industry lobbyists' warnings about it discouraging research and innovation on new medications.

US Democrats move to back Harris in presidential race  02:32

What medication has the change impacted, and how much?

The biggest price drop listed by the government was for Merck and Co's diabetes drug Januvia, decreasing by 79%.

Novo Nordisk's insulin aspart products were set for the second-steepest fall, at 76%.

Eight other listed medications would be bought at rates cut by between 38% and 68%, according to the government.

The true extent of the savings made isn't transparent, though. The US government's price comparisons are against list prices for the drugs, not against whatever price Medicare had previously paid, information the government says it can't divulge.

However, the government says its estimated overall savings to spending do take the previous purchasing prices into account.

Medicare is a federal health insurance program in the US mostly for people over the age of 65, but also for younger people with disabilities. It's estimated to cover or partially cover more than 60 million people.

More than half of US voters in 2020 were aged 50 or older, so nearing the eligibility age for Medicare themselves.

Healthcare is estimated to account for about 8% of Americans' household spending, or around 16% of national GDP — making it the most expensive major developed economy in the world when seeking medical assistance.

People with health insurance in the US still typically have medical bills to pay, with prescriptions among these.

But the idea is that Medicare can at least pass list-price savings, or a share of them, on to end users.

Big Pharma push back on first Medicare drug price cuts

New York (AFP) – Major pharmaceutical companies lashed out following a landmark deal unveiled Thursday to cut the costs of 10 key medicines, with some saying the price-setting process was not transparent.


Issued on: 15/08/2024 

Their statements came after US President Joe Biden and Vice President Kamala Harris announced a deal to lower costs of the first 10 drugs picked for Medicare price talks.

The agreement with drugmakers -- who said they came on board with negotiations as they had no choice -- is set to save seniors in the United States $1.5 billion in out-of-pocket costs.

It is the result of months of negotiations and is anticipated to save Medicare $6 billion in the first year alone, said Biden, referring to the federal health insurance for seniors.

While the announcement is a likely boon for Democratic presidential candidate Harris as she works on her economic messaging ahead of November's election, pharmaceutical companies have long resisted the cuts.

The US government is initially limited to picking 10 drugs for price talks and can expand the program in subsequent years.
'Not objective'

The agreements come on the back of the Inflation Reduction Act (IRA), a major package of energy transition policy and social reforms.

The White House announced a deal to lower costs of 10 key medicines selected for Medicare price negotiations, cutting their list prices by between 38 percent and 79 percent

 © SCOTT OLSON / GETTY IMAGES NORTH AMERICA/AFP/File

This allowed Medicare to start negotiating drug costs for the first time in its nearly 60-year existence.

Novartis, whose heart failure treatment Entresto is among the 10 selected medicines, pushed back against the price-setting process as "not objective or transparent."

"Novartis believes the price-setting provisions in the IRA are unconstitutional and will have long-lasting and devastating consequences," the company added in a statement.

It said it agreed to a "maximum fair price" only to "avoid other untenable options including catastrophic fines or the removal of all our products from both Medicare and Medicaid."

For the 10 selected drugs, discounts from 2023 prices range from 38 percent to 79 percent. The new costs will take effect in 2026.

Besides Entresto, the drugs include Farxiga by AstraZeneca used against diabetes, as well as anticoagulant Eliquis -- used by millions of Medicare beneficiaries.

AstraZeneca said in a separate statement that it accepted the price, as "walking away is not an option."

If a manufacturer refused to accept the price, access for Medicare and Medicaid patients could be compromised, it said.
Patient costs?

Companies also warned that patients could still face higher costs and argued that the deal undervalued their products.

Bristol Myers Squibb (BMS), which is behind Eliquis, cautioned that "insurance plans and their pharmacy benefit managers are ultimately responsible for what patients will pay."

"The IRA does not protect patients from potential increases to their cost sharing or restrictions in access" to Eliquis once the maximum fair price goes into effect in 2026, the company added.

CFRA analyst Sel Hardy, however, noted that BMS management seemed confident it could navigate the impact of the IRA on Eliquis.

A Johnson & Johnson spokesperson called the law arbitrary and lacking in scientific approach.

This "undervalues the benefit our medicines deliver to millions of patients," J&J said.
'Historic milestone'

US residents face the highest prescription drug prices globally, leaving many people to pay partially out of their own pockets despite already exorbitant insurance premiums.

The new deal was reached after Democrats pushed for the government to be able to negotiate prices directly with drug manufacturers for federal health programs.

The White House said the agreement for lower prices is a "historic milestone."

"The vice president and I are not backing down," Biden said in a Thursday statement.

His comments came ahead of a first joint public event with Harris since she replaced him as the Democratic candidate in the upcoming election.

"We will continue the fight to make sure all Americans can pay less for prescription drugs and to give more breathing room for American families," he said.

Rising costs of living are a key issue for the 2024 election.

Last October, drugmakers behind the selected medicines for serious illnesses grudgingly agreed to negotiate on cutting prices.

© 2024 AFP

J&J hit with new class action over talc seeking medical monitoring for cancer

Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York

PUBLISHED ONJUNE 18, 2024 

Johnson & Johnson is facing a new proposed class action seeking damages and medical monitoring on behalf of women who have been diagnosed with cancer, or might develop it in the future, allegedly as a result of using the company's baby powder and other talc products.

The lawsuit, filed on Monday (June 17) in New Jersey federal court, is the first to seek medical monitoring, or regular testing meant to catch cancer early, on behalf of talc users. The proposed class could include thousands of women, but would not include the more than 61,000 people who have already filed personal injury lawsuits over J&J's talc, claiming it contains cancer-causing asbestos.

J&J maintains its talc is safe, asbestos-free and does not cause cancer.

The law firms behind the new case are opposed to J&J's proposal to settle nearly all talc claims against it for US$6.48 billion (S$8.74 billion) through a prepackaged bankruptcy. The same firms are also pursuing a separate class action seeking a court order blocking the bankruptcy.

The bankruptcy proposal needs support from 75 per cent of talc claimants, with a three-month voting period ending on July 26.

Erik Haas, J&J's worldwide vice president of litigation, said in a statement that plaintiffs' lawyers brought Monday's "meritless" lawsuit to thwart the bankruptcy plan because they can collect more fees outside of bankruptcy, putting their own interests ahead of their clients.

"The plaintiff firms should cease the obstructionist behaviour, and let their clients decide for themselves whether to accept the pending offer," he said.

Lawyers opposed to the deal have denied that they are motivated by higher fees and said the bankruptcy proposal would not adequately compensate their clients.


Chris Tisi, one of the lawyers bringing the new lawsuit, said in a statement that medical monitoring was necessary because the "inadequate funding" of the bankruptcy plan "doesn't realistically address the needs of women who could develop ovarian cancer in the future because of past baby powder use."

Both the proposed settlement and the new class action concern claims that talc caused ovarian and other gynaecological cancers, which make up the vast majority of cases. A smaller number of claims have been brought by people who developed mesothelioma, most of which have settled.

J&J has already tried and failed twice to resolve current and future talc claims through bankruptcy.

The legal strategy, known as a Texas two-step, involves creating a subsidiary to absorb the company's talc liability, which then declares bankruptcy to settle the cases. The previous efforts failed because courts found that the new subsidiary lacked the "financial distress" to justify bankruptcy.

ALSO READ: Cancer victims ask court to block J&J talc bankruptcy

Johnson & Johnson reaches $700 million talc settlement with US states

A Johnson & Johnson banner is displayed on the front of the NYSE in New York

Updated Tue, Jun 11, 2024
By Jonathan Stempel

NEW YORK (Reuters) - Johnson & Johnson has agreed to pay $700 million to settle an investigation by 42 U.S. states and Washington, D.C. into its marketing of baby powder and other talc-based products blamed for allegedly causing cancer.

The settlement resolves charges that Johnson & Johnson misled consumers into believing its talc products, which it sold for more than a century before stopping, were safe.

J&J did not admit wrongdoing in settling with the states, which were led by Florida, North Carolina and Texas, and has said its talc products are safe and do not cause cancer. The company announced a settlement in principle in January.

"This is a major advancement for consumer product safety," Florida Attorney General Ashley Moody said in a statement.

J&J still faces tens of thousands of talc lawsuits, and a class action accusing the New Brunswick, New Jersey-based company of fraudulently hiding their dangers from shareholders.

As of March 31, about 61,490 people were still suing J&J over talc. Most were women with ovarian cancer, while a smaller number had mesothelioma, a type of cancer linked to asbestos.

J&J stopped selling talc-based baby powder globally last year, switching to corn starch as the main ingredient. It has maintained that its products do not contain asbestos.

The company has twice tried to resolve the litigation by placing into bankruptcy a subsidiary it created to contain its talc liabilities, but courts rebuffed both attempts.

On May 1, J&J proposed a $6.48 billion settlement to resolve most of the litigation through a third bankruptcy filing. It has set aside an $11 billion reserve to cover all talc liabilities.

"The company continues to pursue several paths to achieve a comprehensive and final resolution of the talc litigation," Erik Haas, J&J worldwide vice president of litigation, said in a statement on Tuesday.

"We will continue to address the claims of those who do not want to participate in our contemplated consensual bankruptcy resolution through litigation or settlement," he added.

(Reporting by Jonathan Stempel in New York; editing by Jonathan Oatis and Bill Berkrot)

 

Cost increasingly important motive for quitting smoking for 1 in 4 adults in England

Making much more of potential savings might encourage more people to stub out for good

BMJ

Health concerns are still the primary motive for more than half of those who say they want to stop smoking in England, but cost is now a key factor for more than 1 in 4, finds an analysis of national survey responses, published in the open access journal BMJ Public Health.

Given this shift in thinking, making much more of the potential savings to be had might encourage more people to stub out for good, suggest the researchers.

Health concerns are generally the primary motive for people trying to stop smoking, with social and financial concerns, plus advice from a health professional, also commonly cited reasons, explain the researchers.

But since 2020, England has undergone a period of substantial societal instability, prompted primarily by the COVID-19 pandemic, which might have triggered changes in the reasons smokers give for wanting to ditch tobacco, they suggest.

To find out, the researchers looked at time trends in motives for trying to stop smoking between March 2018 and May 2023, exploring differences by age, sex, socioeconomic status, presence of children in the household and vaping status.

They drew on responses to the ongoing Smoking Toolkit Study, a monthly survey of a representative sample of around 1700 adults in England.

The responses were limited to those who were either current smokers or who had stopped smoking in the past year and had made at least one serious attempt to quit during that time.

Respondents were asked to name the reason(s) behind their most recent quit attempt from among: advice from a health professional; TV advert for a nicotine replacement product; government TV/radio/press advert; a new stop smoking treatment; cost; smoking restrictions; knowing someone else who was quitting; health warning on a cigarette packet; contact from a local NHS stop smoking service; current or future health problems; attending a local stop smoking activity or event; comments by family, friends, children; significant birthday; pregnancy; simple decision to quit; COVID-19 pandemic.

Out of the 101,919 survey respondents between 2018 and 2023, 17,812 reported smoking in the past year. Of these,17,031 (96%) provided data on quit attempts over the past 12 months, 5777 (34%) of whom reported having made at least one serious attempt to do so.

Health concerns were the most frequently cited motives, reported by more than half the sample (52%) across the entire period—especially concerns about future health, reported by more than 1 in 3 (35.5%) compared with 1 in 5 (19%) who were motivated by current health problems.

Cost was the next most frequently cited motive, reported by nearly 1 in 4 (23%), followed by social factors, reported by around 1 in 5 (19%) and advice from a health professional (12%). 

Around 4% said they were motivated by health warnings on a cigarette packet, while smoking restrictions prompted 3.5% to try and stop; a simple decision to quit was cited by just over 3%. The other reasons attracted only around 1% each.

Up to the start of 2020, 1 in 2 quit attempts was motivated by health concerns; 1 in 5 by current health problems (20%), and 1 in 3 by concerns about future health (34%). One in 5 was motivated by social factors (20%) and cost (20%), and 1 in 6 by health professional advice (16.5%).

While there was little overall change in the proportion of quit attempts motivated by health concerns across the entire study period, the proportion of quit attempts motivated by cost increased significantly, rising from just over 19% in March 2018 to just under 25.5% in May 2023.

But the proportion of quit attempts motivated by health professional advice fell significantly over the entire study period, dropping from just over 14% in March 2018 to 8.5% in May 2023.

The COVID-19 pandemic, which began to affect England in March 2020, is likely to have influenced the proportion of respondents reporting health concerns, social factors, and cost as motives for trying to stop smoking, suggest the researchers. 

The proportion of quit attempts motivated by future health concerns increased during 2020 and 2021.“It is likely the pandemic made health concerns (an already prevalent motive) even more salient, particularly during its first year when the virus was spreading rapidly and vaccinations were not yet available,” they write. 

Once the immediate threat of the virus had subsided thanks to the vaccination programme, the proportion of health-related attempts to quit returned to pre-pandemic levels.

The pandemic probably influenced other motives, suggest the researchers, because it prompted loss of income and jobs for many people.

“These economic pressures probably contributed to the rise in cost-motivated attempts to quit around this time. But while the pandemic’s acute risks to health—and, as a result, attempts to quit motivated by concern for health or social factors—waned over time, its economic impacts have been compounded by a cost-of- living crisis,” they explain.

The pandemic’s impact on access to, and availability of, healthcare services may also have contributed to the decline in the proportion of respondents citing healthcare professional advice as a motivating factor, they add.

The researchers acknowledge various caveats to their findings, including that all the study data were self-reported and relied on personal recall, and may not apply to other countries with different attitudes to smoking, tobacco control policies, and provision of smoking cessation services.

But they conclude: “These findings have implications for smoking cessation interventions and clinical practice. ..They indicate that cost is an increasingly important factor motivating people to try to stop smoking. 

“Communicating the potential savings people can make by stopping smoking (even if they switch to alternative nicotine products) could therefore be an effective means for motivating attempts to quit.” 

Notes for editors
Research: Trends in motives for trying to stop smoking: a population study in England, 2018–2023 Doi: 10.1136/bmjph-2023-000420
Journal: BMJ Public Health

External funding: Cancer Research UK

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf

---

JOURNAL

BMJ Public Health

DOI

10.1136/bmjph-2023-000420 

METHOD OF RESEARCH

Observational study

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Trends in motives for trying to stop smoking: a population study in England, 2018–2023

ARTICLE PUBLICATION DATE

22-Apr-2024

COI STATEMENT

JB has received unrestricted research funding from Pfizer and J&J, who manufacture smoking cessation medications. All authors declare no financial links with tobacco companies, e-cigarette manufacturers, or their representatives

 

Stool transplant shows promise for Parkinson's disease

VLAAMS INSTITUUT VOOR BIOTECHNOLOGIE

 

IMAGE: 

FROM LEFT TO RIGHT: DR. ARNOUT BRUGGEMAN (VIB-UGENT-UZ GENT), PROF. DEBBY LAUKENS (UGENT), PROF. ROOSMARIJN VANDENBROUCKE (VIB-UGENT), AND PROF. PATRICK SANTENS (UZ GENT)

view more 

CREDIT: COPYRIGHT: VIB

Ghent (Belgium), 4 April – Parkinson’s disease (PD) is a common neurodegenerative disease that affects millions worldwide. Now, a groundbreaking clinical study conducted by researchers at Ghent University Hospital, VIB, and Ghent University has demonstrated the potential of fecal microbiota transplantation (FMT) to improve symptoms in patients with PD. This research, published in eClinicalMedicine, provides promising evidence that FMT could be a valuable new treatment for this debilitating disorder.

Parkinson's disease is a neurodegenerative disorder that affects millions worldwide. Its prevalence is rapidly increasing due to factors like pesticide use and an aging population. Symptoms of the disease include both motoric and non-motoric symptoms. The motoric symptoms, such as balance problems, stiffness, and the characteristic tremor, are the best known and almost always the reason for the eventual diagnosis. However, non-motor symptoms, such as loss of smell, constipation, and REM sleep disturbances, often develop up to 20 years before diagnosis in a large number of people with the disease.

The role of the microbiome

In Parkinson’s disease, a protein called alpha-synuclein misfolds and clumps together. Those clumps then damage dopamine-producing nerve cells in the brain, which leads to the typical Parkinson’s symptoms. Current treatments, primarily medications that replace dopamine, often have side effects and lose effectiveness over time.

The protein clumps are believed to be formed in the gut wall at a very early stage of the disease, from which they reach the brain cells via the vagus nerve, which connects the gut and the brain. This process can be influenced by gut bacteria. Indeed, emerging research suggests a surprising link between PD and the gut microbiome, ​ the trillions of bacteria residing in our intestines. Patients with Parkinson's often have an altered gut microbiome compared to healthy individuals and they often show more (intestinal) inflammation and a disrupted intestinal barrier.

That’s why the neurology department at University Hospital Ghent (UZ Gent), led by Prof. Patrick Santens, joined forces with Prof. Debby Laukens of Ghent University and the team of Prof. Roosmarijn Vandenbroucke at the VIB-UGent Center for Inflammation Research. The team wanted to investigate whether a fecal microbiota transplant (FMT) with ​ healthy gut bacteria from a donor could have a significant impact on the evolution of Parkinson's disease symptoms over one year. The clinical study showed that after 12 months, the actively treated group showed significantly more improvement in motor symptoms compared to the placebo group.

Via the nose into the small intestine

The clinical study, named GUT-PARFECT, recruited participants with early-stage Parkinson's disease and healthy donors who donated their stool to the Gentse Stoelgangbank. All participants with Parkinson’s disease received the stool through a tube that was inserted through the nose and advanced into the small intestine to deliver the mixture directly there.

“Our results are really encouraging!” says Dr. Arnout Bruggeman, researcher at VIB-UGent-UZ Gent and first author of the study. “After twelve months, participants who received the healthy donor stool transplant showed a significant improvement in their motor score, the most important measure for Parkinson's symptoms.”

The improvement in motor symptoms became even more pronounced between the sixth and twelfth month after the transplant, suggesting a potential long-lasting effect. Additionally, participants had less from constipation, a frequent and bothersome symptom for many people with Parkinson's disease. More research is needed to determine whether this treatment also slows the progression of the disease.

Way forward

This study is a significant step forward in the search for new treatment options for Parkinson's disease.

"Because there were major questions about the feasibility at the start of the study, financing this research was no easy task," says Prof. Patrick Santens. "This research was only possible thanks to the support of patient organizations, donations to the UGent Parkinson Research Fund, and the willingness of participants to undergo the rather invasive procedures."

"Our study provides promising hints that FMT can be a valuable new treatment for Parkinson's disease," says Prof. Roosmarijn Vandenbroucke. "More research is needed, but it offers a potentially safe, effective, and cost-effective way to improve symptoms and quality of life for millions of people with Parkinson's disease worldwide."

"Our next step is to obtain funding to determine which bacteria have a positive influence. This could lead to the development of a 'bacterial pill' or other targeted therapy that could replace FMT in the future," says Prof. Debby Laukens.

---

Publication

Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial. Bruggeman, et al. eClinicalMedicine, 2024. DOI: 10.1016/j.eclinm.2024.102563

This study was made possible because of the patients and their families who participated in the trial, as well as the donors from the Gentse StoelgangBank and support from the Flemish Parkinson’s patient organizations, VPL and Parkili.

The research was funded by the Biocodex Microbiota Foundation, the many gifts to the UGent Parkinson Research Fund, and the FWO Program.

---

JOURNAL

EClinicalMedicine

DOI

10.1016/j.eclinm.2024.102563 

METHOD OF RESEARCH

Randomized controlled/clinical trial

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial.

COI STATEMENT

JR has received grants from Beneo, Cargill, Colruyt group, Danone, DSM, J&J, MRM/Prodigest, Nestle, Pfizer, and Takeda; and has received consulting and/or speaking fees from Aphea, Biofortis, DSM, Ferring, GSK, Janssen Pharmaceuticals, Metagenics, MSD, MRM/Prodigest, Nutricia, Sanofi, Takeda, Tsumura. RV has received grants from MRM Health, Prodigest, CellCarta, Evox Therapeutics and Sanofi. All other authors declare no competing interests.

Judge certifies Johnson & Johnson shareholder class action over talc disclosures


Fri, December 29, 2023 

Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York

 REUTERS/Lucas Jackson/


By Jonathan Stempel

NEW YORK (Reuters) -A federal judge said Johnson & Johnson shareholders may pursue as a class action their lawsuit accusing the company of fraudulently concealing how its talc products were contaminated by cancer-causing asbestos.

U.S. District Judge Zahid Quraishi in Trenton, New Jersey, on Friday allowed shareholders from Feb. 22, 2013, to Dec. 13, 2018, to pursue their securities fraud claims as a group.

He rejected J&J's argument that any class period be at least a year shorter because some events that allegedly caused its stock price to fall contained no "new" information.

J&J's talc products have included its signature baby powder. The company stopped selling talc-based baby powder globally this year, switching to corn starch as the main ingredient. It has said its talc products are safe and do not contain asbestos.

"Johnson & Johnson always strives to provide truthful and fulsome disclosures," Erik Haas, J&J's worldwide vice president of litigation, said in a statement. "We will continue to vigorously litigate cases that challenge the safety of our product or the accuracy of our public statements."

Lawyers for shareholders including the lead plaintiff San Diego County Employees Retirement Association did not immediately respond to requests for comment.

Class actions make it easier for shareholders to recover more money, at lower cost, than if they sued individually. A longer class period could increase the amount recovered.

Shareholders said J&J's stock price fell six times in late 2017 and 2018 following events that confirmed how the New Brunswick, New Jersey-based company and various executives hid the truth about asbestos in its talc products.

These events included a jury awarding $4.69 billion in July 2018 to 22 women who said asbestos caused them to develop ovarian cancer, and a Reuters report five months later that said J&J knew about the asbestos risks for decades.

J&J said the six events could not have hurt its stock price because none contained new information that "corrected" its earlier disclosures.

It said the only new information from the verdict was that jurors accepted the women's arguments, and that all 56 internal documents mentioned in the Reuters report were already public.

Quraishi was unpersuaded. Addressing the Reuters report, he said its "careful analysis" and providing of "necessary context" made it more than a rehash of "stale information."

The share price fell 10% the day the report was released.

J&J also faces mass tort litigation encompassing more than 50,000 lawsuits over its talc products.

Courts have rejected two efforts by the company to use the bankruptcy process to limit its exposure to talc litigation.

The case is Hall v Johnson & Johnson et al, U.S. District Court, District of New Jersey, No. 18-01833.

(Reporting by Jonathan Stempel in New York; Editing by Aurora Ellis and Daniel Wallis)

Johnson & Johnson is pushing to settle baby powder cases linked to asbestos

Jef Feeley, Bloomberg News on Dec 4, 2023


Johnson & Johnson is making a push to resolve lawsuits claiming its talc-based Baby Powder causes cancer linked to asbestos exposure to avoid facing some jury trials next year, according to people familiar with the effort.

A trio of law firms have reached agreements for settlements covering about 100 cases, said the people, who declined to be identified because they weren’t authorized to speak publicly. The financial size of the accords are being kept private, the people added.

The deals may be mentioned Tuesday as part of J&J’s investor presentation at the New York Stock Exchange if company officials update shareholders about the plan for corralling the decadelong talc litigation, the people said. The session’s main focus is the company’s long-term growth outlook and product pipeline.

The company is striving to find a way to resolve all current and future baby powder cases after a judge nixed its attempt to settle them for $9 billion as part of a unit’s bankruptcy filing. The deals are part of the manufacturer’s multipronged strategy to deal with the lawsuits, which have created a drag on its shares.

J&J declined to comment.

‘Hammered by Juries’

“It looks like they are finally stepping up to the plate and acknowledging they are going to have to settle cases to be done with this,” said Carl Tobias, a University of Richmond professor who teaches mass-tort law. “Ridding themselves of trial settings can only work in their favor since they’ve been getting hammered by juries.”

The New Brunswick, New Jersey-based company pulled its talc-based powders off the market in the United States and Canada in 2020, citing slipping sales. The world’s largest maker of health care products replaced talcum with a cornstarch-based version. J&J vowed to remove all its baby powders containing talcum powder worldwide by the end of this year.

J&J faces a spate of jury trials early next year over allegations that its executives knew since the early 1970s that talc contained trace amounts of asbestos, which can cause a cancer called mesothelioma, but failed to alert consumers or regulators. J&J contends that its talc-based products don’t cause cancer and it has marketed Baby Powder appropriately for more than 100 years.

The company faces more than 50,000 suits accusing it of concealing baby powder’s cancer risk to protect its iconic product. Most of those claims are from women with ovarian cancer. The majority of the cases are consolidated before a federal judge in New Jersey.

Inventory Settlements

J&J has reached agreements to do so-called inventory settlements with law firms such as Kazan, McClain Satterley & Greenwood, and Levy Konigsberg to resolve all their mesothelioma cases, the people said. The company has come to similar terms with the Motley Rice firm, the people added.

Joe Satterley, a Kazan lawyer who has won and settled multiple talc cases against J&J, declined to comment on whether he’s settled his inventory of mesothelioma cases. Joe Rice, Motley Rice’s co-founder, also declined to comment. Moshe Maimon, a Levy Konigsberg lawyer who has won talc cases at trial, didn’t immediately respond late Monday to phone and email messages seeking comment.

The settlements resolved a case that was already on trial in state court in Oakland, California, in November and will head off trials that were supposed to start in January and March in state court in New Jersey, the people said. J&J still faces a mesothelioma case in state court in Minnesota later this month, the people added.

Besides getting trials off the calendar, J&J is trying to clear the way for a third bankruptcy filing to resolve the talc litigation in its entirety. Erik Haas, J&J’s lawyer overseeing the talc litigation, said in an October earnings call that the company was “pursuing a consensual resolution of the talc claims through another bankruptcy.”

The consolidated case is In Re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, 16-md-2738, U.S. District Court for the District of New Jersey (Trenton).


©2023 Bloomberg L.P. Visit bloomberg.com. Distributed by Tribune Content Agency, LLC.

LA REVUE GAUCHE - Left Comment: Search results for J&J 

LA REVUE GAUCHE - Left Comment: Search results for TALC 

LA REVUE GAUCHE - Left Comment: Search results for ASBESTOS 

J&J settles first talc cases to go to trial after failed bankruptcies

BRENDAN PIERSON
November 16, 2023 




(Reuters) - Johnson & Johnson on Thursday said it has settled two lawsuits claiming its talc products caused cancer, the first such cases to go to trial since a federal court rejected the company's plan to move its talc liabilities into bankruptcy court.

The settlements resolved lawsuits brought by two men, Rosalino Reyes and Marlin Eagles, who said they developed mesothelioma related to asbestos in J&J talc powder, and was part of a broader deal to settle all talc cases brought by the law firm representing them, Kazan, McClain, Satterley & Greenwood, the company said. Reyes' family continued his lawsuit after he died in 2020.

The company faces more than 50,000 lawsuits over talc, most by women with ovarian cancer. It has said that its talc products are safe and do not contain asbestos.

J&J and the plaintiffs' lawyers did not disclose any terms of the settlement, or how many cases it covered. Reyes' trial had begun last week, while Eagles' was about to begin, with a jury chosen.

"The Eagles and the Reyes families express thanks to the jurors and courtroom personnel who participated in the trial," Joseph Satterley and Denyse Clancy, attorneys for the plaintiffs, said in a joint statement.

"Our negotiations continue with the remaining firms who have a shared interest in achieving a fair and expedient resolution of their clients talc claims," J&J said in a statement.

"For those firms who elect not to pursue reasoned resolutions, we will continue to aggressively litigate their claims in the tort system, where we have prevailed in the overwhelming majority of the cases tried because the claims are meritless and are based upon junk science."

Trials in the cases have a mixed record, with major plaintiff wins including a $2.1 billion judgment awarded to 22 women with ovarian cancer. A New Jersey appeals court last month threw out a $223.7 million verdict against the company, finding the testimony of the plaintiffs' expert witnesses unsound.

The company stopped selling talc-based baby powder in favor of cornstarch-based products, citing an increase in lawsuits and "misinformation" about the talc product's safety.

The settlement comes after J&J failed for a second time in July to move tens of thousands of claims over talc into bankruptcy court, where it hoped to resolve them through a proposed $8.9 billion settlement. It is appealing that ruling.

Trials had mostly been on hold while J&J petitioned the bankruptcy court, but have now been able to resume.

(Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill Berkrot)

US judge refuses to block Medicare from negotiating drug prices

Updated Fri, September 29, 2023 


By Brendan Pierson

(Reuters) -The U.S. government's Medicare health insurance program can begin negotiating prices for some prescription drugs this fall under a new program, a federal judge ruled on Friday, vindicating one of President Joe Biden's signature initiatives.

The order by U.S. District Judge Michael Newman in Dayton, Ohio, comes in a lawsuit brought against the Biden administration by the U.S. Chamber of Commerce.

The nation's largest business lobbying group argues that the program violates the U.S. Constitution by allowing the government to force drugmakers to accept unfairly low prices, and would stifle innovation.

Newman in a preliminary order rejected that argument, finding that drugmakers were unlikely to prevail in the case. He said they were not being forced to give anything up because participating in Medicare is "completely voluntary."

"As there is no constitutional right (or requirement) to engage in business with the government, the consequences of that participation cannot be considered a constitutional violation," he wrote.

The Chamber of Commerce and the U.S. Justice Department did not immediately respond to requests for comment.

The Biden administration "will continue fighting to lower health care costs for American families, no matter how many challenges Republicans and Big Pharma put in our way," White House spokesperson Karine Jean-Pierre said in a statement.

Although Newman's ruling allows the price negotiation program to begin as scheduled on Oct. 1, the judge allowed the lawsuit to continue, denying a motion by the government to dismiss it altogether.

The ruling is the first to come from multiple lawsuits by drug companies and industry groups challenging the program. Newman was appointed to the bench by Republican former President Donald Trump.

The drug price negotiation program is part of the Inflation Reduction Act, which Biden, a Democrat, signed last year.

Americans pay more for prescription medicines than people in any other country. The program aims to save $25 billion annually by 2031 by requiring drugmakers to negotiate the prices of selected expensive drugs with the U.S. Centers for Medicare and Medicaid Service (CMS), which oversees Medicare.

Medicare mostly serves the millions of Americans aged 65 and older.

Drugmakers whose medicines were selected for the first round of pricing negotiations must agree to begin talks on Oct. 1. Those who do not negotiate either would have to pay steep penalties, up to 19 times a drug's sales, or stop participating in the government healthcare programs, which account for a significant portion of the companies' U.S. sales.

CMS announced the first 10 drugs to be negotiated on Aug. 29. They include the blood thinners Eliquis from Bristol Myers Squibb and Pfizer, Xarelto from Johnson & Johnson, Merck & Co's diabetes drug Januvia, and AbbVie's leukemia treatment Imbruvica.

The negotiated prices would take effect in 2026 with a minimum discount from the list price at 25%.

The Chamber of Commerce's lawsuit is one of several similar cases challenging the program. The others were filed by individual drugmakers and by Pharmaceutical Research and Manufacturers of America, the leading drug industry lobbying group.

Companies that have sued over the program include J&J, Merck, Bristol Myers and Boehringer Ingelheim, which make drugs on CMS's negotiation list.

The Chamber of Commerce was the only plaintiff to ask for a preliminary injunction halting the price negotiations while its lawsuit proceeds. The other lawsuits are moving at a slower pace, and judges may not rule on them until next year.

The Biden administration has repeatedly said there is nothing in the Constitution that prohibits drug price negotiations. Many other countries already negotiate drug prices.

(Reporting By Brendan Pierson in New York and Nate Raymond in Boston; additional reporting by Costas Pitas; Editing by Alexia Garamfalvi, Bill Berkrot, Chris Reese and Leslie Adler)

Federal judge denies request to block Medicare negotiation 

Joseph Choi

Fri, September 29, 2023 



A federal judge on Friday declined to block the Medicare Drug Price Negotiation program, meaning companies will have to play ball with the government for the time being.

U.S. District Judge Michael J. Newman ruled against a request for a preliminary injunction on the program that was requested by the Chamber of Commerce in its lawsuit to stop negotiations.

His ruling comes right before the Oct. 1 deadline by which drugmakers whose products were named for negotiation are required to sign agreements to engage in the process or face the penalties.

Along with denying the Chamber’s request for an injunction, Newman also denied a request from the federal government to dismiss the case entirely. The government is arguing the Chamber has no standing to sue over Medicare negotiation since it’s not a pharmaceutical company itself.

Newman issued no opinion on whether the trade group had standing and said he “will entertain the filing of one or more renewed motion(s) to dismiss.” The Chamber has maintained that it can sue on behalf of its members.

The judge noted that while case law regarding associational standing is “scarce,” individual participation from a member of an organization is ” not normally necessary” when a group is seeking relief on behalf of said member.

Many of the companies — Merck, Bristol Myers Squibb and AstraZeneca — have said they plan to sign the agreements, albeit with protest.

Oral arguments over the injunction were heard two weeks ago in the Southern District Court of Ohio.

The legal threshold for obtaining a preliminary injunction involves demonstrating the party which requested it is likely to succeed in the case based on the merits, that the party will suffer irreparable harm without an injunction, the opposing party will not suffer harm as a result and that issuing an injunction is in the interest of the public.

During the oral arguments, the Chamber asserted it would win in the case because the program is not truly a negotiation, but a scheme passed by Congress to “blur lines of accountability.”

In its request, the Chamber said “irreparable harm” would occur and has already been experienced by some of its members. The government pushed back on these assertions, noting that the negotiated prices are years away from going into effect.

The Chamber alleged a host of constitutional violations within the Medicare negotiation program in its lawsuit and they argued that blocking any constitutionally unsound program is in the public’s interest.

Based on his decision, it appears Newman was unconvinced by the Chamber’s argument.

“They have demonstrated neither a strong likelihood of success nor irreparable harm. Consequently, their request for immediate preliminary injunctive relief—to stop implementation of the Program on or before October 1, 2023—is denied,” Newman stated in his ruling.

Another key aspect of the government’s argument against the lawsuits to stop Medicare negotiation is that the program is voluntary at the end of the day, meaning no companies are compelled to take part in it if they disagree with how it’s operated. Newman appeared to agree with this argument in his ruling on Friday.

Noting a prior ruling, Newman found that “participation in Medicare, no matter how vital it may be to a business model, is a completely voluntary choice.”

The lower, negotiated prices are set to go into effect at the start of 2026 if everything goes to plan. The government had argued that all the lawsuits suing to stop Medicare negotiation will likely have been decided by that point, making the supposedly urgent need for an injunction moot.

During the oral arguments, the government emphasized the fact that the Chamber itself is not a pharmaceutical company and would not suffer harm as a result of the negotiation program, even as it is suing on behalf of one of its members.

With the preliminary injunction denied, the negotiation process is now free to proceed as scheduled, with talks set to take place during 2023 and 2024.

This story was updated at 6:27 p.m.

Big Pharma's Johnson & Johnson under investigation in South Africa over 'excessive' drug prices

GERALD IMRAY
Fri, September 15, 2023 

FILE - A Johnson & Johnson logo on the exterior of a first aid kit in Walpole, Mass., Feb. 24, 2021. South Africa-Johnson & Johnson-Investigation. U.S.-based pharmaceuticals company Johnson & Johnson is being investigated in South Africa for allegedly charging “excessive” prices for a key tuberculosis drug. The government-appointed commission that regulates business practices in the country announced the investigation on Friday, Sept. 15, 2023. 

(AP Photo/Steven Senne, File) 

CAPE TOWN, South Africa (AP) — U.S.-based pharmaceuticals company Johnson & Johnson is being investigated in South Africa for allegedly charging “excessive” prices for a key tuberculosis drug, the country's antitrust regulator said Friday.

J&J's Belgium-based subsidiary Janssen Pharmaceuticals is also under investigation, South Africa's Competition Commission said.

The commission, which regulates business practices, said it opened the investigation this week based on information that the companies “may have engaged in exclusionary practices and excessive pricing” of the tuberculosis drug bedaquiline, which is sold under the brand name Sirturo.

The Competition Commission declined to give further details of its investigation, but health advocacy groups in South Africa say the country is being charged more than twice as much for bedaquiline than other middle- and low-income countries.

Bedaquiline was approved in 2012 and is used to treat drug-resistant TB. It is desperately-needed by South Africa, where the infectious disease is the leading cause of death, killing more than 50,000 people in 2021. South Africa has more than 7 million people living with HIV, more than any other country in the world. The World Health Organization says that nearly one-third of deaths among people who have HIV/AIDS are due to tuberculosis.

Globally, TB cases increased in 2021 for the first time in years, according to the WHO.

J&J has previously faced calls to drop its prices for bedaquiline and said last month that it would provide a six-month course of the drug for one patient through the Stop TB Partnerships Global Drug Facility at a cost of $130.

The South African government purchases its bedaquiline directly from J&J and Janssen and not through the Stop TB facility and was paying around $280 for a six-month course for a patient, according to Professor Norbert Ndjeka, who leads the national department of health's TB control and management.

Ndjeka said that South Africa had recently concluded a new two-year deal with J&J for bedaquiline at a slightly higher price than $280 per course, according to a report on the News24 website.

The Competition Commission said it was confirming the investigation due to heightened media interest, but would not respond to requests for comment or more information about the probe.

It comes a week after a health advocacy group released details of South Africa's COVID-19 vaccine purchase contracts with numerous pharmaceutical companies, including J&J and U.S.-based Pfizer. They were obtained after the group, the Health Justice Intiative, won a freedom of information case in court.

The group says the contracts show J&J charged South Africa 15% more per vaccine dose than it charged the much richer European Union. Pfizer charged South Africa more than 30% more per vaccine than it charged the African Union, even as South Africa struggled to acquire doses while having more COVID-19 infections than anywhere else on the continent.

In the contract, South Africa was required to pay Pfizer $40 million in advance for doses, with only $20 million refundable if the vaccines weren't delivered, the Health Justice Initiative said. J&J also required a non-refundable downpayment of $27.5 million.

Pfizer reported record revenues of $100.3 billion in 2022. J&J made $94.9 billion in sales last year.