In re: Juul Labs, Inc. Marketing, Sales Practices & Products Liability Litigation 3:19-md-2913-WHO
By Mark A. York
(May 19, 2021)
Why JUUL MDL 2913 IS NEEDED
It’s business as usual in Big Tobacco and e-cigarettes as they follow the Monsanto-Bayer Roundup “Glyphosate is harmless” and Johnson & Johnson “Talc is safe” models of paying influencers to publish contrived media that diverts the truth. This is a defined example of why Mass Torts in America exist.
AN EXAMPLE OF BIG TOBACCO BAD CONDUCT WHERE SOMEONE ATTEMPTS TO FRAME PUBLIC OPNION IN FAVOR OF “VAPING IS GOOD”
This entity published media that is 100% pro-vaping:
American Institute for Economic Research (AIER)
“Vaping Is Saving Lives” https://www.aier.org/article/vaping-is-saving-lives/
This is the type of bad conduct that is permitted to frame public opinion by use of embedded “purported thought leaders” who have offered statements and guidance via a pay to comment for a fee paid by whomever may write the checks. These are the “under the radar” public speakers and publishers who mitigate risks of drugs and other consumer products introduced into mainstream commerce in not only the United State but around the world. The response to this type of contrived media above is reflected in the State of Massachusetts JUUL Complaint and Exhibits below.
STATE OF MASSACHUSETTS INITIAL JUUL COMPLAINT WITH EXHIBITS, MASSACHUSETTS SUPERIOR COURT, (Feb 12, 2020):
State of Massachusetts JUUL Complaint (PDF 1.5 MB)
Mass Complaint Exhibit A (PDF 8.24 MB)
Mass Complaint Exhibit B (PDF 24.07 MB)
Mass Complaint Exhibit C (PDF 2.82 MB)
Mass Complaint Exhibit D (PDF 14.5 MB)
Mass Complaint Exhibit E – Launch Photo 1 (PDF 599.39 KB)
Mass Complaint Exhibit E – Launch Photo 2 (PDF 546.39 KB)
Mass Complaint Exhibit E – Launch Photo 3 (PDF 768.78 KB)
JPML Initial Transfer Order, October 2, 2019
Excerpt: “On the basis of the papers filed and the hearing session held, we find that these actions involve common questions of fact, and that centralization – of all actions – in the Northern District of California. These actions share multiple factual issues concerning the development, manufacture, labeling, and marketing of JUUL products, and the alleged risks posed by use of those products.
VAPING AND E-CIGARETTE BACKGROUND
Vaping has become quite popular, particularly among young people who may be unaware of the dangers of nicotine addiction associated with this unsafe product.
Among the major manufacturer of e-cigarettes and vapor pods is JUUL that reportedly controls 75 percent of the e-cigarette market and has marketed the products as a safer alternative to cigarettes, which has led to lawsuits alleging deception and misrepresentation in its failure to disclose that its products contain adverse health elements. Cigarette giant Philip Morris bought a 35 percent interest in JUUL in August 2019, for $35 million.
The way e-cigarettes (or vaping) work is by heating up nicotine-containing flavored oils that come in sealed replaceable, single-use pods that create a vapor that can be inhaled by the user. The devices are slim and easily fit in one’s palm or pocket. The enticement for younger people is that the product comes in different flavors camouflaging the nicotine taste. Evidence is being established that e-cigarette manufacturers deliberately marketed their products to children and teens, a vulnerable population in an effort to get them adducted at an early age.
One of the major trigger points to awareness was when a suburban Chicago teen was hospitalized for adverse health effects from vaping. He started vaping at age 16 and said his favorite flavors were mint and mango. The 18-year-old’s lungs reportedly looked like that of a 70-year-old after just two years of vaping use.
The Science of Vaping AE’s:
E-Cigarettes and Vaping-Related Disease, via New England Journal of Medicine “A Vape Adverse Event Repository” evidence based guidance and data on Big Tobacco “Bad Conduct” https://www.nejm.org/vapingHE
Hospitalizations and Deaths Associated with Vaping aka “EVALI”: https://www.nejm.org/doi/full/10.1056/NEJMoa1915314
Summary: As of January 7, 2020, a total of 2558 hospitalized patients with nonfatal cases and 60 patients with fatal cases of e-cigarette, or vaping, product use–associated lung injury (EVALI) had been reported to the Centers for Disease Control and Prevention (CDC.
What’s the FDA’s stance on Juul?
Well, the FDA hasn’t monitored Juul very well at all, permitting the teen marketing campaigns to run amok at will. never considering whate “tobacco compinies might do, once again” given the opportunity to craete addicts and and make maoney at the same time. In April 2018, the FDA demanded that Juul submit marketing and research documents, and explain what Juul knows about the use of its products among teens. A month later, as part of the FDA’s Youth Tobacco Prevention Plan, the agency also requested information from several other e-cigarette manufacturers. And in October 2018, the FDA visited Juul’s San Francisco headquarters to gather information on the company’s sales and marketing tactics.
Despite the fact that selling tobacco products to minors is illegal, the FDA has so far uncovered 40 violations for illegal sales of Juul products to young people. Warning letters were issued for those violations. The company also shut down its Facebook and Instagram accounts in November 2018 to avoid promoting its product to teens and nonsmokers — two groups that Juul specifically says it does not want to become customers.
In a statement, FDA Commissioner Scott Gottlieb said, “…the nicotine in these products can rewire an adolescent’s brain, leading to years of addiction.”
But, he continues: “Make no mistake. We see the possibility for electronic nicotine delivery systems (ENDS) products like e-cigarettes and other novel forms of nicotine-delivery to provide a potentially less-harmful alternative for currently addicted individual adult smokers … But we’ve got to step in to protect our kids.”
The FDA continues to monitor Juul and vaping in general, recently calling Juul out for marketing the device as safer than it really is, as well as investigating the 120-plus vape-related seizure cases.
The Centers for Disease Control and Prevention (CDC) isn’t a fan of Juul or other e-cigarettes, either. The CDC says outright that e-cigarettes aren’t safe, especially for children and teens, and is currently investigating cases of lung disease associated with vaping.
While federal government bodies have been warning people about the health risks of vaping for years, e-cigarette use has become such an epidemic that state and local government bodies are finally taking note. San Francisco — the headquartering city of Juul — became the first city to ban e-cigarette sales completely.
How did Juul get its start?
Juul Labs spun off from Pax Labs in 2015. Founders Adam Bowen and James Monsees co-founded the company when, as former smokers, they decided they wanted a better alternative to cigarettes than anything that was already on the market.
Their idea of “better” manifested as Juul’s high nicotine content and slim design that gives off very little vapor compared to other vapes. Since its debut, Juul has grown to dominate more than 50 percent of the market share.
In December 2018, Altria — one of the world’s largest tobacco products companies — bought a 35% stake of Juul for $12.8 billion dollars. Altria owns Phillip Morris, which owns the brands Marlboro, Virginia Slims, Parliament and other cigarette brands.
What are the main ingredients in Juul pods?
The Juul comprises two parts. There’s the e-cigarette itself, which contains the battery, temperature regulator and sensors that read the charge level. Then there’s the pod, which contains Juul’s patented e-liquid formula. A mixture of nicotine salts, glycerol, propylene glycol, benzoic acid and flavorings.
- Glycerolserves as a humectant, which means it adds moisture to the solution. Glycerol is classified as “generally recognized as safe” by the FDA, so it’s approved for consumption.
- Propylene glycolis a synthetic compound commonly used in polyester production, but it’s also approved as an additive for food, cosmetic and pharmaceutical products.
- Benzoic acidoccurs naturally in many plants, but its synthetic form is also widely used as a food additive and preservative. It’s “generally recognized as safe” for those uses, but can be an environmental and health hazard in large quantities.
- Flavoringsis an ambiguous term, but most often refers to various natural and synthetic ingredients that companies use to flavor their products. For example, Juul doesn’t specify what’s in its mint-flavored pod, but it probably contains peppermint extract or oil.
The nicotine salts in Juul vape juice are a type of nicotine that supposedly feels more like a cigarette when inhaled, as opposed to other vapes that use freebase nicotine. Freebase nicotine, which can cause coughing and leave a film in people’s throats, is harsher and commonly found in cigars.
Juul pods currently come in eight flavors; cucumber, creme, mint, mango, menthol, fruit, Virginia tobacco and classic tobacco. It’s the FDA’s Family Smoking Prevention and Tobacco Control Act banned flavored cigarettes in worth noting that 2009, so it’s possible that this might come into play for vapes one day, too.
How much nicotine is in a Juul pod?
Juul measures nicotine content by weight, which is different from most brands, which usually measure by volume. Juul originally only sold pods with 5% nicotine by weight, but started offering 3% pods in August 2018.
According to an older version of Juul’s FAQ page, one 5% pod contains roughly the same amount of nicotine as one pack of cigarettes, or about 200 puffs. However, this information is no longer available on Juul’s website, and there’s no precise information about 3% pods, either. However, an article in the New England Journal of Medicine says that the 5% pods contain a concentration of 59 milligrams of nicotine per milliliter of liquid.
In contrast, prior to the Juul frenzy most vapes contained roughly 1 to 3% nicotine by volume. A study in the journal Tobacco Control notes that the new average seems to be rising to that 5% mark. Juul’s creators increased the nicotine because they felt other vapes on the market couldn’t compare to the sensations delivered by regular cigarettes.
E-cigarette manufacturers have promulgated the idea that cigarette smokers can get their nicotine in a manner that somewhat replicates regular smoking experience but without the health risks that have been associated with nicotine use. Lawsuits filed against e-cigarette manufacturers by states and municipalities are now the norm, for failing to clearly state the dangerous chemicals contained in their products.
The claims generally allege that between 2016 and 2018 “those who reported using e-cigarettes within the past 30 days increased 40% among 8th graders, 82% among 10th graders, and 72% among 12th graders.” According to one lawsuit, the e-cigarette industry had a 2016 market revenue of $7.1 billion, and the e-cigarette industry as a whole expected to see its valuation rise to $44.61 billion by 2023. JUUL is valued at $38 billion.
Millions of these devices are sold annually. According to the World Health Organization (WHO), vaping use has increased dramatically: from some 7 million in 2011 to 41 million in 2018. Users are expected to reach 55 million by 2021. The United States is the largest market in the world.
Is Juul addictive? Is Juul more addictive than cigarettes?
Nicotine is a known addictive substance, and Juul is no exception. There are currently no studies that prove whether or not Juul is more addictive than regular cigarettes, simply because e-cigarettes are a relatively new phenomenon. However, I certainly know people who seem as addicted to their Juul as they are to their iPhones, and I’ve watched friends throw fits when their pod runs dry.
Nicotine is a harmful drug, regardless of delivery method. It’s linked to various changes in the body and brain, and public health officials worry that most people, especially youths, aren’t aware of the potential consequences.
What are the health effects of vaping?
People incorrectly consider vaping a safer alternative to smoking because it eliminates tobacco, which is a known carcinogen. But cigarettes contain many chemicals beyond tobacco, and e-cigarettes contain some of the same. Much of this is based on false-marketing by the tobacco companies.
Not all e-cigarette liquids contain all of these toxic compounds, and even in those that do contain them, the concentration isn’t always high enough to cause concern. One study looked at the benzene formation of Juul and two other vaping systems versus traditional cigarettes, finding that traditional cigarettes present a higher risk of benzene exposure. However, the study authors note that the benzene exposure created by e-cigarettes is not negligible — that is, there’s still a health risk.
Another study looked at adolescents who use e-cigarettes and found that their urine contained significantly higher amounts of five different chemicals, compared to adolescents who never use e-cigarettes.
Another issue arises when companies don’t disclose what’s in their products. Juul openly states its e-liquid ingredients, but research has found that e-cigarette products aren’t always labeled accurately, which can cause people to inhale more nicotine and chemicals than they think they’re breathing in.
Nicotine is a highly addictive substance that causes cravings and bona fide withdrawal symptoms when those cravings are ignored. Whether or not vaping is a “gateway” to cigarette smoking is irrelevant because vaping itself is an addictive habit.
Nicotine isn’t just addictive, but it’s also toxic. It stimulates your adrenal glands, spiking adrenaline production and leading to a series of bodily reactions: People who use nicotine experience a release of glucose and an increase in heart rate, breathing rate and blood pressure.
The drug seems to act as both a stimulant and a depressant at the same time, as it’s linked to increased alertness but also increased relaxation.
Use of nicotine is also associated with a number of side effects on organs and organ systems, including:
- Increased risk of blood clots
- Peptic ulcers
- Changes in heart rhythm
- Lung spasms
Nicotine can also alter or harm the development of the brain in children and teens.
“The prefrontal cortex, the area of the brain responsible for decision-making, logic, personality expression and many other traits integral to one’s personality, is not fully mature until around the age of 25,” Dr. Lawrence Weinstein, chief medical officer of American Addiction Centers, told CNET. “Introducing nicotine to the brain 10 years prior to that, without speaking of the massive amount of nicotine contained in each cartridge, will undoubtedly alter that developing brain.”
Dentists have also been noticing that their patients who vape are experiencing more cavities, tooth damage and dental issues. Especially when it comes to the enamel on your teeth, once damage is done it cannot be reversed.
Lastly, e-cigarettes work by heating a liquid into an aerosol that the user inhales. While the amount of aerosol in a single puff isn’t likely to harm anyone, it’s worth noting that inhaling aerosols is associated with impaired judgment and functioning.
As for the long-term health effects of Juul and other vapes, doctors and scientists aren’t sure yet. E-cigarettes are too new for health professionals to make any correlative claims like they can with traditional cigarettes. But with so much research in progress, new claims will certainly surface.
The WHO cited several health concerns associated with vaping, pointing out that:
- The long-term effects are unknown
- Nicotine in the liquid that is vaporized in an e-cigarette is addictive
- Users replacing the liquid in refillable e-cigarettes might spill the product on their skin, possibly leading to nicotine poisoning
- Some sweeter flavors of e-cigarettes are irritants, potentially causing inflammation of the airways
Additional Science on E-Cigarettes and Vaping-Related Disease
Federal and state governments have implemented numerous policies to combat the growth of vaping. But policies should protect young people without diminishing adult smokers’ ability to use e-cigarettes to transition away from more harmful combustible cigarettes.
- CORRESPONDENCE MAR 19, 2020An Animal Model of EVALI
T.A. Bhat and OthersN Engl J Med 2020; 382:1175-1177
In this study, investigators developed a mouse model of e-cigarette, or vaping, product use–associated lung injury, showing in mice a vitamin E acetate induced lung injury similar to what has been seen in human cases.
In a study involving 51 patients with electronic-cigarette, or vaping, product use–associated lung injury in 16 states across the United States, vitamin E acetate was detected in samples of bronchoalveolar-lavage fluid from 94% of the patients but not in samples from a healthy comparator group.
- PERSPECTIVE FEB 20, 2020The EVALI and Youth Vaping Epidemics
B.A. King and OthersN Engl J Med 2020; 382:689-691
Interventions aimed at curbing two related U.S. epidemics connected with vaping — an outbreak of lung injuries and a continued surge in use by young people — should take into consideration their underlying drivers.
- SPECIAL REPORT FEB 20, 2020Vaping Syndromic Surveillance
K.P. Hartnett and OthersN Engl J Med 2020; 382:766-772
Increases in EVALI were identified in 2019. Using the National Syndromic Surveillance Program, which includes about 70% of U.S. EDs, researchers found a gradual increase in ED visits associated with shortness of breath and e-cigarette use from January 2017 through early June 2019. A sharp increase was identified in June, peaking in September. A subsequent decrease was observed.
- CORRESPONDENCE JAN 23, 2020Pulmonary Illness Related to E-Cigarette Use
N Engl J Med 2020; 382:384-386
In these letters, Diaz et al. highlight the potential for severe airway reactivity and perioperative challenges when performing bronchoscopy and BAL in patients with e-cigarette, or vaping, product use–associated lung injury, and Russell and Cevik stress the importance of ruling out infectious causes in these patients. Layden et al. respond.
- CORRESPONDENCE OCT 31, 2019Real-Time Surveillance of Vaping-Induced Pulmonary Disease
Y. Hswen and J.S. BrownsteinN Engl J Med 2019; 381:1778-1780
This report documents the ongoing surge in cases of severe pulmonary disease associated with e-cigarettes, collecting online information from news aggregators, eyewitness reports, and official alerts.
- CORRESPONDENCE OCT 31, 2019Pathology of Vaping-Associated Lung Injury
Y.M. Butt and OthersN Engl J Med 2019; 381:1780-1781
This letter describes findings in 17 patients with a history of vaping who had lung biopsies after presenting with symptoms and bilateral pulmonary opacities that led to a clinical diagnosis of vaping-associated lung injury. The lung histopathology is described, along with some preliminary insights into the pathogenesis of acute lung injury.
- CORRESPONDENCE OCT 10, 2019Imaging of Vaping-Associated Lung Disease
T.S. Henry, J.P. Kanne, and S.J. KligermanN Engl J Med 2019; 381:1486-1487
- CORRESPONDENCE OCT 10, 2019Vaping Trends among Adolescents, 2017–2019
R. Miech and OthersN Engl J Med 2019; 381:1490-1491
Vaping by adolescents is a concern because of the risks of nicotine addiction and because of reports of an association between vaping and acute lung injury. This nationally representative survey finds sharp increases in the frequency of vaping among 8th-, 10th-, and 12th-grade students.
- CORRESPONDENCE OCT 10, 2019Pulmonary Lipid-Laden Macrophages and Vaping
S.D. Maddock and OthersN Engl J Med 2019; 381:1488-1489
Until the investigation into the cause of this epidemic of vaping-induced respiratory injury is complete, no conclusions can be drawn as to which compound or compounds are the causes of injury. In light of these cases, however, efforts should be made to increase public awareness of the harmful effect of vaping, and physicians should discourage their patients from vaping.
Original Article Pulmonary Illness Related to E-Cigarette Use in Illinois and WisconsinCorrespondence Pulmonary Lipid-Laden Macrophages and VapingCorrespondence Imaging of Vaping-Associated Lung Disease
- IMAGES IN CLINICAL MEDICINE JUN 20, 2019Injury from E-Cigarette Explosion
M.G. Katz and K.W. RussellN Engl J Med 2019; 380:2460
A 17-year-old boy presented to the ED with pain and swelling in his jaw 2 hours after an e-cigarette exploded during use. He had extensive lacerations in his mouth, multiple disrupted lower incisors, and bony incongruity of his left mandible.
- ORIGINAL ARTICLE FEB 14, 2019E-Cigarettes vs. Nicotine-Replacement Therapy
P. Hajek and OthersN Engl J Med 2019; 380:629-637
In a randomized trial involving 886 smokers, e-cigarettes were more effective than nicotine-replacement therapy with respect to the 1-year abstinence rate (18% vs. 10%). Throat or mouth irritation was more common in the e-cigarette group, and nausea was more common in the nicotine-replacement group.
- CORRESPONDENCE FEB 14, 2019Youth Vaping in Colorado
T.S. Ghosh and OthersN Engl J Med 2019; 380:689-690
In a 2017 survey of Colorado high-school students, 27% reported current use of electronic cigarettes (vaping). These students were also more likely to report risky behaviors (including binge drinking and the use of opioid pain medications without a prescription) than nonusers.
- CORRESPONDENCE JAN 10, 2019Adolescent Vaping and Nicotine Use in 2017–2018
R. Miech and OthersN Engl J Med 2019; 380:192-193
A national survey revealed a large increase in nicotine vaping among high school students; more than 20% of 12th-graders reported that they vaped nicotine in 2018. The increase in adolescent nicotine use from 2017 to 2018 was explained by an increase in vaping; the use of other nicotine products declined.
- PERSPECTIVE SEP 20, 2018Adolescents’ Use of “Pod Mod” E-Cigarettes
J.L. Barrington-Trimis and A.M. LeventhalN Engl J Med 2018; 379:1099-1102
Use of a new e-cigarette product class called “pod mods” is rampant among young people. There is reason to be concerned that adolescents’ use of these products could bring a host of adverse health consequences to the current generation of adolescents and young adults.
- SPECIAL ARTICLE JUN 14, 2018Approaches to Smoking Cessation
S.D. Halpern and OthersN Engl J Med 2018; 378:2302-2310
In a pragmatic trial involving smokers, financial incentives were more effective than free cessation aids; free cessation aids or e-cigarettes were no more effective than usual care. Cessation rates among smokers assigned to financial incentives were less than 3%.
- PERSPECTIVE JAN 18, 2018E-Cigarettes and the Harm-Reduction Continuum
A.L. Fairchild and OthersN Engl J Med 2018; 378:216-219
In recent years, there has been a trend of acknowledging the importance of a harm-reduction approach in policy discussions about e-cigarettes. But some proposed strategies might well limit, if not entirely undermine, the population benefits associated with e-cigarettes.
- REVIEW ARTICLE OCT 06, 2016The Health Effects of Electronic Cigarettes
C. Dinakar and G.T. O’ConnorN Engl J Med 2016; 375:1372-1381
The use of electronic cigarettes is growing, and some hope that they will replace what is felt to be the more dangerous nicotine-delivery system — cigarettes. However, data on the long-term safety of e-cigarettes are still being gathered.
- CORRESPONDENCE OCT 06, 2016Explosion Injuries from E-Cigarettes
E.G. Brownson and OthersN Engl J Med 2016; 375:1400-1402
This report from a single center describes 15 patients with injuries caused by explosions of e-cigarettes that occurred over a period of less than a year. Patients had a combination of flame burns, chemical burns, and blast injuries.
- PERSPECTIVE JUL 21, 2011E-Cigarette or Drug-Delivery Device? Regulating Novel Nicotine Products
N.K. Cobb and D.B. AbramsN Engl J Med 2011; 365:193-195
The FDA intends to regulate e-cigarettes as tobacco products, since the courts blocked it from treating them as drug-delivery devices. Until the FDA asserts its new authority over tobacco, concentrated nicotine products may be sold to consumers, raising safety concerns.
Selected JUUL MDL 2913 case documents of special interest:
High Priority Orders From Outset:
Order Appointing JUUL Leadership:
Pretrial Oder No. 1 “Initial Docket Structure:
Case Census Outline, CMO No. 2:
In re: Juul Labs, Inc. Marketing, Sales Practices & Products Liability Litigation 3:19-md-2913-WHO
May 17, 2021
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