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April 2020

Will Vaping Go Up In Smoke?

Vaping - by now you know exactly what that means. We have all seen the huge cloud of mist or vapor bellowing on sidewalks, in cars, and outside of restaurants.  As a kid, who didn’t love to blow smoke with those gum cigarettes, or even try a puff off of the ne’er-do-well neighbors ill-gotten Kool smokes?  Mine was David Bernstein – the son of a doctor no less – who my parents wisely labeled “a bad influence.”  If we had vaping products in the 70’s at our disposal, I can only imagine the vape circles we would spin. 

Tobacco products have long been marketed internationally and have been the butt of many, many lawsuits. Notwithstanding, the market for electronic nicotine delivery systems, commonly referred to as “e-cigarettes,” has grown remarkably over the past few years. Although these products have been marketed and sold by the cigarette/tobacco industry for decades, recent conditions include bad publicity, increased governmental scrutiny, and a rise in litigation. Most of the suits are targeting the tobacco industry while also including flavoring manufacturers, stores that sell the products, and distributors. With the advent of the COVID-19 shelter-in-place orders, one can only imagine that the use of drugs, alcohol, cigarettes and vaping will rise significantly.  Vaping products differ from traditional cigarettes in many respects, including the vast array of flavors that are sweet, salty, fruity and even sour, yet, like cigarettes contain nicotine. 

In San Francisco, more than 250 cases have been consolidated against various companies alleging the producers of e-cigarettes conspired to target their marketing to teens and concealed the addictive properties of the products.    

Current estimates state that the global e-cigarette market was valued at $11.5 billion in 2018 and forecasted to rise to $41.7 billion by 2024.

Federal and State Regulations

In August 2016, the U.S. Food and Drug Administration (the “FDA”) extended the regulatory authority of the Center for Tobacco Products to cover all tobacco products, including e-cigarettes.[1] Under this new authority, the FDA regulates the manufacturing, importing, packaging, labeling, advertising, promotion, sale, and distribution of e-cigarettes and parts thereof, which include: e-liquids; e-liquid containers; cartridges; atomizers; batteries; cartomizers and clearomizers; digital display or read-out lights; tank systems; drip tips; flavorings; and programmable software.[2]

Anyone who manufactures, processes, labels, and/or imports vaping products must comply with the FDA’s requirements for tobacco manufacturers. Starting in 2018, the FDA required e-cigarettes to bear warning labels on all product packaging and advertisements, stating the product contains nicotine and nicotine is an addictive chemical. The FDA prohibits advertisements that claim e-cigarettes are “safer” than traditional tobacco products, absent an FDA order establishing as such. 

Several state and local governments have enacted laws pertaining to the manufacturing and sale of e-cigarettes in an effort to bring public awareness about the use of such products amid a nationwide increase in vaping.  For instance, San Francisco – the corporate home to Juul Labs, which is the largest producer of e-cigarettes in the United States – voted unanimously to ban the sale and distribution of e-cigarettes in the city.  Meanwhile, Senate Bill 793 (“SB 793”) is currently making its way through the California Legislature.  If it passes, SB 793 would prohibit the sale of all flavored tobacco products in California, including e-cartridges, refillable and tank-based vaping systems, traditional cigarettes, chewing tobacco, and hookah. 

Marketing and Advertising Claims in E-cigarette Litigation

Although e-cigarettes have been around for decades, as indicated above, the industry has recently experienced an increase in lawsuits that focus on alleged deceptive marketing, failure to warn of addiction, and the targeting of youth consumers. Several lawsuits have been filed all over the country, and are currently being coordinated in Federal Court in San Francisco. Numerous defendants have been implicated in this litigation, including the designers and manufacturers of the e-cigarettes, component part manufactures, distributors, and retailers. The plaintiffs in those lawsuits describe a host of alleged injuries including addiction, nicotine poisoning, behavioral issues, cognitive issues, various types of physical injuries, and even death. 

The marketing of e-cigarettes has been similar to that of traditional cigarettes. The initial demographic targets were adult smokers who might make the switch from cigarettes. E-cigarettes were and are still advertised as a “better” alternative to smoking traditional cigarettes.  However, these lawsuits allege that the e-cigarette industry collaborated with traditional cigarette corporations to fraudulently advertise their products to the public.  For example, advertisements showing e-cigarettes paired with food and coffee allegedly lead consumers to believe the products are safe and healthy.  There is also concern that the e-cigarette industry removed various factors from its products in an effort to attract consumers. Specifically, many of the negative side-affects associated with cigarettes do not exist in e-cigarettes, including the smell and taste of tobacco, as well as the harsh hit of inhaling smoke from a lit cigarette.  Essentially, it is alleged that making e-cigarettes easier to use was an intentional move by the industry to make these products more addictive, without warning the consumer of the potential for addiction. 

Many of these lawsuits allege that the e-cigarette industry created its advertisements to target youth consumers.  According to the Centers for Disease Control and Prevention (the “CDC”), from 2011 to present, at least 69% of middle and high school students were exposed to e-cigarette advertisements on the Internet and/or in retail stores, magazines, movies, and television.[3]  Exposure to these advertisements is alleged to be a contributing factor in the increased use of e-cigarettes among youth.  More than one quarter of high school students reported in 2019 that they used e-cigarettes in the past 30 days—an increase from 1.5% in 2011.[4] 

As the attention and criticism regarding the industry’s advertisement methods increases, so too have allegations against the industry for claims of false advertising, fraudulent concealment, negligence, and other causes of action. 

Chemicals in E-cigarettes

Another significant argument raised in these lawsuits is the allegation that the flavoring additives used in e-cigarettes are hazardous to both users and those around them.  While the respiratory health effects of inhalation exposure to e-cigarette flavoring are still in dispute, plaintiffs have alleged the existence of toxicological concerns that the flavor chemicals in e-cigarette fluids are excessively high for inhalation exposure.  It is alleged that because flavoring chemicals were not adequately tested for safety risks associated with inhalation in e-cigarettes, these chemicals should not have been placed into the stream of commerce without warning of the potential risks caused by inhalation.  As a result, the companies who manufacture and supply the flavoring chemicals have also found themselves exposed to litigation. 

Flavoring chemicals that have been utilized in e-cigarettes have included diacetyl, cinnamaldehyde, acetoin, pentanedione, o-vanillin, maltol, and coumarin.  In December 2018, researchers from the Harvard T.H. Chan School of Public Health discovered more than 75% of the 51 tested types of flavored e-cigarettes and refill liquids contained diacetyl.[5]  These tests also showed that approximately 45% of the 51 types of flavored e-cigarettes and refill liquids contained acetyl propionyl, with over 90% also including the chemical acetoin.[6]  The causal connection between exposure to diacetyl and acetyl propionyl and the development of bronchiolitis obliterans, informally known as “popcorn lung,” has been the subject of recent lawsuits throughout the United States.  While recent attention has cast doubts on the existence of a causal connection between exposure to diacetyl and lung disease, lawsuits continue to be filed against flavoring companies. Juries in recent years appear to be less concerned about the cause and more preoccupied with the effect. 

Alleged Injuries Associated with E-cigarette Use

The “vaping” lawsuits have also raised allegations that e-cigarette use increases one’s risk of cardiovascular, pulmonary, and neurological injuries. Specifically, it has been alleged that flavoring compounds used in e-cigarettes result in lung disease, including lipoid pneumonia, eosinophilic pneumonia, bronchiolitis obliterans (popcorn lung), collapsed lung, and alveolar hemorrhage. The CDC has coined the term “e-cigarette, or vaping, product use-associated lung injury” or “EVALI” to identify injuries that may be associated with e-cigarette use.  EVALI cases may include persons with respiratory symptoms, gastrointestinal symptoms, or nonspecific constitutional symptoms (e.g. fever, chills, weight loss, etc.).  EVALI cases may so include behavioral issues (e.g. anger, irritability, mood swings, etc.), cognitive issues (e.g. learning impairments, lack of concentration, etc.), and neurological injuries (e.g. seizures, strokes, etc.).

Although the CDC is working to identify the cause of EVALI cases, it is unclear whether there is a definitive causal link between these alleged injuries and the use of e-cigarettes.  The FDA made headway through the identification of a specific contaminate, vitamin E acetate, with respect to a number of claims throughout the nation.[7]  This contaminate, an oil derived from vitamin E, has been found in cannabis products in samples collected from a number of patients across the nation who purportedly became ill as a result of vaping.[8]  As a corollary, FDA officials have yet to identify anything unusual in the nicotine products collected from these patients.[9]  As of February 2020, a total of 2,807 hospitalized EVALI cases or deaths have been reported to CDC from 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands).[10]  Sixty-eight deaths have been confirmed in 29 states and the District of Columbia.[11]  Due to continued declines in new EVALI cases since September 2019, and the identification of vitamin E acetate as a primary cause of EVALI, the CDC announced its final update on the number of hospitalized EVALI cases and deaths nationally in February 2020.

Conclusion

As the increase of litigation against e-cigarette companies and the industry in general continue to rise, it is important for those affiliated with vaping products to keep apprised of the ongoing changes in policy, regulations, and medical findings.  The proper use and retention of key experts and databases with significant documents, evidence, expert transcripts and historical data are key to an efficient defense.  The attorneys at Gordon Rees Scully Mansukhani, LLP are uniquely poised to assist with any issues related to any claims affiliated with the use of vaping products. 


[3] https://www.cdc.gov/vitalsigns/ecigarette-ads/index.html

[4] https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm

[5] https://www.hsph.harvard.edu/news/press-releases/e-cigarette-flavoring-chemicals-linked-to-respiratory-disease/; Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 1 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes,” Joseph G. Allen, Skye S. Flanigan, Mallory LeBlanc, Jose Vallarino, Piers MacNaughton, James H. Stewart, David C. Christiani, Environmental Health Perspectives, December 8, 2015, doi: 10.1289/ehp.1510185

[6] https://www.hsph.harvard.edu/news/press-releases/e-cigarette-flavoring-chemicals-linked-to-respiratory-disease/; Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 1 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes,” Joseph G. Allen, Skye S. Flanigan, Mallory LeBlanc, Jose Vallarino, Piers MacNaughton, James H. Stewart, David C. Christiani, Environmental Health Perspectives, December 8, 2015, doi: 10.1289/ehp.1510185

[7] https://www.washingtonpost.com/health/2019/09/05/contaminant-found-vaping-products-linked-deadly-lung-illnesses-state-federal-labs-show/; https://www.washingtonpost.com/health/as-vaping-related-lung-illnesses-spike-investigators-eye-contaminants/2019/08/29/cfe26032-ca78-11e9-be05-f76ac4ec618c_story.html

[8] https://www.washingtonpost.com/health/as-vaping-related-lung-illnesses-spike-investigators-eye-contaminants/2019/08/29/cfe26032-ca78-11e9-be05-f76ac4ec618c_story.html

[9] https://www.washingtonpost.com/health/2019/09/05/contaminant-found-vaping-products-linked-deadly-lung-illnesses-state-federal-labs-show/

[10] https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html

[11] https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html

Environmental/Toxic Tort

Nadine A. Hughes
J. Todd Konold
Jason F. Meyer



Environmental/Toxic Tort