11/25/2019
Sending Smoke Signals

Sending Smoke Signals

What you need to know about electronic cigarettes, and why they are the next mass tort

By Jessica Butkera

Whether you know them as e-cigarettes, vape pens, or “Juuls,” electronic cigarettes have grabbed the nation’s attention. As research about the short- and long-term health effects of e-cigarettes develop, alleged predatory advertising to youths captured the government’s attention amidst a recent “vaping-related” illness that is dominating the news. Predictably, this is all leading to a launch of lawsuits, and the next mass tort is on the horizon.

What Are E-Cigarettes?

E-cigarettes, developed for commercial use in China in 2003 and first sold in the United States in 2007, deliver nicotine (and often flavoring) to their users in vapor instead of smoke. Composed of an internal cartridge called a cartomizer (which holds a liquid solution containing varying amounts of nicotine, flavorings, and other chemicals) and a vaporizer (which heats the solution), e-cigarettes are activated when its user puffs or inhales the device, at which point the liquid is vaporized. The user then breathes in this vapor, hence the term “vaping.” E-cigarettes are commonly used to inhale nicotine, but are also used to deliver tetrahydrocannabinol (THC), cannabidiol (CBD), and butane hash oils.

E-cigarettes are small, sleek devices often designed to look like USB flash drives and can be used indoors virtually undetected, as the vapors are often odorless. Because e-cigarettes eliminate tobacco, including the tar and carbon monoxide produced in cigarettes, they are advertised as safer alternatives.

However, the Food and Drug Administration (FDA) has not actually approved e-cigarettes as smoking-cessation devices, in large part due to the lack of long-term research and studies on which it could soundly base such a decision. The World Health Organization slammed e-cigarette companies for claims that e-cigarettes are a “safe and effective smoking cessation aid” because there is “no scientific evidence to confirm the product’s safety and efficacy.”

In addition to containing nicotine, which is well-known to be highly addictive, early testing of some e-cigarette products found that the vapor contained known carcinogens and toxic chemicals that have health effects that could result in a range of significant pathological changes, including cancer. The FDA also found nicotine in some cartridges that were labeled as nicotine-free.

Big Bucks, Big Business

The “Big Three” tobacco companies—Altria, Lorillard, and Reynolds American—have been purchasing independent e-cigarette companies, and may share as much as 75 percent of the profit pool in 10 years.

Mordor Intelligence estimates the e-cigarette market was worth $11.3 billion in 2018 and may reach $18.2 billion by 2024. E-cigarette sales in the U.S. increased by 132 percent from 2012 through 2016. According to the Centers for Disease Control (CDC), unit sales increased from 667 units per 100,000 people in 2012 to 1,547 units per 100,000 people in 2016. According to figures from global market research firm Nielsen Corporation, e-cigarette sales in the U.S. reached $4.5 billion by the end of 2019’s third quarter. Wells Fargo Securities LLC predicted 2019 sales could reach $7 billion.

American electronic cigarette company Juul specifically, which attracted Philip Morris-owner Altria to purchase a 35 percent stake in the company for $13 billion, has dominated the e-cigarette market with a 75.8 percent market share. From 2015 to 2016, its aggregated annual e-cigarette retail sales increased 16 percent from $775 million to $896 million. From 2016 to 2017, it saw a 47 percent increase from $896 million to $1.3 billion.

This large market growth is due in part to the amount of youths currently using e-cigarettes, which has reached epidemic proportions. Ignorant of the addictive qualities of nicotine, attracted to harmless sounding flavors like “bubble gum,” “cloud cookie,” “huggy bear,” and “super strudel,” and influenced by typical peer pressure, youths are using e-cigarettes in droves. Since 2014, they have been the most commonly used tobacco product among U.S. youths. According to the CDC, the number of middle and high school students actively using e-cigarettes went from 2.1 million students in 2017, to 3.62 million students in 2018, to a staggering 4.9 million students as of February 2019. The most recent National Institute of Health “Monitoring the Future” research survey found that 27 percent of all high school seniors vape, as well as 16 percent of high school sophomores and 11 percent of eighth graders.

The devices are not difficult to obtain, either. While many states have banned the sale of vape pens and associated products to minors, the perceived availability of vaping products for students is quite high: Forty-six percent of eighth graders and 67 percent of high school sophomores surveyed indicated that the devices are “fairly easy” or “very easy” to obtain.

The FDA’s Aggressive Response

The FDA believes that the e-cigarette industry, especially Juul, engaged in predatory advertising to youths, and it has responded in kind. Over the past year, it issued several warning letters to dozens of e-cigarette companies, demanding information on how they will address youth access to, and use of, their products, as well as seeking information about whether products are being illegally marketed in circumvention of its current compliance policy.

In September 2018, the FDA even raided Juul’s San Francisco headquarters and seized thousands of pages of documents relating to marketing practices. Keeping the pressure on, the FDA issued another warning letter to Juul in September of 2019, expressing concern with Juul’s presentations made directly to students during which its representatives referred to Juuls as “99 percent safer” than cigarettes, “much safer” than cigarettes, “totally safe,” and a “safer alternative to smoking cigarettes.”

In addition to investigating the industry, the FDA is also reaching out directly to youths. In October 2018, the FDA launched “The Real Cost” youth e-cigarette prevention campaign. Modeled after its 2014 “The Real Cost” anti-smoking campaign—a $247 million effort that studies have shown prevented nearly 350,000 youths from becoming cigarette smokers, saving the nation $31 billion in mortality, earnings losses, and other costs—this updated campaign seeks to educate teens about the dangerous effects of using electronic cigarettes. From television commercials to posters in thousands of school bathrooms, the public-service campaign targets nearly 11 million young people ages 12 to 17 who have used e-cigarettes or are open to trying them.

Vaping-Related Illness

While the FDA is optimistic its ad campaign will be effective in the long-term, the topics of vaping and “vaping-related illnesses” are already pervasive in national news reports. As of October 2019, the CDC has linked 1,479 lung injury cases from every state except Alaska to the use of e-cigarettes, as well as 33 deaths confirmed across 24 states.

All of the identified patients have a reported history of e-cigarette product use, but no consistent evidence of an infectious process has been discovered. As of now, there are three primary diagnoses: chemical pneumonitis; alveolar hemorrhage; and lipoid pneumonia. The patients’ presentations include chest pain, coughing, shortness of breath, difficulty breathing, and, to a lesser extent, chills and gastrointestinal symptoms such as nausea and vomiting. Most patients reported a history of using e-cigarette products containing THC; some reported using THC and nicotine; and some reported only using e-cigarette products that contained nicotine. No consistent e-cigarette or vaping product, substance, or additive has been identified in all cases, and no specific product or substance has been conclusively linked to lung disease in patients.

While the CDC and doctors across the country search for an answer, federal and state agencies and governments, as well as private retailers, are responding quickly and aggressively. The CDC, American Medical Association, American Academy of Pediatrics, and American Lung Association have all urged the public to stop using e-cigarette devices until a cause is identified. As of October 2019, Michigan, New York, Massachusetts, Rhode Island, Montana, Washington, Oregon, and San Francisco have enacted legislation outright banning or drastically limiting online and retail sales of all marijuana and tobacco vaping products, flavored or otherwise. Illinois, New Jersey, and Delaware are currently considering similar legislation. In addition, the following retailers are discontinuing sales of electronic cigarettes in their stores: Rite Aid, Walmart, Sam’s Club, Kroger, Harris Teeter, Ralphs, Fred Meyer, and Walgreens.

In an expected response, the e-cigarette industry placed blame on illegal THC oils and black-market products. However, what was thought to be an automatic reaction could prove valid. The New York State Department of Health’s lab tests showed extremely high levels of vitamin E acetate in nearly all the cannabis products it analyzed, but not in any of the nicotine products tested. The CDC also suggested that products containing THC, particularly those obtained off the street or from other informal sources, may play a major role in the outbreak.

In addition, a recent raid in September 2019 by local officials in Wisconsin uncovered a million-dollar black-market vape empire run by two brothers aged just 20 and 23. Police uncovered more than 31,000 vape cartridges with liquid THC, 98,000 empty vape cartridges, and 57 mason jars filled with liquid THC. Given that the initial outbreaks were reported in Wisconsin, Minnesota, and Illinois, federal authorities are now offering assistance and investigating whether this large-scale, black-market operation could be connected to the outbreak.

Pending Lawsuits and an Impending Mass Tort

Prior to the vaping-related illness outbreak, numerous product liability lawsuits stemming from exploding e-cigarettes were litigated. In addition, Juul was already facing five consumer protection class-action lawsuits across the country, based on allegations that its nicotine vaping solution contained benzoic acid and more nicotine than advertised.

Since the outbreak, dozens of individual and class-action lawsuits are now being filed across the country. For example, in August 2019, Ethan Kocourek filed a product liability and negligence suit against Juul, alleging he suffered numerous seizures after using the product for three years. He contends that he was unaware Juul contained nicotine and asserts that Juul knowingly designed a dangerous product, marketed it to underage consumers, and failed to warn consumers of the adverse risks associated with it.

On Sept. 13, 2019, an attorney for Adam Hergenreder, an Illinois student-athlete, announced that Hergenreder is suing Juul after doctors told him he now has lungs similar to those of a 70-year-old man. This announcement, during which Hergenreder’s attorney referred to vape pens as “toxic time bombs,” came just eight days after Hergenreder’s hospitalization was profiled on “The Today Show.”

On Oct. 11, 2019, Montgomery County in Maryland filed a class-action lawsuit against Juul alleging violations of the Maryland Consumer Protection Act, negligence, and unjust enrichment. Montgomery County contends that it has incurred costs to control vaping, police underage sales, and launch an anti-vaping advertising campaign within Montgomery County public schools.

On Oct. 15, 2019, the first wrongful-death lawsuit against Juul was announced. Lisa Vail filed suit on behalf of her son, David Wakefield, who died in his sleep in August 2018. She contends that he was addicted to Juul and hospitalized three times for breathing and lung complications, and alleges it caused his ultimate death.

Also on Oct. 15, 2019, four Indiana residents filed suit against Juul, alleging that the company violated the Indiana Deceptive Consumer Sales Act, failed to warn its users of the risks of e-cigarettes, and intentionally misrepresented its products.

The trend is apparent and growing. This is, of course, despite the fact that there is no scientific and medical consensus on a specific causative agent and that black-market THC may very well be to blame. As evidenced by recent mass-tort litigations surrounding talc and ovarian cancer or glyphosate and non-Hodgkin’s lymphoma, litigation does not wait on settled science to advance claims. Add in a provocative 24/7 news culture and pages of lawyers advertising for e-cigarette victims online, and it is clear that the next mass tort is upon us.

Unlike consumer class-action lawsuits, in which certified groups of plaintiffs assert massive aggregate harm, personal-injury claims arising from e-cigarette use are too individualized to bind plaintiffs to a class. Each plaintiff’s unique use pattern of e-cigarettes, coupled with his symptoms, injury, and damage, requires an individual lawsuit. In addition, target defendants can vary for each plaintiff, who can assert claims against the manufacturer, distributor, marketer, and retailer—or any combination of the same.

With so many variables at play, it is inevitable that this headline-dominating product will generate a mass of tort suits for the foreseeable future.



Jessica Butkera is a partner in the Baltimore office of Goldberg Segalla LLP. jbutkera@goldbergsegalla.com

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