Category: Litigation

Court of Appeals Stays Bidi Vapor Marketing Denial Order
The U.S. Court of Appeals for the Eleventh Circuit has stayed the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021. The FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December.
The Feb. 1, 2022, ruling allows Bidi Vapor and Kaival Brands to market and sell all of its Bidi Stick electronic nicotine-delivery systems (ENDS), including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.
With the judicial stay decision going in favor of Bidi Vapor, the company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.
“We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor, in a statement. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”
“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA. We are extremely pleased with the court’s decision on this judicial stay order and continue to expect to be successful on the merits case as well.”
“The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel said.
February 3, 2022
Triton Unleashes its Opening Argument in FDA Lawsuit
In a highly anticipated case for the vapor industry, Triton Distribution made its opening arguments Monday in its battle with the U.S. Food and Drug Administration over how the regulatory agency conducted it premarket tobacco product application (PMTA) reviews. Triton’s lawyer urged a three-judge panel of the 5th U.S. Circuit Court of Appeals in Houston to conclude the FDA could not force manufacturers to provide studies that the agency had previously stated would not be required.
“The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies,” said Triton’s attorney Eric Heyer, a partner at Thompson Hine.
Credit: Sergign
In August, the FDA rejected applications to market 55,000 flavored e-cigarettes, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval, according to Reuters. The new requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to keep selling e-cigarettes until another panel could hear its appeal.
In recently released internal FDA correspondence, the agency’s scientific staff conducted “fatal flaw” reviews that only looked for the presence of the newly required long-term studies, and if those studies were not present the agency issued a marketing denial order (MDO). During oral arguments, Heyer said the FDA’s new requirement was “arbitrary and capricious, a position conservative U.S. Circuit Judge Edith Jones appeared to agree with.
“It seems to me that’s the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences,” she said, alluding to COVID-19 vaccines.
Heyer argued that the process the FDA established set Triton up for failure because the new requirements were only conveyed after the deadline for when PMTAs needed to be submitted (Sept.9, 2020) had passed. It was only then that the FDA indicated that applicants would likely need randomized controlled trials (RCTs) and longitudinal cohort studies to demonstrate “comparative efficacy.”
The other two judges questioned Triton’s case. U.S. Circuit Judge Gregg Costa asked whether Triton’s products, such as one called Jimmy the Juiceman Strawberry Astronaut, were really targeted to adults. “That’s supposed to be appealing to a 40-year-old?” he asked.
U.S. Circuit Judge Catharina Haynes questioned why companies like Triton did not have enough time to develop such support for their products’ health benefits for adults given the years they have had to prepare for FDA regulation. The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act. Manufacturers were ultimately given until 2020 to seek approval to market them.
If the court disagrees with Triton’s argument, Heyer has requested that the judges “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy,” according to legal documents.
There is no timeline for a decision in the Triton lawsuit. Judges are expected to take at a minimum weeks, if not months, to make a decision.
February 1, 2022
PMI Earns Wins Over Reynolds in HnB Patents Lawsuit
A Philip Morris International Inc. affiliate has earned two federal patent victories involving its heat-not-burn (HnB) technology dispute with Reynolds American Inc (RAI). A three-judge panel of the federal Patent Trial and Appeal Board said Wednesday it had determined as unpatentable all RAI Strategic Holdings Inc. claims for the “915” patent and claims 1 through 12 and 18 through 30 for the “542” patent.
Credit: Bill Oxford
The “915” patent “relates to smoking articles that employ an electrical heating element and an electrical power source to provide an inhalable substance in a vapor or aerosol form, without substantially burning or completely burning tobacco or other substances,” according to JournalNow.
Meanwhile, the “542” patent “is directed to articles wherein tobacco, a tobacco derived material or other material is heated, preferably without significant combustion, to provide an inhalable substance … in a vapor or aerosol form.” The “542” patent is designed to create improvements and alternatives to “provide the sensations associated with cigarette, cigar, or pipe smoking, without delivering considerable quantities of incomplete combustion and pyrolysis products.”
In both cases, the decisions are the final word from the board. However, those decisions can be appealed for review to the U.S. Court of Appeals for the Federal Circuit, which RAI has indicated it will pursue. According to federal law, a claim is unpatentable if “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”
January 17, 2022
Juice Man Banned From Marketing E-Liquids in Illinois
Illinois Attorney General Kwame Raoul today announced a consent decree with Juice Man LLC that effectively prohibits the company from doing business in the state. The consent decree resolves allegations the company allegedly developed and marketed its products to attract minors.
Credit: Sharafmaksumov
Raoul filed a lawsuit in 2020 against California-based Juice Man alleging the company intentionally developed nicotine products that appeal to minors and has marketed its harmful nicotine products to minors, according to a press release. The consent decree prohibits Juice Man from distributing its products in Illinois and requires the company to take action if it learns Juice Man products are sold in the state.
“E-cigarette manufacturers know that addicting young users is essential to their long-term viability. With candy- and dessert-flavored products marketed by cartoon characters, it is no wonder they are succeeding,” Raoul said. “I filed a lawsuit last year against Juice Man over its blatant efforts to direct advertising toward minors, and this consent decree essentially ends the company’s ability to sell or distribute any Juice Man products in Illinois. I am pleased with this progress in my office’s ongoing work to hold e-cigarette manufacturers accountable for their role in the epidemic levels of e-cigarette usage by minors. The work does not end here, I am committed to continuing to investigate the e-cigarette industry and protecting minors from the long-term dangers of using tobacco products.”
Raoul’s lawsuit alleged that Juice Man offered its products in a variety of flavors – such as pink lemonade, cotton candy, unicorn frappe and cherry blue cola – that are clearly developed and marketed to youth smokers. For example, unicorn frappe is described as an “explosion of tarts, fruits, and creams.”
Additionally, Raoul’s lawsuit alleged that Juice Man unfairly and deceptively marketed its products to minors. The company relies heavily on social media to advertise its products, using hashtags such as “#vapebabes,” “#vapeporn” and “#vapelyfe.” Raoul pointed out that prior to 2016, social media advertising featured images of Juice Man’s products in front of a neutral background.
In his lawsuit, Raoul said Juice Man’s advertisements used bright colors, cartoon characters and children’s cereal. A number of flavored products distributed under Juice Man’s “Zonk!” line relied on packaging that featured graphics similar to those in comic books. Juice Man also marketed variety packs of flavors including watermelon-strawberry and mixed berry as “Lunch Box” assortments. Furthermore, Raoul argued that Juice Man’s age-verification system allows the company to easily interact with and promote products to minors.
The consent decree entered prohibits Juice Man from selling or distributing e-cigarette products to retailers and consumers located in Illinois. The manufacturer is also prohibited from selling e-cigarette products to distributors or wholesalers that intend to sell or distribute those products to retailers or consumers in Illinois. The consent decree requires Juice Man to take actions – including permanently ceasing business with offending entities – if the manufacturer learns that a retailer, distributor or wholesaler provided its e-cigarette products to an Illinois retailer or consumer.
Raoul has taken various actions to hold e-cigarette manufacturers accountable for epidemic usage levels among youth and teens. In 2019, Raoul’s office filed a lawsuit against the nation’s largest e-cigarette manufacturer, Juul Labs Inc., and the litigation is ongoing. The Attorney General’s office is continuing to investigate other e-cigarette manufacturers as part of an ongoing investigation into the e-cigarette industry. Additionally, Raoul has urged the FDA to ban flavored tobacco products and to strengthen e-cigarette guidance by prioritizing enforcement actions against flavored e-cigarettes.
December 27, 2021
EonSmoke Agrees to Pay $50 Million for Marketing to Youth
Now-defunct e-cigarette retailer Eonsmoke and its co-owners have settled a lawsuit with the state of Massachusetts for selling nicotine vaping products to minors. Attorney General Maura Healey today announced that Eonsmoke has agreed to a settlement amount of $50 million, and owners Gregory Grishayev and Michael Tolmach will pay a total of $750,000. The terms of the consent judgment, pending court approval, orders Eonsmoke to end all sales, distribution, marketing, and advertising of any tobacco products to consumers in Massachusetts, according to a press release.
The settlement, filed today in Suffolk Superior Court against Eonsmoke, LLC and Grishayev and Tolmach, resolves allegations that the defendants directly targeted young people for sales of its vaping products through marketing and advertising intended to appeal to youth. Healey’s office also alleged that Eonsmoke failed to verify the age of online purchasers of its products—including electronic nicotine devices, e-liquids, and nicotine pods—and failed to ensure shipments of the products were received by a person 21 years or older, the state’s minimum legal sales age for smoking products.
“Eonsmoke coordinated a campaign that intentionally targeted young people and sold dangerous and addictive vaping products directly to minors through their website,” said Healey. “We were the first to take action against this company and its owners, and today we are holding them accountable and permanently stopping them from conducting these illegal practices in our state.”
Eonsmoke has agreed to a settlement amount of $50 million, and Grishayev and Tolmach will pay a total of $750,000. Eonsmoke ceased all operations and dissolved in 2020. According to the Healey’s complaint, filed in May 2019 and amended in November 2020 to include Defendants Grishayev and Tolmach, the defendants “willfully and repeatedly violated the state’s consumer protection law by using a marketing campaign that directly targeted underage consumers.”
Healey alleges that the defendants directly marketed “Eonsmoke vaping products to young people through social media sites such as Instagram, Snapchat, and YouTube, and included youth popular culture references, social media influencers, celebrity endorsers, cartoons, and internet memes that intentionally minimized or omitted the fact that the vaping products contained nicotine.”
In August of 2020, the Arizona Attorney General’s Office (AGO) obtained a $22.5 million judgment and a permanent injunction against the New Jersey-based vapor company Eonsmoke. The ruling could set a precedent for other states suing vapor companies over marketing practices.
Juul sued Grishayev and Tolmach for trademark infringement in 2018 claiming Eonsmoke illegally marketed its vaping pods as “Juul compatible,” complete with packaging that looked eerily similar to Juul’s. Rather than settle the case, Grishayev and Tolmach were accused of quietly stashing millions in corporate funds out of Juul’s reach — despite a federal judge having warned them last year not to touch the money “outside the ordinary course of business,” according to the New York Post.
“While purposefully using JUUL branding to confuse customers that its illicit products were somehow related to Juul Labs, Eonsmoke flooded the market with pods featuring inappropriate flavors and packaging made with unknown ingredients under unknown quality standards,” said Juul spokesperson Austin Finan at the time. “We will continue to enforce against illegal actors like Eonsmoke to help ensure the vapor category is comprised of companies focused on transitioning adult smokers from combustible cigarettes while following regulations and combatting underage use.”
December 10, 2021
Call for Class Action Status in Juul Overpayment Lawsuits
Lawyers representing U.S. consumers who say they overpaid for Juul Labs’ e-cigarettes on Dec. 6 urged a federal judge to certify their claims as a class action, reports Reuters. Juul argues that the plaintiffs should proceed individually because they bought Juul products under differing circumstances.
Credit: Steheap
More than 2,800 cases have been consolidated in the multidistrict litigation against Juul, its largest shareholder Altria Group and several individual officers and directors. They include both personal injury claims and claims of economic loss by people who say they would have paid less, or not bought the e-cigarettes at all, if Juul had not downplayed their addictiveness and appealed to teenagers through social media campaigns and other means.
The plaintiffs are seeking partial refunds for adult purchasers and full refunds for underage purchasers.
Gregory Stone of Munger, Tolles & Olson, representing Juul, said the plaintiffs’ case rested on whether Juul’s marketing was misleading, whether it targeted teenagers, whether buyers were actually misled and whether the marketing affected their buying decisions.
In a tentative opinion, U.S. District Judge William Orrick said that he was inclined to grant class certification.
December 7, 2021
Juul Settles Youth Marketing Lawsuit With Arizona

Photo: steheap
Juul Labs has agreed to pay $14.5 million to settle a lawsuit by Arizona accusing it of fueling a vaping epidemic by marketing its products to minors.
The settlement, announced Nov. 23 by the office of Arizona Attorney General Mark Brnovich, provides for $12.5 million to be set aside for anti-addiction programs. The remaining $2 million will go to a general consumer protection fund and litigation expenses.
As part of the consent judgment, pending court approval, Juul has committed to company-wide changes to its business practices to ensure that its products will not be marketed or sold to Arizona’s youth.
“Today’s settlement holds Juul accountable for its irresponsible marketing efforts that pushed Arizona minors toward nicotine and the addiction that follows,” said Arizona Attorney General Mark Brnovich in a statement. “Combatting the youth vaping epidemic remains a priority for our office with both our undercover Counter Strike program and zero tolerance for vaping companies that mislead or deceive.”
Juul said the settlement is another step in its ongoing effort to “reset” its company and applauded the Attorney General’s plan to deploy resources to address underage use. “We will continue working with federal and state stakeholders to advance a fully regulated, science-based marketplace for vapor products,” the company wrote in a statement. “As part of that process, we will continue to support Tobacco 21 and enforcement against illicit and illegally marketed products, such as certain disposables, that jeopardize the harm reduction potential of alternative vapor products.”
The company said it remains in discussions with other key stakeholders about litigation related to its past as part of its commitment to earn trust.
In June, Juul settled a similar case brought by North Carolina.
The company still faces more than 2,000 lawsuits, including from state and local governments, accusing the company of creating a spike in nicotine addiction among teens by using fruit-flavored liquid pods, social media campaigns and free giveaways.
Altria Group, which in 2018 acquired a 35 percent stake in Juul, is also named as a defendant in many of the lawsuits.
November 24, 2021
North Carolina Juul Settlement to Fund Tobacco Control

Photo: Chicken Strip
For the first time since 2012, North Carolina’s state budget plan includes funds to help prevent young people from getting addicted to nicotine, reports NC Health News.
Much of that money comes from a $40 million settlement that State Attorney Josh Stein reached this summer with Juul Labs following a lawsuit over the e-cigarette maker’s alleged targeting of young people.
In 1998, North Carolina and 45 other states settled litigation with to recover healthcare cost incurred for treating sick smokers. The four largest U.S. tobacco companies agreed to pay $206 billion over 25 years, and part of that money was to be spent by the states on smoking-cessation programs.
In reality, however, many states have directed their Master Settlement Agreement funds to other priorities. In 2013, when Republicans held control of both the North Carolina General Assembly chambers and the governor’s office, money stopped flowing to programs targeted at young smokers and nicotine users.
The budget that Governor Roy Cooper signed into law on Nov. 18 transfers $2 million from the first $13 million allotment from the Juul settlement to the attorney general’s office to cover litigation costs.
Another $4.4 million will go to tobacco cessation media campaigns, resources and programs to help children in middle school, high school and young adults quit vaping and using tobacco products after becoming addicted.
The budget allocates $3.3 million for “evidence-based media and education campaigns” geared toward prevention of e-cigarette and tobacco use and $1.1 million for data monitoring to better understand how young people are exposed to such products and evaluate programs designed to help users quit.
Nationally, more than two million children in middle school and high school used e-cigarettes in 2021, according to North Carolina health director Elizabeth Cuervo Tilson. Almost half of those high school students used e-cigarettes frequently, for as many as 20 out of 30 days. In North Carolina, Tilson added, a third of people in that age group used tobacco products, most of which are e-cigarettes.
November 24, 2021
Quebec Appeals Court Upholds Vapor Ad Ban

Photo: Matthew Benoit
A panel of three Court of Appeals judges unanimously reversed the parts of a 2019 Quebec Superior Court decision that struck down some provisions of the Tobacco Control Act pertaining to vaping products, reports Global News.
The Quebec Superior Court had ruled that some of the province’s restrictions on vaping products, such as banning advertising, went too far because they could possibly prevent smokers from switching to noncombustible products.
The appeals court judges cited research from the World Health Organization and other experts regarding the rise in youth vaping rates, ruling that the Quebec government has the right to limit potential effects of advertising on youth and nonsmokers.
“In this case, it was therefore reasonable for the legislator to intervene to limit the potential effect of electronic cigarette advertising, especially on young people,” Justice Benoit Moore wrote on behalf of the panel. “The risks associated with the fact that the vaping industry is evolving and that it is gradually being taken over by the tobacco companies cannot be excluded from the analysis of the legislator.”
The court also upheld the right to ban vaping product demonstrations inside shops or specialized clinics.

November 18, 2021
Appeals Court Rejects Breeze Smoke’s Plea for MDO Stay
A divided panel of the U.S. Court of Appeals for the Sixth Circuit rejected Breeze Smoke LLC’s application of a stay of the U.S. Food and Drug Administration’s order Friday, denying the company’s premarket tobacco product application (PMTA) for some of its vaping products.
In Breeze Smoke LLC v. FDA, the Sixth Circuit rejected the Fifth Circuit’s conclusion that the FDA had orchestrated a “surprise switcheroo” in the PMTA review process. This creates an interesting circuit split that might attract Supreme Court interest, according to Reason’s Jonathan Hadler.
The Sixth Circuit’s order, on behalf of Judges Moore and Gilman, concluded that the FDA had never committed itself to accepting PMTA applications for flavored vaping products that lacked long-term studies. Rather, the FDA had merely indicated that “it might accept evidence other than long-term studies, if that evidence had sufficient scientific underpinnings to meet the [Tobacco Control Act’s] statutory mandate of demonstrating that flavored ENDS devices are appropriate for the protection of public health” (emphasis in original).
Thus the court concluded that Breeze Smoke had failed to demonstrate the strong likelihood of success on the merits necessary to support a stay. Judge Kethledge dissented, noting his agreement with the Fifth Circuit’s decision in Wages and White Lion Investments LLC v USFDA.
While rejecting Breeze Smoke’s stay request, the Sixth Circuit panel did note some concern with the FDA’s handling of the company’s application, particularly its “formulaic consideration” of Breeze Smoke’s plans to prevent marketing to youth. This failing, and the impact of a PMTA denial on Breeze Smoke’s business were still not enough to convince a majority of the panel to enter a stay however.
November 17, 2021