Category: Litigation

  • Juul Labs Settles Marketing Suit in Iowa for $5 Million

    Juul Labs Settles Marketing Suit in Iowa for $5 Million

    Credit: Quatrox Productions

    Iowa Attorney General Tom Miller in the U.S. announced that Juul Labs Inc. will update its advertising and retail practices, and pay $5 million over a four-year period in order to resolve potential violations of Iowa law.

    Miller alleged that the e-cigarette manufacturer exposed Iowans under the age of 21 to its nicotine delivery system which would be a violation of Iowa’s Deceptive Trade Practices Act.

    “This agreement strikes a balance in truthful advertising and promotions of Juul devices and pods,” Miller said. “E-cigarettes should be promoted to smokers as a less harmful alternative, but not to youth,” according to KCRG.

    As part of the agreement, Juul Labs will send $1.25 million each year to the Iowa Department of Health and Human Services. The funding will then be used to:

    • provide Iowans with assistance in quitting e-cigarette use
    • fund education or prevention programs
    • establish research in support of preventing ENDS use
    • facilitate the adoption of age-verification technologies
    • enforce related programs in support of Iowa and federal laws.

    Earlier this year, Juul Labs settled more than 5,000 lawsuits for the sum of between $1.2 billion and $1.7 billion.

  • Appeals Court Denies Avail Vapor’s MDO Petition

    Appeals Court Denies Avail Vapor’s MDO Petition

    A unanimous panel of the United States Court of Appeals for the Fourth Circuit on Monday denied Avail Vapor’s petition to have its marketing denial order (MDO) issued by the U.S. Food and Drug Administration for its e-liquid products invalidated.

    Circuit Judge J. Harvie Wilkinson wrote Monday that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health. Wilkinson was joined by Circuit Judges Diana Gribbon Motz and Albert Diaz.

    The court rejected all of Avail’s arguments, including that the FDA’s review of its premarket tobacco product applications (PMTAs) was arbitrary and capricious, according to a copy of the ruling obtained by Vapor Voice.

    “We see no merit in Avail’s remaining arguments that FDA acted arbitrarily and capriciously in reviewing petitioners’ PMTAs,” the decision states. “FDA could not allow young adults to perceive e-cigarettes as another Baby Ruth or Milky Way, only to find themselves in the grip of a surreptitious nicotine addiction. This was hardly arbitrary.”

    Avail’s chief complaint is that the FDA arbitrarily imposed a new “comparative efficacy” standard, which asked applicants to demonstrate through certain long-term studies that their fruit and dessert-flavored products better promote smoking cessation than tobacco-flavored products.

    This standard, Avail complains, was adopted with no explanation to applicants and without consideration of their reliance interests. Avail also raises a substantive objection, arguing that FDA’s imposition of this comparative efficacy standard exceeded its statutory authority under the TCA.

    “First, Avail attempts to tie the hands of the FDA to certain forms of evidence and kinds of studies in what is a rapidly evolving field. Second, in focusing upon procedural points, Avail encourages us to neglect the forest for the trees,” the decision states. “Avail essentially argues that “the FDA’s willingness to consider some forms of evidence, explicitly phrased as such, required the FDA to accept that evidence as meeting a statutory requirement even where the FDA found the evidence unsatisfactory.”

    According to the decision, Avail also filed its marketing plan with its PMTAs, which outlined measures designed to prevent underage use. Such measures consisted of naming its flavored e-liquids with “non-descriptive and non-characterizing names” that do not identify the product flavor to prevent appealing to youth.

    “The agency denied Avail’s application for its flavored electronic cigarettes, chiefly on the grounds that its products posed a serious risk to youth without enough offsetting benefits to adults,” the decision states. “We now uphold that decision and deny Avail’s petition for review.”

    The judge also specifically stated that he did not agree with the U.S. Court of Appeals for the Eleventh Circuit’s decision to stay the MDO issued by the FDA to Bidi Vapor. Persons with knowledge of the Avail suit said that it was a good case to petition for certiorari, a review of the lower court’s decision, to the United States Supreme Court.

  • Juul Labs Agrees to Pay Pennsylvania $38.8 Million

    Juul Labs Agrees to Pay Pennsylvania $38.8 Million

    Credit: mehaniq41

    Juul Labs Inc. has agreed to pay $38.8 million to Pennsylvania’s Department of Health as part of a settlement in a lawsuit over its marketing practices, brought by the state Attorney General’s office.

    Attorney General Josh Shapiro, who is also Pennsylvania’s governor-elect, said in a statement that the company had “knowingly targeted young people with tactics similar to the tobacco companies’ playbook,” according to the Philadelphia Enquirer.

    Pennsylvania is one of many states that have sued Juul over its marketing practices. The company will pay an estimated $1.7 billion to settle more than 5,000 lawsuits by school districts, local governments, and individuals, primarily in California.

    In September, Juul paid $438 million to settle a lawsuit brought by 32 states, including New Jersey and Delaware.

  • Juul Labs Settlement Reported to be $1.2-$1.7 Billion

    Juul Labs Settlement Reported to be $1.2-$1.7 Billion

    Credit: Zimmytws

    The media reports vary. What can be discerned is that Juul Labs has settled more than 5,000 lawsuits for the sum of between $1.2 billion and $1.7 billion.

    New York Times reports that Juul Labs Inc. has agreed to pay $1.7 billion to settle more than 5,000 lawsuits by school districts, local governments and individuals, which claimed that its e-cigarettes were more addictive than advertised, according to people with knowledge of the deal.

    Bloomberg reports Juul Labs has agreed to pay $1.2 billion to resolve about 10,000 lawsuits targeting the e-cigarette maker as a major cause of a U.S. youth-vaping epidemic, according to people with knowledge of the deal.

    The San Francisco Examiner reports that the e-cigarette maker faced more than 8,000 lawsuits suits brought by individuals and families of Juul users, school districts, city governments and Native American tribes. This week’s settlement resolves most of those cases, which had been consolidated in a California federal court pending several bellwether trials.

    The Wall Street Journal, which first reported the story, reported that Juul Labs settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs on Dec. 6. Financial terms of the deal were not disclosed.

    Juul Labs announced in a press release that it has reached settlements with plaintiffs in the federal multidistrict litigation (MDL) and related “Juul Labs Product Cases” (JCCP) that have been consolidated in the United States District Court for the Northern District of California. Juul Labs did not disclose any amounts.

    “These settlements represent a major step toward strengthening Juul Labs’ operations and securing the company’s path forward to fulfill its mission to transition adult smokers away from combustible cigarettes while combating underage use,” the company wrote. 

    The global resolution covers more than 5,000 cases brought by approximately 10,000 plaintiffs against Juul Labs and its officers and directors, according to Juul Labs.

    Over the past year, Juul Labs also has settled with 37 states and territories and remains in ongoing discussions with other key stakeholders to resolve the remaining litigation, according to the release.

    The amount for the deal, which involves a consolidation of cases centered in Northern California, is more than three times the sum reported for other Juul Labs settlements in other state and local cases thus far, according to the New York Times.

    The deal resolves much of the legal uncertainty that had driven the company close to bankruptcy.

    Juul announced on Dec. 6 it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout  that would cover legal liabilities.

    According to Juul CEO K.C. Crosthwaite, the settlement addresses the vast majority of outstanding litigation facing the company, including two pending bellwether trials that were set to go to court early next year, and four broad groups: personal-injury plaintiffs, Juul consumers, government entities such as school districts, and Native American tribes. Lawsuits brought by several attorneys general are pending. 

    A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.

  • Juul Labs to Pay Indiana $15.7 Million to Settle Suit

    Juul Labs to Pay Indiana $15.7 Million to Settle Suit

    Credit: Niro World

    Juul Labs Inc. will pay Indiana more than $15.7 million to settle allegations that the company deliberately marketed its products to minors, Attorney General Todd Rokita announced today. Indiana is one of 32 states participating in a larger agreement under which Juul Labs will pay out nearly $435 million.

    “My team and I fight daily to protect Hoosiers from improper business practices that put families at risk,” Rokita said, as reported by am1050. “Wrongful actions that jeopardize children are especially repugnant and shameful. Fortunately, the money we have recovered in this settlement can go toward safeguarding the same young people targeted by the unethical marketing strategies employed by Juul.”

    Indiana’s funds are intended to be used in support of prevention, education, harm reduction and mitigation efforts related to youth using electronic nicotine-delivery systems.

    Juul Labs has an option to pay over 6-10 years — with the total payout increasing the longer it takes to pay. If Juul Labs chooses a 10-year option, Indiana’s amount would exceed $17.1 million. Juul’s first payment to Indiana will be $1,478,665 — due Dec. 31, 2022. All additional payments are due on Dec. 31 each year.

    Juul Labs announced today that it had settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs.

  • Juul Labs Settles With More Than 10,000 Plaintiffs

    Juul Labs Settles With More Than 10,000 Plaintiffs

    Credit: Juul Labs

    Juul Labs has settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs, reports The Wall Street JournalFinancial terms of the deal were not disclosed. However, several media outlets are reporting the amount to be between $1.2 billion and $1.7 billion.

    The deal resolves much of the legal uncertainty that had driven the company close to bankruptcy.

    Juul announced on Dec. 6 it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout  that would cover legal liabilities.

    According to Juul CEO K.C. Crosthwaite, the settlement addresses the vast majority of outstanding litigation facing the company, including two pending bellwether trials that were set to go to court early next year, and four broad groups: personal-injury plaintiffs, Juul consumers, government entities such as school districts, and Native American tribes. Lawsuits brought by several attorneys general are pending. 

    A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.

    Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.

    Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.

    In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.

    Juul’s e-cigarettes were briefly banned in the U.S. in late June after the FDA concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.

    In October, Juul published the details of its MDO appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.

  • Vape Group Files Amicus Brief Over Flavor Ban

    Vape Group Files Amicus Brief Over Flavor Ban

    Photo: David

    The Vapor Technology Association (VTA) has filed an amicus brief with the U.S. Supreme Court in support of a petition for writ of certiorari in a case against L.A. County’s ordinance banning flavored tobacco products.

    Citing the substantial impact on America’s economy created by the sale of tobacco products, the trade group says Supreme Court review of the flavor ban is critical.

    According to an economic impact report prepared by John Dunham and Associates, the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy.

    In its amicus brief, the VTA argues that this industry would be devastated by unrestricted flavor bans given its unique and substantial reliance on the sale of flavored vapor products to adult consumers.

    The trade group also notes that since the passage of the L.A. County Ordinance, leading tobacco control scientists have challenged the notion of banning e-cigarette flavors and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking cigarettes.

    Instead of blanket bans, these tobacco control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products, the VTA notes in its amicus brief.

    Permitting local and state governments to implement unscientific bans that directly interfere with the fundamental purpose of the Tobacco Control Act and would overrule the Food and Drug Administration’s decision-making for products deemed appropriate for the protection of public health is not only unlawful but is dangerous from a public health perspective, the VTA wrote.

    Tobacco and vape flavor bans have gained momentum in the U.S. On Nov. 8, Californians voted to uphold a state law ending the sale of most flavored tobacco products.

  • Judge Denies LG Chem Exploding Battery Lawsuit

    Judge Denies LG Chem Exploding Battery Lawsuit

    Photo: gangster9686

    LG Chem has defeated a lawsuit in Ohio over an exploding e-cigarette battery after a federal judge ruled he has no jurisdiction to oversee the case, reports Law360.

    Paul Straight sued the South Korean chemicals company after an e-cigarette purchased at a Vapor Station store in Ohio exploded and burned through his jeans and left thigh. He sustained second and third-degree burns to his thighs and left wrist and now limps as a result of his injuries, according to his lawsuit.

    LG Chem maintained it did not authorize Vapor Station to sell single batteries. Rather, they were meant to be used in battery packs for power tools and other products. The company also argued it did not make, sell or distribute the batteries in Ohio.

    The judge did not buy Straight’s assertion that the company’s other business in the state was enough for the judge to exercise specific jurisdiction.

    “LG Chem in fact has established that it neither earned revenue from the sale or distribution of 18650 cells in Ohio nor advertised or solicited business in Ohio with respect to 18650 cells,” Judge James L. Graham of the Southern District of Ohio wrote.

    The case is Paul Straight v. LG Chem Ltd. et al., case number 2:20-cv-06551.

  • USVA Sues FDA for PMTA Impact on Small Business

    USVA Sues FDA for PMTA Impact on Small Business

    Credit: Sergin

    The United States Vaping Association (USVA) is suing the U.S. Food and Drug Administration for its handling of the premarket tobacco product application (PMTA) and its impact on small businesses.

    The USAVA, a trade association that represents the small businesses, suit alleges that the FDA failed to properly consider the impact the “seemingly impossible and expensive” PMTA process would have on small businesses.

    “In the deeming rule, the FDA spoke as if vapor applicants would be able to substantially rely on public data, or on 70 studies the FDA itself was conducting at that time,” the USVA wrote in a statement. “In the end, the FDA wrote an impossibly burdensome PMTA rule that is putting a lot of people in this industry out of business. Yet, in fact the FDA claimed that there would be no significant impact on small businesses.”

    The lawsuit asks for relief for the businesses that are members of the USVA that includes:

    • Declare the PMTA Final Rule in violation of the Regulatory Flexibility Act; 
    • Remand the PMTA Final Rule to the FDA; and 
    • Enjoin the FDA from enforcing the PMTA Final Rule against any members of the USVA, and to take such actions as are necessary and proper to remedy their violations deriving from any such actual or attempted enforcement.

    The suit also criticizes the FDA prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies also were allowed to make changes to issues with their PMTA submissions where smaller companies with the same issues received marketing denial orders for those issues.

  • Reynolds Reignites Vuse IP Suit With Rival Altria

    Reynolds Reignites Vuse IP Suit With Rival Altria

    vuse alto

    R.J. Reynolds Vapor Co. has asked for a new trial after a U.S. District Court awarded rival Altria Client Services $95.23 million in damages related to an e-cigarette intellectual property dispute, reports the Winston-Salem Journal.

    In early September, a federal jury determined that Reynolds Vapor’s Vuse Alto product infringes on three Altria patents.

    In its retrial request, Reynolds Vaper stated that “Altria’s improper injection of inflammatory evidence regarding patent infringement allegations against Reynolds in other cases denied Reynolds a fair trial. Erroneous evidentiary rulings also prejudiced Reynolds’ ability to present its defense. Those errors independently, and under the cumulative error doctrine, affected the verdict such that a complete new trial is required.”

    Altria said in a statement that “this was a fair trial. There is no basis for another trial, and we are pleased that the jury correctly found that Reynolds Vapor has infringed a number of our patents.”

    The complaint concerns three patents awarded to Altria Client Services by the U.S. Patent and Trademark Office based on filings in April 2015.

    Altria alleged Reynolds Vapor violated Altria’s patents covering the pod assembly used in Vuse Alto.

    Reynolds believes the lawsuit was filed in retaliation for patent infringement complaints filed by Reynolds in April 2020 for infringement by Philip Morris International’s IQOS tobacco-heating device of six Reynolds patents.

    Until recently, Altria was the exclusive U.S. distributor for IQOS in the United States.

    On Sept. 29, 2021, the U.S. International Trade Commission upheld an initial determination from May 2021 that Philip Morris International’s IQOS device infringes on two patents owned by Reynolds. The ruling barred Altria Group from importing IQOS products into the U.S.