Category: Litigation

Court Upholds FDA Right to Regulate Vapor as Tobacco
The U.S. Food and Drug Administration’s (FDA) decision to regulate e-cigarettes as tobacco products has been upheld in a federal court. The ruling rejects challenges from the e-cigarette industry claiming the agency had violated the U.S. Constitution’s Appointments Clause.
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A unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled Thursday that the regulation did not run afoul of the Appointments Clause because the FDA official who promulgated it was not appointed by the president and confirmed by the Senate, according to Westlaw Today.
Jonathan Wood of the Pacific Legal Foundation, a lawyer for the plaintiffs, said he and his clients were “disappointed” and considering next steps. “The Appointments Clause is an essential constitutional protection for democratic oversight and accountability,” he said. “Yet the court’s decision all but assures that agencies will suffer no consequences when they violate this clause.”A spokeswoman for the FDA did not immediately respond to a request for comment.
The appeal came from a group of vape shops including Michigan-based Moose Jooce and manufacturers of the liquid used in e-cigarettes, all represented by the Pacific Legal Foundation, a conservative legal group.
They argued that the FDA’s then-associate commissioner for policy Leslie Kux, who issued the 2016 rule deeming e-cigarettes to be tobacco products, lacked the authority to do so because she was a career employee, not a principal officer appointed by the president.
The FDA countered that the authority had been delegated to Kux by the agency’s commissioner. Furthermore, it said, her authority did not matter because the rule was ultimately ratified by two different FDA commissioners, most recently FDA Commissioner Scott Gottlieb in April 2019.
U.S. District Judge Christopher Cooper in Washington, D.C. agreed that the ratification overcame any Appointments Clause issues, and the plaintiffs appealed. Circuit Judge Judith Rogers, writing for a unanimous panel Tuesday, agreed, rejecting the plaintiffs’ arguments that Gottlieb was required to conduct a new review before ratifying the rule, and noting there was no evidence in the record that he had not.
“Commissioner Gottlieb’s ratification, for the reasons discussed, cured any potential Appointments Clause defect arising from Associate Commissioner for Policy Kux’s issuance of the Deeming Rule,” she wrote.
Circuit Judge Cornelia Pillard and Senior Circuit Judge David Sentelle joined in the opinion.
E-cigarettes are handheld electronic devices that vaporize a fluid that often contains the addictive substance nicotine. The devices have been grabbing market share from traditional tobacco companies.
December 2, 2020
New Patent Infringement Suit Against IQOS

Photo: Tobacco Reporter archive
Healthier Choices Management Corp. (HCMC) has filed a patent infringement lawsuit against Philip Morris USA and Philip Morris Products over the IQOS tobacco heating product.
Among other products, HCMC markets vapor products, including the Q-Cup, a small quartz cup that heats cannabis or CBD concentrate.
“We look forward to proving our allegations of infringement in this matter and intend to continue to move forward against any and all companies that infringe upon our intellectual property in both the tobacco and cannabis categories,” said Jeff Holman, CEO of HCMC, in a statement.
IQOS is already the subject of two other patent infringement proceedings filed by R.J. Reynolds Tobacco Co (RJ). One is proceeding before the International Trade Commission and seeks to stop the importation of IQOS into the United States; the other is a patent infringement action currently pending in the Eastern District of Virginia. R.J. Reynolds’ patents are unrelated to and unaffiliated with the patents asserted in the HCMC case.
Philip Morris USA parent Altria Group rejects RJR’s claims and has countersued the company, alleging that RJR’s own electronic nicotine delivery systems products infringe multiple patents owned by Philip Morris International (PMI) and Altria Group.
In April, British American Tobacco (BAT) sued PMI in the United States and Germany for patent infringement. BAT’s claim focuses on IQOS’ heating blade technology, which the company says is an earlier version of the technology used in BAT’s Glo tobacco heating devices.
December 2, 2020
Milwaukee, WI Joins Juul Labs Class Action

Milwaukee Public Schools has voted to join a nationwide lawsuit against Juul Labs.
Keller Rohrback and MWH Law Group filed the class-action lawsuit against Juul Labs Inc., alleging that the e-cigarette company’s advertising and product design deliberately targeted minors, and that Altria Group, a part owner of Juul, knowingly supported targeting minors.
A Juul company spokesman said the company has halted advertising, eliminated flavored products other than menthol and submitted documents to the U.S. Food and Drug Administration outlining the products’ “harm reduction potential” and measures to address underage use, according to a story on milwaukeenns.com. A federal judge recently denied the company’s request to halt the class action.
Milwaukee City Attorney Tearman Spencer said the e-cigarette company has done irreparable damage to the progress the city had made in curbing tobacco use before e-cigarettes arrived.
“It took years to get to the relatively low level of youth tobacco use we had in 2017 before this, at great cost to the city,” Spencer said. “It is not fair for MPS or the city to bear the entire cost of undoing what these companies did.”
The Common Council will also vote on whether to join the suit. Spencer said he’s unsure about the timing of the lawsuit, but that if “we are super lucky,” it’ll take a couple of years.
November 5, 2020
Judge Denies Request to End Juul Labs Lawsuit

A judge in Durham County, North Carolina’s Superior Court denied an attempt by Juul Labs to have a May 2019 lawsuit closed. The suit was filed by the N.C. Attorney General and targets the e-cigarette maker’s business and marketing practices.
Juul filed motions to end the litigation, limit the damages it could be assessed, or postpone the trial currently set for May. Judge Orlando Hudson denied the motions, according to a story in the Winston-Salem Journal.
North Carolina was the first state to sue Juul over accusations that it targets underage youths with its products. Most specifically, the Attorney General’s office accuses Juul of violating the state’s Unfair and Deceptive Trade Practices Act.
October 31, 2020
Juul Labs Class Action Continues to Woo Plaintiffs

Credit: Sebastian Pichler
The multi-district federal class-action lawsuit against defendant Juul Labs continues to grow. South Carolina-based Lexington One School District joined the class action on Oct. 14.
Attorneys around the country continue to woo school districts to join the suit. In a recent presentation to the Leon County School District in Florida, attorneys for the Romano Law Group asked the public school district to join the lawsuit that alleges vaping manufacturers and distributors are targeting young adults in their marketing.
Attorney Eric Romano told the Leon board this week that if the district didn’t join the suit, schools would face extra costs to battle what has been termed a vaping “epidemic.” Recent reports from the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), however, have found that youth vaping is on the decline.
The multi-district federal lawsuit, first filed October 2019 in the Northern District of California, has hundreds of plaintiffs, ranging from unnamed minors to school districts in several states, including Pennsylvania, Maryland and California.
October 29, 2020
Judge Orders New York State to Pay Vapor Group’s Attorney Fees

Credit: Bill Oxford
A judge says the state of New York state will now have to reimburse the Vapor Technology Association’s (VTA) attorney fees after the state attempted to ban flavored vaping products last year.
Acting state Supreme Court Justice Catherine Cholakis said wednesday that she agreed that state officials overreached their authority and thus should cover the legal costs associated with fighting the ban.
Several vape shops and the VTA are seeking about $381,000 in attorneys’ fees and costs from the state. Cholakis noted an evidentiary hearing will be set to determine if the amount is accurate, court records show, according to The Journal News.
In the order, Cholakis noted the state Attorney General’s Office lawyers representing New York made a compelling case that the emergency ban “was in response to the serious problems of underage vaping and pulmonary illnesses traced to vaping.”
But in explaining why the state must cover the group’s attorneys fees, she added: “There can be no denying the seriousness of the health issues surrounding vaping. Concern for those issues, however, cannot excuse clearly unconstitutional action.”
Cholakis, however, questioned the amount of money sought by the vaping groups.
New York state’s lawyers “bristle, though, at the amount of costs and fees sought by (the vaping group),” she wrote.
October 23, 2020
Puff Bar Owner Files $75 Million Suit for Counterfeits

DS Technology Licensing, the owner of registered trademarks associated with the Puff Bar vapor device and its distributor Puff Inc.filed a lawsuit in Los Angeles County Superior Court against over 20 Chinese and American companies accused of distributing counterfeit vaping devices.
The companies included as defendants include international manufacturer and distributor CACUQ, US distributors, e-commerce companies, and brick and mortar retail stores. A list of current Defendants is below. Plaintiffs are represented by the law firm of Gallinger Law PC.
The lawsuit addresses both counterfeit “Puff Bar” vapor devices as well as knockoff products identified as “Puff Smart,” “Puff Mini,” “Puff Stig,” and “Airis Puff” and seeks $50 million in restitutionary and $25 million in punitive damages.
“Defendants in the lawsuit have infringed on the famous “Puff” and “Puff Bar” marks by introducing competing devices which use the stylized “Puff” associated with Puff Bar Vapor Devices as well as by openly selling fake or counterfeit Puff Bar vapor devices. Defendants are believed to be only a small number of the violators, as the anti-counterfeit verification system at puffbar.com has identified thousands of retail stores at which consumers bought devices which failed the check” the company said in a statement.
“Awards will be given to those with information which leads to the seizure of counterfeit goods. Contact 866-PUFF-BAR or report@puffbar.com for more info.”
October 2, 2020
Pittsburgh Latest City to Sue Juul Labs for Marketing

More than 70 school districts across the United States have filed lawsuits against Juul Labs for its marketing practices.
The Pittsburgh Public School district gave approval last week for the district to enter into a contract with the Frantz Law Group of San Diego, the firm filing the lawsuits against Juul Labs in U.S. District Court in the Northern District of California, where the company is headquartered.
“It’s very similar in concept to the tobacco litigation of some 20 years ago except this is not a class action,” district solicitor Ira Weiss said during a school board meeting Wednesday, according to the Pittsburgh Post-Gazette.
The lawsuit seeks damages for the cost of installing vaping detection devices in school restrooms as well as funding for educational programs for students and families about the health risks of vaping.
Weiss said about 70 school districts nationwide have filed similar lawsuits, including several other school districts in Pennsylvania.
Austin Finan, a Juul spokesman, said in a statement that the corporation would respond to the allegations in the complaint through the appropriate legal channels, according to the story. In the meantime, Finan said the company would “seek to earn the trust of society by working cooperatively with attorneys general, legislators, regulators, public health officials and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes.”
“As part of that process, the company reduced its product portfolio, halted television, print and digital product advertising and submitted a Premarket Tobacco Product Application to the U.S. Food and Drug Administration including comprehensive scientific evidence to support the harm reduction potential of its products and data-driven measures to address underage use,” he said.
The lawsuit is a contingent fee case, meaning it will cost the district nothing if the district does not win. The Frantz Law Group would receive 20 percent of any settlement if the case is decided in 2020, or 25 percent if the case is settled in 2021 or later, the story states.
Board member Terry Kennedy said it was a “wise” decision for the district to file the lawsuit.
“We don’t have any upfront expenses, and there’s no risk to the taxpayers,” Ms. Kennedy said. “There’s a lot of benefit to our students if they understand what’s going on related to Juul and the others.”
September 29, 2020
Sony Sued for Exploding E-Cig Battery In New York

On September 24, Bernardino Manuel brought a new product liability action against Sony Corporation in the Southern District of New York. He alleges that the a Sony e-cigarette battery exploded without warning, resulting in severe injuries to the plaintiff as he carried the defendant’s battery in his pocket.
Manuel claimed that the defendant’s battery was made of lithium-ion, which by its chemical makeup is known to pose a heightened risk of “fire and explosion” when used in e-cigarette systems, according to lawstreetmedia. The plaintiff supported this assertion by referencing a “medical case report of a man in New Jersey, whose e-cigarette exploded in his pocket causing him severe burns,” a “California man (who) recently lost his eye as a result of an e-cigarette exploding near him,” and a “Southern California woman (who) was set on fire after an e-cigarette exploded while she was a passenger in a car.”
Manuel also noted that cases like the aforementioned ones in New Jersey and California were only further exacerbated by the federal government’s failure to regulate the devices that power, and only the resulting toxins from, e-cigarettes. For example, the plaintiff averred, in October of 2014, a report was released by the federal government that noted that the Food and Drug Administration, U.S. Fire Administration, nor the U.S. Consumer Product Safety Commission regulated any aspect of the “battery or electronic components of the devices.”
However, Manuel proffered, despite the government’s refusal to regulate, the U.S. Department of Transportation issued a “rule banning e-cigarettes from checked bags on airplanes because they have been known to catch fire,” which supports a claim that there is “mounting evidence the explosions and fires caused by e-cigarettes and lithium-ion batter(ies) are increasing in occurrence.”
Given all this knowledge, Manuel argued that Sony should be held strictly liable for all damages based off of its defective battery. The plaintiff also alleged that the defendant should have provided consumers with similar “warnings, labels, or instructions” stating that the battery was “designed in a manner such that it should not be stored in a pocket.”
Manuel sought damages “to compensate…for his injuries, economic losses and pain and suffering sustained as a result of the use of the (defendant’s) battery.” The plaintiff also sought attorney’s fees, court costs, and punitive damages.
September 26, 2020
NicVape Faces Suit Over SantiHands Brand Sanitizer

Professional Disposables International (PDI) has files suit against South Carolina-based NicVape over its new SantiHands brand hand sanitizer. PDI has been producing Sani-Hands alcohol wipes since 1995.
PDI filed a complaint on Sept. 11 in U.S. District Court, White Plains, for trademark infringement. NicVape, PDI claims, “willfully intended to trade on plaintiff’s reputation and to cause confusion” between SantiHands and Sani-Hands.
PDI says it is a pioneer in manufacturing alcohol prep pads and germicidal disposable wipes. Nice-Pak Products Inc., an affiliated company, was granted the Sani-Hands trademark in 1995 for antiseptic, premoistened towelettes, according to an article on westfaironline.com.
The wipes are more than 99 percent effective against many bacteria, viruses and fungi, according to PDI, in preventing infections. Sani-Hands are marketed to health care staff and patients and foodservice patrons who don’t have access to soap and water.
NicVape’s wipes began showing up in August at Home Depot stores, the complaint states, in the Bronx, Hawthorne, Port Chester and Fairfield, Connecticut. PDI says it asked NicVape to cease and desist from using the SantiHands mark, but NicVape has not responded, according to the story.
The complaint claims that many new hand sanitizer makers do not use the stringent manufacturing and testing procedures that PDI employs. It also notes that the FDA has recently recalled hand sanitizers that contain toxic alcohols, but provides no evidence that SantiHands does so.
A National Drug Code filing lists SantiHands’ active ingredient as alcohol, at 80%. The product label, as depicted in a photo exhibit in the lawsuit, shows its composition as 80 percent ethyl alcohol.
PDI’s Sani-Hands has 70 percent ethyl alcohol.
PDI accuses NicVape of trademark infringement, dilution of Sani-Hands’ reputation for excellence, false designation of origin and unfair competition. It is demanding that NicVape stop using the SantiHands mark, destroy the products, and abandon its application for a trademark.
September 25, 2020