Category: Litigation

FDA Ignored Evidence in ‘Deeming’ Premium Cigars

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The U.S. Food and Drug Administration ignored evidence about health risks in considering premium cigars to be subject to same law as cigarettes, a federal judge ruled on July 5, reports Reuters.
The litigation focuses on the 2016 Deeming Rule, in which the agency identified a wide range of tobacco products, including premium cigars, to be subject to its regulatory authority along with cigarettes under the Family Smoking Prevention and Tobacco Control Act.
The FDA rule requires cigar makers to register their products annually, provide ingredient lists for each product and submit products for laboratory testing—procedures the premium cigar industry considers impractical for its handmade, “artisan” products.
The Premium Cigar Association and Cigar Rights of America challenged the Deeming Rule, arguing that, unlike cigarettes and e-cigarettes, premium cigars do not appeal to young people and are not associated with addiction. They cited studies showing that young people are unlikely to use premium cigars, that users of premium cigars are unlikely to smoke them frequently and that infrequent cigar use is not associated with increased mortality.
U.S. District Judge Amit Mehta in Washington DC agreed that the FDA had not adequately considered the studies cited by the plaintiffs, instead asserting that there was “no evidence” that premium cigars were less harmful.
“Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it,” the judge wrote.
Judge Mehta asked the FDA and the industry groups to submit briefs on whether he should vacate the FDA’s decision or simply remand the matter back to the agency.
July 6, 2022
EPA Ruling Threatens FDA’s Tobacco Plans

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The U.S. Supreme Court’s recent decision to block the Environmental Protection Agency from curbing power-plant emissions also threatens the Food and Drug Administration’s attempts to limit nicotine and ban menthol in cigarettes, according to an article published by Bloomberg Law.
In their ruling, the Supreme Court judges endorsed a legal approach that requires agencies to obtain Congressional approval to address issues of major financial or political importance in novel ways. The court’s conservative members have lamented the power agencies have to create and enforce their own rules.
According to Lindsay Wiley, a professor at UCLA School of Law, the decision will be considered in any situation where an administrative agency is trying to solve a problem using authority given to it by Congress in more general terms.
In the case of tobacco, the FDA will face greater pressure to prove it is authorized by Congress to propose its draft ban on menthol in cigarettes and cigars and other major rule changes, according to Marc Scheineson, a former FDA commissioner.
While the Tobacco Control Act gives the FDA the authority to adopt product standards—including on the content of cigarettes—through notice and comment rulemaking, legal experts believe the June 30 court ruling will embolden tobacco manufacturers to challenge the menthol ban and other policies once they are finalized.
“It definitely provides a roadmap that the industry will follow trying to attack the menthol regulation with everything they can come up with,” said Joelle Lester, director of commercial tobacco control programs at the Mitchell Hamline School of Law’s Public Health Law Center.
July 2, 2022
Court Tosses Punitive Award Against PM

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A U.S. federal appeals court tossed out a $9 million punitive-damages award awarded by a lower court against Philip Morris USA in a case filed by a woman who suffered a smoking-related illness that led to her legs being amputated, reports The Free Press.
Donna Brown filed the lawsuit in 2007 in the federal Middle District of Florida, and a jury sided with her on claims for strict liability, negligence, fraudulent concealment and conspiracy to fraudulently conceal. It awarded Brown nearly $8.29 million in compensatory damages and $9 million in punitive damages.
In its appeal, Philip Morris pointed to a recent Florida Supreme Court opinion that said plaintiffs must show that they relied on misleading information from cigarette makers to prevail on claims for fraudulent concealment and conspiracy to fraudulently conceal.
In its June 30 ruling, the 11th U.S. Circuit Court of Appeals said Brown had presented “insufficient evidence” to show that she relied on specific false or misleading statements by the company.
The Atlanta-based court overturned the verdicts on the fraud-related claims but upheld the verdicts against the cigarette maker on strict liability and negligence.
The lawsuit was one of thousands of cases filed against tobacco companies after a 2006 Florida Supreme Court decision established critical findings about issues such as the dangers of smoking and misrepresentation by cigarette makers. Those lawsuits are known as Engle Progeny cases.
July 2, 2022
Juul Granted Emergency Stay of FDA Order

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Court Grants Juul Emergency Stay of FDA Order
Juul Labs received an emergency stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
The U.S. Court of Appeals for the D.C. Circuit on June 24 granted Juul’s request to delay the FDA’s ban. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.
In its court filing, Juul argued that the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay, according to The Wall Street Journal.
Juul said that the requirement to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period.
The e-cigarette maker also questioned the agency’s handling of the announcement, noting The Wall Street Journal reported on the ban a day before it was announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
Former FDA Center for Products Director Mitch Zeller said that Juul’s e-cigarettes were judged solely on the strength of the company’s application. Political pressure to ban Juul didn’t influence the ruling, nor did Juul’s past actions, he said. “This was a scientific review conducted by subject-matter experts,” he said. “That’s the way the system is supposed to work.”
In a statement, Juul Labs it was exploring all its options under the FDA’s regulations and the law.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Juul Labs Chief Regulatory Officer Joe Murillo.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
Among other options, Juul is reportedly exploring a bankruptcy filing if the company is unable to get relief from the government’s ban, reports The Wall Street Journal, citing people familiar with the matter.
June 24, 2022
Juul Requests Stay of FDA Order

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Juul Labs today asked a federal appeals court to temporarily block the U.S. Food and Drug Administration’s marketing denial order until it can petition the court for an emergency review.
In its filing, Juul said the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay.
On June 23, the regulatory agency ordered Juul Labs to remove its products from the market, saying the e-cigarette company had provided insufficient evidence in its premarket tobacco product application to demonstrate that its products are “appropriate for the protection of public health.”
In particular, the FDA noted that its concerns about genotoxicity and potentially harmful chemicals leaching from the Juul Labs’ proprietary e-liquid pods had not been adequately addressed.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Joe Murillo, chief regulatory officer at Juul Labs, in a statement.

We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
Joe Murillo, chief regulatory officer, Juul Labs
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
In its court filing, Juul said the FDA’s decision followed “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates,” according to The Wall Street Journal.
Juul said that the FDA’s order to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period. The e-cigarette maker also questioned the agency’s handling of the announcement, pointing to the fact that the order had reported in the press before it was officially announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
In a press note, Juul Labs said it is exploring all of its options under the FDA’s regulations and the law. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” the company wrote.

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Meanwhile, the announcement that Juul products must come off the market triggered a run on stores, according to various news outlets, including Bloomberg. “Gonna clear the shelves and hoard ’em like our incandescent bulbs!” one user wrote on Twitter following the news.
June 24, 2022
Top Court: South Africa Tobacco Ban Invalid

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South Africa’s Supreme Court of Appeal (SCA) on June 14 upheld a high court judgement that declared the ban on tobacco products sales during the Covid-19 pandemic unconstitutional, reports Times Live.
In March 2020, Co-Operative Governance and Traditional Affairs Minister Nkosazana Dlamini-Zuma banned the sale of tobacco products to contain the spread of Covid-19.
In June 2020, British American Tobacco, JT International and several tobacco product consumers asked a court to invalidate the ban.
The matter was heard by a full bench of the court in August 2020 and judgment was reserved. Later that month, the minister lifted its tobacco sales ban.
Despite the lifting of the ban, the court passed judgment in December 2020 declaring the regulation inconsistent with the constitution and invalid.
The government appealed the ruling, but lost.
In its June 14 judgment, the SCA said assuming there was a causal link between smoking and the risk of contracting a more severe form of Covid-19, the minister would have had to show that stopping smoking during the tobacco ban would have reversed or reduced the risk of contracting a severe form of Covid-19.
The SCA said this had not been established as evidence.
As regulation 45 was not necessary to achieve any of the purposes listed in section 27 of the Disaster Management Act, it was invalid, the court noted.
Section 27 states that in the event of a national disaster the minister may make regulations dealing with steps that may be necessary to prevent the escalation of the disaster or to alleviate, contain and minimize the effects of the disaster.
June 17, 2022
Thai Court Lowers Philip Morris Fine

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An appeals court in Thailand has lowered a fine imposed on Philip Morris (Thailand) for customs violations to THB121 million ($3.53 million), reports The Bangkok Post.
In November 2019, the country’s criminal court found the tobacco giant guilty of evading taxes due on cigarette imports from the Philippines and ordered the company to pay a fine of THB1.2 billion.
While upholding the guilty verdict, the appeals court on June 1 lowered the fine and instructed authorities to pay rewards to those who provided tips leading to the arrests.
The prosecutor filed a lawsuit against Philip Morris (Thailand) and seven of its employees in 2016 for inaccurate price declarations on cigarettes imported from the Philippines from July 2003 to June 2006. The defendants denied the charges.
According to the lawsuit, Philip Morris (Thailand) set the price of L&M cigarettes imported from the Philippines at THB5.88, while other importers declared the same brand of cigarettes at THB6.81 per packet.
The tobacco firm allegedly also declared the cost, insurance and freight rate on Marlboro from the Philippines at THB7.76 per packet, far lower than the THB27.46 reported by other importers.
June 6, 2022
U.S. Health Groups Call off Menthol Lawsuit

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Action on Smoking and Health (ASH), the African American Tobacco Control Leadership Council (AATCLC), the American Medical Association (AMA) and the National Medical Association (NMA) are dismissing their joint lawsuit against the United States Food and Drug Administration. A rulemaking process to ban menthol as a characterizing flavor is in progress, and “we are grateful to be able to declare victory in this case,” the plaintiffs wrote in a joint statement.
The lawsuit followed the 2013 Citizen’s Petition, which called on the FDA to prohibit menthol in cigarettes.
“As African American physicians, we are thrilled with the FDA’s proposed rule to ban menthol in cigarettes and flavored cigars as a remedy to settle our lawsuit,” said Rachel Villanueva, president of the NMA. “This proposed rule will save lives and improve health within Black communities. This would not have been possible without the leadership and assistance of our co-plaintiffs and attorneys, whom we wish to sincerely thank.”
“We are encouraged by the FDA’s recent action to propose a ban on menthol-flavored cigarettes. We look forward to participating in the rulemaking process as we continue our collective push to ensure these harmful products are removed from the market once and for all,” said AMA President Gerald E. Harmon.
“The FDA has finally taken a major step forward to protect the health of Black Americans, but the work is far from done. We will not stop until no more Black lives are lost due to the predatory marketing of menthol cigarettes and flavored little cigars,” promised Phillip Gardiner, co-chair of the AATCLC.
“ASH’s goal is to use litigation as a tool to protect the right to health of all citizens against the harms of the tobacco industry,” said Kelsey Romeo-Stuppy, managing attorney at ASH. “We are proud to have been a co-plaintiff in this extraordinary demonstration of the power of proactive litigation.”
June 3, 2022
Litigants Agree on Corrective Statements

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The parties to the U.S. government’s long-running racketeering lawsuit against the major tobacco companies have reached an agreement in principle that will require the companies to place “corrective statements” about the health risks of smoking and secondhand smoke in retail outlets that sell cigarettes, according to the Campaign for Tobacco-Free Kids.
Once this agreement is finalized and approved by the court, it will require the tobacco companies to display court-ordered statements detailing the adverse health impacts of smoking near cigarette displays in hundreds of thousands of retail outlets across the country.
On May 4, the parties to the case—the U.S. Department of Justice, the tobacco companies and our six public health groups—filed a joint motion with the U.S. District Court for the District of Columbia that briefly describes the terms of the agreement, which will soon be put in final form and submitted to the court for review and approval.
This agreement will resolve the biggest remaining legal issue in the longstanding tobacco racketeering lawsuit and fully implement the corrective statements U.S. District Judge Gladys Kessler ordered in 2006 when she issued her landmark judgment against the major tobacco companies.
Judge Kessler found that the tobacco companies had violated civil racketeering laws (RICO) and engaged in a decades-long conspiracy to deceive the American public about the health effects of smoking and their marketing to children. To prevent and restrain future RICO violations, Judge Kessler ordered the tobacco companies to publish corrective statements that tell the American public the truth about the adverse health effects of smoking and secondhand smoke.
The corrective statements have previously been published through newspaper and television advertisements and cigarette pack inserts, and they continue to appear on tobacco company websites. However, the tobacco companies and various trade associations representing cigarette retailers have challenged Judge Kessler’s requirement that the corrective statements also be displayed at retail points-of-sale, such as convenience stores and tobacco outlets. The proposed agreement would resolve that issue.
Public health groups welcomed the agreement. “We are pleased to see this important next step taken to ensure that the tobacco industry carries out the court’s order to issue corrective statements after being found guilty of deceiving the American people more than two decades ago,” said Karen E. Knudsen, CEO of the American Cancer Society and the American Cancer Society Cancer Action Network, in a statement.
May 6, 2022
Juul Labs Settles Louisiana Vape Suit

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Juul Labs has agreed to pay $10 million to settle a lawsuit filed by the Louisiana Attorney General’s Office over the e-cigarette manufacturer’s marketing practices. Juul has settled similar cases in Washington state, Arizona and North Carolina.
“This settlement is another step in our ongoing effort to reset our company, and we applaud the Attorney General’s plan to deploy resources to combat underage use,” reads a statement from Juul Labs. “We will continue working with federal and state stakeholders to secure a fully regulated, science-based marketplace for vapor products.”
In the Louisiana case, Attorney General Jeff Landry had accused Juul Labs of marketing its e-cigarettes to youth, according to a news report.
In a 76-page filing in November, Attorney General Jeff Landry claimed Juul used marketing tactics that included designing sleek, concealable devices that featured “fun flavors like mango and cool mint” and edgy ad campaigns directed toward youth.
Landry also accused Juul of “deceptive marketing practices” regarding the device’s concentrations of nicotine. Landry’s office had sought to prevent Juul from selling the product to minors and wanted to limit available flavors to tobacco and menthol. Prosecutors also sought financial penalties from Juul.
April 19, 2022