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American Academy of Pediatrics, et al. v. FDA, et al. [United States] [May 15, 2019]
The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations and several individual pediatricians, challenged the U.S. Food and Drug Administration decision to allow e-cigarettes to remain on the market until 2022 before applying for FDA authorization and permitting products to remain on the market during review. The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The court found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. The court gave the plaintiffs 14 days to submit additional briefing regarding a remedy and the FDA 14 days to respond.
American Academy of Pediatrics, et al. v. FDA [United States] [March 05, 2019]
In 2016, the Campaign for Tobacco-Free Kids in conjunction with seven other health organizations, medical groups, and several individual pediatricians, filed a lawsuit to force the FDA to issue a final rule requiring graphic health warnings on cigarette packing and marketing, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. In September 2018, the District Court ruled in favor of the health groups finding that the FDA had both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic health warnings.
In March 2019, the District Court ordered that the FDA must issue a final rule by March 2020 for graphic health warnings on cigarette packaging and marketing. The ruling also requires the FDA to finish its study on the labels by April 15, 2019, and submit its proposed rule by August 15, 2019.
For the earlier decision, see: American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985 (D. Mass. 2018).
American Academy of Pediatrics et al. v. U.S. Food and Drug Administration [United States] [September 05, 2018]
In a lawsuit filed by eight public health and medical groups and several individual pediatricians, plaintiffs filed suit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring pictorial health warnings on cigarette packs and advertising, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA's previous final rule was struck down in August 2012 by the U.S. Court of Appeals for the D.C. Circuit, which ruled that the proposed warnings violated the First Amendment. Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for pictorial health warnings, finding that this provision did not violate the First Amendment. That court found the warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.” The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling. Taken together, these two federal court decisions meant the FDA was still legally obligated to require pictorial health warnings, and the agency was free to use different images than those struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule, but had yet to act when plaintiffs filed suit.
The judge agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the pictorial warnings. The judge set a deadline of September 26, 2018, for the FDA to provide an expedited schedule for the proposal, review, and issuance of final pictorial health warnings in accordance with the law.
United States v. Philip Morris USA Inc., et al. [United States] [October 05, 2017]
In 1999 the United States sued major U.S. tobacco companies for violating the Racketeer Influenced Corrupt Organization Act (RICO). The suit claimed tobacco companies had violated RICO for decades, by fraudulently misleading American consumers about the risks and dangers of smoking and secondhand smoke. In 2006, the U.S. District Court for the District of Colombia agreed, finding the tobacco companies did violate RICO and would continue to violate RICO.
As a means of preventing future RICO violations, the district court ordered the tobacco companies to issue corrective statements on five topics in which they had misled the public, including the adverse health effects of smoking and the addictiveness of smoking and nicotine. The companies challenged the language of the corrective statements ordered by the court and, in 2016, the district court affirmed the publication of the corrective statements.
Finally, in October 2017, the tobacco companies and U.S. Department of Justice reached an agreement on the details for implementing the corrective statements, which must begin to run on November 26, 2017. The agreement specifies the corrective statements that will be used in television and newspaper advertisements. To ensure the corrective statement are effective in reaching the public, the statements must be in the print and online Sunday edition of newspapers; must air on major television networks during high viewing times; and must appear in both English and Spanish.
Nicopure Labs, LLC v. Food and Drug Administration [United States] [July 21, 2017]
A manufacturer of e-cigarette devices and liquids challenged a federal regulation that deemed e-cigarettes to be “tobacco products.” This rule subjects e-cigarettes to the same federal laws as traditional cigarettes under the Tobacco Control Act (TCA). The manufacturer argued that the Food and Drug Administration (FDA), which issued the regulations, did not have the authority to regulate empty e-cigarettes or nicotine free e-liquids, because they were not made or derived from tobacco. The company also argued that the TCA’s ban on distributing free samples and pre-approval for modified risk statements was arbitrary and violated their First Amendment rights.
In this decision, the District Court upheld the FDA’s rule. The TCA gives the FDA the power to regulate “components” of tobacco products. The court found empty e-cigarettes and nicotine-free e-liquids are “components” of a tobacco product because together they make up an electronic nicotine delivery system. Further, the court found that the rule did not violate the manufacturers’ First Amendment rights because the ban on free samples was regulating conduct, not speech. The court also held that pre-approval for modified risk statements did not violate the First Amendment because it does not ban modified risk statements, it only requires the claims be substantiated. Finally, the court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was not arbitrary.
RJR Nabisco et al. v. European Community et al. [United States] [June 20, 2016]
The U.S. Supreme Court ruled that RJR Nabisco could not be sued under the federal Racketeer Influenced and Corrupt Organizations (RICO) Act for its conduct abroad. The European Union (known as the European Community in this case) sued RJR Nabisco claiming that the company directed and managed a global smuggling and money-laundering scheme with organized crime groups in violation of the RICO law. In this decision, the Supreme Court ruled that certain elements of RICO can apply to conduct that occurs outside of the United States. However, the Court also found that a private entity— this case, a foreign government—cannot sue under RICO in the United States unless it has suffered a domestic injury. Because the European Union had earlier waived its claims of a domestic injury, the Court was forced to dismiss the EU’s remaining claims.
NYC C.L.A.S.H. v. New York Office of Parks, Recreation and Historical Preservation [United States] [March 31, 2016]
A smokers’ rights group challenged a state agency regulation that prohibits smoking in certain outdoor areas, including state parks. The court affirmed an earlier decision finding that the agency’s regulation did not violate the constitutional principle of separation of powers. The court concluded that, in adopting the regulations, the agency acted within that authority delegated to it by the state legislature to provide for the health, safety, and welfare of the public in connection with the state park system.
United States v. Philip Morris USA Inc., et al. [United States] [February 08, 2016]
In 1999, the United States filed a lawsuit in the U.S. District Court for the District of Columbia against the major cigarette manufacturers and related trade organizations alleging that defendants, while acting as an enterprise, fraudulently misled American consumers for decades about the risks and dangers of cigarette smoking and exposure to secondhand smoke in violation of the Racketeer Influenced Corrupt Organizations Act (RICO). In 2006, the court found that defendants violated RICO and that there was a reasonable likelihood that defendants would continue to violate RICO in the future. On appeal, the district court’s findings were upheld, in part, vacated, in part, and remanded, in part, to the district court. After the U.S. Supreme Court declined to hear appeals from both sides in the case in June 2010, the district court began to implement the 2006 final order.
As a means of preventing future RICO violations, the district court ordered the tobacco companies to issue corrective statements on five topics in which they had misled the public, including the adverse health effects of smoking and the addictiveness of smoking and nicotine. The companies challenged the language of the corrective statements ordered by the court. A previous decision upheld all of the corrective statements with the exception of the introductory sentence. In this decision, the district court found that a revised introductory statement submitted by the government is acceptable because it removes any reference to tobacco companies’ prior deceptive conduct. The judge castigated the tobacco companies for attempting to rewrite the corrective statements entirely, calling it a “ridiculous – a waste of precious time, energy, and money for all concerned – and a loss of information for the public.” The court also refused to change any of the terms in the previously agreed upon consent order.
In re NJOY, Inc. Consumer Class Action Litigation [United States] [February 02, 2016]
A court ruled that a lawsuit against e-cigarette maker NJOY could not proceed as a class action. Potential class members had asserted that NJOY: (1) conducted misleading advertising indicating that e-cigarettes are safer than regular cigarettes; and (2) omitted information on its packaging about product ingredients and the risks of such ingredients. The court affirmed an earlier ruling prohibiting the lawsuit from proceeding as a class action, saying that class members failed to demonstrate how damages can be proven for the entire class. Specifically, the court said that the class was not able to show how it could calculate the difference between the price paid by consumers of NJOY and the true market price that reflects the impact of the unfair or fraudulent business practices. Although the ruling means that the case may not proceed as a class action, individuals may sue NJOY independently.
R.J. Reynolds v. United States Food and Drug Administration [United States] [January 15, 2016]
Tobacco companies challenged the composition of the Tobacco Products Scientific Advisory Committee (TPSAC), which was established by the U.S. Food and Drug Administration (FDA) to advise the agency on scientific issues related to tobacco products, including the use of menthol in cigarettes. The tobacco companies alleged that three of the scientific members of the Committee had both an actual and a perceived conflict of interest because each consulted with companies that developed nicotine replacement therapies and testified as expert witnesses in lawsuits against tobacco manufacturers. The court ruled in favor of the tobacco companies, finding that the challenged committee members had both financial conflicts of interest and an appearance of conflicts of interest, which fatally tainted the composition of the Committee and its work product, including the 2011 Committee report on menthol in cigarettes. The court issued an order requiring the FDA to reconstitute the Committee’ membership to comply with ethics laws and barred the agency from using the Committee’s menthol report, which had recommended removing menthol cigarettes from the marketplace. The FDA appealed, and a three-judge panel of the appeals court unanimously reversed the lower court ruling, finding that plaintiffs had not shown imminent injury from the appointment or the actions of challenged Committee members.