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Type of Litigation: Action against Government to Advance the Public Interest

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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.

Dutch Non-Smokers Association CAN v. Netherlands [Netherlands] [February 13, 2018]

A public health organization (CAN) challenged a provision of the Tobacco and Smoking Products Act that permitted the establishment of smoking rooms in catering facilities. CAN argued that Article 8(2) of the WHO Framework Convention on Tobacco Control (FCTC) has direct effect and, therefore, this exception to the smoking ban should be considered non-binding because it conflicts with a higher law - the FCTC. The District Court ruled that FCTC Article 8(2) did not have direct effect and, therefore, could not be invoked in this case. CAN appealed this ruling.

On appeal, the Court concluded that FCTC Article 8(2) has direct effect and rejected the State's argument that the exception in the law is intended as a transitional measure. The Court stipulated that the FCTC Article 8 Guidelines "must be taken into account when interpreting Article 8 paragraph 2 of the WHO FCTC." Taking the Guidelines into account, the Court concluded that it is clear that separate smoking rooms "do not provide adequate protection against exposure to tobacco smoke" and, therefore, the exemption for smoking rooms in catering establishments is "contrary to Article 8(2) of the WHO FCTC."

Esperanza Cerón Villaquirán et al v. Superintendencia de Industria y Comercio (SIC) [Colombia] [November 17, 2017]

Tobacco control advocates challenged the Superintendency of Industry and Commerce (Superintendencia de Industria y Comercio – SIC) resolutions that regulated point of sale tobacco product displays.  Tobacco control advocates alleged that these resolutions violated the complete ban on advertising, promotion and sponsorship established through Law No. 1335. The Colombian State Council held that these resolutions violated Article 13 of the Framework Convention on Tobacco Control (FCTC) and its guidelines that state that product display should be considered a form of advertisement. Consequently, the State Council mandated the SIC to repeal the resolutions, which was done through Resolution No. 1/2018.

S. Cyril Alexander v. Union of India [India] [June 22, 2016]

Cyril Alexander, a tobacco control advocate, filed a public interest lawsuit requesting that the government exclude tobacco companies from the corporate social responsibility (CSR) requirements mandated by Indian law in order to prevent the companies from earning goodwill. The court directed the government to determine how tobacco companies can best meet their CSR obligations and to take appropriate action within four months of the decision. Not satisfied that the government had undertaken the court's requested actions, Mr. Alexander filed a contempt petition. The court dismissed the petition on the basis that a May 2016 government circular clarifies that tobacco industry CSR shall not contravene India's omnibus tobacco control law. Although Mr. Alexander maintained that his request seeks a general prohibition on tobacco industry CSR, the court held that such a request cannot be the subject matter of the contempt petition. 

Black v. Secretary of State for Justice [United Kingdom] [March 08, 2016]

A prisoner claimed that smoking should be prohibited inside a state-run prison. The lower court ruled that the national law prohibiting smoking in workplaces also applied to prisons, including state prisons. The Secretary of State for Justice appealed the decision. The appeals court found that the state is not bound by the national law prohibiting smoking in the workplace. Therefore, the prison is not required to implement the smoking ban. 

Youth Smoking Prevention Foundation v. Netherlands [Netherlands] [November 09, 2015]

A non-governmental organization sued the Dutch government for violating Article 5.3 of the WHO Framework Convention on Tobacco Control (FCTC). Article 5.3 of the FCTC requires Parties to the Convention to protect tobacco control policies from the commercial and vested interests of the tobacco industry.  The court ruled that the NGO cannot require the Dutch government to take action in furtherance of Article 5.3 because the Article does not have a direct effect on the Dutch government. Additionally, the court found that Article 5.3’s requirements are not sufficiently clear. However, as a result of the lawsuit, the government created a document clarifying how it will implement Article 5.3. 

Recommendation of the European Ombudsman in the inquiry into complaint 852/2014/LP against the European Commission regarding its compliance with the Tobacco Control Convention [European Union] [October 01, 2015]

A non-governmental organization (NGO) complained that the European Commission was violating the Framework Convention on Tobacco Control, which requires parties to protect against commercial and other vested interests of tobacco companies. The European Ombudsman agreed with the NGO that the European Commission’s policies did not provide sufficient transparency about its meetings with tobacco industry representatives. The Ombudsman recommended that the Commission put into place a policy—similar to the policy currently in place by the Directorate General for Health and Food Safety—that requires online publication of all meetings with tobacco industry representatives and publication of the minutes from those meetings. 

Rahul Joshi v. Union of India [India] [July 28, 2015]

Rahul Joshi filed a contempt petition citing willful disobedience of the Rajasthan High Court's July 2015 order staying the Government's rules holding in abeyance the implementation of the 2014 pack warnings. The court noted that its July order had the effect of the immediate implementation of the 2014 pack warnings and held that Mr. Joshi's contempt petition will be tagged with a future hearing on the merits of the writ petition.