R.J. Reynolds Tobacco Co. v. United States Food & Drug Administration
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 district 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 district 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.
The Campaign for Tobacco-Free Kids, joined by seventeen other public health and medical groups, filed an amicus brief urging reversal of the district court decision.
R.J. Reynolds Tobacco Company, et al. v. United States Food and Drug Administration, et al., No. 14-5226 (D.C. Cir. January 15, 2016).
United States
Jan 15, 2016
U.S. Court of Appeals for the District of Columbia Circuit
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Any violation of a law designed to ensure fair trade, competition, or the free flow of truthful information in the marketplace. For example, a government may require businesses to disclose detailed information about products—particularly in areas where safety or public health is an issue.
The court might consider procedural matters without touching the merits of the case. These might include: improper joinder, when third parties, such as Health NGOs or government officials, seek to become parties to the suit; lack of standing, where a plaintiff fails to meet the minimum requirements to bring suit; lack of personal jurisdiction, where the court does not have jurisdiction to rule over the defendant; or lack of subject matter jurisdiction, where the court does not have jurisdiction over the issue at suit.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"Plaintiffs claim that the FDA’s appointments of these Committee members caused them three injuries: (1) an increased risk that the FDA will regulate menthol tobacco products adversely to plaintiffs’ interests; (2) access by the challenged Committee members to plaintiffs’ confidential information, with a probability of their using the information
to plaintiffs’ detriment; and (3) the shaping of the menthol report to support the challenged members’ consulting and expert witness businesses, with injuries flowing both from the report itself and from its use as support for their expert testimony and consulting...Under the familiar threefold inquiry, plaintiffs must show an injury-in-fact that is “actual or imminent, not conjectural or hypothetical,” and must show causation and redressability. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992) (internal citations and quotation marks omitted). At summary judgment, plaintiffs cannot rest on “‘mere allegations’ but must ‘set forth’ by affidavit or other evidence ‘specific facts.’” Id. at 561 (quoting FED. R. CIV. P. 56(e)). Addressing the three alleged injuries in the order already presented, we conclude that all three are too remote and uncertain, or, to put the same thing another way, insufficiently imminent. We therefore vacate the district court’s grant of summary judgment."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
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 district 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 district 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.
The Campaign for Tobacco-Free Kids, joined by seventeen other public health and medical groups, filed an amicus brief urging reversal of the district court decision.