food and drug law

Issues

This case asks the Supreme Court to determine whether a manufacturer is allowed to file a petition for judicial review in a place besides the United States Court of Appeals for the District of Columbia, where it also does not reside or have its principal place of business, because the petition is joined by a seller of the manufacturer’s products that is located there. In this case, the Food and Drug Administration denied R.J. Reynolds Vapor Co.’s premarket tobacco product application, and R.J. Reynolds Vapor Co. sought judicial review of this administrative order along with certain retail sellers. The Food and Drug Administration argues that filing a petition for review based on a retail seller’s residence or principal place of business is improper because retail sellers are not covered within the Tobacco Control Act’s zone of interests, the Tobacco Control Act would prohibit retailers from obtaining judicial review, and venue must be proper for all petitioners. R.J. Reynolds Vapor Co. counters that their petition is proper because retail sellers are covered within the Tobacco Control Act’s zone of interests, the Tobacco Control Act would allow retail sellers to obtain judicial review, and venue only needs to be proper for a single petitioner. This case has important implications for the regulation of e-cigarettes, retail sellers of tobacco products, and forum shopping.

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Issues

This case asks the Supreme Court to decide whether the Food and Drug Administration’s (“FDA”) denial of Wages and White Lion Investments, L.L.C.’s (“White Lion”) application to market flavored e-cigarette products was arbitrary and capricious. White Lion submitted an application to the FDA to sell their flavored nicotine liquid, used in e-cigarettes, on the market. The FDA denied their application, claiming that White Lion did not include sufficient scientific study support in their application for the FDA to conclude that the benefits of the flavored nicotine liquid outweighed the risk of use by youth. White Lion claims that the FDA erroneously rejected their application for approval of their flavored nicotine liquid because they lacked a longitudinal comparative study, a requirement that White Lion claims was not communicated to the public. The FDA counters by claiming that longitudinal studies are not required and that White Lion’s application was rejected because they could not show that e-cigarette use reduced smoking. The outcome of this case has significant implications for youth e-cigarette use, public health, state budget stability, and product investment and innovation in the e-cigarette industry.

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After receiving a prescription for sulindac, the generic version of Clinoril, Karen Bartlett developed Stevens-Johnson Syndrome and toxic epidermal necrolysis, rare skin disorders that causes the sufferer’s skin to deteriorate by either being burned off or by turning into an open wound. Bartlett subsequently suffered painful, permanent injuries, including near-blindness, esophageal burns, and lung damage. A New Hampshire federal jury awarded Bartlett $21.06 million for her injuries based on a New Hampshire products liability claim for defective design. Mutual Pharmaceutical Company, a sulindac manufacturer, now challenges that decision by arguing that federal law regulating generic drugs preempts New Hampshire's design-defect law. The United States Court of Appeals for the First Circuit upheld the lower court design, finding no preemption, despite Supreme Court precedent finding preemption in similar contexts. Mutual Pharmaceutical argues that the Food, Drug, and Cosmetic Act preempts the state design-defect law because the Act requires generic drug manufacturers to produce generic medications that are bioequivalent to the corresponding name brand version of the drug. Bartlett responds that the state law does not conflict with federal law because the state law imposes no duty for sellers to change their product from the name brand version. 

Questions as Framed for the Court by the Parties

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Issues

This case presents the Supreme Court the opportunity to determine how to construe the Biologics Price Competition and Innovation Act (“BPCIA”). Specifically, this case focuses on the notice requirements of the BPCIA and asks whether notice of marketing a biosimilar must be provided 180 days after the approval of the biosimilar but before the marketing of the product. In addition, if the Court determines that notice is required after approval, but before marketing, the Court must decide what remedies are proper to correct the improper notice. Pointing to the BPCIA’s purpose, Sandoz Inc. argues that notice is only required 180 days before marketing; and, that injunctions are improper remedies to correct any potential notice-fault. In contrast, Amgen Inc. also points to the BPCIA’s purpose to argue that notice can only be effective if made after FDA approval; and, that the only way to provide a meaningful remedy would be to allow an injunction. Depending on the Court’s holding, this case could impact the balance between innovation and affordability in the biologics market.        

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