Justia Government & Administrative Law Opinion Summaries

The Family Smoking Prevention and Tobacco Control Act requires any tobacco product not on the market before February 15, 2007, to receive FDA approval, 21 U.S.C. 387j(a)(1)–(2). Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” can the product be approved. Manufacturers seeking advance permission to market new products. In 2020, the FDA began taking aggressive action to remove fruit- and dessert-flavored e-cigarettes (electronic nicotine delivery systems (ENDS)) from the market, leaving aside tobacco- and menthol-flavored ENDS. More recently, based on additional studies and market data, the FDA has denied the applications of importers and manufacturers to market menthol-flavored ENDS.An importer challenged that denial, arguing that it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to assess the appropriateness of sweeter flavors, to ultimately reject its applications for its menthol-flavored ENDS to remain on the market, and to do so without granting a transition period. The Third Circuit denied a petition for review. The FDA applied a regulatory framework consistent with its statutory mandate, provided a reasoned explanation for its denial, and based its decision on scientific judgments that courts may not second-guess. View "Logic Technology Development LLC v. United States Food and Drug Administration" on Justia Law

Port Hamilton Refinery purchased an existing St. Croix petroleum refinery at a 2021 bankruptcy auction, hoping to resume operations. The Refinery had for decades served as the backbone of St. Croix’s local economy until it ceased operations in 2012. Months later, the EPA notified Port Hamilton that it would need a Prevention of Significant Deterioration (PSD) permit before the Refinery could resume operations.The PSD program is part of the Clean Air Act (CAA); a facility must not contribute to the violation of applicable air quality standards and must implement the “best available control technology” to limit air pollution, 42 U.S.C. 7475(a), 7479(3). PSD applies to newly constructed stationary sources of air pollution and sources that undergo emissions-altering modifications. Under EPA’s “Reactivation Policy,” an existing facility is “new” if EPA concludes that it had previously been “shut down” and restarted. If the EPA determines that the facility had only been “idled,” it need not obtain a permit.In 2018, EPA notified the Refinery’s prior owner that it need not obtain a PSD permit because the Refinery had been only “idled” since 2012. In 2022, EPA reversed course. The Third Circuit vacated the EPA decision. The Reactivation Policy, as applied to the Refinery, exceeds EPA’s statutory authority. View "Port Hamilton Refining and Transportation LLLP v. United States Environmental Protection Agency" on Justia Law

Gillette, a serial sex offender, received a 27-year sentence for sex crimes. After his release, he never registered as a sex offender. On a tip, law enforcement found that Gillette had been living with a 15-year-old boy and had engaged in sexual contact with that child and another child. Gillette was convicted on 20 counts of territorial-law offenses; federal charges were dismissed. The court sentenced Gillette to 155 years’ imprisonment. The Third Circuit affirmed.Gillette filed a habeas petition in the Virgin Islands Superior Court. At Gillette’s request, the Superior Court issued a subpoena duces tecum to the U.S. Attorney’s Office (USAO). As required by Department of Justice regulations, the USAO requested that Gillette submit “a summary of the information” sought “and its relevance to the proceeding.” Gillette instead moved for contempt and sanctions against the USAO for failing to respond to his subpoena. The USAO then removed the proceedings to federal court and successfully moved to quash the subpoena. The Third Circuit dismissed Gillette’s appeal for lack of jurisdiction. The government never waived its sovereign immunity concerning non-monetary actions against it, so the Superior Court lacked jurisdiction over the USAO; the district court derived its jurisdiction over Gillette’s subpoena-enforcement action from 28 U.S.C. 1442(a)(1) and also lacked jurisdiction. View "Gillette v. Golden Grove Adult Correctional Facility" on Justia Law

Vepuri is the de facto director of KVK-Tech, a generic drug manufacturer. He employed Panchal as its director of quality assurance. KVK-Tech manufactured and sold Hydroxyzine, a prescription generic drug used to treat anxiety and tension. The government alleges that Vepuri, Panchal, and KVK-Tech sourced active ingredient for the Hydroxyzine from a facility (DRL) that was not included in the approvals that they obtained from the FDA and that they misled the FDA about their practices.An indictment charged all three defendants with conspiracy to defraud and to commit offenses against the United States and charged KVK-Tech with an additional count of mail fraud. The district court dismissed the portion of the conspiracy charge that alleges that the three conspired to violate the Food, Drug, and Cosmetic Act (FDCA), which prohibits introducing a “new drug” into interstate commerce unless an FDA approval “is effective with respect to such drug,” 21 U.S.C. 355(a).The Third Circuit affirmed, rejecting an argument that a deviation from the approved drug application means that the approval is no longer effective. The approval ceases being effective only when it has been withdrawn or suspended. The indictment does not include any allegations that the KVK-Tech Hydroxyzine manufactured with active ingredients from DRL had a different composition or labeling than the KVK-Tech Hydroxyzine with the effective approval. View "United States v. Vepuri" on Justia Law

The DRBA, a bi-state agency created by an interstate compact between Delaware and New Jersey, hired Minor as its Deputy Executive Director in 2009 and terminated him in 2017. Minor, believing he was fired for his support of then-incoming New Jersey Governor Murphy, sued the DRBA and its Commissioners for violating his First Amendment right to political affiliation. The court rejected the Commissioners’ request for qualified immunity, finding that a reasonable jury could conclude that Minor’s responsibilities were purely administrative by the time he was dismissed so that the Commissioners were barred potentially by the First Amendment from firing Minor on account of his politics.The Third Circuit vacated. The district court correctly held that the right of certain employees not to be fired based on political affiliation was clearly established. However, there is a genuine dispute of material fact concerning whether Minor held such a position. The question of immunity must await the determination of facts at trial. Third Circuit precedent requires the district court to “analyze separately, and state findings with respect to, the specific conduct of each [Commissioner]” to learn more about whether each Commissioner could know that his specific conduct violated clearly established rights. View "Minor v. Delaware River & Bay Authority" on Justia Law

Kean University implements New Jersey’s Policy Prohibiting Discrimination in the Workplace through its Affirmative Action Office, which conducts an investigation and prepares a report. Kean’s Chief of Staff reviews the report and makes a final determination. A final determination by the Chief of Staff may be appealed to the New Jersey Civil Service Commission. In 2016, adjunct professor Borowski was accused of making insensitive in-class statements about gender, immigration status, ethnicity, and religion. The Chief of Staff ruled against her. Borowski’s teaching assignment was terminated.Borowski appealed to the Commission, which recognized that material facts were in dispute, and referred the matter to an ALJ. Before a decision on the ensuing hearing, Kean alerted the ALJ of an intervening Commission decision, holding that adjunct professors were not civil service employees entitled to appeal final determinations of Policy violations. The ALJ dismissed Borowski’s appeal; the Commission affirmed.Instead of appealing in the state-court system, Borowski sued in federal court. The district court relied on Younger abstention to dismiss the case. The Third Circuit vacated. Younger abstention prevents federal court interference with only certain types of state proceedings, such as quasi-criminal civil enforcement actions. An appeal to the New Jersey Civil Service Commission is neither quasi-criminal nor within another category of Younger-eligible proceedings. Another prerequisite for Younger abstention is that the state proceeding must be ongoing; the Commission’s dismissal was final. View "Borowski v. Kean University" on Justia Law

The IRS investigated the companies to determine whether they are liable for penalties for promoting abusive tax shelters. Summonses led to the production of documents in 2014, including email chains involving the Delaware Department of Insurance, relating to the issuance of certificates of authority to the companies' clients and to a meeting with the Department’s Director of Captive and Financial Insurance Products. The IRS issued an administrative summons to the Department for testimony and records relating to filings by and communications with the companies. “Request 1” seeks all e-mails between the Department and the companies related to the Captive Insurance Program. The Department raised confidentiality objections under Delaware Insurance Code section 6920. The IRS declined to abide by section 6920's confidentiality requirements. The Department refuses to produce any response to Request 1.The government filed a successful petition to enforce the summons. The Sixth Circuit affirmed, rejecting the Department’s argument that, under the McCarran-Ferguson Act (MFA), 15 U.S.C. 1011, Delaware law embodied in section 6920 overrides the IRS’s statutory authority to issue and enforce summonses. While the MFA does protect state insurance laws from intrusive federal action when certain requirements are met, before any such reverse preemption occurs, the conduct at issue (refusal to produce summonsed documents) must constitute the “business of insurance” under the MFA. That threshold requirement was not met here. View "United States v. State of Delaware Department of Insurance" on Justia Law

The Renewable Fuel Standard (RFS) program requires gasoline and diesel fuel refiners, blenders, and importers to ensure that a certain portion of their annual transportation fuel production consists of renewable fuels, 42 U.S.C. 7545(o)). United, a small Pennsylvania refinery, has periodically received hardship exemptions from those requirements, including in the 2017 and 2018 compliance years. In 2019, United sought an exemption. Rather than accepting United's data at face value—as in previous years—EPA asked how United had accounted for the financial benefit of its 2018 RFS exemption. United's amended financial statement explained that revenue from selling its renewable fuel credits (RINS) generated in a particular year was included in net revenues for that year, even if the RINs actually were sold in a later calendar year. United’s amended figures showed a three-year refining margin that was higher than the margin in United’s original submission and higher than the industry average. The Department of Energy (DOE) evaluated United’s submission and initially recommended that United not receive an exemption. DOE later changed its recommendation to account for the effects of COVID-19 and suggested a 50 percent exemption for 2019.EPA denied United any exemption, declining to consider events “that did not emerge until 2020, the year after the petition in question.” The Third Circuit denied a petition for review, rejecting United’s argument that EPA arbitrarily relied on an “accounting trick” that artificially inflated United’s running average net refining margin. View "United Refining Co v. Environmental Protection Agency" on Justia Law

In 2014, National Park Service (NPS) entered a contract with Perini to perform work on Ellis Island and hired Jacobs to provide contract management services on that contract. Jacobs assigned Weber to the project. Weber observed what he believed to be discrepancies between Perini’s work and its billing practices and disclosed those discrepancies to the Office of the Inspector General (OIG), which concluded that there was no misconduct. In 2015, the NPS informed Jacobs that it would not extend its contract, purportedly because there was not enough work. Weber told OIG that he believed NPS’s decision was due to his reports and that he feared Jacobs would not retain him. Jacobs ultimately discharged Weber, who filed an OIG complaint in December 2015. In April 2016, Weber agreed to, an extension of OIG’s 180-day statutory deadline to complete its investigation. In February 2017, beyond the 360-day extended deadline, OIG completed and transmitted its report, with redacted copies to Weber and Jacobs. More than three years later, Jacobs asserted that it had never received the report.Jacobs subsequently declined to respond, asserting that the report was issued after the statutory deadline, 41 U.S.C. 4712, and that OIG lacked jurisdiction. The final determination and order were issued in December 2021, well beyond the 30-day deadline, and concluded that Jacobs had engaged in a prohibited reprisal against Weber. The Third Circuit denied an appeal, holding that the deadlines are not jurisdictional. View "Jacobs Project Management Co v. United States Department of the Interior" on Justia Law

Plaintiffs, employees at the Maid-Rite meatpacking plant, were exposed to COVID-19 in 2020. Maid-Rite issued masks and face shields but allegedly forced workers to work shoulder-to-shoulder. Plaintiffs sent OSHA an inspection request on May 19. Two days later, OSHA requested a response from Maid-Rite within a week, treating the inspection request as “non-formal,” so that it initially proceeded through document exchange. On May 27, Plaintiffs asserted that they continued to face an imminent danger of COVID-19; they also contacted OSHA on June 2, requesting Maid-Rite’s response and reasserting that conditions had not changed. They sent OSHA another letter on June 29th. On July 8, OSHA informed Maid-Rite that OSHA would inspect the plant the following day. OSHA acknowledged that advance notice of an inspection was not “typical,” but cited the need “to protect [OSHA’s] employees” from COVID-19. Plaintiffs claimed the notice allowed Maid-Rite to direct its employees to change their conduct and created the appearance of compliance with mitigation guidance. OSHA determined that the plant's conditions did not constitute an imminent danger and did not seek expedited relief.Plaintiffs sued under the Occupational Safety and Health Act, 29 U.S.C. 662(d), limited private right of action. While OSHA’s motion to dismiss was pending, OSHA concluded its standard enforcement proceedings and declined to issue a citation. The Third Circuit affirmed the dismissal of the complaint, holding that the Act mandated the dismissal of the claim once enforcement proceedings were complete. View "Doe v. Scalia" on Justia Law