Justia Government & Administrative Law Opinion Summaries

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 The approval ceases being effective only when it has been withdrawn or suspended.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

Drug makers participating in Medicare or Medicaid must offer their drugs at a discount to certain “covered entities,” which typically provide healthcare to low-income and rural individuals, 42 U.S.C. 256b, 1396r-8(a)(1), (5) (Section 340B). Initially, few covered entities had in-house pharmacies. A 1996 HHS guidance stated that covered entities could use one outside contract pharmacy each; a 2010 HHS guidance stated that covered entities could use an unlimited number of contract pharmacies. Drug makers thought that contract pharmacies were driving up duplicate discounting and diversion and adopted policies to limit any covered entity’s use of multiple contract pharmacies. A 2020 HHS Advisory Opinion declared that Section 340B required drug makers to deliver discounted drugs to an unlimited number of contract pharmacies.In 2010, Congress told HHS to establish a process for drug makers and covered entities to resolve Section 340B–related disputes. In 2016, HHS issued a notice of proposed rulemaking and accepted comments on the proposed ADR Rule. HHS subsequently listed the proposed rule as withdrawn. In 2020, HHS stated that it had just “paus[ed] action on the proposed rule,” responded to the four-year-old comments. and issued a final ADR Rule.Drug companies sued. The Third Circuit held that Section 340B does not require drug makers to deliver discounted drugs to an unlimited number of contract pharmacies. HHS did not violate the APA by purporting to withdraw the proposed ADR Rule before later finalizing it. View "Sanofi Aventis US LLC v. United States Department of Health and Human Services" on Justia Law

Ascolese, a compliance officer, brought a False Claims Act (FCA) retaliation claim against his former employer, MBP, in connection with a qui tam action involving a federally-funded public housing construction project for the Philadelphia Housing Authority (PHA). In 2009–2010, Congress amended the FCA, 31 U.S.C. 3729(a)(1)(A), to expand the scope of protected conduct shielded from retaliation and the type of notice an employer must have of the protected conduct. The new standard is whether Ascolese showed he engaged in protected conduct in furtherance of an FCA action or other efforts to stop or more violations of the FCA and that he was discriminated against because of his protected conduct. The court believed that the pre-amendment standard was required by the Third Circuit, and concluded that Ascolese failed to show MBP was on notice that he was attempting to stop MBP from violating the FCA and not merely doing his job.The Third Circuit vacated and remanded. The right question is whether Ascolese pled facts that plausibly showed MBP was on notice he tried to stop MBP’s alleged FCA violation. Ascolese sufficiently pled that he engaged in protected conduct when he went outside of his chain of command to report his concerns of fraudulent work to the PHA. View "Ascolese v. Shoemaker Construction Co" on Justia Law

In March 2020, New Jersey Governor Murphy responded to the spread of COVID-19; Executive Order 107 prohibited in-person gatherings and ordered New Jersey residents to “remain home or at their place of residence,” except for certain approved purposes, such as an “educational, political, or religious reason.” EO 107 excepted businesses deemed “essential,” including grocery and liquor stores, which could continue to welcome any number of persons (consistent with social distancing guidelines). Violations of EO 107 were subject to criminal prosecution for “disorderly conduct.” The order granted the Superintendent of the State Police, “discretion to make clarifications and issue [related] orders[.]” He exercised that power, declaring (Administrative Order 2020-4) that gatherings of 10 or fewer persons were presumptively permitted. Neither EO 107 nor AO 2020-4 contained an exception for religious worship gatherings or other First Amendment activity.Two New Jersey-based, Christian congregations, believing that the Bible requires them to gather for in-person worship services, violated the Orders and were cited. Less than a week after the filing of their complaint, challenging the Orders, Governor Murphy raised indoor gathering limits to 50 persons or 25 percent of room capacity (whichever was less), allowing outdoor religious gatherings without any gathering limits. The district court denied the congregations’ motion for a preliminary injunction. The Third Circuit dismissed an appeal as moot. View "Clark v. Governor of New Jersey" on Justia Law