Justia U.S. D.C. Circuit Court of Appeals Opinion Summaries

AstraZeneca, a manufacturer of pharmaceutical products, appealed from the district court's grant of summary judgment. AstraZeneca sought declaratory judgment that the FDA could not approve generic versions of its Seroquel product and sought to restrain the FDA from approving abbreviated new drug applications (ANDAs) for such competing products until the expiration of a period of exclusivity. As a preliminary matter, the court determined that its decision would affect AstraZeneca's actual rights and the case was not moot. On the merits, the court concluded that AstraZeneca's claims failed because the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301-99, only provided exclusivity for changes approved as part of a supplement. Because the FDA reasonably considered Table 2, a table summarizing previously submitted glucose data, as separate from the pediatric supplements, Table 2 was not a change approved in the supplement and therefore the statute did not entitle AstraZeneca to exclusivity for Table 2. Accordingly, the court affirmed the judgment. View "AstraZeneca Pharmaceuticals LP v. FDA, et al" on Justia Law

Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, Pub. L. No. 111-203, 124 Stat. 1376, the SEC promulgated a rule requiring certain companies to disclose payments made to foreign governments relating to the commercial development of oil, natural gas, or minerals. Petitioners challenged the statute and the regulation, raising constitutional and statutory claims. The court dismissed the petition for review for lack of jurisdiction. Because petitioners have simultaneously filed a complaint in the district court, the court need not consider transferring the petition to that court. Additionally, the court's dismissal of the petition was without prejudice to petitioners' suit in the district court. View "American Petroleum Institute, et al v. SEC" on Justia Law

Mingo Logan applied to the Corps for a permit under section 404 of the Clean Water Act (CWA), 33 U.S.C. 1344, to discharge dredged or fill material from a mountain-top coal mine in West Virginia into three streams and their tributaries. The Corps issued the permit to Mingo Logan, approving the requested disposal sites for the discharged materials. Four years later, the EPA invoked its subsection 404(c) authority to "withdraw" the specifications of two of the streams as disposal sites, thereby prohibiting Mingo Logan from discharging them. Mingo Logan then filed this action challenging the EPA's withdrawal of the specified sites. The court reversed the district court's grant of summary judgment to Mingo Logan and concluded that the EPA had post-permit withdrawal authority. Accordingly, the court remanded for further proceedings. View "Mingo Logan Coal Co. v. EPA" on Justia Law

Defenders sued the EPA based on the EPA's alleged failure to promptly promulgate revisions to certain effluent limitations and effluent limitations guidelines under the Clean Water Act (CWA), 33 U.S.C. 1251 et seq. UWAG, an association of energy companies and three national trade associations of energy companies, appealed the denial of intervention and also asserted that the court should vacate the district court's order entering a consent decree between Defenders and the EPA because the district court lacked subject matter jurisdiction. The court affirmed the denial of intervention because UWAG lacked Article III standing and, as there was no appellant with standing, dismissed the remainder of the appeal. View "Defenders of Wildlife, et al v. Jackson" on Justia Law

Appellant pled guilty to persuading a person to travel in interstate commerce to engage in criminal sexual activity. On appeal, appellant challenged all of the computer- and Internet-related conditions of his supervised release. In the district court, however, he objected to only one of those conditions: the single-device restriction. The court held that the district court did not plainly err in imposing the unobjected-to conditions. The court also held that the district court did not abuse its discretion in imposing the single-device restriction on the record that court had before it. The district court explained that the one-device limit was necessary to ensure that the probation officer would be able to effectively monitor appellant's Internet use at a reasonable cost. Given that the Internet was appellant's avenue of choice for seeking out a victim, there was no doubt that such monitoring was itself reasonably related to the nature and circumstances of his offense, to deterring criminal conduct, and to protecting the public from further crimes. Accordingly, the court affirmed the judgment. View "United States v. Legg" on Justia Law

This case stemmed from the Federal Motor Carrier Safety Administration's recent authorization of a pilot program that allowed Mexico-domiciled trucking companies to operate trucks throughout the United States, so long as the trucking companies complied with certain federal safety standards. Drivers Association and Teamsters contended that the pilot program was unlawful. As a preliminary matter, the court concluded that Drivers Association and Teamsters both have standing to challenge the pilot program. On the merits, the court concluded that all seven of Drivers Association's arguments and all six of Teamsters' arguments were unpersuasive. Accordingly, the court denied the petitions for review. View "International Brotherhood of Teamsters, et al. v. DOT, et al." on Justia Law

Plaintiffs, descendants of the Herzog Collection's owner, claimed that following World War II the Hungarian government entered into bailment agreements with them to retain possession of the Collection and later breached those agreements by refusing to return the artwork. Hungary appealed the district court's partial denial of its motion to dismiss. Plaintiffs cross-appealed the dismissal of their claims to eleven pieces of artwork on international comity grounds. The court found Hungary's arguments unpersuasive and affirmed the district court's partial denial of its motion to dismiss. However, because the court agreed with plaintiffs that the district court prematurely dismissed several of their claims on international comity grounds, the court reversed that portion of the decision. View "De Csepel, et al. v. Republic of Hungary, et al." on Justia Law

Defendant moved to suppress evidence found in his apartment after police officers executed a search warrant and seized drugs, firearms, cash, and a variety of drug paraphernalia. Defendant argued that the police officer who prepared the search warrant affidavit made false statements in the affidavit and did so with reckless disregard for the truth. The court reversed the district court's grant of the motion to suppress and concluded that, even with the contested statements excised, the remaining portions of the officer's affidavit demonstrated probable cause for the search warrant. View "United States v. Cardoza" on Justia Law

The District of Columbia appealed from the structural injunction entered by the district court in this class action challenging the policies and practices of the District's "Child Find" system under the Individuals with Disabilities Education Act (IDEA), 20 U.S.C. 1400 et seq. The court vacated the order certifying the class, and consequently, the orders finding liability and ordering relief to that class. The court remanded the case to the district court for reconsideration of whether a class, classes, or subclasses may be certified, and if so, thereafter to redetermine liability and appropriate relief. View "DL, et al v. DC, et al" on Justia Law

Defendant pled guilty to one count of mail fraud and was sentenced to 8 years and 9 months of imprisonment, as well as ordered to pay restitution to his victims. Defendant appealed. The court held that defendant could challenge the application of the vulnerable victim enhancement but, under the due deference standard, the court upheld the enhancement where it was reasonable for the district court to conclude that the combination of the victims' characteristics made them particularly susceptible to defendant's fraud. The court remanded defendant's ineffective-assistance claim that his trial counsel made errors relating to the amount-of-loss calculation because it required further factual development. Finally, the court remanded to the district court to correct the specific amounts of restitution owed to each of defendant's victim so that the amounts added up to total $3,646,747.83. View "United States v. Fareri" on Justia Law