Justia Government & Administrative Law Opinion Summaries

The Food, Drug, and Cosmetic Act requires Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce, 21 U.S.C. 355(a). The manufacturer of an approved drug is prohibited from making any major change to the "qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application." Generic manufacturers are also prohibited from making any unilateral change to a drug’s label. In 2004, a patient was prescribed Clinoril, a brand-name nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by Mutual. The patient developed an acute case of toxic epidermal necrolysis and is severely disfigured, has physical disabilities, and is nearly blind. At the time of the prescription, sulindac’s label did not specifically refer to toxic epidermal necrolysis. By 2005, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. A jury found Mutual liable on a design-defect claim and awarded the patient more than $21 million. The First Circuit affirmed. The Supreme Court reversed. State-law design-defect claims based on the adequacy of a drug’s warnings are preempted by federal law under a 2011 Supreme Court decision, PLIVA, Inc. v. Mensing. It is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the warnings on the label or change sulindac’s design. Redesign was not possible because the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent and, due to sulindac’s simple composition, the drug is chemically incapable of being redesigned. Mutual could only ameliorate sulindac’s "risk-utility" profile, therefore, by strengthening its warnings, an action forbidden by federal law. View "Mut. Pharma. Co. v. Bartlett" on Justia Law

The U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, 22 U.S.C. 7601, authorizes appropriations to fund nongovernmental efforts to combat HIV/AIDS worldwide, with conditions that: no funds “may be used to promote or advocate the legalization or practice of prostitution” and no funds may be used by an organization “that does not have a policy explicitly opposing prostitution” (the Policy Requirement). To enforce the Policy Requirement, the Department of Health and Human Services and the U.S. Agency for International Development require funding recipients to agree that they oppose prostitution. Funding recipients, wishing to remain neutral on prostitution, sought a declaratory judgment that the Policy Requirement violates their First Amendment rights. The district court issued a preliminary injunction, barring the government from cutting off funding during the litigation. The Second Circuit and Supreme Court affirmed. The First Amendment “prohibits the government from telling people what they must say.” The Spending Clause grants Congress broad discretion to fund private programs for the general welfare and to limit the use of funds to ensure they are used in the manner intended. There is a distinction between conditions that define the limits of the spending program and specify the activities Congress wants to subsidize and conditions that seek to leverage funding to regulate speech outside the contours of the federal program itself. The Act’s other condition, prohibiting use of funds “to promote or advocate the legalization or practice of prostitution or sex trafficking,” ensures that federal funds will not be used for prohibited purposes. The Policy Requirement goes further and, by its very nature, affects protected conduct outside the scope of the federally funded program. The Requirement goes beyond preventing recipients from using private funds in a way that could undermine the federal program and requires them to pledge allegiance to government policy. View "Agency for Int'l Dev. v. Alliance for Open Soc'y Int'l, Inc." on Justia Law

Using FOIA requests directed to the South Carolina DMV, attorneys obtained names and addresses, then sent letters to more than 34,000 individuals, seeking clients for a lawsuit against car dealerships for violation of a state law. The letters were headed “ADVERTISING MATERIAL,” explained the lawsuit, and asked recipients to return an enclosed card to participate in the case. Recipients sued the attorneys, alleging violation of the Driver’s Privacy Protection Act of 1994 (DPPA), 18 U.S.C. 2721(b)(4), by obtaining, disclosing, and using personal information from motor vehicle records for bulk solicitation without express consent. The district court dismissed, based on a DPPA exception permitting disclosure of personal information "for use in connection with any civil, criminal, administrative, or arbitral proceeding," including "investigation in anticipation of litigation." The Fourth Circuit affirmed. The Supreme Court vacated and remanded. An attorney’s solicitation of clients is not a permissible purpose under the (b)(4) litigation exception. DPPA’s purpose of protecting privacy in motor vehicle records would be substantially undermined by application of the (b)(4) exception to the general ban on disclosure of personal information and ban on release of highly restricted personal information in cases there is any connection between protected information and a potential legal dispute. The Court noted examples of permissible litigation uses: service of process, investigation in anticipation of litigation, and execution or enforcement of judgments and orders. All involve an attorney’s conduct as an officer of the court, not a commercial actor, seeking a business transaction. A contrary reading of (b)(4) could affect interpretation of the (b)(6) exception, which allows an insurer and certain others to obtain DMV information for use in connection with underwriting, and the (b)(10) exception, which permits disclosure and use of personal information in connection with operation of private tollroads. View "Maracich v. Spears" on Justia Law

The National Voter Registration Act of 1993 (NVRA) requires states to accept and use a uniform federal form to register voters for federal elections, 42 U.S.C. 1973gg–4(a)(1). The form developed by the Election Assistance Commission, requires only that an applicant aver, under penalty of perjury, that he is a citizen. Arizona law required rejection of any application for registration, including the federal form, if not accompanied by documentary evidence of citizenship. The district court granted summary judgment, upholding Arizona’s requirement. The Ninth Circuit reversed in part, holding that the requirement is preempted by the NVRA. The Supreme Court affirmed. The Elections Clause imposes on states the duty to prescribe the time, place, and manner of electing Representatives and Senators, but confers on Congress the power to alter those regulations or supplant them altogether. The Clause confers authority to provide a complete code for congressional elections, including regulations relating to “registration.” The NVRA term “accept” implies that the form is to be accepted as sufficient and Congress, when it acts under the Clause, is always on notice that its legislation will displace some element of a state’s preexisting legal regime. While the NVRA forbids states to demand additional information beyond that required by the federal form, it does not preclude states from denying registration based on information in their possession establishing the applicant’s ineligibility. The NVRA can be read to avoid a conflict, however. The NVRA permits a state to request state-specific instructions on the federal form and a state may challenge rejection of that request. That alternative means of enforcing its constitutional power to determine voting qualifications remains open to Arizona. View "Arizona v. Inter Tribal Council of Ariz., Inc." on Justia Law

The congressionally-sanctioned Red River Compact allocates water rights among Oklahoma, Texas, Arkansas, and Louisiana. The governed area is divided into five "Reaches," each divided into smaller subbasins. Because Louisiana lacks suitable reservoirs to store water during high flow periods and the upstream states were unwilling to release stored water to benefit the downstream state, Reach II granted control over the water in upstream subbasins 1 through 4 to the states in which each subbasin is located and gives the states equal rights to subbasin 5 waters when the flow is 3,000 cubic feet per second (CFS) or more, "provided no state is entitled to more than 25 percent of the water in excess of 3,000" CFS. States are entitled to continue intrastate water administration. Tarrant is a state agency providing water to north-central Texas. After unsuccessfully attempting to purchase water from Oklahoma and others, Tarrant sought a permit from the Oklahoma Water Resources Board (OWRB) to take surface water from a tributary of the Red River in Oklahoma’s portion of subbasin 5. Knowing that Oklahoma effectively prevents out-of-state applicants from taking or diverting water from within Oklahoma, Tarrant sought to enjoin enforcement of state statutes on grounds that they were preempted by federal law (the Compact) and violated the Commerce Clause by discriminating against interstate commerce in unallocated water. The district court granted summary judgment for the OWRB; the Tenth Circuit affirmed. A unanimous Supreme Court affirmed. The Compact does not preempt the Oklahoma statutes. Interstate compacts are construed under contract law principles; the Compact, silent on the topic, is ambiguous regarding cross-border rights, so the Court looked to "the well-established principle that States do not easily cede their sovereign powers," the fact that other interstate water compacts have treated cross-border rights explicitly, and the parties’ course of dealing. The Oklahoma statutes do not violate the Commerce Clause; the water is not unallocated. View "Tarrant Reg'l Water Dist. v. Herrmann" on Justia Law

The Port of Los Angeles is run by a Board of Harbor Commissioners under a municipal ordinance (the tariff) and leases terminal facilities to operators that load and unload ships. Federally-licensed short-haul drayage trucks move cargo in and out of the Port. In response to concerns over proposed port expansion, the Board implemented a Clean Truck Program that involved a standard “concession agreement,” governing the relationship between the Port and drayage companies. It required a placard on each truck including a phone number and submission a plan listing off-street parking locations. Other requirements relate to financial capacity, truck maintenance, and drivers. The Board amended the tariff to make it a misdemeanor for a terminal operator to grant access to an unregistered drayage truck. An association of drayage companies sued, claiming that the requirements are expressly preempted by the Federal Aviation Administration Authorization Act of 1994 (FAAAA), 49 U.S.C. 4501(c)(1), and that even if the requirements are valid, the Port may not enforce them by withdrawing a right to operate at the Port. The district court ruled in favor of the Port. The Ninth Circuit affirmed, finding only the driver-employment provision preempted. A unanimous Supreme Court reversed in part. The FAAAA expressly preempts the placard and parking requirements, which relate to a motor carrier’s price, route, or service with respect to transporting property and “hav[e] the force and effect of law.” The Port exercised classic regulatory authority in forcing terminal operators and, therefore, trucking companies, to alter their conduct by implementing a criminal prohibition punishable by imprisonment. The Port’s proprietary intentions do not control. The Court declined to determine, in a “pre-enforcement posture” whether precedent limits the way the Port can en¬force the financial-capacity and truck-maintenance requirements. View "Am. Trucking Ass'ns., Inc. v. City of Los Angeles" on Justia Law

The Communications Act of 1934 requires state or local governments to act on siting applications for wireless facilities “within a reasonable period of time after the request is duly filed.” 47 U.S.C. 332(c)(7)(B)(ii). The FCC issued a Declaratory Ruling concluding that the phrase “reasonable period of time” is presumptively (but rebuttably) 90 days to process an application to place a new antenna on an existing tower and 150 days to process all other applications. The cities of Arlington and San Antonio challenged the Ruling. The Fifth Circuit found the statute ambiguous and upheld the FCC’s determination that section 201(b)’s broad grant of regulatory authority empowered it to administer section 332(c)(7)(B). The Supreme Court affirmed. Courts must apply the Chevron framework to an agency’s interpretation of a statutory ambiguity that concerns the scope of the agency’s statutory authority (i.e., its jurisdiction). The Court rejected a contention that Chevron deference was not appropriate because the FCC asserted jurisdiction over matters of traditional state and local concern. The statute explicitly supplants state authority. There is no case in which a general conferral of rule-making or adjudicative authority has been held insufficient to support Chevron deference for an exercise of that authority within the agency’s substantive field. A general conferral of rule-making authority validates rules for all the matters the agency is charged with administering. It is sufficient that the preconditions to deference under Chevron are satisfied because Congress has unambiguously vested the FCC with general authority to administer the Communications Act through rule-making and adjudication, and the interpretation at issue was promulgated in the exercise of that authority. View "Arlington v. Fed. Commc'n Comm'n" on Justia Law

Virginia’s Freedom of Information Act grants Virginia citizens access to all public records, but grants no such right to non-Virginians. Citizens of other states, including the owner of a business that obtains real estate tax records on behalf of clients, filed requests under the Act. After each was denied, they filed a 42 U. S. C. 1983 suit, alleging violations of the Privileges and Immunities Clause and the dormant Commerce Clause. The district court granted Virginia summary judgment. The Fourth Circuit and the Supreme Court affirmed. The Constitution does not guarantee the existence of FOIA laws. The Privileges and Immunities Clause protects only privileges and immunities that are “fundamental.” The Clause protects the right of citizens to “ply their trade, practice their occupation, or pursue a common calling,” only with respect to laws enacted for the protectionist purpose of burdening out-of-state citizens. Virginia’s FOIA exists to allow Virginia citizens to obtain an accounting from their public officials; noncitizens have no comparable need. The distinction between citizens and noncitizens recognizes that citizens pay fixed costs underlying record-keeping. The law does not prevent noncitizens from obtaining documents necessary to the transfer of property or deprive noncitizens of “reasonable and adequate” access to Commonwealth courts. It gives noncitizens access to non-privileged litigation documents, to judicial records, and to records pertaining directly to them. Virginia’s FOIA does not violate the dormant Commerce Clause. It neither prohibits access to an interstate market nor imposes burdensome regulation on that market; if there is a “market” for Virginia’s public documents, it is a market for a product that the Commonwealth has created and of which the Commonwealth is the sole manufacturer. View "McBurney v. Young" on Justia Law

The Federal Tort Claims Act (FTCA) waives the government’s sovereign immunity from tort suits, but excepts from that waiver certain intentional torts, 28 U. S. C. 2680(h). Section 2680(h) contains a proviso that extends the waiver of immunity to claims for six intentional torts, including assault and battery, that are based on the “acts or omissions” of an “investigative or law enforcement officer” “who is empowered by law to execute searches, to seize evidence, or to make arrests.” A federal prisoner, sued the United States under the FTCA, alleging assault and battery by correctional officers. The district court granted the government summary judgment; the Third Circuit affirmed, reasoning that the “law enforcement proviso” applies only to tortious conduct that occurs during the course of executing a search, seizing evidence, or making an arrest. The Supreme Court reversed. The law enforcement proviso extends to law enforcement officers’ acts or omissions that arise within the scope of employment, regardless of whether the officers are engaged in investigative or law enforcement activity, or are executing a search, seizing evidence, or making an arrest. Congress intended immunity determinations to depend on a federal officer’s legal authority, not on a particular exercise of that authority. Nor does the proviso indicate that a waiver of immunity requires the officer to be engaged in investigative or law enforcement activity. View "Millbrook v. United States" on Justia Law

The Federal Tort Claims Act waives sovereign immunity from tort suits, 28 U. S. C. 1346(b)(1), except for certain intentional torts, including battery; it originally afforded tort victims a remedy against the government, but did not preclude suit against the alleged tort-feasor. Agency-specific statutes postdating the FTCA immunized certain federal employees from personal liability for torts committed in the course of official duties. The Gonzalez Act makes the FTCA remedy against the U.S. preclusive of suit against armed forces medical personnel, 10 U. S. C. 1089(a), and provides that, “[f]or purposes of this section,” the FTCA intentional tort exception “shall not apply to any cause of action arising out of a negligent or wrongful act or omission in the performance of medical ... functions.” Congress subsequently enacted the Federal Employees Liability Reform and Tort Compensation Act, which makes the FTCA remedy against the government exclusive for torts committed by federal employees acting within the scope of their employment, 28 U. S. C. 2679(b)(1); federal employees are shielded without regard to agency or line of work. Levin, injured as a result of surgery performed at a U. S. Naval Hospital, sued the government and the surgeon, asserting battery, based on his alleged withdrawal of consent shortly before the surgery. Finding that the surgeon had acted within the scope of his employment, the district court released him and dismissed the battery claim. Affirming, the Ninth Circuit concluded that the Gonzalez Act served only to buttress the personal immunity granted military medical personnel and did not negate the FTCA intentional tort exception. The Supreme Court reversed and remanded. The Gonzalez Act section 1089(e) abrogates the FTCA intentional tort exception, allowing Levin’s suit against the U.S. alleging medical battery by a Navy doctor acting within the scope of employment. The operative clause states, “in no uncertain terms,” that the FTCA intentional tort exception “shall not apply,” and confines the abrogation to medical personnel employed by listed agencies. View "Levin v. United States" on Justia Law