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

Plaintiffs and their companies filed suit alleging that the contraceptive mandate in the Affordable Care Act, 42 U.S.C. 300gg-13(a)(4), violated their rights under the Religious Freedom Restoration Act (RFRA), 42 U.S.C. 2000bb et seq., the Free Exercise Clause, the Free Speech Clause, and the Administrative Procedure Act (APA), 5 U.S.C. 500 et seq. The court concluded that, even if the government had a compelling interest - from safeguarding the public health to protecting a woman's compelling interest in autonomy and promoting gender equality, the mandate was not the most restrictive means of furthering that interest. The court concluded that the district court erred in denying a preliminary injunction for plaintiffs on the grounds that their case was unlikely to succeed on the merits; the court reversed the district court's denial of a preliminary injunction for the individual owners; because the district court premised its decision entirely on a question of law, the court must remand for consideration of the other preliminary-injunction factors; and the court affirmed the district court's denial of preliminary injunction with respect to the companies. View "Gilardi, et al. v. HHS, et al." on Justia Law

Millard petitioned for review of the Commission's affirmance of citations issued to Millard for committing violations of emergency response, training, record-keeping, and other requirements after more than 30,000 pounds of anhydrous ammonia escaped from one of Millard's refrigerated storage facilities. The court concluded that Millard's challenges to the two process safety management violations, Millard's contention that OSHA was estopped from asserting that the company violated agency regulations, and Millard's ten remaining challenges either lacked merit or merited neither reversal nor further discussion. Accordingly, the court denied the petition for review. View "Millard Refrigerated Services v. Secretary of Labor" on Justia Law

This case stemmed from Cytori's application to the FDA to market two new medical devices, the Celution 700 and the StemSource 900. Two devices that use adipose tissue as a source of stem cells that could later be used in lab analysis or, potentially, in regenerative medicine. The FDA concluded that the Celution and the StemSource were not substantially similar to devices on the market that extract stem cells from blood or bone marrow. Thus, the FDA ruled that Cytori must go through an extensive premarket approval process for new medical devices, rather than go through the streamlined premarket notification process for new devices that would be substantially equivalent to another device already on the market. Cytori appealed. As a preliminary matter, the court concluded that it was the proper forum for direct review of the FDA's substantial equivalence determination. On the merits, the court concluded that the FDA reasonably concluded and reasonably explained, for purposes of the Administrative Procedures Act, 5 U.S.C. 500 et seq., that the Celution and StemSource did not meet either the "intended use" requirement or the "technological characteristics" requirement for a substantial equivalence determination. View "Cytori Therapeutics, Inc. v. FDA" on Justia Law

Plaintiffs, teaching hospitals, received Medicare payments to offset the costs associated with training "full-time equivalent" residents and intern physicians (FTEs). In 1997, Congress capped those payments in such a way that the number of FTEs the hospitals trained in 1996 would dictate the maximum reimbursement in all future years. Although the parties agreed that the 1996 data was not accurate, the Secretary believed that this predicate fact could not be corrected outside the three-year reopening window. The court held that the reopening regulation allowed for modification of predicate facts in closed years provided the change would only impact the total reimbursement determination in open years. Alternatively, the court agreed with the district court that the Secretary had acted arbitrarily in treating similarly situated parties differently. The court rejected the Secretary's claim that the Medicare Act, 42 U.S.C. 1395 et seq., would not allow the intermediary to change the 1996 GME resident count without changing the corresponding reimbursement amount, which all parties conceded would constitute a reopening of an "Intermediary determination." Accordingly, the court affirmed the judgment. View "Kaiser Foundation Hospitals v. Sebelius" on Justia Law

The DEA, under the authority of the Controlled Substances Act of 1970, 21 U.S.C. 812(b)(1)(B), classified marijuana as a Schedule I drug, the most restricted drug classification under the Act. Petitioners challenged the DEA's denial of its petition to initiate proceedings to reschedule marijuana as a Schedule III, IV, or V drug. The principal issue on appeal was whether the DEA's decision was arbitrary and capricious. First, the court denied the Government's jurisdictional challenge because the court found that at least one of the named petitioners had standing to challenge the agency's action. On the merits, the court held that the DEA's denial of the rescheduling petition survived review under the deferential arbitrary and capricious standard where the petition asked the DEA to reclassify marijuana, which, under the terms of the Act, required a "currently accepted medical use." A "currently accepted medical use" required, inter alia, "adequate and well-controlled studies proving efficacy." The court deferred to the agency's interpretation of these regulations and found that substantial evidence supported the agency's determination that such studies did not exist. Accordingly, the court denied the petition for review. View "Americans for Safe Access, et al v. DEA" on Justia Law

Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law

Appellants were executives at the Purdue Frederick Company when it misbranded the painkiller OxyContin a schedule II controlled substance. The Company was convicted of fraudulent misbranding, and the executives were convicted under the "responsible corporate officer" doctrine of the misdemeanor of misbranding a drug. Based upon their convictions, the Secretary of Health and Human Services later excluded the individuals from participation in federal health care programs for twelve years under 42 U.S.C. 1320a-7(b). Appellants sought review, arguing that the statute did not authorize their exclusion and the Secretary's decision was unsupported by substantial evidence and was arbitrary and capricious. The district court granted summary judgment for the Secretary. The D.C. Circuit Court of Appeals reversed, holding (1) the statute authorized the Secretary's exclusion of Appellants, but (2) the Secretary's decision was arbitrary and capricious for want of a reasoned explanation for the length of the exclusions. View "Friedman v. Sebelius" on Justia Law

Five Medicaid recipients filed a class action against the District, alleging that the District systematically denied Medicaid coverage of prescription medications without providing the written notice required by federal and D.C. law. The district court dismissed the case on the pleadings, concluding that plaintiffs lacked standing to pursue their claims for injunctive and declaratory relief. At least with regard to one plaintiff, John Doe, the allegations sufficiently established injury, causation, and redressability and the court concluded that Doe had standing to pursue his claims for injunctive and declaratory relief. Therefore, the court had no need to decide whether the other plaintiffs had standing and reversed the judgment, remanding for further proceedings. View "NB, et al. v. DC, et al." on Justia Law

In 1995, two non-profit hospitals consolidated to form Pinnacle. Pinnacle subsequently submitted a Medicare reimbursement claim for the losses the hospitals had incurred through the sale of their depreciable assets in the consolidation. The Administrator denied Pinnacle's claim, and that order became the final decision of the Secretary. On Pinnacle's Administrative Procedure Act (APA), 42 U.S.C. 12101 et seq., challenge, the district court upheld the Secretary's decision in full. Because the Secretary's interpretation of the relevant Medicare regulations was not plainly erroneous or inconsistent with the regulation, the court concluded that the Secretary reasonably applied the bona fide sale requirement to a reimbursement request from a participant in a "statutory merger." The court also held that the Secretary's finding that the bona fide sale requirement applied to consolidations involving non-profit Medicare providers, like Pinnacle, was not plainly erroneous or inconsistent with the regulation. Finally, substantial evidence supported the Secretary's finding that Pinnacle did not satisfy the bona fide sale requirement. Accordingly, the court affirmed the district court's judgment. View "Pinnacle Health Hospitals v. Sebelius" on Justia Law

Suppliers appealed the district court's dismissal of their action against the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare and Medicaid Services (CMS). Suppliers challenged a regulation addressing the "applicable financial standards" that a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier must meet to be eligible for a Medicare contract under the competitive process established in 42 U.S.C. 1395w-3 (DMEPOS Statute). The court affirmed the district court's dismissal on the ground that section 1395w-3(11) precluded judicial review of the Secretary's financial standards regulation and that the district court therefore lacked subject matter jurisdiction. View "Texas Alliance For Home Care, et al. v. Sebelius, et al." on Justia Law