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

Hill filed a successful drug application with the FDA for a corticosteroid called "Derma-Smoothe." The FDA later approved three abbreviated new drug applications submitted by Identi for generic versions of Hill's products. Hill sued the FDA arguing that the FDA's approval of Identi's products was arbitrary and capricious under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq. The district court granted summary judgment to the FDA and Hill appealed. The court held that the district court did not abuse its discretion in refusing to consider 21 extra-record declarations; Hill's arguments challenging the FDA's decision to grant bioequivalence waivers to Identi have no merit; and the court rejected Hill's argument that the FDA should not have approved Identi's drugs because Identi did not use the same labeling as Hill. Accordingly, the court held that the FDA's actions were not arbitrary and capricious, and affirmed the district court's grant of summary judgment. View "Hill Dermaceuticals, Inc. v. FDA, et al" on Justia Law

MBIA sued as the third party beneficiary of the Pooling and Servicing Agreements (PSAs) of a failed bank. It alleged that the FDIC as conservator of the successor bank had "approved," the PSAs and then breached its "Put Back" obligations under those agreements, resulting in investor claims of MBIA-issued insurance policies. At issue was whether payments made by MBIA to investors in mortgage securitizations of a failed bank constituted "administrative expenses" entitled to priority under the Financial Institutions, Reform, Recovery, and Enforcement Act (FIRREA), 12 U.S.C. 1821(d)(11)(A). The court held that the district court properly rejected MBIA's broad interpretation of "approved" in section 1821(d)(20) and dismissed MBIA's damage claims in counts I-V and VIII as prudentially moot in light of the FDIC's No Value Determination; the district court did not err in dismissing counts VI-VII for failure to state a claim; and the court rejected MBIA's alternative theory of recovery, claiming that FDIC Corporate was obligated under 12 U.S.C. 1821(m)(13) to fund the failed bank's losses. Accordingly, the court affirmed the judgment. View "MBIA Ins. Corp. v. FDIC" on Justia Law

Plaintiff sued the BBG pursuant to Title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e et seq., after she did not receive a promotion. On appeal, plaintiff challenged the district court's grant of summary judgment in favor of the BBG. The court agreed with the district court's finding that no reasonable employee could believe that the objected-to conduct was unlawful under Title VII and therefore, summary judgment was appropriately granted on plaintiff's retaliation claims. Although the court had not held that bad faith was required for a party to be entitled to a spoliation inference where, as here, there was a duty of preservation, the error was harmless. Plaintiff's objections to the selection process, even applying a spoliation inference, failed to demonstrate that summary judgment was inappropriately granted on her discrimination claims. Accordingly, the court affirmed the judgment. View "Grosdidier v. Broadcasting Board of Governors" on Justia Law

The Union asserted unfair labor practice charges (ULPs) against the VA on behalf of two nurses at a VA medical center. The VA determined that the charges were covered by the nurses' statutory right of collective bargaining but that they arose out of professional conduct or competence within the meaning of 38 U.S.C. 7422(a)-(b). Therefore, the VA decided that the charges were excluded from review by the FLRA. Given the clear definition of collective bargaining, the court held that the district court correctly held that the VA Under Secretary lacked authority under section 7422(d) to exclude these ULPs from the FLRA's jurisdiction. Accordingly, the court affirmed the judgment. View "Amer. Fed. of Govt. Employees v. Shinseki, et al" 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 Muwekma petitioned the court to order Interior to recognize it as an Indian tribe. The court agreed with the district court that Interior's Supplemental Explanation adequately explained why Muwekma was not similarly situated to the Ione Band of Miwok or the Lower Lake Rancheria of California and, accordingly, Muwekma's equal protection claim failed; Muwekma's termination claim, although not barred by the statute of limitations, failed on the merits because Interior did not terminate Muwekma's recognition; because Muwekma had no cognizable property interest, its claim under 5 U.S.C. 554(d) failed; and Interior's Final Determination was neither arbitrary nor capricious. Accordingly, the court affirmed the district court's grant of summary judgment to Interior. View "Muwekma Ohlone Tribe v. Salazar, et al" on Justia Law

Defendant, a Colombian national, was extradited for, charged with, and convicted of conspiracy to distribute cocaine with the knowledge or intent that it would be imported into the United States. On appeal, defendant raised several challenges to his conviction and sentence. Most significantly, defendant maintained that his trial attorney suffered from a conflict of interest that deprived him of his Sixth Amendment right to conflict-free representation and that excessive trial delays violated his constitutional and statutory speedy trial rights. The court concluded that neither claim had merit. Defendant made a rational and informed decision that, given the stipulation and the limited nature of his attorney's conflict, he wanted to proceed with counsel's representation. The district court's explanation of trial delays was sufficient. As to defendant's remaining claims, the court concluded either that the district court made no error or that any such error was harmless. Accordingly, the court affirmed both the conviction and sentence. View "United States v. Lopesierra-Gutierrez" on Justia Law

Defendant was convicted of conspiring to possess and distribute one kilogram or more of PCP. On appeal, defendant claimed that his trial and sentencing were defective in several respects. Defendant's ineffective assistance claim turned on two alleged deficiencies in his counsel's performance, both of which related to the "safety valve" provision of the Sentencing Guidelines. The court concluded that, in defendant's case, the record supported neither a conclusive determination that his ineffective assistance claim would succeed, nor one that it must fail. Accordingly, the court remanded for further proceedings as to defendant's ineffective assistance of counsel claim. The court concluded that defendant's other claims lacked merit. View "United States v. Bell" on Justia Law

After a three-year rulemaking process, the FWS found that, due to the effects of global climate change, the polar bear was likely to become an endangered species and faced the threat of extinction within the foreseeable future (Listing Rule). The agency thus concluded that the polar bear should be listed as a threatened species. A number of industry groups, environmental organizations, and states challenged the Listing Rule as either overly restrictive or insufficiently protective of the polar bear. After a hearing on the parties' submissions, the district court granted summary judgment to the FWS and rejected all challenges to the Listing Rule. Given the evident thoroughness and care of the agency's explanation for its decision, the court concluded that the challenges to the Listing Rule "amount to nothing more than competing views about policy and science." Accordingly, the court affirmed the judgment. View "In re: Polar Bear Endangered Species Act Listing and Section 4(d) Rule Litigation" on Justia Law