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

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

Lone Mountain petitioned for review of an order of the Federal Mine Safety and Health Review Commission denying the company's motions to reopen closed civil penalty proceedings. Following the guidance of Federal Rule of Civil Procedure 60(b), the Commission has long held that it may reopen otherwise final orders, including those that have been rendered final pursuant to the Federal Mine Safety Act of 1977, 30 U.S.C. 815(a). The court held that the Commission's order was arbitrary and capricious, and agreed with Lone Mountain's argument that the Commission abused its discretion by departing from its own precedent without explanation. Accordingly, the court need not consider Lone Mountain's alternative arguments. View "Lone Mountain Processing Inc. v. Secretary of Labor, et al" on Justia Law

FERC fined petitioner $30 million for manipulating natural gas futures contracts. Petitioner, an employee of the hedge fund Amaranth, claimed that FERC lacked authority to fine him because the Commodity Futures Trading Commission (CFTC) had exclusive jurisdiction over all transactions involving commodity futures contracts. The court granted the petition for review because manipulation of natural gas futures contracts fell within the CFTC's exclusive jurisdiction and because nothing in the Energy Policy Act, 15 U.S.C. 717c-1, clearly and manifestly repealed the CFTC's exclusive jurisdiction. View "Hunter v. FERC" on Justia Law

Plaintiffs filed a Freedom of Information Act (FOIA), 5 U.S.C. 552, request for records held by the CIA pertaining to the use of unmanned aerial vehicles (drones) to carry out targeted killings. The district court affirmed the CIA's Glomar response, concluding that a response refusing to confirm or deny that the CIA had such records was justified under the circumstances of this case. The court concluded that it was not "logical or plausible" for the CIA to contend that it would reveal something not already officially acknowledged to say that the CIA "at least has an intelligence interest" in such strikes. The court held that the CIA's broad Glomar response was untenable and therefore, the court reversed the district court's judgment dismissing plaintiffs' FOIA action and remanded for further proceedings. View "American Civil Liberties Union, et al v. CIA" on Justia Law

Appellant challenged the district court's decision to reimpose a 360-month sentence for numerous narcotics- and firearms-related convictions after the court vacated one of the convictions upon which his original sentence was based. The court upheld the sentence, concluding that the district court correctly understood its authority on remand and did not err in exercising that authority. The court also took the opportunity to collect and restate this circuit's rules regarding which arguments the district court could consider on a remand for resentencing when the remand order provided no express instructions. View "United States v. Blackson" on Justia Law

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