Justia Government & Administrative Law Opinion Summaries

Plaintiff and others sought and received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System ("Laser") to correct farsightedness. Plaintiff, on behalf of himself and a class of similarly situated individuals, claimed that, had they known that the FDA had not approved the Laser for this use, they would not have consented to the surgeries. The court held that the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Saf. Code 24171 et seq., because the surgeries were not "medical experiments" subject to the protection of the Act. Plaintiff did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (CLRA), Cal. Civ. Code 1750 et seq., and his other substantive claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Plaintiff's common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments. Even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the FDCA. Accordingly, the court affirmed the dismissal of the complaint. View "Perez, et al v. Nidek Co., Ltd., et al" 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

The NRDC appealed from the district court's grant of summary judgment to the government. At issue was whether the NRDC had standing under Article III to bring this action to compel the FDA to finalize its regulation of triclosan and triclocarban, two chemicals used in over-the-counter antiseptic antimicrobial soap. The court held that the NRDC presented sufficient evidence of standing to withstand summary judgment as to the regulation of triclosan because standing could be based on exposure to a potentially dangerous product. The NRDC's evidence established that triclosan is potentially dangerous and that at least one of its members was frequently exposed to triclosan-containing soap. The court held, however, that the NRDC presented no evidence of members' direct exposure to triclocarban and failed to establish a particularized injury. View "Natural Resources Defense Council v. United States Food and Drug Admin." on Justia Law

Tennessee participates in Medicaid through “TennCare,” Tenn. Code 71-5-102. The Medicaid Act requires that TennCare administer an Early and Periodic Screening, Diagnosis, and Treatment program for all enrollees under age 21, 42 U.S.C. 1396a(a)(43), 1396d(r) and must provide outreach to educate its enrollees about these services. In 1998 plaintiffs filed a putative class action under 42 U.S.C. 1983, alleging that TennCare had failed to fulfill these obligations. The district court entered a consent decree that explained in detail the requirements that TennCare had to meet to “achieve and maintain compliance” with the Medicaid Act, based on the assumption that the Act created rights enforceable under section 1983. Eight years later, the Sixth Circuit held that one part of the Medicaid Act was unenforceable under section 1983. Following a remand, the district court vacated paragraphs of the decree that were based on parts of the Act that are not privately enforceable. After a thorough review of TennCare’s efforts, the court then vacated the entire decree, finding that TennCare had fulfilled the terms of the decree’s sunset clause by reaching a screening percentage greater than 80% and by achieving current, substantial compliance with the rest of the decree. The Sixth Circuit affirmed. View "John B. v.Emkes" on Justia Law

Gayheart applied for Social Security disability insurance benefits in 2005 due to manifestations of anxiety, panic disorder, bipolar disorder, and depression. After an initial denial and three separate hearings, an administrative law judge (ALJ) found that the limitations caused by Gayheart’s impairments did not preclude him from performing a significant number of jobs available in the national economy and denied Gayheart’s application. Gayheart’s request for an administrative appeal was denied. The Report and Recommendation issued by the federal court’s assigned magistrate judge concluded that the ALJ’s decision was not supported by substantial evidence and that Gayheart should be awarded benefits. But the district court sustained the Commissioner’s objections and affirmed the ALJ’s decision. The Sixth Circuit reversed and remanded, holding that the ALJ failed to weigh the medical opinions according to 20 C.F.R. 404.1527. View "Gayheart v. Comm'r of Soc. Sec." on Justia Law

Claimant brought a claim before the Claims Commissioner seeking damages from the State as the coadministrator of the estate of her deceased daughter, who had died while confined in a correctional institution. In the course of Claimant's case, the Commissioner issued subpoenas to the Charlotte Hungerford Hospital requesting information about the decedent's treatment there. The Hospital refused to comply with the subpoena, arguing that the Commissioner had no authority to issue subpoenas to nonparties. The trial court enforced the Commissioner's subpoena, and the appellate court affirmed. Subsequently to the Supreme Court's certification of the Hospital's appeal, Claimant settled underlying case, and consequently, the State no longer sought to enforce the subpoenas. The Supreme Court dismissed the Hospital's appeal as moot and vacated the judgments of the lower courts, as the Court could no longer grant relief. View "State v. Charlotte Hungerford Hosp." 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

Plaintiffs, thirteenth North Carolina residents who lost access to in-home personal care services (PCS) due to a statutory change, brought suit challenging the new PCS program. The district court granted plaintiffs' motions for a preliminary injunction and class certification. Defendants appealed, raising several points of error. The court agreed with the district court's conclusion that a preliminary injunction was appropriate in this case. The court held, however, that the district court's order failed to comply with Federal Rule of Civil Procedure 65 because it lacked specificity and because the district court neglected to address the issue of security. Accordingly, the court remanded the case. View "Pashby v. Delia" 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

Full Life Hospice participates in the federal Medicare program. It sought reimbursement for hospice services provided to Medicare recipients from the Department of Health and Human Services (HHS). A fiscal intermediary, acting on behalf of HHS, later contested some of these reimbursements and demanded repayment of funds that it claimed were distributed in excess of a spending cap. Full Life unsuccessfully challenged HHS intermediary’s determination through an administrative appeal, which was denied as untimely. On appeal to the district court, the court found no basis to excuse Full Life's untimely challenge. Upon review, the Tenth Circuit agreed with the district court that it lacked subject matter jurisdiction because of Full Life's failure to file a timely administrative appeal. View "Full Life Hospice v. Sebelius" on Justia Law