Justia Government & Administrative Law Opinion Summaries

Plaintiffs, a group of prisoners, filed suit against the FDA for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and misapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A). The court concluded that, because there were clear statutory guidelines for the agency to follow in exercising its enforcement powers, the FDA's compliance with section 381(a) was subject to judicial review under the standards of the APA. The court also concluded that the FDA's policy of admitting foreign manufactured thiopental destined for state correctional facilities were not in accordance with law because section 381(a) required the agency to sample and examine for violations of any drug offered for import that had been prepared in an unregistered facility. The court concluded, however, that the district court erred by failing to seek the joinder of the state governments whose possession and use of the thiopental at issue the court declared illegal. Accordingly, the order of the district court pertaining to the thiopental already in the possession of the states was vacated, but the underlying judgment of the district court was affirmed. View "Cook, et al. v. FDA, et al." on Justia Law

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

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 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

Congress enacted section 703 of the National Defense Authorization Act for Fiscal Year 2008, 10 U.S.C. 1074g(f), which subjected all prescriptions purchased at retail pharmacies by service members to the same price caps as drugs procured directly by the Department of Defense. Pursuant to this provision, the Secretary of Defense issued a regulation requiring pharmaceutical manufacturers to refund to the federal government the difference between the retail price and the price cap. The Coalition, a multi-industry interest group that represented pharmaceutical companies, filed suit challenging these actions. The court concluded that the Secretary reasonably interpreted section 703 to impose involuntary price caps and held that the statute itself imposed retroactive rebate liability on pharmaceutical manufacturers. View "Coalition For Common Sense in Government Procurement v. United States, et al" 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

Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer

This was an appeal from a forfeiture order entered by the district court against a total of $116,584 and certain items of personal property. The cash and personal property were seized from several individuals because of their alleged use in violation of the Wyoming Controlled Substances Act. Appellants Joseph Libretti and Frank Hohlios claimed $7,209 of the cash seized and appealed the forfeiture order, contending that the district court erred in holding an evidentiary hearing without ruling on their motions to dismiss or for a more definite statement, and in denying them the opportunity to file answers, conduct discovery, file summary judgment motions, or avail themselves of the right to a jury trial. The Supreme Court affirmed, holding that the district court acted in accordance with the Wyoming Rules of Civil Procedure in ruling on the State's forfeiture complaint and did not deny the rights of Appellants to file answers, conduct discovery, file summary judgment motions, or otherwise fully participate in the proceedings.

Olivia, born in 2000, apparently healthy, became ill after her first vaccinations. Her condition required extensive hospitalization; she still requires a ventilator and a wheelchair. Her parents filed a petition with the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-1 to34. Olivia's injuries are not covered by a table of injuries presumed to be caused by vaccines, so the parents were required to show that one of the administered vaccines caused or significantly aggravated her condition. They submitted two reports by experts. The special master identified unanswered questions, but the parents took the position that it was unreasonable to require such detail at the pre-hearing stage. Based on failure to submit a supplemental report and failure to identify a clear theory of causation, the special master dismissed. The claims court affirmed. The Federal Circuit reversed. The special master did not appropriately review the evidence of causation under the summary judgment standard.