Justia Government & Administrative Law 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

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.

Christopher M. Loften died from a rare disease called Toxic Epidermal Necrolysis (TEN) after taking Motrin. Lofton's wife and children brought suit against defendants asserting that Motrin caused the disease and defendants had failed to warn consumers about the risk of these severe autoimmune allergic reactions. At issue on appeal was whether the district court correctly found that federal law preempted Tex. Civ. Prac. & Rem. Code 82.007(b)(1), which required plaintiffs to assert, in failure to warn cases, that a drug manufacturer withheld or misrepresented material information to the FDA. The court held that section 82.007(b)(1) required a Texas plaintiff to prove fraud-on-the-FDA to recover for failure to warn and this requirement invoked federal law supremacy. Therefore, because the court concluded that section 82.007(b)(1) was a fraud-on-the-FDA provision analogous to the claim considered in Buckman Co. v. Plaintiffs' Legal Comm., the court held that it was preempted by the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., unless the FDA itself found fraud. Accordingly, the court affirmed the district court's grant of summary judgment in favor of defendants.

The FTC sued Lundbeck, Inc., alleging that its acquisition of the drug NeoProfen violated the Federal Trade Commission Act, 15 U.S.C. 41 et seq., the Sherman Act, 15 U.S.C. 1-7, the Clayton Act, 15 U.S.C. 12-27, the Minnesota Antitrust Law of 1971, and unjustly enriched Lundbeck. At issue was whether the district court properly determined that the FTC failed to identify a relevant market where the FTC did not meet its burden of proving that the drugs Indocin IV and Neoprofen were in the same product market. The court held that the district court's finding was not clearly erroneous and affirmed the judgment.

These consolidated lawsuits involved state tort law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for the generic drug metoclopramide. State tort law required a manufacturer that was, or should be, aware of its drug's danger to label it in a way that rendered it reasonably safe. On the other hand, federal drug regulations, as interpreted by the FDA, prevented the manufacturers from independently changing their generic drug safety labels. At issue was whether such federal drug regulations applicable to generic drug manufacturers directly conflicted with, and thus preempted, the state law claims. The Court concluded that the federal drug regulations preempted the state law claims because, if manufacturers had independently changed their labels to satisfy their state law duty to attach a safer label to their generic metoclopramide, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. Thus, it was impossible for the manufacturers to comply with federal and state law. Even if the manufacturers had fulfilled their federal duty to ask for FDA help in strengthening the corresponding brand-name labels, assuming such a duty existed, they would not have satisfied their state tort law duty. State law demanded a safer label, it did not require communication with the FDA about the possibility of a safer label. Therefore, the Court held that when a party could not satisfy its state duties without the Federal Government's special permission and assistance, which was dependent on the exercise of judgment by a federal agency, that party could not independently satisfy those state duties for preemption purposes. The Court also noted that Congress and the FDA retained authority to change the law and regulations if they so desired. Accordingly, the case was reversed and remanded for further proceedings.