Table of Contents | United States v. Elmer Criminal Law, Drugs & Biotech, White Collar Crime US Court of Appeals for the Seventh Circuit | Roane v. Barr Civil Rights, Constitutional Law, Criminal Law, Drugs & Biotech US Court of Appeals for the District of Columbia Circuit | Vectura Ltd. v. GlaxoSmithKline, LLC Drugs & Biotech, Intellectual Property, Patents US Court of Appeals for the Federal Circuit |
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Drugs & Biotech Opinions | United States v. Elmer | Court: US Court of Appeals for the Seventh Circuit Docket: 19-2890 Opinion Date: November 19, 2020 Judge: Scudder Areas of Law: Criminal Law, Drugs & Biotech, White Collar Crime | Elmer owned and operated multiple healthcare-related companies including Pharmakon, a compounding pharmacy that mixes and distributes drugs—including potent opioids like morphine and fentanyl—to hospitals across the U.S.. Pharmakon conducted its own internal potency testing and contracted with a third party to perform additional testing to evaluate whether its compounded drugs had too little of the active ingredient (under-potent) or too much (over-potent). In 2014-2016, testing showed 134 instances of under- or over-potent drugs being distributed to customers. Elmer knew the drugs were dangerous. Rather than halting manufacturing or recalling past shipments, sales continued and led to the near-death of an infant. Elmer and Pharmakon lied to the FDA. Elmer was charged with conspiracy to defraud the FDA (18 U.S.C. 371); introducing adulterated drugs into interstate commerce (21 U.S.C. 331(a), 333(a)(1) & 351); and adulterating drugs being held for sale in interstate commerce (21 U.S.C. 331(k), 331(a)(1) & 351). Pharmakon employees, FDA inspectors, and Community Health Network medical staff testified that Elmer was aware of and directed the efforts to conceal out-of-specification test results from the FDA. The district court sentenced Elmer to 33 months’ imprisonment. The Seventh Circuit affirmed, rejecting challenges to rulings related to the evidence admitted at trial and Elmer’s sentence. The evidence before the jury overwhelmingly proved Elmer’s guilt. The sentence was more than reasonable given the gravity of Elmer’s crimes. | | Roane v. Barr | Court: US Court of Appeals for the District of Columbia Circuit Docket: 20-5329 Opinion Date: November 18, 2020 Judge: Per Curiam Areas of Law: Civil Rights, Constitutional Law, Criminal Law, Drugs & Biotech | In July 2019, the Department of Justice announced a revised protocol for execution by lethal injection using a single drug, pentobarbital. Plaintiffs, federal death row inmates, sought expedited review of three of the district court's rulings, and two plaintiffs with upcoming execution dates moved for stays of execution pending appeal. The DC Circuit held that the district court did not err in granting summary judgment for the government on plaintiffs' Federal Death Penalty Act (FDPA) claim. In this case, plaintiffs had pointed to several alleged discrepancies between the 2019 Protocol and state statutes dictating different methods of execution or aspects of the execution process. The court agreed with the district court's conclusion that there was no conflict, either because the government had committed to complying with the state statutes at issue or because no plaintiff had requested to be executed in accordance with them. However, the court reversed the district court's dismissal of plaintiffs' Eighth Amendment challenge for failure to state a claim. The court held that, by pleading that the federal government's execution protocol involves a "virtual medical certainty" of severe and torturous pain that is unnecessary to the death process and could readily be avoided by administering a widely available analgesic first, plaintiffs' complaint properly and plausibly states an Eighth Amendment claim. The court denied Plaintiffs Hall and Bernard's request for a stay of execution based on the Eighth Amendment claim. The court also held that the district court should have ordered the 2019 Protocol to be set aside to the extent that it permits the use of unprescribed pentobarbital in a manner that violates the Federal Food, Drug & Cosmetic Act (FDCA). Finally, the court affirmed the district court's denial of a permanent injunction to remedy the FDCA violation. | | Vectura Ltd. v. GlaxoSmithKline, LLC | Court: US Court of Appeals for the Federal Circuit Docket: 20-1054 Opinion Date: November 19, 2020 Judge: William Curtis Bryson Areas of Law: Drugs & Biotech, Intellectual Property, Patents | Vectura sued GSK in 2016, alleging direct infringement of claim 3 of the 991 patent, which concerns the production of “composite active particles” for use in pulmonary administration, such as in dry-powder inhalers. The composite active particles described in the patent consist of additive material that is adhered to particles of the active ingredient. The active ingredient produces the desired chemical or biological effect, while the additive particles promote the dispersion and delivery of the active ingredient into the lungs when the inhaler is activated. The Federal Circuit affirmed holdings that the patent was infringed and not invalid. The court rejected arguments that Vectura failed to present substantial evidence that the accused inhalers use additive material that “promotes the dispersion” of the active material, that the district court’s construction of the term “composite active particles” was erroneous, that there were flaws in the calculation of the royalty proposed by Vectura’s damages expert, and that Vectura made prejudicial references to GSK’s sales and advanced an improper “pennies on the dollar” argument in comparing Vectura’s royalty request to GSK’s sales. | |
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