Justia U.S. 1st Circuit Court of Appeals Opinion Summaries

Articles Posted in Drugs & Biotech
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The First Circuit denied Petitioners' petition for review in this action challenging a final rule promulgated by the Drug Enforcement Administration (DEA) that set the framework through which applicants may register to lawfully manufacture and cultivate cannabis for research purposes, holding that Petitioners were not entitled to relief on their claims.Petitioners - Dr. Lyle Craker, a botany professor, and Scottsdale Research Institute (SRI), a clinical research company - brought this action raising two perceived procedural defects with the DEA's notice of proposed rulemaking that would demand that the final rule be set aside. The First Circuit denied relief, holding (1) Petitioners were not entitled to relief on their claim that the APA required the DEA to include more detail about the legal basis of the proposed rule; (2) the proposed rule did not exceed the DEA's rulemaking authority; (3) Petitioners' challenge to the DEA's definition of "medicinal cannabis" was unavailing; and (4) the DEA's new regulatory framework for registrations was not arbitrary, capricious, or otherwise contrary to law. View "Craker v. U.S. Drug Enforcement Administration" on Justia Law

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The First Circuit affirmed the judgment of the district court dismissing this complaint against Karoypharm Therapuetics, Inc. and its corporate officers (collectively, Defendants) alleging securities fraud in violation of sections 10(b) and 20(a) of the Securities Exchange Act, 15 U.S.C. 78j(b) and 78t(a), and Securities and Exchange Commission (SEC) Rule 10-b, 18 C.F.R. 240.10b-5, holding that the district court correctly dismissed the complaint for failure to state a claim.Plaintiff-investors brought this action following a decline in Karyopharm's stock price, alleging that Karyopharm materially misled them as to the safety and efficacy of the company's cancer-fighting drug candidate selinexor. The district court dismissed the complaint for failure to state a claim, concluding that Plaintiffs failed adequately to plead scienter with respect to Defendants' statements about a certain study of the drug as a treatment for pinta-refractory multiple myeloma. The First Circuit affirmed on other grounds, holding that Plaintiffs did not plausibly allege an actionable statement or omission with respect to the trial disclosures, and therefore, dismissal was appropriate. View "Thant v. Karyopharm Therapeutics Inc." on Justia Law

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The First Circuit affirmed the judgment of the district court resentencing Defendant while applying two sentencing enhancements under the United States Sentencing Guidelines, holding that both enhancements applied.Defendant, a former supervising pharmacist at the New England Compounding Center (NECC), was convicted for his conduct in connection with a criminal investigation into a 2012 deadly nationwide outbreak of fungal meningitis that was traced to the NECC's shipments of contaminated drugs. The district court sentenced Defendant to a term of imprisonment of ninety-six months. On appeal, the First Circuit vacated and remanded Defendant's sentence. On remand, the district court held that two enhancements applied to Defendant and resentenced him to a 126-month term of imprisonment. The First Circuit affirmed, holding that the district court did not err in applying the two enhancements. View "United States v. Chin" on Justia Law

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The First Circuit affirmed the judgment of the district court ordering compliance with an administrative subpoena issued to Appellant by the United States Drug Enforcement Administration (DEA) pursuant to 21 U.S.C. 876, to produce certain prescription drug records of an individual, holding that there was no error.The instant subpoena was issued by the DEA pursuant to 21 U.S.C. 876 to produce the prescription drug records kept by New Hampshire's Prescription Drug Monitoring Program (the PDMP) of an individual. The district court ordered Appellant, who was then the PDMP program manager, to comply with the subpoena. The First Circuit affirmed, holding (1) the district court did not abuse its discretion in concluding that the subpoena was enforceable under 21 U.S.C. 876(c); and (2) the third-party doctrine applied to this case. View "U.S. Dep't of Justice v. Jonas" on Justia Law

Posted in: Drugs & Biotech
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The First Circuit affirmed the judgment of the district court dismissing a relator's qui tam action brought under the False Claims Act (FCA), 31 U.S.C. 3729 through 3733, holding that the district court did not err in dismissing the action.At issue before the First Circuit was the function of the hearing provided by statute when the government files a motion to dismiss a relator's FCA qui tam action over the relator's objections. The Court held (1) the government must provide its reasons for seeking dismissal such that the relator can attempt to convince the government to withdraw its motion at the hearing; (2) if the government does not agree to withdraw its motion, the district court should grant the motion unless the relator can show that, in seeking dismissal, the government is transgressing constitutional limitations or perpetrating a fraud on the court; and (3) the district court properly granted the government's motion to dismiss this case. View "Borzilleri v. Bayer AG" on Justia Law

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The First Circuit affirmed the judgment of the district court in favor of Defendants, denying Plaintiff's motion for class certification, and denying Plaintiff's motion to file a third amended complaint, holding that Defendant sufficiently warned investors about the vulnerability of its manufacturing infrastructure so that Plaintiff knew of the investment risks when he purchased his shares.Plaintiff was an investor who lost money when he bought stock in Keryx Biopharmaceuticals, Inc. and watched the value plummet soon after that purchase. Plaintiff sued Keryx and its executives, alleging that Keryx's inadequate disclosures about its manufacturing defects amounted to securities fraud. The district court allowed Defendants' motion for judgment on the pleadings. The First Circuit affirmed, holding that Plaintiff failed to state a claim under section 10(b) of the Securities Exchange Act. View "Karth v. Keryx Biopharmaceuticals, Inc." on Justia Law

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The First Circuit affirmed the judgment of the district court granting summary judgment in favor of CVS Pharmacy, Inc. and dismissing this complaint involving a pharmacist's dispensation of a prescription that triggered the pharmacy's internal warning system, holding that the district court did not err.Plaintiff brought this action alleging that he sustained permanent ocular damages as a result of a medication dispensed by CVS. Plaintiff brought a claim for negligence, a claim under Mass. Gen. Laws ch. 93A, and a claim for product liability. The district court granted summary judgment for CVS. The First Circuit affirmed, holding that Plaintiff did not provide any adequate basis for reversing the district court's decisions. View "Carrozza v. CVS Pharmacy, Inc." on Justia Law

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The First Circuit affirmed the district court's denial of Defendant's motion for judgment as a matter of law and for a new trial in this civil enforcement action brought by the Securities and Exchange Commission, holding that the evidence was sufficient to support the verdict.At issue was whether Defendant, the CFO of AVEO Pharmaceuticals, knowingly misled investors by the manner in which he responded to investor inquiries about the substance of AVEO's discussions with the Food and Drug Administration (FDA) about the results of AVEO's clinical trial for tivozanib, a kidney cancer drug candidate. A jury found against Defendant. On appeal, Defendant argued (1) he was entitled to judgment as a matter of law because he had no duty to disclose the substance of the FDA discussions and because the evidence of scienter was insufficient, and (2) he was entitled to a new trial because the district court improperly instructed the jury. The Supreme Judicial Court affirmed, holding (1) the evidence of fraud and scienter was sufficient to support the verdict; and (2) the challenged instructions were not given in error. View "Securities & Exchange Commission v. Johnston" on Justia Law

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The First Circuit affirmed Defendant's conviction of violating federal laws by conspiring to receive, and of receiving, kickbacks from the pharmaceutical company Insys in exchange for prescribing its synthetic opioid, Subsys, holding that there was no merit to Defendant's arguments on appeal.Specifically, the First Circuit held (1) the government introduced sufficient evidence to prove that Defendant participated in a conspiracy to receive kickbacks or to prove that he accepted those kickbacks in exchange for prescribing Subsys; (2) Defendant's conduct fell outside the Anti-Kickback Statute's safe harbor provision; and (3) the district court did not err in failing to instruct the jury about that same safe harbor provision. View "United States v. Clough" on Justia Law

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The First Circuit affirmed the judgment of the district court denying Akebia Pharmaceuticals, Inc.'s motion for a preliminary injunction, holding that the district court did not err or abuse its discretion in denying a preliminary injunction in this case.Akebia sued the Administrator of the Centers for Medicare & Medicaid Services (CMS), the Secretary of the Department of Health and Human Services, and other related defendants asserting that CMS acted arbitrarily, capriciously, and contrary to law regarding the reimbursement protocol for Auryxia, a drug owned by Akebia, when prescribed for treatment of iron deficiency anemia in patients with chronic kidney disease. Akebia moved for a preliminary injunction seeking to pause the coverage determination until CMS's interpretation could be entirely litigated. The district court denied the motion. The First Circuit affirmed, holding that the district court did not err in holding that Akebia failed to carry its burden of showing that it was likely to succeed on the merits of its claims. View "Akebia Therapeutics, Inc. v. Azar" on Justia Law

Posted in: Drugs & Biotech