Justia Drugs & Biotech Opinion Summaries

In this appeal arising out of a multidistrict litigation concerning the pharmaceutical drug ondansetron hydrochloride, better known as Zofran, the First Circuit affirmed the order of the district court granting summary judgment in favor of GlaxoSmithKline (GSK), holding that there was no error or abuse of discretion.Various plaintiffs filed separate lawsuits alleging that the use of Zofran during pregnancy caused birth defects and that GSK engaged in an intentionally misleading plan to market Zofran for pregnancy in violation of state law. The district court granted summary judgment in favor of GSK, holding that federal law preempted Plaintiffs' state law claims. The First Circuit affirmed, holding that federal law preempted Plaintiffs' state law claims that GSK should have warned both prescribing doctors and pregnant people that "animal studies showed harm to the fetus when Zofran was ingested during pregnancy." View "Perham v. GlaxoSmithKline, LLC" on Justia Law

The First Circuit affirmed the judgment of the district court dismissing Amyndas Pharmaceuticals, S.A.'s claims against Zealand Pharma A/S and vacated the dismissal of Amyndas's claims against Zealand Pharma U.S., Inc., holding that the district court erred in dismissing Amyndas's claims against Zealand Pharma U.S.When Amyndas was considering separate joint ventures with Zealand Pharma and Alexion Pharmaceuticals, Inc. it shared trade secrets before understanding that neither of the joint ventures would materialize. Zealand Pharma and Zealand US, its newly established affiliate, subsequently announced a partnership with Alexion Pharmaceuticals, Inc. Amyndas sued for misappropriation of trade secrets and other confidential information. The district court (1) dismissed Amyndas's claims against Zealand Pharma on the ground that Amyndas was required to litigate those claims in Denmark; and (2) dismissed Amyndas's claims against Zealand US for failure to state a claim. The First Circuit vacated in part and remanded the case for further proceedings, holding that the district court (1) correctly dismissed Amyndas's claims against Zealand Pharma; and (2) erred in concluding that Amyndas's claims against Zealand US were futile. View "Amyndas Pharmaceuticals, S.A. v. Zealand Pharma A/S" on Justia Law

The First Circuit affirmed in part and vacated in part the judgment of the district court granting Edge Pharma, LLC's motion to dismiss for failure to state a claim the allegations brought by Azurity Pharmaceuticals, Inc. under both the Lanham Act and Mass. Gen. Laws ch. 93A based on statements that Edge made on its website, holding that Azurity's claims cannot survive.Azurity's suit alleged that the statements at issue falsely represented that Edge was not in violation of the Food, Drug, and Cosmetic Act (FDCA) and that the statements falsely held out Edge's vancomycin drug as being superior to Azurity's. The district court concluded that the FDCA precluded Azurity's Lanham Act claim, which meant that the Chapter 93A likewise failed "as it is premised on the same allegations" as the Lanham Act claim. The First Circuit held (1) the district court properly dismissed the Lanham Act claim on the alternative ground that Azurity did not plausibly allege that some of the statements made a misleading representation of fact and that other statements at issue were in violation of the Lanham Act; and (2) insofar as no variant of Azurity's Lanham Act claim could survive, for the same reasons this Court vacates and affirms in part the dismissal of Azurity's Chapter 93A claim. View "Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC" on Justia Law

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

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

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

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

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

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

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