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

Articles Posted in Drugs & Biotech
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A group of individuals filed a lawsuit against Genzyme Corporation, a drug manufacturer, for injuries allegedly caused by the company's mishandling of a prescription drug shortage between 2009 and 2012. The lawsuit was filed several years after the events in question occurred and would typically have been considered too late under the applicable statutory limitations periods. However, the plaintiffs argued that previous class actions, a savings statute, and a tolling agreement between the parties allowed the lawsuit to proceed. The district court partially agreed and rejected Genzyme's argument that the delay in filing required dismissal of the lawsuit. However, it dismissed the claims of all but four plaintiffs for lack of standing, and dismissed the remaining claims on the merits.On appeal, the United States Court of Appeals for the First Circuit found that all plaintiffs have standing and the court has jurisdiction to proceed with the case, at least with respect to the plaintiffs' individual claims. However, it concluded that four plaintiffs waited too long before filing this lawsuit, and their claims are time-barred. For the remaining plaintiffs, the court vacated the judgment dismissing their claims and remanded the case to the district court for further proceedings. View "Wilkins v. Genzyme Corporation" on Justia Law

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In this case, Virginia Cora Ward, as the administratrix of the estate of Edmund Edward Ward, brought a case against AlphaCore Pharma, LLC (ACP) and Bruce Auerbach. The decedent, Edmund Ward, was a participant in a clinical trial for a drug known as ACP-501, which was developed by ACP and administered by the National Institutes of Health (NIH). The trial took place in Maryland, where Ward traveled from his home in Massachusetts to receive treatment. Ward later withdrew from the trial due to deteriorating kidney function.In 2016, Ward filed a complaint against ACP, Auerbach, and several others, alleging fraudulent inducement to participate in the clinical trial. ACP and Auerbach moved to dismiss the case for lack of personal jurisdiction, arguing that they lacked sufficient contacts with Massachusetts. The United States District Court for the District of Massachusetts agreed with them and dismissed the case. Ward appealed to the United States Court of Appeals for the First Circuit.The First Circuit affirmed the district court's decision. The court held that neither ACP nor Auerbach had sufficient related and purposeful contacts in and with Massachusetts to establish personal jurisdiction. The court rejected Ward's claims that ACP and Auerbach had contacts with Massachusetts through their interactions with Ward's Massachusetts-based doctor, their alleged shipment of the drug to Massachusetts, their involvement in drafting the clinical trial protocol, and their alleged reimbursement of Ward's travel expenses. The court found that these claims were either unsupported by evidence or were not sufficient to establish personal jurisdiction. As a result, the court affirmed the district court's dismissal of the case against ACP and Auerbach for lack of personal jurisdiction. View "Ward v. Schaefer" on Justia Law

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Former executives of medical device manufacturer Acclarent, Inc., William Facteau and Patrick Fabian, were found guilty of multiple misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FDCA) for commercially distributing an adulterated and misbranded medical device. They appealed their convictions, claiming First Amendment violations, due process violations, and insufficiency of evidence. The United States Court of Appeals for the First Circuit rejected all of these claims and affirmed the convictions. The court held that the use of promotional speech as evidence of a device's intended use did not implicate the First Amendment. The court also found that the term "intended use" was not unconstitutionally vague and that Facteau and Fabian had fair warning of the conduct prohibited under the FDCA. Finally, the court found that the evidence was sufficient to support the convictions and that Fabian's fine did not violate the Eighth Amendment. View "United States v. Facteau" on Justia Law

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The First Circuit affirmed the judgment of the district court dismissing Plaintiff's putative class action against McNeil Nutritionals, LLC and Johnson & Johnson Consumer, Inc. challenging certain statements on the packaging of Lactaid products, holding that the district court correctly dismissed the complaint.Plaintiff brought this action claiming that Lactaid's labels violated federal labeling requirements, leading Plaintiff to have been mislead into purchasing Lactaid products, which she claimed were more expensive than other lactase supplements. The district court granted Defendants' second motion to dismiss. The First Circuit affirmed, holding that Plaintiff's claims were impliedly preempted by the statutory enforcement authority of the Food and Drug Administration. View "DiCroce v. McNeil Nutritionals, LLC" on Justia Law

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The First Circuit affirmed the decision of the district court granting summary judgment to Vitamin Shoppe and ruling that the Food, Drug, and Cosmetic Act (FDCA) preempted Plaintiffs' state law tort claims, holding that Plaintiffs' state law claims were expressly preempted by the FDCA.Plaintiffs purchased three dietary supplements containing glutamine as a main ingredient. Plaintiffs brought this action against the products' manufacturers claiming that the labels on the supplements contained statements that were false and misleading under state law. The district court granted summary judgment in favor of Vitamin Shoppe, holding that the FDCA preempted Plaintiffs' state law claims. The First Circuit affirmed, holding (1) the statements on Vitamin Shoppe's labels were structure/function claims under 343(r)(6), and Vitamin Shoppe complied with the FDCA's requirements to make such claims; and (2) therefore, Plaintiffs' state law claims challenging the statements about glutamine were expressly preempted by the FDCA. View "Ferrari v. Vitamin Shoppe Industries LLC" on Justia Law

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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

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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

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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

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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