Justia Government & Administrative Law Opinion Summaries

The FDA filed suit against the Clinic, alleging that the Clinic's stem cell procedure violates the Federal Food, Drug, and Cosmetics Act. The Clinic offers a procedure, which purportedly treats all kinds of chronic conditions, in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective.The Eleventh Circuit affirmed, concluding that the Clinic's stem cell procedure does not fall within the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. The procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. Furthermore, the procedure does not fall within the 361 HCT/P exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. View "United States v. US Stem Cell Clinic, LLC" on Justia Law

The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 321(g) regulates homeopathic drugs. A 1988 FDA guidance document outlined the circumstances in which the FDA intended to exercise its discretion not to enforce the full force of the FDCA against homeopathic drugs. In 2019, the FDA withdrew the guidance document, explaining that the homeopathic drug industry had expanded significantly and it had received numerous reports of “[n]egative health effects from drug products labeled as homeopathic.” The FDA then implemented a “risk-based” enforcement approach and added six of MediNatura’s prescription injectable homeopathic products to an import alert, notifying FDA field staff that the products appeared to violate the FDCA.The D.C. Circuit affirmed the dismissal of MediNatura’s challenges. When a product is detained under an import alert, the importer is given notice and an opportunity to be heard, so the import alert was non-final agency action. The court declined to enjoin the withdrawal of the 1988 guidance, noting the public’s strong interest in the enforcement of the FDCA. Requiring the FDA to keep in place a guidance document that no longer reflects its current enforcement thinking, particularly in light of present public health concerns related to homeopathic drugs, is not in the public interest. View "MediNatura, Inc. v. Food and Drug Administration" on Justia Law

Abbott Laboratories and Abbott Laboratories, Inc. (collectively, "Abbott"), petitioned the Alabama Supreme Court for a writ of mandamus to direct the Mobile Circuit Court to dismiss all claims asserted by the Mobile County Board of Health and the Family Oriented Primary Health Care Clinic (collectively, "Mobile Health") against Abbott on the basis that those claims are barred by the rule of repose or by the applicable statute of limitations. Mobile Health alleged that Abbott had participated in the marketing of a specific prescription drug, OxyContin. Mobile Health alleged that this marketing campaign "precipitated" an "opioid crisis" in the United States, and specifically in Alabama, because it caused an astronomical increase in the use of opioids by patients who quickly became dependent upon the drugs. Mobile Health asserted that it brought this action because of the burdens it had to bear as a result of the "opioid epidemic." The Alabama Supreme Court concluded the applicable statutes of limitations barred Mobile Health's claims against Abbott. Therefore, the Court granted Abbott's petition for a writ of mandamus, and directed the circuit court to enter an order dismissing Mobile Health's claims against Abbott. View "Ex parte Abbott Laboratories and Abbott Laboratories, Inc." on Justia Law

The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law

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

The People of the State of California, by and through the Santa Clara County Counsel, the Orange County District Attorney, the Los Angeles County Counsel, and the Oakland City Attorney, filed suit against various pharmaceutical companies involved in the manufacture, marketing, distribution, and sale of prescription opioid medications. The People alleged the defendants made false and misleading statements as part of a deceptive marketing scheme designed to minimize the risks of opioid medications and inflate their benefits. The People alleged this scheme caused a public health crisis in California by dramatically increasing opioid prescriptions, opioid use, opioid abuse, and opioid-related deaths. In their suit, the People allege causes of action for violations of the False Advertising Law, and the public nuisance statutes. After several years of litigation, the defendants served business record subpoenas on four nonparty state agencies: the California State Board of Registered Nursing (Nursing Board), the California State Board of Pharmacy (Pharmacy Board), the Medical Board of California (Medical Board), and the California Department of Justice (DOJ). The Pharmacy Board, the Medical Board, and the DOJ served objections to the subpoenas. The Nursing Board filed a motion for a protective order seeking relief from the production obligations of its subpoena. After further litigation, which is recounted below, the trial court ordered the state agencies to produce documents in response to the subpoenas. In consolidated proceedings, the state agencies challenged the trial court's orders compelling production of documents. After review, the Court of Appeal concluded the motions to compel against the Pharmacy Board and Medical Board were untimely, and the defendants were required to serve consumer notices on at least the doctors, nurses, pharmacists, and other health care professionals whose identities would be disclosed in the administrative records, investigatory files, and coroner’s reports. Furthermore, the Court concluded the requests for complete administrative records and investigatory files, were overbroad and not reasonably calculated to lead to the discovery of admissible evidence. "The requests for complete administrative records and investigatory files also ran afoul of the constitutional right to privacy and the statutory official information and deliberative process privileges." The trial court was directed to vacate its orders compelling production of documents, and to enter new orders denying the motions to compel and, for the Nursing Board, granting its motion for a protective order. View "Board of Registered Nursing v. Super. Ct." on Justia Law

Johnson & Johnson and other pharmaceutical defendants sought mandamus relief from an Alabama circuit court order that refused to transfer venue of the underlying lawsuit to the Jefferson County, Alabama circuit court, on grounds that venue in Conecuh County was not proper as to all plaintiffs, or alternatively, on the basis that convenience of the parties and/or the interest of justice required it. In 2019, the plaintiffs filed a complaint at the Conecuh Circuit Court against numerous defendants that, they averred, manufactured, marketed, distributed, and/or dispensed opioid medications throughout Alabama in a manner that was misleading, unsafe, and resulted in drug addiction, injury, and/or death to Alabama citizens. The complaint asserted claims of negligence, nuisance, unjust enrichment, fraud and deceit, wantonness, and civil conspiracy. The manufacturer defendants moved to transfer the case to Jefferson County, reasoning that because 8 of the 17 plaintiffs either had a place of business in Jefferson County or operated hospitals in Jefferson County or adjacent counties, logic dictated that a large percentage of the witnesses for those plaintiffs (i.e., prescribing doctors, hospital administrators, etc.) and their evidence were located in or around Jefferson County. After a review of the circuit court record, the Alabama Supreme Court determined defendants did not demonstrate a clear, legal right to transfer the underlying case from Conecuh to Jefferson County. Therefore, the petition was denied. View "Ex parte Johnson & Johnson et al." on Justia Law

E-cigarette manufacturers and retailers, as well as a nonprofit organization, challenged the FDA's Deeming Rule, which deemed e-cigarettes to be "tobacco products" subject to the Family Smoking Prevention and Tobacco Control Act's requirements, under the Appointments Clause and the First Amendment of the Constitution.The DC Circuit affirmed the district court's grant of summary judgment to the FDA and held that appellants' Appointments Clause challenge lacks merit and their First Amendment challenge is foreclosed. In this case, even assuming for purposes of argument, that Associate Commissioner for Policy Kux's issuance of the Deeming Rule violated the Appointments Clause and that FDA Commissioner Califf's general ratification of prior actions by the FDA as part of an agency reorganization was invalid, FDA Commissioner Gottlieb's ratification cured any Appointments Clause defect. Furthermore, appellants' challenge to the Act's preclearance pathway for modified risk tobacco products as violative of the First Amendment is foreclosed by Nicopure Labs, LLC v. FDA, 944 F.3d 267, 271 (D.C. Cir. 2019). In Nicopure Labs, the court found unpersuasive the objection that appellants make now, namely that the Deeming Rule violates the First Amendment because it places the burden on manufacturers to show that certain of their marketing claims are truthful and not misleading before they make them. View "Moose Jooce v. Food & Drug Administration" on Justia Law

The Supreme Court held that the Arizona Department of Health Services' (ADHS) interpretation of Arizona Administrative Code R9-17-303, which governs ADHS's allocation of marijuana dispensary registration certificates, violated Ariz. Rev. Stat. 36-2804(C).On June 16, 2016, ADHS announced that, because every county had at least one dispensary, it would allocate new registration certificates based on other factors set forth in R9-17-303. Saguaro Healing LLC timely applied for a certificate for its dispensary in La Paz County. During the application period, the only dispensary in La Paz County relocated out of the county. ADHS, however, did not consider the vacancy when prioritizing registration certificates and did not issue a certificate to Saguaro, leaving La Paz County without a dispensary. Saguaro filed a complaint for special action. The trial court dismissed the complaint because R9-17-303(B) "does not say when, during the process of issuing new certificates, [ADHS] must determine how certificates will be allocated." The Supreme Court reversed, holding (1) Ariz. Rev. Stat. 36-2804(C) requires ADHS to issue at least one medical marijuana dispensary registration certificate in each county with a qualified applicant; and (2) ADHS's interpretation of R9-17-303 contrary to this statutory mandate violates section 36-2804(C). View "Saguaro Healing LLC v. State" on Justia Law

Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out.The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim.The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation. View "Cottingham v. Secretary of Health and Human Services" on Justia Law