Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
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Kennedy worked for Novo, promoting a new diabetes drug, Victoza. FDA approval of Victoza included specific conditions concerning a possible risk of thyroid cancer. According to Kennedy, in preparation for Victoza’s commercial launch, she was directed to market the drug in ways inconsistent with those FDA limitations. Kennedy filed a False Claims Act (FCA) complaint, alleging that Novo caused people to submit millions of dollars in false claims for payment under federal health care programs. Several such cases were consolidated in the District of Columbia. The government intervened. Novo, the government, and Kennedy reached a settlement for $46.5 million.The government filed a separate complaint against Novo, under the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, alleging Victoza was an unlawfully “misbranded” drug. In the FDCA Settlement, Novo admitted that it had trained its employees to undermine the risks and agreed to pay the government $12,150,000. Kennedy was not a party to the FDCA litigation.Kennedy sought a share of the FDCA Settlement, arguing that it was an “alternate remedy” under the FCA, 31 U.S.C. 3730(c)(5). The D.C. Circuit reversed Kennedy’s award. The FCA confines qui tam plaintiffs to recoveries only for claims seeking relief based on fraud or falsehoods covered by that statute. The government’s separate FDCA enforcement action did not involve the type of claim cognizable under the FCA, nor did it allege a false or fraudulent effort to obtain money or property from the government. Kennedy received an agreed-upon FCA payment with knowledge of the separate action and is not entitled to further recovery. View "Kennedy v. Novo A/S" on Justia Law

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Educational Center treats patients with severe mental disabilities, some of whom suffer from severe self-injurious and aggressive behaviors that are difficult or impossible to treat using conventional behavioral and pharmacological techniques. Some patients have suffered brain trauma, broken and protruding bones, and blindness as a result of their behaviors. Before the ban, the Center treated some self-injurious and aggressive patients with an electrical stimulation device called a graduated electronic decelerator, which briefly shocks patients causing them to reduce or cease their self-injurious behaviors. The Center is the only facility in the country that uses electric shock therapy to treat individuals who severely self-injure or are aggressive. Other health care practitioners administer electrical stimulation devices to treat a wide variety of other conditions, including tobacco, alcohol, and drug addictions, as well as inappropriate sexual behaviors following traumatic brain injuries. The Center manufactures its own devices, which are regulated by the FDA, 21 U.S.C. 360c(a)(1)(B).In 2020, the FDA determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients and banned the devices for that purpose. The D.C. Circuit vacated the rule. Banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. 396. View "The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration" on Justia Law

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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

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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

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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

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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. View "Roane v. Barr" on Justia Law

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Plaintiffs, three cigar and pipe tobacco industry associations, filed suit challenging various provisions of the FDA's Deeming Rule, which subjects newly regulated tobacco products, including cigars and pipe tobacco, to requirements akin to those previously imposed by statute on cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Plaintiffs contend that the warning requirements for cigars and pipe tobacco violate the Tobacco Control Act and the Administrative Procedure Act because the FDA did not adequately consider how the warnings would affect smoking. Plaintiffs also argued that the warning requirements violate the First Amendment.The DC Circuit held that Congress required the FDA to consider whether any regulation under section 906(d)(1) of the Federal Food, Drug, and Cosmetic Act would likely affect the number of tobacco users. In promulgating the warning requirements for cigars and pipe tobacco, the court held that the FDA failed to satisfy that obligation. Therefore, the court reversed the district court's grant of summary judgment to the FDA and the denial of summary judgment to plaintiffs. The court dismissed as moot plaintiffs' appeal from the denial of their motion for a preliminary injunction. Finally, the court remanded for further proceedings. View "Cigar Association of America v. Food and Drug Administration" on Justia Law

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Drug manufacturers challenged the Department's rule that broadly requires drug manufacturers to disclose in their television advertisements the wholesale acquisition cost of many prescription drugs and biological products for which payment is available under Medicare or Medicaid.The DC Circuit affirmed the district court's judgment in favor of the drug manufacturers, holding that the Department acted unreasonably in construing its regulatory authority to include the imposition of a sweeping disclosure requirement that is largely untethered to the actual administration of the Medicare or Medicaid programs. The court explained that, in the overwhelming majority of cases, the price that the rule compels manufacturers to disclose bears little resemblance to the price beneficiaries actually pay under the Medicare and Medicaid programs. Therefore, the court held that there is no reasoned statutory basis for the Department's far-flung reach and misaligned obligations, and thus the rule is invalid and is hereby set aside. View "Merck & Co., Inc. v. United States Department of Human and Health Services" on Justia Law

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PMRS petitioned for review of the FDA's denial of PMRS's application to market a prescription opioid drug. The DC Circuit rejected PMRS's challenges under the Administrative Procedure Act (APA), and held that the FDA's decision to deny the application was reasonable and consistent with law. The court held that the FDA examined the material factors, considered the record as a whole, and provided a reasonable explanation for its decision to deny PMRS's application. In this case, the court had no basis to question the agency's conclusion that the operative version of PMRS's proposed label created the false and misleading impression that the drug possessed abuse deterrent physical and chemical properties. The court also held that the FDA's decision to deny PMRS's request for a hearing was not an abuse of discretion. View "Pharmaceutical Manufacturing Research Services, Inc. v. FDA" on Justia Law

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The DC Circuit affirmed the district court's grant of summary judgment in favor of Eagle, in an action brought by Eagle, alleging that the Orphan Drug Act's (ODA), 21 U.S.C. 360aa–360ee, plain language required the FDA to automatically grant Eagle marketing exclusivity upon designating its drug as an orphan drug and approving it for marketing. The court held that the district court correctly determined at Chevron step one that the FDA's post-approval clinical superiority requirement was forbidden and that Eagle was automatically entitled to a seven-year period of exclusive approval when it approved Bendeka for marketing. View "Eagle Pharmaceuticals, Inc. v. Azar" on Justia Law