Justia U.S. D.C. Circuit Court of Appeals Opinion Summaries

Novartis Pharmaceuticals Corporation manufactures Entresto, a drug used to treat chronic heart failure. MSN Pharmaceuticals, Inc. sought approval from the Food and Drug Administration (FDA) to market a generic version of Entresto by submitting an abbreviated new drug application (ANDA). MSN’s application excluded certain methods of use protected by Novartis’s patents and claimed that the generic drug contained the same active ingredients as Entresto. The FDA approved MSN’s application, prompting Novartis to challenge the approval, arguing that the generic’s labeling and composition were unlawfully different from Entresto.The United States District Court for the District of Columbia reviewed Novartis’s claims under the Administrative Procedure Act. Novartis argued that the FDA’s approval of MSN’s ANDA and denial of Novartis’s citizen petitions were arbitrary and capricious, particularly regarding the omission of patented dosing regimens and indications from the generic’s label, and the determination that the generic contained the same active ingredients as Entresto. The district court granted summary judgment in favor of the FDA, finding that the agency’s actions were reasonable and consistent with statutory and regulatory requirements. Novartis appealed this decision.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that the FDA reasonably concluded the generic drug’s labeling changes were permissible to avoid patent infringement and did not render the generic less safe or effective for non-patented uses. The court also found that the FDA’s determination that the generic and Entresto shared the same active ingredients was supported by scientific evidence and regulatory guidance. The court applied de novo review to legal questions and deferred to the FDA’s scientific expertise, ultimately upholding the agency’s approval of MSN’s ANDA. View "Novartis Pharmaceuticals Corp. v. Kennedy" on Justia Law

A group of hospitals challenged the calculation of their Medicare fractions for fiscal year 2007, which is a key component in determining eligibility and payment amounts under the Medicare disproportionate share hospital (DSH) adjustment. The DSH adjustment provides increased reimbursement to hospitals serving a high number of low-income patients. The hospitals disputed the inclusion of Medicare Part C beneficiaries in the Medicare fraction, arguing that this reduced their payments. After the Centers for Medicare and Medicaid Services (CMS) published the Medicare fractions, the hospitals appealed to the Provider Reimbursement Review Board, seeking review of the calculation before the final DSH adjustment was determined.The Provider Reimbursement Review Board dismissed the hospitals’ appeal for lack of jurisdiction, reasoning that a challenge could only be brought after the final determination of the DSH adjustment was made and reflected in the Notice of Program Reimbursement (NPR). The Board concluded that publication of the Medicare fraction alone did not constitute a “final determination” as required by statute. The hospitals then sought review in the United States District Court for the District of Columbia, which disagreed with the Board and held that the hospitals’ challenge could proceed, interpreting precedent to allow appeals at the stage of Medicare fraction publication.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and reversed the district court’s judgment. The court held that the Board lacked jurisdiction to hear the hospitals’ challenge prior to the issuance of the NPR, because only the NPR constitutes the Secretary’s “final determination as to the amount of the payment” under the relevant statutory provision. The court clarified that while some prospective payment system components may be appealed before the NPR, retrospective adjustments like the DSH adjustment require final settlement before an appeal is ripe. View "Battle Creek Health System v. Kennedy" on Justia Law

A pharmaceutical company sought approval from the Food and Drug Administration (FDA) to market tasimelteon, a drug previously approved for a rare sleep disorder, as a treatment for jet lag. The company submitted results from several clinical trials, focusing on both objective sleep measures and subjective assessments of alertness and next-day functioning. The FDA’s Center for Drug Evaluation and Research issued a complete response letter indicating that the application did not provide substantial evidence of efficacy, particularly criticizing the measurement of next-day impairment and the tools used for subjective endpoints. The company engaged in further discussions and dispute resolution with the FDA, including proposing a narrower indication for approval, but these efforts were unsuccessful.After the FDA issued a formal notice of opportunity for a hearing (NOOH), the company requested a hearing and submitted expert declarations supporting the adequacy of its clinical evidence. The FDA ultimately denied both the application and the hearing request, finding no genuine and substantial issue of fact warranting a hearing. The company then petitioned the United States Court of Appeals for the District of Columbia Circuit for review, arguing that the FDA was required to hold a hearing, that material factual disputes existed, that the FDA’s decision-making was arbitrary and capricious, and that the final decision violated the Appointments Clause.The United States Court of Appeals for the District of Columbia Circuit held that the Food, Drug, and Cosmetic Act does not require the FDA to hold a hearing before denying every new drug application, but the agency must grant a hearing if there are material factual disputes. The court found that, in this case, the FDA’s refusal to hold a hearing was arbitrary and capricious because the company’s expert evidence created genuine disputes over the adequacy of the clinical trials. The court remanded the case to the FDA for further proceedings consistent with its opinion. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

Terri R. Winnon, a former executive assistant and controller for a group of skilled nursing facilities (SNFs) in Texas, alleged that her former employers and associated entities engaged in fraudulent schemes to obtain improper reimbursements from Medicare and Texas Medicaid. She claimed that the defendants paid unlawful kickbacks to doctors and hospital discharge planners for patient referrals and inflated therapy service bills to maximize government reimbursements. Winnon’s allegations included specific practices such as employee bonuses tied to Medicare census targets, “sham” medical directorships, and “marketing gifts” to hospital staff, as well as systematic upcoding of therapy services by a contracted provider, RehabCare.After Winnon filed her qui tam action under the False Claims Act (FCA) and related Texas statutes, the United States District Court for the District of Columbia dismissed her claims. The court found that her allegations against RehabCare were barred by the FCA’s public disclosure provision, as similar claims had already been made public in a prior lawsuit, United States ex rel. Halpin & Fahey v. Kindred Healthcare, Inc. The district court also determined that Winnon’s claims against the SNF Defendants did not meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b), as they lacked sufficient particularity regarding the alleged fraudulent conduct.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s dismissals. The appellate court held that Winnon’s claims against RehabCare were precluded by the public disclosure bar because her allegations were substantially similar to those previously disclosed and she did not qualify as an “original source” under the FCA. Regarding the SNF Defendants, the court concluded that Winnon’s allegations failed to satisfy Rule 9(b)’s requirement for particularity, as she did not provide enough specific details to support a strong inference that false claims were actually submitted. The court affirmed the district court’s judgments in full. View "USA v. Lozano" on Justia Law

Jazz Pharmaceuticals, Inc. (Jazz) challenged the FDA's approval of Avadel CNS Pharmaceuticals Inc.'s (Avadel) drug Lumryz, which contains the same active ingredient, oxybate, as Jazz's drug Xywav. Jazz argued that the FDA's approval violated its seven-year marketing exclusivity under the Orphan Drug Act (ODA). The key issue was whether Lumryz and Xywav are considered the "same drug" under the ODA, which would bar the FDA from approving Lumryz during Xywav's exclusivity period.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA and Avadel, concluding that the FDA's approval of Lumryz did not violate the ODA. The court reasoned that the statutory text, history, and purpose indicated that Congress intended to incorporate the FDA's regulatory definition of "same drug," which includes a clinical superiority requirement. The court found that Lumryz, being clinically superior to Xywav due to its once-nightly dosing regimen, was not the "same drug" as Xywav.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's decision. The appellate court held that the FDA did not act beyond its statutory authority in approving Lumryz. The court concluded that Congress, by amending the ODA in 2017, intended to incorporate the FDA's longstanding regulatory definition of "same drug," which includes the concept of clinical superiority. Since Lumryz was found to be clinically superior to Xywav, it was not considered the "same drug," and thus, the FDA's approval of Lumryz during Xywav's exclusivity period was lawful. View "Jazz Pharmaceuticals, Inc. v. Kennedy" on Justia Law

California collects a fee from in-state hospitals and uses the revenue, along with federal Medicaid funds, to provide subsidies to California hospitals serving Medicaid beneficiaries. Out-of-state hospitals near the California border, which sometimes serve California Medicaid beneficiaries but do not pay the fee, sought access to these subsidies. They argued that their exclusion violated the dormant Commerce Clause, the Equal Protection Clause, and federal Medicaid regulations.The United States District Court for the District of Columbia rejected the out-of-state hospitals' arguments and granted summary judgment in favor of the Centers for Medicare and Medicaid Services (CMS). The hospitals appealed the decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo and affirmed the district court's decision. The court held that the QAF program does not discriminate against interstate commerce because it does not tax out-of-state hospitals, and the supplemental payments are based on in-state provision of medical care. The court also found that the program does not violate the Equal Protection Clause, as California could rationally decide to target subsidies to in-state hospitals serving a disproportionate share of Medi-Cal beneficiaries. Lastly, the court concluded that the QAF program does not violate federal Medicaid regulations, as the regulation in question pertains to base payments for specific services rendered to beneficiaries, not supplemental subsidies like the QAF payments. View "Asante v. Kennedy" on Justia Law

Vanda Pharmaceuticals, Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request, citing a partial clinical hold on the drug due to the lack of long-term animal studies to assess its toxicological effects. Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA, upholding the agency's decision. Vanda then appealed to the United States Court of Appeals for the District of Columbia Circuit.The Court of Appeals affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs. The court also noted that the FDA's definition of the unmet medical need as long-term treatment of gastroparesis symptoms was reasonable, given the chronic nature of the condition and the existing short-term treatment options. The court rejected Vanda's arguments that the FDA's decision was inconsistent with its prior positions and that the agency improperly considered the clinical hold. The court concluded that the FDA's decision was supported by a rational connection between the facts found and the choice made. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

The appellant, a federal prisoner serving a twenty-two-year sentence, has a history of filing numerous lawsuits regarding his prison conditions. In this case, he sought to proceed in forma pauperis (IFP) under the Prison Litigation Reform Act (PLRA) despite having three prior cases dismissed as frivolous, malicious, or for failure to state a claim. He claimed imminent danger of serious physical injury due to worsening glaucoma and alleged that prison officials denied him necessary medical treatment and incited other inmates to assault him.The United States District Court for the District of Columbia denied his motion to proceed IFP, finding that he did not demonstrate imminent danger of serious physical injury. The court dismissed his case without prejudice. The appellant then appealed this decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court disagreed with the District Court's assessment regarding the appellant's glaucoma, finding that the appellant's allegations of being denied necessary medical treatment for his worsening glaucoma did place him under imminent danger of serious physical injury. Consequently, the court granted the appellant's motion to proceed IFP and reversed the District Court's denial of his motion, allowing his complaint to be docketed.However, the court also found that some of the appellant's claims were frivolous, particularly those against high-ranking officials such as the United States Attorney General and members of the United States Senate Judiciary Committee. These claims were dismissed under the PLRA's mandate to dismiss frivolous claims. The court's decision allowed the appellant to proceed with his claims related to his medical treatment and alleged assaults but dismissed the frivolous claims against the aforementioned officials. View "Owlfeather-Gorbey v. Avery" on Justia Law

Lake Region Healthcare Corporation operates a hospital in Minnesota and experienced a significant decrease in Medicare inpatient discharges in 2013, qualifying it for a volume-decrease adjustment (VDA). The hospital sought an adjustment of $1,947,967 using a method that estimates the portion of Medicare payments attributable to fixed costs. A Medicare contractor denied the adjustment, applying a method that treats all Medicare payments as compensation for fixed costs, resulting in no adjustment. The Provider Reimbursement Review Board (PRRB) reversed the contractor's decision, but the Centers for Medicare & Medicaid Services (CMS) reinstated it.The United States District Court for the District of Columbia ruled in favor of the government, deferring to CMS's method under Chevron deference. The court found that the statute did not specify how to calculate the VDA and that CMS's method was a reasonable interpretation, even if not the best one. The court concluded that CMS's approach was consistent with the statutory requirement to compensate only for fixed costs.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The court held that CMS's method of attributing all Medicare payments to fixed costs did not comply with the statutory requirement to fully compensate hospitals for their fixed costs. The court noted that Medicare payments cover both fixed and variable costs and that CMS's method overstates the amount of reimbursed fixed costs, thus understating unreimbursed fixed costs. The court found that reasonable proxies exist to estimate the fixed-cost component of Medicare payments and that CMS's method was not a reasonable approximation of full compensation for fixed costs.The court reversed the district court's decision, granted summary judgment to Lake Region, and remanded the case to the agency for further proceedings consistent with the opinion. View "Lake Region Healthcare Corporation v. Becerra" on Justia Law

The plaintiffs, Medicare beneficiaries with chronic illnesses, rely on home health aides for essential care. They allege that Medicare-enrolled providers have either refused to provide in-home care or offered fewer services than entitled, attributing this to the policies of the Secretary of Health and Human Services. They sought systemwide reforms through a lawsuit.The United States District Court for the District of Columbia dismissed the plaintiffs' complaint for lack of Article III standing. The court found that the plaintiffs failed to plausibly allege that their requested relief would redress any harm. The court noted that the injuries were caused by private home health agencies (HHAs) not before the court and that it was speculative whether enjoining the Secretary would change the HHAs' behavior. The court also found the plaintiffs' requested relief too general, making it difficult to evaluate its potential impact.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and affirmed the district court's dismissal. The appellate court held that the plaintiffs failed to demonstrate redressability, a key component of standing. The court noted that the plaintiffs' injuries stemmed from the independent choices of private HHAs, and it was speculative that the requested injunctions would prompt these agencies to change their behavior. The court emphasized that the plaintiffs did not provide sufficient evidence to show that the Secretary's enforcement policies were a substantial factor in the HHAs' decisions. Consequently, the plaintiffs lacked standing to bring the suit, and the dismissal for lack of jurisdiction was affirmed. View "Johnson v. Becerra" on Justia Law