Justia Government & Administrative Law Opinion Summaries

The case involves the Food and Drug Administration (FDA) denying authorization for respondents to market certain flavored e-cigarette products. The FDA's decision was based on the lack of sufficient scientific evidence demonstrating that these products would be appropriate for the protection of public health. The FDA emphasized the need for evidence from randomized controlled trials or longitudinal cohort studies, which the respondents did not provide. Instead, respondents submitted literature reviews and cross-sectional surveys, which the FDA found inadequate.The United States Court of Appeals for the Fifth Circuit, sitting en banc, reviewed the FDA's denial orders. The court found that the FDA acted arbitrarily and capriciously by applying different standards than those articulated in its predecisional guidance. The court was particularly concerned with the FDA's failure to review marketing plans, which it had previously deemed critical. The Fifth Circuit rejected the FDA's argument that any errors were harmless and remanded the case to the FDA.The Supreme Court of the United States reviewed the case and vacated the Fifth Circuit's decision. The Court held that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. However, the Court agreed with the FDA that the Fifth Circuit's interpretation of harmless error was overly broad. The Supreme Court remanded the case to the Fifth Circuit to reconsider the harmless-error question without relying on its expansive reading of Calcutt v. FDIC. View "FDA v. Wages and White Lion Investments, LLC" on Justia Law

Dr. Jeffery D. Milner, a physician, brought a qui tam action under the False Claims Act (FCA) against Baptist Health Montgomery, Prattville Baptist, and Team Health. Milner alleged that while working at a hospital owned by the defendants, he discovered that they were overprescribing opioids and fraudulently billing the government for them. He claimed that he was terminated in retaliation for whistleblowing after reporting the overprescription practices to his superiors.Previously, Milner filed an FCA retaliation lawsuit against the same defendants in the U.S. District Court for the Northern District of Alabama, which was dismissed with prejudice for failure to state a claim. The court found that Milner did not sufficiently allege that he engaged in protected conduct under the FCA or that his termination was due to such conduct. Following this dismissal, Milner filed the current qui tam action in the U.S. District Court for the Middle District of Alabama. The district court dismissed this action as barred by res judicata, relying on the Eleventh Circuit's decisions in Ragsdale v. Rubbermaid, Inc. and Shurick v. Boeing Co.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's dismissal. The court held that Milner's qui tam action was barred by res judicata because it involved the same parties and the same cause of action as his earlier retaliation lawsuit. The court found that both lawsuits arose from a common nucleus of operative fact: the defendants' alleged illegal conduct and Milner's discovery of that conduct leading to his discharge. The court also noted that the United States, which did not intervene in the qui tam action, was not barred from pursuing its own action in the future. View "Milner v. Baptist Health Montgomery" on Justia Law

Relators Tiffany Montcrief and others filed a False Claims Act suit against Peripheral Vascular Associates, P.A. (PVA), alleging that PVA billed Medicare for vascular ultrasound services that were not completed. The claims were categorized into "Testing Only" and "Double Billing" claims. The district court granted partial summary judgment to Relators, concluding that PVA submitted knowingly false claims. A jury found these claims material and awarded approximately $28.7 million in damages against PVA.The district court granted partial summary judgment to Relators on the issues of falsity and knowledge of falsity. The jury found that the claims were material and caused the Government to pay out money. The district court entered judgment against PVA, including statutory penalties and treble damages. PVA appealed, challenging the district court's grant of partial summary judgment and certain rulings during and after the trial.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court affirmed the district court's grant of partial summary judgment on the Testing Only claims but remanded for a new trial on damages. The court reversed the partial summary judgment ruling on the Double Billing claims, vacated the final judgment, and remanded for a new trial consistent with its opinion. The court concluded that the district court erred in interpreting the CPT–4 Manual and in concluding that the Manual required PVA to create separate, written reports for vascular ultrasounds before billing Medicare. The court also found that the district court abused its discretion in relying on Relators' post-trial expert declaration to calculate damages. View "Montcrief v. Peripheral Vascular" on Justia Law

Dr. Omar Almusa, a licensed medical physician and surgeon in Pennsylvania, unlawfully distributed hydrocodone between 2014 and 2018. He pleaded guilty to unlawful dispensing and distributing a controlled substance, conspiracy to distribute, and health care fraud. In 2019, he was sentenced to 24 months in prison followed by three years of supervised release. Consequently, the State Board of Medicine automatically suspended his medical license for at least ten years, effective August 15, 2019.Almusa did not appeal the suspension. In 2020, the General Assembly enacted Act 53, redefining how licensing boards consider criminal offenses, specifying that only drug trafficking offenses (involving at least 100 grams of a controlled substance) warrant automatic suspension. Almusa's offense did not meet this threshold. In 2021, Almusa petitioned for reinstatement of his license, arguing that Act 53 should apply to his case, allowing him to seek reinstatement without waiting ten years.The Board denied his petition, stating that Act 53 did not apply retroactively to suspensions imposed before its enactment. The Commonwealth Court affirmed the Board's decision, interpreting the suspension and reinstatement as a single action requiring a ten-year suspension period.The Supreme Court of Pennsylvania reversed the Commonwealth Court's decision. It held that automatic suspension and reinstatement are separate actions under the Medical Practice Act. The Court found that Act 53, effective December 28, 2020, applies to reinstatement proceedings initiated after this date. Since Almusa's offense did not qualify as drug trafficking under Act 53, the ten-year waiting period did not apply to his reinstatement petition. The Court concluded that Almusa was entitled to have his reinstatement petition considered under the new law. View "Almusa v. State Board of Medicine" on Justia Law

Several skilled nursing facilities challenged the State Department of Health Care Services and its director, Michelle Baass, over the formula used to calculate Medi-Cal reimbursement overpayments. The plaintiffs argued that the Department's method, which was based on the amount Medicare paid for ancillary services rather than the amount Medi-Cal overpaid, violated a ministerial duty and constituted an underground regulation.The trial court sustained the Department's demurrer without leave to amend, concluding that the plaintiffs' claim was not cognizable in a traditional writ of mandate proceeding. The court also found that the plaintiffs failed to state a claim that the Department violated a ministerial duty or adopted an underground regulation. Additionally, the trial court denied the plaintiffs' motion to compel discovery of certain documents, deeming them privileged.The California Court of Appeal, Third Appellate District, reviewed the case. The court determined that some of the plaintiffs' claims were indeed cognizable in a traditional writ of mandate proceeding and that the petition stated a claim for relief regarding the Department's use of an underground regulation when calculating Medi-Cal reimbursement overpayments. However, the court found that the plaintiffs did not provide an adequate record to review whether the trial court erred in denying their motion to compel discovery.The appellate court reversed the judgment of dismissal and affirmed the trial court's order denying the plaintiffs' motion to compel. The case was remanded to the trial court with instructions to vacate its order sustaining the Department's demurrer without leave to amend and to enter a new order overruling the demurrer. The plaintiffs were awarded their costs on appeal. View "California Healthcare & Rehabilitation Center v. Baass" on Justia Law

The case involves the U.S. Centers for Medicare & Medicaid Services (CMS) approving the New York State Department of Health’s (NYSDOH) application to distribute $361.25 million to certain managed care organizations. These organizations were to direct the funds to the top one-third of revenue-generating licensed home care services agencies (LHCSAs) in New York’s four rate regions, provided they agreed to use the funding in a specified manner. The plaintiffs, who are LHCSAs that did not meet the revenue threshold, argued that the approval was unlawful under federal law and regulations because the class of eligible agencies was improperly defined and the application was not assessed for actuarial soundness before approval.The district court dismissed the amended complaint against the State Appellees for failing to adequately allege a cause of action under Ex parte Young and granted summary judgment to the Federal Appellees. The court concluded that the approval of the State’s application did not violate the Administrative Procedure Act (APA) and denied the plaintiffs’ motion to admit extra-record evidence.The United States Court of Appeals for the Second Circuit reviewed the case and agreed with the district court’s decision. The court held that CMS’s approval of NYSDOH’s application complied with federal law. It found that the provider class was properly defined under 42 C.F.R. § 438.6(c)(2)(ii)(B) and that CMS was not required to assess actuarial soundness during the pre-approval process. The court also concluded that CMS did not act arbitrarily or capriciously in approving the application and that the district court did not abuse its discretion in excluding the extra-record evidence. Consequently, the Second Circuit affirmed the judgment of the district court. View "Safe Haven Home Care, Inc. v. United States Department of Health and Human" on Justia Law

In November 2021, Lincoln Medical administered a COVID-19 vaccine to the five-year-old child of Jeremiah Hogan and Siara Jean Harrington at a school clinic without obtaining parental consent. Hogan filed a notice of claim in the Superior Court against the doctor, Lincoln Medical Partners, and MaineHealth, Inc., alleging various torts including professional negligence, battery, and false imprisonment on behalf of the child, and emotional distress and tortious interference with parental rights on behalf of the parents.The Superior Court appointed a chair for the prelitigation screening panel, and Lincoln Medical moved to dismiss the notice of claim, citing immunity under the federal Public Readiness and Emergency Preparedness (PREP) Act. The court granted the motion to dismiss, interpreting the PREP Act to provide immunity to the defendants with no applicable exceptions. Hogan appealed the decision.The Maine Supreme Judicial Court reviewed the case and affirmed the Superior Court's judgment. The court held that the PREP Act provides broad immunity to covered persons, including individuals and corporations, from suits related to the administration of covered countermeasures, such as the COVID-19 vaccine. The court found that the federal statute preempts state law that would otherwise allow Hogan to sue, as the claims were directly related to the administration of the vaccine. The court concluded that the defendants were immune from Hogan’s claims under the PREP Act, and the state tort claims were preempted by federal law. View "Hogan v. Lincoln Medical Partners" on Justia Law

A hospital in Siskiyou County, California, filed a lawsuit against the County of Siskiyou and other defendants, challenging the practice of bringing individuals with psychiatric emergencies to its emergency department under the Lanterman-Petris-Short (LPS) Act. The hospital argued that it was not equipped or licensed to provide the necessary psychiatric care and sought to prevent the county from bringing such patients to its facility unless they had a physical emergency condition. The hospital also sought reimbursement for the costs associated with holding these patients.The Siskiyou County Superior Court denied the hospital's motion for a preliminary injunction, which sought to stop the county from bringing psychiatric patients to its emergency department. The court found that the hospital had not demonstrated a likelihood of success on the merits and that the burden on the county and the potential harm to the patients outweighed the hospital's concerns.The hospital's complaint included several causes of action, including violations of Medicaid laws, disability discrimination laws, mental health parity laws, and section 17000 of the Welfare and Institutions Code. The hospital also alleged breach of an implied-in-fact contract for the costs incurred in providing post-stabilization services to psychiatric patients. The trial court sustained demurrers to the complaint without leave to amend, finding that the hospital failed to identify any clear legal mandate that the county or the Department of Health Care Services had violated.The California Court of Appeal, Third Appellate District, affirmed the trial court's judgment of dismissal. The appellate court concluded that the hospital had not identified any mandatory and ministerial duty that the county or the department had violated, which is necessary to obtain a writ of mandate. The court also found that the hospital's breach of contract claim failed because there were no allegations of mutual consent to an implied contract. Consequently, the hospital's appeal from the denial of its motion for a preliminary injunction was dismissed as moot. View "Siskiyou Hospital v. County of Siskiyou" on Justia Law

Michael Chapman, an Alabama inmate, sued prison officials and staff for deliberate indifference to his medical needs, violating the Eighth Amendment. Chapman alleged that an untreated ear infection led to severe injuries, including mastoiditis, a ruptured eardrum, and a brain abscess. He also claimed that the prison's refusal to perform cataract surgery on his right eye constituted deliberate indifference. The district court granted summary judgment for all defendants except the prison’s medical contractor, which had filed for bankruptcy.The United States District Court for the Middle District of Alabama found Chapman’s claim against nurse Charlie Waugh time-barred and ruled against Chapman on other claims, including his request for injunctive relief against Commissioner John Hamm, citing sovereign immunity. The court also concluded that Chapman’s claims against other defendants failed on the merits and dismissed his state-law claims without prejudice.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court reversed the district court’s determination that Chapman’s claim against Waugh was time-barred, finding that Chapman’s cause of action accrued within the limitations period. The court vacated the district court’s judgment for Waugh and remanded for reconsideration in light of the recent en banc decision in Wade, which clarified the standard for deliberate indifference claims. The court also vacated the judgment for Hamm on Chapman’s cataract-related claim for injunctive relief, as sovereign immunity does not bar such claims. Additionally, the court vacated the summary judgment for all other defendants due to procedural errors, including inadequate notice and time for Chapman to respond, and remanded for further consideration. View "Chapman v. Dunn" on Justia Law

A medical doctor, employed by San Bernardino Medical Group and working for OptumCare Medical Group, faced a summary suspension of his clinical privileges by PrimeCare Medical Network, Inc. after a patient complaint. The patient alleged that the doctor hit her hand during an office visit, which the doctor admitted to in his notes, explaining it was to stop her from arguing. The next day, PrimeCare’s Chief Medical Officer (CMO) summarily suspended the doctor’s privileges, citing imminent danger to patient health.The Corporate Quality Improvement Committee (CQIC) upheld the suspension pending the doctor’s completion of an anger management course. The doctor requested a formal hearing, and PrimeCare’s Judicial Hearing Committee (JHC) found that the summary suspension was not warranted, as the incident was isolated and did not demonstrate imminent danger. The JHC recommended anger management and a chaperone for the doctor but did not find the suspension justified.PrimeCare’s Board of Directors reviewed the JHC’s decision, arguing it was inconsistent with the applicable burden of proof. The Board conducted an independent review, disagreed with the JHC’s findings, and reinstated the suspension, concluding that the doctor’s actions and subsequent comments posed an imminent threat to patients.The doctor filed a petition for writ of administrative mandamus, which the Superior Court of San Bernardino County granted. The court ruled that the Board exceeded its jurisdiction and committed a prejudicial abuse of discretion by independently reviewing and reversing the JHC’s decision. The court ordered the Board to adopt the JHC’s decision, reinstate the doctor’s privileges, and report the reinstatement to relevant entities.The California Court of Appeal, Fourth Appellate District, affirmed the trial court’s judgment, agreeing that the Board’s actions were unauthorized and inconsistent with the statutory requirement that peer review be performed by licentiates. View "Lin v. Board of Directors of PrimeCare Medical Network" on Justia Law