Justia Health Law Opinion Summaries

A group of drug manufacturers that participate in the federal Section 340B program challenged a Mississippi law, H.B. 728, which prohibits manufacturers from interfering with healthcare providers’ use of contract pharmacies to distribute discounted drugs to low-income and uninsured patients. The manufacturers argued that the law compels them to transfer drugs at a discount to private, for-profit pharmacies and expands their obligations under federal law, potentially enabling improper resale of discounted drugs. They sought a preliminary injunction to prevent the law from taking effect, claiming it constituted an unconstitutional taking and was preempted by federal law.The United States District Court for the Southern District of Mississippi denied the manufacturers’ motion for a preliminary injunction. The court found that the manufacturers had not demonstrated a substantial likelihood of success on the merits of their takings or preemption claims, and thus were not entitled to preliminary injunctive relief. The manufacturers appealed this decision.The United States Court of Appeals for the Fifth Circuit reviewed the district court’s denial of a preliminary injunction for abuse of discretion, applying clear error review to factual findings and de novo review to legal conclusions. The Fifth Circuit affirmed the district court’s decision, holding that the manufacturers had not shown a substantial likelihood of success on their claims. The court concluded that H.B. 728 did not effectuate a physical or regulatory taking, nor was it preempted by federal law under either field or conflict preemption theories. The court emphasized that, on the record presented, the manufacturers had not met their burden to justify the extraordinary remedy of a preliminary injunction. The district court’s denial of injunctive relief was therefore affirmed. View "AbbVie v. Fitch" on Justia Law

A group of plaintiffs, including a medical practice, individual physicians, a medical society, and two patients, brought various claims against a health insurer, alleging that the insurer interfered with doctor-patient relationships, denied or delayed coverage for medical services, and caused significant harm to patients. The claims included tortious interference with contractual rights, unfair competition, RICO violations, and emotional distress, with specific factual allegations that the insurer’s actions led to worsened medical outcomes for the patients involved.The Circuit Court of the Third Circuit reviewed the insurer’s motion to compel arbitration based on arbitration clauses in provider agreements and member handbooks. Instead of determining whether the claims were subject to arbitration, the circuit court focused on the alleged unconscionability of the contracts as a whole, finding them to be contracts of adhesion and unconscionable, and denied the motion to compel arbitration. The court also denied summary judgment as to one patient’s claims and did not stay the medical society’s claims pending arbitration.The Supreme Court of the State of Hawaiʻi reviewed the case and held that the circuit court erred by not following the required analytical framework for arbitrability. The Supreme Court vacated the lower court’s order in part, holding that claims arising under the Participating Physician Agreement must be referred to arbitration because the agreement delegated the question of arbitrability to the arbitrator. Claims under the Medicare and QUEST Agreements were also subject to arbitration, as the arbitration clauses were not shown to be substantively unconscionable. However, the Court held that the claims of one patient and the physician as a patient were not subject to mandatory arbitration, and another patient’s claims were not subject to a grievance and appeals clause. The case was remanded for further proceedings consistent with these holdings. View "Frederick A. Nitta, M.D., Inc. v. Hawaii Medical Service Association." on Justia Law

Central Vermont Medical Center (CVMC) submitted its proposed budget for fiscal year 2025, seeking an 11.9% increase in net patient service revenue (NPR) and a 5.5% increase in commercial rates, both of which exceeded the benchmarks set by the Green Mountain Care Board. The Board’s benchmarks, established in its annual guidance, were 3.5% for NPR growth and 3.4% for commercial rate growth. The Board required hospitals exceeding these benchmarks to provide credible justification, such as evidence of improved access or quality of care. CVMC’s submission was reviewed through hearings and public comment, during which the Board found that CVMC’s justifications were insufficient, particularly regarding efficiency, productivity, and cost containment.The Green Mountain Care Board, after considering the evidence and statutory obligations, modified CVMC’s budget, allowing a 6% NPR growth and a 3.4% commercial rate increase. The Board found that CVMC could achieve financial sustainability through cost reductions and improved productivity rather than higher price increases. The Board imposed specific terms and conditions on the budget, emphasizing the need for efficient operations and balancing financial needs with statewide health care affordability and access.On appeal, the Vermont Supreme Court reviewed the Board’s decision under a deferential standard, presuming the Board’s actions valid unless shown otherwise by clear and convincing evidence. The Court rejected CVMC’s arguments that the Board acted with unfettered discretion, violated procedural due process, or was required to regulate on a per-capita basis. The Court found that the Board’s process was guided by statutory standards, rules, and annual guidance, and that CVMC had adequate notice and opportunity to participate. The Supreme Court of Vermont affirmed the Board’s decision. View "In re Central Vermont Medical Center Fiscal Year 2025" on Justia Law

A pharmaceutical company challenged provisions of the Inflation Reduction Act of 2022, which established a program requiring the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate maximum fair prices for certain high-cost prescription drugs covered by Medicare. The company’s drug was selected for the program, and it signed the required agreements to participate. The program imposes significant penalties and an excise tax on manufacturers who do not comply, but allows manufacturers to exit Medicare and Medicaid programs to avoid the tax, a process the company argued was not a realistic option.After its drug was selected, the company filed suit in the United States District Court for the District of New Jersey, alleging that the program violated the Eighth Amendment’s Excessive Fines Clause, the Fifth Amendment’s Takings Clause, and the First Amendment’s Free Speech Clause. The District Court granted summary judgment for the government, holding that participation in the program is voluntary and that the program primarily regulates conduct, not speech. The court also found it lacked jurisdiction over the Eighth Amendment claim due to the Tax Anti-Injunction Act and the Declaratory Judgment Act.On appeal, the United States Court of Appeals for the Third Circuit affirmed. The court held that the company’s Eighth Amendment claim was barred by the Tax Anti-Injunction Act and the Declaratory Judgment Act, as the relief sought would restrain the assessment or collection of a federal tax. The court further held that the program does not violate the Takings Clause or the First Amendment, relying on its recent precedent. The judgment of the District Court was affirmed. View "Novartis Pharmaceuticals Corp v. Secretary Department of Health" on Justia Law

A pharmaceutical company participated in a federal program that required it to report the average price it received for drugs sold to wholesalers, which in turn affected the rebates it owed the government under Medicaid. From 2005 to 2017, the company sold drugs to wholesalers at an initial price, but if it raised the price before the wholesaler resold the drugs to pharmacies, it required the wholesaler to pay the difference. The company reported only the initial price as the average manufacturer price (AMP), excluding the subsequent price increases, which resulted in lower reported AMPs and thus lower rebate payments to the government. The company justified this exclusion by categorizing the price increases as part of a bona fide service fee to wholesalers, even though the increased value was ultimately paid by pharmacies.The United States District Court for the Northern District of Illinois reviewed the case after a qui tam action was filed by a relator, who alleged that the company’s AMP calculations were false and violated the False Claims Act (FCA). The district court granted summary judgment to the relator on the issue of falsity, finding the AMP calculations and related certifications were factually and legally false. The issues of scienter (knowledge) and materiality were tried before a jury, which found in favor of the relator and awarded substantial damages. The company appealed, challenging the findings on falsity, scienter, and materiality, while the relator cross-appealed on the calculation of the number of FCA violations.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s judgment. The court held that the company’s exclusion of price increase values from AMP was unreasonable and contradicted the plain language and purpose of the relevant statutes, regulations, and agreements. The court also held that the jury reasonably found the company acted knowingly and that the false AMPs were material to the government’s payment decisions. The court rejected the cross-appeal on damages, finding the issue was not properly preserved for appeal. View "Streck v Eli Lilly and Company" on Justia Law

A company alleged that a manufacturer of cardiac rhythm devices engaged in an unlawful compensation arrangement involving the sale of implanted cardiac devices paid for by Medicare and other public health insurance programs. The manufacturer hired a sales representative whose brother, a physician, implanted the devices at a hospital. The hospital billed federal health insurance programs for the devices, and the manufacturer paid the sales representative a commission for each sale. The relator claimed that this arrangement violated the Anti-Kickback Statute and the Stark Law, as the commissions were tied to the number of devices implanted by the physician brother.Previously, the United States District Court for the Central District of California dismissed the complaint. The district court found that the action was barred by the False Claims Act’s public disclosure bar, reasoning that a New York Times article had already disclosed that the manufacturer used financial incentives to encourage physicians to use its devices. The district court concluded that the relator’s allegations were not materially different from what had already been publicly disclosed and denied the relator’s motion to amend the judgment.The United States Court of Appeals for the Ninth Circuit reviewed the case. The Ninth Circuit held that the public disclosure bar did not apply because the relator’s complaint provided genuinely new and material information not previously disclosed by the New York Times article or other public documents. The court found that the specific three-way compensation arrangement involving commissions to a physician’s family member was not substantially the same as the general financial incentives described in the article. The Ninth Circuit reversed the district court’s dismissal, vacated the denial of the motion to amend as moot, and remanded the case for further proceedings. View "SAM JONES COMPANY, LLC V. BIOTRONIK, INC." on Justia Law

Three plaintiffs alleged they suffered injuries after receiving the Gardasil vaccine, which is designed to prevent certain strains of human papillomavirus. Each plaintiff experienced adverse symptoms following their Gardasil injections, but the onset of these symptoms occurred more than three years before they filed petitions for compensation under the National Vaccine Injury Compensation Program. The plaintiffs acknowledged to the special master that their petitions were untimely and sought equitable tolling of the Vaccine Act’s limitations period.The special master in the United States Court of Federal Claims found the petitions untimely and denied equitable tolling, resulting in dismissal of the claims. The plaintiffs then filed suit against Merck & Co. and Merck Sharp & Dohme LLC in the United States District Court for the Western District of North Carolina, which was handling multi-district litigation related to Gardasil. Merck moved to dismiss, arguing that the plaintiffs had failed to timely pursue their remedies under the Vaccine Act. The district court dismissed the complaints, holding that the proper forum for challenging the special master’s timeliness rulings was the Court of Federal Claims and the Federal Circuit, not the district court. The court also rejected a constitutional challenge to the process by which Gardasil was added to the Vaccine Injury Table.On appeal, the United States Court of Appeals for the Fourth Circuit affirmed the district court’s rulings. The Fourth Circuit held that the addition of Gardasil to the Vaccine Injury Table did not violate the Constitution. It further held that timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit, and that courts hearing vaccine-related tort suits may not reconsider the timeliness of a Vaccine Act petition once the special master has made a finding. The court affirmed the dismissal of the plaintiffs’ complaints. View "Needham v. Merck & Company Inc." on Justia Law

Two pharmaceutical companies challenged a federal program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain high-expenditure prescription drugs lacking generic competition. Under this program, manufacturers of selected drugs must either negotiate a price with CMS or face steep excise taxes on all sales of those drugs, unless they withdraw all their products from specific Medicare and Medicaid programs. Both companies had drugs selected for negotiation and, while litigation was pending, agreed to participate and reached negotiated prices.The United States District Court for the District of New Jersey resolved the cases on cross-motions for summary judgment, as the parties agreed there were no material factual disputes. The District Court ruled in favor of the government, holding that the program did not violate the Takings Clause, the First Amendment, or the unconstitutional conditions doctrine. The companies appealed, and the United States Court of Appeals for the Third Circuit consolidated the appeals.The Third Circuit affirmed the District Court’s orders. It held that participation in Medicare and the negotiation program is voluntary, so there is no physical taking under the Fifth Amendment. The court found that economic incentives to participate do not amount to legal compulsion. It also held that the program’s requirements do not compel speech in violation of the First Amendment, as any speech involved is incidental to the regulation of conduct and participation is voluntary. Finally, the court concluded that the program does not impose unconstitutional conditions, as any compelled speech is limited to the contracts necessary to effectuate the program and does not restrict speech outside those contracts. The court affirmed summary judgment for the government. View "Bristol Myers Squibb Co v. Secretary United States Department of HHS" on Justia Law

A physician licensed in Florida worked at a weight management clinic, where he was responsible for maintaining a federal registration to dispense controlled substances. After a report of missing controlled substances at the clinic, local police and the Drug Enforcement Administration (DEA) began investigating. The investigation revealed that the physician had issued numerous prescriptions for controlled substances without proper documentation of a doctor-patient relationship, failed to maintain required records, did not properly report or store controlled substances, and dispensed medication in violation of labeling requirements. The physician claimed that another clinic employee had forged his signature on some prescriptions and denied personal wrongdoing.The DEA issued an Order to Show Cause, notifying the physician of its intent to revoke his registration and deny pending applications, citing violations of federal and state law. The physician submitted a Corrective Action Plan but did not request a hearing. The DEA Administrator reviewed the evidence, including expert testimony and the physician’s admissions, and found that the physician’s continued registration would be inconsistent with the public interest. The Administrator revoked the registration and denied all pending applications, emphasizing the physician’s failure to accept responsibility and the inadequacy of his proposed corrective measures.The United States Court of Appeals for the Eleventh Circuit reviewed the DEA’s final order under an abuse of discretion standard, deferring to the agency’s factual findings if supported by substantial evidence. The court held that the physician received adequate procedural due process, as he was given notice and an opportunity for a hearing, which he declined. The court also rejected the argument that the DEA was required to find knowing or intentional misconduct under Ruan v. United States, holding that such a mens rea requirement does not apply to administrative revocation proceedings under 21 U.S.C. § 824. The petition for review was denied. View "Ashraf v. Drug Enforcement Administration" on Justia Law

A former sales representative for a pharmaceutical company alleged that the company engaged in an aggressive campaign to market one of its drugs, Vraylar, for uses not approved by the Food and Drug Administration (FDA), specifically for substance abuse and major depressive disorder (MDD). The representative, who was responsible for promoting the drug to medical providers, claimed that the company trained its sales force to encourage off-label prescriptions and incentivized providers to prescribe Vraylar for these unapproved uses. He further asserted that he faced adverse employment actions, such as loss of promotion and increased workload, after raising concerns internally about the legality and compliance of these marketing practices.After the representative filed a qui tam action under the False Claims Act (FCA) in the United States District Court for the Northern District of Indiana, the government declined to intervene. The plaintiff then amended his complaint, dropping his direct fraud claim and proceeding solely on a theory of retaliation under 31 U.S.C. §3730(h). The district court dismissed the complaint with prejudice, finding that the plaintiff’s internal complaints to the company focused on regulatory noncompliance rather than fraud against the government, and thus did not put the employer on notice of protected activity under the FCA.The United States Court of Appeals for the Seventh Circuit reviewed the case de novo. The court held that, to state a claim for FCA retaliation, an employee must plausibly allege that the employer was on notice that the employee was attempting to prevent fraud against the government, not merely regulatory violations. Because the plaintiff’s communications only referenced regulatory and policy concerns, and did not suggest government fraud, the court found the notice requirement unmet. The Seventh Circuit affirmed the district court’s dismissal and found no abuse of discretion in denying leave to amend. View "Lewis v AbbVie Inc." on Justia Law