Justia Health Law Opinion Summaries

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

In 2018, the plaintiff was placed on an involuntary 72-hour psychiatric hold, resulting in the creation of a confidential record by the Orange County Sheriff’s Department. In 2021, during a legal dispute over their father’s estate, the plaintiff discovered that his sister’s attorney had obtained this confidential record and used it to threaten him in an attempt to force dismissal of his elder abuse lawsuit against his sister. The record had been released by an office specialist at the Sheriff’s Department, who admitted knowing the sister was not entitled to the record but disclosed it anyway, believing she was concerned for the plaintiff’s well-being.A jury in the Superior Court of Orange County found that the office specialist willfully and knowingly disclosed the confidential record, awarding the plaintiff $29,000 in economic damages and $40,000 in noneconomic damages. The jury also found the plaintiff’s sister and her attorney responsible for 25 percent of the damages. However, the trial court granted a motion for partial judgment notwithstanding the verdict, concluding there was insufficient evidence of willfulness, declined to treble the damages, and apportioned both economic and noneconomic damages, entering judgment for 75 percent of the total damages against the office specialist and the County.The California Court of Appeal, Fourth Appellate District, Division Three, reversed the trial court’s order. The appellate court held that “willfully and knowingly” under Welfare and Institutions Code section 5330 means intentionally releasing confidential records to someone known to be unauthorized, regardless of intent to harm. The court found substantial evidence supported the jury’s finding of willfulness, requiring trebling of damages. The court also held that while noneconomic damages could be apportioned to other tortfeasors, economic damages could not. The case was remanded with instructions to enter judgment for $177,000 against the County and the office specialist, jointly and severally. View "Doe v. County of Orange" on Justia Law

Mathew James, a former nurse and owner of a medical billing business, was convicted after a jury trial for health care fraud, conspiracy to commit health care fraud, wire fraud, and aggravated identity theft. The charges arose from a scheme in which James and his employees falsified insurance claims by “upcoding” and “unbundling” medical procedures, directed patients to emergency rooms for pre-planned surgeries, and impersonated patients in communications with insurance companies. The fraudulent activity spanned several years, involved nearly 150 physicians, and resulted in tens of thousands of claims. While some of James’s business was legitimate, the government’s evidence focused on the fraudulent aspects of his operations.The United States District Court for the Eastern District of New York (Judge Seybert) presided over the trial and sentencing. The jury convicted James on most counts but acquitted him of money laundering conspiracy. During trial, jurors were inadvertently given access to transcripts of two recorded calls not admitted into evidence, but the district court declined to conduct an inquiry into the exposure, instead instructing the jury to disregard any material not in evidence. At sentencing, the court imposed a 144-month prison term, a forfeiture order of over $63 million, and restitution of nearly $337 million. The court applied sentencing enhancements for James’s leadership role and abuse of trust, and increased the sentence after considering James’s potential eligibility for earned time credits and rehabilitation programs.The United States Court of Appeals for the Second Circuit affirmed James’s conviction, finding any jury exposure to extra-record material harmless. However, the court vacated the sentence, including the forfeiture and restitution orders, holding that the district court erred by enhancing the sentence based on potential earned time credits and rehabilitation program eligibility, misapplied sentencing enhancements without adequate findings, and failed to properly calculate forfeiture and restitution by including legitimate business revenue. The case was remanded for resentencing. View "United States v. James" on Justia Law

Cordell Sanders, an inmate at Pontiac Correctional Center, suffered from serious mental health issues and spent over eight years in segregation housing due to multiple disciplinary infractions. He received mental health services from various providers employed by Wexford Health Sources, the prison’s contracted healthcare provider. Sanders alleged that these providers were deliberately indifferent to his mental health needs, offering inadequate treatment and failing to advocate for him during disciplinary proceedings. He also claimed that Wexford maintained a widespread practice of denying mental health care until inmates were in crisis and failed to implement policies guiding provider participation in disciplinary hearings.The United States District Court for the Central District of Illinois granted summary judgment in favor of all defendants. The court found that Sanders had not presented sufficient evidence to support his claims of deliberate indifference or to establish a Monell claim against Wexford. Sanders appealed this decision, arguing that the providers’ treatment was ineffective and that Wexford’s practices and lack of policy amounted to constitutional violations.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s summary judgment order de novo. The appellate court held that Sanders failed to provide evidence from which a reasonable jury could find that the providers’ conduct constituted deliberate indifference under the Eighth Amendment. The court emphasized the lack of expert testimony regarding the effectiveness of Sanders’s treatment and found no substantial departure from professional standards. Regarding Wexford, the court concluded that Sanders did not demonstrate a widespread practice of denying care or that the absence of a more detailed policy caused constitutional harm. The Seventh Circuit affirmed the district court’s grant of summary judgment for all defendants. View "Sanders v. Moss" on Justia Law

Lauren Richwine, through her business Death Done Differently, provides services as a “death doula,” assisting clients and their families with end-of-life planning, emotional support, and guidance on funeral arrangements. Richwine is not a licensed funeral director, and her website notes that her services are performed under the supervision of a licensed funeral director. In 2021, a complaint was filed with the Indiana Public Licensing Agency alleging that Richwine was practicing funeral services without a license. Following an investigation, the Indiana Attorney General sought a cease-and-desist order from the State Board of Funeral and Cemetery Service, which was approved. The order prohibited Richwine and her company from advertising or providing certain services related to funeral planning, community death care, and support with funeral homes.After the cease-and-desist order was issued, Richwine and Death Done Differently filed suit in the United States District Court for the Northern District of Indiana, Fort Wayne Division, arguing that enforcement of the Indiana statute against them would violate their First Amendment rights. The district court granted a preliminary injunction, enjoining enforcement of the statute against the plaintiffs. The defendants appealed, arguing that the plaintiffs had waived their rights by signing the cease-and-desist agreement and that federal abstention doctrine barred the suit. The district court rejected these arguments, finding no clear and unmistakable waiver of federal rights and no ongoing state proceeding that would justify abstention.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s decision. The Seventh Circuit held that the Indiana statute, as applied to Richwine and Death Done Differently, burdens substantially more speech than necessary to further the state’s interests in public health, safety, and consumer protection. The court found that the statute’s restrictions on the plaintiffs’ speech and advertising likely violate the First Amendment. The Seventh Circuit affirmed the district court’s preliminary injunction and remanded for further proceedings. View "Richwine v. Matuszak" on Justia Law