Justia Health Law Opinion Summaries

A licensed physician operated pain clinics in Arizona and Wyoming, where he, with assistance from family members, employees, and certain patients, prescribed large quantities of oxycodone and other controlled substances. Many prescriptions were issued without adequate medical examinations and were routinely exchanged for cash or goods. Several individuals helped manage clinic operations, refer new patients, and facilitate prescription transactions, often receiving or providing payment for these activities. One patient, Jessica Burch, died after overdosing on oxycodone obtained through these prescriptions.The physician was initially convicted in the United States District Court for the District of Wyoming on multiple counts, including unlawful dispensing of controlled substances, conspiracy resulting in death, and engaging in a continuing criminal enterprise. On his first appeal, the United States Court of Appeals for the Tenth Circuit affirmed, but the Supreme Court, in light of *Ruan v. United States*, vacated his convictions due to a jury instruction error regarding the required mens rea for the offenses. The Tenth Circuit then remanded the case for a new trial. At retrial, the physician was convicted on seventeen of twenty-one counts. He moved for acquittal or a new trial, but the district court denied these motions and sentenced him to an aggregate term of 25 years’ imprisonment.On appeal to the United States Court of Appeals for the Tenth Circuit, the physician challenged the admission of expert testimony about the law governing prescriptions, the sufficiency of the evidence for the continuing criminal enterprise and death-resulting convictions, and the use of a regulation to define the scope of authorized prescriptions. The Tenth Circuit held that the district court did not abuse its discretion in admitting the expert testimony, found sufficient evidence supported the challenged convictions, and reaffirmed that a DEA-registered physician can be prosecuted under 21 U.S.C. § 841 if acting outside the usual course of professional practice. The court affirmed the convictions. View "United States v. Kahn" on Justia Law

A pretrial detainee housed in the Milwaukee County Jail alleged that, during a medical emergency involving COVID-19 symptoms, two correctional officers failed to provide adequate medical attention. He claimed that despite using his in-cell intercom to request help for chest pain and shortness of breath, the officers did not respond. Later, a nurse administered a COVID-19 test, but the detainee was never informed of the results, and his condition worsened until he eventually passed out and was hospitalized.After recovering, the detainee followed the jail’s grievance procedure by submitting a grievance through the electronic kiosk, updating it as his symptoms persisted, and eventually receiving a response from jail staff that closed the grievance. He did not appeal the grievance. The detainee later filed a lawsuit under 42 U.S.C. § 1983 in the United States District Court for the Eastern District of Wisconsin, alleging violations of his Fourteenth Amendment rights. Before discovery, the defendants moved for summary judgment, arguing that the detainee failed to exhaust his administrative remedies as required by the Prison Litigation Reform Act (PLRA). The district court granted summary judgment for the defendants, concluding that the detainee did not appeal his grievance and that the remedies were available to him, dismissing his assertion that the process was unavailable.Reviewing the appeal, the United States Court of Appeals for the Seventh Circuit held that a genuine dispute of material fact existed as to whether the jail’s grievance appeals process was actually available to the plaintiff. The Seventh Circuit vacated the district court’s summary judgment, finding that the detainee’s sworn declaration provided sufficient evidence to require further fact-finding, either through an evidentiary hearing or a jury trial if the exhaustion issue is intertwined with the merits. The case was remanded for further proceedings. View "Burns v Polk" on Justia Law

A pharmaceutical company that manufactures both branded and generic drugs challenged the federal agency rules implementing the Medicare Drug Price Negotiation Program created under the Inflation Reduction Act of 2022. Specifically, the company objected to two rules: first, the agency’s grouping of two drugs with the same active ingredient and manufacturer, but approved under separate applications, as one “qualifying single source drug” for price negotiation; and second, the agency’s requirement that a generic drug must be engaged in “bona fide marketing” to be considered as marketed, which affects when a branded drug exits the negotiation program. The company argued that these rules exceeded the agency’s statutory authority and that the program deprived it of protected property interests without due process.The United States District Court for the District of Columbia reviewed the case. It found that the statutory bar on judicial review did not prevent the company’s challenges to generally applicable agency guidance. On the merits, the district court upheld the agency’s definition of a qualifying single source drug, ruled that the challenge to the “bona fide marketing” standard was not yet ripe, and rejected the due process claim due to lack of a protected property interest. The company appealed.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The appellate court held that the statutory review bar precludes review only of drug-specific determinations, not generally applicable legal standards. On the merits, it concluded that the statute permits the agency to treat drugs with the same active ingredient and manufacturer as one statutory drug. The court found that the due process challenge failed because the company lacked a protected property interest. However, it determined that the challenge to the “bona fide marketing” requirement was ripe and remanded that issue to the district court for further proceedings. The court thus affirmed in part, reversed in part, and remanded. View "Teva Pharmaceuticals USA, Inc. v. Kennedy" on Justia Law

A pharmaceutical company acquired the rights to a cancer drug called Tibsovo from another manufacturer in April 2021, including the drug’s existing stock and its New Drug Application (NDA). After the acquisition, the company sold the previously manufactured Tibsovo tablets to Medicare Part D patients for the remainder of 2021. While the company began producing its own Tibsovo tablets that year, those were not dispensed to any Part D patient until February 2022. The company had no other Part D drug sales in 2021.When the company sought to participate in the Medicare Manufacturer Discount Program, which requires manufacturers to offer discounts on certain drugs but allows “specified manufacturers” and “specified small manufacturers” a more gradual phase-in, the Centers for Medicare & Medicaid Services (CMS) determined that the company qualified only as a specified manufacturer. CMS found that, although the company owned Tibsovo’s NDA and had manufactured new tablets in 2021, none of those were dispensed to Part D patients during the relevant period; all Tibsovo dispensed in 2021 was manufactured by the prior owner. As a result, the company had zero qualifying sales for 2021 and could not meet the additional requirement for specified small manufacturers.The United States District Court for the District of Columbia granted summary judgment for the government, holding that CMS’s decision was lawful and rejecting the company’s statutory and administrative challenges.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed. The court held that to qualify as a specified small manufacturer, a company must have actually produced, prepared, propagated, compounded, converted, or processed the units of the drug dispensed to Part D patients in 2021. Mere ownership or responsibility for the drug was not enough. The court also rejected challenges to CMS’s use of labeler codes as a means of identifying manufacturers. The district court’s judgment was affirmed. View "Servier Pharmaceuticals LLC v. Kennedy" on Justia Law

A pharmaceutical company developed a medication for a sleep disorder that primarily affects blind individuals. The company’s drug label included the brand name and dosage in both regular print and braille, along with instructions for pharmacists not to cover the braille and to dispense the drug in its original container. When a competing manufacturer sought approval from the Food and Drug Administration (FDA) to market a generic version, its proposed label omitted the braille and related instructions. The FDA approved the generic’s label without these features. The original manufacturer objected, arguing that omitting the braille and instructions violated statutory requirements for generic drugs to have labeling “the same as” the brand-name product, except for changes required due to a different manufacturer.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA and the generic manufacturer, holding that the omission of braille and the accompanying instructions fell within the statutory exception for changes required due to a different manufacturer. The court also rejected arguments that the FDA acted arbitrarily or capriciously.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and held that the statutory exception for changes “required” by a different manufacturer applies only to changes that are mandatory, not merely optional or safe. The court concluded that omitting the brand name in braille was required, but omitting the dosage in braille and the related pharmacist instructions was not shown to be necessary due to the manufacturer change. The court vacated the grant of summary judgment on this issue and remanded the case for the agency to determine whether the generic label, without braille dosage or instructions, still meets the requirement of being “the same as” the brand-name label. The court otherwise affirmed the district court’s judgment. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

Heritage Operations Group operates long-term care facilities in Illinois, with Green Tree Pharmacy providing pharmacy services to these facilities. Both companies are family-owned and operated. A. Samuel Enloe, who has extensive experience in the long-term care pharmacy industry, alleged that Heritage and Green Tree dispensed Schedule II controlled substances to residents without valid prescriptions, particularly during emergencies when the pharmacy was closed. Enloe claimed that this practice violated the Controlled Substances Act (CSA) and that subsequent claims for Medicare reimbursement were fraudulent under the False Claims Act (FCA).The United States District Court for the Northern District of Illinois, Eastern Division, dismissed Enloe’s second amended complaint. The court concluded that Enloe failed to plead his FCA claims with the particularity required by Federal Rule of Civil Procedure 9(b), specifically not identifying the “who, what, when, where, and how” of the alleged fraud. It also found that the CSA does not provide a private cause of action and, as a result, dismissed the related unjust enrichment claim. Enloe appealed, challenging only the dismissal of his FCA claims.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s dismissal de novo. The appellate court held that Enloe’s allegations were speculative and lacked the concrete factual detail required under Rule 9(b). The court found that Enloe did not sufficiently allege either a clear violation of the CSA or that any misrepresentation was material to the government’s payment decision. Thus, the Seventh Circuit concluded that Enloe failed to state a claim under the FCA and affirmed the district court’s judgment dismissing his complaint. View "Enloe v Heritage Operations Group, LLC" on Justia Law

A telehealth clinic specializing in gender-affirming care for minors, including the prescription of puberty blockers and cross-sex hormones, was served with an administrative subpoena by the U.S. Department of Justice (DOJ). The subpoena, issued under the Health Insurance Portability and Accountability Act (HIPAA), sought a broad range of documents related to the clinic’s personnel, billing practices, communications with manufacturers and pharmacies, and patient records. The DOJ’s investigation followed executive orders and internal memoranda from the administration, which had publicly articulated opposition to gender-affirming care for minors and directed DOJ to prioritize investigations into potential violations of federal health care laws, particularly the Federal Food, Drug, and Cosmetic Act (FDCA).The United States District Court for the Western District of Washington quashed the subpoena entirely, finding that it was issued for an “improper purpose”—specifically, to advance the administration’s policy goal of eliminating gender-affirming care, rather than to investigate a legitimate violation of federal law. The district court concluded that the DOJ’s actions were pretextual and that its explanations for the subpoena were inadequate. The court did not reach the clinic’s alternate arguments that the subpoena was overbroad or unduly burdensome.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s order. The Ninth Circuit held that the DOJ had statutory authority to issue the subpoena under HIPAA, had complied with procedural requirements, and that the subpoena was relevant to an authorized investigation. The court further held that the clinic had not met the heavy burden to show the subpoena was issued for an improper purpose, stating that the Executive Branch’s public opposition to gender-affirming care was insufficient to establish bad faith. The case was remanded for the district court to consider the unresolved issues of overbreadth and undue burden. View "QUEERDOC, PLLC V. DOJ" on Justia Law

A licensed physician assistant accepted a remote, part-time position with a telehealth company. His role was to review files sent by the company and sign orders for genetic tests for Medicare beneficiaries. Over approximately ten months, he signed orders for more than 600 beneficiaries, despite having spoken with only about 20 of them. For each file, regardless of test approval, he was compensated. These signed orders led laboratories to bill Medicare for over 14,600 tests, totaling more than $10 million. The physician assistant did not personally bill Medicare and resigned after raising concerns about the company’s practices.A grand jury indicted him on healthcare fraud and making false statements related to healthcare matters. In the United States District Court for the Western District of North Carolina, a jury convicted him on all counts. The court sentenced him to 72 months in prison. On appeal, the defendant argued that the district court erred by excluding documents about the company’s internal compliance, quashing subpoenas for witnesses who invoked the Fifth Amendment, allowing a prosecutorial rebuttal he claimed was improper, giving flawed jury instructions, and miscalculating the sentencing guidelines.The United States Court of Appeals for the Fourth Circuit reviewed and rejected all of the defendant’s challenges. The court held that the exclusion of compliance documents was not an abuse of discretion under Rule 403, that the district court properly quashed subpoenas after a sufficient inquiry into the witnesses’ privilege against self-incrimination, and that any arguably improper prosecution remarks did not deprive the defendant of a fair trial. Additionally, the court found no reversible error in the jury instructions, determined that the evidence sufficiently supported the convictions, and affirmed the sentencing methodology. The appellate court affirmed the judgment of the district court. View "US v. Joyner" on Justia Law

A dispute arose concerning the payment rate for a surgical procedure performed at an out-of-network facility. The patient receiving the surgery was covered by an ERISA-governed health plan provided by the employer and administered by an insurance company. Prior to the surgery, the facility contacted the plan administrator to verify coverage and was told that the plan would reimburse at the usual, customary, and reasonable (“UCR”) rate, not the lower Medicare rate. Relying on this representation, the facility performed the surgery. However, the plan later paid only at the Medicare rate, far less than the full billed amount. The facility’s successor in interest, having obtained the rights to the claim, sought to recover the unpaid balance.The action was first brought in California state court, then removed to the United States District Court for the Central District of California. The plaintiff asserted both ERISA and state law claims. The district court dismissed the ERISA claim for lack of derivative standing, as the plaintiff was not properly assigned the right to sue under ERISA. The court also dismissed the state law claims for negligent misrepresentation and promissory estoppel, holding that these claims were preempted by ERISA because they related to an ERISA-covered plan.The United States Court of Appeals for the Ninth Circuit reviewed the case. It affirmed the district court’s dismissal of the promissory estoppel claim, holding that, under circuit precedent, such claims are preempted by ERISA. However, the Ninth Circuit reversed the dismissal of the negligent misrepresentation claim. The appellate court held that ERISA does not preempt a negligent misrepresentation claim by a provider’s successor in interest when the claim arises from representations made by the plan administrator during a pre-service verification call. The court concluded that such a claim does not sufficiently “relate to” an ERISA plan to trigger preemption, as it is not based on an ERISA-regulated relationship or enforceable under ERISA’s civil enforcement mechanism. The case was remanded for further proceedings on the negligent misrepresentation claim. View "HEALTHCARE ALLY MANAGEMENT OF CALIFORNIA, LLC V. WSP USA, INC." on Justia Law

A company that manufactures flavored e-liquids for use in electronic nicotine delivery systems (ENDS), including fruit and candy flavors, submitted premarket applications to the Food and Drug Administration (FDA) seeking authorization to sell 64 such products. The FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act (TCA) requires that new tobacco products be shown to be “appropriate for the protection of the public health” before they can be marketed. The FDA denied the company’s applications, citing the failure to provide robust comparative evidence demonstrating that its flavored products offer a public health benefit for adult smokers that outweighs the risks to youth, compared to tobacco-flavored ENDS.Following the FDA’s marketing denial order, the company petitioned for review in the United States Court of Appeals for the Ninth Circuit. The company argued that the FDA acted arbitrarily and capriciously by requiring comparative efficacy evidence, failed to adequately consider its marketing and sales restriction plans, and improperly denied authorization for “zero nicotine” products. It also argued that the FDA could only impose a comparative efficacy requirement through notice-and-comment rulemaking under the TCA and the Administrative Procedure Act (APA).The United States Court of Appeals for the Ninth Circuit denied the petition for review. The court held that the FDA’s denial based on the absence of comparative efficacy evidence was neither arbitrary nor capricious, especially since the applicant offered no evidence distinguishing its products’ youth risks from those of other flavored ENDS. The court also found that any error in declining to consider marketing or access restriction plans was harmless. Additionally, the court ruled that the FDA was not required to undertake notice-and-comment rulemaking before applying the comparative efficacy requirement, and the inclusion of “zero nicotine” products in the denial order was proper based on the company’s own representations. View "DRIP MORE LLC V. FDA" on Justia Law