Justia Health Law Opinion Summaries

A group of associations representing infusion centers, cancer patients, and pharmaceutical manufacturers challenged the constitutionality of a program created by the Inflation Reduction Act of 2022, which directs the Secretary of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), to negotiate prices for high-expenditure prescription drugs under Medicare Parts B and D. The program allows HHS to select drugs based on certain criteria, negotiate a “maximum fair price” with manufacturers, and impose an excise tax on manufacturers who refuse to negotiate. The tax is calculated as a high percentage of sales reimbursed by Medicare. Manufacturers may avoid the program by withdrawing from Medicare and Medicaid participation. The statutory scheme also limits administrative and judicial review of key program decisions and allows HHS to implement early cycles of the program through guidance rather than notice-and-comment rulemaking.The United States District Court for the Western District of Texas initially dismissed the case for lack of subject-matter jurisdiction and improper venue. On appeal, the United States Court of Appeals for the Fifth Circuit reversed and remanded, finding that at least one plaintiff had standing and venue was proper. On remand, the district court granted summary judgment for the government, holding that the program did not violate the nondelegation doctrine, that the Anti-Injunction Act barred the plaintiffs’ Eighth Amendment claim, and that the plaintiffs lacked a protected property interest to support their due process claim.Upon further appeal, the United States Court of Appeals for the Fifth Circuit affirmed the district court’s judgment. The court held that the statute provided an “intelligible principle” sufficient to withstand a nondelegation challenge, that the Anti-Injunction Act did not bar the Eighth Amendment claim but the excise tax did not constitute a punitive fine, and that neither manufacturers, providers, nor patients possessed a protected property or liberty interest implicated by the program. The government’s summary judgment was affirmed in full. View "Natl Infusion Center v. Kennedy" on Justia Law

A company sought to introduce a generic version of a prescription drug by filing an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). The first applicant for the generic version had previously entered into a settlement with the brand-name drug manufacturer following patent litigation, obtaining a license to market the drug at a future date but still needed FDA approval. While the first applicant’s ANDA remained pending, another company (the appellant) submitted its own ANDA for the same drug, including certifications that its product would not infringe certain patents or would not be marketed for patented uses. The FDA determined that the first applicant was eligible for a 180-day period of marketing exclusivity, which prevented final approval of the subsequent applicant’s ANDA.The United States District Court for the District of Columbia denied the subsequent applicant’s request for an injunction and granted summary judgment in favor of the FDA and parties supporting the FDA’s position. The court found that the first applicant’s exclusivity remained intact, as not all statutory forfeiture conditions had been met. Specifically, it concluded that the first applicant had not forfeited exclusivity by failing to market or by failing to obtain tentative approval, interpreting the relevant statutory provisions in the FDA’s favor.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the statutory interpretation de novo. The court held that the FDA correctly determined the first applicant had not forfeited exclusivity under the “failure to market” provision, as forfeiture requires triggering events for each qualifying patent certification in the first applicant’s ANDA. However, the appellate court found the FDA applied an incorrect causation standard in assessing whether the first applicant forfeited exclusivity for failure to obtain tentative approval. The court ruled that a but-for causation standard applies and remanded the case for the FDA to apply this correct standard. The judgment was affirmed in part, reversed in part, and remanded. View "Norwich Pharmaceuticals, Inc. v. Kennedy" on Justia Law

A Florida state inmate alleged that he was severely beaten by prison guards on two occasions and subsequently experienced seizures and ongoing pain in his head, hand, and ribs. After the assaults, he sought medical care and was treated for his head wound by staff, but further injuries were not assessed. When he was later evaluated by a prison doctor, he claimed the doctor refused to provide meaningful treatment for his injuries and dismissed his complaints, allegedly in retaliation for grievances the inmate had filed against him. Over the following months, the inmate’s hand injury worsened, and a later orthopedic evaluation confirmed a deformity that required physical therapy. Despite this recommendation, the doctor again refused treatment, allegedly referencing the inmate’s previous grievances as the reason.The United States District Court for the Middle District of Florida granted summary judgment in favor of the doctor, finding that he was not deliberately indifferent to the inmate’s medical needs and had not retaliated against him for filing grievances. The district court concluded that the doctor neither acted with subjective recklessness nor denied medical care for retaliatory reasons.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed whether genuine disputes of material fact precluded summary judgment. The appellate court found that, crediting the inmate’s verified complaint, there was sufficient evidence for a reasonable jury to find that the doctor was deliberately indifferent to serious medical needs regarding both the head and hand injuries, and that he acted with retaliatory motive in denying care after grievances were filed. The Eleventh Circuit reversed the district court’s summary judgment decision and remanded the case for further proceedings, holding that the inmate’s claims should proceed to a jury. View "Burton v. Espino" on Justia Law

Four individuals who were or are patients of a health care system brought a proposed class action against the system, alleging violations of the California Invasion of Privacy Act (CIPA) and the California Confidentiality of Medical Information Act (CMIA). They claimed the health care provider installed web tracking technologies, specifically Meta Pixel and Google Analytics, on its various websites, including a public health risk assessment (HRA) site and a password-protected patient portal. According to the plaintiffs, these tools tracked users’ activities, collected their data—including personally identifiable information, health-related communications, and protected health information—and transmitted it to Meta and Google, who then used the data for advertising purposes.The Superior Court of Los Angeles County denied the plaintiffs’ motion for class certification in its entirety. The court found that the proposed subclasses—patients who logged into the patient portal and those who submitted HRA forms—were not ascertainable, that individual issues predominated over common ones, and that a class action was not the superior or manageable method. It reasoned that determining whether the tracking technologies’ transmissions constituted “contents” under CIPA or “medical information” under CMIA would require individualized inquiries into each user’s data. The court also concluded plaintiffs had abandoned their CIPA claim under section 632.On appeal, the California Court of Appeal, Second Appellate District, affirmed in part, reversed in part, and remanded. The appellate court held that the HRA form subclass and the CIPA claim for the patient portal subclass met the requirements for class certification, as key liability questions could be resolved with common proof. However, it affirmed the denial of class certification for the CMIA claim for the patient portal subclass and agreed that plaintiffs forfeited their CIPA section 632 claim. The court found class action treatment was superior and manageable for the certified subclasses. View "Doe v. Adventist Health System/West" on Justia Law

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