Justia Health Law Opinion Summaries

A ten-year-old child, considered an Indian child under the Indian Child Welfare Act, was taken into emergency state custody due to neglect and self-harm concerns. The Office of Children’s Services (OCS) placed the child in foster care and later admitted him to a residential psychiatric facility for mental health treatment. The Native Village of Hooper Bay, the child’s tribe, intervened in the child in need of aid (CINA) proceeding and sought access to the child’s unredacted psychotherapy records, arguing they were necessary to secure appropriate services for the child. The child’s attorney objected to the release of these records, citing confidentiality concerns, while the court-appointed guardian ad litem (GAL) waived the psychotherapist-patient privilege.The Superior Court for the State of Alaska, Fourth Judicial District, Hooper Bay, ruled that the GAL held the authority to waive the child’s psychotherapist-patient privilege under CINA Rule 9(b)(3)(F)(ii) because the child was under twelve. The court ordered the release of the records to all parties, finding that the child’s attorney’s objection did not nullify the GAL’s waiver. The child’s motions for reconsideration and for an in camera review were denied, and the records were disclosed.The Supreme Court of the State of Alaska reviewed whether a child between ten and twelve can, through an attorney’s objection, override a GAL’s waiver of the psychotherapist-patient privilege in CINA proceedings. The court held that a child’s objection does not nullify the GAL’s waiver of the privilege. However, following an objection, the child bears the burden of showing that confidentiality should be maintained under the multi-factor framework of CINA Rule 9(b)(3)(D). The Supreme Court found that the superior court adequately applied the relevant factors and affirmed the decision to disclose the child’s records. View "Tanuk S. v. State of Alaska" on Justia Law

Two individuals, who were patients of a regional healthcare provider, filed a class action lawsuit alleging that the provider’s website used tracking software to intercept and share users’ personally identifiable health information with a third-party technology company. This software, known as Meta Pixel, collected data such as IP addresses, device identifiers, and details about users’ interactions with the website, transmitting this information to the technology company, which then used it for commercial purposes, including targeted advertising. The healthcare provider also received data analysis from the technology company and was paid for allowing access to this information. The plaintiffs claimed they did not consent to this sharing of their health information.After the claims against the technology company were transferred to another district, the U.S. District Court for the Eastern District of Pennsylvania reviewed several amended complaints against the healthcare provider. The District Court dismissed the plaintiffs’ second amended complaint with prejudice, concluding that the allegations did not sufficiently specify what personal health information was actually shared and that further amendment would be futile. When the plaintiffs sought reconsideration and submitted a proposed third amended complaint, the District Court denied the motion, citing undue delay because the plaintiffs could have included the new details earlier and had been clearly informed of the deficiencies.The United States Court of Appeals for the Third Circuit reviewed the case and affirmed both orders of the District Court. The Third Circuit held that, although plaintiffs had Article III standing, the District Court did not abuse its discretion in dismissing the second amended complaint with prejudice or in denying the motion for reconsideration. The appellate court concluded that plaintiffs had sufficient notice of the complaint’s deficiencies after oral argument and did not act promptly to address them, justifying denial of further amendment. View "Santoro v. Tower Health" on Justia Law

The plaintiff, a former Senior Reimbursement Manager at a national pharmacy provider, alleged that her employer engaged in a scheme to overcharge government healthcare programs such as Medicare and Medicaid. She claimed the company exploited billing system discrepancies and other tactics to cause overpayments, including billing for deceased patients and miscoding pharmacy types for higher reimbursements. The company allegedly concealed these overpayments in its internal accounting and, after a period, transferred the unreturned funds into its own revenues. The plaintiff reported these practices to management and internal audit, but the issues persisted.After filing a complaint in the United States District Court for the Eastern District of New York, the plaintiff amended her allegations. The District Court dismissed all federal claims with prejudice, finding that the plaintiff did not meet the heightened pleading standards for fraud required under Federal Rule of Civil Procedure 9(b) for “direct” False Claims Act (FCA) claims (those based on submitting fraudulent invoices or statements to the government). The court also denied leave to further amend the complaint, and denied reconsideration.On appeal, the United States Court of Appeals for the Second Circuit reviewed the case de novo. The Second Circuit affirmed the District Court’s dismissal of the plaintiff’s direct FCA claims, holding that she did not identify any specific fraudulent submissions to the government, nor adequately allege that such information was solely within the defendants’ control. However, the Second Circuit vacated the dismissal of the “reverse” FCA claim, which is based on knowingly retaining government overpayments. The court found the plaintiff sufficiently alleged that the company had an obligation to return identified overpayments and knowingly concealed or improperly avoided that obligation. The case was remanded for further proceedings on the reverse FCA claim. View "United States v. Amerisource Bergen Corp." on Justia Law

Carrie Musselman, a chiropractor in Illinois, expanded her practice to include non-chiropractic medical services and subsequently engaged in fraudulent billing practices targeting Medicare. She directed staff to bill services performed by nurse practitioners and physician assistants under physicians’ names, circumventing Medicare’s “Incident To” requirements, which resulted in higher reimbursements. Additionally, she billed a non-surgically implanted pain-relief device using a code for surgically implanted devices and billed sublingual allergy drops under a code intended for injectable allergy treatments. Despite repeated internal and external warnings about these improper practices, Musselman persisted, primarily seeking advice from sources with vested financial interests.A federal grand jury indicted Musselman on charges of healthcare fraud, wire fraud, and obstruction of a federal audit. Following a 13-day trial in the United States District Court for the Central District of Illinois, a jury found her guilty of healthcare fraud and five counts of wire fraud, acquitting her on other charges. Post-verdict, the district court discovered that the jury foreperson had created a deliberation guide based on online articles, which included references to non-unanimous verdicts. Musselman moved for a new trial on this basis and challenged the court’s use of an “ostrich” instruction regarding deliberate ignorance. The district court denied both motions, reasoning that the outside research was harmless and the ostrich instruction was justified by the evidence.On appeal, the United States Court of Appeals for the Seventh Circuit affirmed. The court held that the district court properly found no reasonable possibility that the jury’s verdict was affected by the foreperson’s outside research and that Musselman had waived a further evidentiary hearing. The appellate court also concluded that the evidence supported the ostrich instruction, given Musselman’s repeated disregard of obvious red flags and her heightened duty to inquire about her practice’s billing practices. View "USA v. Musselman" on Justia Law

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