Justia Health Law Opinion Summaries

The case involves the National Infusion Center Association (NICA) and other plaintiffs challenging the constitutionality of the Drug Price Negotiation Program established by the Inflation Reduction Act. This program requires the Department of Health and Human Services (HHS) to negotiate drug prices with manufacturers, setting a "maximum fair price" between 40% and 75% of the market price. Manufacturers who do not comply face significant fines or must withdraw from Medicare coverage entirely.The United States District Court for the Western District of Texas dismissed NICA's lawsuit for lack of subject-matter jurisdiction. The district court reasoned that NICA's claims had to be "channeled" through HHS as required by 42 U.S.C. § 405, which mandates that claims arising under the Medicare Act be decided by the relevant agency before being brought to federal court. The district court also dismissed the remaining plaintiffs due to improper venue without NICA.The United States Court of Appeals for the Fifth Circuit reviewed the case and found that NICA had standing based on both economic and procedural injuries. The court determined that NICA's claims did not arise under the Medicare Act but rather under the Inflation Reduction Act, and thus did not require channeling through HHS. The court held that the district court had subject-matter jurisdiction over NICA's claims and reversed the lower court's dismissal, remanding the case for further proceedings. View "Natl Infusion Center v. Becerra" on Justia Law

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

In 2021, Hal de Becker contracted COVID-19 and was treated with ivermectin by his personal physician. Hal was later admitted to Desert Springs Hospital Medical Center, where his ivermectin treatment was stopped without consent, and he was administered remdesivir. Hal's condition deteriorated, and he died shortly after being discharged. Hal's family sued the attending doctors and the hospital, alleging negligence, professional negligence, and wrongful death, claiming the doctors and hospital failed to obtain informed consent and made treatment decisions based on media narratives.The Eighth Judicial District Court dismissed the claims against the doctors and the hospital. The court found that the claims against the doctors were barred by the Public Readiness and Emergency Preparedness Act (PREP Act) and that the expert affidavit provided by the plaintiffs did not meet the requirements of NRS 41A.071. The court also dismissed the claims against the hospital, finding them similarly barred by the PREP Act and that the claims were for professional negligence rather than ordinary negligence.The Supreme Court of Nevada reviewed the case and affirmed the lower court's decision. The court held that the plaintiffs' claims were for professional negligence and required an expert affidavit under NRS 41A.071. The court found the expert affidavit insufficient as to the doctors because it did not specify acts of negligence separately for each doctor. However, the affidavit was sufficient as to the hospital. Despite this, the court concluded that the PREP Act barred the claim against the hospital because it related to the administration of remdesivir, a covered countermeasure. Therefore, the dismissal of the complaint was affirmed. View "De Becker v. UHS of Delaware, Inc." on Justia Law

In two separate cases, mothers petitioned the Juvenile Court to involuntarily commit their children for inpatient care due to substance use disorders under Massachusetts General Laws c. 123, § 35. E.S. was committed for ninety days, and J.P. for thirty days, following hearings where family members and court clinicians testified about the juveniles' substance use and behaviors.In the case of E.S., the Bristol County Juvenile Court judge found clear and convincing evidence of a substance use disorder, citing E.S.'s history of alcohol and marijuana use, recent positive tests for fentanyl, and concerning behaviors such as stumbling and passing out. The judge also found a likelihood of serious harm due to the imminent risk posed by E.S.'s substance use and the lack of immediate outpatient care options. E.S.'s commitment was affirmed on appeal.For J.P., the Essex County Juvenile Court judge ordered commitment based on testimony about J.P.'s daily marijuana use, behavioral changes, and a single incident of driving under the influence. However, the court clinician did not find J.P. to be a danger to himself or others. On appeal, the Supreme Judicial Court found the evidence insufficient to support a likelihood of serious harm, noting the lack of clear evidence of imminent risk. J.P.'s commitment order was reversed.The Supreme Judicial Court of Massachusetts held that a finding of a substance use disorder under § 35 must be supported by clinical evidence to comply with substantive due process. The court affirmed E.S.'s commitment but reversed and vacated J.P.'s commitment, remanding the case for entry of an order consistent with its opinion. View "In the Matter of J.P." on Justia Law

Dignity Health, operating as French Hospital Medical Center, filed a complaint against orthopedic surgeon Troy I. Mounts, M.D., and his corporation to recover an advance paid under their Physician Recruitment Agreement. Mounts filed a cross-complaint alleging retaliation for his complaints about patient care quality, interference with his economic opportunities, and unlawful business practices. Dignity responded with an anti-SLAPP motion to strike the cross-complaint, which the trial court initially denied. The appellate court reversed this decision and remanded the case for further consideration.Upon remand, the trial court concluded that Mounts had not demonstrated a probability of prevailing on his claims. The court found that Dignity's actions were protected by the litigation privilege, the common interest privilege, and were barred by the statute of limitations. Consequently, the court granted Dignity's motion to strike the cross-complaint and ordered Mounts to pay Dignity's attorney fees and costs.The California Court of Appeal, Second Appellate District, Division Six, reviewed the case. The court affirmed the trial court's decision, holding that all of Mounts' claims were based on conduct protected by the litigation privilege (Civil Code § 47, subd. (b)) and the common interest privilege (Civil Code § 47, subd. (c)). The court also found that Dignity's actions were immune under federal law (42 U.S.C. § 11137) and that some claims were barred by the statute of limitations. The appellate court upheld the trial court's orders granting the motion to strike and awarding attorney fees to Dignity. View "Dignity Health v. Mounts" on Justia Law

M.G. and C.V., medically fragile children under New Mexico’s Medicaid program, sued the New Mexico Human Services Department (HSD) for failing to provide the private duty nursing (PDN) hours they are entitled to. They sought a preliminary injunction to compel HSD to take good faith steps to provide these hours. The district court granted the injunction, and HSD appealed.The United States District Court for the District of New Mexico found that M.G. and C.V. were consistently not receiving their required PDN hours, which placed them at risk of severe medical harm. The court concluded that M.G. and C.V. were likely to succeed on the merits of their Medicaid Act claims, which mandate the provision of PDN services. The court also found that the children would suffer irreparable harm without the injunction, that the balance of harms favored the plaintiffs, and that the injunction was in the public interest. The injunction required HSD to take specific steps, such as negotiating with managed care organizations and increasing monitoring of PDN hour shortfalls, to provide the necessary PDN hours.The United States Court of Appeals for the Tenth Circuit affirmed the district court’s decision. The appellate court held that M.G. and C.V. had standing to seek injunctive relief and that the district court did not err in its conclusions. The court found that the injunction was not impermissibly vague and that the Supreme Court’s decision in Armstrong v. Exceptional Child Center, Inc. did not preclude the issuance of the injunction. The Tenth Circuit concluded that the district court acted within its discretion in granting the preliminary injunction, given the likelihood of success on the merits, the risk of irreparable harm, the balance of harms, and the public interest. View "M.G. v. Armijo" on Justia Law

Carl McDaniel, a Wisconsin prisoner with multiple serious medical conditions, sued the Wisconsin Department of Corrections under the ADA and the Rehabilitation Act, claiming the Department violated his rights by denying him a cell in a no-stairs unit, a single-occupancy cell, and a bed without a top bunk. He also brought an Eighth Amendment claim against Dr. Salam Syed, alleging deliberate indifference to his medical needs. The district court granted summary judgment for the Department on all claims and for Dr. Syed on the Eighth Amendment claim. McDaniel appealed.The United States District Court for the Eastern District of Wisconsin initially handled the case. McDaniel, representing himself, submitted evidence that he missed approximately 600 meals in one year due to the pain and difficulty of navigating stairs to access meals and medications. The district court, however, largely discounted McDaniel’s factual statements and granted summary judgment for the defendants, concluding that McDaniel’s cell assignment was reasonable and that his medical treatment did not violate the Eighth Amendment.The United States Court of Appeals for the Seventh Circuit reviewed the case. The court affirmed the summary judgment for the Department on the claims for a single-occupancy cell and no top bunk, as well as the Eighth Amendment claim against Dr. Syed. However, it reversed the summary judgment on the refusal to assign McDaniel to a no-stairs unit. The court found that McDaniel presented sufficient evidence that the denial of a no-stairs unit effectively denied him access to meals and medications, which could be seen as an intentional violation of the ADA and the Rehabilitation Act. The court also held that McDaniel’s ADA and Rehabilitation Act claims for compensatory damages survived his release from prison and his death.The Seventh Circuit concluded that a reasonable jury could find that the denial of a no-stairs unit amounted to an intentional violation of McDaniel’s rights under the ADA and the Rehabilitation Act, and that the Department was not entitled to sovereign immunity. The case was remanded for further proceedings consistent with this opinion. View "McDaniel v. Syed" on Justia Law

Elizabeth Holt, a former insurance agent for Medicare Medicaid Advisors, Inc. (MMA), alleged that MMA and several insurance carriers (Aetna, Humana, and UnitedHealthcare) violated the False Claims Act (FCA). Holt claimed that MMA engaged in fraudulent practices, including falsifying agent certifications and violating Medicare marketing regulations, which led to the submission of false claims to the Centers for Medicare and Medicaid Services (CMS).The United States District Court for the Western District of Missouri dismissed Holt's complaint. The court found that no claims were submitted to the government, the alleged regulatory violations were not material to CMS’s contract with the carriers, and the complaint did not meet the particularity standard required by Federal Rule of Civil Procedure 9(b). The court also denied Holt's motion for reconsideration, which introduced a fraudulent inducement theory and requested leave to amend the complaint.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Holt's allegations did not meet the materiality requirement under the FCA. The court applied the materiality standard from Universal Health Services, Inc. v. United States ex rel. Escobar, considering factors such as whether the government designated compliance as a condition of payment, whether the violations were minor or substantial, and whether the government continued to pay claims despite knowing of the violations. The court found that the alleged violations did not go to the essence of CMS’s contract with the carriers and were not material to the government's payment decisions.The Eighth Circuit also upheld the district court's denial of Holt's motion for reconsideration and request to amend the complaint, concluding that adding a fraudulent inducement claim would be futile given the immateriality of the alleged violations. View "United States ex rel. Holt v. Medicare Medicaid Advisors" on Justia Law

A licensed professional counselor in Colorado challenged the state's Minor Conversion Therapy Law (MCTL), which prohibits mental health professionals from providing conversion therapy to minors. Conversion therapy is defined as any practice attempting to change an individual's sexual orientation or gender identity. The plaintiff argued that the MCTL violates the Free Speech and Free Exercise Clauses of the First Amendment and sought a preliminary injunction to prevent its enforcement.The United States District Court for the District of Colorado denied the plaintiff's motion for a preliminary injunction, finding that the plaintiff had standing but failed to demonstrate a likelihood of success on the merits of her First Amendment claims. The court concluded that the MCTL regulates professional conduct that incidentally involves speech and is therefore subject to rational basis review, which it survives.The United States Court of Appeals for the Tenth Circuit affirmed the district court's decision. The Tenth Circuit held that the MCTL regulates professional conduct by prohibiting a specific therapeutic treatment (conversion therapy) provided by licensed mental health professionals to minors. The court found that the MCTL does not target speech based on its content but regulates the practice of conversion therapy, which incidentally involves speech. The court concluded that the MCTL is subject to rational basis review and serves legitimate state interests in protecting minors from harmful and ineffective therapeutic practices and maintaining the integrity of the mental health profession. The court found that the MCTL is rationally related to these interests, as the record showed that conversion therapy is harmful to minors and lacks clinical utility. View "Chiles v. Salazar" on Justia Law

O.L.K. was admitted to Montana State Hospital in January 2022 following a disturbance at a mental health treatment center. The petition for involuntary commitment was based on an evaluation by Michale McLean, LCSW, which included observations and reports from medical staff and law enforcement. O.L.K. had been brought to the hospital twice in one day for aggressive behavior, including threatening his therapist and threatening to burn down the treatment center. During his second hospital visit, he made several threatening statements, including threats to kill someone.The Fourth Judicial District Court, Missoula County, appointed Shannon McNabb, a Licensed Clinical Professional Counselor, to evaluate O.L.K. McNabb testified that O.L.K. exhibited disorganized and delusional behavior and diagnosed him with Bipolar I disorder. She relied on various records, including the St. Patrick’s Report, and testified about O.L.K.’s threats and delusional statements. The District Court overruled hearsay objections raised by O.L.K.’s attorney, admitting the St. Patrick’s Report under the medical records exception. The court found that O.L.K. presented an imminent risk to others and committed him to Montana State Hospital for up to 90 days.The Supreme Court of the State of Montana reviewed the case and affirmed the District Court’s decision. The Supreme Court held that while the District Court erred in admitting the St. Patrick’s Report as a hearsay exception, there was substantial admissible evidence from McNabb’s testimony to support the finding of an overt act. The court concluded that O.L.K.’s statements to McNabb, which included threats to kill someone, were sufficient to demonstrate an imminent threat of injury to others. The decision to commit O.L.K. was therefore upheld. View "In re O.L.K." on Justia Law