Justia Health Law Opinion Summaries

M.H.W. has been involuntarily committed to the Montana Mental Health Nursing Care Center (NCC) since June 16, 2020, due to paranoid schizophrenia and an inability to manage his diabetes. The Tenth Judicial District Court extended his commitment several times, with the most recent extension being on January 6, 2022. On December 14, 2022, a petition was filed to extend his commitment for another year. Notice was served, indicating that if a hearing was requested less than 10 days before the termination of the previous commitment, the commitment would be extended until the hearing. However, the court did not issue an order extending the commitment beyond January 6, 2023.On February 8, 2023, M.H.W.'s counsel requested a contested hearing, which was scheduled for April 6, 2023, and later rescheduled to June 1, 2023. The District Court ordered that M.H.W. remain committed until the hearing. At the hearing, the court found that M.H.W. continued to exhibit symptoms of schizophrenia and could not manage his basic needs, including his diabetes. The court ordered his recommitment to NCC for up to one year.The Montana Supreme Court reviewed the case. The court held that the expiration of M.H.W.'s commitment did not deprive the District Court of jurisdiction, as the commitment was extended by operation of law when no hearing was requested before January 6, 2023. The court also held that the District Court's failure to enter an order extending the commitment did not constitute plain error, as M.H.W. received due process through the contested hearing. The Supreme Court affirmed the District Court's order of recommitment. View "In re M.H.W." on Justia Law

In 2008, Santiago Alirio Gomez Rivera began working with co-conspirators in Latin America to obtain and transport cocaine for importation into the United States. Rafael Segundo Castro Diaz joined the conspiracy later, helping transport 1,200 kilos of cocaine in April 2013. The United States Coast Guard intercepted the boat carrying the cocaine, and the men aboard were arrested. Years later, a federal grand jury returned three indictments against Gomez Rivera and Castro Diaz, with the second superseding indictment expanding the conspiracy period from January 2008 to September 2013.The United States District Court for the Southern District of Florida denied the defendants' motions to dismiss the second superseding indictment, which they argued was untimely and broadened the original charges. The defendants then negotiated a stipulated bench trial, preserving their right to appeal the denial of their motions to dismiss. The district court adjudicated them guilty, but there were clerical errors in Castro Diaz's judgment documentation.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that a superseding indictment can satisfy the statute of limitations if it is independently timely or relates back to a timely prior indictment. The second superseding indictment was independently timely, as it was returned within five years of the alleged conspiracy period. The court also found sufficient evidence to support the convictions, as both defendants stipulated to facts indicating their involvement in the conspiracy until September 2013. The court affirmed the convictions and sentences but remanded for the correction of clerical errors in Castro Diaz's judgment. View "USA v. Santiago Alirio Gomez Rivera" on Justia Law

The City of Huntington and the Cabell County Commission filed lawsuits against AmerisourceBergen Drug Corp., Cardinal Health, Inc., and McKesson Corp., alleging that the defendants contributed to the opioid epidemic by distributing excessive quantities of opioids to pharmacies. The plaintiffs claimed that the defendants' actions created a public nuisance that should be abated under West Virginia common law. The cases were consolidated and remanded to the United States District Court for the Southern District of West Virginia, which held a ten-week bench trial.The district court ruled in favor of the defendants, concluding that the plaintiffs failed to prove that the defendants' conduct was unreasonable or that it proximately caused the opioid epidemic. The court found that the defendants substantially complied with their duties under the Controlled Substances Act (CSA) and that the plaintiffs did not provide sufficient evidence to show that the volume of opioids distributed was excessive or that the defendants failed to maintain effective controls against diversion. The district court also determined that the plaintiffs' proposed abatement plan was not appropriate.The plaintiffs appealed to the United States Court of Appeals for the Fourth Circuit, contesting the district court's factual findings and legal conclusions. The Fourth Circuit certified a question to the Supreme Court of Appeals of West Virginia, asking whether conditions caused by the distribution of a controlled substance can constitute a public nuisance under West Virginia common law and, if so, what the elements of such a claim are.The Supreme Court of Appeals of West Virginia declined to answer the certified question, citing the disputed factual findings and related legal conclusions on appeal. The court emphasized that it could not address the legal issue without a sufficiently precise and undisputed factual record, and any answer would be advisory given the unsettled facts. View "City of Huntington and Cabell County Commission v. AmerisourceBergen Drug Corporation" on Justia Law

BlueCross BlueShield of Tennessee (BlueCross) is an insurer and fiduciary for an ERISA-governed group health insurance plan. A plan member in New Hampshire sought coverage for fertility treatments, which BlueCross denied as the plan did not cover such treatments. The Commissioner of the New Hampshire Insurance Department initiated an enforcement action against BlueCross, alleging that the denial violated New Hampshire law, which mandates coverage for fertility treatments. BlueCross sought to enjoin the state regulatory action, arguing it conflicted with its fiduciary duties under ERISA.The United States District Court for the Eastern District of Tennessee denied BlueCross's request for relief and granted summary judgment to the Commissioner. The court found that the Commissioner’s enforcement action was against BlueCross in its capacity as an insurer, not as a fiduciary, and thus was permissible under ERISA’s saving clause, which allows state insurance regulations to apply to insurers.The United States Court of Appeals for the Sixth Circuit reviewed the case and affirmed the district court’s decision. The Sixth Circuit held that the Commissioner’s action was indeed against BlueCross as an insurer, aiming to enforce New Hampshire’s insurance laws. The court noted that ERISA’s saving clause permits such state actions and that BlueCross could not use its fiduciary duties under ERISA to evade state insurance regulations. The court also referenced the Supreme Court’s decision in UNUM Life Insurance Co. of America v. Ward, which established that state insurance regulations are not preempted by ERISA when applied to insurers. Thus, the Sixth Circuit concluded that ERISA did not shield BlueCross from the New Hampshire regulatory action. View "BlueCross BlueShield of Tennessee v. Nicolopoulos" on Justia Law

AstraZeneca Pharmaceuticals LP and AstraZeneca AB challenged the Drug Price Negotiation Program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain high-expenditure drugs. CMS issued guidance on selecting qualifying drugs for 2026, including Farxiga, manufactured by AstraZeneca. AstraZeneca sued the Secretary of the Department of Health and Human Services and the CMS Administrator, claiming the Negotiation Program violated procedural due process and that parts of CMS’s guidance violated the Administrative Procedure Act (APA).The United States District Court for the District of Delaware ruled that AstraZeneca failed to state a due process violation and lacked standing to pursue its APA claims. The court entered judgment in favor of the government.The United States Court of Appeals for the Third Circuit reviewed the case. The court found that AstraZeneca lacked Article III standing to challenge the CMS guidance under the APA because the company did not demonstrate a concrete and particularized injury. AstraZeneca's claims about the impact on its business decision-making and difficulty valuing Farxiga in negotiations were deemed hypothetical and conjectural.Regarding the due process claim, the court held that AstraZeneca did not have a protected property interest in selling its drugs at a market rate. The court noted that federal patent laws do not confer a right to sell at a particular price, and the Negotiation Program only sets prices for drugs reimbursed by CMS, not private market transactions. Consequently, the court affirmed the District Court’s judgment, granting summary judgment in favor of the government on both the APA and due process claims. View "AstraZeneca Pharmaceuticals LP v. Secretary United States Department of Health and H" on Justia Law

Paul Cropper applied for disability insurance benefits and supplemental security income in February 2020, citing various impairments such as anxiety, depression, ADHD, insomnia, and COPD. His application was denied initially and upon reconsideration by the Social Security Administration. Cropper then requested a hearing before an administrative law judge (ALJ), where he presented opinions from his medical providers indicating severe limitations. The ALJ conducted a five-step analysis and denied the application, finding that while Cropper had severe impairments, he could still perform certain jobs available in the national economy. The ALJ found the opinions of Cropper’s primary care provider and psychiatrist unpersuasive.Cropper sought judicial review in the United States District Court for the District of Minnesota, arguing that the ALJ improperly evaluated the evidence, leading to an incorrect residual functional capacity determination. The district court granted summary judgment in favor of the Commissioner, concluding that substantial evidence supported the ALJ’s decision to find the medical opinions unpersuasive.The United States Court of Appeals for the Eighth Circuit reviewed the case de novo and affirmed the district court’s decision. The court held that the ALJ adequately considered the supportability and consistency of the medical opinions as required by the revised regulations. The court emphasized that the ALJ’s findings were supported by substantial evidence, including the conservative course of treatment and the lack of significant outpatient therapy. The court also noted that the ALJ’s reasoning was sufficiently clear to allow for appropriate judicial review. View "Cropper v. Dudek" on Justia Law

Incyte Corporation and Incyte Holdings Corporation (collectively, Incyte) own U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat autoimmune disorders. Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) secured FDA approval for an oral deuterated ruxolitinib product, branded as Leqselvi, to treat alopecia areata (AA) and planned to launch it in October 2024. Incyte sued Sun for allegedly infringing the ’335 patent and moved for a preliminary injunction to prevent Sun from launching Leqselvi.The United States District Court for the District of New Jersey granted Incyte’s motion for a preliminary injunction, finding that Incyte would suffer irreparable harm if Sun launched Leqselvi. The district court based its decision on the theory that Sun’s launch would give it an unjust head start in the AA market, diminishing the value of Incyte’s investments in developing its own topical deuterated ruxolitinib product.Sun appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the grant of the preliminary injunction for an abuse of discretion, focusing on whether the district court made a clear error in its irreparable harm analysis. The Federal Circuit found that the district court clearly erred in its finding of irreparable harm, as it was based on the incorrect assumption that Incyte would be first to market if the injunction were granted. The court noted that Sun’s multi-year head start was inevitable regardless of the injunction, as Incyte’s product would not launch until several years after the ’335 patent expired.The Federal Circuit reversed the district court’s order granting the preliminary injunction, concluding that Incyte failed to provide non-speculative evidence of irreparable harm. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, LTD. " on Justia Law

Broc Waltermeyer, an incarcerated federal inmate, alleged that he received inadequate medical treatment for his chronic knee pain while at the Federal Correctional Institute in Berlin, New Hampshire. He claimed that despite receiving various non-surgical treatments, including cortisone injections, pain medication, special shoes, knee braces, access to a low bunk, and a cane, he continued to experience pain. Waltermeyer argued that he should have been provided with knee replacement surgery, which was recommended to be deferred by an outside specialist until he was older.The United States District Court for the District of New Hampshire dismissed Waltermeyer's complaint, holding that his claims failed because he had an alternative administrative remedy. The district court also denied his motion for a preliminary injunction, as he had been transferred to a different facility, making the defendants no longer responsible for his care. Waltermeyer then amended his complaint to seek only money damages, leading to the current appeal.The United States Court of Appeals for the First Circuit reviewed the case and affirmed the district court's dismissal. The court held that Waltermeyer's claims were meaningfully different from those in Carlson v. Green, where the Supreme Court recognized a Bivens-type Eighth Amendment claim against federal prison officials for deliberate indifference to serious medical needs. The court found that Waltermeyer received substantial treatment, albeit not the treatment he preferred, and that the medical procedures administered were in accordance with doctors' recommendations. The court concluded that the differences in the nature of the medical care provided and the absence of gross inadequacy or deliberate indifference made Waltermeyer's case distinct from Carlson, thus precluding the extension of a Bivens remedy. View "Waltermeyer v. Hazlewood" on Justia Law

Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz") manufacture and sell sodium oxybate products, Xyrem and Xywav, for treating narcolepsy and idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals, LLC ("Avadel") sought FDA approval for Lumryz, a sodium oxybate product, for treating narcolepsy. Jazz sued Avadel, alleging that Avadel's FDA submission infringed Jazz's U.S. Patent 11,147,782. The district court found in favor of Jazz, issuing a permanent injunction against Avadel from seeking FDA approval for Lumryz for IH and from marketing Lumryz for that indication.The U.S. District Court for the District of Delaware initially ruled that Avadel's submission of its New Drug Application (NDA) constituted infringement under 35 U.S.C. § 271(e)(2). The court issued a permanent injunction prohibiting Avadel from seeking FDA approval for Lumryz for IH, offering open-label extensions (OLEs) to clinical trial participants, and initiating new clinical trials. Avadel appealed, arguing that the injunction was overly broad and that certain activities were protected under the safe-harbor provision of 35 U.S.C. § 271(e)(1).The United States Court of Appeals for the Federal Circuit reviewed the case. The court reversed the injunction prohibiting Avadel from initiating new clinical trials and offering OLEs, finding these activities to be protected under the safe-harbor provision. The court vacated the injunction preventing Avadel from seeking FDA approval for new indications of Lumryz, remanding the issue to the district court for further consideration. The court instructed the district court to determine whether Avadel's submission of a paper NDA for additional indications would constitute an act of infringement under 35 U.S.C. § 271(e)(2) and to reassess the eBay factors if necessary. View "JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC " on Justia Law

In January 2023, J.F., a 39-year-old woman with a history of substance abuse, began experiencing severe delusions and paranoia, believing her parents wanted to kill her and her children. After a series of incidents, including living in her car and being admitted to the St. Vincent Stress Center, J.F. was temporarily committed by a trial court for up to ninety days due to her mental illness and inability to keep herself safe.J.F. appealed the commitment, arguing insufficient evidence supported the order. The Court of Appeals dismissed her appeal as moot, stating it did not present a novel issue or particularized harmful consequence. J.F. then petitioned for transfer to the Indiana Supreme Court.The Indiana Supreme Court held that temporary commitment appeals are not moot upon expiration unless the appellee proves no collateral consequences exist. The court emphasized the significant liberty interests and lifelong collateral consequences involved in such commitments, warranting appellate review. The court found sufficient evidence to support J.F.'s commitment, noting her impaired reasoning, inability to function independently, and the danger she posed to herself. Consequently, the court affirmed the trial court's temporary commitment order. View "In re Commitment of J.F." on Justia Law