Justia Health Law Opinion Summaries

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

A woman, Lila B., was detained at a psychiatric hospital for a mental health evaluation due to a severe head-lice infestation. The hospital staff sought to shave her head without her consent, arguing it was necessary to treat the lice and prevent their spread to other patients and staff. Lila objected, citing her religious beliefs and the psychological impact of head-shaving.The Superior Court of Alaska authorized the involuntary head-shaving, finding that the hospital had a compelling interest in preventing the spread of lice and that shaving her head was the least restrictive means of achieving this. The court relied on testimony from hospital staff that other treatments, such as permethrin shampoo, would be ineffective due to the severity of the infestation and that isolation was not feasible.The Supreme Court of Alaska reviewed the case and held that the State must demonstrate by clear and convincing evidence that head-shaving is the least restrictive means of advancing a compelling government interest. The court found that the State failed to meet this heightened standard. The evidence did not clearly and convincingly establish that less restrictive alternatives, such as using permethrin shampoo in conjunction with a head covering or some form of isolation, were inadequate. The court concluded that the State did not sufficiently explore these alternatives.As a result, the Supreme Court of Alaska vacated the order authorizing the involuntary head-shaving, emphasizing the need for the State to meet a substantial evidentiary burden before infringing on a patient's fundamental rights. View "In the Matter of the Necessity for the Hospitalization of Lila B." on Justia Law

The veteran served in the U.S. Army from March 1944 to May 1945 and was diagnosed with Hodgkin’s lymphoma in 1978. He received radiation therapy at a VA facility, which successfully treated the lymphoma but led to his death in early 1979 due to pulmonary complications. The veteran’s wife, Hatfield, filed a claim for dependency and indemnity benefits, which was denied by the Regional Office (RO) for lack of service connection. Hatfield appealed to the Board of Veterans’ Appeals (the Board), asserting that the veteran’s death was due to negligent VA medical care. In 1980, the Board denied the appeal, finding the VA provided adequate care and the veteran’s reaction was a recognized complication of radiation therapy.Hatfield later filed an application to reopen her claim in 2010, arguing entitlement to compensation under a 2004 regulation requiring informed consent for VA-administered medical care. The Board denied the application, but the Veterans Court reversed, granting benefits from August 1, 2010, due to the VA’s failure to obtain informed consent. In 2020, Hatfield filed a motion to revise the 1980 Board decision, claiming clear and unmistakable error (CUE) for not considering informed consent under 38 U.S.C. § 4131. The Board denied the motion, and the Veterans Court affirmed, stating there was no indication in 1980 that failure to obtain informed consent amounted to a compensable negligence claim.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the Veterans Court’s decision. The court held that Hatfield did not demonstrate that the 1980 Board committed CUE, as there was no undebatable error in the application of the law at that time. The court found no evidence that the failure to obtain informed consent under 38 U.S.C. § 4131 was considered a compensable negligence claim under 38 U.S.C. § 351 in 1980. View "HATFIELD v. COLLINS " on Justia Law

The case involves the defendant, Gene L. Zarella, who is charged with four counts of aggravated felonious sexual assault. Following his indictment, Zarella sought the production of the complainant's confidential counseling and hospitalization records for in camera review by the trial court. The trial court granted these motions and reviewed the records, finding them discoverable. Zarella then moved for in camera review of additional records from various private counseling, mental health, and medical care providers. The trial court granted these motions as well.The complainant, joined by one of the counseling providers, moved to intervene and quash the orders for production, citing statutory privileges and the complainant's constitutional right to privacy under Part I, Article 2-b of the New Hampshire Constitution. The Superior Court (Ignatius, J.) granted the motion to intervene but denied the motion to quash, applying the standard from State v. Gagne, which allows in camera review if the defendant establishes a reasonable probability that the records contain material and relevant information.The New Hampshire Supreme Court reviewed the case and concluded that Part I, Article 2-b of the State Constitution abrogates the application of the Gagne standard to records held by private organizations, as established in State v. Cressey. The court held that to obtain in camera review and disclosure of confidential or privileged records held by private organizations, the defendant must follow the procedures outlined in RSA 173-C:5 for records privileged under RSA chapter 173-C or demonstrate an essential need for the records for those privileged under RSA 329-B:26 and RSA 330-A:32. The court also mandated that notice and an opportunity to object must be provided to the individual whose records are sought. The court vacated the trial court's order and remanded for further proceedings consistent with this opinion. View "State v. Zarella" on Justia Law

State Farm Mutual Automobile Insurance Company and others filed a lawsuit against Michael LaRocca and his associated chiropractic clinics, alleging that the clinics submitted fraudulent insurance claims for services that were not medically necessary. The clinics, owned by LaRocca, were operating under an exemption from Florida's Health Care Clinic Act, which requires clinics to be licensed unless they are wholly owned by licensed health care practitioners who are legally responsible for compliance with all federal and state laws.The United States District Court for the Middle District of Florida denied State Farm's motion for partial summary judgment, rejecting the argument that LaRocca's failure to ensure compliance with all laws invalidated the clinics' exemption and rendered their charges noncompensable. The court found that the term "legally responsible" did not impose an affirmative duty on LaRocca to ensure compliance with all laws but rather indicated accountability for violations.The United States Court of Appeals for the Eleventh Circuit reviewed the case and determined that the interpretation of "legally responsible" within the context of Florida's Health Care Clinic Act was a matter best decided by the Florida Supreme Court. The Eleventh Circuit certified the question to the Florida Supreme Court, seeking clarification on whether the term imposes an affirmative duty on clinic owners to ensure compliance with all federal and state laws to maintain their exemption status. The Eleventh Circuit deferred its decision pending the Florida Supreme Court's interpretation. View "State Farm Mutual Automobile Insurance Company v. LaRocca" on Justia Law