Justia Health Law Opinion Summaries

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

Detectives with the Fort Myers Police Department observed Alphonso Lataurean James engaging in suspected drug transactions at a gas station. James was seen wearing a cross-body bag, which he later took into a vehicle. After stopping the vehicle, detectives found the bag containing a handgun and ammunition. They also discovered drugs in the car, including fentanyl and cocaine. James admitted to possessing the bag but denied knowledge of the firearm. DNA testing linked James and others to the gun. James, a convicted felon, was charged with possession of a firearm by a convicted felon.The United States District Court for the Middle District of Florida sentenced James to ninety-two months in prison, applying a four-level enhancement under U.S.S.G. § 2K2.1(b)(6)(B) for possessing a firearm in connection with another felony offense. James objected, arguing that the enhancement was improperly applied based on the Sentencing Guidelines' commentary. The district court overruled his objections, finding that the firearm was in close proximity to the drugs, thus meeting the "in connection with" requirement.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that the phrase "in connection with" in U.S.S.G. § 2K2.1(b)(6)(B) is unambiguous and does not require deference to the Sentencing Guidelines' commentary. Despite the district court's error in relying on the commentary, the appellate court found that the district court's factual findings were sufficient to support the enhancement. The court affirmed James's sentence, concluding that he possessed the firearm in connection with drug trafficking. View "USA v. James" on Justia Law

Roy Lee Jones, Jr. was involved in a methamphetamine-trafficking organization in North-Central Louisiana. He received large shipments of methamphetamine from his California-based supplier, DeLewis Johnson IV, and redistributed them to Willie Todd Harris, who then sold them to street-level dealers. After a ten-month investigation, federal law enforcement initiated grand jury proceedings, resulting in a five-count indictment. Jones was charged under 21 U.S.C. §§ 841(a)(1) and 846 for conspiracy to distribute and possess with intent to distribute methamphetamine.Jones and Johnson were tried as co-defendants and convicted by a jury. The initial presentence report (PSR) calculated Jones' offense level as 37, recommending a Guidelines range of 210-262 months. The district court sentenced Jones to 210 months' imprisonment. Jones appealed his conviction and sentence, which were affirmed by the United States Court of Appeals for the Fifth Circuit. The Supreme Court denied Jones' petition for a writ of certiorari.Jones filed a motion for a sentence reduction under Amendments 821 and 825 of the United States Sentencing Guidelines. The district court denied the motion, finding that Jones was ineligible for a reduction under USSG § 4C1.1(a)(10) because he had received an aggravating role enhancement under § 3B1.1 and had engaged in a continuing criminal enterprise as defined in 21 U.S.C. § 848.The United States Court of Appeals for the Fifth Circuit reviewed the district court's decision for abuse of discretion, its interpretation of the Guidelines de novo, and its findings of fact for clear error. The court held that either receiving a § 3B1.1 adjustment or engaging in a continuing criminal enterprise is sufficient to disqualify a defendant from a sentence reduction under § 4C1.1(a)(10). Since Jones received an aggravating role enhancement, he was ineligible for a reduction. The court affirmed the district court's decision. View "United States v. Jones" on Justia Law

Dr. Timothy Baxter, while working for Indivior, a pharmaceutical company, distributed misleading information to Massachusetts’s Medicaid program about the safety of new opioid drugs. This led to his conviction for misdemeanor drug misbranding. Following his conviction, the Secretary of Health and Human Services banned him from participating in federal healthcare programs for five years. Baxter challenged this exclusion, arguing that his crime did not categorically relate to the delivery of an item or service under a state healthcare program.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the Secretary, rejecting Baxter’s claims. Baxter then appealed to the United States Court of Appeals for the Fourth Circuit.The Fourth Circuit reviewed the case and held that the exclusion statute, 42 U.S.C. § 1320a-7(a), does not require a categorical approach. Instead, it employs a circumstance-specific approach, meaning it looks at the actual conduct of the individual rather than the elements of the statute of conviction. The court found that Baxter’s conduct—misbranding drugs to influence MassHealth’s coverage decisions—was related to the delivery of an item under a state healthcare program. Therefore, his exclusion was mandatory under the statute.The Fourth Circuit affirmed the district court’s decision, upholding Baxter’s exclusion from federal healthcare programs. View "Baxter v. Kennedy" on Justia Law