Justia Health Law Opinion Summaries

Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law

The Supreme Judicial Court affirmed the judgment entered by the probate court appointing the Department of Health and Human Services as T.'s adult guardian and conservator pursuant to Me. Rev. Stat. 5-301, 5-401(2), holding that the probate court did not err in determining that the emergency and final hearings on the Department's petition constituted a unified proceeding.The Department filed a petition for appointment of a full guardian and conservator for T., age eighty-six, in the probate court, and also requesting the appointment of an emergency guardian and conservator. The court held an evidentiary emergency review hearing, after which the court ordered that an emergency appointment continue pending a final hearing. The court then held a final hearing and granted the Department's petition. T. appealed, arguing that the court should not have considered certain testimony given at the emergency hearing because the court's conclusion that the two proceedings were part of a unified proceeding was erroneous. The Supreme Judicial Court affirmed, holding that when the trial judge in a guardianship and conservatorship proceeding has heard the evidence presented in prior stages of the proceeding, that judge may consider the evidence in later stages because the process is a unified proceeding. View "In re Adult Guardianship & Conservatorship of T." on Justia Law

R.A.C. Rolling Hills LP, dba ActivCare at Rolling Hills Ranch, and ActivCare Living, Inc. (together, ActivCare), appealed an order denying their petition to compel arbitration in the elder abuse lawsuit filed by Mary Leger. ActivCare contended the trial court erred in concluding that it had waived its right to arbitration because it sought to compel arbitration less than 30 days after filing its answer. Under the unique facts of this case, the Court of Appeal concluded substantial evidence supported the trial court’s waiver finding and affirmed the order. View "Leger v. R.A.C. Rolling Hills" on Justia Law

The Supreme Court reversed the order of the district court committing Appellant to the Montana State Hospital at Warm Springs for a period of up to ninety days, holding that the district court committed reversible error when it allowed a professional person to testify by telephone over Appellant's objection.The State filed a petition for Appellant's involuntary commitment due to her disorganized thinking and confusion. At a hearing on the petition, the State called Amanda Torres, a licensed clinical professional counselor, to testify by telephone due to technical difficulties with courtroom video capabilities. The district court overruled Appellant's rejection and allowed Torres to testify by telephone. Relying on Torres's testimony, the district court concluded that Appellant suffered from a mental disorder and required commitment. The Supreme Court reversed, holding that the district court erroneously overruled Appellant's objection and that the court was statutorily mandated to prohibit Torres's testimony by telephone because it did not satisfy the requirement for two-way audio-video communication and because Appellant objected. View "In re S.E." on Justia Law

Plaintiff saw Cognium, a “nutraceutical” manufactured by Natrol, on sale. Cognium, according to Natrol’s advertising, improves memory and concentration. Its packaging stated that Cognium is “powered by Cera-Q, a natural protein from silkworm cocoons,” and can improve “Memory Recall Efficiency” by 90% when taken twice daily for four weeks. The box claimed that “nine clinical studies in adults, seniors and children showed statistically significant improvements in memory and cognition in 4 weeks or less when taken as directed.”   Plaintiff filed a putative class action complaint against Natrol, seeking damages for herself and establishment of a National Class and Missouri Consumer Subclass. Plaintiff alleged that, prior to her purchases of Cognium, two of the nine clinical studies noted on its packaging had been retracted, including one for “data fabrication and falsification.”   With Plaintiff’s individual claims dismissed, the court determined the sole named plaintiff could not represent the purported class and dismissed the entire action. On appeal, Plaintiff argued the district court erred in granting summary judgment dismissing her MMPA and unjust enrichment claims.   The Eighth Circuit affirmed. The court explained that here Plaintiff purchased a product that expressly stated on the label it was “not intended to” do what she stated she purchased it for, serve as a substitute treatment for her prescription medication. Thus, for Plaintiff the actual value of the Cognium she purchased, and the value of Cognium without Natrol’s alleged marketing misrepresentations was “zero.” The benefit of the bargain rule does not apply in this situation, so Plaintiff cannot prove that she suffered ascertainable loss “as a result of” Natrol’s unlawful practice. View "Christine Vitello v. Natrol, LLC" on Justia Law

Amy’s employs 2,500 people to manufacture vegetarian meals. It purchased comprehensive property insurance from Fireman’s for a period ending in July 2020. The policy included coverage extensions for communicable diseases and for loss avoidance and mitigation: Fireman’s “will pay for direct physical loss or damage to Property" caused by or resulting from a "communicable disease event at a location.” The policy defines “communicable disease event” as one in which “a public health authority has ordered that a location be evacuated, decontaminated, or disinfected due to the outbreak of a communicable disease.” Amy’s incurred costs “to mitigate, contain, clean, disinfect, monitor, and test for the effects of” the coronavirus at insured locations, and to avoid or mitigate potential coronavirus-related losses, including temperature-screening equipment to test for COVID, protective shields to prevent transmission on assembly lines, masks and goggles, cleaning supplies, and “hero pay.” People with confirmed COVID-19 cases were on Amy’s premises. The complaint cited “various require[d safety measures] for all essential businesses.”Fireman’s denied Amy’s claim. The court of appeal affirmed the dismissal of the complaint. Under communicable disease extension, the need to clean or disinfect infected or potentially infected covered property constitutes “direct physical loss or damage” of the property; Amy’s has not pled a “communicable disease event” but should be given leave to amend to do so. View "Amy's Kitchen, Inc. v. Fireman's Fund Insurance Co." on Justia Law

The underlying dispute before the Pennsylvania Supreme Court in this case involved the adequacy of state funding for community participation support ("CPS") services, which were designed to help individuals with autism or intellectual disabilities live independently. The primary issue on appeal related to the exhaustion requirement. The Pennsylvania Department of Human Services ("DHS") issued ODP Announcement 19-024, indicating it intended to change the rate structure for CPS services provided under the Home and Community Based Services (“HCBS”) waivers. Petitioners filed an action for declaratory and injunctive relief, challenging the legality of the new fee schedule and alleged the new reimbursement rates were too low to sustain the provision of CPS services to eligible recipients. Pertinent here, the Commonwealth Court agreed with one of DHS' preliminary objections that Petitioners failed to exhaust their administrative remedies, as required by case precedent, before seeking judicial review. The court acknowledged a narrow exception to the exhaustion requirement whereby a court may consider the merits of a claim for declaratory or injunctive relief if a substantial constitutional question is raised and the administrative remedy is inadequate. It clarified, however, that the exception only applied where the plaintiff raises a facial constitutional challenge to the statute or regulation in question, as opposed to its application in a particular case. Here, the court concluded, the Petitioners were attacking the fee schedule in the Final Notice, which was produced by application of the legal authority cited in that notice, and not advancing a facial constitutional challenge. The court also found Petitioners failed to demonstrate the administrative remedy was inadequate. The Supreme Court affirmed the Commonwealth Court’s order insofar as it sustained the preliminary objection asserting that the Petitioners failed to exhaust their administrative remedies, and dismissed the Petition as to those parties. The order was vacated in all other respects, and the matter was remanded for further proceedings. View "Rehabilitation & Community Providers Association, et al. v. Dept. Human Svcs" on Justia Law

Sream manufactures water pipes (bongs). According to Sream, its packaging and labels have long included the statement that such products “should be sold, marketed or used for legal, non-prohibited use only.” Since July 2020, Sream has also placed the following label on its products as a “purely defensive” measure: “WARNING: This product can expose you to chemicals including arsenic, which is known ... to cause cancer."EHA filed a private enforcement action, alleging Sream had failed to provide a warning that its products exposed consumers to marijuana smoke in violation of California’s Safe Drinking Water and Toxic Enforcement Act (Health & Safety Code, 25249.5, “Proposition 65”). Section 25249.6 provides: “No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.” “Marijuana smoke” was added to the list of carcinogens in 2009.The trial court granted Sream judgment on the pleadings, finding EHA had not alleged that Sream’s products require marijuana to function or can only be used with marijuana. The court of appeal affirmed. EHA does not allege direct contact, but instead that individuals “may be exposed to marijuana smoke” if they use Sream’s water pipes with marijuana. Requiring a warning for possible indirect contact, depending on how a consumer chooses to use the product, would introduce confusion into that decision-making process. View "Environmental Health Advocates, Inc. v. Sream, Inc." on Justia Law

In 2013, Craig (age 49) executed an Illinois statutory short-form health care power of attorney, appointing his mother as his agent. In 2016, Craig was hospitalized at McFarland after being charged with burglary and found unfit to stand trial. In 2018, a McFarland psychiatrist sought to involuntarily administer psychotropic medications to Craig under the Mental Health Code, 405 ILCS 5/2-107. Craig alleged that decisions on his medical treatment rested with his agent. A psychiatrist testified that Craig was diagnosed with schizoaffective disorder, bipolar type, when he was 25 years old and had been experiencing hallucinations with symptoms of paranoia, inability to sleep, poor impulse control, hypersexuality, physical aggression, and psychomotor agitation; Craig had no understanding of his mental illness and lacked the capacity to make rational treatment decisions. She opined that the benefits of the medications outweighed the potential risks. Without treatment, Craig was unable to live outside a hospital. Craig’s 82-year-old mother declined to consent, believing that the medications caused brain damage, made Craig “like a zombie,” and made him look “like a man without a head.”The trial court granted the petition for involuntary administration of psychotropic medication for a period not to exceed 90 days. The appellate court and Illinois Supreme Court affirmed. The Mental Health Code, which includes strict standards for an order permitting involuntary administration of psychotropic medications, provides a narrow exception to an agent’s authority to make a principal’s health care decisions. View "In re Craig H." on Justia Law

On November 4, 2016, Kernan had an External Cephalic Version (ECV) procedure to rotate her healthy 39-week fetus from a breech position. The hospital recorded the ECV as successful. Post-procedure fetal monitoring was “reassuring.” The next day, Kernan could not detect fetal movement and returned to the hospital. After an ultrasound, doctors informed Kernan that she had suffered an intrauterine fetal demise and that they could not determine the cause of death. They noted that nothing in the literature linked ECV with fetal demise. Kernan delivered a stillborn baby on November 7. The delivery doctor, Vargas, told Kernan that he could not see any indicators as to why Kernan’s baby died. Kernan eventually ordered an autopsy. After months of delay due to Dr. Vargas not responding to Kernan’s requests to review the autopsy report with her, Kernan met with Dr. Kerns on July 10, 2017, and learned that doctors had discussed her case during a morbidity and mortality conference. Kernan claims she first became subjectively suspicious of medical negligence during that meeting. On November 6, 2017, Kernan served notice of her intention to file suit. Within 90 days, she filed her negligence complaint.The court rejected the suit as time-barred under Code of Civil Procedure 340.5’s one-year limitations period. The court of appeal reversed. The hospital’s records demonstrate that reasonable minds could differ as to whether Kernan should have suspected negligent performance of the ECV on November 5, 2016. View "Kernan v. Regents of the University of California" on Justia Law