Justia Health Law Opinion Summaries

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

The plaintiffs/appellees, doctors, parents, and the Oklahoma State Medical Association, (collectively, doctors) brought a declaratory judgment action against the State of Oklahoma and the Governor seeking: (1) a declaration that Senate Bill 658 (codified as 70 O.S. Supp. 2021 Ch. 15, §§1210-189 and 190), which restricted school districts of local control of public schools from making decisions about mask wearing to school in order to protect all students from contracting or spreading a highly contagious and infectious disease, only when the Governor declared a state of emergency was unconstitutional; and (2) an injunction enjoining the alleged unconstitutional legislation from being enforced. The trial court granted a temporary injunction, enjoining the State from enforcing portions of Senate Bill 658. The State and Governor appealed. The Oklahoma Supreme Court held that 70 O.S. Supp. 2021 §§1210-189 and 190, were an unconstitutional, impermissible delegation of Legislative authority. However, because the objectionable provision was stricken, the remainder of the statutes could be upheld. View "Ritter v. Oklahoma" on Justia Law

Access Behavioral Health appeals from the district court’s judgment upholding an order of the Idaho Department of Health and Welfare that demanded recoupment of Medicaid payments made to Access. The Department sought to recoup certain payments made to Access because it failed to meet the Department’s documentation requirements. Following an audit of provider billings, the Department found Access billed Medicaid for two codes for services provided to the same patient on the same day without documentation to support its use of the codes. The Department concluded the documentation deficiencies violated IDAPA Rule 16.03.09.716 and the Handbook. The Idaho Supreme Court determined the Department had legal authority to issue recoupment demands to Access. Access failed to demonstrate an entitlement to payment of those funds sought to be recouped. The False Claims Act's materiality requirement was inapplicable to the Department’s administrative action. Finally, laches did not bar the Department’s administrative actions. Judgment was thus affirmed. View "Access Behavioral Health v. IDHW" on Justia Law

The United States Court of Appeals for the Fourth Circuit certified a question of law to the South Carolina Supreme Court. In June 2005, Poly-Med, Inc. (Poly-Med) entered into a Sale of Materials and License Agreement with the predecessor in interest to Defendants Novus Scientific Pte. Ltd., Novus Scientific, Inc., and Novus Scientific AB (collectively, Novus). The Agreement required Poly-Med to develop a surgical mesh for Novus's exclusive use in hernia-repair products. The dispute between Poly-Med and Novus arose from two ongoing obligations in the parties' Agreement. As characterized by the Fourth Circuit, the alleged breach of the Agreement centered on the contractual provisions that contained these two obligations: the "hernia-only" provision and the "patent-application" provisions. The federal court asked whether, under a contract with continuing rights and obligations, did South Carolina law recognize the continuing breach theory in applying the statute of limitations to breach-of-contract claims, such that claims for separate breaches that occurred (or were only first discovered) within the statutory period are not time-barred, notwithstanding the prior occurrence and/or discovery of breaches as to which the statute of limitations has expired? The Supreme Court found South Carolina did not recognize the continuing breach theory. "Moreover, it may matter greatly 'if the breaches are of the same character or type as the previous breaches now barred.'" Nevertheless, in a contract action, the Court held it was the intent of the parties that controlled: "Whether separate breaches of the same character or type as time-barred breaches trigger a new, separate statute of limitations depends on the parties' contractual relationship—specifically, what the parties intended." View "Poly-Med, Inc. v. Novus Scientific Pte. Ltd., et al." on Justia Law

Nexus Pharmaceuticals, Inc. (Nexus) developed the trademarked and FDA-approved drug Emerphed, ready-to-use ephedrine sulfate in a vial. Drug compounding by “outsourcing facilities” is permitted without FDA approval, but 21 U.S.C. Section  353b, a part of the Food, Drug, and Cosmetic Act, excludes from this exception compounded drugs that are “essentially a copy of one or more approved drugs.” To avoid the Act’s bar on private enforcement, Nexus alleged violation of state laws that prohibit the sale of drugs not approved by the FDA.   The Ninth Circuit affirmed the district court’s dismissal, for failure to state a claim, of state law claims brought by Nexus against Central Admixture Pharmacy Services, Inc., operator of a network of compounding pharmacies that sold the drug ephedrine sulfate pre-loaded into ready-to-use syringes without FDA approval.   The panel affirmed the district court’s conclusion that, under the implied preemption doctrine, Nexus’s state law claims were barred because they were contrary to the Food, Drug, and Cosmetic Act’s exclusive enforcement provision, which states that proceedings to enforce or restrain violations of the Act, including the compounding statute, must be by and in the name of the United States, not a private party. The panel held that all of Nexus’s claims depended on a determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Nexus’s Emerphed, and the plain text of the Food, Drug, and Cosmetic Act left that determination in the first instance to the FDA and its enforcement process. View "NEXUS PHARMACEUTICALS, INC. V. CAPS, ET AL" on Justia Law

Plaintiffs are a married couple who have each been deaf since early childhood. They appealed the district court’s judgment, entered following a three-day bench trial, on their claims under (1) the Americans with Disabilities Act (ADA), (2) Section 504 of the Rehabilitation Act (Section 504), (3) Section 1557 of the Affordable Care Act (ACA), and (4) California’s Unruh Civil Rights Act (Unruh Act) against Defendant Doctors Medical Center of Modesto, Inc. (DMC), an acute care hospital. Plaintiffs alleged that DMC failed to afford them effective communication during a series of hospital stays between 2015 and 2017.   The Ninth Circuit affirmed the district court’s judgment, after a bench trial, in favor of Defendants. The panel affirmed the district court’s dismissal as moot of plaintiffs’ ADA claims for injunctive relief.   As to the Section 504 Rehabilitation Act claims, the panel held that the district court properly ruled that Plaintiffs failed to show that they were denied program benefits on the basis of their disabilities because they did not show that the hospital failed in its affirmative obligation to provide the auxiliary aids necessary to afford them effective communication. The panel held that the district court did not err by failing to apply “primary consideration,” an ADA Title II rule, to the Section 504 claims, because there is no evidence that Section 504 contains an implicit requirement that a covered entity give primary consideration to the requests of the individual with disabilities when determining what types of auxiliary aids to use. Because Plaintiffs did not establish that the hospital engaged in any disability discrimination, their California Unruh Act claims also failed. View "MARK BAX, ET AL V. DOCTORS MED. CTR. OF MODESTO, ET AL" on Justia Law

In 1985, Messing, an attorney, obtained a long-term disability (LTD) insurance policy through Provident. Beginning in 1994, Messing struggled with depression. In 1997, Messing was hospitalized for his depression for more than three weeks. Provident began paying LTD benefits but later initiated a dispute. Messing's subsequent lawsuit settled in 2000 with Provident resuming payments. In 2018, Provident sought proof, beyond Messing’s own certifications, that he was unable to work as an attorney. Messing’s treating psychiatrist, Dr. Franseen, submitted a report diagnosing Messing with “Major Depressive Disorder, recurrent, minimal to mild,” and noting that Messing had stopped using medications to treat his depression in 2012 “and ha[d] been stable for the most part since then.” Franseen refused to render an opinion as to whether Messing could return to work. Provident had Dr. Lemmen interview Messing. Lemmen concluded, “[t]here is no objective evidence that [Messing] would not be able to practice as an attorney, should he desire to do so.” Messing appealed the termination of his benefits, providing affidavits from attorneys and a report from a third psychiatrist, Callaghan.The Sixth Circuit affirmed the denial of Provident’s claim for reimbursement of benefits it had paid but reversed with respect to the termination of benefits. Messing has proven that he remains unable to return to work as an attorney. Improvements in Messing’s health do not necessarily mean he can return to working as a full-time personal injury attorney. Dr. Callaghan noted Messing’s progress is likely attributable to his abstention from practicing law. View "Messing v. Provident Life & Accident Insurance Co." on Justia Law