Justia Civil Procedure Opinion Summaries

Articles Posted in Health Law
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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

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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

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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

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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

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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

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Robert Owen died 11 days after being transferred from Huntsville Hospital to the University of Alabama at Birmingham Hospital ("UAB Hospital") for cardiac treatment. His widow Gloria Owen, as the personal representative of his estate, sued the ambulance company that had transported him, Huntsville Emergency Medical Services, Inc. ("HEMSI"), as well as HEMSI employees Jacob Steele, Calvin Hui, Christopher Nunley, and Dea Calce, alleging that events that occurred during Robert's transport had "caused him unnecessary stress, worry, concern, anxiety, and/or a delay in treatment," leading to further heart damage and his eventual death. During discovery, Gloria sought information from the HEMSI defendants about the previous conduct and employment record of Steele, a licensed emergency medical technician ("EMT") and the assigned driver of the HEMSI ambulance that transported Robert. The HEMSI defendants objected to Gloria's requests and sought a protective order, arguing that the Alabama Medical Liability Act ("the AMLA") governed her claims and prohibited discovery related to any acts and omissions of a defendant that were not specifically described in the complaint. The circuit court rejected the HEMSI defendants' request for a protective order and directed them to produce the requested discovery; they petitioned the Alabama Supreme Court for mandamus relief, specifically a writ directing the trial court to amend its order to give effect to what they claimed were the applicable privilege and discovery protections of the AMLA. The Supreme Court granted the petition in part, and denied in part. The Court held all claims asserted by Gloria in this action were governed by the AMLA and subject to the limitations on discovery imposed by § 6-5-551. To the extent that the trial court's October 2021 order did not give effect to the § 6-5-551 privilege, the HEMSI defendants' petition was granted and the trial court was directed to modify that order. But to the extent the HEMSI defendants sought to prevent Gloria from discovering information regarding acts or omissions that were specifically alleged and described in her complaint, their petition was denied. View "Ex parte Huntsville Emergency Medical Services, Inc., et al." on Justia Law

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Section 1557 of the Patient Protection and Affordable Care Act prohibits health care programs that receive federal funds from discriminating against patients on the basis of sex. Section 1557 incorporates Title IX’s definition of prohibited sex discrimination. The Secretary of HHS has authority to issue regulations to implement Section 1557.In May 2016, HHS issued a rule interpreting Section 1557’s prohibition of “discrimination on the basis of sex.” Plaintiffs claimed the rule violated the Administrative Procedure Act (APA) by defining “sex discrimination” inconsistently with Title IX. Initially, the district court issued a nationwide preliminary injunction and ultimately granted summary judgment to Plaintiffs but denied permanent injunctive relief. Significant litigation followed.In this case, HHS argues that any challenge to the 2016 Rule is now moot because the district court already vacated the parts of the rule that violated the APA, and because the 2020 Rule rescinded the 2016 Rule. The Fifth Circuit agreed. View "Franciscan Alliance v. Becerra" on Justia Law

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The Mississippi Division of Medicaid (DOM) and Yalobusha County Nursing Home (YNH) disputed four costs submitted for reimbursement by YNH in its fiscal year 2013 Medicaid cost report. The DOM appealed a Chancery Court’s judgment ordering the DOM to reverse the four adjustments at issue. Because the DOM correctly interpreted the appropriate statutes and because its decisions were supported by substantial evidence, the Mississippi Supreme Court reversed the chancery court’s order and rendered judgment reinstating the decisions of the DOM. View "Mississippi Division of Medicaid v. Yalobusha County Nursing Home" on Justia Law

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Plaintiffs, the heirs and executor of the estate of Viviana Ruscitto, filed complaints seeking compensatory and punitive damages on numerous counts after Ruscitto’s death from leiomyosarcoma, a rare cancer that cannot be reliably diagnosed preoperatively, following the hysterectomy she underwent at defendant Valley Hospital with the use of a power morcellation device. Ruscitto sought treatment for uterine fibroids from defendant Howard Jones, a gynecologic surgeon at the hospital with whom Ruscitto met four times before she underwent surgery. Approximately six months before Ruscitto’s surgery, the FDA issued a Safety Communication discouraging the use of power morcellation. Valley Hospital administrators and Dr. Jones exchanged emails about the continued use of power morcellation. They considered factors including that “without the morcellator these cases would be open instead of laparoscopic, which “increases morbidity”; the fact that “the numbers at Valley” did not support the “1 sarcoma in 350 operations” number suggested by the FDA; and the role of informed consent. A “power morcellation group” was convened to draft an informed consent form. A form was prepared and approved by the legal department but was never implemented or used prior to Ruscitto’s surgery. One month after her surgery, the FDA issued an updated communication explicitly warning against the use of power morcellators in the majority of cases. Valley Hospital then discontinued use of the power morcellation device. Plaintiffs brought claims against several defendants, including Dr. Jones and the Valley Hospital administrators, and defendants sought partial summary judgment dismissing the punitive damages claim. The trial court denied the motions, and the Appellate Division denied leave to appeal. The New Jersey Supreme Court concluded a reasonable jury could not find by clear and convincing evidence that punitive damages were warranted based on the facts of this case, and partial summary should have been granted. View "Rivera v. Valley Hospital, Inc." on Justia Law

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The Georgia Division of Family and Children Services (DFCS) was the temporary custodian of Appellants John and Brittani Chandler’s three children. The Chandlers sought a determination they had constitutional and statutory rights to object on religious grounds to DFCS’s immunization of their children. Because the juvenile court applied the wrong standard in finding that the Chandlers’ religious objection was insincere, the Georgia Supreme Court vacated the trial court’s order and remanded this case for application of the correct standard. View "In the Interest of C.C. et al., children" on Justia Law