Justia Civil Procedure Opinion Summaries

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

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

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

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

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

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

Plaintiff Yesenia Pacheco sought contraception from Neighborcare Health, a federally funded community health center, “to prevent the birth of an unwanted child.” The method Pacheco and her care providers selected was Depo-Provera, “a highly effective” injectable contraceptive medication that “must be administered on a timely basis every eleven to thirteen weeks.” Pacheco received regular Depo-Provera injections from December 2009 until July 2011. On September 30, 2011 for her next scheduled appointment, a medical assistant “mistakenly injected [Pacheco] with a flu vaccine instead.” The medical assistant “failed to confirm why Ms. Pacheco was there, to document consent to the flu vaccine or a change in the orders, or to advise Ms. Pacheco of the side effects of a flu shot and/or the consequences of skipping a Depo-Provera injection.” Neighborcare did not inform Pacheco of its mistake until December 2011, when she sought an appointment for her next Depo-Provera injection. At that time, Neighborcare asked Pacheco to come to the clinic for a pregnancy test, which was positive. Plaintiff S.L.P. was born to Pacheco and plaintiff Luis Lemus, diagnosed with perisylvian polymicrogyria (PMG), a congenital defect resulting in permanent disabilities. In March 2017, Pacheco, Lemus, and S.L.P. filed an amended complaint against the United States pursuant to the Federal Tort Claims Act (FTCA) at the federal district court for the Western District of Washington, seeking damages relating to Pacheco’s pregnancy and S.L.P.’s PMG. The federal district court certified a question of law to the Washington Supreme Court, asking whether a patient who received negligent reproductive health care could recover all damages proximately caused by the provider’s negligence, regardless of the patient’s reason for seeking care. To this, the Supreme Court answered yes: if any Washington health care provider breaches their duty “to follow the accepted standard of care,” then damages proximately caused by the provider’s negligence may be recovered upon the necessary factual findings. Where negligent contraceptive care results in the birth of a child, and that child has a congenital defect, the provider may be liable for damages relating to the child’s condition. Such liability does not require proof that the child was at a known, heightened risk for developing congenital defects or that the patient sought contraception for the specific purpose of preventing the birth of a child with congenital defects. View "Pacheco v. United States" on Justia Law

When Plaintiff-appellant Linda Smith purchased a prescribed continuous blood glucose monitor (CGM) and its necessary supplies between 2016 and 2018, she sought reimbursement through Medicare Part B. Medicare administrators denied her claims. Relying on a 2017 ruling issued by the Centers for Medicare and Medicaid Services (CMS), Medicare concluded Smith’s CGM was not “primarily and customarily used to serve a medical purpose” and therefore was not covered by Part B. Smith appealed the denial of her reimbursement claims through the multistage Medicare claims review process. At each stage, her claims were denied. Smith then sued the Secretary of the Department of Health and Human Services in federal court, seeking monetary, injunctive, and declaratory relief. Contending that her CGM and supplies satisfied the requirements for Medicare coverage. Instead of asking the court to uphold the denial of Smith’s claims, the Secretary admitted that Smith’s claims should have been covered and that the agency erred by denying her claims. Rather than accept the Secretary’s admission, Smith argued that the Secretary only admitted error to avoid judicial review of the legality of the 2017 ruling. During Smith’s litigation, CMS changed its Medicare coverage policy for CGMs. Prompted by several adverse district court rulings, CMS promulgated a formal rule in December 2021 classifying CGMs as durable medical equipment covered by Part B. But the rule applied only to claims for equipment received after February 28, 2022, so pending claims for equipment received prior to that date were not covered by the new rule. Considering the new rule and the Secretary’s confession of error, the district court in January 2022 remanded the case to the Secretary with instructions to pay Smith’s claims. The district court did not rule on Smith’s pending motions regarding her equitable relief claims; instead, the court denied them as moot. Smith appealed, arguing her equitable claims were justiciable because the 2017 ruling had not been fully rescinded. The Tenth Circuit agreed with the Secretary that Smith’s claims were moot: taken together, the December 2021 final rule and the 2022 CMS ruling that pending and future claims for CGMs would be covered by Medicare deprived the Tenth Circuit jurisdiction for further review. View "Smith v. Becerra" on Justia Law