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Justia Weekly Opinion Summaries

Health Law
August 21, 2020

Table of Contents

Liberian Community Ass'n v. Lamont

Civil Rights, Class Action, Constitutional Law, Government & Administrative Law, Health Law

US Court of Appeals for the Second Circuit

United States v. UCB, Inc.

Civil Procedure, Government & Administrative Law, Government Contracts, Health Law

US Court of Appeals for the Seventh Circuit

Cottingham v. Secretary of Health and Human Services

Drugs & Biotech, Government & Administrative Law, Health Law, Legal Ethics, Personal Injury

US Court of Appeals for the Federal Circuit

Sanford Health Plan v. United States

Government & Administrative Law, Government Contracts, Health Law, Insurance Law

US Court of Appeals for the Federal Circuit

Saguaro Healing LLC v. State

Drugs & Biotech, Government & Administrative Law, Health Law

Arizona Supreme Court

Jarman v. HCR ManorCare, Inc.

Health Law, Personal Injury

Supreme Court of California

In re Individuals in Custody of State of Hawai'i

Criminal Law, Health Law

Supreme Court of Hawaii

LP Louisville East, LLC v. Patton

Arbitration & Mediation, Contracts, Health Law, Personal Injury

Kentucky Supreme Court

COVID-19 Updates: Law & Legal Resources Related to Coronavirus

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Legal Analysis and Commentary

Democracy Is on the Ballot: One Party Defends It, The Other Would Let It Die

AUSTIN SARAT

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Austin Sarat—Associate Provost, Associate Dean of the Faculty, and William Nelson Cromwell Professor of Jurisprudence and Political Science at Amherst College—explains why the 2020 Democratic National Convention was unlike any other political gathering in American history for reasons beyond its virtual platform. Sarat argues that the future of American democracy lies in the balance, and when we vote in November, it will be up to us whether democracy lives or dies.

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Health Law Opinions

Liberian Community Ass'n v. Lamont

Court: US Court of Appeals for the Second Circuit

Docket: 17-1558

Opinion Date: August 14, 2020

Judge: Debra Ann Livingston

Areas of Law: Civil Rights, Class Action, Constitutional Law, Government & Administrative Law, Health Law

Plaintiffs filed suit challenging the quarantine decisions of certain Connecticut state officials in response to an Ebola epidemic in West Africa. On appeal, plaintiffs challenged the district court's denial of their motion for class certification and dismissing their suit for lack of standing and based on qualified immunity. Plaintiffs primarily argue that they suffered actual or imminent injuries that create standing to seek prospective relief to avert allegedly unconstitutional future quarantines; clearly established law required that any quarantine imposed be medically necessary and comport with certain procedural safeguards; and their class is sufficiently numerous to merit certification. The Second Circuit affirmed and held that the district court properly deemed plaintiffs' injuries too speculative to support standing. In this case, plaintiffs failed to plead a sufficient likelihood that, under the revised policy, any of them faces a substantial risk of suffering a future injury. The court also held that the law surrounding quarantines was not clearly established such that a state official may be held liable for the actions taken here. The court did not reach the class certification issue because it is mooted by the court's conclusion as to standing. Accordingly, the court remanded with instructions to amend the judgment to clarify that the state law claims were dismissed without prejudice.

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United States v. UCB, Inc.

Court: US Court of Appeals for the Seventh Circuit

Docket: 19-2273

Opinion Date: August 17, 2020

Judge: HAMILTON

Areas of Law: Civil Procedure, Government & Administrative Law, Government Contracts, Health Law

The False Claims Act, 31 U.S.C. 3729–3733, authorizes relators to file qui tam suits on behalf of the U.S. government. If such an action is successful, the relator receives part of the recovery. The Act prohibits presenting to a federal healthcare program a claim for payment that violates the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), Venari formed 11 daughter companies, each for the purpose of prosecuting a separate qui tam action, alleging essentially identical violations of the False Claims Act by pharmaceutical companies. CIMZNHCA, a Venari company, filed suit alleging illegal kickbacks to physicians for prescribing Cimzia to treat Crohn’s disease in patients who received federal healthcare benefits. The government did not exercise its right “to intervene and proceed” as the plaintiff but moved to dismiss the action, representing that it had investigated the Venari claims and found them to lack merit. The court denied that motion, finding the government’s general evaluation of the Venari claims insufficient as to CIMZNHCA and that the decision to dismiss was “arbitrary and capricious.” The Seventh Circuit reversed with instructions to dismiss, construing the government’s motion as a motion to both intervene and dismiss. By treating the government as seeking to intervene, a court can apply Federal Rule of Civil Procedure 41, which provides: “The Government may dismiss the action” without the relator’s consent if the relator receives notice and opportunity to be heard.

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Cottingham v. Secretary of Health and Human Services

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1596

Opinion Date: August 19, 2020

Judge: Jimmie V. Reyna

Areas of Law: Drugs & Biotech, Government & Administrative Law, Health Law, Legal Ethics, Personal Injury

Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out. The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim. The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation.

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Sanford Health Plan v. United States

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1290

Opinion Date: August 14, 2020

Judge: Richard Gary Taranto

Areas of Law: Government & Administrative Law, Government Contracts, Health Law, Insurance Law

In the Patient Protection and Affordable Care Act (ACA), Congress directed each state to establish an online exchange through which insurers may sell health plans if the plans meet certain requirements. One requirement is that insurers must reduce the “cost-sharing” burdens—such as the burdens of making co-payments and meeting deductibles—of certain customers. When insurers meet that requirement, the Secretary of Health and Human Services shall reimburse them for those cost-sharing reductions, 42 U.S.C. 18071(c)(3)(A). In October 2017, the Secretary stopped making reimbursement payments, due to determinations that such payments were not within the congressional appropriation that the Secretary had, until then, invoked to pay the reimbursements. Sanford, a seller of insurance through the North Dakota, South Dakota, and Iowa exchanges, and Montana Health, a seller through the Montana and Idaho exchanges, sued. The trial courts granted the insurers summary judgment, reasoning that the ACA reimbursement provision is “money-mandating” and that the government is liable for damages for its failure to make reimbursements for the 2017 reductions. The court did not reach the contract claim in either case. The Federal Circuit affirmed, citing the Supreme Court’s 2020 “Maine Community,” addressing a different payment-obligation ACA provision. Maine Community indicates that the cost-sharing-reduction reimbursement provision imposes an unambiguous obligation on the government to pay money; that obligation is enforceable in the Claims Court under the Tucker Act, 28 U.S.C. 1491(a)(1).

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Saguaro Healing LLC v. State

Court: Arizona Supreme Court

Docket: CV-19-0129-PR

Opinion Date: August 20, 2020

Judge: Beene

Areas of Law: Drugs & Biotech, Government & Administrative Law, Health Law

The Supreme Court held that the Arizona Department of Health Services' (ADHS) interpretation of Arizona Administrative Code R9-17-303, which governs ADHS's allocation of marijuana dispensary registration certificates, violated Ariz. Rev. Stat. 36-2804(C). On June 16, 2016, ADHS announced that, because every county had at least one dispensary, it would allocate new registration certificates based on other factors set forth in R9-17-303. Saguaro Healing LLC timely applied for a certificate for its dispensary in La Paz County. During the application period, the only dispensary in La Paz County relocated out of the county. ADHS, however, did not consider the vacancy when prioritizing registration certificates and did not issue a certificate to Saguaro, leaving La Paz County without a dispensary. Saguaro filed a complaint for special action. The trial court dismissed the complaint because R9-17-303(B) "does not say when, during the process of issuing new certificates, [ADHS] must determine how certificates will be allocated." The Supreme Court reversed, holding (1) Ariz. Rev. Stat. 36-2804(C) requires ADHS to issue at least one medical marijuana dispensary registration certificate in each county with a qualified applicant; and (2) ADHS's interpretation of R9-17-303 contrary to this statutory mandate violates section 36-2804(C).

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Jarman v. HCR ManorCare, Inc.

Court: Supreme Court of California

Docket: S241431

Opinion Date: August 17, 2020

Judge: Ming Chin

Areas of Law: Health Law, Personal Injury

The Supreme Court held that the monetary cap of $500 in statutory damages in Cal. Health & Safety Code 1430(b) applies per action, not per regulatory violation. Section 1430(b) gives a current or former nursing care patient or resident the right to bring a private cause of action against a skilled nursing facility for violating certain regulations. The remedies include injunctive relief, attorney fees, and up to $500 in statutory damages. Plaintiff in the instant case filed a complaint against a nursing facility alleging violations of the Patients Bill of Rights, elder abuse and neglect, and negligence. The jury awarded Plaintiff $100,000 in damages and $95,500 in statutory damages - $250 for each of 382 violations. At issue on appeal was whether the $500 cap is the limit in each action or instead applies to each violation committed. The Supreme Court reversed, holding that section 1430(b) authorizes a $500 per lawsuit cap.

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In re Individuals in Custody of State of Hawai'i

Court: Supreme Court of Hawaii

Docket: SCPW-20-0000509

Opinion Date: August 14, 2020

Judge: Per Curiam

Areas of Law: Criminal Law, Health Law

Given the rising number of COVID-19 cases at the O'ahu Community Correctional Center (OCCC) and the difficulties with social distancing the Supreme Court requested additional information to assist the court and parties in addressing the public health and safety concerns raised by the cluster of COVID-19 cases at OCCC. The Office of the Public Defender (ODP) filed a petition for extraordinary writ and/or a writ of mandamus seeking a reduction of the inmate populations at the State's correctional centers and facilities in an effort to mitigate the harm that COVID-19 may inflict upon the inmates, correctional staff, and general public. The Supreme Court stated that there was an urgent and immediate concern in reducing the inmate populations at OCCC and ordered that the DPS shall provide to the OPD a list of all inmates at OCCC who meet certain criteria.

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LP Louisville East, LLC v. Patton

Court: Kentucky Supreme Court

Dockets: 2019-SC-0016-D, 2019-SC-0211-D

Opinion Date: August 20, 2020

Judge: Hughes

Areas of Law: Arbitration & Mediation, Contracts, Health Law, Personal Injury

In this action brought against a long-term care facility by Kenneth, as administrator of Estate of Tommy Patton, the Supreme Court reversed in part the court of appeals' decision concluding that an arbitration agreement was enforceable as to Kenneth's individual wrongful death claim but that the agreement was not enforceable as to the Estate's claims, holding that the agreement was valid as to both claims. Kenneth signed an arbitration agreement at the time his father, Tommy, was admitted to Signature HealthCARE of East Louisville's long-term care facility. Tommy later suffered a fall and died a few weeks later. Kenneth brought sued Signature, alleging negligence and wrongful death. Signature filed a motion to compel arbitration. The trial court denied the motion in its entirety. The court of appeals reversed in part, concluding that the arbitration agreement was not enforceable against the Estate but that Kenneth's wrongful death claim was arbitrable because he executed the arbitration agreement in his individual capacity. The Supreme Court reversed in part, holding that both the Estate's and Kenneth's individual claims were subject to arbitration because the arbitration agreement was valid and enforceable as to the Estate claim and as to Kenneth's individual wrongful death claim.

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