Providing a Safe Harbor for Those Who Play by the Rules: The Case for a Strong Regulatory Compliance Defense

On September 25, 2003, a fire broke out at the National Health Care (NHC) nursing home facility in Nashville, Tennessee, causing sixteen deaths and a number of injuries from smoke inhalation. Thirty-two victims subsequently filed suit against the nursing home, alleging that NHC was negligent for failing to install sprinklers in its facility. This claim was made notwithstanding the fact that applicable federal, state, and local safety regulations did not require the installation of sprinklers in this particular type of building, and notwithstanding that the NHC facility had been inspected by state fire inspectors just months before the fire and was found to be in compliance with all requirements of the fire code. NHC eventually settled these lawsuits in order to avoid the uncertainty and expense of further litigation. The NHC case illustrates how good-faith compliance with applicable safety regulations provides businesses with almost no protection against potentially devastating tort liability. The problem is with the legal rule that governs compliance with government regulations. In effect, most courts treat a defendant\u27s compliance with governmental regulations as evidence of due care, but allow the jury to find that a defendant was negligent, notwithstanding his or her compliance with legislative or administrative regulations. We shall refer to this as the traditional approach to regulatory compliance. The traditional approach originated in Grand Trunk Railway Co. of Canada v. Ives, decided by the United States Supreme Court in the late nineteenth century. Later, § 288C of the Second Restatement of Torts endorsed this version of the rule, declaring that compliance with safety regulations was not conclusive evidence that a defendant exercised due care. The American Law Institute is currently in the process of drafting the Third Restatement of Torts, and the revised version of the regulatory compliance defense is substantially similar to that of the Second Restatement. In our view, there are many problems with the traditional approach. First, legislatures and administrative agencies have more expertise than lay juries when it comes to determining efficient levels of safety, but the traditional approach allows lay juries to second guess them. Second, under our constitutional system, legislative bodies and administrative agencies, not courts, are responsible for making resource allocation and other policy decisions. Therefore, courts should accept the trade-offs that are often embodied in safety regulations instead of allowing plaintiffs to use the litigation process to substitute their own policy choices for those of legislative bodies and administrative agencies. Third, the traditional approach wrongly assumes that government safety regulations merely set minimum standards, while, in reality, modem regulations typically reflect state-of-the-art standards. Thus, by adding jury-created safety standards on top of existing regulatory requirements, the traditional approach to regulatory compliance adds to the cost of doing business without achieving significant safety gains. Fourth, the traditional approach to regulatory compliance undermines the principle of uniform application of regulatory standards. Because jury verdicts are seldom consistent, business entities are often subjected to nonuniform safety standards. Finally, the traditional approach deters useful economic activity by imposing potentially crushing tort liability upon those who have complied in good faith with regulatory standards. Part II of this Article examines the traditional approach to the regulatory compliance defense, beginning with the Supreme Court\u27s opinion in Grand Trunk Railway Co. of Canada v. Ives, and proceeding to the Restatement (Second) § 288C and the Restatement (Third) of Torts: Liability for Physical Harm § 16. In Part III, we discuss a number of cases that explicitly recognize a strong regulatory compliance defense, as well as cases that achieve a similar objective by expressly or impliedly applying the Second Restatement\u27s § 16, comment (a) exception. Part IV reviews some of the arguments that support a stronger regulatory compliance defense. These include: (1) the institutional competence argument, (2) the separation of powers argument, (3) the regulatory efficiency argument, (4) the nonuniform standards argument, and (5) the overdeterrence argument. In Part V, we focus on nursing home regulation to -see what impact a stronger regulatory compliance defense would have on this socially useful industry. Finally, in Part VI, we set forth a proposed alternative to the current version of Restatement (Third) of Torts: Liability for Physical Harm § 16

Investigation of hospital discharge cases and SARS-CoV-2 introduction into Lothian care homes

Background The first epidemic wave of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in Scotland resulted in high case numbers and mortality in care homes. In Lothian, over one-third of care homes reported an outbreak, while there was limited testing of hospital patients discharged to care homes. Aim To investigate patients discharged from hospitals as a source of SARS-CoV-2 introduction into care homes during the first epidemic wave. Methods A clinical review was performed for all patients discharges from hospitals to care homes from 1st March 2020 to 31st May 2020. Episodes were ruled out based on coronavirus disease 2019 (COVID-19) test history, clinical assessment at discharge, whole-genome sequencing (WGS) data and an infectious period of 14 days. Clinical samples were processed for WGS, and consensus genomes generated were used for analysis using Cluster Investigation and Virus Epidemiological Tool software. Patient timelines were obtained using electronic hospital records. Findings In total, 787 patients discharged from hospitals to care homes were identified. Of these, 776 (99%) were ruled out for subsequent introduction of SARS-CoV-2 into care homes. However, for 10 episodes, the results were inconclusive as there was low genomic diversity in consensus genomes or no sequencing data were available. Only one discharge episode had a genomic, time and location link to positive cases during hospital admission, leading to 10 positive cases in their care home. Conclusion The majority of patients discharged from hospitals were ruled out for introduction of SARS-CoV-2 into care homes, highlighting the importance of screening all new admissions when faced with a novel emerging virus and no available vaccine

SARS-CoV-2 Omicron is an immune escape variant with an altered cell entry pathway

Vaccines based on the spike protein of SARS-CoV-2 are a cornerstone of the public health response to COVID-19. The emergence of hypermutated, increasingly transmissible variants of concern (VOCs) threaten this strategy. Omicron (B.1.1.529), the fifth VOC to be described, harbours multiple amino acid mutations in spike, half of which lie within the receptor-binding domain. Here we demonstrate substantial evasion of neutralization by Omicron BA.1 and BA.2 variants in vitro using sera from individuals vaccinated with ChAdOx1, BNT162b2 and mRNA-1273. These data were mirrored by a substantial reduction in real-world vaccine effectiveness that was partially restored by booster vaccination. The Omicron variants BA.1 and BA.2 did not induce cell syncytia in vitro and favoured a TMPRSS2-independent endosomal entry pathway, these phenotypes mapping to distinct regions of the spike protein. Impaired cell fusion was determined by the receptor-binding domain, while endosomal entry mapped to the S2 domain. Such marked changes in antigenicity and replicative biology may underlie the rapid global spread and altered pathogenicity of the Omicron variant

Coffee Rings as Low-Resource Diagnostics: Detection of the Malaria Biomarker <i>Plasmodium falciparum</i> Histidine-Rich Protein-II Using a Surface-Coupled Ring of Ni(II)NTA Gold-Plated Polystyrene Particles

We report a novel, low-resource malaria diagnostic platform inspired by the coffee ring phenomenon, selective for <i>Plasmodium falciparum</i> histidine-rich protein-II (<i>Pf</i>HRP-II), a biomarker indicative of the <i>P. falciparum</i> parasite strain. In this diagnostic design, a recombinant HRP-II (rcHRP-II) biomarker is sandwiched between 1 μm Ni­(II)­nitrilotriacetic acid (NTA) gold-plated polystyrene microspheres (AuPS) and Ni­(II)­NTA-functionalized glass. After rcHRP-II malaria biomarkers had reacted with Ni­(II)­NTA-functionalized particles, a 1 μL volume of the particle–protein conjugate solution is deposited onto a functionalized glass slide. Drop evaporation produces the radial flow characteristic of coffee ring formation, and particle–protein conjugates are transported toward the drop edge, where, in the presence of rcHRP-II, particles bind to the Ni­(II)­NTA-functionalized glass surface. After evaporation, a wash with deionized water removes nonspecifically bound materials while maintaining the integrity of the surface-coupled ring produced by the presence of the protein biomarker. The dynamic range of this design was found to span 3 orders of magnitude, and rings are visible with the naked eye at protein concentrations as low as 10 pM, 1 order of magnitude below the 100 pM <i>Pf</i>HRP-II threshold recommended by the World Health Organization. Key enabling features of this design are the inert and robust gold nanoshell to reduce nonspecific interactions on the particle surface, inclusion of a water wash step after drop evaporation to reduce nonspecific binding to the glass, a large diameter particle to project a large two-dimensional viewable area after ring formation, and a low particle density to favor radial flow toward the drop edge and reduce vertical settling to the glass surface in the center of the drop. This robust, antibody-free assay offers a simple user interface and clinically relevant limits of biomarker detection, two critical features required for low-resource malaria detection