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

Water Quality Impacts of Natural Riparian Grasses Part 1: Empirical Studies

Studies were conducted on the effectiveness of natural riparian grass buffer strips in removing sediment and ag chemicals from surface runoff. No till and conventional tillage erosion plots served as the sediment and chemical source area. Runoff from the plots was directed onto 15, 30, and 45 foot filter strips where the inflow and outflow concentrations and sediment size distributions. Trapping percentages for sediment and ag chemicals typically ranged near or above 90%. An evaluation was made of the distribution of trapped chemicals among infiltrated mass and mass stored in the surface layer and on plant surfaces. The analysis showed that most of the chemicals were trapped by infiltration onto the soil matrix

Intruder bands and configuration mixing in the lead isotopes

A three-configuration mixing calculation is performed in the context of the interacting boson model with the aim to describe recently observed collective bands built on low-lying $0^+$ states in neutron-deficient lead isotopes. The configurations that are included correspond to the regular, spherical states as well as two-particle two-hole and four-particle four-hole excitations across the Z=82 shell gap.Comment: 20 pages, 4 figures, accepted by PRC, reference added for section 1 in this revised versio

A phase I/II study of CY and topotecan in patients with high-risk malignancies undergoing autologous hematopoietic cell transplantation: the St Jude long-term follow-up

Fifty-eight consecutive children with high-risk malignancies were treated with CY, and targeted topotecan followed by autologous hematopoietic cell transplantation (AHCT) in a phase I/II Institutional Review Board-approved study. Twelve participants enrolled in phase I; 5 received dose level 1 of topotecan 3 mg/m(2) per day, with subsequent doses targeted to total systemic exposure of 100±20 ng h/mL and CY 750 mg/m(2) per day. Seven participants received dose level 2. CY dose escalation to 1 g/m(2) per day was considered excessively toxic; one died from irreversible veno-occlusive disease and two experienced reversible hepatotoxicity. These adverse events halted further dose escalation. A total of 46 participants were enrolled in phase II; results are on the 51 participants who received therapy at dose level 1, the maximum tolerated dose. Diagnoses included neuroblastoma (26), sarcoma (9), lymphoma (8), brain tumors (5), Wilms (2) and retinoblastoma (1). Twenty participants (39.3%) were in CR1 at enrollment; median age was 5.1 years. Most common non-hematological grade III-IV toxicity was gastrointestinal (n=37). Neutrophil and platelet engraftment occurred at a median of 15 and 24 days, respectively. Twenty-six (51%) participants remain alive at a median of 6.4 years after AHCT. CY 3.75 g/m(2), and targeted topotecan followed by AHCT are feasible and produce acceptable toxicity in children with high-risk malignancies.Bone Marrow Transplantation advance online publication, 19 March 2012; doi:10.1038/bmt.2012.51

Associations of variants In the hexokinase 1 and interleukin 18 receptor regions with oxyhemoglobin saturation during sleep

Sleep disordered breathing (SDB)-related overnight hypoxemia is associated with cardiometabolic disease and other comorbidities. Understanding the genetic bases for variations in nocturnal hypoxemia may help understand mechanisms influencing oxygenation and SDB-related mortality. We conducted genome-wide association tests across 10 cohorts and 4 populations to identify genetic variants associated with three correlated measures of overnight oxyhemoglobin saturation: average and minimum oxyhemoglobin saturation during sleep and the percent of sleep with oxyhemoglobin saturation under 90%. The discovery sample consisted of 8,326 individuals. Variants with p −6 were analyzed in a replication group of 14,410 individuals. We identified 3 significantly associated regions, including 2 regions in multi-ethnic analyses (2q12, 10q22). SNPs in the 2q12 region associated with minimum SpO2 (rs78136548 p = 2.70 × 10−10). SNPs at 10q22 were associated with all three traits including average SpO2 (rs72805692 p = 4.58 × 10−8). SNPs in both regions were associated in over 20,000 individuals and are supported by prior associations or functional evidence. Four additional significant regions were detected in secondary sex-stratified and combined discovery and replication analyses, including a region overlapping Reelin, a known marker of respiratory complex neurons.These are the first genome-wide significant findings reported for oxyhemoglobin saturation during sleep, a phenotype of high clinical interest. Our replicated associations with HK1 and IL18R1 suggest that variants in inflammatory pathways, such as the biologically-plausible NLRP3 inflammasome, may contribute to nocturnal hypoxemia

The effects of theaflavin-enriched black tea extract on muscle soreness, oxidative stress, inflammation, and endocrine responses to acute anaerobic interval training: a randomized, double-blind, crossover study

<p>Abstract</p> <p>Background</p> <p>Muscle soreness and decreased performance often follow a bout of high-intensity exercise. By reducing these effects, an athlete can train more frequently and increase long-term performance. The purpose of this study is to examine whether a high-potency, black tea extract (BTE) alters the delayed onset muscle soreness (DOMS), oxidative stress, inflammation, and cortisol (CORT) responses to high-intensity anaerobic exercise.</p> <p>Methods</p> <p>College-age males (N = 18) with 1+ yrs of weight training experience completed a double-blind, placebo-controlled, crossover study. Subjects consumed the BTE (1,760 mg BTE·d^-1) or placebo (PLA) for 9 days. Each subject completed two testing sessions (T1 & T2), which occurred on day 7 of the intervention. T1 & T2 consisted of a 30 s Wingate Test plus eight 10 s intervals. Blood samples were obtained before, 0, 30 & 60 min following the interval sessions and were used to analyze the total to oxidized glutathione ratio (GSH:GSSG), 8-isoprostane (8-iso), CORT, and interleukin 6 (IL-6) secretion. DOMS was recorded at 24 & 48 h post-test using a visual analog scale while BTE or PLA continued to be administered. Significance was set at <it>P < 0.05</it>.</p> <p>Results</p> <p>Compared to PLA, BTE produced significantly higher average peak power (<it>P = 0.013</it>) and higher average mean power (<it>P = 0.067</it>) across nine WAnT intervals. BTE produced significantly lower DOMS compared to PLA at 24 h post test (<it>P < 0.001</it>) and 48 h post test (<it>P < 0.001</it>). Compared to PLA, BTE had a slightly higher GSH:GSSG ratio at baseline which became significantly higher at 30 and 60 min post test (<it>P < 0.002</it>). AUC analysis revealed BTE to elicit significantly lower GSSG secretion (<it>P = 0.009</it>), significantly higher GSH:GSSG ratio (<it>P = 0.001</it>), and lower CORT secretion (<it>P = 0.078</it>) than PLA. AUC analysis did not reveal a significant difference in total IL-6 response (<it>P = 0.145</it>) between conditions.</p> <p>Conclusions</p> <p>Consumption of theaflavin-enriched black tea extract led to improved recovery and a reduction in oxidative stress and DOMS responses to acute anaerobic intervals. An improved rate of recovery can benefit all individuals engaging in high intensity, anaerobic exercise as it facilitates increased frequency of exercise.</p

The Impact of Hydrogen Bonding on Amide 1H Chemical Shift Anisotropy Studied by Cross-Correlated Relaxation and Liquid Crystal NMR Spectroscopy

Site-specific (1)H chemical shift anisotropy (CSA) tensors have been derived for the well-ordered backbone amide moieties in the B3 domain of protein G (GB3). Experimental input data include residual chemical shift anisotropy (RCSA), measured in six mutants that align differently relative to the static magnetic field when dissolved in a liquid crystalline Pf1 suspension, and cross-correlated relaxation rates between the (1)H(N) CSA tensor and either the (1)H-(15)N, the (1)H-(13)C&#39;, or the (1)H-(13)C(alpha) dipolar interactions. Analyses with the assumption that the (1)H(N) CSA tensor is symmetric with respect to the peptide plane (three-parameter fit) or without this premise (five-parameter fit) yield very similar results, confirming the robustness of the experimental input data, and that, to a good approximation, one of the principal components orients orthogonal to the peptide plane. (1)H(N) CSA tensors are found to deviate strongly from axial symmetry, with the most shielded tensor component roughly parallel to the N-H vector, and the least shielded component orthogonal to the peptide plane. DFT calculations on pairs of N-methyl acetamide and acetamide in H-bonded geometries taken from the GB3 X-ray structure correlate with experimental data and indicate that H-bonding effects dominate variations in the (1)H(N) CSA. Using experimentally derived (1)H(N) CSA tensors, the optimal relaxation interference effect needed for narrowest (1)H(N) TROSY line widths is found at similar to 1200 MHz