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

Perceiving What Is Reachable Depends on Motor Representations: Evidence from a Transcranial Magnetic Stimulation Study

Background: Visually determining what is reachable in peripersonal space requires information about the egocentric location of objects but also information about the possibilities of action with the body, which are context dependent. The aim of the present study was to test the role of motor representations in the visual perception of peripersonal space. Methodology: Seven healthy participants underwent a TMS study while performing a right-left decision (control) task or perceptually judging whether a visual target was reachable or not with their right hand. An actual grasping movement task was also included. Single pulse TMS was delivered 80 % of the trials on the left motor and premotor cortex and on a control site (the temporo-occipital area), at 90 % of the resting motor threshold and at different SOA conditions (50ms, 100ms, 200ms or 300ms). Principal Findings: Results showed a facilitation effect of the TMS on reaction times in all tasks, whatever the site stimulated and until 200ms after stimulus presentation. However, the facilitation effect was on average 34ms lower when stimulating the motor cortex in the perceptual judgement task, especially for stimuli located at the boundary of peripersonal space. Conclusion: This study provides the first evidence that brain motor area participate in the visual determination of what is reachable. We discuss how motor representations may feed the perceptual system with information about possibl

An Intergenic Region Shared by At4g35985 and At4g35987 in Arabidopsis Thaliana is a Tissue Specific and Stress Inducible Bidirectional Promoter Analyzed in Transgenic Arabidopsis and Tobacco Plants

On chromosome 4 in the Arabidopsis genome, two neighboring genes (calmodulin methyl transferase At4g35987 and senescence associated gene At4g35985) are located in a head-to-head divergent orientation sharing a putative bidirectional promoter. This 1258 bp intergenic region contains a number of environmental stress responsive and tissue specific cis-regulatory elements. Transcript analysis of At4g35985 and At4g35987 genes by quantitative real time PCR showed tissue specific and stress inducible expression profiles. We tested the bidirectional promoter-function of the intergenic region shared by the divergent genes At4g35985 and At4g35987 using two reporter genes (GFP and GUS) in both orientations in transient tobacco protoplast and Agro-infiltration assays, as well as in stably transformed transgenic Arabidopsis and tobacco plants. In transient assays with GFP and GUS reporter genes the At4g35985 promoter (P85) showed stronger expression (about 3.5 fold) compared to the At4g35987 promoter (P87). The tissue specific as well as stress responsive functional nature of the bidirectional promoter was evaluated in independent transgenic Arabidopsis and tobacco lines. Expression of P85 activity was detected in the midrib of leaves, leaf trichomes, apical meristemic regions, throughout the root, lateral roots and flowers. The expression of P87 was observed in leaf-tip, hydathodes, apical meristem, root tips, emerging lateral root tips, root stele region and in floral tissues. The bidirectional promoter in both orientations shows differential up-regulation (2.5 to 3 fold) under salt stress. Use of such regulatory elements of bidirectional promoters showing spatial and stress inducible promoter-functions in heterologous system might be an important tool for plant biotechnology and gene stacking applications

Landscape of somatic single nucleotide variants and indels in colorectal cancer and impact on survival

Colorectal cancer (CRC) is a biologically heterogeneous disease. To characterize its mutational profile, we conduct targeted sequencing of 205 genes for 2,105 CRC cases with survival data. Our data shows several findings in addition to enhancing the existing knowledge of CRC. We identify PRKCI, SPZ1, MUTYH, MAP2K4, FETUB, and TGFBR2 as additional genes significantly mutated in CRC. We find that among hypermutated tumors, an increased mutation burden is associated with improved CRC-specific survival (HR=0.42, 95% CI: 0.21-0.82). Mutations in TP53 are associated with poorer CRC-specific survival, which is most pronounced in cases carrying TP53 mutations with predicted 0% transcriptional activity (HR=1.53, 95% CI: 1.21-1.94). Furthermore, we observe differences in mutational frequency of several genes and pathways by tumor location, stage, and sex. Overall, this large study provides deep insights into somatic mutations in CRC, and their potential relationships with survival and tumor features. Large scale sequencing study is of paramount importance to unravel the heterogeneity of colorectal cancer. Here, the authors sequenced 205 cancer genes in more than 2000 tumours and identified additional mutated driver genes, determined that mutational burden and specific mutations in TP53 are associated with survival odds

Genetic variation and exercise-induced muscle damage: implications for athletic performance, injury and ageing.

Prolonged unaccustomed exercise involving muscle lengthening (eccentric) actions can result in ultrastructural muscle disruption, impaired excitation-contraction coupling, inflammation and muscle protein degradation. This process is associated with delayed onset muscle soreness and is referred to as exercise-induced muscle damage. Although a certain amount of muscle damage may be necessary for adaptation to occur, excessive damage or inadequate recovery from exercise-induced muscle damage can increase injury risk, particularly in older individuals, who experience more damage and require longer to recover from muscle damaging exercise than younger adults. Furthermore, it is apparent that inter-individual variation exists in the response to exercise-induced muscle damage, and there is evidence that genetic variability may play a key role. Although this area of research is in its infancy, certain gene variations, or polymorphisms have been associated with exercise-induced muscle damage (i.e. individuals with certain genotypes experience greater muscle damage, and require longer recovery, following strenuous exercise). These polymorphisms include ACTN3 (R577X, rs1815739), TNF (-308 G>A, rs1800629), IL6 (-174 G>C, rs1800795), and IGF2 (ApaI, 17200 G>A, rs680). Knowing how someone is likely to respond to a particular type of exercise could help coaches/practitioners individualise the exercise training of their athletes/patients, thus maximising recovery and adaptation, while reducing overload-associated injury risk. The purpose of this review is to provide a critical analysis of the literature concerning gene polymorphisms associated with exercise-induced muscle damage, both in young and older individuals, and to highlight the potential mechanisms underpinning these associations, thus providing a better understanding of exercise-induced muscle damage

Genome-wide association study identifies multiple susceptibility loci for pancreatic cancer

We performed a multistage genome-wide association study (GWAS) including 7,683 individuals with pancreatic cancer and 14,397 controls of European descent. Four new loci reached genome-wide significance: rs6971499 at 7q32.3 (LINC-PINT; per-allele odds ratio [OR] = 0.79; 95% confidence interval [CI] = 0.74–0.84; P = 3.0×10−12), rs7190458 at 16q23.1 (BCAR1/CTRB1/CTRB2; OR = 1.46; 95% CI = 1.30–1.65; P = 1.1×10−10), rs9581943 at 13q12.2 (PDX1; OR = 1.15; 95% CI = 1.10–1.20; P = 2.4×10−9), and rs16986825 at 22q12.1 (ZNRF3; OR = 1.18; 95% CI = 1.12–1.25; P = 1.2×10−8). An independent signal was identified in exon 2 of TERT at the established region 5p15.33 (rs2736098; OR = 0.80; 95% CI = 0.76–0.85; P = 9.8×10−14). We also identified a locus at 8q24.21 (rs1561927; P = 1.3×10−7) that approached genome-wide significance located 455 kb telomeric of PVT1. Our study has identified multiple new susceptibility alleles for pancreatic cancer worthy of follow-up studies

The Legal Status of a National Bank\u27s Automatic Stock Investment Service Under Sections 16 & 21 of the Glass-Steagall Act of 1933

For many years, commercial banks bought and sold common stock while acting in an agency capacity for their customers. Frequently, these transactions were made while the bank was acting as trustee or as custodian for its beneficiaries or principals. Generally,the banks did not advertise this service extensively, but limited promotional activities to prior bank customers. In 1973, a dramatic change began as several commercial banks, notably Security Pacific National Bank of Los Angeles and Chase Manhattan of New York,began to promote this service vigorously in advertising addressed to the general public through the various media. Threatened by the increased competition for the investor\u27s dollar, the mutual fund industry, the broker-dealer community, and the stock exchanges immediately challenged the legality of this service by petitioning to the office of the Comptroller of the Currency. The Comptroller ruled in June 1974 that the banks\u27 investment service was not proscribed by sections 16 and 21 of the Glass-Steagall Act of 1933. This Note will examine one of the first legal hurdles that an agency stock service must surmount--whether such a service is permitted under the relevant banking laws-sections 16 and 21 of the Glass-Steagall Act. Pursuant to this examination, this Note will focus on the following areas: (1) The legal restrictions currently imposed on national banks\u27 buying and selling common stock; (2) The history of national banks\u27 acting as agents for customers in stock transactions; (3) The policies restricting an agency service as stated by the Supreme Court in Investment Company Institute v. Camp; (4) The Comptroller\u27s opinion approving the service; and (5) An analysis of the arguments on legality of such a service under sections 16 and 21 of the Act