Snap Removal: Concept; Cause; Cacophony; and Cure

So-called “snap removal” – removal of a case from state to federal court prior to service on a forum state defendant – has divided federal trial courts for 20 years. Recently, panels of the Second, Third and Fifth Circuits have sided with those supporting the tactic even though it conflicts with the general prohibition on removal when the case includes a forum state defendant, a situation historically viewed as eliminating the need to protect the outsider defendant from possible state court hostility. Consistent with the public policy underlying diversity jurisdiction – availability of a federal forum to protect against defending claims in an inconvenient or hostile forum – such removals are barred so long as resident defendants are properly joined “and served.” Defendants preferring the federal forum have invested significant resources monitoring state trial dockets in order to race to remove before service on forum defendants can be effectuated. Where such snap removal is permitted, defendants, both in-state and outsider are allowed to select their preferred forum – an outcome in derogation of the history, purpose, and logic of permitting removal. This clever strategy of defense counsel is facilitated and accelerated by electronic docket monitoring and sometimes (as in the Third Circuit case) attorney trickery amounting to deceit. The recent federal appellate decisions are regrettable both in taking the wrong fork of the metaphorical road regarding snap removal and in shifting the trial court landscape from one of resistance to snap removal to one of toleration. Disturbingly, the appellate decisions (without recorded dissent) analyzed the issue through the simplistic lens of textual literalism with nary a nod to the history, purpose, and public policy of federal removal law. In doing so, the Circuit panels not only reached a problematic result but also displayed an impoverished interpretative methodology. Corrective action by Congress can put a stop to these mistaken results in a manner that vindicates the intent and purpose of the 1948 Congress that added the service requirement and that adequately protects the interests of both plaintiffs and defendants. We outline and assess the most prominent suggestions for fixing the snap removal problem, including our own preferred solution

The Elastics of Snap Removal: An Empirical Case Study of Textualism

This article reports the findings of an empirical study of textualism as applied by federal judges interpreting the statute that permits removal of diversity cases from state to federal court. The “snap removal” provision in the statute is particularly interesting because its application forces judges into one of two interpretive camps—which are fairly extreme versions of textualism and purposivism, respectively. We studied characteristics of cases and judges to find predictors of textualist outcomes. In this article we offer a narrative discussion of key variables and we detail the results of our logistic regression analysis. The most salient predictive variable was the party of the president who appointed the judge. Female judges and young judges were also more likely to reach textualist outcomes. Cases involving torts were substantially more likely to be removed even though the statute raises a pure legal question upon which the subject matter of the case should have no bearing. Our most surprising finding was the impact of a judges’ undergraduate and legal education: the eliteness of the educational institution was positively correlated with removal for judges appointed by Republicans, but negatively correlated for judges appointed by Democrats. This disordinal interaction was especially striking since there was no party effect among judges who attended non-elite institutions. In addition to the aforementioned variables which were significant, several variables that were not predictive are also discussed; these include race, seniority, state court experience, and the prospect of multi-district case consolidations

Assessing the Multiple Impacts of Extreme Hurricanes in Southern New England, USA

The southern New England coast of the United States is particularly vulnerable to land-falling hurricanes because of its east-west orientation. The impact of two major hurricanes on the city of Providence (Rhode Island, USA) during the middle decades of the 20th century spurred the construction of the Fox Point Hurricane Barrier (FPHB) to protect the city from storm surge flooding. Although the Rhode Island/Narragansett Bay area has not experienced a major hurricane for several decades, increased coastal development along with potentially increased hurricane activity associated with climate change motivates an assessment of the impacts of a major hurricane on the region. The ocean/estuary response to an extreme hurricane is simulated using a high-resolution implementation of the ADvanced CIRCulation (ADCIRC) model coupled to the Precipitation-Runoff Modeling System (PRMS). The storm surge response in ADCIRC is first verified with a simulation of a historical hurricane that made landfall in southern New England. The storm surge and the hydrological models are then forced with winds and rainfall from a hypothetical hurricane dubbed “Rhody”, which has many of the characteristics of historical storms that have impacted the region. Rhody makes landfall just west of Narragansett Bay, and after passing north of the Bay, executes a loop to the east and the south before making a second landfall. Results are presented for three versions of Rhody, varying in the maximum wind speed at landfall. The storm surge resulting from the strongest Rhody version (weak Saffir–Simpson category five) during the first landfall exceeds 7 m in height in Providence at the north end of the Bay. This exceeds the height of the FPHB, resulting in flooding in Providence. A simulation including river inflow computed from the runoff model indicates that if the Barrier remains closed and its pumps fail (for example, because of a power outage or equipment failure), severe flooding occurs north of the FPHB due to impoundment of the river inflow. These results show that northern Narragansett Bay could be particularly vulnerable to both storm surge and rainfall-driven flooding, especially if the FPHB suffers a power outage. They also demonstrate that, for wind-driven storm surge alone under present sea level conditions, the FPHB will protect Providence for hurricanes less intense than category five

Effect of inhaled corticosteroid particle size on asthma efficacy and safety outcomes: a systematic literature review and meta-analysis

BACKGROUND: Inhaled corticosteroids (ICS) are the primary treatment for persistent asthma. Currently available ICS have differing particle size due to both formulation and propellant, and it has been postulated that this may impact patient outcomes. This structured literature review and meta-analysis compared the effect of small and standard particle size ICS on lung function, symptoms, rescue use (when available) and safety in patients with asthma as assessed in head-to-head randomized controlled trials (RCTs). METHODS: A systematic literature search of MEDLINE was performed to identify RCTs (1998-2014) evaluating standard size (fluticasone propionate-containing medications) versus small particle size ICS medication in adults and children with asthma. Efficacy outcomes included forced expiratory volume in 1 s (FEV1), morning peak expiratory flow (PEF), symptom scores, % predicted forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%), and rescue medication use. Safety outcomes were also evaluated when available. RESULTS: Twenty-three independent trials that met the eligibility criteria were identified. Benefit-risk plots did not demonstrate any clinically meaningful differences across the five efficacy endpoints considered and no appreciable differences were noted for most safety endpoints. Meta-analysis results, using a random-effects model, demonstrated no significant difference between standard and small size particle ICS medications in terms of effects on mean change from baseline FEV1 (L) (-0.011, 95% confidence interval [CI]: -0.037, 0.014 [N = 3524]), morning PEF (L/min) (medium/low doses: -3.874, 95% CI: -10.915, 3.166 [N = 1911]; high/high-medium doses: 5.551, 95% CI: -1.948, 13.049 [N = 749]) and FEF25-75% predicted (-2.418, 95% CI: -6.400; 1.564 [N = 115]). CONCLUSIONS: Based on the available literature, no clinically significant differences in efficacy or safety were observed comparing small and standard particle size ICS medications for the treatment of asthma. TRIAL REGISTRATION: GSK Clinical Study Register No: 202012

Serious asthma events with fluticasone plus salmeterol versus fluticasone alone

Background: the safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. Methods: in this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone-salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. Results: of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone-salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone-salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P=0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone-salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P<0.001). Conclusions: patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group. (AUSTRI ClinicalTrials.gov number, NCT01475721)

Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study

Background Poor adherence with prescribed asthma medication is a major barrier to positive treatment outcomes. This study was designed to determine the effect of a once-daily administration of mometasone furoate administered via a dry powder inhaler (MF-DPI) on treatment adherence compared with a twice-daily administration. Methods This was a 12-week open-label study designed to mimic an actual clinical setting in patients ≥12 years old with mild-to-moderate persistent asthma. Patients were randomized to receive MF-DPI 400 μg once-daily in the evening or MF-DPI 200 μg twice-daily. Adherence was assessed primarily using the number of actual administered doses reported from the device counter divided by the number of scheduled doses. Self-reports were also used to determine adherence. Health-related quality of life, healthcare resource utilization, and days missed from work or school were also reported. Results 1233 patients were randomized. The mean adherence rates, as measured by the automatic dose counter, were significantly better (P < 0.001) with MF-DPI 400 μg once-daily in the evening (93.3%) than with MF-DPI 200 μg twice-daily (89.5%). Mean adherence rates based on self-reports were also significantly better (P < 0.001) with MF-DPI 400 μg QD PM (97.2%) than with MF-DPI 200 μg twice-daily (95.3%). Adherence rates were lower in adolescents (12-17 years old). Health-related quality of life improved by 20% in patients using MF-DPI once-daily in the evening and by 14% in patients using MF-DPI twice-daily. Very few (<8%) patients missed work/school. Conclusion Mean adherence rates were greater with a once-daily dosing regimen of MF-DPI than with a twice-daily dosing regimen. This trial was completed prior to the ISMJE requirements for trial registration

The Related Transcriptional Enhancer Factor-1 Isoform, TEAD4216, Can Repress Vascular Endothelial Growth Factor Expression in Mammalian Cells

Increased cellular production of vascular endothelial growth factor (VEGF) is responsible for the development and progression of multiple cancers and other neovascular conditions, and therapies targeting post-translational VEGF products are used in the treatment of these diseases. Development of methods to control and modify the transcription of the VEGF gene is an alternative approach that may have therapeutic potential. We have previously shown that isoforms of the transcriptional enhancer factor 1-related (TEAD4) protein can enhance the production of VEGF. In this study we describe a new TEAD4 isoform, TEAD4216, which represses VEGF promoter activity. The TEAD4216 isoform inhibits human VEGF promoter activity and does not require the presence of the hypoxia responsive element (HRE), which is the sequence critical to hypoxia inducible factor (HIF)-mediated effects. The TEAD4216 protein is localized to the cytoplasm, whereas the enhancer isoforms are found within the nucleus. The TEAD4216 isoform can competitively repress the stimulatory activity of the TEAD4434 and TEAD4148 enhancers. Synthesis of the native VEGF165 protein and cellular proliferation is suppressed by the TEAD4216 isoform. Mutational analysis indicates that nuclear or cytoplasmic localization of any isoform determines whether it acts as an enhancer or repressor, respectively. The TEAD4216 isoform appears to inhibit VEGF production independently of the HRE required activity by HIF, suggesting that this alternatively spliced isoform of TEAD4 may provide a novel approach to treat VEGF-dependent diseases

Reassessing the Evidence Hierarchy in Asthma: Evaluating Comparative Effectiveness

Classical randomized controlled trials are the gold standard in medical evidence because of their high internal validity. However, their necessarily strict design can limit their external validity and the ability to extrapolate these data to real world patients. Therefore, alternatively designed studies may play a complementary role in evaluating the comparative effectiveness of therapies in nonidealized patients in more naturalistic, real world settings. Observational studies have high external validity and can evaluate real world outcomes. Their strength lies in hypothesis generation and testing and in identifying areas in which further clinical trials may be required. Pragmatic trials are designed to maximize applicability of trial results to usual care settings by relying on clinically important outcomes and enrolling a wide range of participants. A combination of these approaches is preferable and necessary

Stoney Road Out of Eden: The Struggle to Recover Insurance for Armenian Genocide Deaths and Its Implications for the Future of State Authority, Contract Rights, and Human Rights

The Armenian Genocide during the waning days of the Ottoman Empire continues to represent one of history’s underappreciated atrocities. Comparatively few people even know about the 1.5 million deaths or the government-sponsored extermination attempt that provided Hitler with a blueprint for the Nazi Holocaust. Unlike the Holocaust, however, there was never any accounting demanded of those responsible for the Armenian Genocide. In the aftermath of both tragedies, insurers seized upon the resulting disarray and victimization to deny life insurance benefits owed as a result of the killings. American-based litigation to vindicate rights under the Armenian polices faced substantial legal and political hurdles. To this day, official Turkish policy remains one of denial, including opposition to the insurance benefits litigation. The United States government has occasionally been Turkey’s ally in this embarrassing episode. Despite the opposition, efforts to collect these long past due insurance proceeds have achieved some measure of recompense and recognition through settlement and oscillatingly successful litigation that remains in flux. The litigation, detailed in this article, has highlighted questionable application of American legal doctrine designed to protect the foreign affairs power of the presidency while simultaneously showing that adjudication can meaningfully address issues shunted aside by the other branches of American government, foreign nations, and the international community