La funzione limitatrice dei principi - valori costituzionali nella giurisprudenza costituzionale. Riflessi ed implicazioni sulla legalità penale

La tesi di ricerca si propone di indagare il riflesso che i principi/valori producono sul parametro nel sindacato di legittimità costituzionale, al fine di verificarne le implicazioni sulla legalità, in termini di prevedibilità e certezza. In particolare, delineata la connessione tra principi e valori costituzionali e, ricostruito, secondo la teoria dell'ordinamento, il rapporto tra valori e normatività,si analizzano i riflessi prodotti, sul piano interpretativo, dall’apertura del parametro costituzionale alla logica dei valori, enfatizzandone le ricadute sul controllo di costituzionalità delle leggi. Identificato il nesso tra principi e valori nella capacità funzionale dei primi di realizzare i diritti fondamentali, si è inteso rimarcare come la più estesa realizzazione dei principi-valori costituzionali potrebbe compiersi a spese della legge e della certezza del diritto, in una relazione inversamente proporzionale. Ciò apparirebbe evidente dall’ottica privilegiata della materia penale, per cui una legalità materiale, letta alla luce di criteri di adeguatezza e di ragionevole proporzione, seppur vicina alle esigenze di giustizia del caso concreto, se spinta in eccessi interpretativi rischia di invadere il campo del legislatore, unico deputato a compiere scelte di valore.

Effect of risk factors on complicated and uncomplicated ulcers in the TARGET lumiracoxib outcomes study

BACKGROUND ; AIMS: Selective cyclooxygenase-2 inhibitors were developed to reduce the gastrointestinal risk associated with nonsteroidal anti-inflammatory drugs (NSAIDs). The Therapeutic Arthritis Research and Gastrointestinal Event Trial was the largest study to evaluate primarily the gastrointestinal safety outcomes of selective cyclooxygenase-2 inhibitors. Data from the Therapeutic Arthritis Research and Gastrointestinal Event Trial were used to identify risk factors and investigate the safety of lumiracoxib in subgroups. METHODS: Patients with osteoarthritis (age, >or=50 y) were randomized to receive lumiracoxib 400 mg once daily, naproxen 500 mg twice daily, or ibuprofen 800 mg 3 times daily for 12 months. Events were categorized by a blinded adjudication committee. The primary end point was all definite or probable ulcer complications. RESULTS: For patients taking NSAIDs, factors associated with an increased risk of ulcer complications were age 65 years or older (hazard ratio [HR], 2.30; 95% confidence interval [CI], 1.48-3.59), previous history of gastrointestinal bleed or ulcer (HR, 3.61; 95% CI, 1.86-7.00), non-Caucasian racial origin (HR, 2.10; 95% CI, 1.35-3.27), and male sex (HR, 1.70; 95% CI, 1.08-2.68). With lumiracoxib, significant risk factors were age 65 years or older (HR, 3.18; 95% CI, 1.40-7.20), male sex (HR, 2.60; 95% CI, 1.25-5.40), non-Caucasian racial origin (HR, 2.16; 95% CI, 1.02-4.59), and concomitant aspirin use (HR, 2.89; 95% CI, 1.40-5.97). Increased risks in patients age 65 years and older were increased further if other risk factors were present. Lumiracoxib maintained an advantage over NSAIDs across all subgroups except aspirin use. CONCLUSIONS: Lumiracoxib was associated with a reduced risk of ulcer complications compared with NSAIDs in all significant subgroups except aspirin users.

Swiss Patent Jurisprudence 2012

The new Swiss Federal Patent Court, with nationwide first-instance jurisdiction over all civil patent matters, has been operating since 1 January 2012. This article reviews and contextualizes the most important patent cases the Swiss Federal Patent Court and the Swiss Federal Supreme Court. It concludes that the revamped Swiss patent litigation system has the potential of turning Switzerland into a competitive venue for the adjudication of patent matters in Europe.

Virtues and Perils of Anonymity: Should Intermediaries Bear the Burden?

On October 10, 2013, the Chamber of the European Court of Human Rights (ECtHR) handed down a judgment (Delfi v. Estonia) condoning Estonia for a law which, as interpreted, held a news portal liable for the defamatory comments of its users. Amongst the considerations that led the Court to find no violation of freedom of expression in this particular case were, above all, the inadequacy of the automatic screening system adopted by the website and the users’ option to post their comments anonymously (i.e. without need for prior registration via email), which in the Court’s view rendered the protection conferred to the injured party via direct legal action against the authors of the comments ineffective. Drawing on the implications of this (not yet final) ruling, this paper discusses a few questions that the tension between the risk of wrongful use of information and the right to anonymity generates for the development of Internet communication, and examines the role that intermediary liability legislation can play to manage this tension.

Swiss Patent Jurisprudence 2012

The new Swiss Federal Patent Court, with nationwide first-instance jurisdiction over all civil patent matters, has been operating since January 1, 2012. This article reviews and contextualizes the most important patent cases published in 2012 by the Swiss Federal Patent Court and the Swiss Federal Supreme Court. More specifically, the article covers cases on issues such as the evidentiary status of party expert opinions, the formal requirements for requests for injunctive relief, the infringement and non-obviousness tests employed by the Swiss Federal Patent Court, the use of reports and statements from technical judges in lieu of expert opinions, and the procedural devices for the pre-trial taking of evidence, in particular the new patent-specific device of precise description. The author suggests that designing the Federal Patent Court to include technically trained judges may lead to a more automatic adoption of the practices and case law of the European Patent Office. The article concludes that the revamped Swiss patent litigation system has the potential of turning Switzerland into a competitive venue for the adjudication of patent matters in Europe.

IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial

BACKGROUND The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL). METHODS/DESIGN IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI. DISCUSSION This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014. TRIAL REGISTRATION NCT00941733

Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials

Aims: The aim of this study was to identify predictors of adverse events among patients with ST-elevation myocardial infarction (STEMI) undergoing contemporary primary percutaneous coronary intervention (PCI). Methods and results: Individual data of 2,655 patients from two primary PCI trials (EXAMINATION, N=1,504; COMFORTABLE AMI, N=1,161) with identical endpoint definitions and event adjudication were pooled. Predictors of all-cause death or any reinfarction and definite stent thrombosis (ST) and target lesion revascularisation (TLR) outcomes at one year were identified by multivariable Cox regression analysis. Killip class III or IV was the strongest predictor of all-cause death or any reinfarction (OR 5.11, 95% CI: 2.48-10.52), definite ST (OR 7.74, 95% CI: 2.87-20.93), and TLR (OR 2.88, 95% CI: 1.17-7.06). Impaired left ventricular ejection fraction (OR 4.77, 95% CI: 2.10-10.82), final TIMI flow 0-2 (OR 1.93, 95% CI: 1.05-3.54), arterial hypertension (OR 1.69, 95% CI: 1.11-2.59), age (OR 1.68, 95% CI: 1.41-2.01), and peak CK (OR 1.25, 95% CI: 1.02-1.54) were independent predictors of all-cause death or any reinfarction. Allocation to treatment with DES was an independent predictor of a lower risk of definite ST (OR 0.35, 95% CI: 0.16-0.74) and any TLR (OR 0.34, 95% CI: 0.21-0.54). Conclusions: Killip class remains the strongest predictor of all-cause death or any reinfarction among STEMI patients undergoing primary PCI. DES use independently predicts a lower risk of TLR and definite ST compared with BMS. The COMFORTABLE AMI trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00962416. The EXAMINATION trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00828087.

AIDS defining opportunistic infections in patients with high CD4 counts in the combination antiretroviral therapy (cART) era: things ain't what they used to be.

INTRODUCTION According to reports from observational databases, classic AIDS-defining opportunistic infections (ADOIs) occur in patients with CD4 counts above 500/µL on and off cART. Adjudication of these events is usually not performed. However, ADOIs are often used as endpoints, for example, in analyses on when to start cART. MATERIALS AND METHODS In the database, Swiss HIV Cohort Study (SHCS) database, we identified 91 cases of ADOIs that occurred from 1996 onwards in patients with the nearest CD4 count >500/µL. Cases of tuberculosis and recurrent bacterial pneumonia were excluded as they also occur in non-immunocompromised patients. Chart review was performed in 82 cases, and in 50 cases we identified CD4 counts within six months before until one month after ADOI and had chart review material to allow an in-depth review. In these 50 cases, we assessed whether (1) the ADOI fulfilled the SHCS diagnostic criteria (www.shcs.ch), and (2) HIV infection with CD4 >500/µL was the main immune-compromising condition to cause the ADOI. Adjudication of cases was done by two experienced clinicians who had to agree on the interpretation. RESULTS More than 13,000 participants were followed in SHCS in the period of interest. Twenty-four (48%) of the chart-reviewed 50 patients with ADOI and CD4 >500/µL had an HIV RNA <400 copies/mL at the time of ADOI. In the 50 cases, candida oesophagitis was the most frequent ADOI in 30 patients (60%) followed by pneumocystis pneumonia and chronic ulcerative HSV disease (Table 1). Overall chronic HIV infection with a CD4 count >500/µL was the likely explanation for the ADOI in only seven cases (14%). Other reasons (Table 1) were ADOIs occurring during primary HIV infection in 5 (10%) cases, unmasking IRIS in 1 (2%) case, chronic HIV infection with CD4 counts <500/µL near the ADOI in 13 (26%) cases, diagnosis not according to SHCS diagnostic criteria in 7 (14%) cases and most importantly other additional immune-compromising conditions such as immunosuppressive drugs in 14 (34%). CONCLUSIONS In patients with CD4 counts >500/ µL, chronic HIV infection is the cause of ADOIs in only a minority of cases. Other immuno-compromising conditions are more likely explanations in one-third of the patients, especially in cases of candida oesophagitis. ADOIs in HIV patients with high CD4 counts should be used as endpoints only with much caution in studies based on observational databases.

Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial.

BACKGROUND Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation. OBJECTIVES The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI). METHODS Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR. RESULTS Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080). CONCLUSIONS In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).

Causes of late mortality with dual antiplatelet therapy after coronary stents.

AIMS In the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study. METHODS AND RESULTS Patients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% (P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% (P = 0.01) over the randomized period (Months 12-30). Rates of fatal bleeding were 0.2 vs. 0.1% (P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% (P = 0.36), Months 12-33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% (P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% (P = 0.16). CONCLUSION Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00977938.

Los casos difíciles y el pragmatismo de los jueces : claves de la declinación del Estado de Derecho

El Estado de Derecho se asienta en una serie de condiciones esenciales para el normal desenvolvimiento de una república. Entre esas condiciones figura la independencia política de los jueces, es decir, la imparcialidad de los magistrados en la tarea de administrar justicia. Dicha imparcialidad suele asociarse a la idea de afianzar la justicia “tratando igual a los iguales". Para el formalismo jurídico tradicional, eso implica aplicar la ley vigente sin apelar a las preferencias políticas ni a los valores morales de los jueces. Sin embargo, la pretensión de imparcialidad parece imposible de alcanzar en los “casos difíciles", es decir, en aquellos casos en que no parece existir una única solución que pueda obtenerse por vía deductiva a partir de la ley vigente. El presente trabajo discute el alcance de tal pretensión a la luz de una propuesta desafiante y perturbadora gestada al seno del pragmatismo jurídico norteamericano.

La penalidad de la ebriedad en el código penal y en la praxis judicial bonaerense 1878-1888

La sanción del código penal en la provincia de Buenos Aires en el año 1877, fijó en el homicidio la penalidad y determinó las circunstancias del delito mediante la enumeración de los atenuantes y agravantes. El objetivo era contemplar todas las posibilidades del delito para reducir el "arbitrio judicial". Sin embargo, deteniéndonos en los cambios operados en cuanto a la ebriedad en la normativa legal y en la práctica judicial, se puede observar que la función del juez no se redujo únicamente a computar la pena según el delito. A su cargo quedó la apreciación de las pruebas y la interpretación legal. En este sentido, la ley dejó márgenes para considerar a la ebriedad como atenuante o no de la penalidad. Sin embargo, los jueces le negaron tal beneficio al imputado, lo cual marcó una ruptura con respecto al período anterior. Interpretación que estuvo determinada no por un cambio en la percepción sobre el efecto del alcohol como perturbador de la conciencia, sino por ciertos prejuicios que otorgaron una jerarquía y un valor a los motivos que pudieran cegar al trasgresor. Considerada aun como un vicio y no una patología, revelaron la condena a esta práctica social determinando que hechos ya no quedaban comprendidos como circunstancias atenuantes. En definitiva, la ebriedad posibilita apreciar el complejo proceso de codificación que consistió no únicamente en la aplicación literal de la ley sino también en la interpretación que de ella se hiciera.

La penalidad de la ebriedad en el código penal y en la praxis judicial bonaerense 1878-1888

La sanción del código penal en la provincia de Buenos Aires en el año 1877, fijó en el homicidio la penalidad y determinó las circunstancias del delito mediante la enumeración de los atenuantes y agravantes. El objetivo era contemplar todas las posibilidades del delito para reducir el "arbitrio judicial". Sin embargo, deteniéndonos en los cambios operados en cuanto a la ebriedad en la normativa legal y en la práctica judicial, se puede observar que la función del juez no se redujo únicamente a computar la pena según el delito. A su cargo quedó la apreciación de las pruebas y la interpretación legal. En este sentido, la ley dejó márgenes para considerar a la ebriedad como atenuante o no de la penalidad. Sin embargo, los jueces le negaron tal beneficio al imputado, lo cual marcó una ruptura con respecto al período anterior. Interpretación que estuvo determinada no por un cambio en la percepción sobre el efecto del alcohol como perturbador de la conciencia, sino por ciertos prejuicios que otorgaron una jerarquía y un valor a los motivos que pudieran cegar al trasgresor. Considerada aun como un vicio y no una patología, revelaron la condena a esta práctica social determinando que hechos ya no quedaban comprendidos como circunstancias atenuantes. En definitiva, la ebriedad posibilita apreciar el complejo proceso de codificación que consistió no únicamente en la aplicación literal de la ley sino también en la interpretación que de ella se hiciera.

La penalidad de la ebriedad en el código penal y en la praxis judicial bonaerense 1878-1888

La sanción del código penal en la provincia de Buenos Aires en el año 1877, fijó en el homicidio la penalidad y determinó las circunstancias del delito mediante la enumeración de los atenuantes y agravantes. El objetivo era contemplar todas las posibilidades del delito para reducir el "arbitrio judicial". Sin embargo, deteniéndonos en los cambios operados en cuanto a la ebriedad en la normativa legal y en la práctica judicial, se puede observar que la función del juez no se redujo únicamente a computar la pena según el delito. A su cargo quedó la apreciación de las pruebas y la interpretación legal. En este sentido, la ley dejó márgenes para considerar a la ebriedad como atenuante o no de la penalidad. Sin embargo, los jueces le negaron tal beneficio al imputado, lo cual marcó una ruptura con respecto al período anterior. Interpretación que estuvo determinada no por un cambio en la percepción sobre el efecto del alcohol como perturbador de la conciencia, sino por ciertos prejuicios que otorgaron una jerarquía y un valor a los motivos que pudieran cegar al trasgresor. Considerada aun como un vicio y no una patología, revelaron la condena a esta práctica social determinando que hechos ya no quedaban comprendidos como circunstancias atenuantes. En definitiva, la ebriedad posibilita apreciar el complejo proceso de codificación que consistió no únicamente en la aplicación literal de la ley sino también en la interpretación que de ella se hiciera.