scholarly journals Carga de la prueba y estándar mínimo de la prueba por indicios en materia de responsabilidad por los daños ocasionados por un producto farmacéutico defectuoso (a propósito de la STJUE de 21 de junio de 2017) = Burden of proof and circumstantial evidence standard for pharmaceutical product liability: commentary to ECJ judgment of 21 june 2017

2017 ◽  
Vol 9 (2) ◽  
pp. 709
Author(s):  
Bárbara Sánchez López
Keyword(s):  
Burden Of Proof ◽  
Product Liability ◽  
Indirect Evidence ◽  
Causal Link ◽  
Pharmaceutical Product ◽  
The State ◽  
Circumstantial Evidence ◽  
Valid Method

Resumen: La Sentencia del TJUE de 21 de junio de 2017 (Sala 2ª), Sanofi Pasteur MSD SNC, C-621/15, aborda la compatibilidad de la llamada «prueba por indicios» con el art. 4 de la Directiva 85/374, sobre responsabilidad por los daños causados por productos defectuosos, en circunstancias en las que el estado de la ciencia no permite demostrar, pero tampoco excluir, la relación entre un producto farmacéutico y los daños. La sentencia examina las condiciones y los límites que debe reunir y respetar para constituirse en un método válido para levantar la carga de la prueba sobre el carácter defectuoso del producto, el daño causado y la relación de causalidad que el artículo 4 de la Directiva arroja sobre el perjudicado.Palabras clave: prueba por indicios, prueba indirecta, carga de la prueba, valoración probatoria judicial, standard probatorio, presunciones legales, responsabilidad por productos defectuosos.Abstract: The ECJ judgment of 21 June 2017 (Second Chamber), Sanofi Pasteur MSD SNC, C-621/15, addresses the compatibility of the so-called “evidence for presumptions or indications” with art. 4 of Directive 85/374 on liability for damage caused by defective products, in circumstances where the state of science does not allow to demonstrate, but does not exclude, the relation between a pharmaceutical product and the damage. The judgment examines the conditions and limits which it must comply with in order to constitute a valid method of lifting the burden of proof on the defectiveness of the product, the damage caused and the causal link which article 4 of the Directive imposes on the injured.Keywords: circumstantial evidence, indirect evidence, burden of proof, evidence standard, legal presumptions, product liability.

scholarly journals Pharmaceutical Product Liability, Litigation Regimes, and the Propensity to Patent: An Empirical Firm-Level Investigation

SAGE Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 215824402110094
Author(s):  
Mitja Kovac ◽  
Salvini Datta ◽  
Rok Spruk
Keyword(s):  
Burden Of Proof ◽  
Product Liability ◽  
Pharmaceutical Product ◽  
European Patent ◽  
Firm Level ◽  
Country Level ◽  
Validation Rate ◽  
Negative Effect ◽  
Unobserved Effects ◽  
Variable Bias

Do different pharmaceutical product liability regimes in different countries induce propensity to patent? We exploit the variation in pharmaceutical liability and litigation rules across firms in the pharmaceutical industry and countries to explain the firm-level propensity to patent. Drawing on a large dataset from European Patent Office (EPO) covering over 9,950 pharmaceutical patents from 63 countries over the period 1991–2015, we compute the conditional probabilities of individual pharmaceutical firms to acquire a valid-based patent on the validation outcomes and examine whether different liability regimes encourage or deter firm-level propensity to patent. Our empirical strategy addresses firm-level idiosyncrasies, country-level unobserved effects, and common technology shocks that potentially invoke omitted variable bias in the effects of liability regimes on the propensity to patent. Our investigation reveals that liability regimes combined with damage caps, broad statutory excuses, and reversed burden of proof have a strong positive effect on the firm-level patent stock and a negative effect upon EPO patent validation rate. The evidence suggests that not all liability rules and related litigation procedures are created equal. Firms are systematically more likely to hold (firm-level patent stock) valid patents at the EPO when the liability and litigation rules are not complex and when the damage cap, broad statutory excuses, and reversed burden of proof are introduced.

scholarly journals Pharmaceutical Product Liability, Litigation Regimes and the Propensity to Patent: an Empirical Firm-level Investigation

2020 ◽  
Author(s):  
Mitja Kovac ◽  
Salvini Datta ◽  
Rok Spruk
Keyword(s):  
Legal Status ◽  
Patent Application ◽  
Product Liability ◽  
Pharmaceutical Product ◽  
European Patent ◽  
Firm Level ◽  
Patent Applications ◽  
A Minor ◽  
Second Category ◽  
The Empirical Analysis

<p>Our data on the legal status of patent applications is from European Patent Office's (EPO) PATSTAT database which contains bibliographic and legal status firm-level patent data from leading industrialized and developing countries for the period 1995-2015. Sixteen different forms of legal statues are broadly classified and systematized into four broad categories. The first category entails the patent applications sent to EPO. This category is used to code firm-level observations based on whether the patent application has been submitted to EPO. The second category comprises the pooled firm-level observations for which the patent application has been approved and official validated. This category comprises the firms for which a valid patent has been approved in a given year. The third category comprises the firms whose patent application has been rejected by EPO on various ground which exceed the scope of this paper. And fourth, the remaining forms of legal status were coded into miscellaneous category which amounts to a minor fraction of the whole set of applications and which are omitted from the empirical analysis.</p>

Ch.7 Non-performance, s.4: Damages, Art.7.4.3

2015 ◽  
Author(s):  
McKendrick Ewan
Keyword(s):  
Burden Of Proof ◽  
Causal Link ◽  
Reasonable Degree ◽  
Degree Of Certainty ◽  
Sufficient Degree ◽  
Future Harm

This commentary analyses Article 7.4.3 of the UNIDROIT Principles of International Commercial Contracts (PICC) concerning the certainty of harm. Under Art 7.4.3, compensation is due only for harm, including future harm, that is established with a reasonable degree of certainty. Compensation may be due for the loss of a chance in proportion to the probability of its occurrence. If the amount of damages cannot be established with a sufficient degree of certainty, the assessment is at the discretion of the court. There is a link between the requirement that the harm must be proved with sufficient certainty and the requirement that there be a causal link between the harm and the non-performance. The burden of proof is upon the aggrieved party to establish both the existence and the extent of the harm with a reasonable degree of certainty.

scholarly journals XVI. Account of an assemblage of fossil teeth and bones of elephant, rhinoceros, hippopotamus, bear, tiger, and hyæna, and sixteen other animals; discovered in a cave at Kirkdale, Yorkshire, in the year 1821: with a comparative view of five similar caverns in various parts of England, and others on the continent

1822 ◽  
Vol 112 ◽  
pp. 171-236 ◽  
Keyword(s):  
Royal Society ◽  
Interesting Case ◽  
The State ◽  
Circumstantial Evidence ◽  
The City

Having been induced in December last to visit Yorkshire, for the purpose of investigating the circumstances of the cave at Kirkdale, near Kirby Moorside, about 25 miles N. N. E. of the city of York, in which a discovery was made last summer of a singular collection of teeth and bones, I beg to lay before the Royal Society the result of my observations on this new and interesting case, and to point out some important general conclusions that arise from it. The facts I have collected, seem calculated to throw an important light on the state of our planet at a period antece­dent to the last great convulsion that has affected its surface; and I may add, in limine, that they afford one of the most complete and satisfactory chains of consistent circumstantial evidence I have ever met with in the course of my geological investigations.

scholarly journals BUKTI TIDAK LANGSUNG (INDIRECT EVIDENCE) DALAM PENEGAKAN HUKUM PERSAINGAN USAHA DI INDONESIA

2018 ◽  
Vol 13 (2) ◽  
pp. 187-200
Author(s):  
Mahmul Siregar
Keyword(s):  
Indirect Evidence ◽  
Circumstantial Evidence

Penggunaan bukti tidak langsung (indirect evidence, circumstantial evidence) dalam penegakan UU No.5 Tahun 1999 sangat diperlukan mengingat karakteristik khusus dari hukum persaingan usaha dan perbuatan anti persaingan itu sendiri. Namun demikian, penggunaan bukti tidak langsung tersebut masih mengandung kontraversi dan ketidakpastian hukum. Keberadaan bukti tidak langsung tidak disebutkan secara eksplisit dalam UU No. 5 Tahun 1999 tetapi keberadaannya dikenal luas dalam penegakan hukum persaingan usaha di berbagai negara dan praktek-praktek internasional. Oleh karena itu diperlukan tindakan-tindakan yang strategis untuk mewujudkan kepastian hukum terkait penggunaan bukti tidak langsung

scholarly journals Judicial Systems and Authoritarian Transitions

2006 ◽  
Vol 45 (4II) ◽  
pp. 1301-1321 ◽  
Author(s):  
Hilton L. Root ◽  
Karen May
Keyword(s):  
Economic Growth ◽  
Property Rights ◽  
Rule Of Law ◽  
Causal Link ◽  
The State ◽  
Alternative View ◽  
Donor Agencies ◽  
Ultimate Objective ◽  
Hearts And Minds ◽  
Judicial Systems

For several decades, development policy specialists and donor agencies have championed investment in the judicial systems of developing countries to promote economic growth and, eventually, democracy. The assumption of a causal link among these three phenomena motivates donors’ investments in the physical and human capacity of the legal system. Some reforms are narrowly focused—better enforcement of property rights and contract law—conducive to enhanced trade and investment. Although these narrow reform programs imply that political liberalisation is an ultimate objective, studies are unable to substantiate causality between the rule of law, economic growth and democracy [Carothers (2003)]. Autocratic regimes may establish courts to protect the property rights of regime insiders and to expropriate the rights of outsiders. In our view a rule of law will have emerged only once the state has achieved legitimacy in the hearts and minds of citizens. The idea that better rule of law would generate economic growth, which would in turn build constituencies for democratic reforms will be questioned in this paper. An alternative view will be suggested, most notably the alignment of national identity with the institutions of the state is critical to establishing a rule of law.

scholarly journals PEMBUKTIAN DALAM SENGKETA TATA USAHA NEGARA

Solusi ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 336-357
Author(s):  
Johansyah Johansyah
Keyword(s):  
Burden Of Proof ◽  
Active Role ◽  
The State ◽  
Legal Research ◽  
Trial Process ◽  
State Administration ◽  
General Explanation

The purpose of this study is to find out and analyze the evidentiary process at the trial in a State Administration dispute involving evidence, the burden of proof and evaluation of the evidence carried out in the State Administrative Court. This type of research is normative legal research. Proof is a procedure for establishing evidence of a fact in a State Administration case to be used as a basis for consideration in passing a decision. In general explanation of Law Number. 5 of 1986 stated that the teaching of proof used in the State Administrative Court is the teaching of free proof, in the State Administrative Court, the judge plays a more active role in the trial process to obtain material truth. An administrative suit does not in essence delay the implementation of the disputed State Administration Decree. The judge has the authority to provide an assessment of the results of evidence in examining, deciding, and resolving State Administration Disputes based on Article 107 of Law Number 5 of 1986.

Coastal marine methyl iodide source and links to new particle formation at Cape Grim during February 2006

2007 ◽  
Vol 4 (3) ◽  
pp. 172 ◽  
Author(s):  
Michael R. Grose ◽  
Jill M. Cainey ◽  
Andrew McMinn ◽  
John A. E. Gibson
Keyword(s):  
Methyl Iodide ◽  
Indirect Evidence ◽  
Particle Formation ◽  
Causal Link ◽  
Sea Surface ◽  
New Particle Formation ◽  
Biological Origin ◽  
Iodide Concentration ◽  
Formation Pathway ◽  
Cape Grim

Environmental context. Emissions of methyl iodide of a biological origin from inshore and coastal waters can be an important component of the atmospheric budget of iodine. Iodine from this and other sources is important in the natural ozone cycle in the troposphere and stratosphere, and may play a role in the formation of new small particles that can then grow to seed clouds. The specific coastal ecology at each location is important to the magnitude and characteristics of this methyl iodide source. Abstract. Methyl iodide concentration in seawater and in the air directly above the sea was measured at an inshore site adjacent to the Cape Grim Baseline Air Pollution Station (Cape Grim BAPS) near a bed of Bull Kelp (Durvillaea potatorum) over daylight cycles and along a transect out to 5 km offshore. Most inshore samples had low and variable methyl iodide concentrations in seawater (14.8–57.7 pM) and in air immediately above the sea (2.1–3.8 parts per trillion by volume), with a partial tidal influence. A period of elevated methyl iodide concentration in the water (144.5 pM) and in air above the sea surface (5.5 pptv) was immediately followed by a measurement of new particles at the Cape Grim BAPS. This correlation provided indirect evidence that emission of methyl iodide from kelp is connected to the new particle formation pathway, but there was no evidence of a direct causal link. Elevated levels of atmospheric methyl iodide were not detected at the station (adjacent to the site but on top of a 94-m cliff) at the same time, which suggests the effect was localised above the sea surface. A rapid decrease of methyl iodide out to 5 km suggested that a source at the coastal reef was greater than from pelagic phytoplankton; this source could be the intertidal kelp beds.

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