Participant injury in clinical trials conducted in New Zealand for the benefit of manufacturers: an unfair system?

A patient with a long-standing medical condition was enrolled in a clinical trial, deemed as conducted for the benefit of the manufacturer. The patient entered the trial and, shortly afterward, developed a severe illness that left him with a significant permanent disability. Clinical investigators and clinicians not involved in the trial believed the illness was related to trial participation. Because the trial was for the manufacturer's benefit, the participant was not eligible for compensation from the Accident Compensation Corporation (ACC). Discussions with the trial sponsor took many years to resolve. This case highlights the numerous barriers faced by patients seeking compensation from trial sponsors for adverse events probably resulting from trial participation. Legal changes are required to resolve this situation. Without such changes, potential participants and researchers should consider carefully whether to participate and invite people to participate in trials conducted for the benefit of a manufacturer, as there may be little support available should a trial-related illness occur.

Types Of Medico-Legal Cases Reported At The Casualty Department Of Ayub Teaching Hospital Abbottabad.

BACKGROUND: Medicolegal data is very important for administrators, health officials, philanthropists, social workers, law enforcement agencies. Because it is used for planning and implementation of strategies in order to reduce further incidents. This study is conducted with the aim to determine different types of medicolegal cases and patterns of weapons used. METHODS: A total of 246 cases were studied from 1st September 2017 to 31st January 2018. All information was collected on a pro forma. Statistical analysis was done by MS Excel. RESULTS: Out of 246 cases, 219 were male and 27 were female with age ranging from 3 to 72 years. Among total, 162(65.85%) patients were injured due to blunt weapon, 17 (6.91%) cases of firearms, 23 (9.34%) in road traffic accidents, 15 (6.09%) sharp-edged weapons, 7 (2.84%) cases were of sexual violence, 11 (4.47%) were of poisoning. CONCLUSIONS: Injuries of blunt weapons followed by sharp edge and accidental cases occurred more frequently.

Liability Determination of School Sports Injury Accidents: An Analysis Framework Based on Evolutionary Game.

In recent years, the outbreak of many school sports injury accidents aroused widespread public concern about liability determination of accident. Previous studies have examined the legal application of the liability principles from a law perspective, but few kinds of research attempted to analyze the progress of liability determination from the perspective of "law economics". To fill this research gap, we introduce the evolutionary game model, as an important theoretical tool of "law economics", to investigate how various factors influence the strategy selection of the parties, as well as examine what liability principle can effectively treat school sports injury accidents. The results indicate that the strategic selection of the subject of liability is significantly related to the accident compensation cost and the prevention cost of both parties. Moreover, we also find that both strict and proportional liability rules can play key roles in dealing with the issue of liability determination of school sports injury accidents, but the two liability rules have different effects on the strategic selection of parties. More specifically, compared to the strict liability principle, the proportional liability principle can motivate both the school and the students to adopt the active strategy of "appropriate caution" to prevent occurring sports injury accidents in schools.

Lethal asphyxiation due to sadomasochistic sex training - How some sex partners avoid criminal responsibility even though their actions lead to someone's death.

INTRODUCTION: Erotic asphyxiation is a sexual phenomenon in which one partner reduces the other person's brain oxygen level through strangulation. This study analyzes deaths caused by sexually-motivated strangulation to cases of homicidal choking - summarizing criminal penalties for defendants, depending on the presence of drugs, or alcohol intoxication. METHODS: The mode of analysis involves three sources of data. First, a retrospective chart review of our clinics' two recent cases. Second, a meta-analysis of these materials in relationship to forensic reports obtained from prosecutor's office. Third, we examine the prevalence of death due to strangulation in erotic and non-erotic cases using central court database. Lastly, we provide the summary of interviews involving the country's only forensic unit, which investigates criminal cases involving voluntary and involuntary strangulation. RESULTS: In total, we analyzed 15 cases of sexual asphyxiation - 2 of our own; 5 reported in prosecutor's archives; 8 control cases ruled as a non-sexual homicide. The two of our clinical cases describe two victims of voluntary erotic asphyxiation, involving complex sexual environment in which a sexual partner accidentally strangulated the other one during sex. The first case describes a 30 years-old female, who required all of her past sexual partners to choke her with hands in order to reach orgasm. The second case is that of a 41 years-old homosexual male, who was still a novice to kinky play and succumbed to death as a result of being tied with a set of ropes around his neck and body. By combining findings from the analysis of our clinic's cases with 5 files obtained from prosecutor's office - we are able to compare results of these cases to controls (involving homicidal suffocation using the plastic bag). In our cases, the defendants who avoid serving prison time for strangulating in course of erotic play typically exhibit these characteristics - at the time of the killing, they were not under influence of drugs; the deceased had documented (based on witness interview, review of personal items, or medical documentation) long-standing paraphilic disorder. In controls, the likelihood of being convicted of voluntary manslaughter was lower for people who acted under the influence of drugs but higher for those under the influence of alcohol. CONCLUSIONS: These findings show that documented presence of paraphilic tendencies in the deceased might serve as grounds for not sentencing their sex partners for prison time if they acted to satisfy someone else's kinky needs.

Vehicular Hyperthermia-A Highly Preventable and Potentially Fatal Problem.

A child dying of heat injury due to being left unattended in a motor vehicle is a needless tragedy. Each year in the United States an average of 38 children mostly younger than age 2 years die of vehicular hyperthermia, frequently the result of a parental lapse of attention and not intentional neglect. Serious illness results quickly from exposure to rising heat within the passenger compartment, even on days when the temperature is fairly moderate. Prevention is paramount in addressing this problem and can best be accomplished by a combination of technological means, such as passive warning systems, laws that make leaving a child in a car alone illegal, and public education campaigns. [Pediatr Ann. 2018;47(3):e88-e90.].

[Medicolegal Assessment for Chronic Musculoskeletal Pain - 4th Update of the German Guideline for Medicolegal Assessment of Persons in Chronic Pain]. / Begutachtung chronischer muskuloskeletaler Schmerzen.

Medicolegal assessments of claimants with chronic muskuloskeletal pain conditions are frequent. The first German guideline published in 2005 for the medicolegal assessment of claimants in chronic pain is now available in its 4th version (AWMF register number 094 - 003). It gives recommendations for the procedure and serves to ensure the quality of expert opinions when complaints about chronic pain are the leading symptom. In the current version, the indications for ordering medical assessments in pain syndromes have been reformulated, the assessment criteria have been adapted to ICF specifications, and an unequivocal distinction has been introduced between questions of state and causal assessment. A separate chapter on symptom validity assessment has been engrafted.

[A retrospective study of expert opinions of a psychosomatic-psychotherapeutic university hospital for public and private customers over a period of 12 years]. / Evaluation von Gutachten einer Universitätsklinik für Psychosomatik und Psychotherapie für öffentliche und private Auftraggeber über einen Zeitraum von zwölf Jahren.

A retrospective study of expert opinions of a psychosomatic-psychotherapeutic university hospital for public and private customers over a period of 12 years Objectives: Both the public and the legislative have developed an increasingly critical awareness for the fact that expert witnesses need to be independent. In contrast, to date there have been few studies concerning the quantity and the results of psychosomatic-psychotherapeutic expert opinions for public and private clients. METHODS: In a retrospective study design, 285 expert opinions of a psychosomatic-psychotherapeutic university hospital stemming from consecutive, unselected random sampling over a 12-year time period (1990-2011) were analyzed using a predefined list of criteria. Besides client data, the study also noted the type and the objectives of the expertise, the sociodemographic data of the subjects, the biographic data of the subjects, the size of records, the particular psychopathological findings including conflict and structural diagnostics via the Operationalized Psychodynamic Diagnostics (OPD-2, Research Group 2006), syndromic diagnostics according to ICD-10 (WHO) including the related Impairment Scale Score (ISS, Schepank 1995), and the Global Assessment of Functioning-Scale (GAF, Heuft 2016). RESULTS: 54% of the subjects were men. All subjects were 46 years old at the time of examination; on average symptomatology had existed for 7 years, which made assessment of causality difficult. Most assignments referred to the effects of diseases or accidents in private contexts, followed by pension reports. Among the expert opinions related to possible implications of acts of violence, 95% were women. In 43.2% (n = 123) of the cases, the assessment had occurred in the context of legal action. In 65 cases at least one party had requested a supplemental written report during further procedure. In 17.8% (n = 22) of the cases sought by the courts, the expert witness was requested by at least one party to present the assessment verbally. DISCUSSION: It should be emphasized that OPD conflict and structural diagnostics appear indispensable also for assessing mental health prior to an external event (accident or assault). The use of the two severity ratings (ISS, GAF) is discussed. It is proposed that expert witnesses be requested to name all their clients fromthe last 5 years at the beginning or end of the expert opinion, so that their independence from possible conflicts of interest can be established.

[Expert Assessment of Traumatic Disc Herniations]. / Gutachtliche Beurteilung des traumatischen Bandscheibenvorfalls.

In numerous legal areas, expert assessments are needed to clarify the causality of herniated discs: Was the damage caused by an accident? The literature mentions specific requirements regarding the trauma mechanism as well as temporal criteria, which prescribe the causality test. These are essentially high-energy traumas with immediate functional impairments. Accident-related MRI examinations are of paramount importance in the expert assessment process to confirm the primary body harm. In examining the causality constituting liability, competitive causes must be assessed. Since the legal requirements of the causality test differ in civil and social law, legal norms need to be taken into account. We present a test scheme that supports the assessment process through entry, implementation and decision-making levels.

Injury severity in pediatric all-terrain vehicle-related trauma in Nova Scotia.

BACKGROUND/PURPOSE: In 2004-2005, legislation restricting all-terrain vehicle (ATV) use by children and an extensive social marketing campaign intended to reduce pediatric ATV-related morbidity. The frequency, nature, and severity of pediatric ATV-associated trauma were compared before and after such interventions. METHODS: A retrospective cohort study was performed for all pediatric ATV-related injuries that presented to the provincial level 1 pediatric trauma center from 1998 to 2014. National databases were queried for ATV-related injury hospitalizations (n=258), trauma center emergency department visits (n=342), and admissions (n=136) in Nova Scotia from 2002 to 2014. Admissions between 1998 and 2003 (n=68) and 2006-2014 (n=60) were compared using chi square analysis for age and gender distribution, length of stay, critical care admission, helmet use, mechanism, and severity of injury. RESULTS: Admissions, trauma center emergency room visits and admissions initially decreased following legislative and social marketing interventions and subsequently gradually increased. Interventions resulted in no significant difference in age or gender distribution, length of hospital stay, critical care admission, helmet use, and mechanism of injury. There was a significantly higher proportion of severe injuries post interventions. CONCLUSIONS: Legislation and social marketing interventions had a short-term decrease on the frequency of ATV-related injuries and no sustained effect on the frequency, nature, and severity of ATV-related injuries. LEVEL OF EVIDENCE: Level IV.

[Causal Participation in Accident Assessment]. / Zur kausalen Mitwirkung in der Unfallbegutachtung.

A variety of different factors may participate in causing an accident or in influencing its course. These have different legal consequences in different areas of insurance. These differences are outlined for the assessment areas, together with the different states of evidence. In particular, it is discussed whether and under which conditions a trauma can indirectly (as a participating factor) either cause, trigger or exacerbate detachment of the retina.

Accidents at work in the health care - legal aspects in Poland.

An accident at work is a sudden event caused by external circumstances that occurred in relation to work. Referring to the current legislation, the Supreme Court judgments and the opinions contained in publications, the authors discuss the legal aspects of selected accidents: needle stick injuries, cuts with other sharp tools, heart attacks and strokes among health professionals and social workers in Poland. It has been stressed that defining rigid criteria that allow for stating unequivocal work - accidents relationships would be difficult or even impossible. Especially in the case of medical personnel the long-term and negative impact of stress on health is significant, and thus the occurrence of work accidents - heart attack or stroke.

El papel de los Institutos de Medicina Legal en la valoración de las lesiones por tráfico / The role of Institutes of Legal Medicine in the assessment of road traffic accident injuries

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Nuevo sistema para la valoración de los daños y perjuicios causados a las personas en accidentes de circulación. Opinión favorable de las asociaciones de víctimas / Favourable opinion of victims associations on the new system for the assessment of damages caused to persons in motor accidents

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Nueva tabla 2.A.1. del baremo médico. Clasificación y valoración de las secuelas en accidentes de circulación en España / New table 2.A.1. of medical scale. Classification and valuation of the aftermath in traffic accidents in Spain

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[Cardinal errors in expert opinions for the statutory accident insurance]. / "Kardinalfehler" bei der Begutachtung für die gesetzliche Unfallversicherung.

Expert opinions are subject to restrictions and must abide by the rules laid down by the legal system, much more so than therapies. Cardinal errors in expert opinions for the statutory accident insurance (GUV) are sometimes mistakes which can be found in all forms of expert opinions but in some cases where special questions of social law and the statutory accident insurance are concerned. The first group of mistakes are the differences between the requirements of an expert and a therapist with respect to the certainty of expert opinions, the responsibility of the commissioning authority alone for the non-medical components of an expert opinion, the generally valid principle of only giving opinions on areas of proven expertise and the extremely important aspect of personal responsibility. The second group of mistakes involve specific questions for the statutory accident insurance, such as the principles of causality, the rules of evidence, the estimation of the consequences of an accident with respect to reduction in earning capacity (MdE) and the significance of pre-existing damage.

[Suicide in childhood or accidental hanging? A case report]. / Suizid im Kindesalter oder unfallbedingtes Erhängen? Eine Fallvorstellung.

Suicides of children, adolescents and young adults are a rare manner of death. Hanging is the dominant suicide method in all age groups. Risk factors for suicide at a young age are mental diseases, use of illicit drugs, antisocial behaviour and problems within the family. A 10-year-old boy was found to have hanged himself with a scarf at the handrail of a staircase. He had had school problems and was often sent home earlier as he tended to disturb classes. In the week prior to his death the headmaster of his school had told him that he should better attend another type of school. The deceased's elder brother had recorded a video with his mobile phone some years before showing his sister in a simulated hanging situation. Apart from the macroscopic and microscopic findings of the reported case, the frequency and special characteristics of suicides in childhood and adolescence are discussed.