Legal epidemiology of paediatric dog bite injuries.

BACKGROUND: Dog bite injuries cause over 100 000 paediatric emergency department visits annually. Our objective was to analyse associations between regional dog ownership laws and incidence of paediatric dog bites. METHODS: This observational study used an online search to locate local dog-related policies within Ohio cities. Data collected by Ohio Partners For Kids from 2011 through 2020 regarding claims for paediatric dog bite injuries were used to compare areas with and without located policies and the incidence of injury. RESULTS: Our cohort consisted of 6175 paediatric patients with dog bite injury encounters. A majority were white (79.1%), male (55.0%), 0-5 years old (39.2%) and did not require hospital admission (98.1%). Seventy-nine of 303 cities (26.1%) had city-specific policies related to dogs. Overall, the presence of dog-related policies was associated with lower incidence of dog bite injury claims (p=0.01). Specifically, metropolitan areas and the Central Ohio region had a significantly lower incidence when dog-related policies were present (324.85 per 100 000 children per year when present vs 398.56 when absent; p<0.05; 304.87 per 100 000 children per year when present vs 411.43 when absent; p<0.05). CONCLUSIONS: The presence of city-specific dog-related policies is associated with lower incidence of paediatric dog bite injury claims, suggesting that local policy impacts this important public health issue. There are limited dog-related policies addressing dog bite prevention, with inconsistencies in breadth and depth. Creating consistent, practical requirements among policies with vigorous enforcement could ameliorate public health concerns from paediatric dog bite injuries.

Informed consent and compulsory medical device registries: ethics and opportunities.

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.

Predictive Genetic Testing by the U.S. Military: Legal and Ethical Issues.

INTRODUCTION: Precision medicine is a significant component of the military medical vanguard. One area of growing interest involves predictive genetic testing (PGT)-which can be used for both medical evaluation and operational planning. Predictive genetic testing is likely to play an increasingly important role in the military, in terms of both medically related testing to predict the risk of disease or injury and testing for non-medical traits that may be relevant to military performance. MATERIALS AND METHODS: This article describes predictive tests that currently are in use by the military or that might be of interest to the military. The article also explores the risks and benefits associated with PGTs, describes the ambiguities in the current laws and directives governing the military use of PGT, and proposes a set of guidelines for the use of PGTs by the military. RESULTS: There is no publicly available law or DoD policy that prevents the military from conducting PGT before or after accession. Currently, the only genetic testing routinely employed by the U.S. military is for medical purposes. In addition to non-routine genetic testing to diagnose genetic diseases and conditions, the military also uses targeted testing for predictive purposes. As additional predictive genetic tests are developed and become widely used, the military can be expected to employ those that are of relevance. Predictive military genetic testing of active duty service members could reduce their risk of illness and injury, improve their physical and mental fitness, enhance the health and well-being of the unit, make mission accomplishment more certain and efficient, and reduce medical and other costs for the military and veterans. Moreover, individuals with genetic variants that might enhance the likelihood of successfully completing a military mission could be preferred for certain positions or assignments, such as special operations. At the same time, there are risks that genetic information may be used for improper purposes or may stigmatize service members. CONCLUSIONS: Predictive genetic testing is likely to play an increasingly important role in the military, in terms of both medically related testing to predict the risk of disease or injury and testing for non-medical traits that may be relevant to military performance. In instances where PGT meets standard scientific measures of validity and utility, test results can be used to promote the health and welfare of individual service members, units, and military missions. In cases where PGT does not rise to the level of meeting standard scientific criteria, officials should proceed cautiously in incorporating the information into clinical care and military decision-making. There needs to be an appropriate method of collectively calculating risks and benefits. Moreover, although military directives prohibit "unlawful discrimination," this term has received no elaboration in any publicly available military pronouncements. This lacuna should be rectified to provide proper guidance to service members, medical personnel, and the public. Although the promise of PGT may compel military officials to consider ways to maximize the use of test results, the risk of undermining military goals with unverified uses also should be considered appropriately.

Airmen and health-care providers' attitudes toward the use of genomic sequencing in the US Air Force: findings from the MilSeq Project.

PURPOSE: The use of genomic sequencing (GS) in military settings poses unique considerations, including the potential for GS to impact service members' careers. The MilSeq Project investigated the use of GS in clinical care of active duty Airmen in the United States Air Force (USAF). METHODS: We assessed perceived risks, benefits, and attitudes toward use of GS in the USAF among patient participants (n = 93) and health-care provider participants (HCPs) (n = 12) prior to receiving or disclosing GS results. RESULTS: Participants agreed that there are health benefits associated with GS (90% patients, 75% HCPs), though more HCPs (75%) than patients (40%) agreed that there are risks (p = 0.048). The majority of both groups (67% HCPs, 77% patients) agreed that they trust the USAF with genetic information, but far fewer agreed that genetic information should be used to make decisions about deployment (5% patients, 17% HCPs) or duty assignments (3% patients, 17% HCPs). Despite their hesitancy, patients were supportive of the USAF testing for nondisease traits that could impact their duty performance. Eighty-seven percent of patients did not think their GS results would influence their career. CONCLUSION: Results suggest favorable attitudes toward the use of GS in the USAF when not used for deployment or assignment decisions.

Inside the courtroom: An analysis of malpractice litigation in gallbladder surgery.

BACKGROUND: Cholecystectomy is one of the most commonly performed operations in the United States, yet it still carries up to a 6% risk of major morbidity. Lawsuits are a major source of emotional, financial, and personal stress for surgeons. We sought to characterize malpractice claims associated with gallbladder surgery as well as define contributing factors and costs with these claims. METHODS: The Westlaw database (Thomson Reuters Corporation, Toronto, Canada) was queried for jury verdicts and settlements related to cholecystectomy and malpractice between 2000 and 2018. Data were abstracted from the case files and details of the settlements, jury verdicts, and factors related to the claims were assessed. RESULTS: Among 231 cases, a plaintiff verdict was reached in 45 (19.5%) and a defendant verdict was reached in 122 (53%); other cases were either settled (n = 29, 12%), dismissed (n = 31, 13%), or denied (n = 4, 2%). Plaintiff cases often involved young (median age, 44 years [interquartile range: 35-57]) female (n = 146, 63%) patients. The attending surgeon accounted for 59% of defendants. Procedural error (49%), wrongful death (18%), or failure to treat in a timely manner (13%) were the most commonly cited reasons for litigation. Among the 134 cases where a second surgical procedure was performed, the most common types of procedures were biliary tract repair (n = 82, 61%) and bowel repair (n = 16, 12%). The total cost of the claims over the study period was $22 million with a median payout of $500,000; the median time from operative event to final disposition was over 5 years (interquartile range: 4-7). CONCLUSION: A plaintiff verdict or settlement was reached in 1 in 3 cases, and large payouts were common. Minimizing procedural error and improving care of patients after cholecystectomy complications should be emphasized.

A Natural Experiment: Using Immersive Technologies to Study the Impact of "All-Natural" Labeling on Perceived Food Quality, Nutritional Content, and Liking.

The "all-natural" label is used extensively in the United States. At many point-of-purchase locations, employed servers provide food samples and call out specific label information to influence consumers' purchase decisions. Despite these ubiquitous practices, it is unclear what information is conveyed to consumers by the all-natural label or how it impacts judgments of perceived food quality, nutritional content, and acceptance. We used a novel approach incorporating immersive technology to simulate a virtual in-store sampling scenario where consumers were asked by a server to evaluate identical products with only one being labeled all-natural. Another condition evaluated the impact of the in-store server additionally emphasizing the all-natural status of one sample. Results indicated the all-natural label significantly improved consumer's perception of product quality and nutritional content, but not liking or willingness to pay, when compared to the regular sample. With the simple emphasis of the all-natural claim by the in-store server, these differences in quality and nutritional content became even more pronounced, and willingness to pay increased significantly by an average of 8%. These results indicate that in a virtual setting consistent with making food purchases, an all-natural front-of-pack label improves consumer perceptions of product quality and nutritional content. In addition, information conveyed to consumers by employed servers has a further, substantial impact on these variables suggesting that consumers are highly susceptible to social influence at the point of purchase.

Parental Refusal of Childhood Vaccines and Medical Neglect Laws.

OBJECTIVES: To examine the relation of vaccine refusal and medical neglect under child welfare laws. METHODS: We used the Westlaw legal database to search court opinions from 1905 to 2016 and identified cases in which vaccine refusal was the sole or a primary reason in a neglect proceeding. We also delineated if religious or philosophical exemptions from required school immunizations were available at the time of adjudication. RESULTS: Our search yielded 9 cases from 5 states. Most courts (7 of 9) considered vaccine refusal to constitute neglect. In the 4 cases decided in jurisdictions that permitted religious exemptions, courts either found that vaccine refusal did not constitute neglect or considered it neglect only in the absence of a sincere religious objection to vaccination. CONCLUSIONS: Some states have a legal precedent for considering parental vaccine refusal as medical neglect, but this is based on a small number of cases. Each state should clarify whether, under its laws, vaccine refusal constitutes medical neglect.

Public Health Law and Institutional Vaccine Skepticism.

Vaccine-hesitant parents are often portrayed as misinformed dilettantes clinging to unscientific Internet chatter and a debunked study that linked the MMR vaccine and autism. While this depiction may be an accurate portrayal of a small (but vocal) subset, scholars have unearthed a more complex picture that casts vaccine hesitancy in the context of broader notions of lack of trust in government and industry. At the same time, commentators have highlighted limitations of the vaccine injury compensation program and US Supreme Court Justices Sonia Sotomayor and Ruth Bader Ginsburg have argued that preemption laws that provide vaccine manufacturers with broad legal immunities create "a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products." In short, the discussions surrounding vaccine hesitancy that dominate public discourse detract from serious debate as to whether amendments to vaccine-related laws can address the limitations of the existing framework governing immunizations. This commentary examines these issues through a public health law lens.

Waiving legal rights in research.

The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects waive or appear to waive legal rights. We argue that policies that prevent human subjects from waiving legal rights in research can be ethically justified under the rationale of group, soft paternalism. These policies protect competent adults from making adverse decisions about health and legal matters that they may not understand fully. However,this rationale is less defensible if there is a comprehensive compensation for injury programme available in which subjects are asked to waive some legal rights in order to participate in the programme. In this situation, subjects should be allowed to waive some legal rights to obtain the benefits of the programme.