Distribution of Abatement Funds Arising From US Opioid Litigation.

This Viewpoint discusses the settlement agreements reached against several major pharmaceutical distributors resulting from the US opioid epidemic and how those funds will be distributed amongst the states.

Five-year results of no-fault compensation related to childbirth injuries in Taiwan.

OBJECTIVE: Increasing obstetric medical litigations had great impacts in health care system resulted in lower recruitment of residents and higher medical cost of defensive medicine in Taiwan. In order to reduce medical litigation, the "Childbirth Accident Emergency Relief Act" was implemented in June 2016. This study presented five-year results of a novel childbirth accident compensation system. MATERIALS AND METHODS: The purpose of the Relief Act was to establish a national relief system to ensure timely relief, reduce medical disputes, promote the partnership between patient and medical personnel. The compensations included maximal 2 million NTD for maternal death, maximal 0.3 million NTD for neonatal and fetal deaths, and 3, 2, and 1.5 million NTD for maternal or neonatal profound, severe, and moderate disabilities, respectively. Puerperal hysterectomy was included with maximal 0.8 million NTD compensation. RESULTS: Since June 30, 2016 to June 30, 2021, there were 1340 applications reviewed by Committee and 1258 were approved with total relief of 744.7 million NTD (26.6 million USD) with approve rate of 93.9%. It took an average of 109.8 days to start application from childbirth and 102.4 days to get compensation from application. 66.1% of accident victims agreed this system can restore doctor-patient relationship by immediate care and assistance from medical institutions. CONCLUSION: The Relief Act is the first government leading compensation system to establish a national relief system. It was enacted to reduce medical disputes, promote the partnership between patient and medical personnel, and enhance health and safety of women during childbirth. A no-fault compensation would be an efficient alternative disputes resolution to childbirth accidents.

A proposal for a legally enforceable no-fault compensation framework for clinical trial-related injury in Malaysia.

Clinical trials play a critical role in the development of life-enhancing and life-sustaining biomedical advances. It is costly and, regardless of how well-designed and ethically conducted, there are always inherent uncertainties which subsequently expose human participants to the risk of injuries or even death. In Malaysia, compensation for clinical trial-related injury has not been incorporated into standard national regulations or policies. Therefore, when clinical trial-related injuries do occur, such participants cannot be compensated by researchers, and with the absence of specific statutory laws governing trial-related injury within the local legal framework, aggrieved parties need to seek legal redress and can only depend on the existing tort laws. To propose a viable compensation framework, the existing compensation regulations and policies implemented in India and South Africa are analyzed, and their best principles have been recommended. This study proposes the implementation of a no-fault compensation framework in Malaysia which should be disbursed efficiently at minimum administrative cost. This proposed approach should be mandated by the amendment of current laws governing biomedical research and, in the interim, should be adopted voluntarily by research sponsors, institutions and investigators conducting clinical trials in Malaysia.

Jury verdicts, outcomes, and tort reform features of malpractice cases involving thoracic outlet syndrome.

OBJECTIVE/BACKGROUND: Thoracic outlet syndrome (TOS) is most often referred to vascular surgeons. However, there is a lack of understanding of the malpractice cases involving TOS. The goal of this study is to better understand the medicolegal landscape related to the care of TOS. METHODS: The Westlaw Edge AI-powered proprietary system was retrospectively reviewed for malpractice cases involving TOS. A Boolean search strategy was used to identify target cases under the case category of "Jury Verdicts & Settlements" for all state and federal jurisdictions from 1970 to September 2020. The settled case was described but not included in the statistical analysis. Descriptive statistics were used to report our findings, and when appropriate. The P ≤ .05 decision rule was established a priori as the null hypothesis rejection criterion to determine associations between jury verdicts outcomes and state's tort reform status. RESULTS: In this study, 39 cases were identified and met the study's inclusion criteria from the entire Westlaw Edge database. Among plaintiffs who disclosed age and/or gender, median age was 35.0 years with a female majority (67.6%). Cases involving TOS were noted to be steadily decreasing since the mid-1990s. The cases were unevenly spread across 18 states, with the highest number of cases (14, 35.9%) from California and the second highest (4, 10.3%) from Pennsylvania. A similar uneven distribution was seen among U.S. census regions, in which the West had the highest cases (39.5%). The study revealed that more cases were brought to trials in tort reform states (26, 68.4%) than in non-tort reform states (12, 31.6%). A total of 24 of 39 (61.5%) plaintiffs had one specific claim, which resulted in their economic and noneconomic damages. Negligent operation and treatment complication represented an overwhelming majority of claims brought by 38 of 39 plaintiffs (97.4%). Misdiagnosis and lack of informed consent were both brought nine times (23.1%) by the group. Intraoperative nerve injury (20 patients, 51.3%) was the most commonly reported complication. Excluding one case with a settlement of $965,000, 30 of 38 (78.9%) cases went to trials and received defense verdicts. Eight cases (20.5%) were found in favor of plaintiffs with a median payout of $725,581. CONCLUSIONS: This study highlighted higher than average payouts to plaintiffs and risk factors that may result in malpractice lawsuits for surgeons undertaking TOS treatment. Future studies are needed to further clarify the relationships between tort reform and outcomes of malpractice cases involving TOS.

Judicial Vulnerability on the Exercise of Orthodontics: Construction and Validation of a Questionnaire

Abstract Objective: To develop and validate a questionnaire to measure the vulnerability of orthodontists, measuring the risks of being involved in civil liability lawsuits. Material and Methods: In-depth interviews were performed with three groups: G1- law professionals, G2 - orthodontists, and G3 - orthodontic patients. From the analysis of the content of Bardin, domains for the construction of the first version of the 53-question questionnaire were identified. The questionnaire was submitted to experts for validation, inclusion and exclusion of questions, but maintaining the 53-question format. It was submitted to the test-retest phases and verification of internal consistency. Results: 247 professionals answered the final version of the questionnaire. The intraclass correlation coefficient was 88.8%. Cronbach's alpha was 0.946, with high internal consistency. The Kaiser-Meyer-Olkin and Bartlett's tests confirmed internal consistency showing the values of 0.909 and significance of <0.001, respectively. From the total score and factorial analysis, the sample was divided into three groups of judicial vulnerability. Conclusion: The results of this study demonstrated that the questionnaire is a valid tool to measure the risks of involvement in civil liability lawsuits by orthodontists. It presented a multidimensional character and might be applied as well as face to face or online, without prejudice to quality (AU).

Vaccine injury compensation: the Israeli case.

BACKGROUND: Following other countries, Israel passed the Vaccine Injury Compensation Law in 1989, which provides for compensation to vaccine recipients who had suffered injuries without proving negligence. In 2021, after deliberations between the ministries of health and of finance Covid-19 vaccines (administered from the beginning of the campaign on December 20, 2020 and up to December 21, 2022) were included within the compensation law. The current study aims to examine the objectives of Israel's Vaccine Injury Compensation Law, at the time of its enactment, and to explore barriers to their fulfillment. These issues are especially relevant in light of the discussions held on the option for liability exemption which excludes the possibility of redress from the Covid-19 vaccine manufacturers in case of injury attributed to the vaccine, and considering the heavy burden of proof required in standard tort law. METHODS: The study employed a qualitative methodology which made use of both content analysis of relevant documents and in-depth interviews. RESULTS: In passing the Vaccine Injury Compensation Law, legislators sought to assist vaccine recipients who had suffered injuries by both lowering their burden of proof as well as establishing a short and efficient procedure for deliberating their claims. Furthermore, legislators believed that the assurance of compensation to vaccine recipients who had suffered injuries would help to encourage a high rate of vaccination compliance. An examination of the law's implementation over time revealed that the aforementioned goals were not attained. CONCLUSIONS: Implementation of the law since its enactment missed the opportunity to fulfill its original purposes to promote public health fundamental principles of fairness and solidarity. In addition, the adversarial proceedings as well as some of the law's provisions have the potential to undermine public trust in the State's willingness to grant compensation for injuries that are attributed to vaccines and thereby subvert the law's pivotal objective of promoting trust and vaccine compliance. We suggest that allowing circumstantial evidence as to an association between vaccine and an injury, transitioning to administrative deliberation, making available to the public details of cases where compensation was awarded, as well as other possible emendations would help it better reflect the values of fairness and solidarity that underlying the law's purpose. These would also promote the level of trust in healthcare authorities which is essential to preserving high vaccine coverage.

Medico-legal implications for the colon perforation during colonoscopy.

Colon perforation is the most serious complication of colonoscopy, and tends to be considered as malpractice. The aim of this study was to identify the characteristics and causes of medical accidents by analyzing lawsuit cases on colon perforation during colonoscopy. We collected judgment results that were ruled from 2005 to 2015 using the keyword 'colonoscopy' in the 'Korea's Written Judgment Public Reading System' of the Supreme Court, and extracted the cases of colon perforation. Characteristics of medical accidents and the decisions of courts were analyzed from written judgments. Twenty-two lawsuits were analyzed. Most cases were ruled in favor of the plaintiff (n = 20). The allegations against defendants, as filed by the plaintiffs, were performance error (n = 22), improper monitoring after colonoscopy (n = 7), and a lack of informed consent (n = 8). The median compensation was 9335.47 US dollars; this is about 130 times the cost of a single colonoscopy in Korea. The greater the intestinal damage, the greater the amount of compensation (p = 0.016). The time interval from procedure to diagnosis of perforation was most frequently 24 h later (n = 9). It is important to educate patients completely about the symptoms of colon perforation and to guide them to contact medical institutions immediately when symptoms occur. In addition, doctors should explain sufficiently the possibility of perforation before colonoscopy to the patient, and not the caregiver, and get informed consent.

Employer Liability for "Take-Home" COVID-19.

Workplace exposure to SARS-CoV-2 has sickened workers and, subsequently, their family members. Family members might be able to recover from the employer in a negligence action using "take-home" liability theory.

Pigs Don't Fly and You Cannot Expect Absolutely Safe COVID-19 Vaccines (But You Should Expect a Fair Compensation).

This paper focuses on the COVID-19 vaccines authorised for use in the European Union, and explores the mechanisms in place to control vaccine safety and to compensate injured patients, mainly in the context of European law. Based on these considerations, the paper concludes that the refusal by some potential vaccinees to take the vaccine based on safety concerns is ungrounded and an indication of unrealistic expectations, but that in order to build public trust proper compensation mechanisms should be in place.

[Compensation of damage in cancerology]. / Réparation du dommage en cancérologie.

In a few situations, the consequences secondary to a carcinological pathology require an assessment of damages for compensatory purposes. This is particularly the case when liable parties have been found to be at cause of the disease: occupational pathologies in the case of inexcusable employer's fault, exposure to a radioactive risk, for example in the context of full compensation for damages suffered by the victims of nuclear experiments performed by France, or lastly, in the after-effects of late diagnosis. This article does not discuss the imputability of cancer pathologies to an event, but it proposes an adaptation of methods for assessing damages, in an attempt to provide full compensation for damages.

Clinical Negligence Claims Against Vascular Surgery in the United Kingdom: An Observational Study.

BACKGROUND: Claims for clinical negligence awarded to patients and their families are on the increase. The annual "cost of harm" is approximately £7-9 billion in the United Kingdom. In 2017, the National Health Service (NHS) resolution service reported that they mediated more claims than in their entire history. Vascular surgery is a specialty with a disproportionately higher number of claims for clinical negligence. The aim of this observational study was to review the trends of clinical negligence claims in vascular surgery within the United Kingdom. The costs and the primary cause for the complaint were evaluated. METHODS: A retrospective observational study was performed. Clinical negligence claims in vascular surgery between the financial years of April 2005/2006 to April 2018/2019 were requested from NHS resolution under the Freedom of Information Act. Data were provided on November 8, 2019. All data were anonymized, and any categories containing fewer than five claims were removed to protect the identity of claimants. RESULTS: Over the 13-year period, 1,189 claims in vascular surgery were identified, with the annual mean (range) being 91 (20-134) claims per year. Of 1,189 claims, 875 (74%) are closed with payments made to the claimants. The mean annual total payment was £10,015,373. Delay in treatment was the most common cause for litigation claims in vascular surgery with 157 closed claims costing £33,255,248 over the 13-year period. Lower limb amputation was the most common primary injury claim with 140 closed cases but had a larger financial cost at £64,155,969. CONCLUSIONS: Clinical negligence claims in vascular surgery within the United Kingdom have been increasing steadily over the last 13 years and with a changing claims culture is expected to continue. The most common cause for claims with damages paid was delay in treatment, and lower limb amputation was the most common injury suffered. Improved consent, better communication with patients, and a higher surgical skill level could significantly reduce the number of future claims.

A Step Too Far? Whittington Hospital NHS Trust v XX [2020] UKSC 14.

This comment piece explores the decision in Whittington Hospital NHS Trust v XX [2020] UKSC 14. It argues that despite notable shifts in public policy in respect of the acceptability of surrogacy as a means of family formation in the past twenty years, the Supreme Court has taken a step too far in deciding that foreign commercial surrogacy is as widely socially accepted. This impacts on the reasonableness of any claim for damages in negligence for the costs of commercial surrogacy. It is posited that the issue of whether damages for foreign commercial surrogacy are reasonable or not will be the key battleground in future negligence cases of this type.

Dulling the Pain of Future Damages: High Court Ruling Addresses Periodic Payments.

Texas Supreme Court decision carries new implications for periodic payment of future medical expenses.

Tort Reform on Trial: Houston Case Challenges Noneconomic Damage Cap.

Houston case poses challenge to key tort reform limit on noneconomic damages.

The Public Health Value of Opioid Litigation.

Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products. The litigation can serve to address gaps in regulatory and legislative policymaking and in market self-regulation pervasive in the prescription opioid domain. Moreover, prior opioid settlements have satisfied civil tort litigation objectives of obtaining compensation for injured parties, deterring harmful behavior, and holding certain opioid manufacturers, distributors and pharmacies accountable for their actions. In this way, opioid litigation represents progress over prior public health litigation campaigns involving tobacco, lead paint, and asbestos, which had more limited tort litigation effects. Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms.