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.

Provenance and risk in transfer of biological materials.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

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.

Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018.

PURPOSE: To evaluate the types of anesthesia-related closed claims and their contributing factors, using data from the Ophthalmic Mutual Insurance Company (OMIC). DESIGN: Retrospective analysis of preexisting data. PARTICIPANTS: Plaintiffs who filed a professional liability claim or suit (written demand for money) against OMIC-insured ophthalmologists, ophthalmic practices, or surgicenters in which the surgical case occurred. METHODS: Plaintiff claims were collected from the OMIC database from 2008 to 2018 using search queries for terms associated with known complications of ophthalmic anesthesia. MAIN OUTCOME MEASURES: Number and types of anesthesia-related injuries and claims, who administered the anesthesia, the outcomes of the claim or suit, cost to defend, and payments made to plaintiffs. RESULTS: Sixty-three anesthesia-related claims or suits were filed by 50 plaintiffs. Anesthesia-related injuries included globe perforation (n = 17), death (n = 13), retrobulbar hemorrhage (n = 7), optic nerve damage (n = 4), vascular occlusions (n = 2), pain (n = 2), eye or head movement resulting in injury (n = 2), and 1 case each for numbness, diplopia, and tooth loss during intubation. All but 1 patient who died had preexisting, significant comorbidities. Two deaths were related to brainstem anesthesia. Regarding the type of anesthesia in the closed claims, retrobulbar and peribulbar anesthesia were the most common types (n = 16 each), followed by local infiltration around the lids and facial nerve (n = 6), topical anesthesia (n = 5), and general anesthesia (n = 5). In 2 cases, the exact type of anesthesia was unknown but not general. The 5 topical with sedation anesthesia-related claims were due to inadequate pain control (n = 2), ocular movement resulting in capsular rupture (n = 2), or death (n = 1) allegedly related to excessive or inadequate monitoring of sedation. There were 5 claims related to general anesthesia including 4 deaths and 1 tooth loss during intubation. Sedation was alleged to be a factor in 5 cases resulting in death. Anticoagulants were a factor in 3 retrobulbar hemorrhage cases. CONCLUSIONS: Although claims and suits were infrequent given the large number of insured ophthalmologists and the large number of surgical cases requiring various types of anesthesia performed over the 10.5-year study period, severe injuries can occur.

The paralyzing legal costs of facial nerve injury in head and neck tumors.

PURPOSE: Facial nerve paralysis from head and neck tumors can result from disease progression or iatrogenic causes, leading to litigation. The aim of this study was to investigate lawsuits regarding facial paralysis as a consequence of these tumors to understand and better educate physicians behind the reasons for litigation. METHODS: Jury verdict reviews were obtained from the Westlaw database from 1985 to 2018. Gathered data, including verdicts, litigation reasons, defendant specialties, and amounts awarded, were analyzed via Statistical Package for the Social Sciences. RESULTS: Of the 26 lawsuits analyzed, the leading reason for litigation was failure to diagnose (53.8%), followed by iatrogenic injury (34.6%). The average award was $2,704,470. Otolaryngologists were the most common defendants. Defendants that included an otolaryngologist had shorter delays of diagnosis compared to those that did not (p < 0.05). CONCLUSION: Failure to diagnose parotid injury was the leading cause of litigation. In instances where the jury found for the plaintiff, the amount was material. There were equivalent incidences of cases in favor of plaintiffs and defendants.

International Commercial Surrogacy as a New Head of Tortious Damage: XX v Whittington Hospital NHS Trust [2018] EWCA Civ 2832.

In XX v Whittington Hospital NHS Trust [2018] EWCA Civ 2832, the Court of Appeal recognised commercial surrogacy in California as a permissible head of damage in a case of negligently inflicted infertility. Due to changing public policies and judicial opinion regarding the practice, and by incorporating the three-part test of illegality developed for civil claims by the Supreme Court in Patel v Mirza [2016] UKSC 42 into tort law, the Court of Appeal held that the principle of restorative justice required a departure from the precedent established in Briody v St Helens and Knowsley AHA [2001] EWCA Civ 1010.

Big Data Governance Needs More Collective Responsibility: The Role of Harm Mitigation in the Governance of Data Use in Medicine and Beyond.

Harms arising from digital data use in the big data context are often systemic and cannot always be captured by linear cause and effect. Individual data subjects and third parties can bear the main downstream costs arising from increasingly complex forms of data uses-without being able to trace the exact data flows. Because current regulatory frameworks do not adequately address this situation, we propose a move towards harm mitigation tools to complement existing legal remedies. In this article, we make a normative and practical case for why individuals should be offered support in such contexts and how harm mitigation tools can achieve this. We put forward the idea of 'Harm Mitigation Bodies' (HMBs), which people could turn to when they feel they were harmed by data use but do not qualify for legal remedies, or where existing legal remedies do not address their specific circumstances. HMBs would help to obtain a better understanding of the nature, severity, and frequency of harms occurring from both lawful and unlawful data use, and they could also provide financial support in some cases. We set out the role and form of these HMBs for the first time in this article.

Medication related litigation in Ireland: A 6-year review.

AIMS: The primary aims of the study were to identify those medications most frequently associated with clinical litigation in Ireland and to quantify the cost of such litigation. Secondary aims were to identify where in the medication-use process claims were most likely to arise, the medication incident types involved and the primary injury alleged. METHODS: The National Incident Management System (NIMS) for incident and claims management was searched to identify all medication-related claims finalised from 2011 to 2016 (inclusive). The physical case files were obtained and additional data not available on NIMS was extracted in order to build a detailed picture of the incident and subsequent claim. RESULTS: The search identified 79 relevant claims, of which 48 closed with a payment to the plaintiff. These 48 claims involved 54 medications. Medication groups identified included general anaesthetics (n = 7), opioids (n = 6), penicillins, antithrombotics and local anaesthetics (all n = 5). The errors alleged occurred exclusively at the administration (58%) and prescribing (42%) stages of the medication-use process. Medication incident types included wrong dose/strength (n = 17), wrong drug (n = 7) and adverse drug reaction (n = 6). The most commonly pleaded primary injuries were allergic reaction (n = 9), deterioration in clinical status (n = 9) and post-traumatic stress disorder (n = 8). The median total cost of these claims was €60 991, including median damages of €33 858. CONCLUSIONS: This study links data on medication incidents, actual harm to patients and litigation costs. Thus, it presents a comprehensive picture of the consequences of medication error.

Effect of Increasing Malpractice Insurance Cost and Subsequent Practice of Defensive Medicine on Out-of-Hospital Birth Rates in the United States.

BACKGROUND: Across the United States, the burden of malpractice litigation has influenced obstetricians and obstetric institutions to avoid high-risk patients, favor cesarean delivery, and decrease availability of trial of labor after cesarean. Recently, the United States has experienced an increase in out-of-hospital (OOH) births. OBJECTIVE: The main purpose of this article is to investigate the association between malpractice insurance premium (MIP) and OOH births in the United States from 2000 to 2014. STUDY DESIGN: We analyzed changes in OOH birth rates and MIP from 2000 to 2014 using birth data from the National Vital Statistics System and Medical Liability Monitor's annual survey, respectively. The change in OOH birth rates was then compared with the change in MIP. RESULTS: Between 2000 and 2014, there has been approximately 60% increase in MIP from national average of $40,949 to $65,210 (p < 0.05). OOH births increased 57% from 39,398 births to 59,674 births (p < 0.05). There was a significant positive correlation between increase in MIP and increase in OOH births (p < 0.05, R 2 = 0.14). CONCLUSION: MIP and OOH birth rates have a significantly associated increase from 2000 to 2014. Given that malpractice climate affects other aspects of obstetric practice, we cautiously propose that increasing MIP may be associated with an increase in OOH births.

Guiding industry settlements of opioid litigation.

Background: The recent $270 million settlement of Purdue Pharmaceuticals and the State of Oklahoma on March 26, 2019 concerning the state's opioid litigation is a harbinger of industry settlements to come. Thousands of opioid-related cases with impending trial dates may stimulate opioid manufacturers, distributors, and retailers to seek new deals to escape historic liability. Objectives: Against a backdrop of massive damage potential of a two decade opioid epidemic, reaching appropriate settlements is key. Parties to opioid lawsuits must balance an array of factors to assure industry accountability while preserving access to opioids among legitimate patients seeking palliative care. Methods: We examined major bases for opioid litigation across the U.S. Thousands of cases have been filed against opioid manufacturers, distributors, pharmacies, pharmacy benefit managers, and others. Hundreds of these cases are consolidated in a federal district court in Cleveland, Ohio where trials are scheduled as early as October 2019. Grounds for litigation are highly varied. Results: Multiple factors underlying responsible settlements include (1) a primary focus on contemporary treatment and prevention strategies supplemented by research innovations; (2) primary access to life-saving treatments for at-risk individuals; (3) fair and equitable allocation of settlement resources; (4) dedication to lawful, efficacious interventions; (5) cross-sharing of industry data and practices to promote good faith compliance; and (6) continued assurance of access to palliative care for deserving patients. Conclusions: Negotiated settlements must align with highly effective public health priorities. Crafting wise settlement agreements is necessary to assign responsibility for huge public harms and ensure future treatments that are prudent and efficacious.

Rethinking the Obvious: Time for New Ideas on Medical Malpractice Tort Reform.

States have engaged in medical malpractice litigation reforms over the past 30 years to reduce malpractice insurance premiums, increase the supply of physicians, reduce the cost of health care, and increase efficiency. These reforms have included caps on noneconomic damages and legal procedural changes. Despite these reforms, health care costs in the United States remain among the highest in the world, provider shortages remain, and defensive medicine practices persist. The purpose of this study was to determine how successful traditional medical malpractice reforms have been at controlling medical costs, decreasing defensive medicine practices, lowering malpractice premiums, and reducing the frequency of medical malpractice litigation. Research has shown that direct reforms and aggressive damage caps have had the most significant impact on lowering malpractice premiums and increasing physician supply. Out of the metrics that were improved by malpractice reforms, similar improvements were shown because of quality reform measures. While traditional tort reforms have shown some targeted improvement, large-scale, system-wide change has not been realized, and thus it is time to consider alternative reforms.

The Sale of 'Liquid Gold' in Ireland: Some Thoughts from Tort Law.

At present, the sale of human milk in Ireland is completely unregulated. When the transaction concerns tainted breast milk and physical harm subsequently occurs, however, it may still be subject to the law of tort. By selling unsafe milk, a seller may be in breach of their statutory duty under the Liability for Defective Products Act, 1991 and their conduct may amount to negligence under the common law.

[Medico-legal risk in urology: Analysis of a portfolio of insured persons by a French insurance company between 2009 and 2018]. / Risque médico-légal en urologie : analyse d'un portefeuille d'assurés auprès d'une compagnie d'assurances française entre 2009 et 2018.

OBJECTIVE: Presentation of data collected on urology claims from the register of a French insurance company. MATERIAL AND METHOD: Compensation claims involving urologists covering the period 2009-2018 were identified and analyzed. RESULTS: A total of 37 files were found. Oncological and functional surgical interventions accounts for 78% of repair claims. Postoperative complications represent 76% of the cases. The most represented acts are total prostatectomy (5) and promonto-fixation (4). The average time of complaint is 28.6 months [1-144 months], the average duration of a procedure (opening-closing) is 32.8 months [12-72 months]. The Conciliation and Compensation Commissions (CCC) and the High Court Courts (HCC) were solicited respectively in 51% and 33% of the proceedings. An amicable agreement is found in 16% of cases. There was no criminal or disciplinary proceedings. The average cost of a closed urology file is 7836 € [0-31,120 €]. In total, 64.8% of the expertises confirm practices in the respect of the rules of the art. CONCLUSION: This series presents the first forensic analysis of a portfolio of urologists on a period of 9 years in French urology. There is a rate of responsibility retained against the practitioner in only 27% of cases. The low rate of faulty files, the absence of a conviction for breach of the duty to provide information and in connection with antibiotic prophylaxis seem to confirm that the practice of urology in France is of good quality, a further study on a longer period of time and on a larger cohort of urologists would allow a finer medico-legal approach. LEVEL OF EVIDENCE: 3.

Medical Malpractice Damage Caps and Provider Reimbursement.

A common state legislative maneuver to combat rising healthcare costs is to reform the tort system by implementing caps on noneconomic damages awardable in medical malpractice cases. Using the implementation of caps in several states and large database of private insurance claims, I estimate the effect of damage caps on the amount providers charge to insurance companies as well as the amount that insurance companies reimburse providers for medical services. The amount providers charge insurers is unresponsive to tort reform, but the amount that insurers reimburse providers decreases for some procedures. Copyright © 2015 John Wiley & Sons, Ltd.

[Liability for damages resulting from hospital falls].

The aim of the work is to analyze the conditions for liability of medical institutions for damages resulting from hospital fails. The study identifies achievements of polish jurisprudence. The authors also pointed to factors specific for claims of this type. The paper discusses: legal consequences of failure to provide security of patient stay and the responsibilities of hospitals in relation to patients especially vulnerable to falls. It also analyzes the problems faced by patients claiming compensation for damages resulting from such events: constraints of the evidence in establishing the conditions for liability, the argument unpredictability of event and the detrimental impact of the actions taken in the hospital to reduce the risk of falling.

Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature.

BACKGROUND: Obstructive sleep apnea (OSA) is common in patients undergoing surgery. OSA, known or suspected, has been associated with significant perioperative adverse events, including severe neurologic injury and death. This study was undertaken to assess the legal consequences associated with poor outcomes related to OSA in the perioperative setting. METHODS: A retrospective review of the legal literature was performed by searching 3 primary legal databases between the years 1991 and 2010 for cases involving adults with known or suspected OSA who underwent a surgical procedure associated with an adverse perioperative outcome. OSA had to be directly implicated in the outcome, and surgical mishaps (i.e., uncontrolled bleeding) were excluded. The adverse perioperative outcome had to result in a lawsuit that was then adjudicated in a court of law with a final decision rendered. Data were abstracted from each case regarding patient demographics, type of surgery, type and location of adverse event, associated anesthetic and opioid use, and legal outcome. RESULTS: Twenty-four cases met the inclusion criteria. The majority (83%) occurred in or after 2007. Patients were young (average age, 41.7 years), male (63%), and had a known diagnosis of OSA (96%). Ninety-two percent of cases were elective with 33.3% considered general procedures, 37.5% were ears, nose and throat procedures for the treatment of OSA, and 29.1% were considered miscellaneous interventions. Complications occurred intraoperatively (21%), in the postanesthesia care unit (33%), and on the surgical floors (46%). The most common complications were respiratory arrest in an unmonitored setting and difficulty in airway management. Immediate adverse outcomes included death (45.6%), anoxic brain injury (45.6%), and upper airway complications (8%). Overall, 71% of the patients died, with 6 of the 11 who suffered anoxic brain injury dying at an average of 113 days later. The use of opioids and general anesthetics was believed to play a role in 38% and 58% of cases, respectively. Verdicts favored the plaintiffs in 58% of cases and the defendants in 42%. In cases favoring the plaintiff, the average financial penalty was $2.5 million (±$2.3 million; range, $650,000--$7.7 million). CONCLUSIONS: Perioperative complications related to OSA are increasingly being reported as the central contention of malpractice suits. These cases can be associated with severe financial penalties. These data likely underestimate the actual medicolegal burden, given that most such cases are settled out of court and are not accounted for in the legal literature.

Managing clinical negligence litigation and costs in the NHS.

John Tingle, Reader in Health Law, Nottingham Trent University, discusses recent Government proposals to improve NHS maternity services and make changes to litigation and patient safety investigation procedures.

Pharmaceutical Waste: A Checklist For Compliance.

The improper disposal of drugs isn't only an environmental threat, it can put the center at risk of substantial penalties.