Westlaw Database Research Articles

Litigation Patterns in Inguinal Hernia Surgery: A 25 Year Review

BackgroundInguinal herniorraphyis among the most common procedures performed by general surgeons, but risk factors for litigation related to this surgery are poorly defined. MethodsCases were retrieved by searching the Westlaw database from 1991 through 2016 using the search terms “inguinal hernia” OR “inguinal herniorrhaphy” OR “inguinal hernioplasty” and “medical malpractice.” Data were compiled on the demographics of the patient, operative case details, nature of injury, legal allegations, verdicts, and indemnities. ResultsForty-six cases met inclusion criteria and were selected for review. Verdicts for the defendant predominated (67%). The average plaintiff's monetary award for a plaintiff verdict or settlement was $1.21 million (median $500,000). The most frequent legal argument was improper performance (n = 35, 76%), followed by failure of informed consent (n = 14, 30%). The most common complications were nerve/chronic pain (n = 20, 45%) and testicular damage (n = 10, 23%). No association was discovered between case outcome and patient gender (P = 0.231) or age (P = 0.899). Case outcome was not different between open and laparoscopic repairs (P = 0.722). Patient mortality was not associated with case outcome (P = 0.311). There was no chronological trend in case outcome or award amount. Settlement award amounts were not significantly different than plaintiff awards (P = 0.390). ConclusionsSuccessful litigation after inguinal hernia surgery was relatively infrequent—only 21.7%—with an additional 10.9% resulting in settlement awards. Case outcome in litigation for hernia surgery was not predicted by patient demographics, type of procedure, or type of complication in this data set.

Invited commentary

The authors reviewed a highly selected cohort of medical malpractice cases that involve the placement of inferior vena cava filters. The state cases that populate the LexisNexis and Westlaw databases are chosen because they either represent a unique or important application of the law or have been subject to the appellate process. They may represent as little as 5% of the cases filed. As referenced in the paper, there are a large number of cases that are either settled or simply not chosen to be a part of these databases. In addition, because it appears that the original charts of these patients were not evaluated, it must be remembered that all clinical factual material is based on the filings of the plaintiff/patient. On occasion, the defendant's response to the facts submitted is also cited in the court documents. Accordingly, the indications for the procedure, hypercoagulable status, diagnosis of recurrent pulmonary embolism, and device migration may not correctly reflect the medical facts. Therefore, the application of any conclusions derived from this paper is significantly limited. In addition, the terms academic center, private practitioner, and community hospital are not defined, further limiting the impact of these data. Outcomes and associated factors in malpractice litigation involving inferior vena cava filtersJournal of Vascular Surgery: Venous and Lymphatic DisordersVol. 6Issue 4PreviewPlacement of inferior vena cava (IVC) filters is a controversial focus of medical malpractice. Clinicians currently have little information to guide them regarding key issues and outcomes in litigation. In this retrospective legal case review, we analyzed the factors associated with malpractice actions involving IVC filters. Full-Text PDF

Invited Commentary

I read with interest the preceding article in this issue of Annals of Vascular Surgery by Phair et al. regarding medical malpractice and vascular surgeons. The authors make an excellent attempt at giving us a better understanding of the factors that lead to the filing of medical malpractice claims against members of our specialty by reviewing cases from a national databank. However, as noted in their manuscript, the Westlaw database is extremely limited and contains only a small fraction of the cases that are filed each year. In addition, the majority of the medical data reviewed are based upon the filings of the plaintiff. Only occasionally are the defendant's responses documented. Unfortunately, the medical information presented by attorneys is often incomplete or medically incorrect. This, too, limits the applicability of the data obtained. It is quite common for attorneys to present multiple theories of negligence in a specific case in the hopes that the jury or the court will be persuaded by at least one of their arguments. This legal tactic also results in significant confusion regarding the specific medical negligence that served to initiate the lawsuit. Therefore, the medical data obtained from the Westlaw review are a lay person's interpretation of the medical facts and may not accurately reflect the patient's medical course. Finally, many of the cases contained in the Westlaw database are cases that have been subject to review by the appellate courts. Therefore, the monetary judgments obtained likely do not reflect the amounts of money that are paid in the standard verdicts or settlements. Regardless, the authors are to be congratulated for their efforts to shine a light on the issue of medical malpractice and vascular surgery. Why Do Vascular Surgeons Get Sued? Analysis of Claims and Outcomes in Malpractice LitigationAnnals of Vascular SurgeryVol. 51PreviewThe objective of the study was to analyze causes and outcomes of malpractice claims against vascular surgeons in the United States. Full-Text PDF

Why Do Vascular Surgeons Get Sued? Analysis of Claims and Outcomes in Malpractice Litigation

The objective of the study was to analyze causes and outcomes of malpractice claims against vascular surgeons in the United States. Cases entered into the Westlaw database from January 1, 1999 to December 31, 2014 were reviewed. Search terms "vascular" and "surgeon" were used. Data were compiled on the allegation, subject matter, and outcome of each case. Additional data including demographics of the defendant were obtained from the U.S. News Health reports on practicing physicians. Of a total of 785 cases identified from the Westlaw database using the search terms "vascular" and "surgeon", 485 (61.8%) were identified where a vascular surgeon was the defendant or expert witness. Of these, 135 (27.8%) had a vascular surgeon identified as a defendant. Among these 135 cases, 88 (65.2%) were found for the defendant with 31 (23%) and 15 (11.1%) being found for the plaintiff or settled, respectively. Of the 31 cases found for the plaintiff, the median award was $750,000 and mean award was $1,830,000. Mean time from incident to verdict was 4.8years. The most common procedures which led to litigation were open or endovascular peripheral revascularization (PR) (14.8%), carotid interventions (CIs) (11.85%), aortic interventions (AI) (11.1%), vascular trauma (9.63%), dialysis access (8.15%), and venous surgery (5.93%). The most common allegation was "failure to diagnose and treat" (48.9%), followed by complication of open surgery (31.85%) and negligent procedure (25.19%). The most common injuries reported were death (31.85%), major amputation (23.7%), neurovascular injury (14.8%), and bleeding (5.9%). Analysis of vascular surgery malpractice litigation in the Westlaw database revealed details regarding the subject matter and outcomes of these cases. Through this closed claims analysis, the most common procedures leading to litigation were found to be PR, CI, and AI and not thoracic outlet syndrome procedures as commonly believed. Furthermore, the most common allegations were a "failure to diagnose and treat" and "open surgical complication". Analysis of the salient features and outcomes in these cases can provide a framework for heightened awareness of issues which lead to malpractice claims and can ultimately improve patient care and safety.

PHP38 - Biosimilar Regulatory Policies Issues and Implications: Where are we Headed?

Eight biosimilars are currently approved in the United States, accounting for $446 billion alone and is anticipated to grow exponentially by 2020. The goal of this review was to assess the regulatory policy issues and legislative interplay regarding biosimilars in the United States, providing potential insights into possible implications and remedies. A targeted literature review was conducted in PubMed and Google Scholar to identify studies that provided a scientific backbone for the regulatory and legislative issues. An additional targeted search of Westlaw databases was conducted to identify case studies for legislative issues concerning biosimilars. Searches were supplemented with manual citation review of the selected studies and for landmark cases. Regulatory issues impact processes regarding development, approval, manufacturing, and marketing of biosimilars. The regulatory issues identified in this review impact all aspects of the US biosimilar market. Key regulatory policy issues concerning biosimilars included interchangeability with the innovator biologic, extrapolation to another therapeutic area, and reimbursement. We identified 27 cases that directly (16 cases related to biosimilar or pharmaceutical patents) or indirectly (11 cases) affect regulatory process for biosimilars. Biosimilars with structural variability had regulatory and legislative advantages over their innovator biologic, unlike generic drugs. In the patent infringement cases, the court rulings generally upheld the Biologics Price Competition & Innovation Act, favoring biosimilar approval and marketing. Biosimilars hold promise for patients, reducing both patient and national burden of diseases and promoting further research for better healthcare. This review takes a novel approach in the light of the biosimilar patent infringement cases and the corresponding court rulings to better understand the regulatory framework for biosimilar marketing. There is a need for rigorous policy framework from Congress and Food and Drug Administration that promote biosimilar safety, improve patient access, and reduce the cost of biosimilars.

Inferior Vena Cava Filter Malpractice Litigation: Damned if You Do, Damned if You Don't

The aim of this study was to analyze malpractice litigation trends and to better understand the causes and outcomes of suits involving inferior vena cava filters (IVCF) to prevent future litigation and improve physician education. Jury verdict reviews from the Westlaw database from January 1, 2000, to December 31, 2015, were reviewed. The search term "inferior vena cava filter" was used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. A total of 156 cases were identified. Duplicates and cases in which the IVCF was incidentally included were excluded from the analysis. Forty-nine cases involving either failure to place or a complication of IVCF placement were identified. Throughout the last 15years, there has been increased number of jury verdicts toward IVCF. The most frequent defendants were internal medicine physicians (38%), vascular surgeons (19%), and cardiothoracic surgeons (12%). The most frequent claims were denied treatment or delay in treatment (in 35% of cases), negligent surgery (in 24% of cases), and failure to diagnose and treat complications (in 24% of cases). Of these, the most frequent specific claims were failure to place IVC filter (41%), implantation failure such as misplacement and/or misaligned implant (24%), erosion of IVC/retroperitoneal bleed (6%), and discontinuation of anticoagulation prematurely (6%). Seventeen cases (35%) were found for the plaintiff, with median awards worth of $1,092,500. In the 21 cases where pulmonary embolism (PE) was involved (43% of cases), 19 were fatal (90%). Of the fatal PE cases, 8 cases ended with verdicts in favor of the plaintiff (42%). Both nonfatal PE cases were won by the defense. IVCF placement with subsequent PE and death results in verdicts that favor the plaintiffs. This study emphasizes that adequate and transparent communication regarding preoperative planning, decision for IVCF placement, and informed consent may reduce the frequency of litigation. Public awareness of complications related to the placement of IVCF is increasing largely and spurned by aggressive advertising and marketing by plaintiff attorneys. Conditions for which IVCF placement is contemplated carry significant risk of malpractice litigation.

Malpractice Litigation in Cornea and Refractive Surgery: A Review of the WestLaw Database.

To report and analyze the causes and outcomes of malpractice litigation in cornea and refractive surgery. The WestLaw database was reviewed for all malpractice litigation related to ophthalmology in the United States between 1930 and 2014. Search terms included ophthalmology or ophthalmologist and malpractice anywhere in the retrieved results. All cases involving cornea and refractive surgery were included in this analysis, and results were compared with ophthalmology as a whole. One hundred fifty-nine cornea and refractive surgery cases between the years 1964 and 2014 were included. Ninety-three cases (58.5%) were resolved through a jury trial, 21.5% of which were associated with plaintiff verdicts with a median adjusted jury award of $588,896 (mean $1,518,686). Nineteen cases (11.9%) resulted in settlements with a median adjusted indemnity of $782,533 (mean $761,963). Commonly litigated scenarios included laser-assisted in situ keratomileusis (74.2%) and corneal transplantation (8.2%). Overall, 88.7% of cases involved surgical or procedural claims, 8.8% involved noninterventional claims, and 2.5% involved medical claims only. Cornea and refractive surgery is a high-risk subspecialty of ophthalmology. Laser-assisted in situ keratomileusis and corneal transplant claims were the most commonly litigated entities in this series. Many cases focus on failure to achieve patients' desired expectations after elective refractive procedures or the negligent performance of refractive surgery on patients with contraindications to surgery, both highlighting the importance of detailed informed consent discussions, realistic goal setting with patients, and thorough examinations and preoperative evaluation.

Falling short: how state laws can address health information exchange barriers and enablers.

Research on the implementation of health information exchange (HIE) organizations has identified both positive and negative effects of laws relating to governance, incentives, mandates, sustainability, stakeholder participation, patient engagement, privacy, confidentiality, and security. We fill a substantial research gap by describing whether comprehensive state and territorial HIE legal frameworks address identified legal facilitators and barriers. We used the Westlaw database to identify state and territorial laws relating to HIEs in effect on June 7, 2016 (53 jurisdictions). We blind-coded all laws and addressed coding discrepancies in peer-review meetings. We recorded a consensus code for each law in a master database. We compared 20 HIE legal attributes with identified barriers to and enablers of HIE activity in the literature. Forty-two states, the District of Columbia, and 2 territories have laws relating to HIEs. On average, jurisdictions address 8.32 of the 20 criteria selected in statutes and regulations. Twenty jurisdictions unambiguously address ≤5 criteria in statutes and regulations. None of the significant legal criteria are unambiguously addressed in >60% of the 53 jurisdictions. Laws can be barriers to or enablers of HIEs. However, jurisdictions are not addressing many significant issues identified by researchers. Consequently, there is a substantial risk that existing legal frameworks are not adequately supporting HIEs. The current evidence base is insufficient for comparative assessments or impact rankings of the various factors. However, the detailed Centers for Disease Control and Prevention dataset of HIE laws could enable investigations into the types of laws that promote or impede HIEs.

Impact of HIPAA's minimum necessary standard on genomic data sharing.

PurposeThis article provides a brief introduction to the HIPAA Privacy Rule’s minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions.MethodsThis research used the Thomson Reuters Westlaw™ database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data-sharing. We considered relevant example cases of genomic data-sharing needs.ResultsIn a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized—whether for research, public health, or clinical interpretation and medical practice support—affects how the minimum necessary standard applies and its overall impact on data access and use.ConclusionThere is no clear regulatory guidance on how to apply HIPAA’s minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy-makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.

Legislative Efforts to Reduce Concussions in Youth Sports: An Analysis of State Concussion Statutes

Sport-related concussions are a serious public health issue. While concussions are prevalent among all age groups, youth sport participants are at a greater risk of sustaining such injury due to their immature brain structure and the lack of concussion management policies at the organizational level compared with those found in intercollegiate and professional sports (Kim, Spengler, & Connaughton, 2016). To address this problem, legislation has been adopted in all 50 states and the District of Columbia to mandate some of the standardized measures of concussion management. The purpose of this study was to review the existing state concussion statutes. The statutes were obtained via the LEXIS/NEXIS and West Law databases. Key categories were selected by the researchers and language was compared among statutes. Although the vast majority of concussion statutes shared some similarities, a comprehensive review revealed wide inconsistencies in language. Suggestions that promote more consistency among statutes o...

Communication-related allegations against physicians caring for premature infants.

Maternal-fetal medicine physicians (MFMp) and neonatal-perinatal medicine physicians (NPMp) caring for premature infants and their families are exposed to significant risk for malpractice actions. Effective communication practices have been implicated to decrease litigious intentions but the extent of miscommunication as a cause of legal action is essentially unknown in this population. Analysis of communication-related allegations (CRAs) may help toward improving patient care and physician-patient relationships as well as decrease litigation risks. We retrospectively reviewed the Westlaw database, a primary online legal research resource used by United States lawyers and legal professionals, for malpractice cases against physicians involving premature infants. Inclusion criteria were: 22 to 36 weeks gestational age, cases related to peripartum events through infant discharge and follow-up, and legal records with detailed factual narratives. The search yielded 736 legal records, of which 167 met full inclusion criteria. A CRA was identified in 29% (49/167) of included cases. MFMp and/or NPMp were named in 104 and 54 cases, respectively. CRAs were identified in 26% (27/104) and 35% (19/54) of MFMp- and NPMp-named cases, respectively, with a majority involving physician-family for both specialties (81% and 74%, respectively). Physician-family CRAs for MFMp and NPMp most often regarded lack of informed consent (50% and 57%, respectively), lack of full disclosure (41% and 29%, respectively) and lack of anticipatory guidance (36% and 21%, respectively). This study of a major legal database identifies CRAs as significant causes of legal action against MFMp and NPMp involved in the care of high-risk women and infants delivered preterm. Physicians should be especially vigilant with obtaining genuine informed consent and maintaining open communication with families.

Medicolegal cases involving periviable births from a major United States legal database

Objective: The management of expectant mothers and infants born at the threshold of viability is challenging. We describe medicolegal cases from a major United States legal database involving periviable births in an effort to identify areas for improvement.Study design: We conducted a retrospective review of all United States state and federal cases in the Westlaw database from 1980 through 2016 involving peripartum and immediate post-delivery management of infants born between 22 0/7 and 25 6/7 weeks’ gestation.Results: Our search criteria returned 736 results, and 15 cases met full inclusion criteria. Eight cases involved conflicts on resuscitation contrary to parental directives. Eleven cases comprised alleged miscommunication between families and providers. Of these, seven cases alleged inadequate prenatal counseling of infant's chances of survival and neurological outcome, whilst four cases alleged miscommunication of infant's condition post-delivery.Conclusions: Miscommunication between providers and families during prenatal counseling and after birth was a major component of malpractice cases regarding infants born at the threshold of viability. The infant’s immediate post-delivery condition and long term prognosis were of primary interest to parents, and improving effective communication may aid toward more genuinely informed resuscitation directives.

Legal Mapping Analysis of State Telehealth Reimbursement Policies.

There exists rapid growth and inconsistency in the telehealth policy environment, which makes it difficult to quantitatively evaluate the impact of telehealth reimbursement and other policies without the availability of a legal mapping database. We describe the creation of a legal mapping database of state-level policies related to telehealth reimbursement of healthcare services. Trends and characteristics of these policies are presented. Information provided by the Center for Connected Health Policy was used to identify statewide laws and regulations regarding telehealth reimbursement. Other information was retrieved by using: (1) LexisNexis database, (2) Westlaw database, and (3) retrieval from legislative Web sites, historical documents, and contacting state officials. We examined policies for live video, store-and-forward, and remote patient monitoring (RPM). In the United States, there are 24 states with policies regarding reimbursement for live video transmission. Fourteen states have store-and-forward policies, and six states have RPM-related policies. Mississippi is the only state that requires reimbursement for all three types of telehealth transmission modes. Most states (47 states) have Medicaid policies regarding live video transmission, followed by 37 states for store-and-forward and 20 states for RPM. Only 13 states require that live video will be reimbursed "consistent with" or at the "same rate" as in-person services in their Medicaid program. There are no widely accepted telehealth reimbursement policies across states. They contain diverse restrictions and requirements that present complexities in policy evaluation and in determining policy effectiveness across states.

State legal innovations to encourage naloxone dispensing

ObjectivesThe opioid overdose epidemic continues to claim the lives of tens of thousands of Americans every year. Increased access to the opioid antagonist naloxone can reduce opioid-related morbidity and mortality. In this commentary, we describe several recent legal innovations designed to encourage pharmacists to ensure that naloxone is available when and where it is needed, and dispel some common misconceptions regarding potential legal risks associated with pharmacy naloxone dispensing. Data sourcesData are drawn from state laws and regulations, as catalogued by the Westlaw database. SummaryStates have rapidly modified law and policy to increase layperson access to naloxone. As of August 2016, 44 states permit naloxone to be prescribed for administration to a person with whom the prescriber does not have a prescriber-patient relationship. Forty-two states permit naloxone to be dispensed via a non–patient-specific mechanism such as a standing or protocol order, and 5 states permit some pharmacists to prescribe naloxone on their own authority. The liability risk associated with naloxone dispensing is no higher than any other medication, and may be lower than some. However, to encourage the prescription and dispensing of naloxone, 36 states provide additional protection from civil liability for pharmacy naloxone dispensing, and 32 states provide protection from potential criminal action. Naloxone access laws in 31 states explicitly provide that dispensing naloxone as permitted by law cannot be grounds for disciplinary action by the state board of pharmacy or similar entity. ConclusionPharmacists are key members of the health care team and are uniquely situated to reduce potential opioid overdose risk. Pharmacists should be aware of and utilize innovative state laws designed to increase access to naloxone.

Dissecting malpractice in pancreaticoduodenectomy cases

BackgroundMedical malpractice is a growing concern for physicians in all fields. Surgical fields have some of the highest malpractice premiums and litigation rates. Pancreaticoduodenectomy (PD) has become a popular procedure; however, it is still associated with significant morbidity and mortality. This study is the first to analyze factors involved in litigation regarding PD cases. MethodsThe Westlaw database was searched for jury verdicts and settlements using the terms “medical malpractice” and “pancreaticoduodenectomy”. Twenty-nine cases from 1991 to 2012 were initially collected. Seven entries not involving PD and three duplicate cases were excluded. Nineteen cases were included for analysis. ResultsOf the 19 cases included in the analysis, three (15.8%) reached a settlement, three (15.8%) were ruled in favor of the plaintiff, and 13 (68.4%) were ruled in favor of the physician. The average settlement award was $398,333 (range, $195,000-500,000), and the average plaintiff award was $4,288,869 (range, $1,066,608-10,300,000). The most common factors raised in litigation included PD being allegedly unnecessary (47.4%), followed by postoperative negligence and misdiagnosis (36.8% each). ConclusionsThe most common factors present in litigation included the allegation that PD was unnecessarily performed. The cases that are awarded large monetary sums are those that involve continued medical care. Ways to improve patient safety and limit litigation include increasing transparency and communication with a thorough discussion between surgeon and patient of the most common topics of litigation discussed.

Malpractice Litigation in Pediatric Ophthalmology

ImportanceUnderstanding outcomes of pediatric malpractice litigation allows ophthalmologists to gain insight into how to best care for patients and prevent such litigation.ObjectivesTo report and analyze the causes and outcomes of ophthalmology medical malpractice litigation involving patients younger than 18 years.Design, Setting, and ParticipantsThe WestLaw database was reviewed from April 1 to 30, 2015, for ophthalmology-related lawsuits, including settlements and trial verdicts, in the United States from January 1, 1930, to December 31, 2014. Search terms included ophthalmology or ophthalmologist and malpractice anywhere in the retrieved documents. Cases in which the plaintiffs were younger than 18 years at the time of the inciting event were included. Pediatric cases were compared with adult cases.Main Outcomes and MeasuresPediatric malpractice case outcomes and settlement amounts.ResultsSixty-eight ophthalmology malpractice cases involving plaintiffs younger than 18 years were included in the study. Thirty-five cases (51.5%) were resolved via jury trial. Of these 35 cases, verdicts in favor of the plaintiff were issued in 17 pediatric cases (48.6%), compared with 168 of 584 adult cases (28.8%) (difference, 33%; 95% CI, −24% to 64%; P = .01). The 17 cases that resulted in verdicts in favor of the pediatric plaintiff had a mean jury award of $4 815 693 (median, $883 281; range, $147 765-$42 061 690). Nine of the total 68 cases (13.2%) resulted in a settlement, with mean adjusted indemnities of $1 912 738 (median, $1 377 689; range, $92 070-$8 493 086). The remaining 24 cases (35.3%) involved appellate rulings, pretrial and posttrial relief rulings, and 1 bench verdict. Jury awards were higher in pediatric vs adult cases (difference, $3 422 134; 95% CI, −$3 422 134 to $8 731 916; P = .002), as were indemnity payments (difference, $1 186 757; 95% CI, −$69 074 to $3 342 588; P = .003). Cases involving legal blindness were more likely to result in verdicts in favor of the plaintiff (difference, 60.5%; 95% CI, −1% to 62%; P = .30). Common clinical scenarios in cases of litigation were traumatic ocular injury (15 [22.1%]), retinopathy of prematurity (12 [17.6%]), and endophthalmitis (6 [8.8%]).Conclusions and RelevanceMalpractice litigation involving pediatric patients was more likely to be resolved in favor of the plaintiff and was associated with higher monetary awards than was adult litigation. Cases involving retinopathy of prematurity resulted in the highest payments to plaintiffs, and cases involving legal blindness and/or endophthalmitis were more likely to be resolved in favor of the plaintiff. This information may give pediatric ophthalmologists insight into the situations and conditions that commonly lead to litigation.

Eleven-year descriptive analysis of closed court verdicts on medical errors in Spain and Massachusetts

ObjectivesTo evaluate and compare the characteristics of court verdicts on medical errors allegedly harming patients in Spain and Massachusetts from 2002 to 2012.Design, setting and participantsWe reviewed 1041 closed court verdicts obtained from data on litigation in the Thomson Reuters Aranzadi Westlaw databases in Spain (Europe), and 370 closed court verdicts obtained from the Controlled Risk and Risk Management Foundation of Harvard Medical Institutions (CRICO/RMF) in Massachusetts (USA). We included closed court verdicts on medical errors. The definition of medical errors was based on that of the Institute of Medicine (USA). We excluded any agreements between parties before a judgement.ResultsMedical errors were involved in 25.9% of court verdicts in Spain and in 74% of those in Massachusetts. The most frequent cause of medical errors was a diagnosis-related problem (25.1%; 95% CI 20.7% to 31.1% in Spain; 35%; 95% CI 29.4% to 40.7% in Massachusetts). The proportion of medical errors classified as high severity was 34% higher in Spain than in Massachusetts (p=0.001). The most frequent factors contributing to medical errors in Spain were surgical and medical treatment (p=0.001). In Spain, 98.5% of medical errors resulted in compensation awards compared with only 6.9% in Massachusetts.ConclusionsThis study reveals wide differences in litigation rates and the award of indemnity payments in Spain and Massachusetts; however, common features of both locations are the high rates of diagnosis-related problems and the long time interval until resolution.

ASTRO APEx® and RO-ILS™ are applicable to medical malpractice in radiation oncology.

To analyze malpractice trials in radiation oncology and assess how ASTRO APEx® and RO-ILS™ apply to such cases. The Westlaw database was reviewed using PICOS/PRISMA methods. Fisher's exact and Mann-Whitney U tests were used to find factors associated with outcomes. Of 34 cases identified, external beam was used in 26 (77%). The most common factors behind malpractice were excessive toxicity (80%) and lack of informed consent (66%). ASTRO APEx pillars and ROI-LS had applicability to all but one case. Factors favoring the defendant included statute of limitations (odds ratio: 8.1; 95% CI: 1.3-50); those favoring the plaintiff included patient death (odds ratio: 0.7; 95% CI: 0.54-0.94). APEx and RO-ILS are applicable to malpractice trials in radiation oncology.

PC094. Why Do Vascular Surgeons Get Sued? Analysis of Claims and Outcomes in Malpractice Litigation

Background The objective of the study was to analyze causes and outcomes of malpractice claims against vascular surgeons in the United States. Methods Cases entered into the Westlaw database from January 1, 1999 to December 31, 2014 were reviewed. Search terms “vascular” and “surgeon” were used. Data were compiled on the allegation, subject matter, and outcome of each case. Additional data including demographics of the defendant were obtained from the U.S. News Health reports on practicing physicians. Results Of a total of 785 cases identified from the Westlaw database using the search terms “vascular” and “surgeon”, 485 (61.8%) were identified where a vascular surgeon was the defendant or expert witness. Of these, 135 (27.8%) had a vascular surgeon identified as a defendant. Among these 135 cases, 88 (65.2%) were found for the defendant with 31 (23%) and 15 (11.1%) being found for the plaintiff or settled, respectively. Of the 31 cases found for the plaintiff, the median award was $750,000 and mean award was $1,830,000. Mean time from incident to verdict was 4.8 years. The most common procedures which led to litigation were open or endovascular peripheral revascularization (PR) (14.8%), carotid interventions (CIs) (11.85%), aortic interventions (AI) (11.1%), vascular trauma (9.63%), dialysis access (8.15%), and venous surgery (5.93%). The most common allegation was “failure to diagnose and treat” (48.9%), followed by complication of open surgery (31.85%) and negligent procedure (25.19%). The most common injuries reported were death (31.85%), major amputation (23.7%), neurovascular injury (14.8%), and bleeding (5.9%). Conclusions Analysis of vascular surgery malpractice litigation in the Westlaw database revealed details regarding the subject matter and outcomes of these cases. Through this closed claims analysis, the most common procedures leading to litigation were found to be PR, CI, and AI and not thoracic outlet syndrome procedures as commonly believed. Furthermore, the most common allegations were a “failure to diagnose and treat” and “open surgical complication”. Analysis of the salient features and outcomes in these cases can provide a framework for heightened awareness of issues which lead to malpractice claims and can ultimately improve patient care and safety.

Analysis of lawsuits related to point-of-care ultrasonography in neonatology and pediatric subspecialties.

Point-of-care ultrasonography (POCUS) is becoming increasingly available for neonatologists and pediatric subspecialists (PSS); however, concerns over potential litigation from possible missed diagnoses or incorrect management have been documented. This study aims to define the extent and quality of lawsuits filed against neonatologists and PSS related to POCUS. We conducted a retrospective study of all United States reported state and federal cases in the Westlaw database from January 1990 through October 2015. Cases were reviewed and included if either a neonatologist or PSS were accused of misconduct or the interpretation or failure to perform an ultrasound/echocardiogram was discussed. Descriptive statistics were used to evaluate the data. Our search criteria returned 468 results; 2 cases were determined to be relevant to the study objective. The two cases alleged a failure to perform a diagnostic test and implicated POCUS as an option. There were no cases of neonatologists and PSS being sued for POCUS performance or interpretation. This study of a major legal database suggests that POCUS use and interpretation is not a significant cause of lawsuits against neonatologists and PSS.