Research Topics
| David M StuddertSummaryAffiliation: Harvard University Country: USA Publications
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Publications
Personal choices of health plans by managed care expertsDavid M Studdert
Harvard School of Public Health, Boston, Massachusetts, USA
Med Care 40:375-86. 2002..Expert opinion has not been used as a basis for comparing different forms of health insurance, in part because this perspective may not be appropriately sensitive to aspects of care that consumers value...
Nursing home litigation and tort reform: a case for exceptionalismDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
Gerontologist 44:588-95. 2004..Drawing on findings from our previous study of nursing home litigation, we outline these features and argue for careful attention to them as policymakers evaluate options for reform...
Nature of conflict in the care of pediatric intensive care patients with prolonged stayDavid M Studdert
Harvard School of Public Health, Boston, MA 02115, USA
Pediatrics 112:553-8. 2003..To determine the frequency, types, sources, and predictors of conflict surrounding the care of pediatric intensive care unit (PICU) patients with prolonged stay...
Conflict in the care of patients with prolonged stay in the ICU: types, sources, and predictorsDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA
Intensive Care Med 29:1489-97. 2003..To determine types, sources, and predictors of conflicts among patients with prolonged stay in the ICU...
Defensive medicine among high-risk specialist physicians in a volatile malpractice environmentDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, Boston, Mass 02115, USA
JAMA 293:2609-17. 2005..How often physicians alter their clinical behavior because of the threat of malpractice liability, termed defensive medicine, and the consequences of those changes, are central questions in the ongoing medical malpractice reform debate...
Claims, errors, and compensation payments in medical malpractice litigationDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
N Engl J Med 354:2024-33. 2006..In the current debate over tort reform, critics of the medical malpractice system charge that frivolous litigation--claims that lack evidence of injury, substandard care, or both--is common and costly...
Disclosure of medical injury to patients: an improbable risk management strategyDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, USA
Health Aff (Millwood) 26:215-26. 2007..A policy question more pressing than whether moving toward routine disclosure will expand litigation is the question of how large such an expansion might be...
Medical monitoring for pharmaceutical injuries: tort law for the public's health?David M Studdert
Department of Health Policy and Management, Harvard School of Public Health, Boston, Mass 02115, USA
JAMA 289:889-94. 2003..Medical monitoring arms the courts with a new mechanism for addressing harms proactively rather than reactively, which could yield new victories for public health...
Charges of human immunodeficiency virus discrimination in the workplace: the Americans with Disabilities Act in actionDavid M Studdert
RAND, Santa Monica, CA, USA
Am J Epidemiol 156:219-29. 2002..The findings should help to target dissemination and support activities, designed to help workers take advantage of antidiscrimination protections, at the subgroups of workers who need them most...
Are damages caps regressive? A study of malpractice jury verdicts in CaliforniaDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, USA
Health Aff (Millwood) 23:54-67. 2004..Use of sliding scales of damages instead of or in conjunction with caps would mitigate their adverse impacts on fairness...
Enrollee appeals of preservice coverage denials at 2 Health Maintenance OrganizationsDavid M Studdert
Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA
JAMA 289:864-70. 2003..Congress and state legislatures are considering patient bills of rights that seek to strengthen opportunities for patients to have denials of coverage reconsidered by their health plans. Little is publicly known about such appeals systems...
Effects of a malpractice crisis on specialist supply and patient access to careMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
Ann Surg 242:621-8. 2005..To investigate specialist physicians' practice decisions in response to liability concerns and their perceptions of the impact of the malpractice environment on patient access to care...
Caring for patients in a malpractice crisis: physician satisfaction and quality of careMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, USA
Health Aff (Millwood) 23:42-53. 2004..First, perceptions influence behavior with respect to practice environment and clinical decision making. Second, perceptions influence the physician-patient relationship and the interpersonal quality of care...
Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsorsMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA
Account Res 12:163-91. 2005..Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements...
Beyond negligence: avoidability and medical injury compensationAllen B Kachalia
Department of Internal Medicine, Brigham and Women s Hospital, 75 Francis Street, PB 6 Administration, Boston, MA 02115, USA
Soc Sci Med 66:387-402. 2008..Importantly, all three nations are harnessing their systems' power to improve patient safety, and the avoidability standard appears to be well suited for this task...
Patterns of technical error among surgical malpractice claims: an analysis of strategies to prevent injury to surgical patientsScott E Regenbogen
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
Ann Surg 246:705-11. 2007..To identify the most prevalent patterns of technical errors in surgery, and evaluate commonly recommended interventions in light of these patterns...
Changes in physician supply and scope of practice during a malpractice crisis: evidence from PennsylvaniaMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, USA
Health Aff (Millwood) 26:w425-35. 2007..We discuss methodological issues that could explain the disparate findings regarding physician supply effects in studies using administrative data sets and survey data...
"Health courts" and accountability for patient safetyMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
Milbank Q 84:459-92. 2006....
Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claimsTejal K Gandhi
Brigham and Women's Hospital and Harvard School of Public Health, Boston, Massachusetts 02115, USA
Ann Intern Med 145:488-96. 2006..Awareness of the most common types of breakdowns and factors could help efforts to identify and prioritize strategies to prevent diagnostic errors...
Decision making and satisfaction with care in the pediatric intensive care unit: findings from a controlled clinical trialMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
Pediatr Crit Care Med 5:40-7. 2004..To facilitate critical decision making and improve satisfaction with care among families of patients in a pediatric intensive care unit...
The new medical malpractice crisisMichelle M Mello
Harvard School of Public Health, Boston, USA
N Engl J Med 348:2281-4. 2003
Hospitals' behavior in a tort crisis: observations from PennsylvaniaMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, USA
Health Aff (Millwood) 22:225-33. 2003..It concludes by connecting these trends to larger medical malpractice policy issues...
Medical malpracticeDavid M Studdert
Harvard School of Public Health, Boston, USA
N Engl J Med 350:283-92. 2004
Financial conflicts of interest in physicians' relationships with the pharmaceutical industry--self-regulation in the shadow of federal prosecutionDavid M Studdert
Harvard School of Public Health, Boston, USA
N Engl J Med 351:1891-900. 2004
Obesity--the new frontier of public health lawMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, USA
N Engl J Med 354:2601-10. 2006
Analysis of surgical errors in closed malpractice claims at 4 liability insurersSelwyn O Rogers
Brigham and Women's Hospital, Boston, Mass; Brigham and Women's Hospital and Center for Surgery and Public Health, Boston, Mass, USA
Surgery 140:25-33. 2006..001). CONCLUSIONS: Systems factors play a critical role in most surgical errors, including technical errors. Closed claims analysis can help to identify priority areas for intervening to reduce errors...
Patterns of communication breakdowns resulting in injury to surgical patientsCaprice C Greenberg
Center for Surgery and Public Health, Brigham and Women s Hospital, Boston, MA 02115, USA
J Am Coll Surg 204:533-40. 2007..Communication breakdowns are a common threat to surgical safety, but there are little data to guide initiatives to improve communication...
Claiming behaviour in a no-fault system of medical injury: a descriptive analysis of claimants and non-claimantsMarie M Bismark
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA
Med J Aust 185:203-7. 2006..Hence, substantial underclaiming occurs in both negligence and no-fault systems. The disproportionately low propensity of elderly, poor and minority patients to seek compensation also appears to be pervasive...
Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurersAllen Kachalia
Division of General Medicine, Brigham and Women s Hospital, Boston, MA, USA
Ann Emerg Med 49:196-205. 2007..Diagnostic errors in the emergency department (ED) are an important patient safety concern, but little is known about their cause. We identify types and causes of missed or delayed diagnoses in the ED...
Incidence, patterns, and prevention of wrong-site surgeryMary R Kwaan
Department of Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA
Arch Surg 141:353-7; discussion 357-8. 2006..Current site-verification protocols could have prevented only two thirds of the examined cases. Many protocols involve considerable complexity without clear added benefit...
Administrative compensation for medical injuries: lessons from three foreign systemsMichelle M Mello
Harvard School of Public Health, USA
Issue Brief (Commonw Fund) 14:1-18. 2011..American policymakers may find many of the elements of these countries' systems to be transferable to demonstration projects in the U.S...
Patients in conflict with managed care: a profile of appeals in two HMOsCarole Roan Gresenz
RAND, Arlington, Virginia, USA
Health Aff (Millwood) 21:189-96. 2002..The success rate among retrospective appeals involving emergency room services--95 percent at both plans--was particularly striking...
Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosuresAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America
PLoS Med 9:e1001280. 2012..It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author...
Analysis of errors reported by surgeons at three teaching hospitalsAtul A Gawande
Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA 02155, USA
Surgery 133:614-21. 2003....
Risk factors for retained instruments and sponges after surgeryAtul A Gawande
Departments of Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA
N Engl J Med 348:229-35. 2003..Case--control analysis of medical-malpractice claims may identify and quantify risk factors for specific types of errors...
Professional liability issues in graduate medical educationAllen Kachalia
Brigham and Women's Hospital, Boston, Mass, USA
JAMA 292:1051-6. 2004..Work hour restrictions and a growing understanding of the role of organizational factors in contributing to and preventing medical injury may increase the legal expectations imposed on GME programs...
National costs of the medical liability systemMichelle M Mello
Harvard School of Public Health, Department of Health Policy and Management, and Brigham and Women s Hospital, Boston, MA, USA
Health Aff (Millwood) 29:1569-77. 2010..Overall annual medical liability system costs, including defensive medicine, are estimated to be $55.6 billion in 2008 dollars, or 2.4 percent of total health care spending...
False Claims Act prosecution did not deter off-label drug use in the case of neurontinAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 30:2318-27. 2011....
Professional oversight of physician expert witnesses: an analysis of complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006Aaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
Ann Surg 249:168-72. 2009..The program adjudicates complaints against AANS members for their work as expert witnesses in medical malpractice litigation...
Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigationAaron S Kesselheim
Brigham and Women s Hospital and the Harvard School of Public Health, Boston, Massachusetts 02120, USA
Obstet Gynecol 108:273-9. 2006..We sought to describe characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation...
Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaintsAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, United States of America
PLoS Med 8:e1000431. 2011..However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing...
Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005Aaron S Kesselheim
Brigham and Women s Hospital, Boston, Massachusetts, USA
Ann Intern Med 149:342-9. 2008..6 billion (39%) of total recoveries. This study illuminates the scope and characteristics of qui tam fraud litigation and the whistleblowers who animate this important tool for addressing waste in the health care sector...
Using malpractice claims to identify risk factors for neurological impairment among infants following non-reassuring fetal heart rate patterns during labourAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA02120, USA
J Eval Clin Pract 16:476-83. 2010..We sought to use a novel case-selection methodology to identify antenatal or intrapartum risk factors associated with neonatal neurological impairment following non-reassuring fetal heart rate patterns during labour...
Role of professional organizations in regulating physician expert witness testimonyAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02120, USA
JAMA 298:2907-9. 2007
Academic medical centers' standards for clinical-trial agreements with industryMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
N Engl J Med 352:2202-10. 2005..We studied institutional standards regarding contractual provisions that restrict investigators' control over trials...
Cognitive errors and logistical breakdowns contributing to missed and delayed diagnoses of breast and colorectal cancers: a process analysis of closed malpractice claimsEric G Poon
Division of General Medicine and Primary Care, Department of Medicine, Brigham and Women s Hospital, 3 F 1620 Tremont Street, Boston, MA, 02120, USA
J Gen Intern Med 27:1416-23. 2012..To erform a process analysis of missed and delayed diagnoses of breast and colorectal cancers to identify: (1) the cognitive and logistical factors that lead to these diagnostic errors, and (2) prevention strategies...
The Leapfrog standards: ready to jump from marketplace to courtroom?Michelle M Mello
Harvard School of Public Health, USA
Health Aff (Millwood) 22:46-59. 2003..This undesirable potential outcome compounds the importance of selecting these standards with the utmost care...
The pharmaceutical industry versus Medicaid--limits on state initiatives to control prescription-drug costsMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, USA
N Engl J Med 350:608-13. 2004
The rise of litigation in human subjects researchMichelle M Mello
Harvard School of Public Health, Brigham and Women's Hospital, Boston, MA 02115, USA
Ann Intern Med 139:40-5. 2003....
Managing care: utilization review in action at two capitated medical groupsKanika Kapur
RAND, Santa Monica, California, USA
Health Aff (Millwood) . 2003....
Process of care failures in breast cancer diagnosisSaul N Weingart
Center for Patient Safety, Dana Farber Cancer Institute, 44 Binney St, Boston, MA, 02115, USA
J Gen Intern Med 24:702-9. 2009..Process of care failures may contribute to diagnostic errors in breast cancer care...
Will physician-level measures of clinical performance be used in medical malpractice litigation?Aaron S Kesselheim
Department of Health Policy and Management, Harvard School of Public Health, Brigham and Women s Hospital, Boston, Mass 02115, USA
JAMA 295:1831-4. 2006
The reliability of medical record review for estimating adverse event ratesEric J Thomas
Brigham and Women's Hospital and Harvard School of Public Health, Harvard University, Boston, Massachusetts 02115, USA
Ann Intern Med 136:812-6. 2002....
The McLawsuit: the fast-food industry and legal accountability for obesityMichelle M Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, USA
Health Aff (Millwood) 22:207-16. 2003..In this paper we consider the reasonableness of the claims against fast-food companies and discuss several social effects that the litigation may have irrespective of its outcome in court...
Hospital disclosure practices: results of a national surveyRae M Lamb
Radio New Zealand, Wellington
Health Aff (Millwood) 22:73-83. 2003..Reluctance to disclose preventable harms was twice as likely to occur at hospitals having major concerns about the malpractice implications of disclosure...
Administrative compensation of medical injuries: a hardy perennial blooms againPaul J Barringer
Common Good
J Health Polit Policy Law 33:725-60. 2008..We conclude by examining conditions that may facilitate or impede progress toward establishing demonstration projects of health courts...
The rise of nursing home litigation: findings from a national survey of attorneysDavid G Stevenson
Harvard University, USA
Health Aff (Millwood) 22:219-29. 2003..These findings elevate concerns about quality of nursing home care and indicate that litigation diverts resources from resident care, which may fuel quality problems...
Reduced medicolegal risk by compliance with obstetric clinical pathways: a case--control studyScott B Ransom
Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Bloomfield Hills, Michigan 48301, USA
Obstet Gynecol 101:751-5. 2003....
Results of a clinical trial on care improvement for the critically illJeffrey P Burns
Department of Anesthesia, Harvard Medical School and Children's Hospital, Boston, MA. USA
Crit Care Med 31:2107-17. 2003..The lessons learned from the experience with this intervention should be helpful in ongoing efforts to improve care and to achieve outcomes desired by critically ill patients, their families, and critical care clinicians...
Impact of the National Practitioner Data Bank on resolution of malpractice claimsTeresa M Waters
Center for Health Services Research, Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA
Inquiry 40:283-94. 2003..Because this disruption appears to have decreased the proportion of questionable claims receiving compensation, the NPDB actually may have increased overall tort system specificity...
Disputes over coverage of emergency department services: a study of two health maintenance organizationsCarole Roan Gresenz
RAND Corporation, Arlington, VA 22202, USA
Ann Emerg Med 43:155-62. 2004..We describe the characteristics and outcomes of enrollee-health plan disputes over insurance coverage for emergency department (ED) services at 2 large health maintenance organizations (HMOs) that apply the prudent layperson standard...
Physician responses to the malpractice crisis: from defense to offenseAllen Kachalia
Division of General Medicine, Brigham and Women's Hospital, USA
J Law Med Ethics 33:416-28. 2005
Medical errors involving trainees: a study of closed malpractice claims from 5 insurersHardeep Singh
Health Policy and Quality Program, Houston Center for Quality of Care and Utilization Studies, Houston, Texas, USA
Arch Intern Med 167:2030-6. 2007..To describe the characteristics of and factors contributing to trainee errors, we analyzed malpractice claims in which trainees were judged to have played an important role in harmful errors...
Clinical trials registries: a reform that is past dueJennifer L Gold
University of Toronto Faculty of Law
J Law Med Ethics 33:811-20. 2005
A quiet revolution: law as an agent of health system changeM Gregg Bloche
Georgetown University, Washington, DC, USA
Health Aff (Millwood) 23:29-42. 2004..We conclude with four lessons about law's role in the health sphere-lessons that stress the power of legal conflict to shape perceptions and to thereby change behavior before legal change occurs...
Can liability rules keep pace with best practice? The case of multidisciplinary cancer careDavid M Studdert
Med J Aust 188:380-1. 2008
