Current Projects

Design of a Reliable System of Medical Justice Project

Principal Investigator: Michelle Mello

Sponsor: Robert Wood Johnson Foundation.  Supplemental funding was received from The Commonwealth Fund and the Harvard Interfaculty Program on Health Systems Improvement.

Summary: The goal of this study is to provide research to support demonstration projects of an administrative compensation system for medical injury, called “health courts”. The project is investigating issues such as compensation criteria, costs, appropriate damages, constitutionality, and relationship of the system to patient safety. The study is being conducted in partnership with the Washington-based legal reform organization Common Good, whose role is to disseminate research findings and build political consensus in favor of policy experiments with health courts.

Papers:

Siegal G, Mello MM, Studdert DM. Adjudicating severe birth injury claims in Florida and Virginia: The experience of a landmark experiment in personal injury compensation. Am J Law Med 2008;34:489-533. Read It

Mello MM, Studdert DM, Moran P, Dauer EA. Policy experimentation with administrative compensation for medical injury: issues under state constitutional law.  Harvard J Legis 2008;45:59-106.  Read it

Mello MM, Studdert DM, Kachalia A, Brennan TA.  “Health courts” and accountability for patient safety.  Milbank Q 2006;84:459-492.  Read it

Kachalia AB, Studdert DM, Brennan TA, Mello MM.  Beyond negligence: avoidability and medical injury compensation. Soc Sci Med 2008;66:387-402.  Read it

Barringer PJ, Studdert DM, Kachalia A, Mello MM. Administrative compensation of medical injuries: a hardy perennial blooms again. J Health Polit Pol’y Law 2008;33(4):725-760.  Read it

Mello MM, Kachalia A, Studdert DM. Administrative compensation for medical injuries: lessons from three foreign systems (New York: Commonwealth Fund, 2011).  Read it

Studdert DM, Kachalia AB, Salomon JA, Mello MM. Rationalizing noneconomic damages: a health-utilities approach. Law & Contemp Prob 2011;74:57-101.   Read it

Work in Progress:

Ongoing work on this project is addressing how much a health court system would cost, compared to the tort system.

Materials for Policymakers:

The project has developed a policymaker’s guide to the health courts proposal and other informational materials for policymakers, liability insurers, and health care provider organizations interested in working on implementing demonstration projects of health courts.

Blogs and Podcasts:

The Robert Wood Johnson Foundation has hosted a blog regarding this project; read it and contribute comments here.

For a brief summary of the project, listen to the HSPH podcast here. 

Project Report:

The Robert Wood Johnson Foundation has a summary of the project and its results here.

Responding Justly to Patients Harmed by Medical Care: Disclosure, Compensation, and Litigation

Principal Investigators: Michelle Mello and Thomas Gallagher

Sponsor: Robert Wood Johnson Foundation Investigator Awards in Health Policy Research

Summary: The Institute of Medicine’s 2000 report, To Err Is Human, and the widespread media attention it received, dramatically increased awareness of the extent of medical mistakes in U.S. hospitals. Since then, a number of states and national quality organizations have adopted policies requiring or encouraging medical professionals to tell patients and families when unanticipated “adverse events” occur.  Some organizations and insurers have gone even further by adopting programs through which disclosures of adverse events are accompanied by offers of compensation (known as disclosure-and-offer programs).  Still, prompt disclosure of medical errors and fair compensation remain the exception rather than the rule.  The major goal of this project is to more fully understand the effects of disclosure initiatives and innovative disclosure-and-offer programs on malpractice costs and patients’ access to compensation.  The work is exploring how policy levers can be used to make disclosing medical injuries more routine and evaluating the design and effectiveness of disclosure-and-offer programs.

Publications:

Gallagher TH, Bell SK, Smith KM, Mello MM, McDonald TB. Disclosing harmful errors to patients: tackling three tough cases. Chest 2009;136:897-903.

Mello MM, Gallagher TH. Malpractice reform—opportunities for leadership by healthcare institutions and liability insurers. N Engl J Med 2010. Read it 

Mastroianni A, Mello MM, Gallagher TH. State laws promoting disclosure and apology to patients after unanticipated outcomes: a critical appraisal. 2009 (under peer review).

Work in Progress:  This project began in June 2008.  The current phase of the project is focusing on analysis of the design and structure of disclosure-and-offer programs and the strengths and weaknesses of mandatory disclosure and apology laws.

State Policy Approaches to Foster Uptake of the Human Papillomavirus Vaccine

Principal Investigator: Michelle Mello

Sponsor: Robert Wood Johnson Foundation.

Summary: The major goal of this project is to study the legal and policy approaches that states are taking to fostering uptake of the HPV vaccine. The project is analyzing HPV vaccination as a case example of the use of laws and policies to promote public health, examining its insights for the goal of making public health laws legitimate, evidence-based, effective, and respectful of potential burdens on individuals.  The research methodology includes legal and policy research and key informant interviews with policy makers and stakeholders in 6 states.

Publications: Colgrove J, Abiola S, Mello MM. School mandates for HPV vaccination—public health law making amid political and scientific controversy. N Engl J Med 2010;363(8):785-791.  Read it.

Work in Progress:  Work is ongoing on additional articles, expected to be available in 2011.

Ethical Issues in the Pharmaceutical Industry

Principal Investigator: Michelle Mello

Sponsor: Greenwall Foundation – Faculty Scholars Program

Summary: This project is examining a series of legal and ethical challenges confronting the pharmaceutical, including issues of drug safety, disclosure of clinical trial data, drug pricing and access, product liability, obligations to human subjects in clinical trials, and relationships with academic researchers.

Papers: 

Brennan TA, Mello MM. Sunshine laws and the pharmaceutical industry. JAMA 2007;297:1255-1257.

Mello MM.Rationalizing vaccine injury compensation. Bioethics 2008;822(1):32-42.

Kesselheim AS, Mello MM.  Confidentiality laws and secrecy in medical research: improving access to data on drug safety.  Health Aff 2007;26:483-491.

Mello MM, Joffe S. Compact versus contract: an ethical and legal analysis of industry sponsors’ obligations to research subjects. N Engl J Med 2007;356:2737-2743.  Read it

Miller FG, Mello MM, Joffe S. Incidental findings in human research: what do investigators owe research participants? J Law Med Ethics 2008;36(2):271-279.

Mello MM, Studdert DM, Brennan TA. Shifting terrain in the regulation of off-label promotion of pharmaceuticals. N Engl J Med 2009;360(15): 1557-1566. Read it

Malpractice Insurers Medical Error Prevention Study

Principal Investigator: David Studdert

Sponsor: Agency for Healthcare Research and Quality

Summary: The major goals of this study are to harness the potential of malpractice insurance programs to operate as a nationwide medical error reporting system; to identify the most frequent factors contributing to errors found in a review of malpractice claims files; and to use claims data to facilitate design and implementation of a series of targeted patient safety interventions in hospitals.

Papers:

Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. A case-control study of the retention of instruments and sponges after surgery. N Engl J Med 2003;348:229-235

Kwaan M, Studdert DM, Zinner M, Gawande AA. Incidence, patterns, and prevention of wrong-site surgery. Arch Surg, 2006:141:353-357.

Rogers SO, Gawande AA, Kwaan M, Puopolo AL, Yoon C, Brennan TA, Studdert DM. Analysis of surgical errors in closed malpractice claims at four insurers. Surgery 2006;140:25-33.

Studdert DM, Mello MM, Gawande AA, Gandhi TK, Kachalia A, Yoon C, Puopolo AL, Brennan TA. Accuracy of the medical malpractice system: relationship between claims, errors, and outcomes of litigation. N Engl J Med 2006;354:2024-33.  Read it

Gandhi TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon C, Brennan TA, Studdert DM. Missed and delayed diagnoses in the ambulatory setting. Ann Intern Med 2006;145-488-496.

Kachalia A, Gandhi TK, Gawande AA, Puopolo AL, Yoon C, Poon E, Thomas EJ, Brennan TA, Studdert DM. Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims for 4 liability insurers. Ann Emerg Med 2007;49:196-205.

Greenberg CC, Regenbogen SE, Studdert DM, Lipsitz SR, Rogers SO, Zinner MJ,  Gawande AA. Patterns of communication breakdowns resulting in injury to surgical patients. J Am Coll Surg 2007;:533-40.

Studdert DM, Mello MM. When tort resolutions are “wrong”: predictors of discordant outcomes in medical malpractice litigation. J Leg Stud 2007 (in press).  Read it

Mello MM, Studdert DM. Deconstructing negligence: the role of individual and system factors in causing medical injuries. Georgetown Law J 2008;96:599-623.  Read it