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 (in press).
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
Work in Progress:
Ongoing work on this project is addressing two questions:
1. How much would a health court system cost, compared to the tort system?
2. How could a fair and rational framework for scheduling noneconomic damages be created?
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. These are available on the Common Good website.
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.
Legislative Activity:
Common Good maintains a list of state and federal legislative initiatives cueing off the health courts proposal.
Public Forums:
Transcripts and other materials from public forums on health courts convened by Common Good and the HSPH study team are available here, here , and 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.
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 will (1) identify successful and less
successful state HPV vaccination policies in order to generate "best practices"
and (2) analyze HPV vaccination as a case example of the use of laws and
policies to promote public health, analyzing 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.
Work in Progress: This project began in December 2007 and is currently in the data collection phase.
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 200;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
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