Michelle Mello is a leading empirical health law scholar whose research is focused on understanding the effects of law and regulation on health care delivery and population health outcomes. She is the author of more than 180 articles and book chapters on the medical malpractice system, medical errors and patient safety, public health law, regulation pf pharmaceuticals, biomedical research ethics and governance, obesity policy, and other topics. The recipient of a number of awards for her research, she was elected to the National Academy of Medicine at the age of 40.
From 2000 to 2014, Dr. Mello was a professor at the Harvard School of Public Health, where she directed the School’s Program in Law and Public Health. She has also served as a Lab Fellow at Harvard University’s Edmond J. Safra Center for Ethics.
Dr. Mello teaches courses in torts and public health law. She holds a J.D. from the Yale Law School, a Ph.D. in Health Policy and Administration from the University of North Carolina at Chapel Hill, an M.Phil. from Oxford University, where she was a Marshall Scholar, and a B.A. from Stanford University.
Boards, Advisory Committees, Professional Organizations
Board of Directors, ChangeLab Solutions (2016 - Present)
Affiliated Faculty, Meta-Research Innovation Center at Stanford (METRICS) (2014 - Present)
M.Phil., University of Oxford (UK), Comparative Social Research (1995)
Ph.D., University of North Carolina at Chapel Hill, Health Policy and Administration (1999)
J.D., Yale Law School, Law (2000)
- Disclosing Prescription-Drug Prices in Advertisements - Legal and Public Health Issues. The New England journal of medicine 2018
Effects Of A Communication-And-Resolution Program On Hospitals' Malpractice Claims And Costs.
Health affairs (Project Hope)
2018; 37 (11): 1836–44
To promote communication with patients after medical injuries and improve patient safety, numerous hospitals have implemented communication-and-resolution programs (CRPs). Through these programs, hospitals communicate transparently with patients after adverse events; investigate what happened and offer an explanation; and, when warranted, apologize, take responsibility, and proactively offer compensation. Despite growing consensus that CRPs are the right thing to do, concerns over liability risks remain. We evaluated the liability effects of CRP implementation at four Massachusetts hospitals by examining before-and-after trends in claims volume, cost, and time to resolution and comparing them to trends among nonimplementing peer institutions. CRP implementation was associated with improved trends in the rate of new claims and legal defense costs at some hospitals, but it did not significantly alter trends in other outcomes. None of the hospitals experienced worsening liability trends after CRP implementation, which suggests that transparency, apology, and proactive compensation can be pursued without adverse financial consequences.
View details for DOI 10.1377/hlthaff.2018.0720
View details for PubMedID 30395501
Can Communication-And-Resolution Programs Achieve Their Potential? Five Key Questions.
Health affairs (Project Hope)
2018; 37 (11): 1845–52
Communication-and-resolution programs (CRPs) are intended to promote accountability, transparency, and learning after adverse events. In this article we address five key challenges to the programs' future success: implementation fidelity, the evidence base for CRPs and their link to patient safety, fair compensation of harmed patients, alignment of CRP design with participants' needs, and public policy on CRPs. While the field has arrived at an understanding of the core communication-and-resolution practices, limited adherence fuels skepticism that programs are meeting the needs of patients and families who have been injured by care or improving patient safety. Adherence to communication-and-resolution practices could be enhanced by adopting measures of CRP quality and implementing programs in a comprehensive, principled, and systematic manner. Of particular importance is offering fair compensation to patients in CRPs and supporting their right to attorney representation. There is evidence that the use of CRPs reduces liability costs, but research on other outcomes is limited. Additional research is especially needed on the links between CRPs and quality and on the programs' alignment with patients' and families' needs. By honoring principles of transparency, quality improvement, and patient and family empowerment, organizations can use their CRPs to help revitalize the medical profession.
View details for DOI 10.1377/hlthaff.2018.0727
View details for PubMedID 30395493
- Behind Schedule - Reconciling Federal and State Marijuana Policy. The New England journal of medicine 2018
Clinical Trial Participants' Views of the Risks and Benefits of Data Sharing
NEW ENGLAND JOURNAL OF MEDICINE
2018; 378 (23): 2202–11
Background Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants' perceptions of the risks of data sharing. Methods We conducted a structured survey of 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. Surveys were distributed by mail (350 completed surveys) and in clinic waiting rooms (421 completed surveys) (overall response rate, 79%). Results Less than 8% of respondents felt that the potential negative consequences of data sharing outweighed the benefits. A total of 93% were very or somewhat likely to allow their own data to be shared with university scientists, and 82% were very or somewhat likely to share with scientists in for-profit companies. Willingness to share data did not vary appreciably with the purpose for which the data would be used, with the exception that fewer participants were willing to share their data for use in litigation. The respondents' greatest concerns were that data sharing might make others less willing to enroll in clinical trials (37% very or somewhat concerned), that data would be used for marketing purposes (34%), or that data could be stolen (30%). Less concern was expressed about discrimination (22%) and exploitation of data for profit (20%). Conclusions In our study, few clinical trial participants had strong concerns about the risks of data sharing. Provided that adequate security safeguards were in place, most participants were willing to share their data for a wide range of uses. (Funded by the Greenwall Foundation.).
View details for DOI 10.1056/NEJMsa1713258
View details for Web of Science ID 000434263000008
View details for PubMedID 29874542
- HIPAA and Protecting Health Information in the 21st Century. JAMA 2018
- Ethics of randomized trials in a public health emergency PLOS NEGLECTED TROPICAL DISEASES 2018; 12 (5): e0006313
- Commentary: How Should Hospitals Respond to Surgeons' Requests to Schedule Overlapping Surgeries? Neurosurgery 2018; 82 (4): E91–E98
- Avoiding Malpractice Suits: The Authors Reply HEALTH AFFAIRS 2018; 37 (4): 676
- What Patients Expect and Deserve Reply JAMA INTERNAL MEDICINE 2018; 178 (4): 578-+
Legal Barriers to the Growth of Health Information ExchangeBoulders or Pebbles?
2018; 96 (1): 110–43
Policy Points: Historically, in addition to economic and technical hurdles, state and federal health information privacy laws have been cited as a significant obstacle to expanding electronic health information exchange (HIE) in the United States. Our review finds that over the past decade, several helpful developments have ameliorated the legal barriers to HIE, although variation in states' patient consent requirements remains a challenge. Today, health care providers' complaints about legal obstacles to HIE may be better understood as reflecting concerns about the economic and competitive risks of information sharing.Although the clinical benefits of exchanging patients' health information electronically across providers have long been recognized, participation in health information exchange (HIE) has lagged behind adoption of electronic health records. Barriers erected by federal and state health information privacy law have been cited as a leading reason for the slow progress. A comprehensive assessment of these issues has not been undertaken for nearly a decade, despite a number of salient legal developments.Analysis of federal and state health information privacy statutes and regulations and secondary materials.Although some legal barriers to HIE persist, many have been ameliorated-in some cases, simply through improved understanding of what the law actually requires. It is now clear that the Health Insurance Portability and Accountability Act presents no obstacles to electronically sharing protected health information for treatment purposes and does not hold providers who properly disclose information liable for privacy breaches by recipients. The failure of federal efforts to establish a unique patient identifier number does slow HIE by inhibiting optimal matching of patient records, but other action to facilitate matching will be taken under the 21st Century Cures Act. The Cures Act also creates the legal architecture to begin to combat "information blocking." Varying patient consent requirements under federal and state law are the most important remaining legal barrier to HIE progress. However, federal rules relating to disclosure of substance-abuse treatment information were recently liberalized, and development of a technical standard, Data Segmentation for Privacy, or DS4P, now permits sensitive data requiring special handling to be segmented within a patient's record. Even with these developments, state-law requirements for patient consent remain daunting to navigate.Although patient consent requirements make HIE challenging, providers' expressed worries about legal barriers to participating in HIE likely primarily reflect concerns that are economically motivated. Lowering the cost of HIE or increasing financial incentives may boost provider participation more than further reducing legal barriers.
View details for DOI 10.1111/1468-0009.12313
View details for Web of Science ID 000426657500009
View details for PubMedID 29504197
View details for PubMedCentralID PMC5835678
- Vaccination without Litigation - Addressing Religious Objections to Hospital Influenza-Vaccination Mandates NEW ENGLAND JOURNAL OF MEDICINE 2018; 378 (9): 785–88
What Makes Ensuring Access to Affordable Prescription Drugs the Hardest Problem in Health Policy?
MINNESOTA LAW REVIEW
2018; 102 (6): 2273–2305
View details for Web of Science ID 000442543500001
Beyond financial conflicts of interest: Institutional oversight of faculty consulting agreements at schools of medicine and public health.
2018; 13 (10): e0203179
IMPORTANCE: Approximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown.OBJECTIVE: To investigate the nature of institutional oversight of faculty consulting contracts at U.S. schools of medicine and public health.DESIGN: Structured telephone interviews with institutional administrators. Questions included the nature of oversight for faculty consulting agreements, if any, and views about consulting as a private versus institutional matter. Interviews were analyzed using a structured coding scheme.SETTING: All accredited schools of medicine and public health in the U.S.PARTICIPANTS: Administrators responsible for faculty affairs were identified via internet searches and telephone and email follow-up. The 118 administrators interviewed represented 73% of U.S. schools of medicine and public health, and 75% of those invited to participate.INTERVENTION: Structured, 15-30 minute telephone interviews.MAIN OUTCOMES AND MEASURES: Prevalence and type of institutional oversight; responses to concerning provisions in consulting agreements; perceptions of institutional oversight.RESULTS: One third of institutions (36%) required faculty to submit at least some agreements for institutional review and 36% reviewed contracts upon request, while 35% refused to review contracts. Among institutions with review, there was wide variation the issues covered. The most common topic was intellectual property rights (64%), while only 23% looked at publication rights and 19% for inappropriately broad confidentiality provisions. Six in ten administrators reported they had no power to prevent faculty from signing consulting agreements. Although most respondents identified institutional risks from consulting relationships, many maintained that consulting agreements are "private."CONCLUSIONS AND RELEVANCE: Oversight of faculty consulting agreements at U.S. schools of medicine and public health is inconsistent across institutions and usually not robust. The interests at stake suggest the need for stronger oversight.
View details for DOI 10.1371/journal.pone.0203179
View details for PubMedID 30372431
Four States With Robust Prescription Drug Monitoring Programs Reduced Opioid Dosages.
Health affairs (Project Hope)
2018; 37 (6): 964–74
State prescription drug monitoring programs (PDMPs) aim to reduce risky controlled-substance prescribing, but early programs had limited impact. Several states implemented robust features in 2012-13, such as mandates that prescribers register with the program and regularly check its registry database. Some states allow prescribers to fulfill the latter requirement by designating delegates to check the registry. The effects of robust PDMP features have not been fully assessed. We used commercial claims data to examine the effects of implementing robust PDMPs in four states on overall and high-risk opioid prescribing, comparing those results to trends in similar states without robust PDMPs. By the end of 2014 the absolute mean morphine-equivalent dosages that providers dispensed declined in a range of 6-77mg per person per quarter in the four states, relative to comparison states. Only in one of the four states, Kentucky, did the percentage of people who filled opioid prescriptions decline versus its comparator state, with an absolute reduction of 1.6percent by the end of 2014. Robust PDMPs may be able to significantly reduce opioid dosages dispensed, percentages of patients receiving opioids, and high-risk prescribing.
View details for DOI 10.1377/hlthaff.2017.1321
View details for PubMedID 29863921
- Length of Stay After Overlapping Surgery Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 2017; 318 (21): 2140–41
- The Evolving Story of Overlapping Surgery JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 2017; 318 (3): 233–34
- Medical Liability - Prospects for Federal Reform NEW ENGLAND JOURNAL OF MEDICINE 2017; 376 (19): 1806-1808
Relationship Between State Malpractice Environment and Quality of Health Care in the United States.
Joint Commission journal on quality and patient safety
2017; 43 (5): 241-250
One major intent of the medical malpractice system in the United States is to deter negligent care and to create incentives for delivering high-quality health care. A study was conducted to assess whether state-level measures of malpractice risk were associated with hospital quality and patient safety.In an observational study of short-term, acute-care general hospitals in the United States that publicly reported in the Centers for Medicaid & Medicare Services Hospital Compare in 2011, hierarchical regression models were used to estimate associations between state-specific malpractice environment measures (rates of paid claims, average Medicare Malpractice Geographic Practice Cost Index [MGPCI], absence of tort reform laws, and a composite measure) and measures of hospital quality (processes of care, imaging utilization, 30-day mortality and readmission, Agency for Healthcare Research and Quality Patient Safety Indicators, and patient experience from the Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]).No consistent association between malpractice environment and hospital process-of-care measures was found. Hospitals in areas with a higher MGPCI were associated with lower adjusted odds of magnetic resonance imaging overutilization for lower back pain but greater adjusted odds of overutilization of cardiac stress testing and brain/sinus computed tomography (CT) scans. The MGPCI was negatively associated with 30-day mortality measures but positively associated with 30-day readmission measures. Measures of malpractice risk were also negatively associated with HCAHPS measures of patient experience.Overall, little evidence was found that greater malpractice risk improves adherence to recommended clinical standards of care, but some evidence was found that malpractice risk may encourage defensive medicine.
View details for DOI 10.1016/j.jcjq.2017.02.004
View details for PubMedID 28434458
Improving reconciliation following medical injury: a qualitative study of responses to patient safety incidents in New Zealand.
BMJ quality & safety
Despite the investment in exploring patient-centred alternatives to medical malpractice in New Zealand (NZ), the UK and the USA, patients' experiences with these processes are not well understood. We sought to explore factors that facilitate and impede reconciliation following patient safety incidents and identify recommendations for strengthening institution-led alternatives to malpractice litigation.We conducted semistructured interviews with 62 patients injured by healthcare in NZ, administrators of 12 public hospitals, 5 lawyers specialising in Accident Compensation Corporation (ACC) claims and 3 ACC staff. NZ was chosen as the research site because it has replaced medical malpractice litigation with a no-fault scheme. Thematic analysis was used to identify key themes from interview transcripts.Interview responses converged on five elements of the reconciliation process that were important: (1) ask, rather than assume, what patients and families need from the process and recognise that, for many patients, being heard is important and should occur early in the reconciliation process; (2) support timely, sincere, culturally appropriate and meaningful apologies, avoiding forced or tokenistic quasi-apologies; (3) choose words that promote reconciliation; (4) include the people who patients want involved in the reconciliation discussion, including practitioners involved in the harm event; and (5) engage the support of lawyers and patient relations staff as appropriate.Policymakers and healthcare institutions are keenly interested in non-litigation approaches to resolving malpractice incidents. Interviewing participants involved in patient safety incident reconciliation processes suggests that healthcare institutions should not view apology as a substitute for other remedial actions; use flexible guidelines that distil best-practice principles, ensuring that steps are not missed, while not prescribing a 'one size fits all' communication approach.
View details for DOI 10.1136/bmjqs-2016-005804
View details for PubMedID 28280075
Public Awareness of and Contact With Physicians Who Receive Industry Payments: A National Survey.
Journal of general internal medicine
The Physician Payments Sunshine Act, part of the Affordable Care Act, requires pharmaceutical and medical device firms to report payments they make to physicians and, through its Open Payments program, makes this information publicly available.To establish estimates of the exposure of the American patient population to physicians who accept industry payments, to compare these population-based estimates to physician-based estimates of industry contact, and to investigate Americans' awareness of industry payments.Cross-sectional survey conducted in late September and early October 2014, with data linkage of respondents' physicians to Open Payments data.A total of 3542 adults drawn from a large, nationally representative household panel.Respondents' contact with physicians reported in Open Payments to have received industry payments; respondents' awareness that physicians receive payments from industry and that payment information is publicly available; respondents' knowledge of whether their own physician received industry payments.Among the 1987 respondents who could be matched to a specific physician, 65% saw a physician who had received an industry payment during the previous 12 months. This population-based estimate of exposure to industry contact is much higher than physician-based estimates from the same period, which indicate that 41% of physicians received an industry payment. Across the six most frequently visited specialties, patient contact with physicians who had received an industry payment ranged from 60 to 85%; the percentage of physicians with industry contact in these specialties was much lower (35-56%). Only 12% of survey respondents knew that payment information was publicly available, and only 5% knew whether their own doctor had received payments.Patients' contact with physicians who receive industry payments is more prevalent than physician-based measures of industry contact would suggest. Very few Americans know whether their own doctor has received industry payments or are aware that payment information is publicly available.
View details for DOI 10.1007/s11606-017-4012-3
View details for PubMedID 28265803
- Association of Unsolicited Patient Observations With the Quality of a Surgeon's Care. JAMA surgery 2017
Testing the Immunity of the Firearm Industry to Tort Litigation
JAMA INTERNAL MEDICINE
2017; 177 (1): 102-105
In the absence of congressional action to reinstate the federal ban on assault weapons, tort litigation offers an alternative strategy for regulating what have become the weapons of choice in mass shootings. However, opportunities to bring successful claims are limited. To prevail, plaintiffs must show that their suit fits within exceptions to the broad immunity from tort actions that Congress gave the firearm industry in the 2005 Protection of Lawful Commerce in Arms Act. In one particularly high-profile lawsuit, families of victims of the school shooting in Newtown, Connecticut, in 2012 sued the makers and sellers of the military-style rifle used in the attack, alleging negligence and deceptive marketing. The trial court dismissed the case on October 14, 2016, but the plaintiffs plan to appeal. We review the history of tort litigation against the firearm industry, outline the Newtown families' claims, and describe the decision.
View details for DOI 10.1001/jamainternmed.2016.7043
View details for Web of Science ID 000392196200023
View details for PubMedID 27842188
- Relationship between state malpractice environment and quality of health care in the United States Jt Comm J Qual Patient Saf 2017; 43 (5): 241-250
Outcomes In Two Massachusetts Hospital Systems Give Reason For Optimism About Communication-And-Resolution Programs.
Health affairs (Project Hope)
2017; 36 (10): 1795–1803
Through communication-and-resolution programs, hospitals and liability insurers communicate with patients when adverse events occur; investigate and explain what happened; and, where appropriate, apologize and proactively offer compensation. Using data recorded by program staff members and from surveys of involved clinicians, we examined case outcomes of a program used by two academic medical centers and two of their community hospitals in Massachusetts in the period 2013-15. The hospitals demonstrated good adherence to the program protocol. Ninety-one percent of the program events did not meet compensation eligibility criteria, and those events that did were not costly to resolve (the median payment was $75,000). Only 5 percent of events led to malpractice claims or lawsuits. Clinicians were supportive of the program but desired better communication about it from staff members. Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively.
View details for DOI 10.1377/hlthaff.2017.0320
View details for PubMedID 28971925
Patients' Experiences With Communication-and-Resolution Programs After Medical Injury.
JAMA internal medicine
2017; 177 (11): 1595–1603
Dissatisfaction with medical malpractice litigation has stimulated interest by health care organizations in developing alternatives to meet patients' needs after medical injury. In communication-and-resolution programs (CRPs), hospitals and liability insurers communicate with patients about adverse events, use investigation findings to improve patient safety, and offer compensation when substandard care caused harm. Despite increasing interest in this approach, little is known about patients' and family members' experiences with CRPs.To explore the experiences of patients and family members with medical injuries and CRPs to understand different aspects of institutional responses to injury that promoted and impeded reconciliation.From January 6 through June 30, 2016, semistructured interviews were conducted with patients (n = 27), family members (n = 3), and staff (n = 10) at 3 US hospitals that operate CRPs. Patients and families were eligible for participation if they experienced a CRP, spoke English, and could no longer file a malpractice claim because they had accepted a settlement or the statute of limitations had expired. The CRP administrators identified hospital and insurer staff who had been involved in a CRP event and had a close relationship with the injured patient and/or family. They identified patients and families by applying the inclusion criteria to their CRP databases. Of 66 possible participants, 40 interviews (61%) were completed, including 30 of 50 invited patients and families (60%) and 10 of 16 invited staff (63%).Patients' reported satisfaction with disclosure and reconciliation efforts made by hospitals.A total of 40 participants completed interviews (15 men and 25 women; mean [range] age, 46 [18-67] years). Among the 30 patients and family members interviewed, 27 patients experienced injuries attributed to error and received compensation. The CRP experience was positive overall for 18 of the 30 patients and family members, and 18 patients continued to receive care at the hospital. Satisfaction was highest when communications were empathetic and nonadversarial, including compensation negotiations. Patients and families expressed a strong need to be heard and expected the attending physician to listen without interrupting during conversations about the event. Thirty-five of the 40 respondents believed that including plaintiffs' attorneys in these discussions was helpful. Sixteen of the 30 patients and family members deemed their compensation to be adequate but 17 reported that the offer was not sufficiently proactive. Patients and families strongly desired to know what the hospital did to prevent recurrences of the event, but 24 of 30 reported receiving no information about safety improvement efforts.As hospitals strive to provide more patient-centered care, opportunities exist to improve institutional responses to injuries and promote reconciliation.
View details for DOI 10.1001/jamainternmed.2017.4002
View details for PubMedID 29052704
View details for PubMedCentralID PMC5710270
- In search of global governance for research in epidemics. Lancet (London, England) 2017; 390 (10103): 1632–33
- Drug Companies' Liability for the Opioid Epidemic. The New England journal of medicine 2017; 377 (24): 2301–5
Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.
2017; 7 (12): e017917
To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers.Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level.The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries.Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress.
View details for DOI 10.1136/bmjopen-2017-017917
View details for PubMedID 29208616
View details for PubMedCentralID PMC5728266
- The evolving story of overlapping surgery JAMA 2017; 318 (3): 233-234
Collaboration with Regulators to Support Quality and Accountability Following Medical Errors: The Communication and Resolution Program Certification Pilot
HEALTH SERVICES RESEARCH
2016; 51: 2569-2582
Communication and resolution programs (CRPs) involve institutions responding to adverse events using transparency with patients, event analysis, recurrence prevention, and compensation. Collaboration with regulators around CRPs could enhance health care quality.Health care institutions, liability insurers, and the Medical Quality Assurance Commission (MQAC, board of medicine) in Washington State.MQAC has collaborated with the Foundation for Health Care Quality (FHCQ) on the CRP Certification pilot. A panel of physicians, risk managers, and patient advocates at FHCQ will review cases for use of the CRP key elements. Cases meeting this standard will be "CRP Certified." If MQAC determines that the CRP enhanced patient safety comparable or better than board action, the Commission may close the case.Developing this process identified the following issues: (1) protecting information submitted for CRP Certification; (2) determining what information the Commission needs to assess whether additional investigation is warranted; (3) preserving the Commission's responsibility to protect the public while working with health care organizations; and (4) addressing concerns that CRP Certification not shield incompetent providers.The CRP Certification program is a promising example of collaboration among institutions, insurers, and regulators to promote patient-centered accountability and learning following adverse events.
View details for DOI 10.1111/1475-6773.12557
View details for Web of Science ID 000389146300011
View details for PubMedID 27601424
Challenges of Implementing a Communication-and-Resolution Program Where Multiple Organizations Must Cooperate.
Health services research
To implement a communication-and-resolution program (CRP) in a setting in which liability insurers and health care facilities must collaborate to resolve incidents involving a facility and separately insured clinicians.Six hospitals and clinics and a liability insurer in Washington State.Sites designed and implemented CRPs and contributed information about cases and operational challenges over 20 months. Data were qualitatively analyzed.Data from interviews with personnel responsible for CRP implementation were triangulated with data on program cases collected by sites and notes recorded during meetings with sites and among project team members.Sites experienced small victories in resolving particular cases and streamlining some working relationships, but they were unable to successfully implement a collaborative CRP. Barriers included the insurer's distance from the point of care, passive rather than active support from top leaders, coordinating across departments and organizations, workload, nonparticipation by some physicians, and overcoming distrust.Operating CRPs where multiple organizations must collaborate can be highly challenging. Success likely requires several preconditions, including preexisting trust among organizations, active leadership engagement, physicians' commitment to participate, mechanisms for quickly transmitting information to insurers, tolerance for missteps, and clear protocols for joint investigations and resolutions.
View details for DOI 10.1111/1475-6773.12580
View details for PubMedID 27807858
Case Outcomes in a Communication-and-Resolution Program in New York Hospitals.
Health services research
To determine case outcomes in a communication-and-resolution program (CRP) implemented to respond to adverse events in general surgery.Five acute-care hospitals in New York City.Following CRP implementation, hospitals recorded information about each CRP event for 22 months.Risk managers prospectively collected data in collaboration with representatives from the hospital's insurer. External researchers administered an online satisfaction survey to clinicians involved in CRP events.Among 125 CRP cases, disclosure conversations were carried out in 92 percent, explanations were conveyed in 88 percent, and apologies were offered in 72.8 percent. Three quarters of events did not involve substandard care. Compensation offers beyond bill waivers were deemed appropriate in 9 of 30 of cases in which substandard care caused harm and communicated in six such cases. In 44 percent of cases, hospitals identified steps that could be taken to improve safety. Clinicians had low awareness of the workings of the CRP, but high satisfaction with their experiences.The bulk of CRPs' work is in investigating and communicating about events not caused by substandard care. These CRPs were quite successful in handling such events, but less consistent in offering compensation in cases involving substandard care.
View details for DOI 10.1111/1475-6773.12594
View details for PubMedID 27781266
Association Between State Medical Malpractice Environment and Surgical Quality and Cost in the United States
ANNALS OF SURGERY
2016; 263 (6): 1126-1132
The US medical malpractice system is designed to deter negligence and encourage quality of care through threat of liability.To examine whether state-level malpractice environment is associated with outcomes and costs of colorectal surgery.Observational study of 116,977 Medicare fee-for-service beneficiaries who underwent colorectal surgery using administrative claims data. State-level malpractice risk was measured using mean general surgery malpractice insurance premiums; paid claims per surgeon; state tort reforms; and a composite measure. Associations between malpractice environment and postoperative outcomes and price-standardized Medicare payments were estimated using hierarchical logistic regression and generalized linear models.thirty-day postoperative mortality; complications (pneumonia, myocardial infarction, venous thromboembolism, acute renal failure, surgical site infection, postoperative sepsis, any complication); readmission; total price-standardized Medicare payments for index hospitalization and 30-day postdischarge episode-of-care.Few associations between measures of state malpractice risk environment and outcomes were identified. However, analyses using the composite measure showed that patients treated in states with greatest malpractice risk were more likely than those in lowest risk states to experience any complication (OR: 1.31; 95% CI: 1.22-1.41), pneumonia (OR: 1.36; 95%: CI, 1.16-1.60), myocardial infarction (OR: 1.44; 95% CI: 1.22-1.70), venous thromboembolism (OR:2.11; 95% CI: 1.70-2.61), acute renal failure (OR: 1.34; 95% CI; 1.22-1.47), and sepsis (OR: 1.38; 95% CI: 1.24-1.53; all P < 0.001). There were no consistent associations between malpractice environment and Medicare payments.There were no consistent associations between state-level malpractice risk and higher quality of care or Medicare payments for colorectal surgery.
View details for DOI 10.1097/SLA.0000000000001538
View details for Web of Science ID 000377765400022
View details for PubMedID 27167562
- Have Tobacco 21 Laws Come of Age? NEW ENGLAND JOURNAL OF MEDICINE 2016; 374 (17): 1601-1604
- Managing the Risks of Concurrent Surgeries JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 2016; 315 (15): 1563-1564
- Legal and Policy Interventions to Improve Patient Safety CIRCULATION 2016; 133 (7): 661-671
Prevalence and Characteristics of Physicians Prone to Malpractice Claims.
New England journal of medicine
2016; 374 (4): 354-362
The distribution of malpractice claims among physicians is not well understood. If claim-prone physicians account for a substantial share of all claims, the ability to reliably identify them at an early stage could guide efforts to improve care.Using data from the National Practitioner Data Bank, we analyzed 66,426 claims paid against 54,099 physicians from 2005 through 2014. We calculated concentrations of claims among physicians. We used multivariable recurrent-event survival analysis to identify characteristics of physicians at high risk for recurrent claims and to quantify risk levels over time.Approximately 1% of all physicians accounted for 32% of paid claims. Among physicians with paid claims, 84% incurred only one during the study period (accounting for 68% of all paid claims), 16% had at least two paid claims (accounting for 32% of the claims), and 4% had at least three paid claims (accounting for 12% of the claims). In adjusted analyses, the risk of recurrence increased with the number of previous paid claims. For example, as compared with physicians who had one previous paid claim, the 2160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11; 95% confidence interval [CI], 2.84 to 3.41); this corresponded in absolute terms to a 24% chance (95% CI, 22 to 26) of another paid claim within 2 years. Risks of recurrence also varied widely according to specialty--for example, the risk among neurosurgeons was four times as great as the risk among psychiatrists.Over a recent 10-year period, a small number of physicians with distinctive characteristics accounted for a disproportionately large number of paid malpractice claims.
View details for DOI 10.1056/NEJMsa1506137
View details for PubMedID 26816012
Sociodemographic Predictors of Vaccination Exemptions on the Basis of Personal Belief in California
AMERICAN JOURNAL OF PUBLIC HEALTH
2016; 106 (1): 172-177
We examined the variability in the percentage of students with personal belief exemptions (PBEs) from mandatory vaccinations in California schools and communities according to income, education, race, and school characteristics.We used spatial lag models to analyze 2007-2013 PBE data from the California Department of Public Health. The analyses included school- and regional-level models, and separately examined the percentage of students with exemptions in 2013 and the change in percentages over time.The percentage of students with PBEs doubled from 2007 to 2013, from 1.54% to 3.06%. Across all models, higher median household income and higher percentage of White race in the population, but not educational attainment, significantly predicted higher percentages of students with PBEs in 2013. Higher income, White population, and private school type significantly predicted greater increases in exemptions from 2007 to 2013, whereas higher educational attainment was associated with smaller increases.Personal belief exemptions are more common in areas with a higher percentage of White race and higher income.
View details for DOI 10.2105/AJPH.2015.302926
View details for Web of Science ID 000373428000041
View details for PubMedID 26562114
- Building a National Surveillance System for Malpractice Claims. Health services research 2016; 51 Suppl 3: 2642–48
- Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape A Conference Report From the American Heart Association Data Summit 2015 JOURNAL OF THE AMERICAN HEART ASSOCIATION 2015; 4 (11)
- Shifting Vaccination Politics - The End of Personal-Belief Exemptions in California NEW ENGLAND JOURNAL OF MEDICINE 2015; 373 (9): 785-787
- Should Malpractice Settlements Be Secret? JAMA INTERNAL MEDICINE 2015; 175 (7): 1135-1137
- Searching for Public Health Law's Sweet Spot: The Regulation of Sugar-Sweetened Beverages. PLoS medicine 2015; 12 (7): e1001848
- Searching for Public Health Law's Sweet Spot: The Regulation of Sugar-Sweetened Beverages. PLoS medicine 2015; 12 (7)
Institutional Oversight of Faculty-Industry Consulting Relationships in US Medical Schools: A Delphi Study
JOURNAL OF LAW MEDICINE & ETHICS
2015; 43 (2): 383-396
The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful.
View details for DOI 10.1111/jlme.12255
View details for Web of Science ID 000359087400026
View details for PubMedID 26242961
- Half-baked--the retail promotion of marijuana edibles. New England journal of medicine 2015; 372 (11): 989-991
- Medical liability and reporting malpractice payments--reply. JAMA 2015; 313 (10): 1058-1059
- Supporting Those Who Go to Fight Ebola PLOS MEDICINE 2015; 12 (1)
The Medical Liability Climate and Prospects for Reform
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2014; 312 (20): 2146-2155
For many physicians, the prospect of being sued for medical malpractice is a singularly disturbing aspect of modern clinical practice. State legislatures have enacted tort reforms, such as caps on damages, in an effort to reduce the volume and costs of malpractice litigation. Attempts to introduce similar traditional reform measures at the federal level have so far failed. Much less prominent, but potentially more important, are proposed alternative approaches for resolving medical injuries; a number of these efforts are currently being tested in federally sponsored demonstration projects. These nontraditional reforms have considerable promise for addressing some of the system's most challenging issues, including high costs and barriers to accessing compensation. In this Special Communication, we review recent national trends in medical liability claims and costs, which indicate a sharp reduction in the rate of paid claims and flat or declining levels in compensation payments and liability insurance costs over the last 7 to 10 years. We discuss a number of nontraditional reform approaches--communication-and-resolution programs, presuit notification and apology laws, safe harbor legislation, judge-directed negotiation, and administrative compensation systems--and we conclude by describing several forces likely to shape change in the medical liability environment over the next decade.
View details for DOI 10.1001/jama.2014.10705
View details for Web of Science ID 000345626800018
- What Is a Public Health "Emergency"? NEW ENGLAND JOURNAL OF MEDICINE 2014; 371 (11): 986-988
- Clinical Trials and the Right to Remain Silent JAMA INTERNAL MEDICINE 2014; 174 (9): 1505-?
Communication-And-Resolution Programs: The Challenges And Lessons Learned From Six Early Adopters
2014; 33 (1): 20-29
In communication-and-resolution programs (CRPs), health systems and liability insurers encourage the disclosure of unanticipated care outcomes to affected patients and proactively seek resolutions, including offering an apology, an explanation, and, where appropriate, reimbursement or compensation. Anecdotal reports from the University of Michigan Health System and other early adopters of CRPs suggest that these programs can substantially reduce liability costs and improve patient safety. But little is known about how these early programs achieved success. We studied six CRPs to identify the major challenges in and lessons learned from implementing these initiatives. The CRP participants we interviewed identified several factors that contributed to their programs' success, including the presence of a strong institutional champion, investing in building and marketing the program to skeptical clinicians, and making it clear that the results of such transformative change will take time. Many of the early CRP adopters we interviewed expressed support for broader experimentation with these programs even in settings that differ from their own, such as systems that do not own and control their liability insurer, and in states without strong tort reforms.
View details for DOI 10.1377/hlthaff.2013.0828
View details for Web of Science ID 000330289300004
View details for PubMedID 24395931
How Policy Makers Can Smooth The Way For Communication-And-Resolution Programs
2014; 33 (1): 11-19
Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees' experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants' fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers' financial recourse following medical error).
View details for DOI 10.1377/hlthaff.2013.0930
View details for Web of Science ID 000330289300003
View details for PubMedID 24395930
Implementing Hospital-Based Communication-And-Resolution Programs: Lessons Learned In New York City
2014; 33 (1): 30-38
In 2010 five New York City hospitals implemented a communication-and-resolution program (CRP) in general surgery. The program's goals were to improve reporting of serious adverse events to risk management, support clinical staff in discussing these events with patients, rapidly investigate why injuries occurred, communicate to patients what was discovered, and offer apologies and compensation when the standard of care was not met. We report the hospitals' experiences with implementing the CRP over a twenty-two-month period. We found that all five hospitals improved disclosure and surveillance of adverse events but were not able to fully implement the program's compensation component. These experiences suggest that strong support from top leadership at the hospital and insurer levels, and adequate staff resources, are critical for the success of CRPs. Hospitals considering adopting a CRP should ensure that their organizations can tolerate risk, their leaders are willing to reinforce CRP implementation, and resources are in place to educate clinical staff about how the program can benefit them.
View details for DOI 10.1377/hlthaff.2013.0849
View details for Web of Science ID 000330289300005
View details for PubMedID 24395932
Critical Opportunities for Public Health Law: A Call for Action
AMERICAN JOURNAL OF PUBLIC HEALTH
2013; 103 (11): 1979-1988
Although legal interventions are responsible for many sentinel public health achievements, law is underutilized as a tool for advancing population health. Our purpose was to identify critical opportunities for public health lawmaking. We articulated key criteria and illustrated their use with 5 examples. These opportunities involve significant health problems that are potentially amenable to change through law and for which an effective legal intervention is available: optimizing graduated driver licensing laws, increasing tax rates on alcoholic beverages, regulating sodium in foods, enacting laws to facilitate reversal of opioid overdoses, and improving mental health interventions in the college setting. We call for a national conversation about critical opportunities for public health law to advance evidence-based policymaking.
View details for DOI 10.2105/AJPH.2013.301281
View details for Web of Science ID 000331038500036
View details for PubMedID 24028265
High Physician Concern About Malpractice Risk Predicts More Aggressive Diagnostic Testing In Office-Based Practice
2013; 32 (8): 1383-1391
Despite widespread agreement that physicians who practice defensive medicine drive up health care costs, the extent to which defensive medicine increases costs is unclear. The differences in findings to date stem in part from the use of two distinct approaches for assessing physicians' perceived malpractice risk. In this study we used an alternative strategy: We linked physicians' responses regarding their levels of malpractice concern as reported in the 2008 Health Tracking Physician Survey to Medicare Parts A and B claims for the patients they treated during the study period, 2007-09. We found that physicians who reported a high level of malpractice concern were most likely to engage in practices that would be considered defensive when diagnosing patients who visited their offices with new complaints of chest pain, headache, or lower back pain. No consistent relationship was seen, however, when state-level indicators of malpractice risk replaced self-rated concern. Reducing defensive medicine may require approaches focused on physicians' perceptions of legal risk and the underlying factors driving those perceptions.
View details for DOI 10.1377/hlthaff.2013.0233
View details for Web of Science ID 000323154800008
View details for PubMedID 23918482
The Politics of HPV Vaccination Policy Formation in the United States
JOURNAL OF HEALTH POLITICS POLICY AND LAW
2013; 38 (4): 645-681
This article explores the political dimensions of policy formation for the human papillomavirus (HPV) vaccine through case studies of six states: California, Indiana, New Hampshire, New York, Texas, and Virginia. Using thematic content analysis of semistructured key informant interviews with policy stakeholders, newspaper articles, and archival materials, we describe the trajectory of public health policy developments for HPV immunization and analyze key influences on policy outcomes through the theoretical lens of the Multiple Streams framework. Specifically, we examine factors influencing the extent to which HPV was perceived as a problem meriting policy action; political forces that facilitated and impeded policy adoption, including interest-group opposition and structural and ideological features of the states' political environments; and factors affecting which policy alternatives received consideration. We find that effective policy entrepreneurship played a critical role in determining policy outcomes. We conclude by discussing lessons from the case of HPV vaccination for future efforts to craft vaccination policies.
View details for DOI 10.1215/03616878-2208567
View details for Web of Science ID 000323186800003
View details for PubMedID 23645875
Survey Finds Public Support For Legal Interventions Directed At Health Behavior To Fight Noncommunicable Disease
2013; 32 (3): 486-496
The high prevalence of chronic diseases in the United States with lifestyle-related risk factors, such as obesity and tobacco use, has sparked interest in legal strategies to influence health behavior. However, little is known about the public's willingness to accept these policies as legitimate, which in turn may affect compliance. We present results from a national survey of 1,817 US adults concerning the acceptability of different public health legal interventions that address noncommunicable, or chronic, diseases. We found that support for these new interventions is high overall; substantially greater among African Americans and Hispanics than among whites; and tied to perceptions of democratic representation in policy making. There was much support for strategies that enable people to exercise healthful choices--for example, menu labeling and improving access to nicotine patches--but considerably less for more coercive measures, such as insurance premium surcharges. These findings suggest that the least coercive path will be the smoothest and that support for interventions may be widespread among different social groups. In addition, the findings underscore the need for policy makers to involve the public in decision making, understand the public's values, and communicate how policy decisions reflect this understanding.
View details for DOI 10.1377/hlthaff.2012.0609
View details for Web of Science ID 000316557900007
View details for PubMedID 23459727
Disclosure, Apology, and Offer Programs: Stakeholders' Views of Barriers to and Strategies for Broad Implementation
2012; 90 (4): 682-705
The Disclosure, Apology, and Offer (DA&O) model, a response to patient injuries caused by medical care, is an innovative approach receiving national attention for its early success as an alternative to the existing inherently adversarial, inefficient, and inequitable medical liability system. Examples of DA&O programs, however, are few.Through key informant interviews, we investigated the potential for more widespread implementation of this model by provider organizations and liability insurers, defining barriers to implementation and strategies for overcoming them. Our study focused on Massachusetts, but we also explored themes that are broadly generalizable to other states.We found strong support for the DA&O model among key stakeholders, who cited its benefits for both the liability system and patient safety. The respondents did not perceive any insurmountable barriers to broad implementation, and they identified strategies that could be pursued relatively quickly. Such solutions would permit a range of organizations to implement the model without legislative hurdles.Although more data are needed about the outcomes of DA&O programs, the model holds considerable promise for transforming the current approach to medical liability and patient safety.
View details for DOI 10.1111/j.1468-0009.2012.00679.x
View details for Web of Science ID 000312137000003
View details for PubMedID 23216427
Disclosure-And-Resolution Programs That Include Generous Compensation Offers May Prompt A Complex Patient Response
2012; 31 (12): 2681-2689
Under "disclosure-and-resolution" programs, health systems disclose adverse events to affected patients and their families; apologize; and, where appropriate, offer compensation. Early adopters of this approach have reported reduced liability costs, but the extent to which these results stem from effective disclosure and apology practices, versus compensation offers, is unknown. Using survey vignettes, we examined the effects of different compensation offers on individuals' responses to disclosures of medical errors compared to explanation and apology alone. Our results show that although two-thirds of these individuals desired compensation offers, increasing the offer amount did not improve key outcomes. Full-compensation offers did not decrease the likelihood of seeking legal advice and increased the likelihood that people perceived the disclosure and apology as motivated by providers' desire to avoid litigation. Hospitals, physicians, and malpractice insurers should consider this complex interplay as they implement similar initiatives. They may benefit from separating disclosure conversations and compensation offers and from excluding physicians from compensation discussions.
View details for DOI 10.1377/hlthaff.2012.0185
View details for Web of Science ID 000312602100011
View details for PubMedID 23213152
Legal and policy approaches to the obesity epidemic
SURGERY FOR OBESITY AND RELATED DISEASES
2012; 8 (5): 507-513
Although 85% of the American public believes that obesity is an "epidemic," great controversy exists what role the government, public policy, and law should play in addressing the problem. This keynote address discusses the philosophical and economic justifications for treating obesity as a public health problem meriting government intervention and explores the possible legal and policy solutions.
View details for DOI 10.1016/j.soard.2012.05.001
View details for Web of Science ID 000309695100003
View details for PubMedID 22695172
- Does Tort Law Improve the Health of Newborns, or Miscarry? A Longitudinal Analysis of the Effect of Liability Pressure on Birth Outcomes JOURNAL OF EMPIRICAL LEGAL STUDIES 2012; 9 (2): 217-245
Pharmaceutical Companies' Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination
AMERICAN JOURNAL OF PUBLIC HEALTH
2012; 102 (5): 893-898
We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders' perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry.We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations.Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.Although policymakers acknowledge the utility of manufacturers' involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.
View details for DOI 10.2105/AJPH.2011.300576
View details for Web of Science ID 000302969300022
View details for PubMedID 22420796
Administrative compensation for medical injuries: lessons from three foreign systems.
Issue brief (Commonwealth Fund)
2011; 14: 1-18
The United States requires patients injured by medical negligence to seek compensation through lawsuits, an approach that has drawbacks related to fairness, cost, and impact on medical care. Several countries, including New Zealand, Sweden, and Denmark, have replaced litigation with administrative compensation systems for patients who experience an avoidable medical injury. Sometimes called "no-fault" systems, such schemes enable patients to file claims for compensation without using an attorney. A governmental or private adjudicating organization uses neutral medical experts to evaluate claims of injury and does not require patients to prove that health care providers were negligent in order to receive compensation. Information from claims is used to analyze opportunities for patient safety improvement. The systems have successfully limited liability costs while improving injured patients' access to compensation. American policymakers may find many of the elements of these countries' systems to be transferable to demonstration projects in the U.S.
View details for PubMedID 21770079
Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints
2011; 8 (4)
Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing.We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%).Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.
View details for DOI 10.1371/journal.pmed.1000431
View details for Web of Science ID 000289937700004
View details for PubMedID 21483716
View details for PubMedCentralID PMC3071370
Relationship between Quality of Care and Negligence Litigation in Nursing Homes
NEW ENGLAND JOURNAL OF MEDICINE
2011; 364 (13): 1243-1250
It is unclear whether high-quality health care institutions are less likely to be sued for negligence than their low-performing counterparts.We linked information on tort claims brought against 1465 nursing homes between 1998 and 2006 to 10 indicators of nursing home quality drawn from two U.S. national data sets: the Online Survey, Certification, and Reporting system and the Minimum Data Set Quality Measure/Indicator Report. We tested for associations between the incidence of claims and the quality measures at the facility calendar-quarter level, correcting for facility clustering and adjusting for case mix, ownership, occupancy, year, and state. Odds ratios were calculated for the effect of a change of 1 SD in each quality measure on the odds of one or more claims in each facility calendar-quarter.Nursing homes with more deficiencies (odds ratio, 1.09; 95% confidence interval [CI], 1.05 to 1.13) and those with more serious deficiencies (odds ratio, 1.04; 95% CI, 1.00 to 1.08) had higher odds of being sued; this was also true for nursing homes that had more residents with weight loss (odds ratio, 1.05; 95% CI, 1.01 to 1.10) and with pressure ulcers (odds ratio, 1.09; 95% CI, 1.05 to 1.14). The odds of being sued were lower in nursing homes with more nurse's aide-hours per resident-day (odds ratio, 0.95; 95% CI, 0.91 to 0.99). However, all these effects were relatively small. For example, nursing homes with the best deficiency records (10th percentile) had a 40% annual risk of being sued, as compared with a 47% risk among nursing homes with the worst deficiency records (90th percentile).The best-performing nursing homes are sued only marginally less than the worst-performing ones. Such weak discrimination may subvert the capacity of litigation to provide incentives to deliver safer care.
View details for Web of Science ID 000288951300008
View details for PubMedID 21449787
Physicians' Fears Of Malpractice Lawsuits Are Not Assuaged By Tort Reforms
2010; 29 (9): 1585-1592
Physicians contend that the threat of malpractice lawsuits forces them to practice defensive medicine, which in turn raises the cost of health care. This argument underlies efforts to change malpractice laws through legislative tort reform. We evaluated physicians' perceptions about malpractice claims in states where more objective indicators of malpractice risk, such as malpractice premiums, varied considerably. We found high levels of malpractice concern among both generalists and specialists in states where objective measures of malpractice risk were low. We also found relatively modest differences in physicians' concerns across states with and without common tort reforms. These results suggest that many policies aimed at controlling malpractice costs may have a limited effect on physicians' malpractice concerns.
View details for DOI 10.1377/hlthaff.2010.0135
View details for Web of Science ID 000281601300005
View details for PubMedID 20820012
The Flaws In State 'Apology' And 'Disclosure' Laws Dilute Their Intended Impact On Malpractice Suits
2010; 29 (9): 1611-1619
Apologies are rare in the medical world, where health care providers fear that admissions of guilt or expressions of regret could be used by plaintiffs in malpractice lawsuits. Nevertheless, some states are moving toward giving health care providers legal protection so that they feel free to apologize to patients for a medical mistake. Advocates believe that these laws are beneficial for patients and providers. However, our analysis of "apology" and "disclosure" laws in thirty-four states and the District of Columbia finds that most of the laws have major shortcomings. These may actually discourage comprehensive disclosures and apologies and weaken the laws' impact on malpractice suits. Many could be resolved by improved statutory design and communication of new legal requirements and protections.
View details for DOI 10.1377/hlthaff.2009.0134
View details for Web of Science ID 000281601300009
View details for PubMedID 20820016
National Costs Of The Medical Liability System
2010; 29 (9): 1569-1577
Concerns about reducing the rate of growth of health expenditures have reignited interest in medical liability reforms and their potential to save money by reducing the practice of defensive medicine. It is not easy to estimate the costs of the medical liability system, however. This article identifies the various components of liability system costs, generates national estimates for each component, and discusses the level of evidence available to support the estimates. 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.
View details for DOI 10.1377/hlthaff.2009.0807
View details for Web of Science ID 000281601300003
View details for PubMedID 20820010
View details for PubMedCentralID PMC3048809
- HPV Vaccination Mandates - Lawmaking amid Political and Scientific Controversy NEW ENGLAND JOURNAL OF MEDICINE 2010; 363 (8): 785-791
Making the Case for Laws That Improve Health: A Framework for Public Health Law Research
2010; 88 (2): 169-210
Public health law has received considerable attention in recent years and has become an essential field in public health. Public health law research, however, has received less attention.Expert commentary.This article explores public health law research, defined as the scientific study of the relation of law and legal practices to population health. The article offers a logic model of public health law research and a typology of approaches to studying the effects of law on public health. Research on the content and prevalence of public health laws, processes of adopting and implementing laws, and the extent to which and mechanisms through which law affects health outcomes can use methods drawn from epidemiology, economics, sociology, and other disciplines. The maturation of public health law research as a field depends on methodological rigor, adequate research funding, access to appropriate data sources, and policymakers' use of research findings.Public health law research is a young field but holds great promise for supporting evidence-based policy making that will improve population health.
View details for Web of Science ID 000278933700002
View details for PubMedID 20579282
- Whistle-Blowers' Experiences in Fraud Litigation against Pharmaceutical Companies NEW ENGLAND JOURNAL OF MEDICINE 2010; 362 (19): 1832-1839
Federal Trade Commission Regulation of Food Advertising to Children: Possibilities for a Reinvigorated Role
JOURNAL OF HEALTH POLITICS POLICY AND LAW
2010; 35 (2): 227-276
Growing awareness of the role that food and beverage advertising plays in the epidemic of childhood obesity has prompted calls for stricter oversight of advertising practices. The food and beverage industries have taken voluntary steps in this direction, but many commentators have called for increased government regulation. The mission of the Federal Trade Commission (FTC) makes it an obvious candidate to lead a new regulatory effort. However, the FTC has a troubled history in the area of children's advertising regulation, and several political and legal factors constrain its ability to act. This article reviews those obstacles as well as the opportunities that exist at present to expand FTC oversight of food advertising to children. The FTC has considerable latitude to regulate individual food advertisements more rigorously, either on the basis that they are deceptive or on the basis that they are unfair. Broader rule making under the unfairness authority would require congressional intervention to expand the FTC's scope of authority, but there exist possibilities for rule making under the deception doctrine. Finally, the FTC could strengthen its efforts to encourage the food industry to regulate its own advertising practices more stringently and could provide mechanisms for making voluntary initiatives more meaningful.
View details for DOI 10.1215/03616878-2009-051
View details for Web of Science ID 000276941200005
View details for PubMedID 20388868
Disclosing Harmful Medical Errors to Patients Tackling Three Tough Cases
2009; 136 (3): 897-903
A gap exists between recommendations to disclose errors to patients and current practice. This gap may reflect important, yet unanswered questions about implementing disclosure principles. We explore some of these unanswered questions by presenting three real cases that pose challenging disclosure dilemmas. The first case involves a pancreas transplant that failed due to the pancreas graft being discarded, an error that was not disclosed partly because the family did not ask clarifying questions. Relying on patient or family questions to determine the content of disclosure is problematic. We propose a standard of materiality that can help clinicians to decide what information to disclose. The second case involves a fatal diagnostic error that the patient's widower was unaware had happened. The error was not disclosed out of concern that disclosure would cause the widower more harm than good. This case highlights how institutions can overlook patients' and families' needs following errors and emphasizes that benevolent deception has little role in disclosure. Institutions should consider whether involving neutral third parties could make disclosures more patient centered. The third case presents an intraoperative cardiac arrest due to a large air embolism where uncertainty around the clinical event was high and complicated the disclosure. Uncertainty is common to many medical errors but should not deter open conversations with patients and families about what is and is not known about the event. Continued discussion within the medical profession about applying disclosure principles to real-world cases can help to better meet patients' and families' needs following medical errors.
View details for DOI 10.1378/chest.09-0030
View details for Web of Science ID 000269733400035
View details for PubMedID 19736193
Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section
2009; 47 (2): 234-242
Since the 1990s, nationwide rates of vaginal birth after cesarean section (VBAC) have decreased sharply and rates of cesarean section have increased sharply. Both trends are consistent with clinical behavior aimed at reducing obstetricians' exposure to malpractice litigation.To estimate the effects of malpractice pressure on rates of VBAC and cesarean section.We used state-level longitudinal mixed-effects regression models to examine data from the Natality Detail File on births in the United States (1991-2003). Malpractice pressure was measured by liability insurance premiums and tort reforms. Outcome measures were rates of VBAC, cesarean section, and primary cesarean section.Malpractice premiums were positively associated with rates of cesarean section (beta = 0.15, P = 0.02) and primary cesarean section (beta = 0.16, P = 0.009), and negatively associated with VBAC rates (beta = -0.35, P = 0.01). These estimates imply that a $10,000 decrease in premiums for obstetrician-gynecologists would be associated with an increase of 0.35 percentage points (1.45%) in the VBAC rate and decreases of 0.15 and 0.16 percentage points (0.7% and 1.18%) in the rates of cesarean section and primary cesarean section, respectively; this would correspond to approximately 1600 more VBACs, 6000 fewer cesarean sections, and 3600 fewer primary cesarean sections nationwide in 2003. Two types of tort reform-caps on noneconomic damages and pretrial screening panels-were associated with lower rates of cesarean section and higher rates of VBAC.The liability environment influences choice of delivery method in obstetrics. The effects are not large, but reduced litigation pressure would likely lead to decreases in the total number cesarean sections and total delivery costs.
View details for Web of Science ID 000262913200014
View details for PubMedID 19169125
View details for PubMedCentralID PMC3096673
Spillover Effects of State Mandated Benefit Laws: The Case of Outpatient Breast Cancer Surgery
INQUIRY-THE JOURNAL OF HEALTH CARE ORGANIZATION PROVISION AND FINANCING
2009; 46 (4): 433-447
This paper examines the "spillover effects" of state laws that mandate inpatient coverage for breast cancer surgery. It looks at outpatient utilization of two types of breast cancer surgery among Medicare fee-for-service patients, who are exempt from state regulation. Using data from the Surveillance, Epidemiology and End Results cancer registries and Medicare claims, we performed difference-in-differences analyses of patients in nine states from 1993 to 2002. The analyses show that state laws had a significant impact on only the likelihood of outpatient mastectomy, which was reduced by five percentage points. Such a spillover effect may diminish the expected impact of federal coverage laws for inpatient breast cancer surgery, which have been proposed to achieve similar ends.
View details for Web of Science ID 000274842100007
View details for PubMedID 20184169
Administrative compensation of medical injuries: A hardy perennial blooms again
JOURNAL OF HEALTH POLITICS POLICY AND LAW
2008; 33 (4): 725-760
Periods in which the costs of personal injury litigation and liability insurance have risen dramatically have often provoked calls for reform of the tort system, and medical malpractice is no exception. One proposal for fundamental reform made during several of these volatile periods has been to relocate personal injury disputes from the tort system to an alternative, administrative forum. In the medical injury realm, a leading incarnation of such proposals in recent years has been the idea of establishing specialized administrative "health courts." Despite considerable stakeholder and policy-maker interest, administrative compensation proposals have tended to struggle for broad political acceptance. In this article, we consider the historical experience of administrative medical injury compensation proposals, particularly in light of comparative examples in the context of workplace injuries, automobile injuries, and vaccine injuries. We conclude by examining conditions that may facilitate or impede progress toward establishing demonstration projects of health courts.
View details for DOI 10.1215/03616878-2008-014
View details for Web of Science ID 000257747100004
View details for PubMedID 18617673
Incidental findings in human subjects research: What do investigators owe research participants?
JOURNAL OF LAW MEDICINE & ETHICS
2008; 36 (2): 271-279
The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.
View details for Web of Science ID 000256411400005
View details for PubMedID 18547194
The interplay of public health law and industry self-regulation: The case of sugar-sweetened beverage sales in schools
AMERICAN JOURNAL OF PUBLIC HEALTH
2008; 98 (4): 595-604
It is increasingly recognized that sugar-sweetened beverage consumption contributes to childhood obesity. Most states have adopted laws that regulate the availability of sugar-sweetened beverages in school settings. However, such policies have encountered resistance from consumer and parent groups, as well as the beverage industry. The beverage industry's recent adoption of voluntary guidelines, which call for the curtailment of sugar-sweetened beverage sales in schools, raises the question, Is further policy intervention in this area needed, and if so, what form should it take? We examine the interplay of public and private regulation of sugar-sweetened beverage sales in schools, by drawing on a 50-state legal and regulatory analysis and a review of industry self-regulation initiatives.
View details for DOI 10.2105/AJPH.2006.107680
View details for Web of Science ID 000254595500011
View details for PubMedID 17901427
- A Longitudinal Analysis of the Impact of Liability Pressure on the Supply of Obstetrician-Gynecologists JOURNAL OF EMPIRICAL LEGAL STUDIES 2008; 5 (1): 21-53
Rationalizing vaccine injury compensation
2008; 22 (1): 32-42
Legislation recently adopted by the United States Congress provides producers of pandemic vaccines with near-total immunity from civil lawsuits without making individuals injured by those vaccines eligible for compensation through the Vaccine Injury Compensation Program. The unusual decision not to provide an alternative mechanism for compensation is indicative of a broader problem of inconsistency in the American approach to vaccine-injury compensation policy. Compensation policies have tended to reflect political pressures and economic considerations more than any cognizable set of principles. This article identifies a set of ethical principles bearing on the circumstances in which vaccine injuries should be compensated, both inside and outside public health emergencies. A series of possible bases for compensation rules, some grounded in utilitarianism and some nonconsequentialist, are discussed and evaluated. Principles of fairness and reasonableness are found to constitute the strongest bases. An ethically defensible compensation policy grounded in these principles would make a compensation fund available to all individuals with severe injuries and to individuals with less-severe injuries whenever the vaccination was required by law or professional duty.
View details for DOI 10.1111/j.1467-8519.2007.00590.x
View details for Web of Science ID 000251627400006
View details for PubMedID 18154587
Deconstructing negligence: The role of individual and system factors in causing medical injuries
GEORGETOWN LAW JOURNAL
2008; 96 (2): 599-623
View details for Web of Science ID 000253035300013
Empirical health law scholarship: The state of the field
GEORGETOWN LAW JOURNAL
2008; 96 (2): 649-702
View details for Web of Science ID 000253035300015
Beyond negligence: Avoidability and medical injury compensation
SOCIAL SCIENCE & MEDICINE
2008; 66 (2): 387-402
Disenchantment with the tort system and negligence standard in the United States is fueling interest in alternate compensation systems for medical injury. One possibility is experimentation with administrative "health courts," through which specialized adjudicators would utilize neutral experts to render compensability determinations. Compensation would be based not on negligence, but rather on a broader avoidable medical injury (avoidability) standard. Although considerable interest in health courts exists, stakeholders frequently express uncertainty about the meaning and operation of an avoidability standard. Three nations-Sweden, Denmark, and New Zealand-have long operated administrative schemes. We conducted interviews with administrators and stakeholders in these systems. Our goal was to garner lessons on how to operate a health court, and specifically, how to develop and apply alternate compensation criteria such as avoidability. This article reports our findings on the origins and operations of the systems, the evolution of their compensation criteria, and how these criteria are actually applied. We found that all three systems had their primary genesis in ensuring compensation for the injured, as opposed to sanctioning providers. All have abandoned the negligence standard. The Nordic systems use an avoidability standard, principally defined as injury that would not occur in the hands of the best practitioner. Their experience demonstrates that this definition is feasible to apply. New Zealand's recent move to a no-fault system sheds light on the benefits and drawbacks of a variety of compensation standards. Key lessons for successfully applying an alternate standard, such as avoidability, include a strict adherence to national precedent, the use of neutral and experienced experts, and a block on routine transfer of information from compensation investigations to disciplinary authorities. 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.
View details for DOI 10.1016/j.socscimed.2007.08.020
View details for Web of Science ID 000252822000016
View details for PubMedID 17931762
Policy experimentation with administrative compensation for medical injury: Issues under state constitutional law
HARVARD JOURNAL ON LEGISLATION
2008; 45 (1): 59-105
View details for Web of Science ID 000253913100002
- Adjudicating Severe Birth Injury Claims in Florida and Virginia: The Experience of a Landmark Experiment in Personal Injury Compensation AMERICAN JOURNAL OF LAW & MEDICINE 2008; 34 (4): 493-537
When tort resolutions are "wrong": Predictors of discordant outcomes in medical malpractice litigation
Conference on Current Research on Medical Malpractice Liability
UNIV CHICAGO PRESS. 2007: S47–S78
View details for Web of Science ID 000254223400003
Changes in physician supply and scope of practice during a malpractice crisis: Evidence from Pennsylvania
2007; 26 (3): W425-W435
The extent to which liability costs cause physicians to restrict their scope of practice or cease practicing is controversial in policy debates over malpractice "crises." We used insurance department administrative data to analyze specialist physician scope-of-practice changes and exits in Pennsylvania in 1993-2002. In most specialties the proportions of high-risk specialists restricting their scope of practice did not increase during the crisis; however, the supply of obstetrician-gynecologists decreased by 8 percent in the three years following premium increases in 1999. We discuss methodological issues that could explain the disparate findings regarding physician supply effects in studies using administrative data sets and survey data.
View details for DOI 10.1377/hlthaff.26.3.w425
View details for Web of Science ID 000246458300066
View details for PubMedID 17456502
Confidentiality laws and secrecy in medical research: Improving public access to data on drug safety
2007; 26 (2): 483-491
Pharmaceutical manufacturers have long considered results collected from drugs' clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs.
View details for DOI 10.1377/hlthaff.26.2.483
View details for Web of Science ID 000244763500022
View details for PubMedID 17339677
- Regulatory and judicial oversight of nonprofit hospitals NEW ENGLAND JOURNAL OF MEDICINE 2007; 356 (6): 625-631
Advance care planning in patients undergoing hematopoietic cell transplantation
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
2007; 13 (1): 65-73
Few data are available on the prevalence of advance care planning (ACP) in patients undergoing hematopoietic cell transplantation (HCT). We surveyed adult patients pre-HCT to ascertain completion of various elements of ACP. We also reviewed medical records for documentation of discussions regarding ACP and for the presence of written advance directives. Evaluable surveys were returned by 155 of 335 patients (46%) who underwent HCT during the study period; we obtained permission for medical record review from 137 of these 155 survey respondents (88%). We found that 69% of the respondents reported having designated a health care proxy, 44% had completed a living will, 61% had prepared an estate will, and 63% had discussed their wishes regarding life support with family and friends. In contrast, only 16% had discussed their wishes regarding life support with their clinicians. Documentation of discussions between clinicians and patients regarding most elements of ACP was rare. Written advance directives were present in the charts of 54 patients (39%). ACP was more common in older, college-educated, and allogeneic transplant patients. Even though ACP was more prevalent among this sample than in the general population, its use still could be enhanced, given the high risks of decisional incapacity and death that HCT patients face.
View details for DOI 10.1016/j.bbmt.2006.08.042
View details for Web of Science ID 000243959300007
View details for PubMedID 17222754
Disclosure of medical injury to patients: An improbable risk management strategy
2007; 26 (1): 215-226
Pressure mounts on physicians and hospitals to disclose adverse outcomes of care to patients. Although such transparency diverges from traditional risk management strategy, recent commentary has suggested that disclosure will actually reduce providers' liability exposure. We tested this theory by modeling the litigation consequences of disclosure. We found that forecasts of reduced litigation volume or cost do not withstand close scrutiny. 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.
View details for DOI 10.1377/hlthaff.26.1.215
View details for Web of Science ID 000244223200024
View details for PubMedID 17211031
The role of law in public health: The case of family planning in the Philippines
SOCIAL SCIENCE & MEDICINE
2006; 63 (2): 384-396
Compared to neighboring countries, the Philippines has high fertility rates and a low prevalence of modern-method contraception use. The Philippine government faces political and cultural barriers to addressing family planning needs, but also legal barriers erected by its own policies. We conducted a review of laws and policies relating to family planning in the Philippines in order to examine how the law may facilitate or constrain service provision. The methodology consisted of three phases. First, we collected and analyzed laws and regulations relating to the delivery of family planning services. Second, we conducted a qualitative interview study. Third, we synthesized findings to formulate policy recommendations. We present a conceptual model for understanding the impact of law on public health and discuss findings in relation to the roles of health care provider regulation, drug regulation, tax law, trade policies, insurance law, and other laws on access to modern-method contraceptives.
View details for DOI 10.1016/j.socscimed.2006.01.010
View details for Web of Science ID 000238933600009
View details for PubMedID 16488063
Claims, errors, and compensation payments in medical malpractice litigation
NEW ENGLAND JOURNAL OF MEDICINE
2006; 354 (19): 2024-2033
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.Trained physicians reviewed a random sample of 1452 closed malpractice claims from five liability insurers to determine whether a medical injury had occurred and, if so, whether it was due to medical error. We analyzed the prevalence, characteristics, litigation outcomes, and costs of claims that lacked evidence of error.For 3 percent of the claims, there were no verifiable medical injuries, and 37 percent did not involve errors. Most of the claims that were not associated with errors (370 of 515 [72 percent]) or injuries (31 of 37 [84 percent]) did not result in compensation; most that involved injuries due to error did (653 of 889 [73 percent]). Payment of claims not involving errors occurred less frequently than did the converse form of inaccuracy--nonpayment of claims associated with errors. When claims not involving errors were compensated, payments were significantly lower on average than were payments for claims involving errors (313,205 dollars vs. 521,560 dollars, P=0.004). Overall, claims not involving errors accounted for 13 to 16 percent of the system's total monetary costs. For every dollar spent on compensation, 54 cents went to administrative expenses (including those involving lawyers, experts, and courts). Claims involving errors accounted for 78 percent of total administrative costs.Claims that lack evidence of error are not uncommon, but most are denied compensation. The vast majority of expenditures go toward litigation over errors and payment of them. The overhead costs of malpractice litigation are exorbitant.
View details for Web of Science ID 000237413100007
View details for PubMedID 16687715
"Health courts" and accountability for patient safety
2006; 84 (3): 459-492
Proposals that medical malpractice claims be removed from the tort system and processed in an alternative system, known as administrative compensation or "health courts," attract considerable policy interest during malpractice "crises," including the current one. This article describes current proposals for the design of a health court system and the system's advantages for improving patient safety. Among these advantages are the cultivation of a culture of transparency regarding medical errors and the creation of mechanisms to gather and analyze data on medical injuries. The article discusses the experiences of foreign countries with administrative compensation systems for medical injury, including their use of claims data for research on patient safety; choices regarding the compensation system's relationship to physician disciplinary processes; and the proposed system's possible limitations.
View details for Web of Science ID 000240027400002
View details for PubMedID 16953807
Effects of a malpractice crisis on specialist supply and patient access to care
ANNALS OF SURGERY
2005; 242 (5): 621-628
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.A perennial concern during "malpractice crises" is that liability costs will drive physicians in high-risk specialties out of practice, creating specialist shortages and access-to-care problems.Mail survey of 824 Pennsylvania physicians in general surgery, neurosurgery, orthopedic surgery, obstetrics/gynecology, emergency medicine, and radiology eliciting information on practice decisions made in response to rising liability costs.Strong majorities of specialists reported increases over the last 3 years in patients' driving distances (58%) and waiting times (83%) for specialist care or surgery, waiting times for emergency department care (82%), and the number of patients forced to switch physicians (89%). Professional liability costs and managed care were both considered important contributing factors. Small proportions of specialists reported that they would definitely retire (7%) or relocate their practice out of state (4%) within the next 2 years; another third (32% and 29%, respectively) said they would likely do so. Forty-two percent of specialists have reduced or eliminated high-risk aspects of their practice, and 50% are likely to do so over the next 2 years.Our data suggest that claims of a "physician exodus" from Pennsylvania due to rising liability costs are overstated, but the malpractice situation is having demonstrable effects on the supply of specialist physicians in affected areas and their scope of practice, which likely impinges upon patients' access to care.
View details for DOI 10.1097/01.sla.0000182957.54783.9a
View details for Web of Science ID 000233215500001
View details for PubMedID 16244532
- Are medical malpractice damages caps constitutional? An overview of state litigation JOURNAL OF LAW MEDICINE & ETHICS 2005; 33 (3): 515-?
The future of surgery: today's residents speak.
2005; 62 (5): 543-546
New Accreditation Council for Graduate Medical Education (ACGME) resident duty hour requirements were implemented in July 2003. A recent study suggests that these requirements have resulted in substantial work-hour reductions and improvements in quality of life for general surgery residents. The impact of these changes on the culture of surgery and attitudes about future practice patterns among current surgical residents is unknown.To characterize future practice patterns desired by the current generation of general surgery residents.A confidential survey was administered to all residents enrolled in 21 general surgery residency programs in New England (n = 668).Completed responses were received from 238 residents. Three quarters of the respondents wish to limit their practice to a subspecialty, and two thirds wish to work 60 hours or less per week as attending surgeons. About one quarter find a job-sharing arrangement desirable. Seventy-one percent report that being on-call for their patients at all times with no night or weekend cross-coverage would be undesirable. Over 90% desire sharing on-call responsibilities with members of a group. Over one quarter would feel comfortable allowing cross-covering colleagues to manage their operative complications routinely, including reoperation. Over one quarter would pass off a scheduled operation that was delayed into the night or weekend.The current surgical residents desire practice patterns that substantially differ from those of today's surgeons. To the extent that these attitudes spring from changes in resident working conditions wrought by the ACGME duty hour requirements, these requirements have the potential to change the nature of surgical practice in this country.
View details for PubMedID 16125618
Surgical residents' perceptions of the effects of the ACGME duty hour requirements 1 year after implementation
2005; 138 (2): 246-253
In July 2003, the Accreditation Council for Graduate Medical Education implemented nationwide requirements on resident duty hours with the aim of improving quality of care. Our objectives were (1) to determine the extent and means of compliance with the ACGME requirements within general surgery residency programs and (2) to examine general surgery residents' perceptions of the effects of the ACGME requirements on patient care and residents' training experience.A survey was mailed to residents in 19 New England general surgery programs in spring 2004 (n=238).The overall response rate was 36%. More than 89% of respondents reported that the requirements generally were being enforced, and respondents' mean work hours (80.8 +/- 11.7 per week) supported this claim. Forty-three percent felt that quality of care had deteriorated. Although 70% perceived decrements in continuity of care, only 32% believed that the risk of patient management errors had increased. Sixty percent reported doing fewer operations, and half felt that residents missed out on too many learning opportunities. Yet, only 39% reported that the requirements had worsened the quality of training. Residents consistently reported an improved quality of life. Seventy-five percent felt that, overall, the requirements were a good thing.Most surgical residents do not believe that the ACGME duty hour requirements have had their intended effect of improving quality of care and are ambivalent about effects on the quality of their training. However, they report an improved quality of life, and most residents do support the requirements overall.
View details for DOI 10.1016/j.surg.2005.06.010
View details for Web of Science ID 000232019800017
View details for PubMedID 16153433
Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.
Accountability in research
2005; 12 (3): 163-191
We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.
View details for PubMedID 16634168
Effects of a professional liability crisis on residents' practice decisions
OBSTETRICS AND GYNECOLOGY
2005; 105 (6): 1287-1295
Pennsylvania, like many states, is in a professional liability crisis characterized by escalating cost and decreasing availability of liability insurance. Medical and surgical specialists have experienced especially large increases in insurance premiums. The objective of this study was to estimate the impact of liability concerns during a professional liability crisis on Pennsylvania residents' decisions regarding their future practice. It was hypothesized that liability concerns would negatively affect Pennsylvania residents' propensity to practice in the state following residency.Statewide mail surveys were completed in 2003 by 68 Pennsylvania residency program directors and 360 residents nearing the end of their training in anesthesiology, general surgery, emergency medicine, obstetrics and gynecology, orthopedics, and radiology residencies.One third of residents in their final or next-to-last year of residency planned to leave Pennsylvania because of the lack of availability of affordable malpractice coverage. Although, in general, residents' geographic decisions are influenced by a range of factors, those who are about to leave Pennsylvania named malpractice costs as the primary reason 3 times more often than any other factor. Seventy-one percent of residency program directors reported a decrease in retention of residents in the state since the onset of the professional liability crisis. For some programs the decreases were very large.An environment of mounting liability costs in Pennsylvania appears to have dissuaded substantial numbers of residents in high-risk specialties from locating their clinical practices in the state. The impact of decreased resident retention on the future availability of specialist services in high-cost states merits close monitoring.
View details for DOI 10.1097/01.AOG.0000163255.56004.b5
View details for Web of Science ID 000229361200003
View details for PubMedID 15932819
Fostering rational regulation of patient safety
JOURNAL OF HEALTH POLITICS POLICY AND LAW
2005; 30 (3): 375-426
After decades of inattention to the problem of medical injuries, patient safety is now occupying a prominent place on the health policy agenda and garnering renewed regulatory interest. Health care providers' behavior, with respect to patient safety and health care quality improvement, is now being shaped by top-down regulation through statutes and administrative agency oversight, as well as bottom-up drivers such as tort litigation and the forces of the consumer-driven health care market. Patient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public; it also demonstrates the difficulties of coordinating regulatory signals from multiple sources and regulating incomplete information. This article reviews the evolution of the regulatory environment for patient safety, examines some of the tensions and challenges that currently define patient safety oversight, and suggests strategies for more rational and responsive regulation.
View details for Web of Science ID 000237158400004
View details for PubMedID 16089110
Defensive medicine among high-risk specialist physicians in a volatile malpractice environment
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2005; 293 (21): 2609-2617
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.To study the prevalence and characteristics of defensive medicine among physicians practicing in high-liability specialties during a period of substantial instability in the malpractice environment.Mail survey of physicians in 6 specialties at high risk of litigation (emergency medicine, general surgery, orthopedic surgery, neurosurgery, obstetrics/gynecology, and radiology) in Pennsylvania in May 2003.Number of physicians in each specialty reporting defensive medicine or changes in scope of practice and characteristics of defensive medicine (assurance and avoidance behavior).A total of 824 physicians (65%) completed the survey. Nearly all (93%) reported practicing defensive medicine. "Assurance behavior" such as ordering tests, performing diagnostic procedures, and referring patients for consultation, was very common (92%). Among practitioners of defensive medicine who detailed their most recent defensive act, 43% reported using imaging technology in clinically unnecessary circumstances. Avoidance of procedures and patients that were perceived to elevate the probability of litigation was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years, including eliminating procedures prone to complications, such as trauma surgery, and avoiding patients who had complex medical problems or were perceived as litigious. Defensive practice correlated strongly with respondents' lack of confidence in their liability insurance and perceived burden of insurance premiums.Defensive medicine is highly prevalent among physicians in Pennsylvania who pay the most for liability insurance, with potentially serious implications for cost, access, and both technical and interpersonal quality of care.
View details for Web of Science ID 000229443400019
View details for PubMedID 15928282
Academic medical centers' standards for clinical-trial agreements with industry
NEW ENGLAND JOURNAL OF MEDICINE
2005; 352 (21): 2202-2210
Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.Of 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent).Standards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.
View details for Web of Science ID 000229333300008
View details for PubMedID 15917385
- The experience of a community representative on an ethics consult team JOURNAL OF CLINICAL ETHICS 2004; 15 (3): 296-301
Are damages caps regressive? A study of malpractice jury verdicts in California
2004; 23 (4): 54-67
Caps on damages have emerged as the most controversial legislative response to the new malpractice crisis. We analyzed a sample of high-end jury verdicts in California that were subjected to the state's dollars 250,000 cap on noneconomic damages. We found strong evidence that the cap's fiscal impact was distributed inequitably across different types of injuries. In absolute dollar terms, the reductions imposed on grave injury were seven times larger than those for minor injury; the largest proportional reductions were for injuries that centered on pain and disfigurement. Use of sliding scales of damages instead of or in conjunction with caps would mitigate their adverse impacts on fairness.
View details for DOI 10.1377/hlthaff.23.4.54
View details for Web of Science ID 000222499600007
View details for PubMedID 15318567
Caring for patients in a malpractice crisis: Physician satisfaction and quality of care
2004; 23 (4): 42-53
The rhetoric of malpractice reform is at fever pitch, but political advocacy does not necessarily reflect grassroots opinion. To determine whether the ongoing liability crisis has greatly reduced physicians' professional satisfaction, we surveyed specialist physicians in Pennsylvania. We found widespread discontent among physicians practicing in high-liability environments, which seems to be compounded by other financial and administrative pressures. Opinion alone should not determine public policy, but physicians' perceptions matter for two reasons. 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.
View details for DOI 10.1377/hlthaff.23.4.42
View details for Web of Science ID 000222499600006
View details for PubMedID 15318566
Medical malpractice as an epidemiological problem
SOCIAL SCIENCE & MEDICINE
2004; 59 (1): 39-46
The notion that the tort liability system deters negligence in health care has been invoked to make the "business case for patient safety." However, existing data on the relationship between hospital adverse events and malpractice claims typically are interpreted as evidence that the tort system does not deter negligence because of the poor fit between those who are negligently injured and those who sue. Using a familiar analogy from epidemiology--the problem of false positives in screening tests for rare diseases--and data from two large studies of medical injuries and malpractice claims in the United States, this paper presents an argument that the standard interpretation overlooks a complexity in the data. Although most malpractice claims do not actually involve a negligent injury, a patient who suffers a negligent injury is more than 20 times more likely, on average, to file a claim than a patient who does not. However, because malpractice claiming is a rare event with many false positives, for the average hospital or group practice, even substantial improvements in rates of negligent injury will not lead to a large reduction in claims rates. These findings suggest that the strength of the business case for patient safety depends on the perspective from which one views the data.
View details for DOI 10.1016/j.socscimed.2003.09.034
View details for Web of Science ID 000221190600004
View details for PubMedID 15087141
Decision making and satisfaction with care in the pediatric intensive care unit: findings from a controlled clinical trial.
Pediatric critical care medicine
2004; 5 (1): 40-47
To facilitate critical decision making and improve satisfaction with care among families of patients in a pediatric intensive care unit.Prospective observational study followed by a nonrandomized controlled trial of a clinical intervention to identify conflicts and facilitate communication between families and the clinical team.The pediatric intensive care unit of a Boston teaching hospital.A total of 127 patients receiving care in the pediatric intensive care unit in 1998-1999 and their families.Interviews were conducted with surrogates and decisionally capable older children concerning the adequacy of information provided, understanding, communication, and perceived decisional conflicts. Findings were relayed to the clinical team, who then developed tailored follow-up recommendations.A survey administered to surrogates at baseline and day 7 or intensive care unit discharge measured satisfaction with care. Information on patient acuity and hospital stay were extracted from medical records and hospital databases. Wilcoxon rank-sum tests and incidence rate comparisons were used to assess the impact of the intervention on satisfaction and sentinel decision making, respectively. Incidence rates of care plan decision making, including decisions to adopt a comfort-care-only plan and decisions to forego resuscitation, were lower among families who received the intervention. The intervention did not significantly affect satisfaction with care.Prospectively screening for and intervening to mitigate potential conflict did not increase decision making or parental satisfaction with the care provided in this pediatric intensive care unit.
View details for PubMedID 14697107
From the field - Hospitals' behavior in a tort crisis: Observations from Pennsylvania
2003; 22 (6): 225-233
View details for Web of Science ID 000186632200029
Hospitals' behavior in a tort crisis: observations from Pennsylvania.
2003; 22 (6): 225-233
Pennsylvania, like many states around the country, is in the throes of a "tort crisis." The cost of professional liability insurance for physicians and hospitals is escalating rapidly, as its availability shrinks. Many hospitals are poorly situated to bear these rising costs, especially in an environment of flat reimbursement rates and poor investment returns. This paper examines the impact of the liability crisis on Pennsylvania hospitals and the strategies being used to weather the storm, including alternative risk financing and closer ties between hospitals and affiliated physicians. It concludes by connecting these trends to larger medical malpractice policy issues.
View details for PubMedID 14649450
Trends - The McLawsult: The fast-food industry and legal accountability for obesity
2003; 22 (6): 207-216
Recent litigation brought by a group of overweight children against the McDonald's Corporation that seeks compensation for obesity-related health problems has provoked an intense public response. Many have derided this lawsuit as representing the worst excesses of the tort liability system, while others have drawn parallels to tobacco litigation. Fast-food litigation raises the question of where accountability for the economic and public health consequences of obesity properly rests. 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.
View details for Web of Science ID 000186632200027
View details for PubMedID 14649448
Work hours reform: Perceptions and desires of contemporary surgical residents
JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
2003; 197 (4): 624-630
New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. General surgery residents, because of their long duty hours, are likely to be among those most affected by changes imposed to comply with the ACGME requirements. There are few contemporary data on their attitudes toward work hours reform.The study entailed a region-wide survey of residents enrolled in general surgery residencies in New England to characterize the perceptions and desires of surgical residents on the issue of work hours reform.Respondents reported working a mean of 105 +/- 0.7 hours per week, considerably more than the 80-hour limit stipulated by the ACGME. Of the respondents, 81% reported that sleep deprivation had negatively affected their work. A strong majority of respondents believe that work hours reform would improve their quality of life but less than one half expect it to have a positive impact on patient care. A greater percentage of senior residents than junior residents (p < 0.05) have negative perceptions of work hour limitations, particularly with respect to consequences for patient care. Other findings suggest that residents who have actually experienced work hour restrictions are less positive about such restrictions than these residents who had not yet experienced them.Changes imposed by residency programs to comply with work hour requirements might have detrimental effects on senior residents and patient care. The impact of such changes should be carefully monitored as the ACGME requirements are implemented.
View details for DOI 10.1016/S1072-7515(03)00602-1
View details for Web of Science ID 000185765700019
View details for PubMedID 14522334
Conflict in the care of patients with prolonged stay in the ICU: types, sources, and predictors
INTENSIVE CARE MEDICINE
2003; 29 (9): 1489-1497
To determine types, sources, and predictors of conflicts among patients with prolonged stay in the ICU.We prospectively identified conflicts by interviewing treating physicians and nurses at two stages during the patients' stays. We then classified conflicts by type and source and used a case-control design to identify predictors of team-family conflicts.Seven medical and surgical ICUs at four teaching hospitals in Boston, USA.All patients admitted to the participating ICUs over an 11-month period whose stay exceeded the 85th percentile length of stay for their respective unit ( n=656).Clinicians identified 248 conflicts involving 209 patients; hence, nearly one-third of patients had conflict associated with their care: 142 conflicts (57%) were team-family disputes, 76 (31%) were intrateam disputes, and 30 (12%) occurred among family members. Disagreements over life-sustaining treatment led to 63 team-family conflicts (44%). Other leading sources were poor communication (44%), the unavailability of family decision makers (15%), and the surrogates' (perceived) inability to make decisions (16%). Nurses detected all types of conflict more frequently than physicians, especially intrateam conflicts. The presence of a spouse reduced the probability of team-family conflict generally (odds ratio 0.64) and team-family disputes over life-sustaining treatment specifically (odds ratio 0.49).Conflict is common in the care of patients with prolonged stays in the ICU. However, efforts to improve the quality of care for critically ill patients that focus on team-family disagreements over life-sustaining treatment miss significant discord in a variety of other areas.
View details for DOI 10.1007/s00134-003-1853-5
View details for Web of Science ID 000185665800015
View details for PubMedID 12879243
Nature of conflict in the care of pediatric intensive care patients with prolonged stay
2003; 112 (3): 553-558
To determine the frequency, types, sources, and predictors of conflict surrounding the care of pediatric intensive care unit (PICU) patients with prolonged stay.A tertiary care, university-affiliated PICU in Boston.All patients admitted over an 11-month period whose stay exceeded 8 days (the 85th percentile length of stay for the PICU under study), and intensive care physicians and nurses who were responsible for their care.We prospectively identified conflicts by interviewing the treating physicians and nurses at 2 stages during the patients' PICU stay. All conflicts detected were classified by type (team-family, intrateam, or intrafamily) and source. Using a case-control design, we then identified predictors of conflict through bivariate and multivariate analyses.We enrolled 110 patients based on the length-of-stay criterion. Clinicians identified 55 conflicts involving 51 patients in this group. Hence, nearly one half of all patients followed had a conflict associated with their care. Thirty-three of the conflicts (60%) were team-family, 21 (38%) were intrateam, and the remaining 1 was intrafamily. The most commonly cited sources of team-family conflict were poor communication (48%), unavailability of parents (39%), and disagreements over the care plan (39%). Medicaid insurance status was independently associated with the occurrence of conflict generally (odds ratio = 4.97) and team-family conflict specifically (odds ratio = 7.83).Efforts to reduce and manage conflicts that arise in the care of critically ill children should be sensitive to the distinctive features of these conflicts. Knowledge of risk factors for conflict may also help to target such interventions at the patients and families who need them most.
View details for Web of Science ID 000185035100027
View details for PubMedID 12949283
Patient safety and medical malpractice: A case study
ANNALS OF INTERNAL MEDICINE
2003; 139 (4): 267-273
The system of tort liability for medical malpractice is frequently criticized for poorly performing its theoretical functions of compensating injured patients, deterring negligence, and dispensing corrective justice. Working from an actual malpractice case involving serious injury but no apparent negligence, the authors explore these criticisms from the perspectives of both the plaintiff-patient and the defendant-physician. They then examine the tort system through the lens of patient safety and conclude that the tensions between the system and patient safety initiatives suggest a need to reexamine our attachment to adversarial dispute resolution in health care. They propose targeted reforms that could improve the functioning of the system and create incentives to improve safety and quality.
View details for Web of Science ID 000184795600005
View details for PubMedID 12965982
Results of a clinical trial on care improvement for the critically ill
CRITICAL CARE MEDICINE
2003; 31 (8): 2107-2117
To develop, deploy, and evaluate an intervention designed to identify and mitigate conflict in decision making in the intensive care unit.Nonrandomized, controlled trial.Seven intensive care units at four Boston teaching hospitals.A total of 1,752 critically ill patients, including 873 study cases analyzed here.Social workers interviewed families of patients deemed at high risk for decisional conflict and provided feedback to the clinical team, who then implemented measures to address the problems identified.Patient or surrogate satisfaction with intensive care unit care and the probability of choosing a specific plan for treatment in the intensive care unit was studied. Inclusion criteria identified 873 patients at risk for decisional conflict. Thirty-nine percent of the patients in the intervention phase of the study (172 patients) received the intervention. In multivariate analyses, receiving the intervention significantly increased the likelihood of deciding to forgo resuscitation (odds ratio [OR] = 1.81, p =.017), the likelihood of choosing a treatment plan for comfort-care only (OR = 1.94, p =.018), and the likelihood of choosing an aggressive-care treatment plan (OR = 2.30, p =.002). Receiving the intervention did not significantly affect overall satisfaction with the care provided (OR = 0.68, p =.14), satisfaction with the amount of information provided (OR = 0.86, p =.44), or satisfaction with the degree of involvement in decision making (OR = 0.84, p =.54).Although there was no impact on patient or surrogate satisfaction with care provided in the intensive care unit, the intervention did facilitate deliberative decision making in cases deemed at high risk for conflict. 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.
View details for DOI 10.1097/01.CCM.0000069732.65524.72
View details for Web of Science ID 000184797600005
View details for PubMedID 12973167
The rise of litigation in human subjects research
ANNALS OF INTERNAL MEDICINE
2003; 139 (1): 40-45
Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.
View details for Web of Science ID 000183823200006
View details for PubMedID 12834317
Understanding biased selection in Medicare HMOs
HEALTH SERVICES RESEARCH
2003; 38 (3): 961-992
To investigate the extent of favorable health maintenance organization (HMO) selection for a longitudinal cohort of Medicare beneficiaries, examine whether the extent of favorable selection varies with the degree of Medicare HMO market penetration in a county, and explain conflicting findings in the literature on favorable HMO selection.A panel of 1992-1996 data from the Medicare Current Beneficiary Survey (MCBS), supplemented with linked data from the Area Resource File and Medicare administrative datasets.Using random effects probit estimation, we model a beneficiary's HMO enrollment status as a function of self-reported health status and Medicare HMO market penetration.The MCBS data for beneficiaries residing in states served by Medicare HMOs in 1992-1996 were linked by county to the supplementary datasets.We find that favorable selection persists in the cohort over time on some, but not all, measures. We find no substantial association between favorable HMO selection and HMO market penetration. We find that conflicting findings in the literature on favorable HMO selection may be explained by several methodological choices, including the choice of health status measure and the structure of the sample.Our results support further risk adjustment of the adjusted average per capita cost (AAPCC) payment formula.
View details for Web of Science ID 000183315500012
View details for PubMedID 12822921
Implementing resident work hour limitations - Lessons from the New York State experience
ANNALS OF SURGERY
2003; 237 (4): 449-455
To determine the impact of work hour limitations imposed by the 405 (Bell) Regulations as perceived by general surgery residents in New York State.New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. State regulations stipulating similar resident work hour limitations have already been enacted in New York.A statewide survey of residents enrolled in general surgery residencies in New York was administered.Most respondents reported general compliance with 405 Regulations in their residency programs, a finding corroborated by reported work hours and call schedules. Whereas a majority of residents reported improved quality of life as a result of the work hour limitations, a substantial portion reported negative impacts on surgical training and quality and continuity of patient care. Negative perceptions of the impact of duty hour restrictions were more prevalent among senior residents and residents at academic medical centers than among junior residents and residents at community hospitals.Implementation of resident work hour limitations in general surgery residencies may have negative consequences for patient care and resident education. As surgical residency programs develop strategies for complying with ACGME requirements, these negative consequences must be addressed.
View details for Web of Science ID 000185834400001
View details for PubMedID 12677136
Reduced medicolegal risk by compliance with obstetric clinical pathways: A case-control study
OBSTETRICS AND GYNECOLOGY
2003; 101 (4): 751-755
To estimate whether guideline compliance affected medicolegal risk in obstetrics and whether malpractice claims data can provide useful information on guideline noncompliance by focusing on the claims experience of a large health system delivering approximately 12000 infants annually.We retrospectively identified 290 delivery-related (diagnosis-related groups 370-374) malpractice claims and 262 control deliveries at the health system during the period from 1988 to 1998. Clinical pathways for vaginal and cesarean delivery implemented in 1998 were used as a "standard of care." We compared rates of noncompliance with the pathways in the claims and control groups, calculated an odds ratio for increased risk of being sued given departure from the guideline standards, and calculated the elevated risk of litigation introduced by noncompliance. We also compared the frequencies of different types of departures across claims and control groups.Claims closely resembled controls on several descriptive measures (mother's age, location of delivery, type of delivery, and complication rates), but noncompliance with the clinical pathway was significantly more common among claims than controls (43.2% versus 11.7%, P <.001; odds ratio = 5.76, 95% confidence interval 3.59, 9.2). In 81 (79.4%) of the claims involving noncompliance with the pathway, the main allegation in the claim related directly to the departure from the pathway. The excess malpractice risk attributable to noncompliance explained approximately one third (104 of 290) of the claims filed (attributable risk = 82.6%). There were no significant differences in the types of deviation from the guidelines across claims and control groups.In addition to reducing clinical variation and improving clinical quality of care, adherence to clinical pathways might protect clinicians and institutions against malpractice litigation. Malpractice data might also be a useful resource in understanding breakdowns in processes of care.
View details for DOI 10.1016/S0029-7844(02)03129-0
View details for Web of Science ID 000181899700023
View details for PubMedID 12681881
The leapfrog standards: Ready to jump from marketplace to courtroom?
2003; 22 (2): 46-59
The Leapfrog Group, a consortium of large employers, aims to use its collective purchasing power to motivate hospitals to implement particular measures designed to improve patient safety and the quality of care. While these criteria are meant to be purely aspirational, and while Leapfrog's effort is praiseworthy, we caution that the articulation of these standards of care may have unintended legal consequences. Efforts by aggressive medical malpractice attorneys could rapidly transform Leapfrog's standards from marketplace advantages for compliant hospitals to performance expectations required by law. This undesirable potential outcome compounds the importance of selecting these standards with the utmost care.
View details for Web of Science ID 000181450400011
View details for PubMedID 12674407
Medical monitoring for pharmaceutical injuries - Tort law for the public's health?
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2003; 289 (7): 889-894
A remarkable development in personal injury litigation in recent years involves attempts to expand legal claims beyond existing injuries to anticipated future harms. Attorneys have begun to sue on behalf of individuals exposed to defective pharmaceutical products who have no current injury, but who may be at risk for developing one after a latency period. This strategy seeks to make drug manufacturers pay for medical monitoring, a court-ordered program that provides diagnostic tests to exposed individuals to facilitate early detection of adverse health effects. Because medical monitoring does not depend on the existence of an actual injury and large populations may be exposed, some commentators have warned that it has the potential to spiral out of control. We examine medical monitoring in the context of 2 major cases involving diet drugs and an oral hypoglycemic drug. We conclude that this expansion of tort law should be applied sparingly, but that the performance of courts to date in these cases gives cause for optimism. Judges appear to be paying close attention to sophisticated epidemiological, clinical, and cost-effectiveness considerations. Medical monitoring arms the courts with a new mechanism for addressing harms proactively rather than reactively, which could yield new victories for public health.
View details for Web of Science ID 000181072200034
View details for PubMedID 12588274
Do Medicare HMOs still reduce health services use after controlling for selection bias?
2002; 11 (4): 323-340
This study models the relationship between Medicare beneficiary decisions to join Medicare HMOs and subsequent health services utilization. The relationship between health plan choice and utilization is thought to be endogenous because of favorable selection into HMOs. Previous studies found significantly lower inpatient utilization among Medicare HMO enrollees than among nonenrollees, but lacked strong controls for selection bias. Thus, a firm conclusion could not be drawn as to whether the observed differences were attributable to the HMO practice setting or to baseline differences in the illness profiles of the two groups studied. The present study uses simultaneous equations methods, including discrete factor estimation, to test the effect of Medicare HMOs on utilization when strong controls for selection bias are imposed. The model was run on a panel of 1993-1996 data from the Medicare Current Beneficiary Survey, supplemented with linked data on Medicare HMO characteristics and area supply characteristics. The study found that even when favorable selection is controlled for, Medicare HMOs significantly reduce both the probability of hospitalization and the number of inpatient days used by those who are hospitalized. Medicare HMOs do not, however, appear to reduce the use of physician services.
View details for DOI 10.1002/hec.664
View details for Web of Science ID 000175873700003
View details for PubMedID 12007164
Policing Medicaid and Medicare managed care: The role of courts and administrative agencies
JOURNAL OF HEALTH POLITICS POLICY AND LAW
2002; 27 (3): 465-494
The much-publicized 2000 case of Frew v. Gilbert, in which a federal judge castigated the State of Texas for deficiencies in its Medicaid program, brought renewed attention to the issue of regulating the quality of care in Medicaid and Medicare HMOs. Frew and other recent cases highlight both the promise and the pitfalls of relying on courts to correct deficiencies in public managed care programs. This article argues that while litigation over inadequacies in Medicare and Medicaid managed care can serve an important signaling function in alerting agencies and legislatures about the need for reform, the role of the courts in policing public managed care is circumscribed by several constraints. Barriers to class action litigation and differences in the institutional capacities of courts and administrative agencies mean that litigation is best viewed as a supplement, not an alternative, to a renewed commitment to strong quality monitoring on the part of Centers for Medicare and Medicaid Services and state Medicaid agencies.
View details for Web of Science ID 000176264400006
View details for PubMedID 12092677
Deterrence of medical errors: Theory and evidence for malpractice reform
TEXAS LAW REVIEW
2002; 80 (7): 1595-1637
View details for Web of Science ID 000176824900004
The controversy over high-dose chemotherapy with autologous bone marrow transplant for breast cancer
2001; 20 (5): 101-117
In the 1990s more than 41,000 patients underwent high-dose chemotherapy plus autologous bone marrow transplant (HDC-ABMT) for breast cancer, despite a paucity of clinical evidence of its efficacy. Most health plans reluctantly agreed to cover the treatment in response to intensive political lobbying and the threat of litigation. The results of five recent major randomized trials showed that HDC-ABMT offers no advantage over standard-dose treatment for breast cancer. Our experience with HDC-ABMT coverage cautions against allowing politics to overwhelm science in the area of evaluating experimental procedures, and against relying on the courts as a means of resolving disagreements about coverage of these interventions.
View details for Web of Science ID 000170862800010
View details for PubMedID 11558695
- Demystifying the law/science disconnect JOURNAL OF HEALTH POLITICS POLICY AND LAW 2001; 26 (2): 429-438
Of swords and shields: The role of clinical practice guidelines in medical malpractice litigation
UNIVERSITY OF PENNSYLVANIA LAW REVIEW
2001; 149 (3): 645-710
View details for Web of Science ID 000167553100001