Melbourne School of Population and Global Health - Research Publications

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    Claims, errors, and compensation payments in medical malpractice litigation
    Studdert, DM ; Mello, MM ; Gawande, AA ; Gandhi, TK ; Kachalia, A ; Yoon, C ; Puopolo, AL ; Brennan, TA (MASSACHUSETTS MEDICAL SOC, 2006-05-11)
    BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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    Academic medical centers' standards for clinical-trial agreements with industry
    Mello, MM ; Clarridge, BR ; Studdert, DM (MASSACHUSETTS MEDICAL SOC, 2005-05-26)
    BACKGROUND: 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. METHODS: We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors. RESULTS: 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). CONCLUSIONS: 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.
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    On selling "no-fault"
    STUDDERT, D ; Sharpe, VA (Georgetown University Press, 2004)
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    External review of coverage denials in managed care
    Gresenz, CR ; STUDDERT, D ( 2005)
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    Who Pays for Medical Errors? An Analysis of Adverse Event Costs, the Medical Liability System, and Incentives for Patient Safety Improvement
    Mello, MM ; Studdert, DM ; Thomas, EJ ; Yoon, CS ; Brennan, TA (Wiley, 2007-12)
    Patient safety advocates argue that the high costs of adverse events create economic incentives for hospitals to invest in safety improvements. However, this may not be the case if hospitals externalize the bulk of these costs. Analyzing data on 465 hospital adverse events derived from medical record reviews, we investigated the amounts that hospitals and other payers incurred in medical‐injury‐related expenses. On average, the sampled hospitals generated injury‐related costs of $2,013, and negligent‐injury‐related costs of $1,246, per discharge. However, hospitals bore only 22 percent of these costs. Legal reforms or market interventions may be required to address this externalization of injury costs.
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    Liability, Patient Safety, and Defensive Medicine What Does the Future Hold?
    Brennan, TA ; Mello, MM ; Studdert, DM ; Sage, WM ; Kersh, R (CAMBRIDGE UNIV PRESS, 2006)