The Problem of Medical Misadventures: A Review of E. Haavi Morreim's Holding Health Care Accountable

See the proposal for a no-fault compensation system, Studdert D.M. Brennan T.A. , “No-Fault Compensation for Medical Injuries: The Prospect for Error Prevention,” JAMA, 286 (2001): 217–23.

and the critical response by Sage W.M. , “Principles, Pragmatism and Medical Injury,” JAMA, 286 (2001): 226–28.

Kohn L.T. Corrigan J.M. Donaldson M.S. , eds., Committee on Quality of Health Care in America, Institute of Medicine, To Err Is Human: Building a Safer Health System (Washington, D.C.: National Academy Press, 2000), available at <http://books.nap.edu/books/0309068371/html/R1.html#pagetop> [hereafter cited as IOM Report].

The IOM report projected up to 98,000 deaths per year attributable to medical error. This projection has recently been criticized as based on a methodology that is likely to overstate the death rate. See Hayward R.A. Hofer T.P. , “Estimating Hospital Deaths Due to Medical Errors: Preventability Is in the Eye of the Reviewer,” JAMA, 286 (2001): 415–20.

Latham S.R. , “System and Responsibility: Three Readings of the IOM Report on Medical Error,” American Journal of Law & Medicine, 27 (2001): 163–179, at 177 (“If the point of the tort law of medical malpractice is not the redress of wrong, but is instead the prevention of medical harm, then it only makes sense to give medical error to medicine, which is manifestly better situated than law to investigate the root causes of error and to extirpate them.”).

“Patient safety is also hindered through the liability system and the threat of malpractice, which discourages the disclosure of errors. The discoverability of data under legal proceedings encourages silence about errors committed or observed. Most errors and safety issues go undetected and unreported, both externally and within health care organizations.” IOM Report, supra note 2, at 43.

See for example Edmondson A.C. , “Learning from Mistakes Is Easier Said Than Done: Group and Organizational Influences on the Detection and Correction of Human Error,” Journal of Applied Behavioral Science, 32, no. 1 (1996): 5–27, at 24–25 (Surfacing of medical errors depends on the team leaders' attitudes; the primary influence on detected errors in the health-care setting is the unit members' willingness to discuss mistakes openly, and more accessible and open managers seem to elicit error disclosure at higher levels. More authoritarian leaders inhibit candid discussions and willingness of staff to reveal and discuss mistakes openly.);.

Edmondson A.C. Bohmer R.M. Pisano G. , “Disrupted Routines: Team Learning and New Technology Implementation in Hospitals” (unpublished paper, April 24, 2001, on file with author) (importance of team leaders in the successful implementation of new medical technologies).

Galanter M. , “Real World Torts: An Antidote to Anecdote,” Maryland Law Review, 55 (1996): 1093–160.

“[H]eavier reliance on the tort system signifies not only what the United States has more of, but also what it has less of. Compared to our industrialized counterparts, we do not have an administrative state with intensive governmental regulation of risks, nor do we have a comprehensive welfare state. … In short, our greater reliance on tort reflects not greater generosity to victims, but less reliance on administrative controls and social insurance.” Id. at 1141.

“Softening the tort signal will also change only those practices that are consciously motivated by fear of liability.” Office of Technology Assessment, 103rd Cong., Defensive Medicine and Medical Malpractice, OTA-H-602 (Washington, D.C.: Office of Technology Assessment, 1994): At 198.

Galanter argues that by dulling the tort signal to physicians, they will alter their behavior less, thus reducing potentially beneficial defensive medicine and resulting in medicine with less clinical value. Galanter, supra note 7, at 1094.

See also Trebilcock M.J. , “Incentive Issues in the Design of ‘No-Fault’ Compensation Systems,” University of Toronto Law Journal, 39 (1989): 19–54.

“[T]he notion that the consequences of accidents, and perhaps other classes of misfortunes, should be solely a community rather than an individual responsibility ignores the fact that accident (or misfortune) rates are often significantly influenced by the conduct of individuals, which targeted pricing and benefit policies and a residual role for the tort system are likely to influence significantly. In short, it is assumed, without justification, that economic incentives do not influence individual behavior. Neither theory nor empirical evidence supports this assumption.” Id. at 53.

Evidence exists in the product area that liability promotes innovation, at least for firms with lower liability costs. See Viscusi W.K. Moore M.J. , “Rationalizing the Relationship Between Product Liability and Innovation,” in Schuck P.H. , ed., Tort Law and the Public Interest: Competition, Innovation and Consumer Welfare (New York: Norton, 1991): At 123.

I made this point recently in Furrow B.R. , “Pain Management and Provider Liability: No More Excuses,” Journal of Law, Medicine & Ethics, 29, no. 1 (2001): 28–51, at 31–33.

Furrow , supra note 11, at 30.

Galanter , supra note 7, at 1160.

Morreim H. , Holding Health Care Accountable: Law and the New Medical Marketplace (New York: Oxford University Press, 2001).

Id. at 6.

Id. at ix.

Id. at 186.

Id. at 5.

Id. at 57.

Id. at 59.

Havighurst C.C. , “The Backlash Against Managed Health Care: Hard Politics Make Bad Policy,” Indiana Law Review, 34 (2001): 395–417, at 415–16 at 415(proposing a default rule to make health plans vicariously and exclusively liable for medical malpractice and other torts committed by the health providers it procures to treat its enrollees).

Morreim , supra note 14, at 60.

Id. at 61.

Id.

Id. at 64.

Id. at 69.

Id.

Id. at 72.

Id. at 79.

Id. at 86.

Id. at 95.

Id.

Id. at 98.

Id. at 125.

Id. at 113.

Id. at 114.

See Epstein R. , Mortal Peril: Our Inalienable Right to Health Care? (Reading, Massachusetts: Addison-Wesley Publishing Co., 1999).

Morreim , supra note 14, at 130.

Id. at 131.

Id. at 134.

Id. at 136.

Id. at 146.

Id. at 147.

Id. at 166.

Mertens v. Hewitt Associates, 508 U.S. 248 (1993).

Jacob J.A. , “Consumer-Driven Health Plans Could Mean End of Capitation,” American Medical News, August 13, 2001, at 15, 18.

Furrow B.R. , “The Changing Role of the Law in Promoting Quality in Health Care: From Sanctioning Outlaws to Managing Outcomes,” Houston Law Review, 26 (1989): 147–90.

American Healthways is one example. It is the leading provider of specialized comprehensive care enhancement services to health plans, physicians, and hospitals, including managing patients with diabetes, cardiac conditions, and other health problems. Part of its strategy is the use of the Internet to increase patients' compliance with their medications through reminders and other interventions. See <http://www.americanhealthways.com> (last visited August 24, 2001).

“No End in Sight to Rising Premiums, Wall Streeters Say,” Medicine & Health, 55, no. 29 (2001): 7–8, at 8.

Becher E.C. Chassin M.R. , “Improving Quality, Minimizing Error: Making It Happen,” Health Affairs, 20, no. 3 (2001): 68–81 (noting barriers to change that include little demand for higher quality by consumers or their representatives, lack of information technology to integrate all the components of a health-care system, and skewed financial incentives, since savings are realized by third parties and not the provider engaged in quality improvement).

I have written previously about drug liability. See Furrow B.R. , “Enterprise Liability for Bad Outcomes from Drug Therapy: The Doctor, the Hospital, the Pharmacy, and the Drug Firm,” Drake Law Review, 44 (1996): 377–437. The ideas in this section are derived in large part from the earlier article.

See IOM Report. See also Bates D.W. , “A 40-Year-Old Woman Who Noticed a Medication Error,” JAMA, 285 (2001): 3134–40;.

Kaushal R. , “Medication Errors and Adverse Drug Events in Pediatric Patients,” JAMA, 285 (2001): 2114–20. Researchers found that errors occurred in 5.7 percent of the medication orders during the care of 1,120 pediatric patients admitted to two urban teaching hospitals in 1999.

The rate of potential adverse drug events, or ADEs — that is, errors caught before medication was administered to a child — was three times the rate of potential ADEs found in a similar study of hospitalized adults. Doctors handwrote orders, and copies were sent to the pharmacy. Physician reviews determined that computerized physician order entry and decision support could have prevented 93 percent of potential ADEs. Ward-based clinical pharmacists participating in ward rounds could have prevented 94 percent of potential ADEs. Kids have more limited internal reserves to buffer errors and poorer communication skills in warning clinicians about potential mistakes. Id.

Burling S. , “Lab Error Blamed in Pair of Deaths,” Philadelphia Inquirer, August 16, 2001, at A1, A11.

See “Unfilled Jobs in Pharmacies Raise Fears of Drug Errors,” New York Times, August 26, 2001, at 25.

Restatement (Third) of Torts: Products Liability § 6 (1998):.

(a) A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective drug or medical device is subject to liability for harm to persons caused by the defect. A prescription drug or medical device is one that may be legally sold or otherwise distributed only pursuant to a health care provider's prescription.

(b) For purposes of liability under Subsection (a), a prescription drug or medical device is defective if at the time of sale or other distribution the drug or medical device:.

(1) contains a manufacturing defect as defined in § 2(a); or.

(2) is not reasonably safe due to defective design as defined in Subsection (c); or.

(3) is not reasonably safe due to inadequate instructions or warnings as defined in Subsection (d).

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

(d) A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:.

(1) prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or.

(2) the patient when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

(e) A retail seller or other distributor of a prescription drug or medical device is subject to liability for harm caused by the drug or device if:.

(1) at the time of sale or other distribution the drug or medical device contains a manufacturing defect as defined in § 2(a); or.

(2) at or before the time of sale or other distribution of the drug or medical device the retail seller or other distributor fails to exercise reasonable care and such failure causes harm to persons.

Section 6 requires that a plaintiff advancing a design defect claim involving a prescription drug or medical device prove that the foreseeable risk of harm is so great, in relation to foreseeable therapeutic benefits, that no reasonable health care provider, knowing of those risks and benefits, would prescribe the drug or medical device for any class of patients. Therefore, if a drug or medical device benefits one class of patients, it is not defective in design, even if it is harmful to other patients.

See Schwartz A. , “Proposals for Products Liability Reform: A Theoretical Synthesis,” Yale Law Journal, 97 (1988): 353–419, at 368–69.

For a critical review of strict products liability, and a proposal for enterprise liability, see Croley S.P. Hanson J.D. , “What Liability Crisis? An Alternative Explanation for Recent Events in Products Liability,” Yale Journal on Regulation, 8 (1991) 1–84.

Furrow , supra note 51, at 428.

See, e.g., Danzon P. , Medical Malpractice: Theory, Evidence and Public Policy (Cambridge, Massachusetts: Harvard University Press, 1985): at 3.

Id.

Even critics of tort litigation acknowledge the rational market responses to expanded products liability risks. Viscusi observes that “[d]ecisions to discontinue products that are the subject of litigation are rational responses to changing economic circumstances.” W.K. Viscusi, “Toward a Diminished Role for Tort Liability: Social Insurance, Government Regulation, and Contemporary Risks to Health and Safety,” Yale Journal on Regulation, 6 (1999): 65–107, at 82.

Croley Hanson , supra note 56, at 9.

Id. at 11.

See, e.g., Huber P.W. , Liability: The Legal Revolution and Its Consequences (New York: Basic Books, 1989).

The physician is also the indirect agent of the drug firm since his or her purchase orders through prescriptions generate revenues for the firm. Drug firms, therefore, have worked to influence physicians' purchase decisions, with substantial success. See Chren M. Landefeld C.S. , “Physicians' Behavior and Their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary,” JAMA, 271 (1994): 684–89 (finding that requests by physicians that drugs, be added to a hospital formulary were strongly and specifically associated with the physicians' interactions with the companies that manufactured the drugs.).

Margaret Gilhooley argues that risk information should be furnished directly to patients and that written patient labeling furnished when the drug is prescribed is more effective than physician disclosures or other alternatives. See generally Gilhooley M. , “Learned Intermediaries, Prescription Drugs, and Patient Information,” Saint Louis University Law Journal, 30(1986): 633–702.

See also Gilhooley M. , “Innovative Drugs, Products Liability, Regulatory Compliance, and Patient Choice,” Seton Hall Law Review, 24 (1994): 1481–506.

See Merrill R.A. , “Compensation for Prescription Drug Injuries,” Virginia Law Review, 59 (1973): 1–120, at 22–23 (noting that the manufacturers of MER/29 allegedly misled consumers and the FDA about the risks associated with the use of their product.).

See Ross-Degnan D. , “Examining Product Risk in Context: Market Withdrawal of Zomepirac as a Case Study,” JAMA, 270 (1993): 1937–42, at 1940.

The authors found that McNeil's advertising campaign was very effective, leading to rapid acceptance and large market share for Zomax. After several users died, McNeil sent out over 200,000 letters to physicians warning them of the side-effects. These mailed warnings had “no detectable effect on zomepirac use.”.

See Page J.A. , “Generic Product Risks: The Case Against Comment K and for Strict Tort Liability,” New York University Law Review, 58 (1983): 853–91, at 853–59. Page argues that in cases of product risks unknown at the time of sale, strict liability should be imposed as an incentive to manufacturers to improve product safety and as a means of satisfying justifiable consumer expectations.

See Latin H. , “‘Good’ Warnings, Bad Products, and Cognitive Limitations,” 41 UCLA Law Review, 1193–295, at 1270–72 (1994) (discussing cases involving over-the-counter drugs such as acetaminophen and the risks they create of kidney damage from sustained use Latin asks: “Why should the presence of a “good” warning, no matter how explicit, prevent courts from considering the value of alternative marketing strategies in light of the common tendency of people to overuse over-the-counter drugs that provide relief from chronic ailments?”).

Id. at 1271.

See Furrow , supra note 51.

See Gilhooley , “Innovative Drugs, Products Liability, Regulatory Compliance, and Patient Choice,” supra note 65.

This insurance function is generally conceded to be one of the two goals of products liability law. See generally Croley Hanson , supra note 56, at 12.

The American Law Institute, Reporters' Study: Enterprise Responsibility for Personal Injury, vol. 2, Approaches to Legal and Institutional Change (Philadelphia: American Law Institute, 1991): At 50.

Priest G.L. , “The Current Insurance Crisis and Modern Tort Law,” Yale Law Journal, 96 (1987): 1521–90, at 1553–55.

Priest G.L. , “The Invention of Enterprise Liability: A Critical History of the Intellectual Foundations of Modern Tort Law,” Journal of Legal Studies, 14 (1985): 461–528, at 520.

Priest , supra note 74, at 1537.

Croley Hanson , supra note 56, at 59–67;.

Croley S.P. Hanson J.D. , “Rescuing the Revolution: The Revived Case for Enterprise Liability,” Michigan Law Review, 91 (1993): 683–797;.

Hanson J.D. Logue K.D. , “The First-Party Insurance Externality: An Economic Justification for Enterprise Liability,” Cornell Law Review, 76 (1990) 129–96, at 137–59.

Croley Hanson , supra note 56, at 111.

Merrill , supra note 66.

Id. at 87–88.

Id. at 93.

Id. at 94.

Becher E.C. Chassin M.R. , “Improving Quality, Minimizing Error: Making It Happen,” Health Affairs, 20, no. 3 (2001): 68–81, at 78.

See also Robinson J.C. , “Blended Payment Methods in Physician Organizations under Managed Care,” JAMA, 282 (1999): 1258–63;.

Kindig D.A. , “Purchasing Population Health: Aligning Financial Incentives to Improve Health Outcomes,” Health Services Research, 33, no. 2 (1998): 223–42.

See, e.g. Kiefe C.I. , “Improving Quality Improvement Using Achievable Benchmarks for Physician Feedback,” JAMA, 285 (2001): 2871–79.

See generally Becher Chassin , supra note 82 (proposing penalties for failing to adopt computerized clinical management systems and making such clinical management hardware and software a condition of licensure, contracting, malpractice insurance policies, and reimbursement).

Robinson J.C. , “Theory and Practice in the Design of Physician Payment Incentives,” Milbank Quarterly, 79, no. 2 (2001): 149–77. Robinson concludes that the ideal payment structure for physicians would blend both prospective and retrospective payments by a mix of base salary, commission, bonuses, profit-sharing and other complex devices. He suggests a performance bonus on top of a base salary would provide a better incentive blend.

See Hyman D.A. Silver C. , “Just What the Patient Ordered: The Case for Result-Based Compensation Arrangements,” Journal of Law, Medicine & Ethics, 29, no. 2 (2001): 170–73.

For a critique of the effectiveness of such arrangements, see Morreim Haavi E. , “Result-Based Compensation in Health Care: A Good, But Limited, Idea,” Journal of Law, Medicine & Ethics, 29, no. 2 (2001): 174–81.

Committee on Quality of Health Care in America, Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century (Washington, D.C.: National Academy Press, 2001): at 194 (recommending that both private and public purchasers build in incentives for quality improvement).

Committee on Quality of Health Care in America, supra note 87, at 211–16.

See Winkelman J.W. , “Cost Savings in a Hospital Clinical Laboratory with a Pay-for-Performance Incentive Program for Supervisors,” Archives of Pathology and Laboratory Medicine, 115 (1991): 38. For an earlier discussion of such an idea,

see Furrow B.R. , “The Changing Role of the Law in Promoting Quality in Health Care: From Sanctioning Oudaws to Managing Outcomes,” Houston Law Review, 26 (1989): 147–90.

See Enthoven A. , “Managed Competition of Alternative Delivery Systems,” Journal of Health Politics, Policy and Law, 13, no. 2 (1988): 305–21.

The health accounting proposal of John Williamson requires that doctors and other professionals identify important areas of weakness in their programs, as judged by a perceived failure to achieve improvements in health status that the program should be capable of achieving. An acceptable level of health outcomes is then set for each problem selected and, after the lapse of a preset period of time, the degree of success in meeting the standards is determined. Williamson J.W. , Assessing and Improving Health Care Outcomes: The Health Accounting Approach to Quality Assurance (Cambridge, Massachusetts: Ballinger, 1978);.

Williamson J.W. Braswell H. Horn S.D. , “Validity of Medical Staff Judgments in Establishing Quality Assurance Priorities,” Medical Care, 17 (April 1979): 331–46;.

Williamson J.W. , “Priority Setting in Quality Assurance: Reliability of Staff Judgments in Medical Institutions,” Medical Care, 16 (November 1978): 931–40.

Andreas Laupacis and colleagues have proposed a “yardstick” by which to assess measures of the consequences of treatment — “the reciprocal of the absolute risk reduction (i.e., the number of patients with a given disorder that a physician must treat in order to protect one of them from the disorder's potential consequences).” Laupacis A. Sackett D.L. Roberts R.S. , “Clinically Useful Measures of the Consequences of Treatment,” N. Engl. J. Med., 318 (1988): 1728–33, at 1728.

One of the interesting early proposals, Medical Adversity Insurance, used the hospital as the basis for the compensation scheme for malpractice reform since the authors observed that it was the best central authority to manage such a system. See Havighurst C.C. Tancredi L.R. , “‘Medical Adversity Insurance’ — A No-Fault Approach to Medical Malpractice and Quality Assurance,” Milbank Memorial Fund Quarterly: Health and Society, 51 (Spring 1973): 124–68, reprinted in Insurance Law Journal (February 1974): 69–100.

Sloan F.A. , “Experience Rating: Does It Make Sense for Medical Malpractice Insurance?,” American Economic Review, 80, no. 2 (1990): 128–33.

See also Phelps C.E. , Experience Rating in Medical Malpractice Insurance, Pub. No. P-5877-1 (Santa Monica: Rand Corporation, 1978).

Kinney E.D. , “Malpractice Reform in the 1990s: Past Disappointments, Future Success?,” Journal of Health Politics, Policy and Law, 20 (1995): 99–136, at 124–25.