An eight-year-old boy sat upright on a stretcher in Exam Room 3, his damp swimsuit soaking through the disposable sheet beneath him. His face, pink and smiling, showed none of the drama unfolding around him. A few nurses paused to smile at his bright demeanor; this was hardly the scene they'd expected when the EMS call for a drowning patient had first crackled over the radio. His vital signs on the monitor were reassuringly bland: heart rate steady, at 84 beats per minute, oxygen saturation glued at 99%. His lungs were crisp and clear, devoid of even the faintest crackle or wheeze. Yet, just outside the door, two seasoned emergency physicians debated quietly. “It's textbook,” said one physician, voice firm but hushed. “Vitals normal, lung exam perfect. There's no medical reason to keep him.” The other doctor shifted uneasily. “What about secondary drowning?” she asked reflexively, knowing the phrase carried baggage but feeling its weight anyway. It was a term she'd heard since residency, repeated in hushed parental warnings and amplified online through frantic social media posts. “Secondary drowning isn't real,” the first physician responded gently but definitively. “It's folklore. Patients who drown, drown in the water. No delayed reaction days later.” He paused, softening. “But I get it. Tradition says hold them six hours, ‘just in case.’” The nurses glanced from physician to physician, awaiting instructions as monitors beeped rhythmically, indifferent to clinical uncertainty. Finally, one doctor sighed, understanding that habit often trumped logic in medicine. But tonight, the evidence would push back against fear. They knew the child looked perfect, but could they trust data over dogma? Drowning Data Revolution Medicine is no stranger to fear-driven myths, but few have been as persistently frustrating as the misconception of secondary drowning. For decades, clinicians have maintained an instinctive hesitation about discharging asymptomatic patients who experienced even brief immersion events. Tradition alone, unsupported by science, dictated prolonged observation periods for fear of unseen, delayed complications. Recent robust evidence, however, demands reconsideration of this clinical ritual. A recent study out of Australia, known as the Rapid Drowning Clearance (RDC) trial, directly challenged the dogmatic hold of secondary drowning.1 This rigorous prospective analysis included 255 pediatric patients evaluated immediately after water immersion episodes. Each child enrolled was asymptomatic at initial emergency department presentation: no abnormal vital signs, no respiratory distress, and pristine lung exams. Under the old rules, all would have faced hours of medically questionable observation. The results, however, were definitive. Among these 255 children, zero adverse events were observed during follow-up. The conclusion was clear: children who appear healthy after water immersion simply do not deteriorate unexpectedly hours later. Reinforcing these contemporary data is a classic 1997 beach surveillance series, still frequently cited as a foundational source on drowning outcomes.2 Researchers reviewed hundreds of open-water rescues and found that patients with clear lungs on initial evaluation had a mortality rate of 0%. Even decades-old data align cleanly with recent studies, reinforcing a consistent clinical truth: normal lungs at presentation predict universally favorable outcomes. This is not new thinking. In 2018, I wrote that “there has never been a case reported in medical literature of an otherwise asymptomatic and healthy child who suddenly developed serious respiratory distress or died days after being in water.”3 That remains true. And yet, the myth of delayed deterioration still holds sway in too many emergency departments. Further support comes from a well-reviewed 2019 retrospective pediatric cohort study, which examined children who appeared well after submersion and were kept under observation purely out of caution.4 Among those who remained asymptomatic at six hours, not a single one went on to develop complications. Six-hour watches in these cases don't catch emergencies—they simply manufacture cost, anxiety, and delay. The medical literature is consistent. The supposed threat of secondary drowning in asymptomatic patients has never materialized. Not one credible report exists of a healthy child deteriorating after a normal exam. The absence of evidence here isn't a research gap; it's definitive proof. As I wrote back then, “drowning is never dry.” It is immediate, visible, and physiologically obvious. The panic over hidden danger has never held up under scrutiny. Secondary drowning is not a precautionary diagnosis; it's a clinical superstition. And, like any superstition, it persists not because of data but because of habit, fear, and inertia. It's time to call it what it is and let evidence, not folklore, govern our decisions at the bedside. Emergency medicine has faced similarly entrenched fears before, particularly in the management of chest pain. Like drowning patients, those with chest pain historically faced extensive observation periods driven more by medicolegal anxiety than by clinical data. Yet here, too, compelling evidence eventually pushed back against outdated, overly cautious practice. In my first-ever In Focus column, I discussed the unnecessary hospital stays imposed by outdated chest pain protocols.5 Highlighting multiple landmark trials, the column called on physicians to trust contemporary data, which overwhelmingly support the safe, immediate discharge of many low-risk patients with chest pain. Foremost among these studies was the HiSTORIC trial of 2021, a pivotal multicenter analysis involving thousands of patients who presented to emergency departments with chest pain.6 In this study, a remarkable 71% of participants were safely discharged after brief evaluations, with no subsequent increase in heart attacks or deaths within 30 days. Outcomes improved, beds were freed, and patient satisfaction soared. Other influential research has established that ultra-rapid high-sensitivity troponin assays safely eliminate prolonged observation in patients presenting with chest pain. Zero- and one-hour protocols boast a negative predictive value of 99.5%, effectively indistinguishable from absolute certainty. Yet, despite clear proof of safety, these pathways continue to meet fierce resistance from emergency physicians raised on the HEART Score and hesitant to relinquish ingrained habits. The culprit is an entrenched cultural mindset fixated on zero-risk clinical practice, an impossible standard that medicine cannot, and should not, sustain. Physicians must embrace the challenge of reorienting clinical thinking around data-driven certainty rather than medicolegal anxiety. The parallels to pediatric drowning are clear and powerful. Just as meticulous chest pain research demolished outdated clinical dogmas, drowning data unequivocally demonstrate that stable, asymptomatic pediatric immersion victims do not deteriorate after discharge. Patient-centered outcomes, safety, satisfaction, and reassurance, align seamlessly across these clinical domains. Patients discharged immediately after appropriate evaluation in both settings overwhelmingly remain safe, content, and complication-free. As with chest pain, rejecting unwarranted fears around drowning demands bravery from clinical leadership. Chest pain management ultimately evolved because clinicians courageously placed trust in data and decisively reframed their approach. Emergency medicine now stands at an identical crossroads with pediatric drowning. Will clinicians perpetuate disproven rituals out of caution, or confidently embrace rigorous evidence for immediate discharge? The decision, while uncomfortable for some, is clinically obvious and ethically imperative. Just as chest pain guidelines evolved from unfounded fear to firm, data-driven pathways, pediatric drowning guidelines must similarly abandon needless caution for confident clinical clarity. The outcome, supported by decades of robust data, is unequivocal—zero-miss medicine that prioritizes patients above outdated anxieties. At its core, the reluctance to abandon outdated observation protocols is driven not by evidence, but by entrenched psychological and cultural forces. Foremost among these is the pervasive myth of “zero-miss” medicine: the unattainable belief that physicians can eliminate every conceivable risk. Emergency medicine, more than any other specialty, operates beneath a relentless spotlight, constantly pressed to defend each clinical decision against hypothetical worst-case scenarios. This anxiety is not without tangible consequences. Surveys consistently demonstrate that fear of litigation directly increases unnecessary hospital admissions and drives excess diagnostic testing. A comprehensive national survey of emergency physicians revealed that over 90% order tests or admit patients explicitly out of malpractice anxiety rather than clinical necessity.7 Such practices provide a false sense of security, inflating costs while delivering no measurable improvement in patient outcomes. Amplifying these fears are persistent misinformation campaigns propagated across social media platforms. Viral anecdotes about so-called “dry drowning” have been particularly effective at instilling unwarranted parental panic, indirectly pressuring clinicians into unnecessary interventions. Despite repeated clarifications from authoritative medical bodies dismissing the concept as unfounded, sensationalized reports persistently resurface each summer, prompting waves of worried parents to flood emergency departments with children who are, by all clinical measures, entirely healthy. Chest pain management mirrors this psychology precisely. Although robust, validated protocols provide near-certainty of safe discharge within hours, clinicians often default to extended stays purely out of medicolegal worry. Even with clear data like the nearly 100% negative predictive value from zero- and one-hour troponin protocols, the fear of missing a rare catastrophic event remains disproportionately influential. The consequence of this fear-driven mindset extends beyond individual patients. It shapes the culture of emergency departments nationwide, reinforcing practices grounded in caution rather than confidence, defensive reflexes rather than decisive action. Physicians conditioned by the fear of litigation and social-media-driven anxieties inevitably lean toward caution, even when caution offers no additional safety, only increased cost and patient discomfort. Addressing the culture of unnecessary observation means acknowledging these entrenched fears for what they are: costly relics of defensive medicine, incompatible with contemporary evidence. To meaningfully improve care, clinicians must confront these psychological barriers directly, reframing medical bravery as reliance on robust data rather than defensive routines. The next step is clear: quantifying the real, measurable costs of fear-driven medicine and recognizing the systemic harms hidden beneath caution's comforting veneer. The financial and systemic burdens of fear-based observation extend far beyond the bedside. Every hour spent observing a healthy drowning patient or a chest-pain sufferer with normal troponins drains finite healthcare resources. For example, the RDC protocol demonstrated that immediate discharge of asymptomatic drowning patients saved an average of six bed-hours per patient, time that could be redeployed toward those genuinely needing emergency care. Similar economic clarity emerges from rapid chest-pain protocols. Studies evaluating accelerated high-sensitivity troponin pathways reveal average per-patient savings exceeding $1,000 when low-risk patients are confidently discharged early. This reduction in unnecessary testing and hospital stays significantly alleviates financial strain, freeing hospital capacity for truly emergent cases. But the greatest benefits of eliminating needless observation are likely patient-centered. Immediate discharge avoids the tangible harms of prolonged hospitalization, from increased iatrogenic risk to family disruption and anxiety. Children return swiftly to reassuring homes and adults are spared overnight hospital stays, a truly patient-first approach. Ultimately, embracing evidence-based discharge protocols isn't merely about money saved. It's about stewardship: making responsible use of resources to ensure timely, compassionate care for every patient. Emergency physicians face a clear imperative: it's time to choose data over dread. Decades of evidence demonstrate the futility, and harm, of fear-driven observation practices. Now, clinicians must step forward confidently and let robust data guide clinical decisions. Three concrete steps can immediately dismantle unnecessary caution: Universally adopt RDC protocols. If children have clear lungs and stable vitals after submersion, discharge them home without delay. Fully embrace accelerated, high-sensitivity troponin protocols for chest pain. Rapid discharge pathways safely free hospital resources and spare patients' needless anxiety. Routinely audit departmental observation habits. Identify lingering fear-based practices and root them out, replacing them with evidence-based discharge criteria. Change will require courage, the kind that emergency physicians routinely demonstrate when lives are visibly at stake. Now, the stakes are subtler but equally significant: patient comfort, resource stewardship, and clinical integrity. Medicine's commitment to patients demands action that aligns with data rather than outdated rituals. The smiling, healthy child on the stretcher needs no more watching. He simply needs doctors brave enough to send him home. CME for InFocus Earn CME by completing a quiz about this article. You may read the article here or on our website, and then complete the quiz, answering at least 70 percent of the questions correctly to earn CME credit. The cost of the CME exam is $10. The payment covers processing and certificate fees. Visit http://CME.LWW.com for more information about this educational offering and to complete the CME activity. This enduring material is available to physicians in all specialties, nurses, and other allied health professionals. Lippincott Continuing Medical Education Institute, Inc., is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Lippincott Continuing Medical Education Institute, Inc., designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity expires July 31, 2027. Learning Objectives for This Month's CME Activity: After participating in this CME activity, readers should be better able to justify the adoption of Rapid Drowning Clearance (RDC) and high-sensitivity troponin protocols, and propose evidence-based discharge criteria when managing patients who experienced prolonged submersion.
The Supreme Court, in the 2016 case Spokeo, Inc. v. Robins, announced a framework for determining whether a plaintiff had alleged an injury that would permit entry into federal court. The Court indicated that a plaintiff, in order to have constitutional standing, needed to suffer harm that was “concrete” or “real.” In explaining how courts could ascertain whether an alleged harm was concrete, the Court created a category of “intangible” harm subject to a distinctive, and arguably more demanding, concreteness inquiry than “tangible” harm, a category that seemingly includes only physical or economic harm. In particular, Spokeo directed courts to inquire into whether an intangible harm bears a sufficiently close relationship to a historically recognized cause of action and into whether such a harm has been elevated by congressional action to the level of cognizability. Since Spokeo, federal courts have wrestled with how to operationalize the Supreme Court’s statements on intangible harm and standing. Beneath the growing body of doctrine lie fundamental questions about which values are at stake in categorizing harm into tangible and intangible varieties; whether the advancement of these values is justified; and whether, if so, this advancement is best accomplished through the conceptual tools that federal courts have applied to the task. This Article investigates and challenges the principles underlying the categorizations of harm outlined in Spokeo, particularly the distinction between tangible and intangible harm. This Article argues that this distinction, and the Spokeo Court’s emphasis on the “concreteness” of harm more broadly, reflect an effort to identify a set of uncontroversially pressing human interests that would justify access to judicial proceedings. These interests are often conceptualized in terms of those commensurable with money, quantifiable, or susceptible to evidentiary proof. Yet this approach invites courts to make contestable normative judgments about essential human interests in a way that risks undermining judicial legitimacy, and it obscures the internal complexity and contextual specificity of physical and economic harm. For example, economic loss, as well as pain and suffering resulting from physical harm, are treated as intangible in certain legal contexts, and the damage resulting from economic and physical harm cannot always be readily proven or valued at a given point in time. The Supreme Court’s emphasis on concreteness and its invocation of tangibility, this Article contends, are not needed in order to achieve a nuanced balance between competing features of standing doctrine: concerns about the separation of powers and the efficient administration of justice, on the one hand, and concerns about access to the federal courts and judicial legitimacy, on the other. Rather, courts should eschew concreteness as a factor in the standing inquiry independently of whether harm is adequately particularized. Moreover, particularity can fruitfully be understood, in statutory cases, in terms of whether the legal provision under which a plaintiff is suing defines the scope of potential plaintiffs with sufficient specificity.
Canadian courts use simple probability reasoning inconsistently in personal injury litigation, subjecting litigants to irregular legal principles and potentially improper compensation. Turning to foundational principles of tort litigation, I suggest a new framework for the availability of simple probability that would promote greater coherence. Simple probability reasoning is understood as an alternative standard of proof that enables compensation for a loss proportional to the likelihood that the loss will occur. Accordingly, the availability of simple probability is thought to depend on which types of facts (past vs. future vs. hypothetical facts) are amenable to balance of probabilities proof versus simple probability. This is the ‘type of fact’ framework, but it is not applied consistently. Part 1 argues that the inconsistency is rooted in the mischaracterization of simple probability reasoning as a standard of proof. It is better conceived of as a method of enabling chances, in their own right, to become legally relevant facts. Understood this way, simple probability is available only where chances are relevant to the legal determination at stake. I apply this characterization in Part 2, concluding that while simple probability reasoning is irrelevant to liability determinations, it is crucial in appropriately assessing damages.
The American malpractice system is a mess, and in orthopaedic surgery, it is messier still. One problem is frivolous lawsuits. The Harvard Medical Practice Study [5] reviewed the hospitalization records of more than 30,000 patients and determined for each case whether negligence was committed and a suit was filed. The researchers found most of the events for which claims were made did not involve negligence. It is small consolation that physicians usually prevail at trial. Even when a doctor wins the case, defending a malpractice claim is a losing proposition. At best, the physician is portrayed by the plaintiff’s counsel as a bumbling incompetent. Also, malpractice insurance (which routinely exceeds USD 100,000 per year in some states) indemnifies against only financial damages; the losses of time, reputation, and serenity are for the physician alone to bear. The net drain on happiness probably exceeds what one experiences in contracting appendicitis or breaking an ankle. In response, the orthopaedic surgery community has pressed for change. The hallmark of the orthopaedic approach is limits on noneconomic damages. These so-called “caps” would mandate that while all medical expenses and lost wages caused by malpractice are compensable, no more than a given amount, say USD 250,000, can be awarded for “pain and suffering.” Caps are an appeal to logic and fairness. For one thing, the argument goes, it is impossible to place a precise dollar value on pain and suffering, and if any amount is to be arbitrary, why not keep the dollar values modest? In addition, limits on noneconomic damages mitigate the harm caused by “runaway” juries, making the system less volatile and therefore less expensive for all. But let’s face it: the real appeal of caps is that they limit the number of suits. Most cases are brought forward on a contingency basis; the lawyers get paid only if they win. If the payoff of a case is limited, its attractiveness to an attorney is, likewise, limited. Caps work. In general, malpractice premiums are much lower in those states (such as California) that have caps in place [10]. But the problem with caps is that they solve the wrong problem. While there is plenty amiss with the American medical malpractice system, the largest flaw is not having too many lawsuits. If anything, there are too few. The Harvard Medical Practice Study cited above, for example, reported only eight of the 280 patients (2.9%) who were the victims of medical negligence actually filed malpractice claims. As such, if we can agree a central purpose of a malpractice system is to compensate victims of negligence, we can also agree caps, which discourage litigation across the board, and not just the frivolous cases, undermine that purpose. And, if another central purpose of a malpractice system is to deter errors, then we might also agree any method that discourages litigation in general, benefiting bad physicians as well as good ones, similarly undermines deterrence. Orthopaedic surgeons should favor a system that minimizes physician pain yet allows victims of error unfettered access to fair compensation. Abraham and Weiler [1] have proposed such a system. They call it “enterprise liability.” Under this approach, it is the organization, not the physician, that is named as the defendant in a suit. The rationale is simple: because many medical errors are, in fact, systems failures, it stands to reason that the enterprise should bear primary responsibility for compensation and deterrence. Local enterprises, when held accountable in this way, should likewise do a better job of policing practice and eliminating bad practitioners, as opposed to the current approach to malpractice, which indiscriminately lumps (and punishes) many good surgeons along with the few bad players. There are, of course, impediments to applying enterprise liability. For one thing, even for procedure-oriented specialties like orthopaedic surgery, much health care is not delivered within the confines of a single enterprise. Also, it is not assured that enterprises themselves will avoid hunting for scapegoats. Even so, the advent of Accountable Care Organizations (as promoted by the 2010 Patient Protection and Affordable Care Act) and the heightened political awareness among physicians regarding liability rules will, respectively, mitigate those concerns. Enterprise liability is a practical option moving forward. We orthopaedic surgeons, as advocates for our patients, should favor a system that limits error and compensates victims when errors occur. As human beings, we can’t help but hate attacks on our competence and character. Thus, we are also right to favor a system that minimizes finger pointing. A system of enterprise liability meets all of those standards. Enterprise liability, not caps on noneconomic damages, should be our favored approach. Commentary James Herndon MD, MBA Chairman Emeritus, Department of Orthopaedic Surgery, Harvard Medical School; Partners Healthcare System, Boston, MA, USA Dr. Bernstein has raised an important issue: the use of a method of professional liability reform called enterprise liability. The US medicolegal system has not accepted it in the past, and it will be difficult to implement such a major culture change in the future. However, Dr. Bernstein raised this method of compensating injured patients because he sees a new opportunity for change under the Patient Protection and Affordable Care Act, with the new development of Accountable Care Organizations. I agree with him on this point and would argue it is also a desired method in the new practice model in which physicians are increasingly becoming paid employees of a hospital or hospital system. The best example of enterprise liability in practice that I know of involves the aviation industry. As in medicine, system errors can occur, but also individuals make mistakes. In the case of an airplane crash, the airline company is responsible for all damages. The pilots are not personally liable because their profession has agreed to full transparency and reporting of individual errors. However, the pilot does bear individual responsibility under two circumstances: when he or she is under the influence of drugs or alcohol at the time of the crash or if he or she did not follow the required checklist for flying the aircraft. This model seems perfect for surgeons and hospital systems to adopt. But I am pessimistic that it will happen. In the past, trial lawyers have mounted strong opposition to any professional liability reform; the courts and our legislators (most of whom are lawyers) likewise have not favored such change. There is too much money at stake. Also, I am pessimistic that even our own profession would support enterprise liability. For just as pilots have to admit and disclose their individual errors, so would surgeons under this approach. Physicians fear the loss of reputation, the resultant loss of income, and the difficulty of admitting to colleagues and patients that we erred and caused harm. I believe our profession would accept individual responsibility for errors committed while under the influence of drugs or alcohol, but the challenge for many surgeons will be the acceptance and use of required checklists before, during, and after surgery. Most changes in past attempts at healthcare reform have been at the margins: a small fix or BAND-AID® here, a small change there. It would be wonderful if leaders of the professions of medicine, law, and politics, along with our patients, would come together and implement enterprise liability in health care as it is used in the airline industry. Such are quixotic dreams. Only if state and federal leaders, along with physicians, agreed such reform was necessary because of the continued rise in healthcare costs, the continued threat of adverse events, and the importance of shared decision making, would such reform become a possibility. Even then, though, it would be but a small one. Commentary Christopher D. Stombaugh JD Laufenberg, Stombaugh & Jassak, SC, Milwaukee, WI, USA “It isn’t what we don’t know that gives us trouble, it’s what we know that ain’t so.” Will Rogers It is becoming more and more difficult to engage physicians and lawyers who represent patients in a productive dialogue about fixing what ails the medical liability system. Each group views the other with suspicion and distrust. Nonetheless, to have a productive dialogue, the participants must first agree about the nature of reality. Evidence-based liability reform, like evidence-based medicine, must look at the facts as they are, not as we assume them to be. The arguments in favor of medical liability reform are more faith-based than fact-driven. The author begins by rounding up the usual suspects: “frivolous lawsuits,” caps on “pain and suffering,” discouraging lawyers from bringing cases. These are driven by fears. The fears of plaintiff’s counsel, loss of reputation, rising liability insurance premiums, loss of time, loss of peace and enjoyment of life, runaway juries. Fears, although real, do not make the thing feared a reality. Truth should matter, especially when it comes to changing our laws to deny a person his or her right to full and fair compensation. That person would surely be awarded compensation if only he or she had been injured in a road wreck caused by driver error, rather than violation of the standard of medical care by a physician who commits medical errors. Review of the relevant literature shows the arguments made in support of so-called reform proposals are simply untrue [3]. An ambitious project of the nonprofit Center for Justice & Democracy at New York Law School [3] is an updated survey of the data every orthopaedic surgeon should read. This freely downloadable, heavily footnoted book leads to the conclusion that whatever the infirmities of the current system, they cannot be laid at the feet of the injured patients and their advocates. Rather, we learn the inconvenient truth: We are not inundated with frivolous medical lawsuits. “[P]ortraits of a malpractice system that is stricken with frivolous litigation are overblown” [7]. Capping pain and suffering damages does not reduce malpractice insurance premiums [9] and does not affect physician supply, but it does prevent legitimate cases from being filed [3]. Legitimate cases actually improve the cause of patient safety [3]. Dr. Bernstein’s contention that too few malpractice cases are being filed is also borne out by the literature [2]. Medical errors occur at an alarming number and are, largely, system failures [4]. Recently, there have been small steps in increasing acceptance for physicians to admit medical mistakes as part of the healing process. Most notable was the recent Technology, Entertainment, Design (TED) talk of Canadian emergency physician Brian Goldman MD [8]. This is also good for the overall cause of improving patient safety. In place of the current system, Dr. Bernstein advances the idea of enterprise liability. Enterprise liability has several advantages as a method of bearing the costs of medical errors, obtaining coverage in a pool, holding the system responsible for system failures, and making system wide improvements in the interest of patient safety. Additionally, the enterprise is in a better position to police the few bad, serial malpracticing physicians who create most of the medical negligence payouts and who receive shockingly little discipline from state medical boards [6]. An enterprise liability system would also have the benefit of depersonalizing the effects of litigation. Unfortunately, as of now, this is not the law anywhere in America. A reasonable, workable alternative is the Wisconsin system, The Injured Patients and Families Compensation Fund. Doctors in Wisconsin have unlimited coverage since every healthcare provider has that type of coverage. The fund has nearly USD 1 billion in assets and pays out only a small portion of that every year and is financed through assessments on healthcare providers. Commentary David Seligson MD Chief of Orthopedics, Department of Orthopedic Surgery, University of Louisville Hospital, Louisville, KY, USA Our current tort system resolves disputes through litigation. Dr. Bernstein notes researchers found most events for which claims were made did not involve negligence. This suggests the current system works, since most malpractice suits find for the defendants. Error is not the same thing as malpractice. Although malpractice litigation is demeaning, can be tedious, and certainly is expensive, the alternative—compensating those who allegedly suffer from medical misadventures—would be far worse. Prioritizing the business of medicine first and putting the patient with a bad result in charge are mistakes. Here’s why: Among the patients whose treatment could have been better are other people who think they have been mistreated, and worse, individuals who believe they deserve compensation for actual or imagined dysfunction. Our society, our hospitals, and our prisons are loaded with folks who feel they are entitled. Compensation for situations that are judged by some flawed process to have been caused by medical care will provide a whole new apparatus for undeserved rewards. In real life, few patients tell the whole truth about what happened to them, what they have taken, or what they have done. Review of the discovery process of any lawsuit makes this clear enough. Enterprise liability is a concept borrowed from manufacturing. If a part fails, the company issues a recall and fixes the problem. The underlying assumption is that there has been a flaw in the creation of the product somewhere from design to production and the process is at fault. This concept fits less well when applied to an unemployed motorcycle driver on alcohol and drugs who loses his leg in a high-speed injury that he or she caused. My wise accountant opined any audit will disclose discrepancies; similarly any chart review will find courses of action that might have led to better results. Where will the funds come from to compensate patients for damages they allege? Government? Healthcare insurers? Doctors? Surely a torrent of preferred pathways, algorithms for treatment, and computer-driven systems to control losses will follow; these will, almost necessarily, stifle innovation. We can develop a new system wherein a well-intentioned (though perhaps not well informed) someone will assert an adverse outcome could have been averted, and we even can compensate patients under such a system. But we will probably find ourselves with much more paperwork and in a much-less favorable atmosphere to treat patients as individuals and with dignity and kindness. Commentary Mark A. Geistfeld JD Sheila Lubetsky Birnbaum Professor of Civil Litigation, New York University School of Law, New York, NY, USA The claim that more tort liability could be a cure for our ailing system of medical malpractice liability will undoubtedly strike many physicians as preposterous. The logic of this proposed tort reform, however, is compellingly as laid out by Joseph Bernstein in this column on medical malpractice. Indeed, the case for enterprise liability—a system that shifts liability from physicians to the enterprises that supply health care—is even stronger than Dr. Bernstein shows. In sharp contrast to the current system, enterprise liability is triggered by the occurrence of medically caused injuries, regardless of fault. No-fault liability would result in more tort liability across the run of cases, but this expansion of tort liability could solve the malpractice problem by removing blame from the liability equation. No one likes to be sued, especially when the allegation is one of professional malpractice. Rather than having one’s competence impugned, many physicians understandably engage in defensive medicine or otherwise cover up their mistakes. These allegations can also be upsetting to patients who place faith in their physicians and feel grateful for the care that they have received, even when the physician ultimately is unable to provide a cure. These patients are often loath to sue their physicians, regardless of whether further investigation would support a malpractice claim, whereas others who feel their physicians have not been adequately sensitive can end up blaming the physician for the failure to provide a cure, even if malpractice is not involved. The resultant mismatch between the incidence of medical error and the incidence of malpractice claims is well described by Bernstein and more extensively documented by others [2]. To be sure, fault-based liability has a number of appealing attributes. It requires proof that the defendant was legally at fault for the plaintiff’s injury, enabling risky actors to avoid tort liability by exercising reasonable care. The failure to exercise reasonable care constitutes legal fault, a conclusion that can be quite different from the colloquial attribution of fault. No one can be blamed for not being perfect. We all make mistakes, but any misstep, whether the result of professional incompetence or a simple lapse of attention, can be sufficient to establish negligence liability. The frequency of these mistakes can be reduced by procedures or the design of systems for delivering health care, but fault-based liability largely ignores these issues by instead placing blame on the provider whose inadvertent mistake directly caused the patient’s harm. Requiring the patient to prove instead that the “fault” lies with the enterprise is no panacea because the optimal design of systems and procedures involves complexities that render such proof practically inaccessible to plaintiffs. Is the injured patient, or more precisely, the contingency-fee lawyer, really the party best able to identify the practices that ought to be utilized by the enterprise of health care? By placing responsibility for all medically caused injuries on the enterprise itself, tort liability would create financial incentives for these institutions to adopt procedures and systems that would both reduce the incidence of inadvertent error and provide internal mechanisms for addressing instances of professional incompetence. Eliminating blame from the liability inquiry could be the best way to address the problem of medical error, but doing so requires an expansion and redirection of tort liability, a reform quite different from the reduction of tort liability often championed by medical professionals.
The optimal stringency of the burden of proof is characterized in a model in which relaxing the proof burden enhances deterrence but also chills desirable behavior. The result are strikingly different from those in prior work that uses a simpler model in which individuals only choose whether to commit a harmful act (so only deterrence is at stake). Moreover, the qualitative differences between the optimal rule and the familiar preponderance of the evidence rule—and related rules that look to Bayesian posteriors—are great, much more so than revealed by prior work.
Occasionally investigations by state boards1 take longer than desired. Sometimes complainants take months or even years to file a complaint with a medical board. Cases may be complex and finding witnesses and obtaining expert opinions can lengthen the time it takes to complete a case. Sometimes the medical board must wait for another entity to complete its criminal investigations before the board can begin an investigation or bring charges. A delay, however, may prejudice a physician's ability to defend against the charges. This installment of Legal Briefs looks at the doctrine of laches (pronounced “latches”) and its applicability to state boards, as well as alternatives to laches.First, what exactly is laches? In legal terms, it is the concept of unreasonable delay in pursuing a right or claim — in a way that prejudices the opposing party. When asserted in litigation, it is in the category of “an equitable defense” or “doctrine.” The person invoking laches asserts that an opposing party has “slept on its rights,” and that during the elapsed time period, circumstances have changed and a plaintiff's original claim should not be granted.The courts have five methods for handling cases that have become stale in this way. The first is to apply any applicable statute of limitation. The second is to apply the Due Process clause in the U.S. Constitution. The third is to distinguish precatory suggestions from mandatory requirements. The fourth is to use the equitable remedy of estoppel. The fifth is to use the doctrine of laches. After reviewing the first four, this article will focus on the doctrine of laches. While reviewing laches, it must be remembered that the purpose of a medical board's administrative proceeding is not disciplinary but public protection.2Brown v. State Personnel Board established that statutes of limitation, “like the equitable doctrine of laches, in their conclusive effects are designed to promote justice by preventing surprises through the revival of claims that have been allowed to slumber until evidence has been lost, memories have faded, and witnesses have disappeared.”3Nevertheless, Lindsey v. Miller's Lessee concluded that “[i]t is a well settled principle that the statute of limitations does not run against a state.”4 Specifically, “It has been held that there are no statutes of limitation applicable to [professional] disciplinary proceedings.”5Courts, however, may apply a statute of limitation to administrative proceedings.6 Sahu v. Iowa Board of Medical Examiners concluded that “if an administrative proceeding is in the public interest, such as disciplinary proceedings against a medical professional, courts will not apply the general statute of limitations.”7 Therefore, “courts have held without exception that in the absence of a statute which applies specifically to medical license revocation proceedings, statutes of limitations do not apply to such disciplinary proceedings.”8It is a well-established proposition that procedural due process requires notice and the opportunity to be heard in a meaningful time and in a meaningful manner.9 Due process applies when the government seeks to deny a person of a property or liberty interest.10 Physicians have a property interest in their license. Therefore, due process applies to disciplinary proceedings. As one court stated, “[i]t is fundamentally unfair to make a physician defend a nine-year-old complaint when the complaint was not delayed by fraud or the lack of ability to discover the misconduct. To hold otherwise would be to hold that there is no constitutional outer time limit, and we will not do that. Due process is the New Hampshire Constitution's version of the principles of equity, and application of a laches-type doctrine is deemed a part of the process due a person whose economic life and professional career are on the line.”11Precatory language in statutes and regulations is merely a set of recommendations. Precatory language does not create an imperative obligation. Mandatory language in a statute or regulation establishes a duty that the agency must follow. Generally, if the statute does not contain a consequence for the agency's failure to act, then the statute is precatory. If the statute does contain a repercussion for failure to act, then the statute is mandatory.12One court concluded that a legislature, in implementing timeframes, could not have meant for the state to lose jurisdiction.13 Here as elsewhere the public policy of public protection predominates over an individual's desire for a quick resolution.Lake Havasu City v. Arizona Dept. of Health Services established that “uses of the word ‘shall’ in statutes and rules does not mean the language is mandatory because such a construction would undermine the authority of the government.”14 In holding that the secretary of labor, who failed to investigate a claim within a statutory timeframe, did not bar him from continuing with the case, the Supreme Court provided several factors for determining when timeframes divest agencies from acting outside a legislative timeframe. These are legislative history, the statutory consequences for failure to act within the period and the availability of less drastic remedy.15Thus, as established in Sierra Pacific Industries v. Lyng, “[a] statutory time limit is not mandatory unless it both expressly requires an agency or public official to act within a particular period and specifies a consequence for failure to comply with the provision.”16 Nonetheless, even if the language is precatory, laches may still apply.Equitable estoppel is used when a party seeks to enforce a right or perform a duty after the other party has relied upon the inaction. Equitable estoppel requires proof of reliance upon another's conduct to one's detriment.17 Brown v. State Personnel Board found that “The policy to expedite justice underlying the rule exists where the proceeding is before a local administrative agency exercising quasi-judicial functions such as the board… Thus, the administrative agency must diligently pursue the disciplinary action as if it were seeking equitable relief. In measuring diligence the courts will apply notions of laches borrowed from the civil law.”18 Estoppel is very similar to laches; however, laches is the better method for analyzing stale claims. Equitable estoppel focuses on detrimental reliance, while laches focuses on delay and prejudice.Laches is an “equitable doctrine premised on unreasonable delay in asserting a right, which causes disadvantage or prejudice to another.”19 Laches cannot be inferred by the passage of time alone. It must be determined from all of the circumstances of the case, one of which must be the existence of harm caused by the delay. According to Bash v. Board of Medical Practice, “The party asserting laches bears the burden of proving both that the delay was unreasonable and that prejudice resulted from the delay.”20In the administrative law arena, statutes of limitation do not apply, and it is not clear if the doctrine of laches applies. On the one hand, “[laches] has been made applicable to quasi-adjudicative proceedings as a common law policy pursuant to the inherent power of the courts.”21 On the other hand, as in State v. Josefsberg, “the contrary has been held, by the weight of authority, the defense of laches is not available against the government, state or national, in a suit by it to enforce a public right or to protect a public interest…”22If laches applies, the public may be exposed to harm because the board would be stopped from proceeding with the case. If laches does not apply, however, a physician may have to defend against charges that are many years old. In calculating the time to apply to laches, the party must look at both the time it took for the complainant to complain and the time it took for the agency to act upon the complaint.23The first element in demonstrating laches applies is unreasonable delay. What makes the delay unreasonable in the case of laches is that it results in prejudice.24 As noted in Brown v. State Personnel Board: “It is said, ‘[t]here is no fixed rule as to the circumstances that must exist or as to the period of time which must elapse before the doctrine of laches can be appropriately applied.’”25 Ordinarily delay alone does not constitute laches. “Thus ‘[d]elay is not a bar unless it works to the disadvantage or prejudice of other parties.’”26In Stebbins, the court rejected an insurance salesman's argument that he was denied a “speedy trial” because of a 10-month delay while the State Insurance Commission investigated a complaint against him before filing a charge.27 The court agreed that the investigation could have been conducted more expeditiously. As noted in Caldwell v. State Bar: “However, petitioner has cited no cases, nor have we found any, which invalidate an administrative decision solely on the ground that there was a period of unreasonable delay during an agency investigation that preceded the initiation of formal proceedings.”28However, the courts, using their inherent authority, have applied laches to quasi-judicial administrative actions.29 Therefore, the delay must be unreasonable, but delay by itself is not sufficient to apply laches to an agency action or inaction.The second element in demonstrating that laches applies is prejudice because of the delay. Prejudice “cannot be inferred merely from the passage of time.”30 As established in Brown v. State Personnel Board: “Because of the relationship between prejudice and delay, the circumstances which give rise to laches vary widely depending upon their interplay in the specific case.”31 Miller v. Eisenhower Medical Center viewed it this way: “Prejudice is never presumed; rather it must be affirmatively demonstrated by the defendant in order to sustain his burdens of proof and the production of evidence on the issue.”32Excuse is a defense against a laches claim. Occasionally a state agency may have a compelling excuse as to why a significant amount of time elapsed between receiving the complaint and filing charges. Brown v. State Personnel Board found that “In order to excuse delay, [the responsible party] must show exceptional circumstances prevented earlier action.”33 In Sahu, “the Board properly delayed filing the complaint during the pendency of the federal criminal charges, the disciplinary proceeding was commenced within a reasonable time after the conclusion of the criminal trial.”34 Therefore, excuse provides a valid response to a laches claim.Agency mistake may excuse delay. Fahmy v. Medical Board of California noted: “It is matter of common knowledge that statutes of limitation do not run against the State. That no laches can be imputed to the king, and that no time can bar his rights, was the maxim of the common law, and was founded on the principle of public policy, that as he was occupied with the cares of government he ought not to suffer from the negligence of his officers and servants.”35The principle applies to state and national governments, which necessarily act through its agents to preserve the public's interests.36 U.S. v. Nashville stated: “It is settled beyond doubt or controversy, upon the foundation of the great principle of public policy…which forbids that the public interests should be prejudiced by the negligence of the officers or agents to whose care they are confided…”37Lake Havasu City v. Arizona Department of Health Services established that “The United States Supreme Court [held] that there is and must be a strong public policy against allowing the mistakes of an agency or employee to limit the government's ability to enforce its laws.”38 And Brock v. Pierce County noted “We would be most reluctant to conclude that every failure of an agency to observe a procedural requirement voids subsequent agency action, especially when important public rights are at stake.”39The government acts within its sovereign authority when it acts to protect the public. Galang v. State Medical Examining Board concluded: “It is well established that the objectives of professional discipline include the rehabilitation of the licensee, the protection of the public, and deterrence to other licensees from engaging in similar conduct.”40 Thus, when the state regulates the medical profession, it is acting in its sovereign capacity and for the public good.41When acting in its sovereign capacity, laches is not a defense. The court has noted the general principle of laches on the part of the government in bringing suit is not to be a defense in the case of a claim which is founded on a sovereign right and held that since this action was brought by the state in its sovereign capacity to protect a public right, the doctrine of laches was not available.42 These are all within the states' sovereign authority to protect the public. Thus, a medical board's disciplinary proceeding should not be barred by laches.Even when, as noted in Webb v. West Virginia Board of Medicine, “there [are] circumstances in a physician discipline proceeding when…a substantial degree of prejudice to a physician that is caused by an unreasonable delay not of the physician's making might nevertheless be outweighed by the strong interests of the state, the public and the profession in fully addressing allegations of serious professional misconduct — so as to tip the equitable balance in favor of continuing with a proceeding.”43Fahmy v. Medical Board of California concluded: “There is without a doubt a realization on the part of the Legislature that administrative agencies such as the Medical Board take action for the public welfare rather than for their own financial gain, and should not be hampered by time limits in the execution of their duty to take protective remedial action. That is particularly true in the case of the Medical Board, which is charged with protecting the lives and health of the citizenry from incompetent or grossly negligent medical practitioners. It is apparent that the Legislature wishes to have the Board protect California patients from physicians who are incapable of providing appropriate services in life or death situations, regardless of how long it takes the Board to act.”44Although its application is rare, occasionally laches is successfully applied in administrative cases. There can be no doubt that time does not bar a sovereign entity when it is acting to protect the public. State government protects the public through medical and osteopathic boards. Therefore, the state boards are just one means for the government to exercise its sovereign authority. Thus, laches should not apply to state board administrative proceedings. The centuries-old axiom Nullum Tempus Occurrit Regi — No Time Runs Against the King — should continue to be the rule.
The issue of hospital autonomy has aroused considerable international interest since the mid-1990’s, especially with regard to its linkage to governmental decentralization processes and reform of the health field. Non-profit hospitals have increasingly been obliged to become more autonomous as they compete for funding with private institutions. Objective: to understand how autonomy expresses itself through key management processes in non-profit and for-profit hospitals both in Medellín, the second largest city of Colombia, and its metropolitan area. Different institutional factors—political, administrative and economic—influencing autonomy are examined. Methods: a grounded theory method was used, consisting of semi-structured interviews with managers in six hospitals. Results: findings suggest that autonomy is perceived more as an ideal to aspire to, which would enable the hospital management to make free decisions, providing services in a manner that ensures financial sustainability. In practical terms, however, the degree of administrative and financial autonomy is circumscribed by both internal organizational factors associated with hospitals characteristics and external factors associated with institutional environment.
Society has become more emancipated and far more demanding. The same applies to patients. The media is confronting physicians with this trend every day. Telling proof of this tendency is the growing number of damage claims. This creates the impression that physicians and others rendering assistance and care to patients are treading in a minefield while practising their profession. It seems as if they must tie themselves in numerous knots in order to respect their professional ethical code and all relevant legislation. Is this a correct impression? Can one speak of a medical ‘malaise’? Is the liability of a physician immediately at stake when a treatment or surgery causes damage to a patient or won’t it come to that in such a hurry?
Review of histologic sections and cytologic smears is often a key component of civil litigation in cases of alleged negligence or medical malpractice. While the outcome of such cases may hinge on the testimony of expert witnesses, determining who is qualified to serve as an expert in such cases is generally left to the court. The Board of Governors of the College of American Pathologists has adopted separate statements for review of histologic slides and Papanicolaou (Pap) tests that outline some of the issues that should be considered in this context. These guidelines were developed in an effort to ensure accuracy and fairness in expert testimony when histologic or cytologic slides are reviewed as part of litigation.Departure from the standard of care in the practice of medicine is defined as conduct that falls below that which a reasonable physician would practice under similar circumstances. Finding a deviation from the standard of care in surgical pathology is in sharp contrast to a difference of opinion, which may not represent an error on the part of the original pathologist. When histologic slides are reviewed in the context of litigation, several issues must be considered before determining whether the standard of practice has been met or whether negligence has occurred. Such issues include the following:The following guidelines have been prepared by the College of American Pathologists to help ensure accuracy and fairness in expert testimony when histologic slides are reviewed for reasons of litigation, potential litigation, or disciplinary action.1. Individuals performing slide review in the context of litigation must have significant experience examining and reporting the disease and type of specimen under consideration. Those lacking such experience are not qualified to render an expert opinion on whether the original pathologist met the standard of care. Instead, the court should rely on the testimony of expert witnesses who have, at a minimum, the following qualifications:2. The standard of care should be that of a reasonable and prudent practitioner following normal practices at the time the original diagnosis was rendered. Finding a deviation from the standard of care requires showing that the diagnosis was inappropriate based on examination of the original slides and clinical information that was available to the pathologist. This finding should not be based on clinical outcome or subsequent changes in diagnostic criteria.3. To reduce the effect of hindsight bias, histologic slide review should be done without knowledge of clinical outcomes or the specifics of the claim. Disclosing a subsequent recurrence, metastasis, or other significant development to the reviewing expert witness before he or she has reviewed the slides introduces the possibility of bias into the review.4. Review should occur in an environment that, as closely as possible, approaches a normal practice environment. This may be in the reviewing pathologist's own office or laboratory, but can occur in other settings.5. When slides are reviewed for the purposes of litigation or the determination of negligence, the same slides that were the basis for the original interpretation must be the subject of the review.6. Fair and impartial review of histologic slides must not discriminate between defendant and plaintiff.7. Compensation of the physician-witness should reasonably reflect the time and effort expended by the witness in preparation, depositions, and trial. Compensation of a physician-witness must not be contingent on the outcome of the trial, as this introduces the possibility of bias and the appearance of possible impropriety.The Pap test is the most effective cancer screening test in medical history and remains the most effective screening method for the identification of premalignant cervicovaginal conditions. The Pap smear has been associated with a 70% to 80% decrease in the death rate from cervical cancer in the United States.If the Pap test is to continue as an effective cancer screening procedure, it must remain widely accessible and reasonably priced for all women, including those who are economically disadvantaged and at high risk for cervical cancer. There must also be an understanding of the inherent limitations of this procedure.The Pap test is a screening test that involves subjective interpretation by a cytotechnologist or pathologist of the 50 000 to 100 000 cells that are present on a typical Pap smear. Experience indicates an irreducible false-negative rate of at least 5%. Although rescreening can reduce the false-negative rate, zero-error performance can never be attained. Many factors, including the subjectivity involved in diagnosing difficult cases and sampling problems with specimen collection, prevent zero-error performance.The following guidelines should be used for review of Pap tests for litigation or potential litigation.1. The finding of a false-negative smear is not necessarily evidence of practice below the standard of care. The decision as to whether a false-negative smear is the result of negligence should be made not only on the basis of the individual result, but also in the context of the laboratory's overall performance on Pap tests.2. Atypical cells of undetermined significance represent a poorly defined diagnosis with poor interobserver and intraobserver reproducibility. Therefore, disputed cases of atypical squamous cells of undetermined significance and atypical glandular cells of undetermined significance are not likely to represent reasonable grounds for allegations of practice below the standard of care.3. Papanicolaou test slides being assessed for possible litigation should be reviewed without knowledge of clinical outcome and in an environment that simulates the normal screening practice as closely as possible. This may be accomplished through an unbiased screening review process that includes the contested case as one of a number of normal and abnormal Pap smears representing a variety of disease states. Review with knowledge of subsequent development of carcinoma biases the objectivity of the review and does not reflect standard practice.4. The standard of care should be that of the reasonable and prudent practitioner. Courts should recognize that a false-negative result is not sufficient proof of negligence. Rather, the courts should look to whether the overall Pap test practices of the laboratory meet the standard of care.5. Professional expert witnesses who do not have significant experience in cytopathology are not qualified to express an expert opinion on the standard of care. Instead, a court should rely on the testimony of expert physician-witnesses that have, at a minimum, the following qualifications:6. Compensation of the physician-witness should reasonably reflect the time and effort expended by the witness in preparation, depositions, and trial. Compensation of a physician-witness contingent on the outcome of the case introduces the possibility of bias and should not be permitted.7. The state should adopt a mechanism by which nonbinding arbitration would be required prior to the filing of any civil action alleging negligence in the taking, examining, or reviewing of a Pap test or the reporting of its results. The nonbinding arbitration mechanism should include the following features:If the state does not adopt such a plan, the parties should strongly consider mediation or nonbinding arbitration by a panel of individuals trained and having experience in cytopathology before proceeding with civil litigation relating to a Pap test.The usefulness of the Pap test guidelines in actual litigation has been demonstrated on numerous occasions in the 2 to 3 years since they were adopted by the College. Their credibility has been further strengthened by the adoption of similar guidelines with minor modifications by the American Society of Cytopathology,1 the American Society for Cytotechnology,2 and by more than 30 state pathology societies. Of particular significance has been the acknowledgment that a Pap test being reviewed should be examined “through an unbiased screening review process that includes the contested case as one of a number of normal and abnormal Pap smears representing a variety of disease states.”Multiple-slide, blinded rescreening panels3,4 have emerged as unbiased objective prelitigation tests and have been used in numerous cases before assertions of a breach of the standard of practice are entertained. The guidelines in general represent a science-based approach to protect the interests of patients, laboratories, and the public alike in maintaining and protecting medical history's most effective cancer screening test.
On Taking Substituted Judgment Seriously I am a long-time advocate of patients' rights in general and the right to die in particular, but i believe the U.S. Supreme Court rendered the right decision in Cruzan. This is not a comfortable position for me. I have witnessed the lingering death of members of my immediate family three times in the last five years. My heart goes out to the Cruzan family. But the Court's unwillingness to overturn Missouri law is no more to blame for the Cruzans' plight than is your and my unwillingness to kidnap Nancy and spirit her away to a place where she can die in peace. The Court, in my opinion, did not have legal authority to do what the Cruzans asked of it. The U.S. Supreme Court does not sit as a super legislature over the states. It has no authority to rule on the wisdom of state laws or general power to promulgate uniform rules of state law. The Court has only the power to strike down state laws that conflict with federal law, including the U.S. Constitution. Thus, when the Court refused to invalidate Missouri's and convincing requirement for substituted judgment, it was saying only that it did not find the requirement to be in conflict with the Constitution or other valid federal law. It was not approving of the requirement or imposing it on all those states that have not adopted it, but merely saying it was permissible for Missouri (or any other state) to make that requirement part of its law--if it wanted to. For the Court to have overturned the Missouri requirement as unconstitutional, it would have had to find that the measure had been motivated by an illegitimate state purpose, or that the state purpose it advanced and the reasons for advancing it by the means chosen were clearly out-weighed by the burden imposed upon individual liberty interests. By neither of these tests is Missouri's approach to substituted judgment unconstitutional. If Missouri's approach burdens individual liberty interests, so does that of every other state that employs substituted judgment for PVS cases. By requiring clear and convincing, evidence of substituted judgment, Missouri prevents death decisions for some persons who are in PVS. But so do those states that do not require clear and convincing evidence for substituted judgment. Such states do not allow death decisions where there is no evidence for substituted judgment, or where the patient's family has not reached a death decision for the patient. What reason is there for thinking that Missouri's procedural safeguards that cause many PVS patients to be continued on life support are unconstitutionally burdensome but those of other states are not? Missouri's purpose is requiring the safeguards is the same as the presumed purpose in other states--to ensure that death is in fact what the patient would want for herself. This is centainly not an illegitimate state purpose. If the liberty interest here is that of patient choice, it can be argued that Missouri's higher standard of proof is designated to protect that interest. In contexts where less important liberty interests were at stake, the Court has not only allowed use of a clear and convincing standard, but at times required it. Similarly, denying family members a general power to make death decisions for patients is arguably more protective of patient liberty than less. …
This study evaluated hospital demographics, staffing, pharmacy variables, health care outcomes measures (severity of illness-adjusted mortality rates, drug costs, total cost of care, and length of stay) and medication errors. A database was constructed from the 1992 American Hospital Association's Abridged Guide to the Health Care Field, the 1992 National Clinical Pharmacy Services database, and 1992 mortality data from the Health Care Financing Administration. Simple statistical tests and a severity of illness-adjusted multiple regression analysis were employed. The study population consisted of 1116 hospitals that reported information on medication errors and 913 hospitals that reported information on medication errors that adversely affected patient care outcomes. We evaluated factors associated with the 430,586 medication errors and 17,338 medication errors that adversely affected patient care outcomes. Medication errors occurred in 5.07% of the patients admitted each year to these hospitals. Each hospital experienced a medication error every 22.7 hours (every 19.73 admissions). Medication errors that adversely affected patient care outcomes occurred in 0.25% of all patients admitted to these hospitals/year. Each hospital experienced a medication error that adversely affected patient care outcomes every 19.23 days (or every 401 admissions). The following factors were associated with increased medication errors/occupied bed/year: lack of pharmacy teaching affiliation (slope = 0.8875, p=0.0416), centralized pharmacists (slope = 1.0942, p=0.0001), number of registered nurses/occupied bed (slope = 1.624, p=0.032), number of registered pharmacists/occupied bed (slope = 25.0573, p=0.0001), hospital mortality rate (slope = 2.8017, p=0.0192), and total cost of care/occupied bed/year (slope = 0.01432, p=0.0091). Factors associated with decreased medication errors were location in the Mid-Atlantic census region (slope = -1.5182, p=0.03), affiliation with a pharmacy teaching program (slope = -1.0252, p=0.0349), decentralized pharmacists (slope = -0.9843, p=0.0037), and number of medical residents/occupied bed (slope = -1.478, p=0.0014). There was a 45% decrease in medication errors (1.81-fold decrease) in hospitals that had decentralized pharmacists, compared with hospitals that had centralized pharmacists. In addition, there was a 94% decrease in medication errors that adversely affected patient care outcomes (16.88-fold decrease) in hospitals that had decentralized pharmacists compared with hospitals that had only centralized pharmacists. Based on previous field studies and our findings in 1116 hospitals, it appears that one of the most effective ways to prevent or reduce medication errors is to decentralize pharmacists to patient care areas. The results of this study should help hospitals reduce the number of medication errors that occur each year.