Pain management and provider liability: No more excuses

Pain1 is undertreated in the American health-care system at all levels: physician offices, hospitals, longterm care facilities.2 The result is needless suffering for patients, complications that cause further injury or death, and added costs in treatment overall. The health-care system's failure to

Physicians have long been accused of poor pain management for their patients.3 The term "opiophobia" has been coined to describe this remarkable clinical aversion to the proper use of opioids to control pain.4 If the professional mandate of the health-care professional is to relieve suffering, then physicians are falling far short of their obligations5 by accepting myths about the use of opioids in the face of evidence to the contrary.6

The possible reasons for health-care providers' failures to property manage pain are many. First, physicians are poorly educated in medical school about narcotics and proper pain management, and they remain ignorant in practice about appropriate treatment choices for pain management,7 often rapidly absorbing professional norms that simply reflect a culture hostile to drug use.8 Second, threats of legal action loom large in providers' vision: criminal prosecution for use of controlled substances; sanctions involving the loss of hospital staff privileges for use of opiates; medical licensing board disciplinary action; and so on. Uncertainty about legitimate opioid use, coupled with a regulatory system that threatens sanctions, intimidates physicians.9 Third, patients, worried about tolerance and addiction to the opioids, receive little adequate information or education by providers.10 Patients suffer unnecessary pain as a result.11 Fourth, lack of insurance coverage may deny patients access to costly long-term pain management with its multiple modalities of treatment.12

Scholars have examined many of these barriers - restrictions on insurance reimbursement,13 Medicare and Medicaid limits,14 and criminal prosecutions - and their effect on the use of effective tools for pain control.15 It is clear that the legal and regulatory environment is a complicated one, with cross-currents that make it difficult for physicians to offer optimal care. What is missing is an external source of norms that articulate the values of pain relief and impose a penalty on providers for their shortcomings. Such a source of pressure can counteract the fears of criminal prosecution and the pressures of both inertia and restrictions on reimbursement that push physicians, hospitals, managed care organizations, and nursing homes to undertreat pain. Tort liability is a powerful external threat, and it can work in tandem with other constructive pressures in the environment to improve provider management of patient pain.

The threat of a malpractice suit for undertreatment of pain is presently quite low. Few judicial decisions discuss pain management and undertreatment. Pain as a component of a tort suit shows up primarily in pain and suffering awards for a physician's negligent treatment or diagnosis of a patient that leads to physical harm and accompanying pain; workers compensation claims for pain treatments; or a component of emotional distress claims. If, however, a physician's treatment of the patient's illness meets the medical standard of care, then the pain attendant on the normal course of illness has typically not been the object of tort damages. What is needed is recognition that the standard of care in treating patients includes pain management as much as it does treatment of the disease.

Treatment and management of pain by both physicians and institutional providers can be improved by the threat of tort litigation, which would spotlight providers' failures to comply with an emergent standard of proper pain management. This threat of litigation can be a powerful incentive to change medical practices. This article will analyze existing and emerging liability theories and doctrines that should have an impact on the attitudes of physicians and institutional providers toward pain management.

I. THE NATURE OF PAIN: TOUGHING IT OUT

Pain is often viewed as an inevitable part of illness, as a necessary adjunct to disease and its treatment. Too often physicians simply force patients to tough it out, to cope with pain that is unnecessary and debilitating. Patients may also share an attitude that pain is normal and should simply be endured, although this is in contrast to patients with advanced diseases, who welcome pain management for their symptoms.16 Most pain can be treated and relieved, even though sadly it is too often untreated or poorly managed. 17

A. Categories of pain

Pain is traditionally divided into acute and chronic pain. Acute pain may be the result of surgery, dental work, burns, or other somatic damage that results in pain of limited duration. Chronic pain may be divided into cancer pain and nonmalignant pain. For nonmalignant pain, palliative medicine is the therapeutic response, defined as "the study and management of patients with active, progressive, far-advanced disease for whom the prognosis is limited and the focus of care is the quality of life."18 Such pain is also often termed "intractable," to mean any condition or situation that is unmanageable or untreatable.19 While the disease or condition may be untreatable, the pain and symptoms most often can be treated. Chronic pain is usually viewed as appropriately treatable by opioid analgesics on a long-term basis.20

Cancer pain is one of the largest categories of pain. Millions of cancer patients suffer pain that could be relieved and managed by proper treatment. One estimate is that more than 90 percent of cancer pain can be controlled with available treatment options.21 Analgesic drugs, in particular, are an effective approach to managing cancer pain; these include aspirin, codeine, morphine, and their substitutes.

The elderly, particularly in nursing homes, suffer high levels of pain - chronic and nonmalignant in many cases -- that is poorly managed up to 70 percent of the time. According to clinical practice guidelines on the management of chronic pain in older persons, "For some conditions, chronic pain is defined as pain that exists beyond an expected time frame for healing. For other conditions, it is well recognized that healing may never occur. In many cases, chronic pain is understood as persistent pain that is not amenable to routine pain control methods. Because there are many differences in what may be regarded as chronic pain, the definition remains flexible and related to specific diagnoses or cases."22

The standard of practice for pain management is well articulated for cancer pain, for surgical pain, and for nonmalignant chronic pain. But medical practice has been slow to adopt this standard due to fear of addiction and a multiplicity of other factors.23

B. Proper pain management

Pain management is defined in the most recent Joint Commission on Accreditation of Healthcare Organizations JCAHO) guidelines as "a comprehensive approach to the needs of patients, residents, clients, or other individuals served who experience problems associated with acute or chronic pain."24 Proper assessment of pain, based on patient selfreporting, is at the heart of any organizational approach to pain management. Pain comes in many forms, but treatment of so-called "intractable" pain follows a generally agreedupon pyramid of treatment, in which the non-steroidal antiinflammatory drugs (NSAIDs) and other drugs in combination with patient training come first, and opioids are the final and effective treatment for all forms of pain that fail to respond to milder drugs. As Joranson and colleagues state, "the use of opioids in the class of morphine is the cornerstone of pain management."25 Yet patients and clinicians continue to be unduly concerned about addiction. Joranson and colleagues comment that "[h]ealth care professionals may be reluctant to prescribe, administer, dispense, or stock controlled substances for fear of causing addiction or contributing to the drug abuse problem. 1121 Addiction is viewed as an evil to be avoided even when its likelihood is low, leaving patients to a stoic absorption of pain that most cannot achieve. Recent studies confirm that abuse of opioid analgesics has remained low in spite of increases in their medical use.27

Failure to properly manage pain - to assess, treat, and manage it - is professional negligence.28 The problem from a malpractice perspective is one of establishing a standard of care based on a clear practice in favor of sophisticated pain management. The current versions of the ethical principles governing clinical practice - the Hippocratic Oath and the Code of Ethics of the American Medical Association (AMA) - and the statements of medical leaders do articulate the duty to relieve suffering. For example, the AMis Code of Medical Ethics states in pertinent part, "[p]hysicians have an obligation to relieve pain and suffering and to promote the dignity and autonomy of dying patients in their care. This includes providing effective palliative treatment even though it may foreseeably hasten death."29 Nurses likewise are admonished to "use full and effective doses of pain medication for the proper management of pain in the dying patient. The increasing titration of medication to achieve adequate symptom control, even at the expense of life, thus hastening death secondarily, is ethically justified."30 But medical practice at all levels lags behind these ethical expressions of the duty to treat pain.

II. PHYSICIAN FAILURES TO TREAT PAIN: TORT AS A BEACON

A. Functions of tort liability

The rules developed by courts in malpractice suits serve a range of functions in altering medical practice. First, tort rules reinforce good medical practice. Case law is the voice of common law judges stating minimum principles of generally accepted medical practice. The cases typically defer to the medical consensus on a standard of practice without much judicial scrutiny of the standard. But case law is still an influencing force on medical practice nonetheless, as it imposes financial burdens on providers and their malpractice insurers for medical errors, ignorance of good practice, and tolerance of sloppy practice. A lawsuit inflicts a price on providers in insurance costs and defense costs. Providers, as consumers of lawyers and insurance, are at least somewhat sensitive to increases in price, heightening their sensitivity to bright-line rules of practice.

Second, tort rules give voice to patients who have been patronized, ignored, actively manipulated, or cruelly treated by physicians. Informed-consent doctrine has forced medical recognition of patients' informational needs; EMTALA has forced stabilizing treatment by hospitals inclined to simply push patients out the door; disclosure obligations have built on the physician's fiduciary duty toward patients.

Third, malpractice litigation drives institutional practices toward convergence on validated standards of practice. Lawyers can introduce evidence of emerging clinical practice guidelines as a way of arguing for a standard of care that the defendant failed to satisfy. Proof of malpractice thus slowly moves from elastic expert opinion toward more empirically validated clinical practices. This means that the defense has less wiggle room in the average malpractice case and, as a result, the law indirectly forces physicians toward heightened awareness of standards.

Fourth, tort law often articulates new duties of care for providers. Physicians not only must pay attention to emerging practices, but must also disclose risks to third parties created by a patient, candidly make a referral to a more skilled specialist, be honest with the patient, and watch out for the patient's interests over those of the provider. These new duties force providers to focus on the patient as primary.

These tort functions have implications for improving pain management. We have come to expect providers to master these new roles: provider of full information to patients as consumers of health care; protector of public health, through obligations to warn family members and third parties; stabilizer of patients even without a contractual relationship; and comforter and counselor of families. But current incentives in the health-care system push powerfully toward physicians' undertreating pain. As Ann Martino writes: [S]trong rewards, both internal and external to the practice of chronic pain management, reinforce the principle in the ethic of under prescribing to say no. A practitioner who accepts that addiction is harmful and that assisting or hastening death is a wrong has a duty to prescribe drugs in a manner that will not result in either. Federal and state prescribing laws, societal norms about the dangers of drugs, and board rules and regulations reward practitioners who under prescribe by making saying yes a risky proposition - to practitioners' livelihood, reputation, and status in the practice community and under the law.31

The threat of malpractice litigation may offset these powerful forces, making anxious providers either overestimate the risk of suit or at least adjust their practice to a new assessment of the risk of suit. Surprisingly, most patients do not file a malpractice claim because of uncertainty as to the cause of their injury.32 This is true even though studies of medical error have concluded that "the burden of iatrogenic injury is large enduring, and an innate feature of hospital care in the United States."33 Even for patients with major permanent injuries, it appears that only about one in six file suit.34 However, the threat of tort litigation has a substantial psychological impact on physicians in excess of the diluted financial incentives created.35 Physicians overestimate the risk of being sued and the size of feared judgments.36 The sheer unpleasantness of being sued also deters, although it has been argued that the lack of clarity as to the locus of negligence in most cases does not provide useful feedback to providers.37

Physicians clearly perceive a threat from the system, judging their risk of being sued as much higher than it actually is. The Harvard New York Study, surveying New York physicians, found that physicians who had been sued were more likely to explain risks to patients, to restrict their scope of practice, and to order more tests and procedures.38 Malpractice insurers, particularly the physician-owned companies in many states, now engage in aggressive review of claims. These companies insure about 40 percent of physicians in active patient care. They routinely use physicians to review applications for insurance and to review the competence of those sued. Physicians with claims due to negligence, as assessed by the peer reviews, may be terminated, surcharged, or have restrictions on their practice imposed.39 If a physician loses his malpractice insurance, he may quit, switch jobs, or go without insurance. He may also go to a surplus-lines insurance company that charges much higher premiums for coverage. Claims exposure can thus lead to a direct financial impact on the physician who is forced to carry such expensive insurance.40

The litigation process is neither as arbitrary nor as unfair as critics suggest.41 The jury turns out to be a surprisingly reliable decision-making institution.42 Lawyers are good screens for frivolous cases. A physician named as a defendant may, as a consequence, spend more time on exams or patient histories, invest in further training, increase support staff, or develop a more systematic approach to pain management. The few available studies have found that physicians who have been malpractice defendants often alter their practice as a result, even if they win the litigation. Perceived risk is thus important to physician conduct.43 Hospitals have instituted risk management offices and quality assurance programs; informed-consent forms have become ubiquitous; medical record-keeping with an eye toward establishing proof of care at trial has become the rule. There is little doubt that the threat of malpractice litigation has had some effect on provider practices, and that increases in litigation over inadequate pain management would likely spur improvements at the individual provider and institutional levels.44

B. The general malpractice rule

1. National standards of care

A liability analysis of pain management starts with the physician, since it is the physician who fails to prescribe proper medication or to assess and manage patient pain. The liability of physicians is governed by general medical malpractice principles. Malpractice is usually defined as unskillful practice resulting in injury to the patient, which constitutes a failure to exercise the "required degree of care, skill and diligence" under the circumstances.45 A physician is not a guarantor of good results, nor is he or she required to exercise the highest degree of care possible. As one court said, "The physician will not be held to a standard of perfection nor evaluated with benefit of hindsight."46

The standard of care by which most state courts measure the conduct of both general practitioners and specialists is a national standard. A good statement of this standard is found in Hall v. Hilbun:

The duty of care ... takes two forms: (a) a duty to render a quality of care consonant with the level of medical and practical knowledge the physician may reasonably be expected to possess and the medical judgment he may be expected to exercise, and (b) a duty based upon the adept use of such medical facilities, services, equipment and options as are reasonably available.47

Most jurisdictions impose a national standard of care on physicians48 because of concerns about a "conspiracy of silence,"49 unfair limitations on the use of experts, and a recognition of the national character of medical education and practice.50 Nonetheless, many jurisdictions allow evidence describing the practice limitations under which the defendant labors.51 Some jurisdictions explicitly allow the trier of fact to consider the facilities, staff, and other equipment available to the practitioner in the institution where he or she is affiliated. This follows the general rule that courts should take into account the locality, proximity of specialists, and special facilities for diagnosis and treatment.52 The standard of care governs a physician's conduct during the period when the patient was under his or her care; this includes follow-up care to ensure that a patient obtains medical records and information as requested.53

Proving negligent pain management is difficult for the plaintiff in light of contemporary failures by the medical profession to practice pain management practices. Traditionally, tort law has allowed the medical profession to set the standards of practice, with the courts enforcing these standards in tort suits. Defendants trying to prove a standard of care normally present expert testimony describing the actual pattern of medical practice, historically without any reference to the effectiveness of that practice. Most jurisdictions give professional medical standards conclusive weight, so that the trier of fact is not allowed to reject the practice as improper.54 On rare occasions, the courts have allowed the case to proceed in spite of agreement that the defendant satisfied the customary practice of his or her specialty because evidence was presented that the defendant was aware of the dangers in the standard practice.55 Other more recent decisions have found that proof of "ordinary care" can prevail over a defense of compliance with custom.56

The standard of care is not usually a bright-line rule. The standard in Hall for judging the defendant's conduct was "minimally competent physicians in the same specialty. 57 This minimal competence test seems less demanding than standard jury instructions in other states that require comparison to "the average practitioner in the class to which he or she belongs."58 "Average" suggests a midpoint in the range of practitioners, while "minimal" places the defendant's conduct distinctly lower on a scale of practice. The standard of care must be at least in compliance with available technology at the time the diagnosis or treatment was offered to the patient, without the benefit of hindsight.59 So the issue of what is known by a "minimally competent" practitioner, held to a national standard and assuming up-to-date education, is a classic jury question, leaving the trier of fact to resolve the dispute among sparring experts from either side.

a. Clinical practice guidelines

What a minimally competent practitioner must know has not traditionally been derived from an external authority, such as a government standard, but rather from medical standards developed through the interaction of leaders in the profession, professional journals and meetings, and networks of colleagues. Most clinical policies develop from an ongoing exchange in the literature, at meetings, and in peer discussions. Over a period of time, a clinical policy takes shape from this series of interactions. If it becomes generally accepted, it becomes "standard practice. "60

The development and proliferation of clinical practice guidelines has speeded the process by which good evidencebased medical practice becomes recognized and disseminated as such. In response to the rapid growth in medical research and published findings, these guidelines have become one of the transforming forces in current medical practice.61

Medical knowledge about evidence-based medicine has accumulated at a staggering rate. Between 1966 and 1995, the number of clinical research articles based on randomized clinical trials jumped from about 100 to 10,000 per year.62 American physicians and specialty groups have expended substantial effort on standard-setting in recent years, specifying treatments for particular diseases. Clinical practice protocols (also referred to as practice parameters or guidelines63) have been developed by specialty societies such as the American Academy of Pediatrics; by the government, through the National Institutes of Health; and by individual hospitals in the clinical setting.

The development of practice standards and guidelines by national medical organizations has accelerated the process of moving all medical practice toward national standards.64 Such guidelines provide a particularized source of standards against which to judge the conduct of the defendant physician, and the fact that they are produced by national medical specialty societies and the government means that they will be influential.65

Such guidelines are sets of suggestions, described in decision rules, based on current medical consensus about how to treat a certain illness or condition. The Institute of Medicine has defined clinical guidelines as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." They are standardized specifications for using a procedure or managing a particular clinical problem. Such guidelines may be quality-oriented, reducing variations in practice while improving patient care;66 they may also be cost-reducing, promoting a lower cost approach to care.

A clinical standard may be presumptive evidence ot due care if expert testimony introduces the standard and establishes its sources and its relevancy.67 The guidelines can also be used to impeach the opinion of a medical expert.68 Clinical guidelines potentially offer an authoritative and settled statement of what the standard of care should be for a given treatment or illness. A court has several choices when such guidelines are offered into evidence. A guideline might be evidence of the customary practice in the medical profession. A doctor practicing in conformity with a guideline would be shielded from liability to the same extent as one who can establish that she or he followed professional custom. A guideline could also serve as a defense to a claim that the defendant deviated from customary practice, insofar as it represents the practice of at least a "respectable" minority of the relevant profession .69 The guideline acts like an authoritative expert witness or a well-accepted review article. Using guidelines as evidence of professional custom, however, is problematic if they are ahead of prevailing medical practice.

Guidelines have already had an effect on settlement patterns, according to surveys of malpractice lawyers.70 Plaintiffs have used such guidelines to their advantage in malpractice cases, particularly the guidelines of the American College of Obstetricians and Gynecologists.71 Such guidelines provide a particularized source of standards against which to judge the conduct of the defendant physician. A widely accepted clinical standard may be presumptive evidence of due care, but expert testimony would still be required to introduce the standard and establish its source and relevancy. A guideline could thus be treated as negligence per se or at least a rebuttable presumption, which could then be countered with evidence.

Standards of care for pain management are increasingly well-established. Organizations such as the Agency for Health Care Policy and Research, the Agency for Healthcare Research and Quality, the American Pain Society, the American Academy of Pain Medicine, the American Geriatric Society, and the American Society of Anesthesiologists have promulgated pain control standards.72 The Joint Commission on Accreditation of Healthcare Organizations and the National Committee on Quality Assurance have also been paying more attention to an institution's standards for pain management during the accreditation process.73

The use of such guidelines in pain management litigation is therefore likely. Consider the Practice Guidelines of the American Society of Anesthesiologists.74 These guidelines develop an interrelated set of approaches to proper pain management, with several levels: a comprehensive evaluation and treatment plan (history, physical examination, psychosocial evaluation, impression and differential diagnosis, and treatment plan); a diagnostic evaluation; counseling and coordination of care; periodic monitoring and measurement of clinical outcomes; and multidisciplinary, multimodal pain management. Multimodal therapy is "concomitant use of separate therapeutic interventions under the direction of a single practitioner to obtain additive beneficial effects or reduction of adverse effects." These interventions might include neural blockade with medications, rehabilitative therapies with neural blockade, and medications of varying strengths.

Pain management guidelines demand at least an initial diagnostic assessment of pain as a clear starting point and then attention to following the patient and using pain management strategies in a well-established hierarchical fashion. For physicians who work in hospital settings or depend on managed care organizations for the bulk of their patients, knowledge of and compliance with guidelines will become a necessity. The guidelines provide the beginning of a brightline test for measuring provider shortcomings in managing patient pain.

b. Web-based databases

The second force that reinforces the power of clinical practice guidelines is their easy availability on a range of Web sites." Web sites have proliferated to help physicians gain efficient and user-friendly access to this even-greater proliferation of guidelines and other medical information.76

The National Guideline Clearinghouse77 is the best example of this; it offers free access to physicians and others to the current clinical practice guidelines, with instantaneous searches of the database. A search produces all guidelines on a given subject, along with an "appropriateness" analysis for each guideline.78 The Clearinghouse also provides a standardized abstract of each guideline, and grades the scientific basis of its recommendations and the development process for each. Full text or links to sites with the guidelines are provided. Readers are given synopses to produce a side-byside comparison of guidelines, outlining where the different sources of guidelines agree and disagree. Physicians can access electronic mail groups to discuss development and implementation.

To be included on the Web site, these guidelines must pass certain entry criteria: They must be current; contain systematically developed statements to guide physician decisions; have been produced by a medical or other professional group, government agency, health-care organization, or other private or public organization; and show that they were developed through a systematic search of peer-reviewed scientific evidence. The benefits of such a database are apparent. It has search features, comprehensiveness, and easy access through its Internet location, making it the most powerful tool for using guidelines to date.79

Clinical practice guidelines have the power to influence the finding of a standard of care in a malpractice case, but are often ignored by busy physicians.80 Physician adherence to guidelines appears to be hindered by inertia, lack of awareness, and external barriers, such as lack of time or difficulty of use.81 As Stephen Lande writes: "The reality of the system ... is that physicians will resist attempts to change treatment practices and will ultimately revert to their own way of thinking except when they are explicitly pressured."82 Physicians who work within managed care systems, as most do today, need to have reminder and feedback systems in place to reinforce their attention to guidelines.

Resistance to pain management practices combines these forces of inertia with the provider's additional fears about the extensive regulation of powerful opioids. However, Internet access to such guidelines in a quick and user-friendly way may hurry along the process of awareness and adoption of such guidelines and increase physicians' comfort level with better pain management practices. The location of current information on the Internet facilitates access for anyone with a computer, and the fact that the guidelines are linked to other commercial sites makes them easy to find, no matter what portal a physician uses to access medical information databases on the Web.83

With the rapid clinical deployment of personal digital assistants (PDAs), which can download material from the Internet and store volumes of clinical reference information, physicians will be expected to be familiar with the appropriate clinical guidelines for the patients they treat. One company, docuCare, now offers a handheld device to document patient care at the bedside - to record vital signs, medications, the physician's pain assessment, and the patient's responses to a pain satisfaction survey.84 The fact that a pain assessment survey is included with the device should emphasize to physicians the standard nature of taking such a survey.

A provider's failure to access medical databases like the National Guideline Clearinghouse is likely to become an important piece of evidence in a malpractice suit, since it is evidence that a physician failed to stay current in his or her field of practice. A physician who displays ignorance of current treatment guidelines may be attacked by the plaintiff using the results of a computer search to display these guidelines and their relative ease of access.85 Refusal to listen to a patient's description of pain or to move to more effective drugs as needed, following the World Health Organization treatment pyramid or the pain management guidelines of various specialty organizations, will not be excused because of a claim that customary practice does not require it.

Other reasons to conform to the standard of care A spectrum of liability doctrines are potentially available in situations where pain management is not given or is substandard.86 The theoretical underpinning of all such theories is the same: failure to be aware of the standard of care for proper pain management or failure to conform to it.

The heart of any malpractice case is proof by the plaintiff that the defendant failed to meet the standard of care. If the physician provides pain management for a patient, it must be done properly. A claim for a failure to treat for pain is dependent on evidence that the standard of care requires proper pain management in the situation experienced by the plaintiff. A patient can expect proper treatment, defined by the emerging standards of care as encompassing a right to relief from pain.87

Can a physician argue defensively that he or she was not trained in medical school as to proper pain management and that the customary practice among physicians is to undertreat pain? If a customary practice is a nonreflective and uninformed practice, it may be attacked by the plaintiff's experts. A growing body of testimony by physicians who have studied pain reflects a growing consensus on the proper treatment of pain - and you can bet that a plaintiff's pain is something about which every jury can understand and empathize.88

The issue is whether the customary practice is a reflective one or the result of ignorance and inertia. Modern case law has at times instructed the trier of fact that customary practice need not always be an absolute defense - that evidence of good practice may be introduced. Judicial deference to customary practice is, in fact, weakening. The Wisconsin Supreme Court observed in Nowatske v. Oserhoh:89

should customary medical practice fail to keep pace with developments and advances in medical science, adherence to custom might constitute a failure to exercise ordinary care.... [W]hile evidence of the usual and customary conduct of others under similar circumstances is ordinarily relevant and admissible as an indication of what is reasonably prudent, customary conduct is not dispositive and cannot overcome the requirement that physicians exercise ordinary care.

The respectable minority defense allows a physician who wants to follow pain management guidelines to defend his or her practice in the face of a different customary practice. Pain management guidelines are already generally accepted and used as a reference in workers compensation cases in many states, since workers often claim both job-related disability and the pain that results from that disability.90 The workers compensation judge often has to make findings as to whether a particular medical treatment is necessary. Statutes clearly allow compensation not only for curative treatment but also for palliative treatment, including aggressive pain management using opioids long term.

In City of Jennings Police Department v. Dorr, for example, the claimant suffered from chronic pain and depression due to a severe back injury. She had tried a variety of drugs, and her physician finally prescribed morphine sulphate for pain relief - specifically, 180 milligrams every eight hours, a dose usually reserved for chronically or terminally ill cancer patients. The court noted that the medical literature supported long-term treatment in certain cases with high dosages, although there was a split of opinion in the medical community. The court found that the level of drugs prescribed was not excessive and upheld the treatment plan of the physician as appropriate.91

Courts in a variety of cases - malpractice, workers compensation, and medical discipline, for example apply a standard increasingly calibrated to proper pain management practices. As long as the physician can present evidence of a thoughtful program of pain management for a particular patient, the courts are willing to respect aggressive opioid use.92

C. Other tort norms forcing pain management

Multidisciplinary pain programs are acknowledged to provide cost-effective approaches to pain.93 The ideal program includes specialists who can provide a range of services, including an anesthesiologist, a behavioral medicine specialist, a physical therapist, rehabilitative medicine specialist, and case managers to oversee and coordinate care.94 Consequently, it is necessary for the primary care physician and other specialists to be familiar with the existence and expertise of a pain specialist. This is more than a statement of medical necessity for the patient; established tort principles require a physician to make a referral to the appropriate specialist when the physician lacks the knowledge or experience to properly treat the patient.95

In Freeman v. Cleveland Clinic Foundation,96 the plaintiffs' son committed suicide. They argued that the surgeon who was treating the young man for his knee injury negligently failed to refer him to a pain management clinic after he concluded that the patient would not benefit from further physical treatment of knee problems. The court held that failure to refer did not proximately cause the young man's death, a common judicial way of avoiding the imposition of liability for suicide. The court did not, however, reject the possibility of such a duty to refer. In a more typical malpractice case, where a patient is experiencing acute or chronic pain and the treating physician fails to treat it because of a lack of pain management knowledge, it is more likely that a duty to refer will be found. For instance, in Johnson v. Kokemoor,97 a Wisconsin informed consent case, the court held that the physician's inexperience with a surgical procedure should have led him to offer the patient the choice of a referral to a nearby experienced surgeon.

The common law tort duty to refer is a well-established one. As the specialties of pain management mature, physicians who do not want to manage their patients' pain have a duty to refer. Patients with complicated pain imbedded in their disease process, like many cancer patients, require pain management as an integral part of their treatment. A pain management specialist must therefore be a part of the treatment team at a minimum. A physician who refuses either to treat the pain in conformity with current guidelines or to refer the patient is acting unethically. One could even argue that refusal to treat a pain patient is analogous to refusing to treat HIV-positive patients. The duty to refer must be carefully developed in light of the problem of pain, typically imbedded in the disease process for many patients. It can be argued that a primary care physician in particular must become familiar with pain management treatments, since referral may not always be possible - either because of insurer limitations or physical proximity. In such cases, the duty of continued treatment binds the physician to learn about pain and its control, or risk an action for abandonment of the patient.

2. Negligent or intentional infliction of mental distress

Can a patient or the family as bystanders sue for infliction of emotional distress because of the patient's tangible suffering unrelieved by proper pain management? The family members of a post-operative patient, or a terminally ill patient, are vulnerable, worried, and anxious. Visible suffering, unrelieved by the tools of pain management, can predictably create emotional distress in family members. Witnessing a family member in a hospital or nursing home suffer from unrelieved pain is itself painful.

No case law exists to support such a duty toward family members, but it can be movingly and persuasively argued. Courts have allowed plaintiffs to sue health-care providers for the negligent infliction of emotional distress under particularly egregious circumstances. One example is Oswald v. Legrand.98 The plaintiffs, a married couple, sued for mental injury as the result of a series of obstetric events. The wife was pregnant and began to have difficulties prior to her fivemonth check-up. She was admitted to the hospital, where she was treated rudely by physicians and staff and finally gave birth to a child who was presumed to be stillborn but turned out to be alive. The sequence of events was outrageous. The Oswalds claimed, among other things, severe emotional distress and mental anguish caused by witnessing the negligent treatment of their newborn infant. The court observed that tort law allows recovery for emotional distress when it is connected to physical injury or "where the nature of the relationship between the parties is such that there arises a duty to exercise ordinary care to avoid causing emotional harm.... Me think liability for emotional injury should attach to the delivery of medical services" (emphasis added).

Oswald focused on the vulnerability of the plaintiffs, coupled with the "crass insensitivity" of the medical staff. A similar case is Wargelin v. Sisters of Mercy Health Corporation,19 where a series of obstetric disasters befell the plaintiffs. The obstetrician made only two visits during labor, even though a Caesarean section was indicated due to the plaintiff's lopsided uterus and the fact that the fetal monitor indicated distress. The staff failed to react, and an intern subsequently delivered the plaintiff's child, not breathing and blue in color, and placed it on the mother's stomach as if it were a healthy child. Realizing the child's condition, the obstetrician then grabbed the child and began to pound on her chest and administer electrical shocks to revive it. A call for a pediatrician to help went unanswered, and after fifteen minutes, the rescue attempt was abandoned. The Michigan court applied the bystander rule, which permits a family member witnessing an injury to a third person to recover if the family member is present or suffers shock "fairly contemporaneous" with the accident. The court held that "the cumulative effect of all the events surrounding the stillbirth of the child, if proven to be negligent at trial, are sufficient to cause a parent to suffer emotional and mental distress."

In these cases, the courts have required observation of the disturbing events.100 "Observation" has been liberally construed by some state courts to include a discussion with a physician about a loved one's deteriorating condition.101 Most courts, however, require some direct observation of the events causing the bad outcome, not just observation of the bad outcome itself. 102

Some jurisdictions are reluctant to allow observational distress, fearing a litigation explosion and difficulties of proof in such cases. In Gray v. INOVA Health Services,103 a mother sued a hospital for negligent infliction of emotional distress after seeing her young daughter's physical reactions to an overdose of drugs during a medical test. The plaintiff alleged that she contemporaneously experienced extreme shock, blacked out, fell to the floor, vomited, and still suffers from mental anguish. The court affirmed a demurrer for the defendant on the grounds that the hospital owed no duty to the mother, only to the child who was the patient. However, Gray is distinguishable from the Oswald case, where active labor and its stresses involved both parents intimately in the birth process and where the staff's behavior was reprehensible. In Gray, the fault lay in a negligent dosage of drugs, not a cascade of rude and insensitive behaviors directed at vulnerable parties.

The doctrine of negligent infliction of emotional distress, therefore, has the potential to offer a remedy to vulnerable family members as they watch a loved one suffer needlessly in pain. The analogy to the labor and delivery cases is clear in the hospital or nursing home setting where the patient is obviously suffering. The doctrine is arguably applicable to any instances of intractable pain and its poor management in extreme cases.

3. The doctrine of informed consent

Can a plaintiff argue that informed-consent doctrine requires that pain management be disclosed as an alternative treatment to doing nothing for intractable pain, even if the physician does not want to use opiates or otherwise manage the pain? Such an obligation is connected to the duty to refer discussed above.

Physicians are required to disclose alternative methods of treatment -- along with their risks and consequences, and their probability of success - if these methods of treatment are generally acknowledged within the medical community as feasible.10 Physicians are obligated to discuss with patients the side-effects of drug treatments where driving or other life activities might be impaired.105 Some courts have held that alternatives should be disclosed even if the alternative is more hazardous 106 or the physician is not capable of performing the procedure or evaluating its risk.107 The threshold is only that the alternative treatment be considered within the standard of care.108 Such alternatives might include access to pain control programs or other specialty services.109 Aggressive pain management through opioid prescription is, at present, at least a minority practice within the medical professions using comprehensive pain management strategies.

The definition of "treatment" for purposes of when "informed consent" is needed has been construed broadly to include diagnostic options and choices of hospitals for performing a procedure. Physicians must disclose diagnostic procedures that might assist patients in making an informed decision about treatment. In Martin v. Richards,110 the physicians failed to inform the parents of a minor patient of the availability of a CAT scan to detect intracranial bleeding and the unavailability of a neurosurgeon at the hospital to operate on the child. The court held that it was for the jury to decide whether these things caused the patient's brain damage.

In Vachon v. Broadlawns Medical Foundation,111 the plaintiff suffered severe multiple trauma injuries. The issue was whether the plaintiff's transfer to a university hospital two hours away instead of to closer trauma hospitals was reasonable. The court held that the decision to transfer was part of the patient's treatment and raised an issue of reasonable care. In Johnson v. Kokemoor,112 the court included within a surgeon's duty of disclosure an obligation to inform the patient of the proximity of experienced providers in a nearby clinical setting who would have been able to perform the operation at a lower risk.

The corresponding pain management issue is whether a physician should be sufficiently aware of choices -- hospices for cancer patients, pain management programs for nonmalignant pain sufferers, or other physicians trained in modern pain management techniques - to be able to inform a patient of his or her options in treatment. It does not seem a stretch to require a duty to inform patients in such circumstances that a full range of pain therapies is available. Failure to discuss pain management options and the possibility of referral or transfer might well appear as a count in the patient's malpractice complaint for pain mismanagement.

D. Proving pain as damages

Present and future pain and suffering is a legitimate component of a damages claim by a malpractice plaintiff. As Dobbs says, "It]he pain for which recovery is allowed includes virtually any form of conscious suffering, both emotional and physical."113 This can even include the pain of recalling past pain.114 Pain experts can testify about such pain, as can the plaintiff; inferences about the degree of pain can also be drawn from the nature of the plaintiff's condition and the kind of medical treatment needed. Pain includes the sensation of physical pain.

In the normal tort case, pain is the result of a bodily injury caused by the defendant. The court is willing to instruct juries on pain and suffering when the plaintiff has suffered tangible injury due to the defendant. In the medical setting, pain from a missed diagnosis and lost opportunity to treat can be part of damages. The pain management failures are more complicated: The physician or provider is responsible not for the patient's condition, but for the mismanagement of pain, which is a by-product and symptom of an underlying disease. Pain, therefore, becomes the only component of damages, by analogy to the mental distress torts. The loss of enjoyment of life, as a corollary of the pain, may be allowed as a separate component of damages. The plaintiff's reactions to the pain and his or her sense of loss as a result may also be compensable.115

III. INSTUTIONAL FAILURES TO MANAGE PAIN: THOUGHTLESS SYSTEMS

Pain is ignored in the institutional setting as well as the physician's office. The consequence of unrelieved pain, particularly cancer pain, is not only patient suffering and decreased quality of life. It has been estimated that "[b]etween 30 and 50 percent of cancer patients in active treatment and 70 to 90 percent of those with advanced disease experience moderate to severe pain...."116 In surveys of surgical patients, it has been found that approximately half of all hospitalized post-operative patients failed to receive adequate pain relief. Patients reporting moderate to high levels of pain received less than half of the pain medication that was ordered.

The result of this undertreatment is decreased quality of life, functionality, activity, appetite, and productivity. The patient, having experienced such severe pain, can also become unwilling to continue treatment and become suicidal. At the MD Anderson Cancer Center in Texas, the annual hospital costs for pain admissions are estimated at $4.7 million annually.117 Most of this pain can be managed by proper assessment of causes and treatment with opioid analgesics.118 And most of this pain is found in patients in institutional clinical settings - general medical, surgical, and oncology wards; burn units; emergency departments; and pediatric wards.119

Failures of pain management can have catastrophic consequences for patients and for health-care institutions. Undertreatment may also lead to patient suffering, surgical complications, and other negative treatment results. Pain is not just a background noise produced by a disease like AIDS or cancer, to be stoically ignored or endured; it is the cause of somatic failures and expensive hospitalization and of patient resistance to treatment. Lower back pain, as one example, costs millions of dollars a year in loss work time. Pain, in other words, operates as an independent medical condition, and its continuation when modalities of treatment are available is iatrogenic - that is, injury that is providerinduced.120

Malpractice tends to isolate the individual physician as the cause of patient injury and suffering. The evidence as to undertreatment suggests that while physicians may often be at fault, it is primarily the system of care that has failed to reorganize its resources to address the problem. Since educational approaches lack efficacy, the better approach is to affect the systems that influence physician behavior.

Treatment and management of pain by institutional providers can be fostered by the possibility of liability for failure to satisfy a standard of care for effective pain relief. These threats of litigation can be powerful incentives to counteract physician resistance to the adoption of sound pain management practices.

A. Hospitals: the mandate of pain management

In the hospital setting, unnecessary patient pain frequently imposes higher costs as the result of lost wages and higher health-care utilization, such as emergency room visits and unnecessary hospitalizations.121 The hospital system has not been designed to recognize pain as a valid indicator of suffering and track and treat it with the intensity with which a fever is treated in a hospital. "[R]eports of unrelieved pain do not invariably result in corrective measures; pain may not be visible at the coordinating centers of the ward, and physicians and nurses have not traditionally been held accountable for providing titrated analgesia. "122

1. The general duty to manage complex systems Hospitals have been slow to adopt pain management practices. Hospital staffs have not made pain relief a priority, and hospital organizational structures have failed to incorporate pain management support.123 For instance, the SUPPORT Study in 1995 found that hospital treatment for dying patients involved poor communication between physicians and patients, overly aggressive treatments, and inattention to patient pain and suffering. It provided a discouraging indictment of the hospital system - namely, that it failed to treat patients with pain at the end of life. Critically ill patients were and continue to be bombarded with the newest medical technologies to extend their lives, even in the face of their stated wishes for a prompt relief of pain and suffering. A recent study of hospital palliative care concluded that lack of financial reimbursement is one of the reasons that end-oflife care is not a priority for hospitals. 124

Guidelines from the Agency for Health Care Policy and Research (AHCPR) provide for the minimization of the incidence and severity of acute pain. 125 These guidelines were published in 1992, but "evidence suggests that suitable pain management programs have yet to be developed." 126 This is despite the fact that the technologies are available, including intraspinal opioid administration, opioid infusion, and inhalational analgesia, 127 and that the organizational structures are well-defined.128

Hospital-based clinical management has neglected postoperative pain. In the words of Blau and colleagues, "[r]ecent data suggest that many patients continue to fear severe pain after surgery, and many post-operative patients continue to have significant pain. Further improvements in the quality of pain control will not occur unless it is recognized as a priority by health care providers, and an institutional approach is taken to assure that high quality analgesic care is consistently provided. "129 In spite of sound guidelines, "many health care institutions continue to lack any organized institutional approach for the management of acute pain."130

Yet the benefits of pain management are apparent. Surgical outcomes are improved by effective post-operative pain management, which may also reduce patient time in an intensive care unit, accelerate discharge readiness, and reduce the overall cost of hospitalization. These outcome benefits are based on inhibition of the metabolic stress response after surgery. Evidence shows that inadequate control of pain can also interfere more directly with recovery by impairing pulmonary function and movement and delaying the recovery of gastric and bowel function.131

Many medical disciplines are responsible for pain management. Pain management needs to be an institutional priority, supported with resources and leadership.132 A health-care institution, whether a hospital, nursing home, or clinic, is liable to its patients for negligence in maintaining its facilities, providing and maintaining medical equipment, hiring, supervising and retaining nurses and other employees, and failing to have procedures in place to protect patients.

Basic negligence principles govern hospital liability for injuries caused by something other than the negligent acts of the medical staff.133 Hospitals are generally held to a national standard of care for hospitals of their size and treatment category. Where, however, a new technology of proven efficacy has been adopted by some hospitals, the standard may be used to measure the practice in all hospitals.134

The professional duty of a hospital is to provide a safe environment for patient diagnosis, treatment, and recovery. If an unsafe condition on the hospital's premises causes injury to a patient as a result of the hospital's negligence, the hospital has breached its duty qua hospital.135 The test is "whether the negligent act occurred in the rendering of services for which the health care provider is licensed. 136 Hospitals must have minimum facilities and support systems to treat the range of problems and side effects that accompany the procedures they offer. Equipment must be adequate for the services offered, although it need not be state of the art.137

Pain management requires a systematic team approach. Much of the case law that has articulated hospital responsibility has come to focus on the administrative and treatment systems in place. For example, short staffing has been rejected as a defense where the available staff could have been juggled to achieve closer supervision of a problem patient.138 Failure to provide an adequate twenty-four hour anesthesia service also may create liability.139 A hospital and its contracting physicians may be liable for damages caused by inadequate or defective systems they develop and implement, particularly where emergency care is involved. Poorly designed systems can create harm just as readily as an incompetent staff member.140 Hospital on-call systems must work properly,141 and systems for storing and supplying medications must function effectively. 142 Another example of such an administrative failure is when a hospital fails to properly schedule a specialist consultation once it has been requested by a staff physician. 143

Hospitals will be liable for injuries caused by inadequacies in the internal programs that are mandated by statutes. 144 Once a hospital assumes a new responsibility, even a voluntary one, it is expected to properly implement that responsibility. 145

2. Corporate negligence

Courts have expanded the doctrine of corporate negligence for hospitals since the 1960s, recognizing that the hospital is no longer just a shell for the physician to use, but an active ring leader in providing care, support, and service. A hospital is thus directly liable for the failure of administrators and staff to properly monitor and supervise the delivery of health care within the hospital. A hospital has a non-delegable duty that extends directly to its patients, and it is liable for a breach of these duties. The liability arises from the hospital's action or inaction regarding its policies, rather than the specific negligent acts of one of its employees.146

The courts have generally required hospitals to provide surveillance of the quality of patient care within the hospital.147 Other courts have imposed on hospitals a duty to follow their own internal procedures 148 and to monitor the risks to patients created by poor treatment by staff physicians.149

Corporate negligence imposes liability on health-care institutions for their failure to protect patients from the harms the institution could have controlled. The doctrine's best recent formulation is found in Thompson v. Nason, decided by the Pennsylvania Supreme Court. 150 The court held that corporate negligence is a doctrine imposing liability on a hospital if it fails to uphold the standard of care to "ensure the patient's safety and well-being while at the hospital." Four areas of liability are involved:

* a duty to use reasonable care in the maintenance of safe and adequate facilities and equipment; "'

* a duty to select and retain only competent physicians;

* a duty to oversee all persons who practice medicine within its walls as to patient care; and

* a duty to formulate, adopt, and enforce adequate rules and policies to ensure quality care for patients.

This articulation of the doctrine of corporate negligence by the Pennsylvania Supreme Court is broader than that of other state courts considering the issue; these other courts have often limited the doctrine to the duty to select and monitor physicians and allied health-care professionals. Thompson expands the scope of the doctrine to encompass the hospital's general duty to ensure quality of care for patients. This recognizes the complexity of the modern health-care institution and the need to impose a patient-centered approach to doing business. The fourth duty articulated - to formulate, adopt, and enforce adequate rules and policies to ensure quality care for patients - is directly relevant to pain management. If a standard of care is established by accreditation standards, then a hospital can be expected, independent of accreditation, to follow such standards.

a. Duty to properly select and retain medical staff

Most jurisdictions have held hospitals to a duty to take reasonable steps to ensure the competence of its medical staff.152 The monitoring and retention of hospital staff have led to expanded duties to detect incompetence. A properly designed utilization review process within an institution will produce data as to unnecessary procedures, high error rates, and other early warnings of problems with a staff physician. The existence of such a process will give a hospital actual notice of possible incompetence, exposing it to liability if it fails to act to deal with the problem.153

In addition to determining which staff physicians are incompetent to handle certain procedures, the hospital must detect any concealment by its staff of medical errors.154 While some courts have limited this duty to only those situations where a hospital has learned of physician insufficiencies,155 others have talked of "negligent supervision" in terms of an affirmative duty to detect problems. 156 The few cases that reject a hospital's duty to monitor are increasingly outside mainstream jurisprudence on hospital responsibility. 157

Pain management obligations should be shouldered by physicians, with continuous feedback and attention to the level and quality of such management by the hospital. A failure to provide training and feedback and to detect physician reluctance to use proper techniques provides an argument of corporate negligence.

b. Duty to formulate, adopt, and enforce adequate rules and policies to ensure quality care

The broad statement of this fourth duty of hospitals, as articulated in Thompson v. Mason, properly defines the role of corporate negligence in addressing institutional management of all dimensions of patient care. The regular charting of pain should be treated as a "fifth vital sign" along with the other vital signs of temperature, pulse, respiration, and blood pressure."' Pain management is now a dimension of hospital administration in light of the new JCAHO standards. The duty to monitor patient care to ensure that staff physicians are properly treating patients must now include proper pain management.

i. JCAHO standards and pain management as a priority

Hospitals are regulated by their states, and state regulation typically defers to the standards of the Joint Commission on Accreditation of Healthcare Organizations JCAHO). The standard of care applied by courts in malpractice actions also reflects a baseline mandated by JCAHO standards, including its peer reviews through internal committee structures. Courts have consistently allowed evidence of JCAHO standards, state hospital licensure laws, and the hospital's own by-laws, which the trier of fact is entitled to accept or reject, as creating a permissive inference of negligence'19 or a rebuttable presumption.

Failure to follow new JCAHO standards for pain management can thus lead to liability, with such standards being admissible as evidence of the standard of care once they are implemented for the hospital's accreditation.160 The standards force integration of pain management into a hospital's overall care of a patient. A team approach to medical practice, incorporating pharmacists and other providers, is likely to further reduce risks. The standards developed by JCAHO and the National Committee on Quality Assurance need to rapidly incorporate the current findings of the Institute of Medicine report, To Err Is Human: Building a Safer Health System, and increase the pressure on individual and institutional health-care providers to redesign their systems to reduce risk.

Only within the last few years have JCAHO standards finally addressed pain management in hospitals and the need for proper organizational structures to promote such management. In 1991, JCAHO mandated that pain be routinely assessed and outcomes of care be routinely documented for terminally ill patients, but not for other patient populations experiencing acute or chronic pain. By 1995, JCAHO had written pain management into its guidelines. Finally, with the 2000 and 2001 editions of the JCAHO accreditation manuals, JCAHO now requires surveyors inspecting hospitals to include in their surveys a systematic look at pain assessment and management; the surveyors must determine whether the hospital has integrated compliance with the pain management standards with the overall care of patients. 161

If proper pain management is now part of the hospital accreditation process, then corporate negligence suits will use such accreditation guidelines, along with common law decisions that generally impose a duty of institutional responsibility for patient care, to establish the hospital's standard of care.

ii. Emergency Medical Treatment and Labor Act (EMTALA)

The Emergency Medical Treatment and Labor Act,162 or EMTALA, provides another source of liability that particularizes the standard of care expected of hospitals that participate in the federal Medicare program 163 and have emergency departments. The Act requires covered hospitals to provide a medical screening examination164 to any patient coming into the emergency department165 of the hospital.

The question from the perspective of pain management is twofold: Is pain an emergency medical condition that requires stabilization before transfer is possible? and Is avoidable or treatable pain a material deterioration of the patient's condition? The control of avoidable physical pain is a significant obligation of medical treatment. Severe physical pain that could have been avoided with appropriate medical care is arguably a material deterioration of the patient's condition.166

If an emergency medical condition 167 is present, the hospital must provide treatment to stabilize168 the patient's medical condition unless the patient requests the transfer in writing, or a physician certifies that the benefit of the transfer to the patient outweighs the risk.169 If the hospital transfers the patient,170 the transport support provided must meet the statutory standards for adequacy of equipment and personnel, the receiving facility must agree to accept the transfer, and the transferring hospital must provide all medical records to the receiving facility.171 Patients may refuse treatment, may refuse to consent to the transfer, and may request transfer.172

EMTALA provides for a private cause of action for violation of the statute. Any individual suffering harm as a "direct result" of a hospital's violation of the statute has a cause of action against the hospital.173 The statute also provides for civil monetary penalties against the hospital and against the "responsible" physician for violations of the Act. 174 The statute provides that civil damages 175 for a hospital's violation of the Act shall be "those damages available for personal injury under the law of the State in which the hospital is located."176 Although claims under EMTALA are not claims for medical malpractice, plaintiffs usually claim both a violation of EMTALA and medical malpractice.

The Act provides that "if any individual... comes to the emergency department, "177 it is the hospital's duty to assess whether the patient has an emergency medical condition. 178 The claim of failure to provide an appropriate medical examination requires that the patient be physically present in the emergency department, but some courts have held that a claim of transfer in an unstable condition does not require that the patient enter the hospital through the emergency room. 179

Courts interpreting EMTALA's medical screening requirement have generally adopted a standard of differential treatment and not professional standards. Plaintiffs must prove that the hospital's policy is to conform with professional standards. To the extent that the hospital has established written guidelines or has followed consistent practices in emergency medical examinations, it is, of course, essential for plaintiffs to prove their content.180 The patient's examination may be so cursory or inadequate as to amount to no examination at all, resulting in a finding that EMTALA was violated.181

A hospital violates the Act if it fails to provide an "appropriate medical screening examination" to the patient arriving in the emergency room. If the hospital provides an appropriate examination that detects an emergency condition or if the patient's emergency condition is otherwise known to the hospital, the hospital is liable under the Act if it transfers or discharges the patient in an unstable medical condition. Courts have required the plaintiff to prove that the hospital actually knew of the plaintiff's emergency condition in order to trigger the duty to stabilize prior to transfer or discharge.182 Where the hospital lacks actual knowledge of the patient's emergency condition as a result of a statutorily inadequate medical screening examination, the hospital would be liable at least for violating the examination requirement of the Act.183

Courts look at several factors in deciding whether a patient was stable before transfer or discharge. If the hospital actually admitted and treated the patient for a significant amount of time, this is some evidence of stability.184 Patient stabilization must be judged from the perspective of professional standards rather than standards established by each hospital.185 The Act explicitly defines "stabilized" as a condition in which "no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer."186

The EMTALA action is a small piece of the liability package for pain mismanagement. No case law has yet developed such a theory with regard to pain. But recognition of the importance of pain management in the new JCAHO pain management guidelines means that hospitals that seek JCAHO accreditation will need to develop policies for assessing and treating patient pain, including emergency admissions. This then sets a standard that must be followed in screening patients and stabilizing them. EMTALA then offers a statutory basis for suit in emergency admissions when patients are not properly screened or stabilized for pain.

B. Managed care organizations: paying for pain relief

Managed care organizations undertake to "manage" the care of subscribers. For outpatient conditions, such as lower back pain or other kinds of disability that can result in chronic intractable pain, it is arguable that a managed care organization should be responsible for designing and paying for institutional approaches to proper pain management. If clinical guidelines describe an ideal approach to pain, then the individual or institutional health-care provider is responsible for implementing such a strategy. Cost-sensitive managed care organizations, however, may resist.

For example, emergency room treatment for pain is likely to be resisted by utilization reviewers, arguing that it is too subjective and will impose excessive costs on the plan. Likewise, hospice care for cancer or other patients at the end of life is not provided consistently by all managed care organizations. 117 Nonmalignant chronic pain, such as that experienced by nursing home residents or those with other disabilities, can be expensive to treat with some of the new treatment approaches and is often neglected because of difficulty in defining it.188 The complex sources of chronic nonmalignant pain make diagnosis and management difficult. As a result, patients with such pain may need extensive diagnostic tests and referral to specialists or multidisciplinary centers.189

Managed care plans are worried about the costs of proper pain management, and with some justification. Susan Wolf notes:

Just as research on pain is in its infancy, research on how well or poorly MCOs [managed care organizations] do in treating pain similarly seems to be at an early point. It is clear that "HMOs' outpatient prescription drug benefits frequently are subject to restrictions ... such as generic substitution, therapeutic substitution, and [limited] formularies." Moreover, these benefits may be available in some HMOs only by subscriber purchase of an extra "rider" to the coverage contract, and coverage affects access to pain-relieving drugs. Much remains to be determined about the effectiveness of MCOs in addressing pain, however, especially for patients at the end of life. 190 Managed care organizations and insurers are reluctant, in large part, because they feel that many of the pain management guidelines are not based on extensive clinical studies.191

Until recently, courts have held that ERISA (the Employee Retirement Income Security Act) preempted most litigation against managed care organizations for medical errors. But this position has been deteriorating in the face of quality-of-care abuses by managed care organizations. At bottom, managed care organizations are businesses. They market their care to potential employers and subscribers in a competitive marketplace for health care. They recruit and organize their physicians through their networks. They design a corporate system in which health care is delivered. And they must administer this system in a safe fashion that avoids injury to subscribers caused by the negligence of plan physicians and other providers. Malpractice claims based on vicarious liability, corporate negligence, negligence per se, and intentional inflection of mental distress may be allowed to proceed against managed care organizations under the current law as quality-of-care issues outside the scope of an ERISA claim for benefits (i.e., quantity-of-care, or coverage, issues).192

1. Agency doctrine

Under theories of agency, managed care organizations may be on the hook for the liability of the physicians and other providers who work for them. Such vicarious liability has been upheld by the majority of courts, having considered the question of liability not to be preempted by ERISA.193 The reason is that the managed care organization's plan is irrelevant to the claim, since the claim of agency does not rise and fall with the plan.194 Rather the claim is established by reference to the parties' reliance and representations, a question of fact not involving the interpretation of an ERISA plan.195 If, however, the underlying claim against the treating physician is a failure to treat - a denial of benefits - then it relates to the benefits plan, and the claim could not be resolved without reference to a determination on benefits. In such a situation, one circuit court has held that ERISA completely preempts the agency claim. 196

2. Substandard plan design and administration

Claims of negligent design and administration of the delivery of health-care services have been allowed in recent cases.197 A negligence claim against a plan for providing contractual benefits in "such a dilatory fashion that the patient was injured are intertwined with the provision of safe care."198 In Pappas v. U.S. Healthcare, the issue was a delay in transporting the plaintiff to a specialty trauma unit for care. The delay arguably was caused by the utilization review process of the managed care organization, which did not allow transport to the best hospital unit in the area for spinal injuries. The case appears to involve both a system-induced delay and a benefits question as to which hospitals were available to the plaintiff. The case was remanded by the U.S. Supreme Court for reconsideration in light of its decision in Pegram v. Herdrich. Absent ERISA preemption as a defense, the doctrine of corporate negligence could be held to apply.199

A claim that a ERISA managed care plan is "substandard" and has led to patient injury as a result has been allowed to avoid ERISA preemption. In Moreno v. Health Partners Health Plan,200 the District Court held that there was "no relation between an action for medical malpractice and the recovery of benefits or the clarification of rights to future benefits under an ERISA plan."201 An action for negligent supervision of plan physicians has been allowed by courts to proceed as a quality issue and has not been deemed preempted by ERISA.202 Likewise, a plan decision to discharge a patient from the hospital to her home rather than a skilled nursing facility has been considered a "quality" issue, not suitable for preemption.203

Where a plan is responsible for the continuum of care and it proves to be inadequate - even if that means it refuses to cover a benefit at a rehabilitation hospital or other facility - courts have found this to be a complaint of substandard care and thus not preempted by ERISA.204 If a plan is negligent in failing to provide appropriate screening tests and studies, this, too, could be viewed as a negligent provision of benefits and not a denial of benefits, thus subject to ERISA.205 The U.S. Supreme Court's recent decision in Pegram v. Herdrich206 further opens the door to state tort litigation against managed care organizations on all the theories that hospitals are subject to, by refusing to interpret ERISA as imposing a fiduciary duty on physicians making "mixed eligibility decisions."

The problem with managed care organization liability is that pain management is still in its infancy. The field lacks clinical practice guidelines that are well-grounded in clinical studies. The practitioners of pain management are credentialed by different organizations and the lack of a consensus as to the gold standard for accreditation means that managed care medical directors are properly uncertain about to whom patients should be referred. Evidence of fraud in hospice billing in some cases has exacerbated managed care organization reluctance. As Diane Hoffmann writes: additional resources and attention need to be devoted to developing guidelines for treatment of various types of pain and ... more research needs to be conducted on the effectiveness and cost effectiveness of various pain treatment modalities and palliative care.... Additionally, there needs to be broader recognition of what constitutes a pain specialist and when a referral to a pain specialist is appropriate....[U]ntil more widespread consensus develops on what constitutes effective treatment of pain, especially chronic pain, or agreement on credentials for certification of pain providers, we can expect insurers and MCOs to be reluctant to approve coverage of some forms of pain treatment and continuing variation across plans in the way they deal with this issue.207 Managed care plans should be expected to be a market for effective pain management practices, since the use of the "substandard" test by the federal courts suggests not only an ERISA preemption defense for plaintiffs, but the emergence of a corporate negligence test that applies directly to managed care organizations.

A set of standards by accrediting bodies such as the Joint Commission on Accreditation of Heathcare Organizations and the National Committee on Quality Assurance will push managed care organizations in the direction of better pain management, both through market pressure and through the provision of a standard of care in tort actions. The law, after all, usually reflects the maturing and solidification of medical practice, demanding of practitioners and institutions that they measure up to standards set by their own institutions. NCQA has not yet provided specific standards for pain management, while JCAHO's new guidelines indicate that the field is maturing. NCQA should be urged to develop a standard that reinforces JCAHO's guidelines, thereby acknowledging the central importance of pain management in the care of patients.

C. Long-term care facilities: pain and quality of life

Nursing homes are increasingly the final stop before death. It has been estimated that half of the Americans who live to the age of 65 will live in a nursing home before they die.208 In 1996, there were over 1.56 million nursing home residents in the United States.209

The elderly in nursing homes are often undertreated for pain.210 Improper pain management in nursing homes can lead to high levels of chronic pain. Most nursing home residents are chronically, rather than acutely, ill. The average length of stay for nursing home patients is much longer than the average length for patients in acute-care hospitals. More than 84 percent of nursing home residents receive help with three or more activities of daily living, including eating, dressing, bathing, toileting, and transferring from one location to another.211 Pain is often the companion for these residents.

The elderly, the primary residents of such long-term care facilities, are poorly treated. The elderly also have lacked effective tort remedies: Causation may be hard to establish, given multiple diseases, and damages are hard to prove, with the exception of pain and suffering. The primary case to date that has imposed a duty to treat for pain is Estate of Henry James v. Hillhaven Corp.212

In this case, James was admitted to a nursing home with prostate cancer that had metastasized to his left femur and spine. Upon admission, it was estimated that he had about six months more to live. His personal physician prescribed 7.5 cc's of oral morphine elixir every three hours, as needed for pain. A nurse at the nursing home countermanded this order, after assessing James as addicted. She implemented a pain management plan using a mild tranquilizer and delaying or withholding analgesics.

The court found that James experienced physical pain and suffering and mental anguish, described as "inhuman treatment" inflicted "without regard to the consequences and without care as to whether or not the patient received analgesic relief and without care that the result and procedures were torture of the human flesh."213 During the trial, medical and nursing experts testified about the standard of care for opioid analgesics and morphine for intractable pain. A nurse also testified that proper quality assurance in nursing homes requires proper pain management.214 Thus, the issue again becomes the role of well-established clinical practice guidelines, JCAHO accreditation standards, and other sources to which a court can turn for a standard in evaluating the failures of a physician or nurse in a long-term care setting or the failure of the facility to detect and correct negligent treatment.215

1. Damages and causal problems wIth nursing home litigation

The nursing home population, in contrast to the typical hospital patient, will have more difficulty in succeeding in private litigation to remedy harms suffered as a result of breaches of established standards of care.216 Physical injuries such as broken bones and bruises in very frail elderly persons may be caused either by ordinary touching or by poor care or abuse. Causation, therefore, is difficult to prove. The mental impairment of many nursing home patients makes them poor witnesses, since they are unable to testify as to their experiences of pain. Their limited lifespan and their disabilities minimize legally recognizable damages for injury or death. They do not suffer lost wages. Their access to private attorneys has been limited because small damage awards discourage contingent fee arrangements and because of the isolation of institutionalization. Because of these limitations, several states have enacted statutes providing for private rights of action for nursing home residents. These statutes generally provide a cause of action for breach of statutory standards and may provide for enhanced damages and attorney's fees.217

2. False Claims actions under OBRA

The newest approach to poor quality of care in nursing homes is the False Claims Act under the Omnibus Reconciliation Act of 1987 COBRA '87).218 OBRA deals with (1) service requirements for those facilities in the Medicare and Medicaid programs; (2) a survey and certification process; and (3) enforcement and sanctions. OBRA requires a thorough assessment of each resident's functional capacity, to be used in developing a written care plan; specialized rehabilitation; a requirement that homes use less restrictive measures before turning to physical restraints; a prohibition of "unnecessary" drugs; and an explicit statutory basis for residents' rights. The goal of OBRA is to address a nursing home resident's condition so that he or she can achieve and maintain the "highest practicable physical, mental, and psychosocial wellbeing. "219

The False Claims Act 220 provides a statutory source, either used by the government or in a Qui Tam action by a private party, for using OBRA as setting the minimum standard for quality of life in a nursing home. A prima facie case need only allege that (1) the defendants presented or caused to be presented to an agent of the United States a claim for payment; (2) the claim was false or fraudulent; (3) the defendants knew the claim was false or fraudulent; and (4) the United States suffered damages as a result of the false or fraudulent claim.

The False Claims Act was initially used for overbilling or billing for unnecessary services. Its use by U.S. Attorneys against nursing homes has been based on allegations of billing for unrendered, yet necessary services, leading to a poor quality of care for residents. Providers claiming reimbursement under the federal Medicare and/or Medicaid programs implicitly certify compliance with all applicable federal regulations pertaining to program eligibility. When providers, either knowingly or recklessly, fail to render the appropriate regulated levels of care, they may be susceptible to liability under the False Claims Act, having falsely certified compliance.221

The False Claims Act has potential for extreme violations and obvious misconduct in nursing homes, such as bed sores and major sanitary problems with fragile elderly patients. Undertreatment of pain, absent an extreme case such as the facts in Henry James and absent an aggressive and protective family, will continue to be difficult to prove, even with this new weapon. But the specter of a large judgment based on a patient's pain is one additional source of pressure on nursing home operators to incorporate effective pain management into their care of residents.

CONCLUSION

Pain management is evolving as critics clamor for improvement in patient care. Progress, however, has been surprisingly slow - the result of continued uncertainty by providers as to appropriate opioid use, lack of institutional attention to pain management, and inattention by medical schools.

A convergence of forces is now building pressure on health-care providers to incorporate pain management into their practices. First, JCAHO's new statement of Pain Assessment and Management establishes a new standard of pain as the "fifth vital sign," which must be monitored and treated by hospitals for continued accreditation. Second, pain management clinical practice guidelines are now readily found through the Internet for easy access by health-care providers. One can only hope that medical school education will also incorporate a contemporary version of pain management into its curriculum.

Tort liability can now build on this convergence in pain management standards. It can reflect this convergence in medical practice and amplify the message so that providers hear it and change their practices accordingly. Patients suffer from too much pain - it is time for our hospitals, nursing homes, and doctor's offices to reduce this suffering.

ACKNOWLEDGMENTS

This project was supported by a grant from the Mayday Fund, as part of its ongoing support of pain management research. I want to thank the many friends and reviewers who made suggestions: Ann Alpers, fence Bonham, David Brushwood, Jesse Goldner, Diane Hoffmann, Sandra Johnson, Tim Jost, Ben Moulton, Fenella Rouse, Nic Terry, and my colleagues at the Faculty Scholarship Workshop at the Widener University School of Law.