Litigation Involving Pain Management

Ben A. Rich

In recent decades, issues arising in the context of pain management have increasingly been raised in the context of law and public policy. Indeed, one of the major professional journals, Pain Medicine, now has an entire section devoted to this area of activity (i.e., forensic pain medicine). Although technically, forensic pain medicine encompasses all instances in which pain medicine and the law converge, this chapter focuses on the area of convergence that is most often associated with the term forensic—litigation. Other aspects of law and public policy affecting pain management are covered in the pain policy chapter of this book (Chapter 14).

American jurisprudence is divided into two broad categories of jurisdiction—state and federal—and four distinct domains within both categories: administrative, civil, criminal, and constitutional. Cases involving pain management have arisen in all four domains, and in this chapter, we will consider representative cases in each and identify the important lessons for practitioners. We will begin with administrative proceedings, all of which involve disciplinary actions by state medical licensing boards against physicians. In reviewing these cases, it will become clear how the pendulum has been swinging over the last 20 to 25 years. Beginning in the early 1990s, the long-standing concern about “overprescribing” of opioid analgesics was disrupted by several cases in which health care institutions and professionals were charged with substandard practice for their failure to provide seriously ill or dying patients with adequate management of pain and/or symptom distress. These proceedings reflect an emerging policy trend among licensing boards to emphasize the important role of pain management in patient care. With the ever-increasing evidence in the last 10 years that opioid overdose deaths have reached epidemic levels in some parts of the country, state boards and federal regulators have begun to revise policies and guidelines to reflect the current level of risk posed by the indiscriminate prescribing of opioids. These policy permutations are more fully discussed in the pain policy chapter (Chapter 14).

The aspect of civil litigation that most often involves health care professionals is medical malpractice. Such claims are a species of tort claim in which an injured party, the plaintiff, asserts that they have sustained compensable injury as a result of the negligence of the other party, the defendant. In order to be successful, medical malpractice claimants must establish four essential elements. The first element is the existence of a duty owed by the defendant to the plaintiff. The generic characterization of such a duty is “due care.”¹ In professional liability cases, this translates to compliance with the prevailing standard of care. However, a health care professional-patient relationship must exist before such a duty may be deemed to have arisen.

The second element is breach of the duty owed, hence in medical malpractice litigation, a material departure from the standard of care. A dispute as to what constitutes the relevant standard of care by which the defendant professional’s conduct is to be evaluated is usually the critical issue in a medical malpractice case, and the outcome often depends on whose expert witness or witnesses are deemed by the jury to be most convincing. Consequently, medical malpractice cases have come to be characterized as little more than a “battle of the experts.” Traditionally, the usual custom and practice of physicians in the same or similar situations to the defendant has set the standard of care. Evidence of compliance by the defendant physician with the custom tended to create an irrefutable presumption that the applicable standard of care had been met. Over the last several decades, there has been a gradual trend by the courts toward a recognition of instances in which the custom and practice of clinicians has lagged noticeably far behind advances in medical science and technology, or physicians have failed to adopt safer or more effective clinical practices such as those advocated by national clinical guidelines. In such situations, the courts have acknowledged that rigid and unreflective adherence to the customary practice might demonstrate a failure to exercise appropriate clinical judgment. We will consider that issue further in the section of the chapter pertaining to civil litigation.

The third element of a tort claim is damage or injury. The breach of a duty of due care that fails to produce an injury or other harm is, from a strictly legal perspective, of no consequence. It is characterized in the law as damnum absque injuria (a wrong without injury). Such circumstances may be of interest to risk managers and quality improvement personnel, but they do not give rise to tort liability. The intriguing aspect of harm in the context of pain management is whether subjecting patients to unnecessary pain through substandard care would be deemed by juries as on the same level as medical errors that produce demonstrable physical injury or even death. The cases we will examine confirm that this is indeed the case, at least for patients who were at the end of life.

Finally, the plaintiff must establish that the breach of the duty of care by the defendant was the proximate (direct and immediate) cause of the damage or injury he or she sustained. In the cases we will be considering, the plaintiff must persuade the jury that pain management consistent with the standard of care would have, to a reasonable degree of medical probability, ensured that the patient did not suffer to the same extent as she did.

In the fourth section of the chapter, we will review criminal prosecutions by both the state and federal governments that concern the prescribing of opioid analgesics for terminal or chronic noncancer pain patients. Finally, in “Constitutional Cases” section, we will consider three US Supreme Court cases in which constitutional issues are raised in the context of cases related to pain management and/or end-of-life care.

Administrative Proceedings

Until recently, disciplinary actions by state medical licensing boards involving the prescribing of opioid analgesics targeted the phenomenon of “overprescribing,” and it was the leading cause of both investigations and disciplinary actions.² Some of these actions were well-founded efforts to punish physicians who prescribed controlled substances inappropriately or without a legitimate medical purpose, thereby endangering their patients and/or society. Others, however, sought to punish physicians who were engaged in a good faith effort to manage chronic noncancer pain and demonstrated either a dismissal
by the boards of the plight of chronic pain patients or an ignorance of the risks, side effects, and benefits of opioid analgesia.³ We will consider two cases from the second group in which the practices of the accused physicians were ultimately vindicated by state appellate court decisions.

IN THE MATTER OF DILEO

Dr. Lucas DiLeo, a general practitioner, prescribed opioid analgesics for some of his patients with significant chronic nonmalignant pain. One of these patients, for example, was an ironworker who had fallen over 40 ft onto concrete and sustained 153 fractures,⁹³ in the face, as well as shattering his knees, ankles, and left femur. He underwent 10 operations, and continued thereafter to suffer with chronic pain. In 1992, the Louisiana Board of Medical Examiners filed an administrative complaint against Dr. DiLeo alleging that his prescribing of opioids to seven patients (an eighth patient was treated for obesity with a combination of benzphetamine [Didrex] and alprazolam [Xanax]) was not for a legitimate medical purpose, demonstrated incompetence, and fell outside acceptable standards of medical practice.

The board’s expert witness, Dr. Linda Stuart, a board-certified family practitioner and addiction specialist, did not question that the seven patients receiving opioids had serious pain problems nor did she challenge the doses prescribed as excessive. However, she did testify that in her opinion, opioid analgesia was provided for too long a period of time, thereby posing an unacceptable risk of addiction and withdrawal symptoms. She acknowledged, however, that there were different schools of thought on this issue in the medical profession. As for the obesity patient, Dr. Stuart questioned the prescribing of Didrex and Xanax at the same time because she considered the former to be a stimulant, whereas the latter was a depressant.

Five of Dr. DiLeo’s patients testified on his behalf, as did a physician whose specialty was internal medicine/endocrinology. The medical board ruled against Dr. DiLeo, and that ruling was affirmed by a trial court. The Louisiana Court of Appeals reversed and dismissed all charges against him after finding that no evidence had been presented by the board to support Dr. Stuart’s assertion that the duration of Dr. DiLeo’s prescriptions was excessive. Indeed, the Court of Appeals held that the board had failed to present any evidence as to what the relevant standard of medical practice was for prescribing opioids for chronic pain. In the absence of such evidence, the unsupported assertions of Dr. Stuart were insufficient to justify the disciplinary measures imposed on Dr. DiLeo, and the charges against him were deemed by the court to be arbitrary, capricious, and an abuse of the board’s discretion.⁴

HOOVER V AGENCY FOR HEALTH CARE ADMINISTRATION

Katherine Hoover, MD, was a board-certified internist who had a number of chronic pain patients in her practice. For some of them, she elected to prescribe opioid analgesics for an extended period of time. The state medical board took a dim view of this and initiated disciplinary proceedings for “inappropriately and excessively” prescribing Schedule II drugs to seven patients. The board’s case against Dr. Hoover consisted of two physicians who had reviewed pharmacy computer printouts documenting the prescriptions written for these patients by Dr. Hoover, and their opinions that the dosages she had prescribed were “excessive, perhaps lethal.” None of these patients had, in fact, suffered any adverse effects from the prescriptions written by Dr. Hoover. Rather, they rallied to her support because she had diligently and successfully worked to manage their pain and restore their ability to function, whereas other physicians had either discounted their reports of pain or refused to prescribe opioids.

The board’s experts did not review the medical records for any of these patients. Also, on cross-examination, these “experts” acknowledged that they did not treat chronic pain patients in their practice. Indeed, under the more stringent standards for expert testimony that have developed in the last 10 years, one could reasonably argue that the medical board’s experts were not really experts in pain management. The hearing officer in the case may have taken the same view because she ultimately ruled that the evidence presented at the hearing supported a conclusion that Dr. Hoover’s care of these patients was entirely appropriate. Nevertheless, the Board of Medicine took the remarkable step of disregarding the hearing officer’s findings and conclusions and imposed sanctions that included an administrative fine of $4,000, continuing medical education (CME) on the prescribing of “abusable drugs,” and 2 years of probation.

Dr. Hoover appealed, and in a scathing opinion by a threejudge panel of the Florida Court of Appeals, the ruling of the medical board was reversed. Noting a disturbing pattern and practice by the medical board, the opinion declared, “The board has once again engaged in the uniformly rejected practice of overzealously supplanting a hearing officer’s valid findings of fact regarding a doctor’s prescription practices with its own opinion in a case founded on a woefully inadequate quantum of evidence.”⁵ Elsewhere in the opinion, the court referred to the board’s “draconian policy of policing pain prescription practice.” Similar to the decision by the Louisiana Court of Appeals in DiLeo, the Florida Court of Appeals noted that the medical board had failed to introduce competent, credible evidence of the standard of care by which Dr. Hoover’s prescribing practices could be evaluated.

One very important implication of the DiLeo and Hoover cases is that the courts will not simply sit back and allow medical boards to declare what the standard of care is in any particular clinical situation. Rather, the board must present persuasive evidence in support of the prevailing standard of care. Moreover, such cases as these appear to represent an “ethic of underprescribing” on the part of state medical boards that persisted for decades.⁶ It was the deeply engrained and pervasive nature of this ethic that prompted some state legislatures to adopt the intractable pain treatment acts (IPTAs) that are discussed in Chapter 14. The thrust of such legislation was to send a message that the public policy of the state should not be to discourage physicians from providing effective pain management to patients with chronic nonmalignant pain, even if in some cases, that would involve the extended use of opioid analgesics. The Hoover case suggests how difficult it was to surmount the prevailing ethic in some boards because that case was brought shortly after the State of Florida had enacted an IPTA. The medical board rationalized its attempt to discipline Dr. Hoover by arguing that she had treated the patients in question prior to the effective date of the Florida law. The Florida Court of Appeals critiqued the cramped and legalistic way in which the board attempted to flaunt the statute, noting that what the board failed or refused to recognize was that the public policy of the state did not support its approach to punishing physicians who dared to prescribe opioids to patients with chronic noncancer pain.

As noted earlier, beginning in the mid-1990s, a few state medical boards adopted policies on pain management that were intended to reassure physicians that the board was not, in fact, hostile to good pain management practice and sought to outline how physicians could care for such patients in a manner that was consistent with good medical practice. Then, in 1998, the Federation of State Medical Boards (FSMB) promulgated model guidelines for the use of controlled substances for the treatment of pain.⁷

The gradual dissemination of medical board policies promoting effective pain relief as an essential component of quality patient care signaled the beginning of a paradigm shift.
Heretofore, the idea that if there could be such a thing as overprescribing of opioids, then as a matter of logic and consistency, there must be an opposite side to the coin (i.e., underprescribing of opioids) seemed to be unintelligible to many medical boards. The inconsistency between perception and reality was truly remarkable. Whereas the medical literature in the 1980s and 1990s was replete with data indicating that pain was significantly undertreated in almost all patient care settings, no medical board had ever encountered a case in which underprescribing was deemed to constitute incompetent or unprofessional conduct.⁸

OREGON BOARD OF MEDICAL EXAMINERS V BILDER

Paul A. Bilder is a pulmonary specialist who in the late 1990s was practicing in a small Oregon community. In 1999, the Oregon Board of Medical Examiners (OBME) initiated disciplinary action against Bilder following an investigation of complaints concerning his alleged failure to properly manage the pain and other distressing symptoms of six patients over a period of 5 years. The disciplinary action ultimately led to a stipulated order in which Bilder agreed to certain remedial measures.⁹ Two of the six were elderly patients with metastatic cancer who were enrolled in hospice. In each instance, the hospice nurse requested an increase in the dosage of pain medication in what turned out to be the last hours of the patient’s life which Dr. Bilder refused to provide because he considered the amount requested excessive. In the other three cases, he refused to provide morphine or similar pain medication to a patient with congestive heart failure (CHF) who was do not resuscitate (DNR) and gasping for breath. The other three cases involved patients who were ventilator-dependent because of chronic obstructive pulmonary disease (COPD) or pneumonia. Dr. Bilder ordered paralytic agents but refused to order antianxiolytics or pain medication.

By the terms of the stipulated order, Dr. Bilder agreed to a 10-year probation, a formal reprimand, successful completion of the board’s Physician’s Evaluation Education Renewal Program, and an approved course in physician-patient communication as well as continuing psychiatric treatment with regular reports from the treating psychiatrist to the board. The Oregon Board once again found it necessary to take disciplinary action against Dr. Bilder 2 years later for similar instances of failure or refusal to appropriately respond to clear indications of patient suffering.¹⁰

ACCUSATION OF EUGENE WHITNEY, MD

In 2003, California became the second state to take disciplinary action against a physician for failure to provide appropriate pain relief. The patient in question was an 85-year-old man with advanced mesothelioma. The care of Lester Tomlinson in the last weeks of his life was the subject of both civil litigation and medical board disciplinary action. The civil litigation will be discussed in the next section of this chapter.

Mr. Tomlinson spent 5 days in a local hospital receiving treatment for pneumonia and pleural effusion. He was then transferred to a skilled nursing facility (SNF) and came under the care of Eugene B. Whitney, MD, for the duration of his stay, which ended with his death approximately 3 weeks later.¹¹ The care of Mr. Tomlinson at the SNF generated a great deal of contention between the members of his family (wife and daughter) and the caregivers. Each administration of pain medication, which began on the fourth day following his transfer from the hospital, was precipitated by a complaint from the family that he was in pain. Medication orders progressed from remazepam (Restoril) to hydrocodone/paracetamol (Vicodin) to various strengths of fentanyl transdermal (Duragesic) patch. Only after the family specifically requested morphine for Mr. Tomlinson’s increasing pain did Dr. Whitney discontinue the hydrocodone/paracetamol (Vicodin) and ordered morphine (Roxanol) 20 mg, 10 mg orally every 6 hours.

Dr. Whitney saw Mr. Tomlinson only once during that period of time, 2 days after the first administration of Roxanol. He found the patient to be in pain and ordered morphine sulfate controlled-release (MS Contin) oral solution 10 mg every 4 hours as needed. As noted in the medical board charges against Dr. Whitney, MS Contin comes in tablet form only and should be provided on a regular schedule and not on an “as needed” basis. Dr. Whitney discontinued the prior order 2 days later and instead ordered MS Contin 5 mg every 2 hours for breakthrough pain. As further noted in the medical board accusation, halving the dose of an opioid analgesic and doubling the frequency of administration will not increase the analgesic potency. Nursing notes at the SNF in the subsequent 2 days until Mr. Tomlinson’s death indicate uncontrolled pain and anxiety.

The Medical Board of California charged Dr. Whitney with unprofessional conduct and incompetence for his failure “to understand the unique properties of Roxanol solution and MS Contin tablets and to prescribe the medications properly.”¹¹ The board and Dr. Whitney entered into a stipulation for public reprimand, the terms and conditions of which require that he obtain CME in pain management, the prescribing of opioid analgesics, and communication with patients and families.¹²

At this point, it is still too early to conclude that the medical board actions against Drs. Bilder and Whitney represent any sort of lasting paradigm shift in philosophy and practice of medical boards generally in regard to opioid prescribing by their licensees. Two cases do not constitute a trend. The FSMB Model Policy concerning controlled substances for pain relief has undergone a number of periodic updates, expansions, and revisions over the last two decades. In the most recent iteration (2013), it states that “evidence for the risk associated with opioids has surged, while the evidence for benefits has remained controversial and insufficient.”¹³ The current document admonishes prescribing professionals to recognize that appropriate pain management includes an ongoing risk-benefit assessment of opioid analgesia versus nonpharmacologic measures.

A majority of state medical boards had adopted the model policies or promulgated policies that emphasize the need to incorporate sound pain management practices into patient care.¹⁴ To some extent, the shift in attitudes about the role of pain management in patient care, and the influence of those new attitudes in the formulation of medical practice guidelines and policies, can be traced to a few dramatic legal cases. We turn now to these cases and their role in informing public attitudes and policies about pain and its management.

Civil Litigation

Despite growing evidence in the clinical literature that pain is often undertreated, and a medical malpractice crisis purportedly arising out of a plethora of malpractice claims yielding significant monetary damage awards, prior to 1990, there had never been a malpractice suit seeking damages for failure to provide appropriate pain relief.

Although somewhat speculative, there are several possible explanations of this curious state of affairs. First, the phenomenon of widespread undertreated pain was not well known outside of the health professions. It had yet to become a featured topic in the print or electronic media. Moreover, laypersons held the erroneous belief that pain was the inevitable result of traumatic injury, serious illness, or a major surgical procedure. Finally, the generally high repute in which health care professionals were held presupposed that they would most certainly not allow a patient to experience unnecessary pain or suffering. The pervasiveness of pain in the clinical setting must, on this view, result from the sheer intractability of the pain associated with major illness and most certainly with the process of dying. From this perspective, the case we now consider is all that more remarkable in its outcome.

ESTATE OF HENRY JAMES V HILLHAVEN CORPORATION

Henry James was a 75-year-old man who carried the diagnosis of stage III adenocarcinoma of the prostate with metastasis to the lumbar sacral spine and left femur. In December of 1986 and January of 1987, he spent nearly 2 months in a local hospital receiving treatment for a pathologic hip fracture. During that hospitalization, in addition to bone debridement and radiation therapy, Mr. James was evaluated by hospice and received Roxanol 150 mg every 3 to 4 hours around the clock for his pain. Progress notes indicate that his pain was well controlled on this regimen.

After a very short stay at home, he was admitted to an SNF owned and operated by the Hillhaven Corporation. The continuing orders for pain medication included 150 mg per day of Roxanol, along with two tablets of acetaminophen (Tylenol) every 4 hours as needed and propoxyphene napsylate and acetaminophen (Darvocet-N) 100 mg. His family had ensured that he received the medication when he was at home and made certain that the nursing home staff was aware of it on his admission.¹⁵

In preparation of the SNF admission documents, a nurse offered the opinion that Mr. James was addicted to morphine and on that basis declared her intent to significantly reduce the amount of opioid analgesia and replace it with a tranquilizing agent. Remarkably, she was able to effectuate this change in the pain management regimen without the review and approval of the patient’s physician. His family learned about the change only after he had been discharged from the facility and was interviewed by investigators for the North Carolina Department of Human Resources, the licensing agency for the facility. Their investigation revealed that at no time during his 23-day stay did he receive pain medication as ordered.¹⁵

Thereafter, the family consulted an attorney and suit was filed against the nurse and the facility for failure to properly treat Mr. James’s pain.¹⁶ In order to prevail in such a case, the plaintiff (Mr. James’s estate) had to establish by a preponderance of the evidence that (1) a recognized standard of care for the management of his pain existed, (2) the standard was violated by the defendants, and (3) the departure from the standard of care caused him to experience pain to an extent that he would not had the standard been met. If the jury answered each of those questions in the affirmative, then it must proceed to determine what several weeks of unnecessary pain should be worth in monetary damages. During the course of the trial, expert witnesses called by the plaintiff challenged the position taken by the nurse at the Hillhaven facility that the dose of morphine prescribed for Mr. James was excessive and not necessary to control his pain.¹⁷

The jury answered each of the questions in the affirmative and awarded the plaintiff compensatory damages of $7.5 million. However, the jury did not stop with that award. In a civil action, when a defendant’s conduct is sufficiently egregious to meet certain criteria, punitive damages may be awarded. The purpose of such damages, as the term suggests, is not to compensate the plaintiff, but rather to make a negative example of and punish the defendant. The jury in this case assessed another $7.5 million in punitive damages. Apparently, the jurors were convinced that there is or ought to be something like a right to effective pain relief, at least for patients in the circumstances of Mr. James, and that the defendant corporation and/or its agent consciously disregarded that right and in the process subjected an elderly, dying patient to unnecessary pain and suffering. In a subsequent section of this chapter, we will consider two cases in which the US Supreme Court appears to adopt a similar position as a matter of constitutional law.

Several years after the verdict and subsequent out-of-court (and confidential) settlement of the Estate of Henry James v Hillhaven Corporation case, North Carolina joined a number of other states in enacting tort reform legislation. Consequently, the same result could not be achieved today even in the same or a very similar case. Punitive damages are now capped at 3 times the amount of compensatory damages or $250,000, whichever is greater. Furthermore, punitive damages cannot even be sought unless the plaintiff can prove by clear and convincing evidence (a higher burden of proof than a preponderance of the evidence) one of the following aggravating factors: (1) the defendant acted out of malice, (2) fraudulently, or (3) in willful and wanton disregard of the rights or safety of the defendant. Punitive damages could not be recovered from a corporation (such as Hillhaven) unless the officers, managers, or directors participated in or condoned the conduct that constituted the aggravating factors.¹⁸

BERGMAN V CHIN, MD, AND EDEN MEDICAL CENTER

William Bergman was an 85-year-old man in severe pain when he arrived at the emergency department (ED) of Eden Medical Center. He had been taking the Vicodin prescribed by his physician but without receiving adequate relief. He was given morphine by the ED physician and experienced significant relief. In order to do a more extensive workup, he was admitted to the hospital and came under the care of a hospitalist, Wing Chin, MD. Out of concerns about the side effects of morphine, in particular respiratory depression, Dr. Chin discontinued it and wrote a standing order for meperidine (Demerol), 25 to 50 mg every 4 hours “as needed.” This order remained in place throughout the 5-day hospital stay, during which the nurses charted pain levels in the range of 7 to 10 on the standard 10-point scale. On the date of Mr. Bergman’s discharge, his numerical pain score was noted to be a 10; nevertheless, Dr. Chin planned to send him home with a prescription for Vicodin. When Mr. Bergman’s daughter protested, Dr. Chin ordered another administration of Demerol and a fentanyl patch.

During the hospitalization, the medical workup was strongly suggestive of lung cancer, although Mr. Bergman refused to consent to a lung biopsy that Dr. Chin believed was indicated in order to make a definitive diagnosis. Despite a diagnosis Dr. Chin deemed less than definitive, shortly following his discharge, Mr. Bergman came under the care of a hospice nurse, who prevailed on another physician in the community to write a prescription for morphine after she found the fentanyl patch to be inadequate to manage Mr. Bergman’s pain. He died 3 days following discharge. No autopsy was performed. The cause of death was considered to be complications from lung cancer.¹⁹

The children of William Bergman became convinced that the last days of their father’s life were severely compromised by a clinical failure to provide effective pain relief. Their conviction resulted in part from a review of his medical record by an expert secured through the assistance of the organization Compassion in Dying (now Compassion and Choices). The family initially filed a complaint against Dr. Chin with the Medical Board of California. In an interesting approach to the case, the board’s own investigation and independent expert review confirmed that the pain relief Dr. Chin provided to Mr. Bergman was inadequate. Nevertheless, the board notified the family that it would not take any adverse disciplinary action against Dr. Chin based on only one episode of inadequate patient care. Displeased by this response, and with continuing support from Compassion in Dying, the Bergman family secured legal counsel and filed a civil action against Dr. Chin and Eden Medical Center. The medical center settled with the plaintiffs prior to trial.

The complaint against Dr. Chin that was tried to a jury was unusual in that it was not a straightforward medical malpractice claim. Such a claim could not have any chance of success in California because, as a result of tort reform legislation, damages
for pain and suffering resulting from medical malpractice can only be recovered by the patient; they are not deemed to “survive” such that they can be recovered following the patient’s death by the personal representative. The only challenge to the medical care provided by Dr. Chin related to his alleged failure to properly manage Mr. Bergman’s pain; hence, the only damages that could be awarded would be for unnecessary pain and suffering. However, if the pain and suffering can be proven to have resulted from acts or omissions that constitute “elder abuse,” under California law, the personal representative of the “victim” of the abuse can recover damages. Consequently, the Bergman family’s suit against Dr. Chin and the hospital alleged elder abuse.

Only gold members can continue reading. Log In or Register to continue