Winter, 2005
By Sandra Johnson, JD, LLM
Tenet Endowed Chair in Health and Ethics
Saint Louis University School of Law and Center for Health Care Ethics
Until recently, legal risks for the medical neglect of pain have been nearly nonexistent, while the physician who treated patients for pain with medications that are controlled substances faced significant risks, including disciplinary action by the state medical board.
Research in the mid-1990's indicated that standards used by state medical boards to review the prescribing practices of physicians treating patients in pain did not conform to newer knowledge and practice patterns,
especially for patients in chronic pain. Instead, boards appeared to rely solely on the amount and duration of the prescription of controlled substances and to reject evidence of patients' improved function and pain relief.1 For example, in 1996, the Florida Court of Appeals rejected disciplinary action against a physician who prescribed controlled substances for pain management, noting that it was "surprising to see agency disciplinary action based upon such a paucity of evidence." In this case, the board's experts had relied solely on pharmacy prescription records and had not evaluated any patients or reviewed any patients' medical records.2
In response to this research, the Federation of State Medical Boards developed "Model Guidelines for the Use of Controlled Substances for the Treatment of Pain."3 the Model Guidelines made three significant policy statements. First, the guidelines stated that controlled substances "may be essential in the treatment of acute pain... and chronic pain." Second, the guidelines rejected "quantity and chronicity" alone as the basis of inappropriate prescribing. Third, the guidelines required certain practice management techniques including physical examination of patients, documentation and appropriate consultation.
In a 2004 revision, the Federation defines "inappropriate treatment of pain" to include "nontreatment, undertreatment, overtreatment and the continued use of ineffective treatments" and specifically recognizes that
state medical boards should "consider inappropriate treatment of pain to be a departure from standards of practice..." 4
At least 40 states have adopted policies, guidelines or regulations governing disciplinary actions related to prescribing for pain.5 In addition, at least 23 states now have statutes relating to prescribing for pain, and almost all of these statutes provide physicians with immunity from any disciplinary action if the physician complies with certain requirements.6 these immunity statutes typically require that the prescribing be for "therapeutic purposes" or meet accepted standards for medical practice. The statutes do not protect physicians who do not maintain documentation of
examination and evaluation of the patient, or who self-prescribe or write false prescriptions. A survey completed in 2002 indicated that attitudes of state medical boards have improved creating a less hostile environment for the use of controlled substances for pain relief. 7
Liability for Neglect of Pain
Some advocate increasing the risk of liability for neglect of pain. They believe this can counteract physicians' undertreatment of pain to the extent undertreatment is based on a fear of disproportionate legal risk for prescribing pain medication, outdated knowledge or carelessness.
Two landmark cases have imposed liability on physicians for neglecting pain. In Bergman v. Eden Medical Center and Tomlinson v. Bayberry care Center, the surviving family members of two patients in California filed suit against the physicians, hospitals and the nursing homes that cared for the patients.8 In bergman, the jury returned a verdict of $1.5 million, which the court reduced to $250,000. In Tomlinson, the defendants settled with the plaintiffs for undisclosed sums.
In each of these cases, the patient had terminal cancer and received patently inadequate medication for pain. There is a strong medical and legal consensus that the pain associated with terminal cancer should be treated aggressively without concern over addiction or diversion.
Lawsuits claiming neglected pain as the only basis for legal action face several obstacles. For example, many states cap the amount of damages that can be awarded for pain and suffering or bar such damages if the patient has died. Further, in Bergman and Tomlinson, neglect was readily apparent, but the treatment of pain in other cases may be more complex and difficult to litigate. It is quite unlikely that such litigation will reach beyond the most egregious cases of medical neglect or recklessness.9
Drug Enforcement Administration
After state medical boards established a more positive legal environment for physicians treating patients in pain, the focus shifted to the role of the DEA in monitoring physician prescribing under the federal controlled Substances Act (CSA) through the DEA's registration requirements. In implementing this registration system, the DEA is authorized to monitor prescribing practices of physicians in relation to any of the medications scheduled under the CSA for the purpose of preventing abuse and diversion. 10 As with any prosecutorial activity against particular physician practices, there is a challenge in providing needed oversight without discouraging physicians from taking care of their patients.
In 2001, the DEA issued a joint statement with more than 20 health organizations: "Promoting Pain Relief and Preventing Abuse of Pain Medications: A Critical Balancing Act."11 In August, 2004, the DEA, again after
much consultation, issued a Frequently Asked Questions (FAQ) document but subsequently retracted it, stating that it contained statements that were "erroneous" and that "further discussion of the subject is warranted" because "abuse of pharmaceutical narcotics and other prescription-controlled substances is increasing" and because "chronic pain is a serious problem for many Americans."12 The reason for the apparent reversal is not clear. The DEA promises more detailed guidance in the future, and advocates are actively engaged in the issue. 13
Footnotes
1 Johnson SH. Disciplinary actions and pain relief. J Law
Med Ethics 1996; 24(4):319-327. Four symposium issues on legal matters in pain
management are available at http://www.aslme.org/research/painjournals.php.
2 Hoover v. Agency of Health Care Administration, 676 So. 2d
1380 (Fla. App. 1996).
3 http://www.medsch.wisc.edu/painpolicy/domestic/model.htm
4 http://www.fsmb.org/
5 http://www.medsch.wisc.edu/painpolicy/matrix.htm
6 Johnson SH. Providing relief to those in pain. J Law Med
Ethics 2003;31(1):15-20.
7 Hoffman DE, Tarzian AJ. Achieving the right balance in oversight of physician opioid prescribing for pain: the role of the state
medical boards. J Law Med Ethics 2003;31(1):21-54. Gilson AM, et al. Improving
state medical board pain policies: influence of a model. J Law Med Ethics
2003;31(1): 119-129. Joranson DE, Gilson AM. Controlled substances and pain management: changes in knowledge and attitudes of state medical regulators, J Pain Symptom
Manage 2001;21(3):227-237.
8 Tucker KL. Medico-legal case report and commentary: inadequate pain management in the context of terminal cancer. The case of
Lester Tomlinson. Pain Med 2004;5:214-217.
9 Johnson SH. Commentary on medico-legal case report. Pain
Med 2004;5:219-220.
10 Noah L. Challenges in the federal regulation of pain
management technologies. J Law Med Ethics 2003:31(1):55-74.
11 http://www.medsch.wisc.edu/painpolicy/Consensus2.pdf
12 69 Federal Register 67170 (November 16, 2004). 13See correspondence at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-25469.pdf
in collaboration with
Dartmouth-Hitchcock Medical Center
The opinions expressed in the journal, Lahey Clinic Medical Ethics,
belong to the individual contributors and do not represent the institutional position
of Lahey Clinic on any subject matters discussed.
