Chapter 85. Medical-Legal Considerations in Pain Management

Physicians involved in pain management should be aware that there are many legal issues involved in the practice of pain management. Some patients who present to pain management centers may be involved in litigation or compensation cases. The impact of these issues on patient outcome is controversial. Patients with pain often are labeled “difficult” because of their responses to the stress of their pain. Furthermore, there is a widespread perception that anesthesiologists working in pain management centers are at a greater risk of being sued for malpractice than those working in the traditional operating room setting.

The available information, however, does not support this perception. For example, during the period 1971 to 1982 in Washington State, of 192 malpractice claims against anesthesiologists, 56 involved regional anesthesia, but only one (for a pneumothorax during stellate ganglion block) involved pain management.1 Data from the claims files of the Risk Management Foundation of the Harvard Medical Institutions shows only one anesthesia pain management claim during a recent 10-year period. In this claim, a man received a corticosteroid injection for meralgia paresthetica. Shortly after leaving the hospital, approximately 50 minutes after receiving the injection, he became dizzy. He returned to the pain clinic and fell, allegedly sustaining a back injury that caused permanent residual pain. The claimant alleged a failure to obtain informed consent and that the physician did not advise him to remain for observation for adverse reactions. The claim was resolved without a lawsuit.

The database of the American Society of Anesthesiologists Closed Claims Project shows that while the proportion of anesthesia malpractice claims involving nonoperative pain management is fairly low, it is increasing over time, from 2% of all claims in the 1970s to 8% of all claims in the 1990s. In a review of the database of closed claims, the most common injuries were pneumothorax, nerve damage, headache, and back pain. Claims for very serious complications such as brain damage or death represent a small but not insignificant fraction (10%) of the claims. The median payment for operative claims was much higher than the payment for nonoperative pain management claims ($100,000 vs $16,250). The likelihood of payment for a claim was similar between the two groups, as was reviewer judgment of appropriateness of care.2

Exposure to the risk of a malpractice claim will vary with the degree of a physician’s involvement with pain management and the type of procedures performed. The greatest risk for major claims appears to be associated with the administration of ablative nerve blocks.3–5

One moderate-sized pain management center in a university teaching hospital doing approximately 1000 procedures (nearly all injections) annually had the following distribution of case mix: lumbar epidural steroids, 66%; epidural narcotic catheters, 1%; transcutaneous electrical nerve stimulation (TENS), 2%; stellate ganglion, 6%; facet, 3%; and blood patch, 1%. Only a few blocks performed during this period were neurolytic. Therefore, this pain center, and other pain centers performing similar procedures, are most likely to be at a relatively low risk for major claims for complications from procedures.

Portions of this chapter reprinted with permission from Danner D. Medical Malpractice: A Primer For Physicians. Rochester, NY: The Lawyers Co-operative; 1986:4–7.

Physicians may be involved as a witness in a malpractice case as either a fact witness or an expert witness. A physician involved in a patient’s care may be forced to testify (by deposition or subpoena) as a fact witness by the plaintiff or the defense. When pain management physicians are subpoenaed as a routine fact witness, involvement of the physician’s own attorney is usually unnecessary. An expert witness renders an opionion (usually for a fee) on the facts of the case.

Pain management practitioners are physicians, not technicians who do procedures “ordered by” referring physicians. It is inappropriate for an orthopedic surgeon, neurosurgeon, or other physician to “order” procedures, such as an epidural corticosteroid injection or stellate ganglion block. It is equally inappropriate (and legally inadvisable) for the anesthesiologist to follow blindly such an order.

The pain management physician becomes a fully responsible provider when the patient is accepted. As an independent practitioner, the pain management physician takes note of the information accompanying the patient but, functionally, must start his or her evaluation from the beginning as any physician does with a new patient. In the event of a complication or unfortunate result, it is no protection to state that one was acting on the suggestion or even “orders” of another physician. A thorough comprehensive medical history and a complete physical examination are absolutely necessary. When indicated, appropriate diagnostic tests must be done. It is insufficient to focus only on the pain problem. Doing so might cause failure to diagnose some previously undiscovered causal or associated condition that is a threat to the patient. Overlooking this underlying problem (such as a pathologic fracture from a metastatic lesion) represents poor quality medical care and exposes the pain management physician to a potential malpractice claim when the overlooked condition is discovered later.

The physician-patient relationship is a consensual agreement, rarely taking the form of an express or written contractual agreement. The relationship, however, is implied readily when the physician begins treating a patient, and the patient accepts the physician’s services and advice.

A physician must have a duty to the patient that is created by the existence of a physician-patient relationship before a physician can be found liable for medical malpractice.

Once a physician has undertaken the care and treatment of a patient, this does not imply an unlimited right to terminate the relationship at will. The relationship may be terminated in one of the following ways: (1) the patient no longer requires the physician’s services, (2) the patient initiates termination of the relationship, or (3) the physician terminates the relationship by giving the patient a reasonable period of notice of termination so that the patient may arrange for alternative services. However, the physician must remain available for consultation until an alternate provider is obtained. It is not clear from case law whether making an appointment (such as with a pain management unit) constitutes a relationship or whether the patient actually must be seen by the physician.

The physician may be liable for abandonment if notice of termination of the relationship is not given in a reasonable and timely fashion. This occurs when the physician does not meet the obligation to provide medical services. Physicians who withdraw from a physician-patient relationship while a need for medical services exists, and without proper notice, may also be found liable for breach of contract. If the patient can prove that some harm resulted from the abandonment, the physician may be liable for malpractice as well.

When the physician wishes to withdraw from the care of a patient, the patient should be notified in writing by registered mail of the intent to terminate the relationship. The physician should indicate willingness to provide medical records to subsequent treating physicians and to see the patient for urgent problems that may arise before services of another physician are secured. The reasonableness of the time between notice and termination depends on factors including the patient’s condition, availability of alternative providers, and the patient’s resources. Although a physician has obligations after a relationship with a patient is established, the physician is not obliged to see every patient seeking an appointment.

After the patient is accepted and a relationship established, it is critical that a complete medical record be kept. Clinics or units that are part of a larger facility (such as a hospital or medical center) usually keep separate charts in the individual unit rather than trust intermittent entries in the large master medical record of the institution. Many malpractice attorneys claim that the medical record is the single most important factor in determining the outcome of a medical malpractice case. A thorough, objective, concise, unaltered record might deter a plaintiff attorney from filing a suit.

The medical record of any treating physician may be subpoenaed (“is discoverable”) by one or both sides in a legal case. It is imperative to keep inflammatory speculation out of the patient’s medical record and document only the actual facts.

All patient interactions (including telephone calls) should be recorded on the physician’s clinic or office record. Problems can arise when there are questions about undocumented telephone conversations in which treatment recommendations are made to the patient. Furthermore, all telephone calls with the patient’s pharmacy must be documented, especially in the event that telephone orders for new medications or refills for current medications are authorized.

All procedures should be documented with a procedure note or, better, on a preprinted graphic record designed for pain treatment. This record should include patient background data, patient positioning for the procedure, technique used, preparation, type of needle used, paresthesias, solution injected over what period of time, responses, vital signs throughout, and patient condition and disposition at the end of the procedure. The recovery period needs a similarly complete record. All follow-up telephone calls and visits to the patient should be recorded. Even the smallest details of care can take on great importance in a malpractice suit.

In one case,6 a patient with chronic pain in the left shoulder and back pain received an injection of 10 mL of a solution of hydrocortisone, lidocaine, and tetracaine. She immediately complained of chest pain and was advised to lie down because she was “probably just upset about the injection.” She did not feel better but was sent home with a prescription for diazepam to calm her. The patient later was admitted to the hospital with a diagnosis of iatrogenic pneumothorax. Her suit alleged that the injection caused the pneumothorax. The defendant’s physician said he gave the injection with a 5/8-in., 25-gauge needle, which all experts agreed probably would not have caused a pneumothorax. However, the plaintiff expert testified that, because the solution would not flow through a 25-gauge needle, a 19-, 20-, or 21-gauge needle was needed, and that it would be able to penetrate to the pleura. The defendant physician did not remember the details of the injection given and had not recorded the size of the needle used. He could testify only to what he thought he would have done. Both plaintiff and defense expert testimony tended to discount the possibility of spontaneous pneumothorax. Therefore, because the defendant could not remember with certainty the size of the needle and had not documented the procedure thoroughly, the question of causation became simply a competition among various expert witnesses.

An inadequate medical record can render a malpractice case difficult to defend. The medical record and memory of the witnesses are all that can be used to counter the plaintiff’s recollection of care rendered. A good medical record can refresh the physician’s memory of a particular case and provide precise details of the history, findings, treatment plans, consent process, procedures done, outcome, and follow-up. Even if the medical record is inadequate, incomplete, or misleading, it is absolutely vital that physicians (or anyone) never alter a record after it has been created. If there is need to amend or explain something in the record, this must be done in a later separate entry that is dated and timed appropriately. Any suggestion that the record has been falsified or tampered with makes a case essentially indefensible. Any problem or uncertainty about the record can cloud the issue. In one case,7 the defendant physician did a disk injection. The plaintiff subsequently complained of numbness; this progressed to paraplegia. One available hospital record stated that an injection of betamethasone and bupivacaine was done under x-ray control. However, the circulating nurse’s operative record, on which the drugs were recorded, was missing from the chart. The physician later testified during two depositions that he believed he used betamethasone and bupivacaine. Four years later, the plaintiff’s counsel discovered that, instead of these drugs, the defendant mistakenly had injected colchicine, a potentially neurotoxic medication that may have caused the paraplegia. After this discovery of discrepancies in the records, the claim was settled for $1 million.

Hospital records and private office records frequently are requested by patients and plaintiff attorneys. Generally, hospital records are accessible to patients and their authorized representatives when written authorization from the patient is obtained. The laws regarding patient requests for physician office records vary from state to state. In all cases, patient medical information should not be released without the express written authorization of the patient. When medical records are requested properly by the patient, the patient’s attorney, or by subpoena, copies of the records should be given to the requesting party. The original files should be retained by the responsible physician or institution.

When prescribing controlled substances to a patient, a number of issues must be addressed in the patient’s medical record to document the validity of prescribing these medications to the patient. These issues include8:

• 1. Medical history and physicial examination including past treatments for the pain problem, history of substance abuse, affects of the pain on physical and psychological function, and a diagnosis that is an indication for the use of controlled substances.
• 2. Periodic reassessment of the patient, including progress toward treatment goals.
• 3. A written treatment plan, including an outline of therapeutic courses and changes of treatment direction; including objectives to be used for treatment success (such as improved physical function).
• 4. Referral to other consultants, as needed.
• 5. An ongoing relationship established with the patient’s pharmacist; the patient should receive controlled substances from only one physician and only one pharmacist, if at all possible.
• 6. Periodic reassessments of addictive behavior; a written agreement between the physician and the patient may be necessary (“narcotic contract”) to delineate patient responsibilities for the continued prescription of controlled substances.
• 7. Documentation that risks, benefits, and alternatives to narcotics were discussed.
• 8. Documentation that treatment with non-narcotic medications have failed.

Obtaining true informed consent for proposed treatment is an important aspect of pain management. The doctrine of informed consent is based on the recognition of the individual’s right to self-determination. For a patient, a nonmedically trained individual, to make an informed decision about whether or not to undergo a proposed course of therapy, the physician must explain and inform the patient fully in language that can be understood. After the patient is informed fully, consent can be given that will help protect the physician from liability exposure for failing to advise the patient fully of potential material risks, benefits, and alternatives to treatment.

Complete informed consent generally requires disclosure of the following elements:

• 1. Explanation of the diagnosis or condition that requires treatment.
• 2. Nature and purpose of the treatment.
• 3. Probable outcome without treatment.
• 4. Known benefits and material risks of proposed treatment.
• 5. Explanation of reasonable alternative treatments, including material risks and benefits.
• 6. The probability of success of the treatment.

The definition of true informed consent is changing. At one time, there was a so-called professional standard9 that required disclosure of risks in a manner customarily used by physicians in the local community. The concept of materiality has, in general, now replaced the concept of professional standard.10 A material risk “is one which the physician knows or ought to know [what] would be significant to a reasonable person in the patient’s position of deciding whether or not to submit to a particular medical treatment or procedure.”11 The Harnish v Children’s Hospital Medical Center12 case showed the importance of disclosing all material risks. If all material risks are not disclosed, then the consent is not fully informed. This decision created many questions about the necessity of disclosing even very rare complications. An important later decision13 qualified the original materiality requirement by stating that it is not necessary to disclose every incredibly rare complication for which the chances are “negligible.”

Attempting to disclose every complication, even those that are extremely rare, was felt to cause unrealistic and unnecessary burdens on practitioners. This decision emphasized the balance that is necessary between full disclosure and fairness for those doing the disclosing. There is no case law defining how rare a complication has to be for it to be negligible.

Individual pain management physicians must evaluate which risks are negligible and which are material and then decide on a case-by-case basis exactly what to disclose in obtaining informed consent. It may be difficult to decide what information will be the most material to an individual patient. Whether all patients receiving blocks should be told that there are remote risks of permanent neurologic damage, or even death, still remains an individual decision. In all cases, careful thought must go into the process of risk disclosure.14 It is especially difficult when a jury, looking in retrospect at an injured plaintiff, feels that a particular undisclosed risk is material to a supposed informed-consent decision that may have occurred years before. The informed-consent process must be documented carefully, and it is important to distinguish between obtaining the consent and documenting it. Although asking a patient to sign a preprinted form with a long list of potential complications can be one way to document obtaining the consent, the signing per se is not informed consent. Informed consent is an ongoing process that depends on discussion and understanding between patient and physician.15 After this is achieved and the patient gives consent for treatment, then the consent must be documented. Having the patient sign a form or even countersign the physician’s note in the medical record is useful to show the contents of the discussion that occurred and that the patient consented. It is valuable to explain to the patient that signing does not constitute a release from liability (which it does not under any circumstance) and does not limit the patient’s rights, but it does serve as a memorial of the conversation that took place. It is desirable that the patient receive a copy of the form to reinforce the information disclosed.

Neurolytic blocks demand the most careful attention to consent. Independent of associated factors (such as advanced metastatic cancer with a bleak short-term prognosis), the gravity and permanence of this type of intervention must be made clear to the patient. Careful explanation of the maximum deficit possible is required.

A printed form for neurolytic blocks in general should contain basic information on potential complications of any anesthetic or related procedure. Then, in addition, the form could list the following risks: increased pain; hyperesthesia; paresthesias; temporary or permanent paralysis of the affected area or a greater area; temporary or permanent loss of sensation in the affected or greater area; temporary or permanent impairment of autonomic function; bladder, bowel, or sexual dysfunction; loss of skin at the injection site; organ or tissue injury from the needle; and for certain central blocks, blindness, seizures, or coma. Such a comprehensive list is not meant to frighten the patient. Patients can be told that it is expected that none of these untoward things will happen, and that the printed form is intended to encourage discussion and disclosure of information.

Virtually all malpractice actions against physicians allege negligence. Negligence, in general, means failure to exercise reasonable care. However, the legal elements of negligence are specific. For an act to be negligent, four elements must be established: duty, breach, causation, and damage.

Duty

The element of duty has two aspects. It first must be proved that the physician owed a duty to the person who was harmed. Second, the scope of the duty owed must be established. Generally, the physician owes a duty of reasonable care to those with whom a physician-patient relationship has been established. Reasonable care, often called “standard of care,” is the care that usually is given by practitioners who are qualified by training and experience to perform a similar service under similar conditions.

Breach

The plaintiff must prove that the physician did not meet the standard of care, and therefore “breached” the duty owed to the patient; that is, that the physician did not meet the standard of care. The claimant must establish (almost always by expert testimony) what the owed standard of care is and then prove that the defendant physician deviated from that standard by omission (that is, by not doing a required act) or commission (that is, doing something that should not have been done).

Causation

The plaintiff must prove that there was a reasonably close causal relation between the breach of duty (or deviation from the standard of care) and the harm suffered by the plaintiff. This is generally the most difficult element of negligence to prove.

Damage

Finally, the plaintiff must prove that an actual loss or damage was suffered. The harm alleged can be physical, financial, or emotional.

Good medical practice and strong patient-physician relationships should help prevent claims of medical malpractice. However, malpractice suits cannot be prevented completely. There are many things to be remembered if you are sued. A noted medical malpractice defense attorney offered many of the following suggestions.16 Unless instructed otherwise by your defense attorney and/or insurance company representative:

• 1. Do not panic when served a summons. Notify your institution (if any), insurance company, and attorney immediately.
• 2. Do not alter your records in any way.
• 3. Do not transfer your assets.
• 4. Do not discuss the case with anyone except your claims representative and defense attorney.
• 5. Do not talk to the plaintiff, their family, and their friends, or the plaintiff’s attorney.
• 6. Do not talk to the media about the suit.
• 7. In your frustration, do not be hostile to your insurance claims representative and defense attorney. They are on your side.
• 8. Do not expect that a counterclaim against the plaintiff will get the suit dropped or be successful.
• 9. Do keep the suit in perspective compared with the entirety of your professional and personal life.
• 10. Do cooperate fully and quickly with the insurance claims representative and defense attorney.
• 11. Do gather all relevant records regarding the plaintiff. This includes office records, hospital records, correspondence with the patient, financial records, and results of diagnostic tests.
• 12. Dictate or write as soon as possible a summary of all that you know about the incidents and parties involved and share it with your claims representative and defense attorney.
• 13. Be prepared to educate your defense attorney and claims representative about the medical aspects of the case.
• 14. If a suit has not been brought yet and the patient requests a meeting, consult with your claims representative before discussing the case with the patient.
• 15. If the patient’s lawyer requests medical records, supply a copy or written summary of your care and treatment after notifying your insurer and attorney. Do not send original records. Also, be sure you have received authorization to release the patient’s records. Once your insurer has been notified, your claims representative and defense attorney will be in contact with you to discuss your case and advise you further.

Some patients referred for treatment in a pain management clinic will be involved in workers’ compensation cases, disability determination cases, or malpractice suits against other physicians. Physicians may choose not to see such patients. This is permissible as long as there has not been the prior clear establishment of a physician-patient relationship. If this relationship has been established, patients may charge abandonment by the physician who refuses to see them. It is more appropriate to exercise this judgment during the prescreening process. An appointment request from a patient’s attorney or compensation board makes the situation clear. Often, the letter from the referring physician will contain information relative to this point; or an inquiry can be made to the referring physician. The use of a medical history questionnaire to be completed by the potential patient before the first appointment is common. Included, if desired, can be the question, “Are you involved in a compensation case or medical malpractice suit related to your pain condition?” In situations in which a prescreening questionnaire is used, the question of exactly when a physician-patient relationship is established may arise. It is not clear from case law whether making an appointment constitutes a relationship or whether the patient actually must be seen by the physician. For those sufficiently concerned on this point, having the patient complete and return a questionnaire before being given an appointment would seem to be the most logical course.

Workers’ Compensation

The American system of workers’ compensation was developed to help relieve the financial impact of a work-related injury. It is an alternative to tort litigation and was developed as a no-fault system. Benefits may include medical care and rehabilitation as well as cash payments. There has been some concern that the workers’ compensation system encourages malingering. In some studies, when return to work time after a work-related injury in US workers was compared with similarly injured patients in other countries, the time of return to work was longer in the US workers. Such factors as job satisfaction, stress, and amount of compensation may also have an impact on return to work status.17

Tort Litigation

Tort litigation is a negligence-based and fault-based system. In the current American system of tort litigation, patients can recover damages for alleged injuries, which may include pain and suffering in addition to economic damages. Subjective pain and suffering are difficult to quantitate or determine when the patient might be fabricating or exaggerating his or her pain. It may be difficult to determine when the patient is misleading the physician. Jury awards for these types of damages have fluctuated widely in amount, and have produced huge awards in some cases.17

Outcome

Whether pending litigation has an impact on outcome is controversial. Some practitioners recommend caution in treating these patients, believing that improvement with treatment is reduced in these individuals. Since permanent injuries tend to be compensated with larger awards than temporary injuries are, this may present some incentive to prevent rehabilitation. Some studies have shown much higher costs in treating comparable injuries in those patients having pending compensation issues, compared with those who do not. It has historically been presumed that pending litigation or disability compensation for pain-related injury encourages functional impairment and compromises rehabilitation effort.

Some authors speculate that patients do not want to admit to experiencing improvement in their pain problem after being involved with litigation or disability claims, in fear that they will be admitting fraud, or that they will be accused of fraud. Others may be concerned that their benefits might be reduced if their case is reviewed in the future and they have shown improvement.18

In one study, patients with chronic low back pain were entered into a multidisciplinary pain management program. This program involved exercise therapy, cognitive restructuring, relaxation therapy, and coping skills. Measures of impairment (measured by flexibility, pain, and muscle endurance) and disability (measured by exercise fitness) were improved in the group as a whole. However, handicap (measured by sickness impact profile scores) were much higher in the patients involved in litigation. The authors speculate that, while the litigant group had improved impairment and disability, the factor of ongoing litigation impedes the restoration of function to their lives.19

Patients’ perceptions about the cause and treatment of their pain may influence their response to treatment. In one study, perception of fault was evaluated in patients with chronic pain. Patients who felt that their pain was someone else’s fault (employer, physician, etc.) had more current distress, less expected improvement from treatment, and a higher incidence of worsened condition from a previous treatment. These negative effects were highest in those patients who felt that their employer was at fault.20

Some authors feel that evidence of the philosophy that compensation and litigation promotes poorer outcome with treatment is somewhat controversial. In reviews of the literature on the effect of the compensation and litigation on low back pain and pain secondary to whiplash injury, the findings are somewhat equivocal, depending, in part, on the patient population studied and the oucome critieria. The type of compensation and litigation may influence return to work status. Some studies have shown that litigation affects return to work in workers’ compensation claimants but not in other insurance claimants.

In one study that evaluated litigation status in patients with whiplash injury, litigation status (current versus postlitigants) was not predictive of employment status. The authors speculate that their results (which are different from several other studies) may be different because of study design. Only one type of pain problem was studied, and only one type of litigation was involved (tort litigation).21

Clinicians who provide medical care to patients who suffer from chronic pain, especially nonmalignant pain, must recognize that legal issues are an important part of the prescription process for controlled substances. Not only must prescribers be familiar with the medical indications for the use of opioids and other scheduled drugs, they must also be familiar with the regulatory restrictions that may impede their ability to prescribe such substances.8

Physicians may be concerned about these legal implications of prescribing controlled substances for their patients, and this may contribute to undertreatment of pain, especially in some patient populations. A 1994 study found that noncancer patients receive less adequate pain treatment than patients with cancer-related pain. Women, elderly, and minority patients are more likely than others to receive inadequate pain treatment.22 In one study, 75% of cancer patients reported suffering pain, with 40% to 50% reporting moderate to severe pain and 25% to 30% reporting severe pain. Over two thirds of nursing home residents experience serious chronic pain. In one California survey of physicians, 69% reported that concern over the possibility of disciplinary action tended to make them more conservative in prescribing opioids for pain. These physicians reported that their own patients might be suffering from untreated pain.23

The use of opioids in pain management is influenced by physicians’ fear of legal consequences—investigation by the state medical board, the Drug Enforcement Administration, or some state agency that regulates controlled substances. Some physicians may be concerned that they will be investigated or disciplined even if they are treating the patient’s pain appropriately. Some state medical boards may use only length of treatment and dosage of opioids as criteria for inappropriate prescribing of controlled substances; some do not understand the difference between drug abusers who are psychologically dependent on a drug and patients who take opioids for pain management who are physically, but not psychologically, dependent on a drug.22

Even the definition of “proper prescribing” of opioids can be controversial. For example, when the Minnesota Board of Medical Examiners evaluated physicians’ philosophies about proper prescribing of narcotics, they found that there were significant variations in physicians’ philosophies: between those who prescribed according to textbook standards and those who prescribed on the basis of their own practice experience; based on practice locale (rural versus urban); and type of practice (primary care specialist versus other specialists).

Approximately 30% of the physicians were less willing to prescribe opioid analgesics for chronic nonmalignant pain than cancer pain. Only 25% of the family practitioners and 30% of the internists were willing to accept new patients who required prescriptions for controlled substances.8

Both federal and state laws are involved in regulating prescriptions written for opioids. The Comprehensive Drug Abuse Prevention and Control Act was passed in 1970, which developed a classification system for drugs with the potential of being abused. This system groups these drugs into five groups on the basis of the potential for physical or psychological dependence. Drugs in schedule V are felt to have low potential for abuse. Drugs in schedule I are felt to have the highest potential for abuse. Drugs in schedule II have less abuse potential than those in schedule I, and so on.

There are also federal laws requiring pharmacists to monitor the prescription process. Pharmacists may be penalized if they fill prescriptions that are not considered to be following standard treatment, or are not issued for a legitimate medical purpose. Therefore, physicians must remember that pharmacists evaluate the behavior of both the patient and the physician when they fill prescriptions for controlled substances.8

States have their own individual regulations and statutes that govern the prescription of controlled substances. Many of these are patterned after federal laws. For example, many states have laws which define the monitoring role of the pharmacist in the prescription process. Physicians should always be aware of the laws and regulations that are in effect where the physician practices, because there are some variations in these laws among the different states.8

The Project on Legal Constraints to Access to Effective Pain Relief (a research project of the American Society of Law, Medicine, and Ethics) developed the proposed Pain Relief Act, in an effort to encourage and improve state regulations concerning pain management and the use of controlled substances. It is hoped that patients will have access to better pain management if health care professionals feel less threatened by disciplinary actions. The Pain Relief Act proposes that if a physician can show that their practice is in compliance with an accepted guidline on pain management, the prescription of controlled substances for relieving intractable pain should not lead to disciplinary action. The Pain Relief Act was also developed to encourage states to adopt similar guidelines. If legislation of this type is adopted, it could be used in litigation to help define standard of care for the treatment of patients with chronic pain. State regulations and guidelines could also address other issues, such as informed consent or record keeping.24

Recently, the Federation of State Medical Boards of the United States developed some guidelines for health care agencies and state medical boards for use in regulating the use of controlled substances. These guidelines encouraged the development of consistent standards throughout the medical community to facilitate the adequate and effective control of pain. These guidelines assured physicians that they would not be disciplined for the appropriate prescription of controlled substances if these medications are for a legitimate medical purpose. The guidelines also encouraged the evaluation of appropriateness of controlled substance prescription to be based on the patient’s medical condition, instead of the quantity and chronicity of the dispensing of these medications.25

Since more guidelines have been developed for pain management, in the future courts may include these guidelines to determine standard of care for pain management. For example, the US Department of Health and Human Services Agency for Health Care Policy and Research has released Acute Pain Management Guidelines and Cancer Pain Management Guidelines. These may be used, along with state guidelines and legislation, the Pain Relief Act, and institutional pain management policies to evaluate standard of care issues. Some states’ statutes recognize guidelines of this type to be admissible in malpractice cases to help determine whether a physician was meeting the standard of care. Increased public recognition of the importance of pain management will broaden liability exposure of health care providers who mismanage pain. In a 1990 lawsuit, for the first time, a health care provider was found liable for inappropriate treatment of pain. A nurse delayed or withheld analgesics from a patient with metastatic prostate cancer on the basis that she felt that he was “addicted to morphine.” The jury verdict was for $15 million on the basis of physical pain and suffering and emotional and mental anguish for this untreated pain.24

Health care institutions can decrease liability risk for inadequate pain management by educating their caregivers about proper pain control and developing pain-management policies that address issues such as physical versus psychological addiction, pain assessment, and treatment of side effects.26

Physicians involved in pain management have an ethical obligation to treat pain as effectively as possible. In the past, chronic pain has often been undertreated due to concerns about legal or disciplinary action for prescribing controlled substances. The development of guidelines dealing with the use of controlled substances for pain management should reduce fear of disciplinary action for prescribing these substances, and lead to more effective pain management. The pain management physician can keep liability risks at a minimum by well-documented medical records, adherence to complete informed consent for all procedures, and familiarity with the risks and possible complications of a procedure. The pain management physician should be aware of what procedures he or she would be comfortable performing, and be willing to refer the patient to another physician to perform those procedures that the pain physician is unfamiliar with. Adherence to the recommendations in this chapter should help to keep the pain management physician’s liability to a minimum.