LEGAL AND REGULATORY ISSUESIN PAIN & PALLIATIVE CARE

Debunking Myths of Negligencein Pain Management Practice

David B. Brushwood

ABSTRACT. Pain management practitioners must meet the standard of care to avoid liability formalpractice. The Court of Appeals of Florida has recently reversed a jury verdict against a surgeonwho provided pain management care to a patient who died after overdosing on opioids obtainedfrom a different physician. The plaintiffs had contended that the surgeon breached the standard ofcare by failing to perform specific activities that would have prevented the patient from obtainingthe drugs that cause her death. The appellate court rejected the plaintiffs’ argument because the ev-idence failed to support malpractice liability of the surgeon. doi:10.1300/J354v21n01_11 [Article cop-ies available for a fee from The Haworth Document Delivery Service: 1-800-HAWORTH. E-mail address:<docdelivery@haworthpress.com> Website: <http://www.HaworthPress.com> © 2007 by The HaworthPress, Inc. All rights reserved.]

KEYWORDS. Pain, liability, negligence, pharmacotherapy, malpractice, standard of care

The threat of liability for medical malprac-tice is a constant presence in the professionallives of those who practice in any field of healthcare. When bad outcomes occur, patients andtheir loved ones are likely to ask what whenwrong and who is at fault. Patients who believetheir health care provider was negligent mayfile a malpractice claim against the health care

provider. Seldom does a health care provider“win” a malpractice lawsuit. Even the mostfrivolous of malpractice claims is often settledwithanuisancepaymentbeingmadeandno ad-mission of liability,but only after precious timeis lost from work, and questions arise about thecompetence of the defendant based simply onthe fact that a malpractice case was filed.

David B. Brushwood, BS Pharm, JD, is Professor of Pharmacy Health Care Administration, College of Phar-macy, University of Florida, Gainesville, FL.

Address correspondence to: David B. Brushwood, BS Pharm, JD, Department of Pharmacy Health Care Admin-istration, P.O. Box 100484 JHMHC, University of Florida, Gainesville, FL 32611-0484 (E-mail: brushwud@cop.ufl.edu).

Journal of Pain & Palliative Care Pharmacotherapy, Vol. 21(1) 2007Available online at http://jppcp.haworthpress.com

© 2007 by The Haworth Press, Inc. All rights reserved.doi:10.1300/J354v21n01_11 47

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Health care providers are not required toguarantee good results from their efforts. Theyare required toperformservicesconsistentwiththe standard of care.1 If their conduct falls be-lowthestandardofcare, then theymaybe liableforharmcaused to thepatient. If theypracticeator above the standard of care, then they will notbe held liable even if the consequence of thecare is a regrettable tragedy.

Standard of care is not a unitary concept.There is usually no single standard of care forclinical practice. There are often severalschools of thought and several possible “rightways” of doing things for a patient. The practi-cal reality is that to avoid malpractice, a healthcare provider must meet “a” standard of care,not “the” standard of care, because reasonableclinicians usually are willing to admit that sev-eral possible courses of action, some of themperhaps very divergent, all could be consideredtomeetastandardofcare foraparticularpatientat a particular time.2 This lack of a single objec-tive standard usually leads to a “battle of the ex-perts,” in which both sides retain noted authori-ties who contend that their way of doing thingsis the standard way of doing them, and that thedefendant either was, or was not, practicingaccording to their standard.

Judges and juries are, not surprisingly, con-fused when experts disagree so strongly. Intheir search for the truth, they may look for ob-jective evidence that the standard requiredsomething be done by the defendant, and if thatthing was not done then they may conclude thatthe health care provider was negligent. In painmanagement, there is a source of standards thathas the potential to provide the objective evi-dence that will simplify a complex disagree-ment over the standard of care. It is the ModelPolicy for the Use of Controlled Substances inthe Treatment of Pain, adopted by the Federa-tion of State Medical Boards.3 Intended as ashield, thisModelPolicycanbeused as a swordwhen a health care provider has not completedall of the tasks recommended by the ModelPolicy.

Florida serves as an example of a state wherethis problem is particularly acute. The FloridaBoard of Medicine is one of the only states tohave adopted the Federation language virtuallyverbatim, and to have incorporated it into law.This was done several years ago when the

Model Policy was known as Model Guidelines.In Florida, the recommendations of the Federa-tion have been incorporated into what areknown as “Standards for the Use of ControlledSubstances for the Treatment of Pain.” By la-beling these recommendations as standards,the Board of Medicine has created a situation inwhich those judging pain managementpracticemightconcludethat failure tofollowtherecom-mendations is below the standard of practiceand therefore is malpractice.

The standards promulgated by the FloridaBoardofMedicineprovide,amongother thingsthat:

• A complete medical history and physicalexamination must be conducted and doc-umented in the medical record.

• For patients with a history of substanceabuse, the physician should use a writtenagreement that includes urine drug tests.

• The patient should receive prescriptionsfrom one physician and one pharmacywhere possible.

• The written treatment plan should containobjectives that will be used to determinetreatment success.4

While there is probably general agreementthat thesepracticesareappropriate,evenneces-sary, in many clinical situations, the criticalquestioniswhether thefailure todothemisnec-essarily below the standard of care in all situa-tions.Must thosewho treatpainalwaysdoallofthese recommended activities to avoid liabilityfor malpractice?

The Third District Court of Appeal forFlorida has recently issued a legal opinion thatsheds light on the expectations of physicianswho provide care to patients in pain.5 In so do-ing, thecourthasdebunkedseveralmythsaboutthe specificactivities thatmustbe done to avoidliability for malpractice in pain medicine.

FACTS OF THE CASE

The court recites a tale of woe that is charac-teristicofchronicpainpatients.Thedescriptionprovided here is taken directly from the court’sopinion, with minimal editing done to redact

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the names of those involved and to facilitate theflow of the story.

A board-certified orthopedic surgeon hadbeen treating a patient since January, 1985, ini-tially for a back injury she suffered at her nurs-ing job. The surgeon observed that the patientwas suffering from recurring blood clots in herright legandapinchedlumbo-sacralnerveroot.Herestrictedthepatient’s liftingandprescribedNSAIDs. The patient’s pain worsened and shewas hospitalized to receive stronger medica-tions intravenously. She was discharged, butagain hospitalized for the pain in October.

The patient’s hospitalizations were helpfulat first, but the pain returned, so she continuedto see the surgeon. By January, 1986, she washaving terrible pain again in her back. The sur-geonperformedamyelogram,whichwasnega-tive. He gave the patient epidural injections totreat the pain in her sciatic nerve. In June, 1986,the surgeon gave her a final, 30-day prescrip-tion for codeine/acetaminophen, and dis-charged her from his care.

The surgeon did not hear from the patientagain until November, 1986, when, after re-injuring herself at work, she returned to himwith pain. When the patient failed to respond tothe surgeon’s treatments, she was hospitalized.Over the next year, the surgeon prescribedphysical therapy which did not always help thepatient and sometimes worsened her pain. InDecember, 1987, he discharged her from hiscare again.

In March, 1988, the patient fell in the showand was taken to the emergency room, whereshe was diagnosed with a compression fractureof avertebra.Thesurgeon treatedheragain.Al-though the fracture resolved, the pain persisted.The surgeon prescribed physical therapy andcodeine/acetaminophen. In March, 1989, thesurgeon recommended that the patient seektreatment at a pain clinic. The patient refused,and the surgeon discharged her from his care.

In April, 1989, the patient fell and frac-tured three ribs. Although the ribs healed, thepatient returned to the surgeon in May be-cause of an exacerbation of the pain in herback and leg. During this time, the surgeontreated her with oxycodone/acetaminophen,codeine/acetaminophen, and NSAIDs.

In October, 1990, the patient called the sur-geon and told him she had run out of

oxycodone/acetaminophen, had not taken anyfor four days, and was in unbearable pain. Thesurgeon sought the opinion of a colleague inneurosurgery. The colleague repeated all of thetests, and determined that the patient did nothave any reason to be in pain and thus did notneed treatment.

Due to the patient’s physical manifestationsof pain, the surgeon disagreed with his col-league’s conclusion that the patient did notneed treatment. The surgeon also rejected a re-quest by an insurance claims representativewho asked thathe stop prescribingnarcotics forthe patient, concluding that this was a decisioninvolving medical judgment and that the pa-tient needed medication to control her pain.

In March, 1991, the surgeon again suggestedto the patient that she obtain treatment at a painclinic. The patient again refused. The surgeonreferred the patient to another orthopedic phy-sician for a second opinion. This consultantfound a vascular abnormality in the patient’sspine that he did not believe was contributing toher pain. Thus, he could not help her surgically.The consultant did conclude, however, that thepatient was suffering from chronic pain. Henoted the same injuries to the patient’s nerveroots that theprimarysurgeonhadseenin1985.

The surgeon continued to treat the patient forpain and prescribed oxycodone/acetaminophenfor her in 30-tablet quantities. The patient wasinjured again in 1991. Her calf contractureworsened and another orthopedic surgeon di-agnosed the patient as showing classic symp-toms of reflex sympathetic dystrophy.

In April, 1992, the patient again had to behospitalized so that she could be given strongerdrugs tocontrolherpain.Thepatient’spainwasbrought under control, but a month later hermuscle contracture worsened to the pointwhere she was walking on her toes. The sur-geonoperatedonher leg,whichwassuccessful,and she was able to walk again.

In October, 1992, the surgeon learned thatthe patient was obtaining opioids from twoother physicians. He spoke to the other physi-ciansandwasassured that theywouldno longerdo this. He told the patient that she would havetostopseekingmedicationsfromotherdoctors.

The patient’s pain continued, so the surgeonsuggested that she be seen by a pain manage-ment team he had formed. This team consisted

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of the surgeon, and interventional anesthesiol-ogist, physical therapists, a psychologist, anaddictionologist, and a physiatrist. In July,1993, the teamreceivedareport fromapharma-cist that the patient was misusing her injectablemorphine by injecting it directly rather than us-ing in her pump. The patient’s family reportedthat she had become incoherent. The pain teamdiscontinued all of the patient’s medicationsand told her that they would no longer providerher with medication until she agreed to hospi-talization.

Following an automobile accident on July10, 1993, the patient was admitted to a detoxifi-cation center. She left the center the next dayagainst medical advice. She informed the painteam that she had ceased all medications on herown and had gone through withdrawal, thus de-toxifying herself. However, she soon returnedin terrible pain. The team concluded that shesuffered from the disease of addiction and thatshe had a chronic pain syndrome. They con-cluded that the opioids should be continued tocontrol her pain.

The pain team decided that they could nottreat the patient without opioids because of hersevere pain. They began to prescribe oral sus-tained release morphine to be taken twice daily.By November, 1993, the morphine had im-proved the patient’s pain control. Both the pa-tient and the team were happy with her paincontrol.By December,however, thepatientbe-gan to experience more pain in her body, whichthe team believed was caused by the spread ofher RSD.

In September, 1994, the patient’s insurancecompany obtained an opinion from a hand sur-geon, who concluded that the patient did notneed treatment for RSD. The entire pain teamdisagreed with this conclusion, but they werewilling to try his approach, which was to dis-continue all of the patient’s opioids. Theaddictionologiston the team took control of hercare. The surgeon noted that the patient’s painwas worsening as her medication levels werereduced.

The patient began to obtain prescriptions fororal sustained release morphine and injectablemorphine from another physician, without theteam’s knowledge. The team began to increasethedosages theyprescribedoforalsustainedre-lease morphine. By May 15, 1995, the patient’s

pain seemed to be stabilized and the treatmentappeared to be going well.

The surgeon saw the patient for the last timeon June 9, 1995. He advised her to decrease herdoses of morphine. He was unaware that threedays earlier the other physician had prescribedinjectable morphine, diazepam and oxyco-done/acetaminophen for the patient. He did notknow that the patient had failed to follow his in-structions toobtainmedicationsonly fromhim.He prescribed 180 doses of sustained releasemorphine.

Later that day the patient was involved in anautomobile accident and was treated in theemergency room for bruises. The hospital gaveher more sustained release morphine and dis-chargedher.Thesurgeonwasnotnotifiedof theaccident. On the night of June 12, 1995, the pa-tient fell asleep while watching television anddied the next morning in her sleep. The coronerdetermined that she died from acute broncho-pneumonia due to an overdose of morphine,diazepam and phenobarbital. At the time of herdeath, thevialof180dosageunitsprescribedbythesurgeonwascompletelyfull.Of the120tab-lets of diazepam prescribed by the other physi-cian a week earlier, only 22 were left. None ofthe ten vials of morphine prescribed by theother physician could be found.

THE LAWSUIT

The patient’s husband and son fileda lawsuitagainst the surgeon for damages resulting fromthe patient’s overdose. They claimed that thepatient’s death was caused by the surgeon’sfailure to wean the patient from opioids that shehad been taking for chronic pain. They did notcontend that the surgeon provided the drugsthatkilled thepatient,but asserted that inallow-ing the patient to become addicted to morphine,it was foreseeable that she would seek out andobtain lethal doses of illegally prescribedopioids from another physician.

At trial, an internist testified that the surgeonhad fallen below the standard of care by:(a) failing to have an exit strategy so that the pa-tient would not have to take pain medicationsforever; (b) continuing to prescribe pain medi-cine beyond the time when it was needed; (c)not referring the patient to a pain clinic. There

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was also evidence that the surgeon was negli-gent in failing to conduct a urine drug screenwhen the patient claimed that she had been de-toxified, that he had failed to elicit support fromthe patient’s family, and that he had not con-tacted the pharmacies that the patient mighthavebeenusingtohaveherprescriptionsfilled.

The jury found the surgeon 70% responsiblefor the patient’s death and awarded the plain-tiffs’ damages in the amount of $2,750,000.00.Judgment was entered against the surgeon inthe amount of $1,925,000.00.

THE APPEAL

The surgeon appealed this verdict, contend-ing that itwascontrary to themanifestweightofthe evidence. The Third District Court of Ap-peal of Florida agreed with the surgeon and re-versed the award. The appellate court reviewedthe patient’s allegations against the surgeon,and concluded that none of them had beenproven.

EXIT STRATEGY

The court reviewed testimony of the plain-tiff’s expert witness, who had testified that: (1)the surgeon had no exit strategy; (2) had therebeen an exit strategy, it would have been suc-cessful; and (3) had a successful exit strategybeen implemented, the patient would not haveobtained drugs elsewhere to cause her over-dose. The court ruled that none of these allega-tions were proven. The surgeon indeed had anexit strategy. He repeatedly discharged the pa-tient fromhispracticewhenhebelievedshehadreached the point where she no longer requiredhis care. But the patient would always return tohim in unbearable pain. When the pain teamtemporarily withdrew all of the patient’s painmedication in an attempt to wean her from it,shesuffered terriblepain thatcontinuedtoesca-late.The court concluded that, given the impos-sibility of implementing a successful exit strat-egy, any alleged failure to have such a strategydid not contribute to the patient’s death.

CONTINUING TO PRESCRIBEMEDICATIONS

The plaintiffs alleged that the surgeonshould not have continued to prescribe opioidanalgesics for the patient once it became appar-ent thatshemightnolongerneedthemfor legiti-mate purposes, and that she might be sufferingfromthediseaseofaddiction.Theallegationin-ferred that the surgeon should have tapered thepatient from the medication and discharged herfrom his practice. The court ruled that the sur-geon’s continuation of the patient’s medicationbeyond what allegedly was the time they wereneeded could not have provided a basis for lia-bility, because it was undisputed that the sur-geon’s prescriptions did not themselves causeor contribute to the patient’s death. The drugsthat killed the patient were provided by theother physician.

FAILURE TO REFERTO A PAIN CLINIC

The court rejected the argument that the sur-geonshouldbeheld liable for failing to refer thepatient to a pain clinic. The evidence showedthat the patient expressly rejected surgeon’s re-peated efforts to send her to a pain clinic. Theonly way the surgeon could have forced the pa-tient into the pain clinic would have beenthrough involuntary hospitalization. The ex-pert witness who criticized the surgeon’s carenever testified that the patient met the criteriafor such action. A physician cannot make pa-tients do what they are told to do. The courtpointed out that a physician “can only give ad-vice and treatment alternatives, then let themmake choices.”

In addition, the court noted evidence that thesurgeon had used all of the methods that wouldhave been offered at the pain clinic. None ofthem were successful with the patient. Thecourt concluded: “In sum, the record was voidof any evidence indicating that the pain cliniccould have offered additional treatment meth-ods that had not been tried unsuccessfully on[the patient].”

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FAILURE TO ORDER URINEDRUG TESTS

The lawsuit had contended that the surgeonwas negligent in failing to conduct urine drugtests. However, the Court of Appeals noted thatno expert testimony had been offered at trial tosubstantiate the allegation. Because the plain-tiffs’ expert witness had not testified that thesurgeon’s failure to order urine drug tests fellbelow the standard of care, the court held thatthis theoryof liabilityshouldnothavebeensub-mitted to the jury. Furthermore, the court notedthat it probably would not have made any dif-ference even if the surgeon had ordered urinedrugtests,becausetheresultofsuchtestswouldnot have provided any additional informationthat would have affected the treatment of thepatient for chronic pain.

FAILURE TO ELICIT FAMILYSUPPORT OR CONTACT PHARMACIES

The jury had been instructed that the surgeoncould be held liable for failing to contact the pa-tient’s family for help and for failing to contactpharmacies in thearea todiscoverwhere thepa-tient was acquiring drugs. The appellate courtrejected both of these arguments. The patient’shusband testified that the patient, a nurse, hadbeen “very private” about her medical condi-tion and “private with the medication she wastaking.” There was no evidence that the familywould have done anything, or could have doneanything, to help the surgeon had he contactedthem. Mere speculation about things that mightpossibly have occurred cannot support liabil-ity, in the absence of any evidence. The courtpointed out that there are a huge number ofpharmacies in the South Florida area, and thereality is that the patient could have gone to anyone of them. Contactingall of these pharmacieswas impractical, if not impossible.

CONCLUSION

The holding by the Court of Appeals in thiscase is significant, not only because it reverses

the illogical and sizeable jury verdict, but be-cause it debunks several myths about actionsthat attorneys may allege physicians necessar-ily must take to avoid liability in pain manage-ment. It serves as notice to attorneys that a law-suit brought against a physician who providedpain management to a difficult patient must beproven throughevidence. It is a roadmapfor thesuccessful defense of a physician who hastreated chronic pain in a difficult patient. Sim-ply because standards of a board of medicinesuggest certain techniques as useful in painmanagementdoesnomeanthat it ismalpracticeto omit those techniques from the care of aparticular patient.

All of the approaches to treatment alleged asbeing “standard of care” in this case have aplace in pain management practice when cir-cumstances call for them. Having an exit strat-egy, tapering a patient off opioids that are nolonger needed, referral to a pain clinic, usingurinedrug tests, consultationwith familymem-bers, and contact with pharmacies are all tech-niques that can be used to good advantage bypain management practitioners. But these tech-niques are not required under all circumstancesand it is not necessarily malpractice to omitthem from a plan of care. As the case reviewedhereshows,painmanagementpracticerequiresdoing those things that are appropriate for eachpatient, and the legal system has the ability todiscern thedifferencebetween those things thatare necessary and those things that are not.

REFERENCES

1. Stark E. Bioethics and physician liability: The lia-bility effects of developing pain management standards.St. Thomas Law Review 2002;14: 601-40.

2. Nist J. Liability for overprescription of controlledsubstances: Can it be justified in light of the currentpractice of undertreating pain? J Legal Medicine 2002;23:85-113.

3. http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf

4. Florida Administrative Code, 64B8-9.013.5. 930 So.2d 659 (Fla.App. 2006).

doi:10.1300/J354v21n01_11

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