6Medical-Legal Risk ManagementJames M. Kelley, III and Gretchen M. Lentz

The word malpractice evokes a guttural response in physiciansand health care providers. This is perhaps more true in the areasof obstetrics and gynecology, where the physical damages are of-ten catastrophic and the economic damages are often in the mil-lions of dollars. The fear of being unjustly involved in litigationand judged by nonphysicians as liable—despite having providedreasonable and appropriate care—seems unavoidable to manyconscientious health care providers. The little-known reality,however, is that the growing consensus of empirical data on out-comes of malpractice actions shows that the legal system worksfor the provider in the end far more often than it does not. Un-derstanding how the system works and making minor practicemodifications to minimize risk are essential to avoiding claimsand adverse outcomes.

A medical negligence case comprises three basic elements: adeviation from the standard of care, proximate causation, anddamages. Each of these elements is required to be proved byway of “competent” expert testimony. The definition of compe-tent varies state to state, but all states are uniform in requiring aphysician to agree that malpractice occurred, and that it directlyresulted in injury. A deviation from the standard of care, al-though a cumbersome legal phrase, is simply a failure to act rea-sonably as compared with another health care provider in thesame or similar clinical circumstance. A deviation from the stan-dard of care can be an act (intraoperative perforation, administra-tion of the wrong medication, etc.) or an omission (failure to runthe bowel intra-op or failure to timely review laboratory results).

Proximate causation is often a more medically complex com-ponent. The law requires that the deviation from the standard ofcare be a direct, proximate cause of injury to the plaintiff. It isimportant to note that the deviation does not have to be the ex-clusive cause of injury but rather need only be a direct proximatecause. Proximate cause, legally, just means that with appropriateor reasonable treatment, the injury would not have occurred.

The final element is damages. Damages are economic andnoneconomic. Economic damages include such items as pastand future medical bills and past and future wage loss. Noneco-nomic damages contemplate such things as past and future phys-ical pain, emotional suffering, and, in certain instances, wrongfuldeath. To be successful, the plaintiff must prove each of theseelements to a probability, through expert testimony, in orderto win. A failure on any of the elements will result in a verdictfor the defendant.

As mentioned, many health care providers will be surprised tolearn what the growing consensus of empirical data reflects re-garding medical claims. A review of approximately 1400 closedmalpractice claims from five different liability carriers showed

that only 3% of claims that were filed had no verifiable medicalinjuries. Additionally, 37% of those did not involve errors, butrather would be what a physician would commonly refer to as“frivolous.” Despite common perceptions about runaway juriesand lottery verdicts levied against faultless physicians, the studydemonstrated that 84% of the claims that did not involve errorsresulted in nonpayment. Conversely, approximately six timesthat rate of claims resulted in nonpayment to the plaintiff,despite the presence of medical errors and verifiable injuries.

Although these data should be heartening for health care pro-viders, they do little to eliminate burdens of excessive litigationcosts, time away from practice and families, and the stress of par-ticipating in litigation. The goal for conscientious providersmust be one focused on risk management: balancing improvedpatient care and minimizing medical legal risk. Realizing law-suits will inevitably occur, the following are practical insightsaimed at helping you enhance patient care and communication,minimize the risk of involvement in meritless litigation, andprovide your best defense in the event a claim is made.

COMMUNICATION

Medical-legal risk management, at its core, centers on commu-nication in both the written and verbal form. Awareness of thecommon pitfalls in the processes employed in communicatinginformation to patients—as well as concurrent and subsequentcare providers—will be invaluable if problems or litigation arise.The medical record, institutional policies and guidelines, and in-formation communicated to patients (prospective plaintiffs) willbe the only information attorneys, claim representatives, andreviewing expert physicians have available to judge the validityof a potential malpractice claim. The following examines good

Box 6-1 What Constitutes Medical Malpractice?

To successfully maintain a medical malpractice action, a plaintiffmust be able to establish three distinct elements of his or hercase by way of expert testimony:

1. Deviation from the standard of care. The health care providerdeviated from what a reasonable provider would have done inthe same or similar circumstances.

2. Causation. The deviation was a direct cause of the injurysuffered.

3. Damages. Economic and noneconomic damages were sufferedas result of the injury.

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practices to improve communications with patients (both beforeand after treatment), improve the accuracy of the medical re-cords, and provide useful information about navigating thelitigation process to your best outcome.

COMMUNICATION WITH THE PATIENT

Physicians well understand that the relationship with their pa-tient is in large measure a relationship of trust. More often thannot, a perceived breach of that trust is the impetus for a patient toseek the advice of an outsider for explanations about unfortunatemedical outcomes. It must become a routine practice for physi-cians to thoroughly and carefully discuss potential problems withtheir patients prior to treatment. Taking the time necessary toassess a patient’s understanding of the procedures and possibleoutcomes, and answering all questions the patient may have,are critical to managing and controlling expectations. Concur-rent notations in the record that you have, in fact, reviewedall risks and benefits of a potential treatment, thoroughlyexplained alternative treatments or procedures, and answeredall patient questions will provide important evidence of carefuland appropriate treatment should it later become necessary.

The abbreviations and words in Box 6-2 are an invaluableresource in the event of a complication or litigation.

In the unfortunate event of a poor outcome, it is imperativeyou communicate more, not less, with your patient or the pa-tient’s family where appropriate. Health care providers oftendramatically change—or end entirely—their relationship withpatients following a maloccurrence. For example, in situationswhere the patient may have ongoing care issues but is transferredto a tertiary center or a different specialist, there is often minimalor no ongoing relationship. Despite what may be the urge to dis-tance yourself from an unpleasant or uncomfortable interaction,keep in mind that your patient and his or her family memberswill begin assessing whether or not you are forthcoming withthem at this very time. If there is an attempt to avoid interactionit can, and likely will, be misperceived as an attempt to avoidexplaining the cause or causes of the bad outcome. It is impor-tant that your trust relationship with the patient and the patient’sfamily continues at this crucial time and that they feel you arewilling to answer all questions.

When discussing the outcome or problem, revisit the discus-sion of risks and outcomes at the time of the informed consent.Reiterate the information you previously provided, and explainhow this result is related to the risks previously discussed, if ap-propriate. Finally, it is also important that you are involved inestablishing the plan for care going forward, even if it is outsideof your specialty. Remaining involved preserves the physician-patient relationship. Patients are far less likely to file claimsagainst physicians with whom they have an ongoing, trusting re-lationship. It is therefore important to make yourself available aslong as is necessary to assure the patient and his or her family thatyou are answering all of their questions. Absence or avoidancewill make the patient or another family member suspicious

and can ultimately lead them to seek answers to their questionsfrom an outside source—most often an attorney.

Once again, it is imperative that you write contemporaneousand accurate notes. The timing of such notes, combined withtheir detail and clarity, will begin to establish good defense inthe event the records are reviewed for a possible claim. It is easyto defend conscientious care, regardless of outcome, if the recordsupports you.

COMMUNICATION THROUGH MEDICAL RECORDS

Once the litigation process has commenced, a plaintiff attorney’sbest friend is inaccurate or inconsistent documentation of thecare provided. Inaccurate documentation can stem from a gen-uine standard-of-care issue; however, inaccuracies can also arisefrom the use of inappropriate nomenclature. In either situation,the health care provider will be in the untenable position ofattempting to defend a narrative note or deposition testimonythat is factually inconsistent with literature, policies, or objectivedata in the medical record. Needless to say, in a courtroom, in-consistencies never favor the inconsistent party. Careful atten-tion to recordkeeping will not only demonstrate attentive careand rationally based treatment decisions, but it will ultimatelybecome a provider’s best defense in a courtroom.

Within your hospital, facility, office, and charts, youmust usenomenclature designed to standardize the verbiage utilized be-tween providers. Unfortunately, despite the attempts at stan-dardization, many health care providers have been slow toadapt. This is often based on variable levels of education by au-thors, and it is also generational. This increases not only the riskof inaccurate communication among health care providers, butalso the risk of a medical record replete with inconsistencies.Inconsistencies can be easily used to portray a provider asincompetent or disingenuous.

From a medicolegal risk management standpoint, it is criticalto keep in mind when a plaintiff’s counsel attempts to determinewhether or not medical malpractice may have occurred; the med-ical record is the primary (and often the only) source of informa-tion available to evaluate the potential claim. Any narrative notessupplied will be read against subsequent health care providers’notes and the objective data such as lab results and imaging.As stated earlier, clearly noted and accurate recognition and de-scription of reassuring and nonreassuring findings in the recordwill demonstrate attentive and competent care. However, inac-curate terminology, when read against the objective data, couldresult in the commencement of litigation.

Beyond the initial review phase of a potential claim, inconsis-tent and inaccurate nomenclature and recordkeeping will conti-nue to present obstacles to a favorable resolution of the claimduring the testimonial phase of trial. When a witness employsmodified or nonstandardized nomenclature, other health careproviders, including expert medical witnesses, do not necessarily

Box 6-2 Practice Tip

Sample Progress NoteRisks/Benefits/Alternatives (R/B/A’s) discussed w/patient.

All ?’s answered in full.

Box 6-3 Practice Tip

Communication with the patient when a problem occurs is anopportunity to explain how the poor outcome happened,despite vigilance. Patients will naturally have questions, andmost who contact a malpractice attorney are doing so to getanswers to questions they feel were not sufficiently answered bythe health care provider.

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understand the full extent of what is meant. This unclear commu-nication can result in actualmedical errors between providers or, ata minimum, the appearance of errors within a medical record.

The preceding example shows how the inappropriate and in-consistent nomenclature forced the physician to be critical of thenurse’s actions, while the nurse attempted to separate herselffrom her own charting. This is not only a difficult posture to de-fend, but also it reflects poorly on the competency and truthful-ness of the parties involved. Simply employing appropriate,consistent nomenclature would have provided an easy defense.

COMMUNICATION CONSISTENT WITHINSTITUTIONAL POLICIES

Published institutional policies and procedures should bereviewed regularly and integrated into your daily practice. Thepurpose of the policies or protocols is not merely for JCAHO,or to fill shelf space, but to effectuate patient care and create aconsistent safe administration of the medication and care to pa-tients. However, each individual patient obviously deserves indi-vidual care and modifications to the policy or protocol as maybe necessary. Policies and protocols relevant to the issues that

are the bases of any litigation should be familiar to you beforeyou provide sworn testimony under oath. Because these writtenpolicies can form the basis of an accepted standard of care in yourinstitution, any testimony or records inconsistent with these pol-icies can be viewed by a jury as being outside the standard of care,or negligent.

Here, a lack of familiarity with the standard policy within thehospital created a scenario where the physician and nurse wereuncertain as to what was expected by the hospital. Compound-ing matters, the lack of familiarity with the policy and protocolprior to deposition created a scenario where not only did thenurse provide testimony that she deviated from the policy, butalso she was forced to acknowledge a total lack of familiarity withthe same. In short, knowledge of and compliance with institu-tional policies, guidelines, and resources can demonstrate the im-plementation of appropriate care, and documentation can be theshield of your defense; or ignorance of and deviation from suchpolicies can provide a documented deviation from the standardof care that will become the plaintiff’s sword.

Box 6-4 Factual Scenario

In a previous deposition, a physician was questioned regarding anursing narrative note.

Q. Dr. Doe, do you expect the nurse to relay to you if there are anypostoperative changes?

A. Any relevant postoperative changes should be relayed to me,particularly if there are more than one.

Q. By relevant change do you mean if any vital signs manifestpersistent change?

A. I do not understand what that means; however, if a nurse seesvitals change, I want to know about it immediately, especially ifit persists.

The narrative notes within the case included the nurse describinglabile blood pressures. Utilizing charting terminology such aslabile created a scenario where the physician had expectationsof being told immediately, and a medical record suggesting thecall should have been made. Further testimony demonstratedthat no information regarding these changes was relayed.The nurse testified as follows:

Q. Did you relay to Dr. Doe that the blood pressures were labile?A. No.Q. Why not?A. Because I felt it was not necessarily significant and may be

routine postop fluctuations.Q. So you felt it was unstable but not labile?A. Yes.Q. So when you chart the word labile, you want the jury to believe it

doesn’t mean labile?A. I guess.

Box 6-5 Practice Tip

The consistent use of appropriate nomenclature not onlyminimizes risk in the defense of a medical legal action. It willalso allow the physicians and nurses to communicate clearly byensuring they are discussing the same findings and placing thesame significance.

Box 6-6 Factual Scenario

Many gynecologic cases involve the failure to recognizeperforations or bleeds. Total abdominal hysterectomy usuallycarries with it a specific physician’s postoperative order or, morecommonly, a hospital’s postoperative policy or protocol. It is ofcritical importance that the nurse and physician both have anunderstanding of the specific details of the policy or protocolprior to executing care and prior to testifying regarding theseissues. The following example highlights why this is important:

Q. Are you aware as to whether or not there is a postoperativepolicy at this facility?

A. I don’t know. I guess there probably is.Q. Do you agree that you as a reasonable nurse have a duty to

follow the policy here at the facility?A. I don’t really know what the policy says, but I’m sure it’s

reasonable and yes I should probably follow it.Q. If you failed to follow the policy, can we agree that you would

have been acting unreasonably and beneath the acceptedstandards of care?

A. I probably should follow a policy if it exists. I guess if I didn’t,I was beneath the standard of care.

The nurse went on to define terms differently from the definitioncontained in the policy and testified that the physician withwhom she was working was aware of her actions. When thephysician was questioned he testified as follows:

Q. Do you expect the nurses to follow your specific orders and,when orders are not present specific to the chart, to followpolicies or protocols that are in place for the delivery of healthcare to patients?

A. Absolutely.Q. For this patient did you write a specific postoperative order?A. No.Q. Your order says, “post TAH protocol”?A. Yes.Q. Does that mean the nurse should follow the hospital’s policy or

protocol?A. Absolutely.Q. Is a reasonable nurse allowed to deviate from that policy or

protocol without calling you first?A. No.

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WHEN A CLAIM IS MADE

The institution of a claim varies from state to state and is defineddifferently among various insurance policies. It is imperative thatyou have an understanding through your institution, insurancepolicy, and within your state as to what constitutes knowledge ornotice of a claim. When notice of a claim is received, it is imper-ative that you immediately notify your hospital or group admin-istrator and your insurance company. A failure to timely notifyindividuals can jeopardize insurance coverage or compromiseyour defense, and in a worst-case scenario it may potentiallyresult in a default judgment for failure to timely respond.Although the legal system does move slowly, there are certainparameters, and timely responses are mandatory at the beginningof litigation.

Participation in a claim is aggravating, frightening, and animposition upon your professional or personal time. However,it is of critical import to avoid procrastination or de-prioritization of the claim regardless of the level of merit or dam-ages you perceive. A lawsuit is typically commenced by the filingof a legal pleading known as a complaint. Thereafter, there will bea statutory amount of time for an answer to be filed on yourbehalf. Thereafter, the first portion of litigation is referred toas discovery. This is where each side exchanges information eitherthrough documents or sworn testimony between the sides—firstregarding factual information, then regarding expert opinions inthe claim. A deposition is simply the opposing attorney’s oppor-tunity to ask questions under oath that are reasonably calculatedto lead to relevant discoverable evidence.

Your deposition is an obligation, not an opportunity. In thatregard, it is critical that you meet with your attorney in advanceof your deposition so you can be prepared for the relevant issues.A critical review of your care with your attorney is important sothat you can anticipate all areas of questioning and avoid beingsurprised under oath. The answers you give under oath are sworntestimony in the case, and oftentimes depositions circulate evenafter the closure of the file. It is recommended that you meet atleast 1 week in advance of your deposition with counsel for a pre-paratory session—which will allow you adequate time in theevent your practice requires a delay or cancellation to reschedulethat meeting—before you actually give your testimony at depo-sition. Additional techniques include a mock deposition, whereanother attorney questions you in a practice session to prepareyou for the format. This can be very useful for pointing outmedically complex issues and for enhancing your preparationfor giving sworn testimony.

Your deposition testimony, along with the other factual wit-nesses, will then become a supplement to the medical recordfor the expert witnesses to utilize and, ultimately, jurors to judgewhich position they deem more reasonable. Accordingly, just asaccurate, concise, and consistent communication in your medicalrecord is a priority, so too should it be within your deposition.

Following discovery, cases are usually scheduled for jury trialsbased on individual court docket systems. You should plan onattending each day of your trial and participating in the same.While it is no physician’s desire to take time away from his orher practice to be in a courtroom, it is imperative that whenyou arrive there, you have an accurate medical record and depo-sition to support the reasonableness of the decisions you made atthe time that you made them.

PHYSICIAN’S DEFENSIVE STRATEGIES

ABANDONMENT

Unilateral dismissal of the patient by the physician withoutproper notice to the patient is popularly conceived of as beingthe entire tort of abandonment. However, failure to keep an ex-press promise (being present for a delivery, making a house call,or treating with a particular modality are common examples),failure to give proper discharge instructions, or abrogating yourauthority to a less qualified individual are much more likely toresult in charges of abandonment. This is particularly true in thecase of the obstetrician/gynecologist, in which the courts con-sider the physician/patient relationship to be particularly per-sonal and private.

Physician’s Defense StrategyExplain your coverage arrangements in a patient brochure anddocument that the patient has received it. Do not sign out to fam-ily practitioners or partially trained gynecologists. If house offi-cers are going to be involved in the patient’s care, explain theirrole and do not allow them to exceed the stated role. Do notmakeexpress promises if there is even a minimal chance a change ofcircumstances will prevent you from keeping your promise.

ABORTION

See the preceding discussion. Two subsequent Supreme Courtcases (Webster v. Reproductive Health Services, 109 S. Ct. 1759[1989]; Planned Parenthood v. Casey, 112 S. Ct. 2791 [1992])have greatly expanded the local control of abortion, and preabor-tion procedures.

Physician’s Defense StrategySeek local legal counsel. Make sure all aspects of your abortionpractice conform to local, state, and federal law. Insist on anopinion letter that covers preabortion, abortion, and post-abortion issues. Do not do the procedure without “on adviceof counsel” protection. Get timely legal reviews.

CANCELLATIONS AND “NO SHOWS”

Cancellations and “no shows” of follow-up patients appointmentsare often ignored in the busy clinic or office. They can be, and are,frequently responsible for subsequent malpractice suits.

Physician’s Defense StrategyEach cancellation or no show should be documented in thechart. The chart should then be reviewed by the treating physi-cian and, where appropriate, a letter or phone call made to thepatient. All efforts to communicate with the patient should bedocumented.

Box 6-7 Practice Tip

1. Secure and isolate the patient’s complete medical record.2. Make no additions, modifications, or alterations to that

chart.3. Notify either your institutional administrative or insurance

representative of the claim, in order to preserve coverage.4. Participate fully—and as a priority—in the defense of the quality

of your care.

108 Part I BASIC SCIENCE

COVERAGE ARRANGEMENTS

As mentioned earlier improper coverage arrangements may leadto charges of abandonment. Poor communication among cover-age groups frequently leads to offended patients and can be thefirst step on the path to a malpractice suit.

Physician’s Defense StrategyThe previously mentioned strategy applies here:

1. List your coverage arrangements in your new patient brochure.2. Sign out to qualified individuals.3. Do not make specific promises as to your presence or

procedures.4. In addition, coverage groups should meet regularly to ex-

change information and maintain protocols.5. Problem patients should be known to the entire group.6. All after-hours care should be carefully documented and en-

tered in the medical record either contemporaneously or atthe latest, the next business day.

7. All medical records should be available to all members of thegroup.

When you have the coverage:

1. Don’t put geographic barriers between you and the patient (al-though it is not written in stone, The Emergency Medicaltreatment and Active Labor Act and other federal regulationsand cases based thereonwould indicate that you should be ableto reach your patient’s bedside within thirty (30) minutes).

2. Do not drink alcohol or take drugs (even prescription drugs)that can affect your cognition or cause somnolence.

3. Document all phone calls. Err on the side of caution.4. Emergency physicians are great, but emergency departments

are often overworked and slow and you are inserting an in-tervening opinion between you and the patient. An “I willmeet you at the emergency room!” has been a great reliefto many a patient and many a physician.

CONTRACEPTION AND STERILIZATION

Contraceptive methods and sterilization procedures can involvethe physician in multiple issues of informed consent, treatmentof minors, emancipation of minors, and court-ordered proce-dures, wrongful pregnancy as well as wrongful life and wrongfulbirth suits.

Physician’s Defense StrategyThere is no escaping the necessity of researching your state’s re-quirements. However, no where in obstetrics/gynecology prac-tice is the communication with the patient more important. Athorough, unbiased informed consent is required. In addition,be careful of your terms. A tubal transection should be truly atubal transection and a piece of tube sent as a pathology speci-men is a splendid proof that the tube was sectioned. A clamped,crushed, or cauterized tube signed out as a tubal transection is amuch less satisfactory form of evidence at a subsequent trial.

FRAUD AND ABUSE

In 1972, as part of the first amendments to the Medicaid andMedicare rules and regulations, Congress passed antifraud andabuse regulations. The first such laws were hardly more than

“a slap on the wrist.” However, in 1977 Congress made thoselaws draconian. False statements, which include:

1. Knowingly and willfully making or causing to be made anyfalse statement or representation of a material fact in seekingto obtain any benefit or payment

2. Fraudulently concealing or failing to disclose information af-fecting one’s rights to a payment

3. Converting any benefit or payment rightfully belonging toanother, and

4. Presenting or causing to be presented a claim for a physi-cian’s service knowing that the individual who furnishedthe service was not licensed as a physician.

These also encompass false claims, bribes, kickbacks, rebatesor “any remuneration” and are felonies with a maximum of 5years in jail and a $25,000.00 fine possible for each such of-fense. (The law states that any provider who knowingly andwillfully solicits, pays, offers, or receives, any remuneration,in cash or in kind, directly or indirectly, overtly or covertly,to induce or in return for arranging for or ordering items orservices that will be paid for by Medicare or Medicaid willbe guilty of a felony). These rules and regulations essentiallymade it impossible to practice without violating some aspectof the fraud and abuse laws. It was, however, 10 years beforethe laws were refined in the Medicaid–Medicare Patient Pro-tection Act of 1987 which provided some “safe harbors” to freenormal course of business procedures. Since 1987, the govern-ment has pursued fraud and abuse cases with ever-increasingvigor. In 2003, settlements in fraud and abuse cases nettedthe government close to $2 billion (Wall Street Journal, A1, Fri-day, June 11, 2004). The real danger to the physician is not thefine that may force him or her into bankruptcy or the unusualimposition of jail time (to date, the government has seemedmore interested in recovering cash and calling a halt to illegalpractices than it has in jailing doctors), but the felony convic-tion that may result in the automatic loss of the license to prac-tice. Thus Medicare/Medicaid fraud and abuse is a far moredangerous hazard than is malpractice.

Physician’s Defense StrategyHave your patients sign in whether they have come for an officevisit or just a procedure. If you are worried about privacy issues,use a privacy sign in sheet that prevents subsequent signers fromseeing who has signed in before (Colwell Publishing providesseveral styles of such sheets and they are very likely suppliedby local firms as well.)

Don’t unbundle procedures that are supposed to be bundledon a physician’s visit. Don’t unbundle surgical procedures.Don’t charge for procedures done by another licensed provideror charge for physician’s services if the physician is not physicallypresent. Send your personnel to an accredited coding course andmake sure your coding is being done in an accurate manner. Donot be tempted to code up. Time studies and statistics are againstyou. Finally, beware of the “coding consultant” who promises toincrease your accounts receivable.

INFORMED CONSENT

Physicians continually ask for a foolproof informed consentform. Informed consent has little to do with a form. Informedconsent has to do with the physician’s fiduciary duty to his or

1096 Medical-Legal Risk Management

her patient. As the patient’s fiduciary, it is the physician’s duty togive the patient all the information needed for the patient tomake an intelligent decision about the therapies suggested.The information given must be accurate for published studiesand compared with the physician’s own figures, unbiased bythe physician’s privileges or other agenda, and presented in lan-guage the patient in question can understand in view of her ed-ucation, intelligence, experience, and social standing. Theinformation should include the diagnosis; a description of thesuggested treatment; an explanation of what the treatment isthought to accomplish; the hoped for prognosis with the treat-ment; the possible side effects and possible adverse happeningswith treatment; the therapeutic alternatives, their benefits, andpossible adverse and side effects; and the patient’s prognosis withthe alternative and no therapy.

Physician’s Defense StrategyGive the woman all the information called for and document itin the medical record. Ask her is she has any questions. Answerthe questions, and document both the questions and the answers.Use diagrams when necessary. Add the diagrams to the medicalrecord and ask the patient to initial the diagrams. Have thepatient sign the consent form—use the statutory form if yourstate has one—if not, use one approved by your clinic or localmedical organization and approved by your attorney. After thepatient signs again ask her if she has any questions. Answer thosequestions, and again document both the questions and answers.Before the surgery, procedure, or therapy covered by the form,again go over the same material, answer any last-minute ques-tions, and document the entire episode. Remember, the dutyto secure informed consent is the physician’s duty, not the nurse’sduty or a hospital admission clerk’s duty. It is still questionablewhether the physician is legally able to delegate that dutyelsewhere.

LABORATORY TESTS

One of the most common reasons for malpractice suits is theunreported abnormal laboratory or X-ray finding. The usualstory is that the pathologist or radiologist returns the reportand the super efficient clerk, receptionist, or nurse staples it inthe medical record and then files the record. The alternative storyis that the report is never sent and there is no follow-up. Ofcourse, normal clerical errors do occur in any business; neverthe-less, the physician’s fiduciary duty extends to communicating theresults and meanings of all abnormal tests to the patient. There-fore, the failure to communicate the results of an abnormal papsmear, glucose tolerance test, or mammogram to a patient canhave disastrous legal consequences.

Physician’s Defense StrategyA gynecologist must have a system to track and document alllaboratory and diagnostic tests and imaging studies ordered.There is no totally satisfactory way to do this. Old-fashioned“tickler” files are the least efficient, but better than nothing.Some office-generated computer programs have been highlysuccessful, and some of the commercially available programseven generate an automatic notification letter. In any case,the physician must track all ordered tests and make every rea-sonable effort to notify the patient. The notification and

follow-up must be documented. Telling the patient to callfor the test results does not relieve the physician of his or herduty to notify. Finally, use the information you secure.Do not order laboratory or other diagnostic tests and thenignore or belittle those results.

MEDICAL HIGH-RISK PATIENTS

Elderly, frail women with or without serious concomitant con-ditions and women of any age with serious gynecologic or con-comitant conditions are legally and medically at high risk.

Physician’s Defense StrategyTreat these women as being at high risk. Question all of yourroutine procedures. Check what medications (prescription,over-the-counter, and health food store) they are taking. Watchthe dosages you prescribe. Make sure your staff assists themfrom the moment they enter the door until they are safely overthe doorstep and into someone else’s capable hands. To let oneof these patients get on or off an examining table by herselfis courting disaster. A premises liability suit can be just as ex-pensive as a malpractice suit, and it is much easier and cheaperto bring.

MEDICAL RECORDS

The 1930s wag who came up with the saying, “Medical recordsare the malpractice witness that never dies!” offered a truism thathas only increased in value over time. The world of judges andjuries of 2012 expects much more than the hand-written scrib-bles on a 4 � 6 inch card that marked the medical record of1930s.

Physician’s Defense StrategyIf at all possible, all your records should be typed. Even the bestpenmanship can be misinterpreted. All records should be writtenor dictated contemporaneously with the event described. All re-cords should be in English, as objective as possible, clear withoutconfusion or ambivalence, dated, timed, signed legibly, and keptin chronological order. Chart by the subjective, objective, assess-ment, plan (SOAP) method whenever possible. Do not use ab-breviations! (That includes abbreviations “approved” by theinstitution or organization. Even the most common abbrevia-tions have multiple meanings. There will always be an expert thatinterprets the abbreviation in a manner contrary to your inter-est.) Scrivener’s errors may be corrected en page. Errors of factor substance should be corrected as a new entry placed in thechart chronologically. Do not obliterate, destroy, change, or“lose” any portion of a medical record. Such activities are termedspoliation of evidence. At best they may call for civil penalties attrial and at worst may constitute malpractice per se or invokecriminal penalties. In any case such spoliation of evidence makesany subsequent suit almost impossible to win. If your state orhospital or the American College of Obstetrics and Gynecology(ACOG) has a standard form that is widely used in the commu-nity, use that form or one even more extensive. Do not leaveblanks on your form. If the question is worth asking it is worthrecording. Although many sources advise keeping medical re-cords for a period of 10 years after the last contact with the pa-tient, a safer approach is to keep the record for a period that

110 Part I BASIC SCIENCE

would allow a conception at the date of last visit to reach matu-rity and expire its statutory limitations or statute of repose instates where there is a discovery rule.

PRESCRIPTIONS

Adverse drug events are among the most common medical er-rors, and although physicians are loathe to admit it, more thantwo thirds of all adverse drug events are caused by physician er-ror. Transmission errors and compounding (filling the prescrip-tion) errors make up the remaining third of the errors. Properprescribing amounts to several simple basics, the appropriatedrug, the appropriate dose, the appropriate directions, the ap-propriate time of administration, the appropriate termination,and the appropriate refill directions. Today the appropriate drugcategory can preclude prescribing a drug ineffective or margin-ally effective for the patient’s diagnosis, a drug the patient is al-lergic to, or a drug with adverse interactions with another drugthat the woman is taking. The prescription of a drug can no lon-ger be thought of as something a physician does “off the top ofhis head.” He needs help from an information base that can ex-plore the medical chart, drug interactions, recorded allergies,drug doses, and the most effective therapy, and then must trans-mit a legible prescription for compounding. Therefore, the bestapproach lies in an extensive electronic medical record and da-tabase system that is updated at least monthly and that controlsprescription writing. Absent such a system we can only offerhomilies.

Physician’s Defense StrategyType or block print all orders and prescriptions.

1. Prescriptions should always be written in duplicate or tripli-cate (one for the patient, one for the medical record, andone as your personal permanent record.) The patient’s copyshould always be on safety paper.

2. Do not issue oral phone orders or call prescriptions to phar-macies; use the fax line.

3. Clear, unabbreviated syntax works best. Never use abbre-viations for drugs.

4. Always use the leading zero; never use the trailing zero(0.4 = yes; .40 = no)

5. Spell out “units” never use the symbol “U.”6. Always specify drug strength and route of administration.7. Avoid decimals whenever possible (1500 mg ratherthan 1.5 g).

8. Think carefully before you sign on the “substitution permit-ted” line. (Generics may have blood levels that vary as muchas �20% from the original. Therefore, if blood level is im-portant, the potential variation of up to 40% from one refillto another should rule against a generic equivalent.)

9. Use reasonable prescription pad security. Do not leave yourprescription pad exposed on your desk or in your examiningrooms.

10. Be careful of multipharmacy especially in the high-risk pa-tient, and be alert to the use of multiple psychoactive drugsincluding opiates.

11. Give your patients printed instructions (Several good sys-tems are on the market, don’t ignore the AMA Patient Me-dicinal Instructions or the USPDispensing Information), donot depend on the nurse or pharmacist.

12. Finally, check each prescription or order you write for clar-ity, legibility, appropriateness of drug and dosage in relationto the information available on the drug, the patient, and thediagnosis.

Addendum: A caution about drug samples. Samples should bestored properly and with reasonable security. (Neither the pa-tient, nor nonmedical personnel should be able to gain accessto samples.) Rotate the samples appropriately, and dispose ofout-of-date samples safely and legally. Samples should be dis-tributed by personnel with prescriptive authority only. (Somestates may permit others to do so under supervision and writtenprotocols.) Do not distribute samples without issuing fulloral and written instructions.

WHEN THINGS ARE NOT GOING AS EXPECTED

Physicians are used to seeing cases progress in a somewhat pre-dictable manner. Some patients progress more rapidly thanothers, but, in general, the course of disease and treatment fol-lows a course that physicians are used to. When things take anunusual turn, physicians are prone to take one or both of twodestructive courses. First, they irrationally get angry at the pa-tient, or they lose perspective on the important issues.

Physician’s Defense StrategyHold your temper in check. A woman who is not progressing asexpected is the patient you need to have the best relations with.Go out of your way to let her know that something unusual ishappening and what you are doing to solve the problem. Donot blame her! Reevaluate your diagnostic reasoning and differ-ential diagnosis early. Check the chart, medication orders,nurses’ notes, and medications given for possible errors. Requestthose cultures, chemistries, and imaging studies you thought youcould short cut. Do not reject the patient’s suggestions out ofhand. If it will do no harm, the expense is not overwhelming,and it is neither unethical or illegal, concede to her wishes.Do not let your ego get in your way.Get help early!Get a formalconsultation, don’t just talk to someone in the doctor’s dressingroom. Get the best help available! Don’t just ask a friend be-cause he will concur with what you are doing. Establish good re-lationships with quality consultants early; do not wait until youneed them to help in a disaster.

CONCLUSION

In the broadest sense, medical malpractice is defined by whetheror not conduct and decisions were reasonable. The fear of allphysicians is that they will be judged ultimately by lesser-trainedindividuals, who identify more with the patient than the pro-vider. The tests of reasonableness they will utilize are often assimple as asking the question, based on the care and testimonyyou provided, would the jurors be comfortable being treated byyou? If the answer to that is yes, regardless of the complications,decision making, and outcomes, the most likely jury verdict willbe in favor of the defendant physician. However, if the care ap-pears to be inattentive or inconsistent and the records or depo-sitions are inaccurate, the chance to explain your decision andthe reasonableness you feel is behind it may be lost throughno one’s fault but your own.

1116 Medical-Legal Risk Management

Breakdowns in the systems of communication—with pa-tients, care providers, or through the medical records—can cre-ate a host of problems for physicians, nurses, and health careinstitutions in the event of an unfavorable treatment outcome.By focusing attentively on both system-wide and individual bestpractices for accurate and contemporaneous communications,

many problems can be avoided or quickly resolved. Awarenessthat your patients will have serious questions about unexpected,often life-altering outcomes is integral to avoiding legal prob-lems. Only when a patient feels that he or she has not receivedsatisfactory answers from care providers will the patient seekthose answers elsewhere—most likely from an attorney.

REFERENCES CAN BE FOUND ONEXPERTCONSULT.com

SUGGESTED READINGS

American College of Obstetricians and Gynecologists:Expert testimony: ACOG Committee OpinionNo. 374: American College of Obstetricians andGynecologists. Washington, DC, Obstet Gynecol110(2 Pt 1):445–446, 2007.

Baker T: The Medical Malpractice Myth, Chicago,2005, University of Chicago Press.

Charles SC, Frish PR: Adverse Events, Stress andLitigation: A Physician’s Guide, New York, 2005,Oxford University Press.

Coping with the stress of medical professional liabilitylitigation. ACOG Committee Opinion No. 406,ACOG, Obstet Gynecol 111:1257, 2008.

Erickson TB, Buys EA, DeFrancescoMS: Report of thePresidential Task Force on Patient Safety in the Of-fice Setting, Washington, DC, March 20 2010,ACOG.

Mann S, Pratt S: Role of clinician involvement inpatient safety in obstetrics and gynecology, ClinObstet Gynecol 53(3):559–575, 2010.

Nygaard I: What does “FDA approved” mean formedical devices? Obstet Gynecol 111(1):4–6, 2008.

Richardson DA: Ethics in gynecologic surgical inno-vation, Am J Obstet Gynecol 170:1–6, 1994.

Wall LL, Brown D: The perils of commercially drivensurgical innovation, Am J Obstet Gynecol 202(1):30, e1-e4, 2010.

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