The concept of informed consent was long since codified, and has been the subject of numerous writings.  The informed consent doctrine requires that each patient be fully apprised – made aware of the risks and advantages of treatment, the same aspects of alternative options, as well as the risks and benefits of doing nothing, etc.

The current approach generally consists of a “form document” that everyone uses, and is usually sold to physicians by organizations for profit – in many instances, their sponsoring professional associations.  While new legal developments as to informed consent occur infrequently, relegating the concept to a “one size fits all approach” contains in significant risks.

Informed consent is anything but standard.

Most physicians recognize that no two situations presented to them are exactly alike, regardless of the overriding commonalities and their training, specialty or experience.  It is virtually impossible for two or more cases to present facts that warrant precisely the same diagnoses, treatment, etc.  So, why do some physicians try to inform patients with the same standardized form?  Today’s society tends to treat everyone the same so that efficiencies (of business, finance, etc.) can be maximized.  But that is usually ill-advised in the learned professions.  In fact, they are specifically trained to identify the esoteric distinctions that may exist among superficially similar cases.

Oftentimes, a standardized informed consent form will “carry the day.”  But there will be cases where the doctrine of informed consent requires far more than the standard form.

In those situations, an adverse outcome can be catastrophic.  A cursory review of medical malpractice cases filed against medical professionals will reveal that there are many cases which were handled very well, but that were decided against the physician or settled solely because informed consent was either absent or lacking.  In many instances, the absent informed consent item related to only one or two rarely needed elements that just happened to arise in a particular case.

Informed consent is, literally, central to every case.

To understand why that occurs requires revisiting the underlying reasons for informed consent.  Every patient is entitled to know exactly what can result from the proposed treatment, its benefits and consequences, the likely outcomes of doing nothing and pursuing other treatment, and so forth.  This is not a requirement that rests on an elementary understanding of the issues; rather, it is a mandate that is unique to each patient that requires that that patient to fully understand all key issues relevant to his or her treatment, however comprehensive and detailed the informed consent must be.  The distant chance that a particular matter might occur is irrelevant.  If it could reasonably occur, then it must be disclosed.

Therefore, although the “form” informed consent can be satisfactory, because many cases will fall outside of those generalized boundaries, the astute physician must be able to recognize those instances where and be aware of the fact that the standardized form will inevitably fall far short.

Unfortunately for physicians, the strictures of good business management, exhaustive credentialing requirements, and other practice pressures result in the need to efficiently allocate time and resources.  The situation is exacerbated by the various organizations and associations that make informed consent forms readily available at minimal cost (and, in some instances, with little thought).  Regardless of those influences, true informed consent should never be relegated to a standardized form where that may reasonably result in misinformation and misunderstandings on the part of the patient.

Juries will readily discharge a case based on a patient’s decision after full disclosure of the facts and risks.  The same juries are equally willing to assess fault to a physician that did not fully explain those issue, particularly when it resulted from a misplaced and ill-advised focus on efficiency.

Practically speaking, if a form is used, then it should contain a blank section that allows the physician to insert his or her personalized items that are unique to the particular case.  Most forms fail in that regard.  If they do not include such an area, then the physician must be willing to write his or her own addendum to properly address the given situation.  The physician must always be mindful of the need to fully inform the patient – regardless of the time or format required to do so.

Perhaps the best way to place proper focus on this issue is to ask yourself:  what would you want to know if you were the patient?  Then you w ill often see that the standardized forms fall far short.

Like most things, good risk management usually takes more time and effort.  Proper informed consent will often go beyond the basic disclosures.  Always ask yourself what you would want to know, and disclose, discuss and document all of that with your patients.   No two cases are alike, and when in doubt, it is always best to disclose and discuss more, rather than less.

One final note – the physician who relies on only his or her notes in the chart as to whether informed consent occurred risks a “he said/she said” situation.  That is not the better approach because in that instance, the jury will be left to determine who is truthful – and the jury may not be right.   The best approach is to always obtain the patient’s signature to whatever document is ultimately used.

As with undertaking proper informed consent, getting the patient’s signature may take longer, but it is usually irrefutable as to whether the patient was properly informed.

How to Handle Bad Outcomes

It is commonplace for treatment to produce unexpected or unintended results.  In some cases, these unanticipated outcomes are positive.  With other cases, however, the treatment result may be far less than desired or intended.

Such poor outcomes may, but often do not, result from a negligent act on the part of the physician.  Multiple variables are part of every patient’s unique situation.  It is frequently difficult, if not impossible, to fully predict with complete accuracy the results that will occur from treatment.

When unexpected or poor outcomes occur, it is important for the practitioner to recognize the best way in which to handle the situation from a risk management standpoint.  For example, issues such as whether and when to inform the patient, whether refunds are in order, and whether to notify the doctor’s professional liability insurance company are some of the issues that must be considered and addressed.

The Role of Informed Consent

Before addressing the way in which to handle bad outcomes once they have occurred, the best place to begin the analysis is with the informed consent process.  Physicians should never guarantee a particular treatment result.  It is impossible for the physician to know with certainty the likely treatment outcome because so many of the relevant variables are beyond the control of the doctor.  Will the patient take all medications as directed?  With there be an intervening cause, such as an unrelated illness or injury that negatively impacts treatment?

In fact, it is best if the informed consent process always include advising the patient that treatment results cannot be guaranteed.  This should be explained orally and acknowledged in writing by the patient in a written informed consent form.  The presence of these disclosures at the outset of treatment will often make the difference between whether the physician is ultimately held liable for the poor treatment result.

Was it Malpractice?

Before any action is undertaken, the first step is to objectively assess whether any negligence occurred.  A poor result, in and of itself, does not necessarily mean that negligence was involved.  However, if malpractice has occurred in any respect, then the manner in which the matter should be handled will differ greatly.  For example, if malpractice was involved, then the physician’s professional liability insurer should be immediately notified, and no action should be taken without prior approval from that carrier.

Informing the Patient

Once the doctor is aware that an unexpected poor treatment result has occurred, there will likely be a tendency to assess whether, and if so how, the patient should be informed.  This is particularly the case in those instances where the patient is unable to ascertain the fact that a poor result has occurred.

Regardless of whether the patient is aware of the bad outcome, the physician is under a legal and ethical duty to promptly advise the patient.  How this is done is equally important, and no discussions with the patient should occur without prior approval of the doctor’s malpractice insurer if negligence was involved in any respect.

As a general rule, it is best to inform the patient as soon as possible after the occurrence of a poor outcome.  Unless there is good reason to delay (such as to obtain additional facts as to alternative treatment options, records, etc.), then it is best to advise the patient at once.  In doing so, the doctor will avoid the perception on the part of the patient that something was being hidden from him or her.

With respect to informing the patient, the rule is to be mindful of the patient’s emotions.  Addressing a poor result with a patient by phone is not the preferable method.  The same goes for handling it via correspondence.  Meeting with the patient in the doctor’s office at a convenient time for the patient is the better approach.  Patients will respect the physician’s honesty and manner in which the bad news is relayed.

Without intending to lessen the need for imparting full information to the patient, it is important to recognize the “less is more” rule.  There is no need to discuss collateral and irrelevant issues.  As the saying goes, “just the facts, please.”  While only relevant and basic information should be provided, it should be relayed in a caring manner.

It is also critical to pay particular attention to the demeanor of the patient during the discussion where the bad news is delivered.  Immediately after the meeting, the doctor should enter what was said by all parties at the meeting on the patient’s chart.

Refunds and Payments

In bad outcome situations, patients will frequently desire a refund of fees for the services or other remuneration.  This can occur without regard to whether any act of negligence has occurred.

If no malpractice is involved, then the question of whether to refund or pay any monies to the patient is essentially a business decision.  The same goes for the amount that is paid.  However, if malpractice is involved, then it is generally far better to pay an amount to the patient outside of the legal system (but not without the knowledge and consent of the doctor’s professional liability carrier).  The same may also apply in those instances where no act of negligence occurred, but the patient presents a difficult demeanor or has unreasonable expectations.

Before paying any funds to the patient, it is imperative that the physician obtain a full and complete release from the patient before making any such payment.  This document will contain several items, including an acknowledgement on the part of the patient that the physician is not admitting any fault or liability by virtue of making the payment.

Legal counsel should typically be involved in any situation involving the payment of money to a patient.

Conclusion

Poor outcomes are never pleasant for either the patient or the doctor.  Handling such outcomes can be challenging, depending on the terms of the informed consent, the patient’s persona, the type of poor outcome involved, and whether malpractice has occurred.  However, utilizing proper informed consent, advising the professional liability insurer at the outset, informing the patient in the right way, and utilizing releases where necessary can mitigate an otherwise dangerous situation.

© 2009 Keystone Mutual Insurance Company.  All rights reserved.

Of all the decisions affecting a doctor’s practice, one of the most important is the selection of a professional liability carrier.  No one believes that they will commit an error that results in a claim, but errors do occur and sometimes lawsuits happen even when there was no mistake.  This is particularly the case in today’s litigious environment.  When that occurs, it is vital that the physician is insured by the right carrier.

This decision is likely more significant in the state of Missouri because the medical malpractice insurance market has been historically volatile.  Carriers have entered and left the State with frequency, and there are a variety of options.

What analysis should be undertaken by the practitioner in making the selection?  It is not one single issue or analysis; rather, the decision involves the thoughtful assessment of a variety of matters.  Cost is obviously a potentially controlling issue, but the informed practitioner recognizes that cost is only part of the analysis – it is also what the premium buys.

Safety and Security. This is the first place to start.  It is imperative that the professional liability insurer be based on sound financial footing.  This means, in essence, that the insurer must have the means by which to pay a claim on your behalf should that occur, and that the carrier has “staying power.”  Reinsurance is basically insurance for insurance companies.  The prudent malpractice carrier will have in place the “backing” of strong reinsurance from highly rated reinsurance companies.  In some instances, the professional liability insurer will have more than one reinsurer.  Another aspect of this examination involves the financial standing of the company, i.e. its balance sheet.

Another aspect concerns the insurer’s underwriting philosophy.  How aggressive is the company in writing business versus capital surplus and/or reinsurance to back that business?  Does the company plan to write as much business as possible without regard to the background of the doctors insured, or does it take a more particularized approach to writing “good” business?  These underwriting issues directly affect a company’s stability.  In short, safety and security should be sought in any professional liability carrier, and it is arguably the most important.

Type and Extent of Coverage. It is important to compare and contrast the various types and aspects of the coverage provided by the candidates.  Although reading an entire insurance policy may be somewhat dull, the policies of each company should be at least generally reviewed.  The physician can usually glean much about a potential insurance company from a simple examination of the policy because, ultimately, the policy is the product being offered and it does, and should, reflect on the company involved.  For example, is it well-written?  Is it understandable?  What is covered and what is not covered?  Are employees covered?  Is the business entity covered?  There may be a need for legal guidance in this area to assist the doctor in comparing various policy versions.

The starting point of this issue concerns whether a claims made or an occurrence policy is desired, and it is important to recognize the distinctions between them.  A claims made policy covers claims that both occur and are reported during the term of the policy (i.e. the policy year).  An occurrence policy covers claims that occur during the term of the policy, regardless of when they are reported.  Both have advantages and disadvantages, but as a practical matter, occurrence policies are rarely offered nowadays.

If it is a claims made policy (as will almost always be the case), most practitioners will want what is called “retroactive coverage” to the effective date of their first claims made policy to ensure that their new insurer will cover claims that may have occurred prior to the date of claims made policy inception with the new carrier.  This will almost always be wanted unless the doctor has purchased “tail coverage” (discussed below) from the prior carrier(s).  While many professional liability insurers offer this, it should be ascertained whether this type of coverage is available, and if so, at what additional cost.

Another requirement for claims made policies is the ability to obtain what is commonly referred to as “tail coverage” in the event that the policy is cancelled by either the insured or the insurance company.  Tail coverage refers to the ability to bind the insurance company to covering claims that may have occurred during the applicable policy period, even thought the claims are reported at a later date.  The ability to obtain tail coverage can vary widely among insurers.  Does the company offer it in the event of death?  Is it offered in the event of a disability or retirement?  If so, is it offered at no cost or is there a charge?  If there is no charge, what is required to obtain a “free tail” (i.e. years with the company, age, etc.)?   Does the company offer a free 30-day tail to accommodate any claims that could occur near the end of the existing policy, but not be reported until the new policy has commenced?  Without such a tail, those claims may not be covered.

Rates. Price is obviously a consideration.  While most insurance companies operate under the same or similar actuarial guidance in establishing their rates, the premiums can differ significantly for a variety of reasons.  For example, companies with lower overhead may pass those savings on to its policyholders.  Some companies, such as mutual assessables, are also exempt from state premium taxes and the savings attributable to that may also be realized in the form of lower premiums.  There is much debate about whether stock-based carriers (i.e. those with shareholders) offer better rates than mutual companies (i.e. those owned by policyholders).  In theory, the absence of shareholder pressure to generate a certain return should mean lower rates for policyholders, assuming all other factors are equal.

With respect to rates, it is also important to assess what is obtained for the premium charged.  The old adage “you get what you pay for” certainly applies to professional liability insurance.  This is the stage where all of the other issues set forth in this article should be considered, i.e. the expertise and quality of defense counsel, consent to settle provisions, the financial wherewithal of the company, etc.

Consent to Settle. The term “consent to settle” refers to the requirement that the insurance company obtain the practitioner’s consent before entering into any settlement on behalf of that doctor.  It is actually part of the coverage terms and features discussed above, but it is sufficiently important to merit its own discussion.  The first issue to be determined is whether the policy includes this right.  If it does, then the terms of the consent to settle requirement should be carefully reviewed because this issue can vary widely among insurers.  For example, the decision to effect settlement is usually made by an insurance company’s claims department.  Is there an ability for the doctor to have that decision second-guessed by company management through due process procedures?

Claims Philosophy. Related to the topic of settlement is the company’s claims philosophy.  Every insurer should have a claims philosophy, which is part of its written corporate policies.  Since the ultimate purpose of a physician’s malpractice policy is to cover claims, it is imperative that the doctor determine how the company approaches claims filed against its insured as a matter of policy.  In other words, when will the company recommend a case be settled?  When will it not entertain settlement?  Does the fact that the claim is meritorious make any difference in terms of this philosophy?  It is not too intrusive to request a copy of this policy, or at least a written explanation of it, from a potential insurance carrier.

Defense Panel. The type of defense counsel utilized by the company should also be explored.  Does the company unilaterally dictate defense counsel to its insureds in the event of a claim, or does the doctor have a say in who represents him or her?  If the physician has input, how much input does he or she actually have?  Does the company opt for “bottom dollar” counsel, or is the decision based on the reputation and skill of the attorney?  What agreements, if any, does the insurance company have with its defense panel?

Management. Careful consideration should also be given to who manages and leads the insurance company.  Have you heard of them?  If so, what is their reputation?  Generally, the greater the quality in the company’s management, the better its operations – that quality will usually be reflected throughout.  A related issue is whether management has incentive or motive to operate the company in a manner consistent with the best interests of the company and its policyholders, or otherwise.  In other words, do the financial arrangements with management point toward long-term policyholder value or solely to management enrichment?

Service. The caliber of service for an insurance company should be no different than any other business enterprise.  Are company staff and management accessible when you submit an inquiry?   Do they respond quickly to your needs?  Are they knowledgeable in their field?  These are all questions that should be considered.  Although it is not always the case, smaller companies are typically more agile, and therefore, more responsive.

Risk Management. Any medical professional liability carrier should offer some form of risk management to its policyholders.  At a minimum, the company should apprise its policyholders of important risk management issues through current newsletters and articles.  The presence and accessibility of in-house counsel for risk management advice is certainly a desirable feature.  The ability to obtain an in-person risk management audit is also good.  Whether the company sponsors or presents risk management programs should also be determined.

The selection of a professional liability carrier is certainly an important one.  While these are just a few of the principal issues to consider, they are some of the most important.  In the end, the key is to evaluate each option carefully and methodically, which will require exploration and direct inquiries to those you might trust to handle any claim that may occur.  Everyone hopes that a claim will not happen, but if it does, it is sure to be one of the most significant events in the lifetime of a practitioner.  The selection of a professional liability carrier should therefore be no less important.

Human beings are just that – human.  They can think and feel.  Doctors (as well as most other learned professions) are trained to think objectively, methodically and logically in their respective fields.  It has been said that the common link among all professions is the ability to critically analyze.

Such analysis often does not entail the assessment of emotions.  In fact, the inclusion of emotional aspects to any problem entails the risk of reaching inaccurate conclusions.  It is obviously difficult to explain to a patient the existence of adverse test results or the need for invasive treatment.  But many doctors do it every day, recognizing that regardless of the emotional aspects, the best interests of the patient are served by full information and appropriate measures.

There are a good number of physicians who have become involved with the treatment of a patient for injuries or worsened physical condition that resulted from a “hothead” or abnormally egotistical mentality on the part of the patient.  Whether it was emergency room care arising out of youthful indiscretions or a debilitating condition that could have been avoided had the patient followed recommended procedures, the same basis existed for each – the patient’s decision that was based on emotional, rather than rational, reasons.

It is also the case that, if pressed, patients are not primarily interested in the emotional makeup of their physicians.  Rather, they are principally focused on the

expertise, training and whether their doctors are “one of the best” professionally.

However, this is not to say that they do not care about such emotional makeup on the part of their caregivers.  Many believe that the manner the message is given is tantamount to the message itself.  Thus, while the patient is interested in intellectual acumen, no one likes to hear bad news delivered with indifference.  Physicians readily recognize that the manner of delivery has little, if anything, to do with the quality of the care being provided.  Patients would likely ultimately recognize that as well.  But, it does not mean they are not concerned with it.

In the legal profession, there is an old saying, which is “people don’t sue people they like.”  This is nearly always the case.  It has nothing to do with educational pedigree, professional memberships or financial standing.  It is a rule derived from actions taken (or more accurately, not taken) on the basis of emotion.

Imagine if a neighbor’s automobile was accidentally damaged by their next door neighbor they liked.  Now imagine if the same neighbor’s vehicle was damaged in exactly the same way by someone they didn’t like.  In nearly all cases, the person suffering the damage would be more likely to pursue a vigorous claim against the latter.

So where does the balance between the obvious need for rational and unemotional thought relative to a patient’s condition converge with the emotional needs and wants of the patient?  It does so in this way:  while the physician’s professional assessment and opinions should never be sacrificed in any respect out of deference to the patient’s emotional expectations, the physician must nonetheless get the patient to like them.

How this is done depends on each case; some cases will require very little, but others will require more.  If the doctor is successful in getting the patient to like him or her, many inadvertent mistakes that could occur will be of no import.  On the other hand, just as with the hypothetical involving the automobile scenarios, the outcome can be disastrous for the physician to the extent the patient has concluded he or she is unlikable.

Many physicians have little difficulty in this area.  They are genuinely concerned about the welfare and condition of their patients, and that concern is evident to those patients.  (The exhibition of such concern is one of the best ways in which to cultivate a favorable view on the part of the patient.)  However, there are some practitioners who, for a variety of both legitimate and illegitimate reasons, neglect or refuse to generate a likeable view of themselves.  To the extent this is intentional, the results will be conceptually similar to the outcome on a medical basis of those patients who made cavalier or “hot headed” decisions without forethought.  If the case is not treated perfectly, a malpractice claim should be expected.

A related risk management issue is the fact that many practitioners who fail to create a likeable impression with their patients will also fail to do so with any jury deciding a malpractice case against them.  This means, therefore, that not only is the filing of a claim more likely, but also that the claim will likely be decided adversely to the doctor.

In short, while it may have little to do with the actual practice of medicine per se, it is imperative that physicians create and cultivate a favorable impression with their patients.  Patients want expertise above all else.  But they feel it should be done with care.  This means remembering that the manner of delivery is of equal importance to the message itself.  It also means ignoring any tendency to treat patients in a cavalier, hurried or disrespectful manner.