As recently reported in McKnights’, the New York Times, and elsewhere, a recent study suggests a significant number of physicians are unaware their prescribing habits are “off-label” for certain drugs.  There is nothing illegal about this.  Many drugs have therapeutic uses that extend well beyond their FDA approved ones.  The FDA does not have the resources to approve every use, especially for drugs which have been proven safe and effective, and are in the use stream or have been for years.  However, depending on medical malpractice standards in the state in which a physician is prescribing drugs, off label prescriptions, especially unknowingly off-label prescriptions, carry with them a significant medical malpractice liability.

Every state is different, but generally physicians will be held to a negligence standard that is compared with their geographic/practice specific peers; that is to say an rural Missouri physician will be expected to perform at the level, and make the same general type of decisions as a similarly situated physician.  She need not perform at the level of the best physician, in the area of the country with the highest concentration of outstanding physicians to be free of negligence (or malpractice), merely at a level in keeping with the generally held standards of physicians in her area, and the profession as a whole.

Off-label prescribing can, and usually does, fit very nicely into this pattern.  In fact, there are many cases where not prescribing under an off-label use could be arguable malpractice.  However, if physicians are assuming “on label” use when prescribing, but are actually not following the approved guidelines for use and effectiveness by the FDA, there exists, then, a strong argument for violation, for malpractice, should an adverse outcome arise out of the unknowingly off-label prescription.

I’ve not explored this topic far enough to cite specific examples, but if the U of Chicago study holds water, then a significant number of physicians are exposing themselves to liability in their prescribing habits.

Letter, if Not Spirit

August 20, 2009

Skilled Nursing Facility administrators often complain the survey process is too focused on the letter of CMS guidelines, and not the spirit of them.  Nurses grouse that good care is evident despite a lack in documentation; “quality of life” is too subjective for so-called “paperwork deficiencies,” and so on.  Earlier this week an appeals court in Chicago turned the same tables onto the Illinois Department of Public Health.

An SNF appealed a Type A, serious type, violation.  The IDPH fine was $10,000.  The successful argument was not based on the merit of the deficiency tagged, but on the timing of the notice.  The Department failed to notify the facility of the Type A violation within 60 days of the end of the annual survey.  (Notice was actually given on the 66th day, though regulation requires it within 60 for violations of that type)

The facility’s lawyer successfully argued that the Department lost jurisdiction to prosecute a violation because the notice fell outside of the window prescribed by Administrative Rule.

This case highlights an important issue within the current regulatory scheme.  1) Such deadlines are essential if facilities are to learn from their mistakes.  That is, prosecution of violations is not merely punitive, but compels facilities to do better next time.  A deadline lets facilities know that, if there are changes to be made, you’ll be told about them in a reasonable time.  This allows regulatory codes like IDPH’s and CMS’s to have what is known as a “channeling function.”  Sure 66 days may be no more unreasonable than 60 in this respect, but for a deadline to have the necessary channeling function effect, it must have a definite cutoff.  2) The regulatory scheme is necessarily (and some would argue counter-productively) adversarial.  It seems like the facility’s lawyer “gamed the system” or “won on a technicality.”  This argument, incidentally, is the same as when facilities claim to have only received a “paperwork deficiency” or have been “caught without documentation.” At the end of the day, an adversary system creates incentive to “beat” the other side, but it also incentivizes winning on the margins.  That is to say it discourages substantive change (which takes more energy and resources than winning on technicalities).

The ideal would be to marry the channeling function of deadlines and the innovation and energy created by the adversarial system while divorcing this kind of small ball, winning on the margins attitude.  That kind of third way is, alas, tremendously difficult to find.  However, I think cases like this one expose the issues that come along with decisions based on the letter, if not the spirit of the Law – – or in this case, Rule.

*Thanks goes to LSN’s Week’s News newsletter for source material.

I have written before, briefly, on the redux edition of The Fairness in Nursing Home Arbitration Act.  It is an unnecessary, unwieldy piece of legistlation that 1) tries to solve a problem that is not really a problem; 2) does so in such a way that is both at the same time damaging to residents’ financial interests and de-limiting of the protectioncs already in place; as well as 3) adds expense without value to the end consumer.  

Attorney T. Andrew Graham has commented on this blog before w/r/t these issues, and has both command and clarity in discussing Arbitration in Nursing Home contracts.  So, I wanted to point to an excellent column he has written for McKnight’s.  Its longish, but summarizes the political, legistlative and judicial aspects of The Fairness in Nursing Home Arbitration Act of 2009 (S. 512) very, very well.  

Hopefully, this legislation will be defeated, as it was last term when it was brought before Congress, but I would highly recommend familarizing oneself with the arguments by reading Attorney Graham’s piece.

The number of lawsuits against nursing homes is rising.  Many of these suits begin with either a sentinel, ‘never-event’ (e.g. dehydration, fecal impaction, etc.) or the emergence or worsening of a late stage pressure ulcer.  In fact, trial lawyers are especially keen to bring negligence and malpractice actions over pressure ulcers because recent nursing literature has encouraged the use of wound photos to track the progression/regression of pressure ulcers as a part of the clinical record.  Not incidentally, these photos are impactful and in many cases disturbing to judges and juries alike.

Let me be very clear.  Emerging pressure ulcers can be a sign of negligent care.  A nursing home should strive to never have an emerging pressure sore, and should work to heal the ones on patients at admission.  This being said, pressure ulcers do happen.  There are compelling arguments for tracking these wounds with photographic evidence, although these photos may make a legal defense more difficult.

Given the recent surge in lawsuits over pressure ulcers, then, I think a discussion on evidence law may be instructive for finding strategies to balance good nursing practice in taking care of these wounds and establishing aggressive practices for legal defense.

Initial Understanding

The rules of evidence dictate those facts which are admissible in open court and those which a jury will never hear.  Evidentiary law is procedural – – it is lawyers’ law; it is the rules by which the game is played.  As such, you can imagine, it is one of the most parsed, argued over and complicated areas of the law. 

In order for the court to allow facts to be heard in open court (admitted as evidence), they must be relevant, material and competent.  Relevance is whether the evidence makes a claim more or less probable.  Material is whether the evidence is offered to help prove a fact at issue.  Competence is the reliability of the evidence to prove what it aims to.  For example, in a lawsuit involving a resident with a pressure ulcer, a photo of a wound is relevant if it shows the wound of the resident suing, not a wound like or similar to the resident’s wound.  It is material if it shows the wound that caused the suit, not, for example, a previously healed wound acquired before nursing home admission.  It is competent if the photo illustrates what it claims to (i.e. it is clear what is depicted in the photo or it has not been Photoshopped).  The materiality, relevance and competency of evidence can be shown with something inherent to the evidence (something like labels on wound pictures) or by testimony of a witness with knowledge of the fact being depicted (example: the risk manager nurse who has the duty of keeping wound care photos).

Introducing Photos and Expert Witnesses

There are many specific and particular rules controlling the introduction of photos (especially specialty subject photos that are medical/clinical) into evidence, however.  The first and most important of these is called the Best Evidence rule.  Best Evidence is actually an ancient legal concept dating to the Ecclesiastical Courts of the Middle Ages, but remains extremely important today.  Essentially, the demand is that if a document (or photo) is introduced into evidence to prove a fact (negligent care, say) it must be the original or, if a copy, you must have a good reason for not presenting the original.  So, a wound photo, assuming it is developed into hard copy, should be the original print to be admissible. 

This rule also dictates how photos taken on a digital camera, and stored electronically, can be admitted, albeit in an oblique manner.  Since the law seeks originals in order to minimize the risk of misunderstanding caused by imperfect copies, a party seeking to admit a digital picture must be able to demonstrate the photo-file is the original one from the camera – – undoctored.  Obviously, this is difficult to do, and may require testimony from someone familiar with the taking and storing of your facility’s digital photos. 

The second related rule is that all real and demonstrative evidence (would photos will fit into either of these two categories) must be attested to with knowledge of the evidence.  This can be anyone who knows where the evidence comes from and how it was produced.  In the case of pressure ulcer photos, the court will also require an expert witness to describe to the jury what the photos are depicting, and what the depiction indicates (e.g. what stage pressure ulcer, how does one get to that stage, what are nursing practices to avoid this type of pressure ulcer, this particular resident’s circumstance which lead to this pressure ulcer etc.).  With this type of testimony accompanying very expressive photos, it becomes obvious why wound photos are so important in these types of cases.

Admission into Evidence: A Facility’s Steps to Protect Itself

It is fairly clear that wound photos are going to be admissible into evidence in a lawsuit alleging negligent care by a nursing home leading to a pressure ulcer.  So, what can facilities do to prepare for such suits?  The obvious answer is to prevent pressure ulcers from emerging and carefully documenting those that are present on admission.  From a legal standpoint the kneejerk answer (and one which many corporate counsel advocate) is to abandon the practice of taking wound photos, and rely instead on the written clinical record, but there are numerous nursing practice drawbacks to this approach.  So, assuming a facility is going to take and keep wound photos for the clinical record, the best defense for any potential suit is to control the wound photos as much as is practicable. 

Facilities should establish procedures whereby wound photos are as accurate is feasible and as precise as they can be.  What this means is that every wound photo should be taken is similar lighting conditions, from the same distance (from camera to wound) with the same camera settings.  Additionally, the photos should include some scaling metric (a ruler) and an indication of directionality.  Many facilities I know of place a five centimeter L-ruler under the wound and easily removable orange sticker in the direction of the head.  Steps like these make certain the wound does not appear worse than it really is (e.g. if there were no scale and the lighting was poor, a wound may appear more infected, larger and deeper than in reality).  Also, facilities should ensure their risk managers or wound care nurses take adequate documentation on all wounds, and be prepared to explain what is depicted in photos.  Last, make certain to take the appropriate number of photos so the progression/regression of a wound can be shown.  Set a schedule for taking these photos – – same time each and every day, for example.

Conclusion

Ultimately, the law of evidence presents an occasion for lawyers to wrangle – – apply their skills and win the suit on procedural issues.  But, despite the complexities of this area of the law, a general understanding can help Administrators prepare for a day that, hopefully, will never come; the day the care a facility provides is put into question.

A Washington state court decided yesterday that a 91 year-old man with dementia and demonstrated delusions was competent to stand trial for second-degree murder.  The accused, Joe Conway, allegedly shot and killed a staff member at the nursing home where he lived when the victim brought food into Mr. Conway’s room.  After a two-day evidentiary trial, the court found Mr. Conway competent, and put his case on the criminal docket.  

As awful and shocking as this news sounds, it is really not all that surprising given the tortured logic the “insanity defense” has gone through in the last forty years of Supreme Court jurisprudence.  All crimes, in order to be crimes, require an action and a mindset.  If one commits the prohibited action (taking a the purse off a woman on the street) with the prohibited state of mind (with knowledge that it is not one’s own and to deprive the rightful owner enjoyment of the purse) then a crime has be committed.  If one commits the action (snatches the purse) without the mindset (but mistakenly believes it was one’s own to start with) no crime has been committed.  This the foundation of the insanity defense.  Essentially, it says that a person is incapable of forming the prohibited mindset, thus their actions are not criminal.  

Sounds simple, and if Mr. Conway has a dementia diagnosis, it would seem impossible for him to form the requisit intent for second-degree murder.  However, intent can only ever be inferred, and the several states and the Supreme Court have devised many different tests for inferring such intent: 1) the M’Naghten test: the defense will hold if at the time of the misconduct, the defendant (accused) lacked the ability to know the wrongfulness of his actions or understand the nature and quality of his actions (i.e. “does not know right from wrong”); 2) the Irresistible Impulse test: the defense will hold if the defendant was unable to control his actions or conform his conduct to the law (i.e. lacked self control and free will; suffered an impulse he could not resist); 3) the Durham test: the defense will hold if the defendant’s conduct was a product of mental illness (i.e. but for the mental illness, the defendant would not have done the act); 4) the Model Penal Code test: the defense only holds if the defendant lacked the substantial capacity to appreciate the criminality of his conduct, or conform his conduct to the requirements of the law (i.e. a combination of the M’Naghten and Irresistible Impulse tests).  Different states use different tests, but as is fairly clear even on first reading, there is a lot of wiggle room in the language of all of the tests. 

So, how does a 91 year-old dementia patient not fail these tests and be found competent?  Unfortunately, the theoretical underpinning for the defense does not really support the court’s finding.  But the tests likely do.  If Mr. Conway had in his mind to kill a person, even if he was delusional as to who the person was or why he was killing him, then, all things being equal, the M’Naghten would not save him.  Dementia standing alone would likely not hold the defense under any of the other three.  Dementia, generally, does not create an impulse to kill, nor is it a mental illness which channels someone towards murder.  I suspect, though, the Supreme Court will revisist these tests in the next few years – – and it will probably be a case like Mr. Conway’s that presents the issue.  Age related dementia is unique enough from other mental illnesses that the Court may carve out some special consideration in the “insanity defense.”  With the next crest of seniors reaching old-old age, the issues may come to a head fairly soon.

*On a totally unrelated note, the insanity defense was first suggested in Anglo-American legal theory by Lord Chief Justice Tindal of the Court of Common Pleas – – this guy was an absolute genius, though he is best known for acting as Queen Caroline’s defense attorney (successful) in her adultery suit.  His wikipedia entry can be found here.

Nursing home administrators face an unexpected ethical (and legal) dilemma when admitting new residents to skilled nursing care. The Nursing Home Care Act undercuts a traditional notion of informed consent in such a way that many residents may be admitted to a nursing home without ever consenting to treatment, or having a meaningful surrogate consent to their treatment. This is clearly an issue of nursing/medical ethics, as well as a font of potential legal liability for providing unauthorized care.

American health care law is predicated on the notion of patient autonomous-direction. Within this notion exist a number of inter-linked rights: the right to self-determination, the right to give consent before treatment, the right to information forming the basis of consent and many others. Curiously, in senior care, as in perhaps no other major area of American health care law, the status of patient autonomous direction, especially with respect to consent before treatment, is less sacrosanct, the exceptions more numerous. This is especially true in the legal quagmire of involuntarily placing adults in nursing homes.

I am most familiar with the Illinois Nursing Home Care Act and it will thus form the background of this discussion, but the Illinois Act is not dissimilar to Nursing Home Care Acts in many other states, at least inasmuch as the acts address the issue of involuntary admission. Clearly involuntary admission of a resident to a nursing home presents moral and ethical issues most families are not experienced in dealing with, not to mention attendant feelings of guilt for the family members and likely betrayal for the patient herself. However, for the health care provider, the nursing home, the struggle is a balance between determining the self-interest rights of the resident and the interests in rendering care.

Admission with Consent/Admission with a Surrogate’s Consent

In Illinois, the default position is that every resident, regardless of diagnosis or infirmity, is presumed to have the capacity to make her/his health care decisions. This includes admission into a nursing home. Providing nursing home care to a person who has capacity to refuse such care, and does refuse it, is paramount to a battery on the patient by the nursing home and would subject the home to potential liability. Determining incapacity is generally a court adjudication, relying in part on advice from a physician, looking at the patient’s ability to make decisions, understand the consequences of one’s own actions and comprehension of one’s diagnosis. If a court determines a person does not possess the capacity to give consent to health care, then a guardian will be appointed to that person to make decisions regarding the person’s health care.

Interestingly, a guardian cannot make the determination to admit her charge into a nursing home unless given express authority by the court to make such a decision. Thus, it is possible (and happens often enough to be noteworthy) where a guardian (usually a family member) who made the decision on behalf of her charge to admit the patient into a hospital must seek specific direction from the issuing court to admit her charge into a nursing home upon discharge from the hospital. Support for this position is fairly widespread and is a outgrowth of the importance of autonomous determination in American health care. In brief: nursing home care is seen as different enough from other provider types, that the type of front-line health care that a guardian usually makes decisions on (administration of prescriptions, whether to have certain hospital-based treatments, etc.), that the decision to admit a patient into a nursing home represents in effect a different, more substantial level of capacity for the court to determine.

Assuming a guardian is granted the authority to admit her charge into a nursing home, this consent will suffice to protect the nursing home from liability, regardless of the manifest wishes of the patient. Yet, the Illinois Act allows for different surrogates other than those specifically appointed by the court to contract with nursing homes for the admission of their charges or wards. A resident may plan for her own incapacity, and avoid the lengthy process of court-ordered and controlled guardianship, by designating a surrogate using a Durable Power of Attorney for Health Care. The Illinois Nursing Home Act creates a statutory form that families can use, although the statutory form has generated many criticisms from commentators because its confusing language may belie the “consent” such forms are supposed to evidence. Such surrogates can consent to nursing home admission so long as the Power of Attorney does not contain language that bars the surrogate making such a decision, either in the presence of manifest intent by the patient/principal, or under any circumstance. Barring this unusual direction in the document itself, a Durable Power of Attorney for Health Care is the most used and safest way residents are involuntarily admitted to nursing homes.

Chipping Away at Informed Consent in the Nursing Home Setting

However, in the absence of a legal surrogate relationship (either a court-directed guardianship or non-exempt Durable Power of Attorney for Health Care), the Illinois Nursing Home Care Act still allows some elements of informed consent to be chipped away. For example, a member of the patient’s family can contract for her admission to a nursing home on the patient’s behalf in the absence of her (the patient’s) positive, manifest consent. This contract is legally binding on the patient/resident so long as she does not object to it once admitted to the nursing home. Thus, a patient can be admitted to a nursing home, a major life change, even when no formal surrogate relationship exists.

The potential harm to patient’s rights caused by the loophole should not be underestimated. Going into a long term care facility represents a major life change for the resident. Generally, they are moving into a new and unknown environment while being taken care of by a physician and nursing staff. Once they are admitted to the nursing home, many residents may be hesitant to voice any objections to their admittance because of cultural imperatives that they do not disagree with medical staff, financial difficulties of living at home and the reluctance to go against the decisions of younger family members who have already arrived at the conclusion that the nursing home is the best place for their continued care.

By requiring only an objection to admission, rather than traditional informed consent, nursing home administrators may be severely impinging on the rights of the residents they serve.

Legal Analysis/Future Action

The legislative history of the Illinois Nursing Home Care Act is disquietingly silent on the issue of creating a statutory distinction between requiring consent for admission and mere objection. Some commentators have described this distinction as being, perhaps, only a scrivner’s error originally, but have harshly criticized the fact that the language creating the distinction has not been changed. They see this as a departure from the foundational premise of patient autonomous-direction.

Whether intentional or not, the artificial distinction serves to create wiggle-room in the informed consent arena that did not previously exist. Given the nature of nursing home care (i.e. a major life-shift for most residents who may be too vulnerable to actually object to admission once they are in the facility), such a distinction creates a potential liability problem for nursing homes and, more importantly, a major ethical concern for providers.

In Illinois this issue has not been addressed by the courts, though there is mounting pressure in the long term care community for some kind of legislative action. The convenience of family members being able to contract with long term care facilities in the absence of express, manifested informed consent by the patient goes against the long tradition of patient autonomous-direction in American health care. Involuntary admission to a nursing home is serious enough that it should be a deliberate decision, a willful cross of the intent of the patient with all of the moral and legal protections and processes that have been created to protect the rights of patients as much as is proper. It should not be a back door policy, a mere absence of objection.