What Is Medical

Surrogate Selection: An Increasingly Viable, but Limited, Solution to Intractable Futility Disputes

My article, "Surrogate Selection: An Increasingly Viable, but Limited, Solution to Intractable Futility Disputes," was just published by the St. Louis University Journal of Health Law and Policy (vol. 3 at 183-252). Here is the issue cover. Here is a final prepublication draft. Here is an abstract:

The focus of this Article is on the avenues for resolution, if the futility dispute proves to be intractable. Many New England Journal of Medicine poll respondents wanted to simply override the son, but noted that they would not do so because of legal concerns. [FN12] Physicians are overwhelmingly reluctant to withhold or withdraw treatment without the *187 consent of the authorized decision maker. [FN13] Accordingly, without explicit permission to do otherwise, physicians generally comply with surrogate requests for treatment even when they think it is cruel and wrong. [FN14]

Only under Texas law do physicians have clear permission to refuse to provide inappropriate treatment. [FN15] When providers and patients' surrogates cannot agree on appropriate life-sustaining medical treatment (“LSMT”), the Texas Advance Directives Act (“TADA”) designates the hospital ethics committee as adjudicator of last resort. [FN16] If the hospital committee agrees that the requested treatment is inappropriate, the provider earns legal immunity for refusing to provide it. [FN17] The Idaho State Senate recently passed a bill to do the same thing. [FN18] And policymakers in other states have considered, or are now considering, similar legislation, albeit most are vaguer than TADA. [FN19]

*188 But Harvard Medical School Professor Robert Truog argues that this too-provider-friendly sort of internal dispute resolution legislation is both unnecessary and dangerous. [FN20] He argues that current healthcare decision laws in every state already give healthcare providers an adequate mechanism to avoid providing inappropriate medicine demanded by surrogates. Specifically, when a surrogate demands treatment that providers deem medically inappropriate, these “surrogate selection” laws often permit (or even encourage) providers to designate a different new surrogate from whom consent to withhold/withdraw can be obtained. [FN21]

*189 Truog argues that a mechanism like TADA is most useful, and most justified, when surrogates make decisions not in the best interests of patients. But in precisely such a situation, there is no need to resort to a TADA-type mechanism. Instead, Truog argues, the “remedy should be to use existing pathways to challenge the legitimacy of the surrogate to make these decisions and to seek appointment of another decision maker.” [FN22]

The logic behind these “surrogate selection” laws is simple. A surrogate is the patient's agent and, as such, must act according to the patient's instructions, known preferences, and best interests. When a surrogate exceeds the scope of her authority, she can and should be replaced. [FN23] For example, providers took a surrogate selection approach in the famous Helga Wanglie case. [FN24] Instead of asking the court to directly determine that their recommended treatment was correct, providers instead asked the court only to make a procedural decision appointing a new surrogate. [FN25] This surrogate, in turn, would make the substantive decision (presumably in accordance with provider recommendations). [FN26]

*190 In Section One, I describe the nature and prevalence of futility disputes. In Section Two, I describe the role of surrogates and the standards that they must apply when making medical treatment decisions on behalf of patients. Unfortunately, the available empirical evidence indicates that surrogates do a rather poor job of representing patient's preferences and interests. So, in Section Three, I argue that unfaithful surrogates should be replaced.

In Section Four, I demonstrate that surrogate replacement is a proven and viable dispute resolution mechanism. While providers were ultimately unsuccessful in both Wanglie and similar cases during the early 1990s, surrogate selection has, more recently, proven to be a successful approach. Emblematic of this trend is a string of cases during 2008 and 2009 in which several courts replaced patients' surrogates because they were demanding inappropriately aggressive end-of-life treatment. [FN27]

Finally, in Section Five, I argue that while surrogate selection has become increasingly well grounded both in statutory standards and in judicial precedent, it remains only a partial solution to intractable futility disputes. To replace a surrogate requires evidence of a contradiction between the surrogate's decision and the patient's instructions, known preferences, or best interests. But, for two main reasons, providers will frequently be unable to demonstrate any such contradiction. First, providers will often lack enough evidence of patient instructions or preferences to demonstrate surrogate deviation. Second, in many cases, surrogate decisions will actually be in harmony with patient wishes.

In sum, Professor Truog is right to endorse surrogate selection as a solution to intractable futility disputes. It is a mechanism that can work, and one that, where possible, should be preferred over power-shifting laws. Yet, since surrogate selection cannot resolve significant categories of conflict, we must still develop dispute resolution mechanisms to handle those remaining disputes in which providers conflict with “irreplaceable” surrogates.

New Report on the Golubchuk Case Forthcoming

Approaching three years since Samuel Golbchuk's death after one of the most high profile futility disputes in the world, the Winnipeg Regional Health Authority is preparing to release a report reviewing his death and how officials can better handle disputes between physicians and patients. (Winnipeg Free Press)

"Secret" Advance Directive Regulations Not Secret Anymore

The media and the blogosphere are abuzz about the Medicare regulations authorizing increased payments for "voluntary advance care planning" discussions. But I was pleased to see Wesley Smith's comment: "Obamacare: New End-of-Life Counseling Regulation a Bureaucratic End Run, But Not Cause for Alarm." The following is a brief clip from CNN's Parker-Spitzer:

Expectations, Hope and Futility: Law and Bioethics in Contemporary Healthcare

The Australasian Association of Bioethics and Health Law 2011 conference is titled "Expectations, Hope and Futility: Law and Bioethics in Contemporary Healthcare." Here are some of the questions that will be addressed:

What is the role of Expectations (realistic or otherwise) in driving contemporary health care?

To what extent can, or should, Hope be fostered – what are the harms and beneﬁts?

After 3 decades of deﬁning, measuring and critiquing medical Futility, where are we in 2011?

Do health consumers’ Expectations and Hope drive Futile care measures across the spectrum of our healthcare system?

Do health professionals’ misunderstanding of what would constitute a good outcome from the patient’s perspective drive Futile care measures?

What impact does this have on health service budgets?

How are these considerations supported or denied in law within Australia and New Zealand?

How should we best frame these questions – ethically, legally or professionally?

The Impact of EMTALA on Futility Disputes : Baby K Still Good Law

Today, CMS published an advance notice of proposed rulemaking requesting comments on the need to publish a proposed rule to address policies related to the Emergency Medical Treatment and Labor Act (EMTALA). CMS said it is “aware that there continues to be a range of opinions even at the Circuit Court level on the topic of EMTALA's application to inpatients. CMS further said it “would find it particularly helpful if commenters could submit specific real world examples that demonstrate whether it would be beneficial to revisit the policies.” Comments will be accepted until Feb. 21, 2011.

In Baby K, the 4th Circuit held that EMTALA required the stabilization of an anencephalic infant's respiratory distress because that was an emergency medical condition. The court held that EMTALA's obligations are categorical and unaffected by medical standards of care. Baby K has never been overruled. Still, its impact has been substantially mitigated by the inpatient exception rule, first adopted by the federal circuits (including the 4th Circuit in Bryan) and later by CMS in regulations. Since most futility disputes concern inpatients (often ICU patients), EMTALA is rarely applicable. If the inpatient rule were eliminated, as it already has been in the 6th Circuit, then that could create real obstacles to appropriate resolution of futility disputes.

Medical Futility and Maryland Law III

I already blogged twice (here and here) about the November 30th conference on Medical Futility and Maryland Law. I prepared a slightly longer summary of the conference and of its target issues in this piece (in PDF) for the forthcoming January 2011 United Seniors of Maryland Newsletter.

Kate Adamson - Locked in a Glass Coffin

In 1995, 33-year-old Kate Adamson fell into Locked-In Syndrome, or total paralysis from brain injury, due to a brain stem stroke. Doctors assumed that she was in a vegetative state when she was completely aware of what was going on around her. At one point, she was operated on without an anaesthetic. (Nelson Mail) Doctors said she had less than a one in a million chance of surviving.

She apparently was that one in a million. Ms Adamson spent three months in rehabilitation, slowly learning everything all over again – how to eat, talk and walk. She still has no use of her left arm, wears a brace on her left leg and walks with the help of a cane. She has written a book, Paralyzed but not Powerless.

Bellevue Hospital Center Erronoeusly Said Patient Died

Emilie Gossiaux was riding her bicycle in October 2010, when an 18-wheel truck making a right turn struck her. After she arrived at Bellevue Hospital Center, her heart stopped for about one minute after she went into cardiac arrest. Emilie had suffered a traumatic brain injury, a stroke and multiple fractures in her head, pelvis and leg. Emilie’s mother said that on the second day a nurse told her that her daughter was gone, and asked about organ donations.(New York Times) But Emilie had not died. Though blinded by the accident, Emilie is still continuing her recovery. Her family is raising money for her expenses here.

Not a great story for engendering trust in terms of provider recommendations regarding organ donation or "tail end of the curve" treatment choices.

Impact of Scholarly Legal Analysis on Law Reform II

This is a brief follow-up to my post a few days ago on the the impact of scholarly legal analysis on law reform. This is not directly about medical futility. But it is about my role in this and other health law and bioethics debates. The latest issue of the University of Queensland Law Journal includes an article by Harvard Law Professor Mark Tushnet titled "Academics as Law-Makers?" Tushnet observes that:

"Legal academics can help make the law . . . they can clarify the concepts used by judges, thereby introducing better ways of understanding what the judges are already doing."

"Conceptual clarification is defensible on its own terms, but it may also have effects on outcomes. . . . [A]cademic legal writing helps judges reach the results that they think appropriate."

"United States legal academics taken as a group overestimate their likely impact on the development of the law. Many think that their articles will directly influence judges and policymakers . . . [But] judges ideologies, predispositions, and attitudes are important and perhaps nearly exclusive determinants of what they view to be the 'right' result. [P]olicymakers are influenced by ideology, politics, and the general cultural atmosphere . . . so much space occupied by things other than the ideas offered by legal academics . . . ."

"[L]egal academics in the United States can be law-makers, to a modest degree. 'Modest,' though, is the right word . . . ."

Constitutional Challenge to Georgia's Assisted Suicide Law

Susan Caldwell, a 43-year-old with Huntington's disease has filed a federal lawsuit alleging that Georgia's assisted suicide law is vague and unconstitutional. She contends it violates her free speech rights because it blocks her from seeking the advice of right-to-die group FINAL EXIT NETWORK. Caldwell's lawsuit claims that Georgia aw violates her free speech rights because instead of criminalizing suicide or assisted suicide, it outlaws people from publicly speaking about assisted suicide and then participating in the death. That means people who only hold the hand of a terminally ill person as they end their life could be prosecuted. (Star-Tribune) I have posted a copy of the Complaint here.

Judges, Afraid of Being "Schiavoed," Rule against Providers

Ken Goodman at the University of Miami posted a brief piece on End-of-Life Ethics: Family Members, Conflict, and Politic to Medscape a few weeks ago. The following part caught my eye:

We see in many jurisdictions family members insisting on the overtreatment of their loved ones . . . . In some cases . . . [they] involve litigation . . . involve court filings . . . . There are judges in some jurisdictions who have actually said, "I don't want to be Schiavoed," meaning they are inclined to rule not in favor of a patient's rights or a patient's refusal of treatment, but in favor of the complaining family member.

Four Months to National Healthcare Decisions Day

National Healthcare Decisions Day is on April 16, 2011. That is four months from today.

The National Healthcare Decisions Day Initiative, now in its third year, is a collaborative effort of national, state and community organizations committed to ensuring that all adults with decision-making capacity in the United States have the information and opportunity to communicate and document their healthcare decisions. The objectives of NHDD are to provide much-needed information to the public, reduce the number of tragedies that occur when a person’s wishes are unknown, and improve the ability of healthcare facilities and providers to offer informed and thoughtful guidance about advance healthcare planning to their patients.

Ten Questions Walter Cronkite Would Have Asked About Health Care Reform

In 2008, Kalamazoo, Michigan nephrologist Kenneth Fisher published In Defiance of Death: Exposing the Real Costs of End-of-Life Care. This week, he published self-published The Ten Questions Walter Cronkite Would Have Asked About Health Care Reform. It obviously covers issues broader than end-of-life care, but that remains a key subject of the new book. Here is a new 30-minute interview with Dr. Fisher on Western Michigan NPR.

The Impact of Scholarly Legal Analysis on Law Reform

Banks McDowell was a law professor at Washburn and at Boston University. I already knew the truth in this quotation from McDowell's 1985 article, The Collateral Source Rule: The American Medical Association and Tort Reform, 24 Washburn L.J. 205 (1985). But I was pleased to find it, and I appreciate the elegant way in which it captures a truth all-too-humbling to the legal academic.

Rarely does scholarly analysis about a legal problem and the need for reform lead directly to change. Some politically active group who stands to gain by the reform has the responsibility of turning a dispassionate analysis into a new and effective legislative program.

PENN Finally Identifies PVS Patient after 4 Months

In August, Michelle Bateman suffered a heart attack in a Philadelphia park. Paramedics did not restore a normal heartbeat until at least 45 minutes later. Bateman was later transferred to the Hospital of the University of Pennsylvania, where she was diagnosed as being in a persistent vegetative state with no chance of cognitive function recovery. This weekend, the Philadelphia Inquirer, ran a story with this patient's picture and story because the hospital had been wholly unable to identify the patient for the past four months. The hospital had been referring to the patient as "Jane Doe." The newspaper coverage worked; the patient was finally identified today. (Philadelphia Inquirer; Fox News)

The Inquirer notes: "Penn has absorbed the cost - well over a quarter-million dollars so far and about $2,000 for each additional day - and will continue to pay for her stay in the hospital or another facility as long as necessary, said Marc Kaplan, a spokesman for the health system." I was pleased to see this. As both a Pennsylvania and a federal taxpayer, I do not want to see my tax dollars (through Medicaid or Medicare) or even my plan dollars (Independence Blue Cross) go the treatment of a patient in a persistent vegetative state. This patient has zero ability to benefit from any treatment at Penn or at any long-term facility to which she might be now transferred.

The Absence of Malpractice Lawsuits for Unilateral Withdrawal of Life-Sustaining Treatment

I have argued and demonstrated (here, here, and here, among other places) that there have been very few successful damages actions against healthcare providers for unilaterally withdrawing life-sustaining treatment where such treatment was determined (by the providers) to be non-beneficial and inappropriate. Physician John Luce is doing a study of California cases, and has similarly found that, among other things, "a lot of such conflicts, Dr. Luce believes, likely never get as far as a courtroom. For one reason, it's difficult to find an expert who will testify that the attending doctor violated the standard of care."

Apart from challenges concerning the merits of such cases are a number of practical obstacles. For a very nice illustration of these, see Tennessee lawyer John Day's post about a physician who wanted to file a malpractice action against another physician and hospital.

Moving Beyond Death Panels - David Goodman, Joanne Lynn (Dec. 10, 2010)

This afternoon at the New America Foundation:

West Virginia -- 50% Advance Directive Completion Rate

West Virginia reports a 50% completion rate of advance directives. On Monday, WV PBS will broadcast The Last Chapter: End of Life Decisions.

The one-hour program examines the need for advance directives including a living will, a medical power of attorney, and a POST form (Physician Orders for Scope of Treatment). While families share heartbreaking stories of the consequences of not having these decisions made before a medical crisis occurs, individuals who have completed these forms share their peace of mind. Through the guidance of The West Virginia Center for End of Life Care, Ruby Memorial Hospital, Thomas Memorial Hospital, and Hospice of Southern West Virginia, the program explains end-of-life care options. It also stresses the rights of patients, including the their ability to make changes to their advance directives at any time.

Medicare Expanded Coverage of Voluntary Advance Care Planning

From the November 29, 2010 Federal Register, 75 Fed. Reg. 73169, 73406.

Comment: We received a number of comments from physicians, health
care providers, and others urging us to add voluntary advance care
planning as an element to the definitions of both the ``first annual
wellness visit'' and the ``subsequent annual wellness visit.'' They
base their recommendation upon a number of recent research studies, and
the inclusion by statute of a similar element in the existing initial
preventive physical examination (IPPE) benefit. One commenter noted
that ``the new wellness visit was wisely designed to build on the
initial preventive physical exam, providing an ongoing, systematic
focus on wellness and prevention by harmonizing Medicare services into
a coordinated benefit.'' Another commenter stated that ``the AWV
provides an appropriate setting for providers to initiate voluntary
conversations about future care wishes, as they counsel beneficiaries
on other aspects of their health and achieving their personal health
goals.'' The commenter added that the ``care plans discussed in the
'Welcome to Medicare visit' should not be frozen in time, but revisited
as an important component of patient wellness.''

Response: We agree that voluntary advance care planning should be
added as an element of the definitions of both the ``first annual
wellness visit'' and the ``subsequent annual wellness visit'' based on
the evidence described below, and the inclusion of a similar element in
the IPPE benefit (also referred to as the Welcome to Medicare visit),
since January 1, 2009. We believe that this will help the physician to
better align the personal prevention plan services with the patient's
personal priorities and goals.

Recently, Detering and colleagues (British Medical Journal 2010;
340:c1345) reported that ``advance care planning improves end of life
care and patient and family satisfaction and reduces stress, anxiety,
and depression in surviving relatives.'' Silveira and colleagues (New
England Journal of Medicine 2010; 362:1211-8) reported that ``data
suggest that most elderly patients would welcome these discussions.''
Lastly, a study by Fischer and colleagues (Journal of the American
Geriatric Society 2010; 58:400-401) found ``no evidence that these
(advance directive) discussions or completing an advance directive lead
to harm.''

Based on the available evidence and other relevant information, we
are adding to the final regulation a definition of the term ``voluntary
advance care planning'' to read as follows:
    ``Voluntary advance care planning'' means, for purposes of this
section, verbal or written information regarding the following areas:
    (1) An individual's ability to prepare an advance directive in the
case where an injury or illness causes the individual to be unable to
make health care decisions.
    (2) Whether or not the physician is willing to follow the
individual's wishes as expressed in an advance directive.
    This definition is based on the definition of ``end-of-life
planning'', which is included as an element of the IPPE as described in
section 1861(ww)(3) of the Act. Thus, the addition of ``voluntary
advance care planning'' to the AWVs extends to those visits a similar
element to the one already in the one-time IPPE.
    We are also revising the definitions of the terms ``First annual
wellness visit'' and ``Subsequent annual wellness visit'' by inserting
a new element (ix) to the definition of the term ``first annual
wellness visit'' and a new element (vii) to the definition of the term
``subsequent annual wellness visit'' in Sec.  410.15 (a) of the final
regulation text that would read as follows: ``Voluntary advance care
planning as that term is defined in this section upon agreement with
the individual.''

Safeguards against Erroneous Stopping but not against Erroneous Providing

In Delaware as in many states, the safeguards regarding life-sustaining treatment all lean one way. That is, they protect against erroneous withholding or withdrawal or life-sustaining treatment. They do not address erroneous provision of such treatment.

16 Del. Code § 2511. Safeguards.

(a) Anyone who has good reason to believe that the withdrawal or withholding of health care in a particular case: (1) Is contrary to the most recent expressed wishes of a declarant; (2) is being proposed pursuant to an advance health-care directive that has been falsified, forged or coerced; or (3) is being considered without the benefit of a revocation which has been unlawfully concealed, destroyed, altered or cancelled; may petition the Court of Chancery for appointment of a guardian for such declarant.

Advance Care Planning Guides and Elizabeth Edwards

As often is the case when a highly visible person dies, the death of Elizabeth Edwards has prompted many mass media producers to discuss hospice, palliative care, and advance care planning. Here is a brief Q&A with Dr. Richard Besser on ABC News.

Delaware End-of-Life Coalition

The Delaware End-of-Life Coalition was featured in the state's main newspaper today. From the article:

The Delaware End-of-Life Coalition aims to increase awareness of hospice, palliative and other end-of-life services among patients by educating more doctors and other health professionals.

The coalition, which was formed 10 years ago, has created a number of initiatives to address issues surrounding end of life, including training programs for health professionals so they are better equipped to discuss end-of-life care with patients and their loved ones. It also spearheaded an effort to get more Delawareans to fill out advance directives.

Medical Futility Law - International Survey

Chad Ball and colleagues recently reported, in JOURNAL OF TRAUMA, on a recent end-of-life survey distributed to over 400 physicians in the United States, Canada, South Africa, Europe, Asia, and Australia. One of the questions was

Does your local government body (country/state/province/county) have a medical futility law stating that if continued care of a given patient is "medically futile," then the clinician may de-escalate care, regardless of what the family member requests? YES NO

The authors report that 14-38% of respondents indicated that they "benefit from a medical futility law allowing them to proceed with different end-of-life care than desired by a patient's family." They also noted that "U.S. clinicians were much more reluctant . . . [which] may result from a complex interaction between the Western hemisphere's heavy emphasis on patient autonomy , litigious concerns, . . . ."

Palliative Care and the "Battered Patient Syndrome"

Upon being called in (too late) an Australian palliative care provider stated: "We can then see very clearly they have been battered and pushed around, beaten until they lose sight of what they want - they suffer what has been called the battered patient syndrome." (Sydney Morning Herald, 2003)

Another provider, more recently describes what he also calls – shockingly – "battered patient syndrome" - Once you've had five, 10, 50 tests you can become physically battered." (Sydney Morning Herald, 2010)

Minimizing Autonomy Errors when Stopping Life Support

It has long been recognized that errors will be made when it comes to stopping life support. On the one hand, some patients will have life support stopped even though they still wanted it. This might result from, among other things: (a) an error in prognosis, (b) an error in determining the patient's preferences, or (c) a failure to follow the patient's preferences. On the other hand, some patients will have life support continued even though they did not want it. This might result from, among other things: (a) an error in prognosis, (b) an error in determining the patient's preferences, or (c) a failure to follow the patient's preferences.

It struck me in Baltimore, on Tuesday, that amending the law to permit unilateral refusal probably does raise at lease the "risk" of erroneous stopping of life support. But such an acknowledgment is not fatal to the effort. First, significant efforts can and should be made to implement safeguards to minimize that risk. Second, the risk of erroneous stopping is surely significantly outweighed by the benefits of reducing erroneous prolongation. But for the latter argument to have persuasive force, the latter type of error must be perceived as serious as the former type of error.

Pulling the Life Support Plug Before the New Year to Escape the Death Tax

Last year at this time, the 2010 federal estate tax provided an incentive for surrogates to keep wealthy patients alive past December 31, 2009. This month, the incentive is the opposite. If the patient dies on or before December 31, 2010, the estate can escape federal estate taxes. Therefore, there is arguably an incentive for surrogates to hasten death. Of course, this may very well be with the wishes and blessing of the patient herself.

Sidney Morning Herald - "The End"

The Sidney Morning Herald just posted an interactive multimedia feature, referred to as a "documentary," comprised of articles and videos on the end of life, on topics from costs, to treatment options, to palliative care. 