Clinical Bioethics Blog

Waiting for medcial records "after discharge" is of no help for decision making

Bernard W Freedman, JD, MPH — Tue, 07 May 2013 07:36:16 -0800

Medical records:

Waiting for medical records “after discharge” is of no help.

Reviewing medical records while an inpatient in the hospital allows the patient and/or a surrogate decision maker to obtain the greatest amount of information possible over a cross section of medical specialties providing care. It can also provide a clear picture of the condition of the patient with respect to cognition, pain and agitation. Review of reports of CT scans, x-rays, and MRI’s can bring a clear picture of improvement and deterioration in the patient’s condition. All of this will enhance consent based upon complete information and make it easier for patients and surrogates to arrive at decisions based upon medical information rather than confusion, fear and guilt.

Yet, almost universally, medical records are withheld from patients, their surrogate decision makers, independent bioethicists, and attorneys until well after the patient is discharged from the hospital. In cases of critical care and end of life this is especially problematic because decisions that will result in the determination of withholding or withdrawing life sustaining treatment forces decisions to be predicated upon a brief summary of care and prognosis provided by one of the physicians caring for the patient.

The patients and their decision makers are entitled to receive all material information required to make an intelligent and informed decision. As the risks of decisions increase the necessity for an increased amount of information must follow.

Today’s patients and decision makers are in a different position than patients 30 or 40 years ago. Their ability to obtain information rapidly using internet searches provide a plethora of information. Additionally, most medical centers are in the process of transitioning to electronic health records. This will ease administrative problems in getting copies of reports by consultants, radiology, labs, etc to decision makers. Medical centers have the ability to establish a “portal” to physicians but bar access to patients and decision makers.

Accordingly, legislation mandating the release of medical records to patients and surrogate decision makers, in the hospital on a timely basis, must be promulgated with real penalties for failing to do so.

Waiting to Speak - Waiting for the Surrogate to Speak

Bernard W Freedman, JD, MPH — Sun, 24 Mar 2013 06:43:40 -0800

Why Wait

The determination of a patient’s capacity to make decisions is based upon her understanding of her disease or illness and the risks and benefits of treatment. If she is unable to articulate a clear understanding it may be determined that she lacks the necessary capacity to make her own decision and is further taken out of the loop of information and adequate and legitimate updates on her condition. Concomitantly, surrogate decision makers are not always available to see the treating physicians and consults, and often get a cursory explanation of the patient’s condition.

Physicians remain exceedingly reluctant to confront the difficult subject of end of life care. The New York times, on January 11, 2009 published an article, by Denise Grady, - “Facing End-of-Life Talks, Doctors Choose to Wait.” Discussing a survey of 4,074 doctors who took care of cancer patients, who had only four to six months left, but was still feeling well. 65 percent said they would talk about the prognosis, but wait to discuss end of life preferences.

67%: Making sure family is not burdened financially by my care
66%: Being comfortable and without pain
61%: Being at peace spiritually
60%: Making sure family is not burdened by tough decisions about my care
60%: Having loved ones around me
58%: Being able to pay for the care I need
57%: Making sure my wishes for medical care are followed
55%: Not feeling alone
44%: Having doctors and nurses who will respect my cultural beliefs and values
36%: Living as long as possible
33%: Being at home
32%: Having a close relationship with my doctor

Why Wait?

As time progresses and severity of illness increases, being able to say what she – the patient - actually wants is of paramount importance. Respecting person’s wishes is both ethically required and legally mandated because we recognize that each of us is owed the respect to decide what is done to our bodies, how we wish to live. These human rights are not relinquished when sever illness must be faced. The need to provide timely information to the patient must not be ignored. If the determination of the true wishes of the patient are, in fact paramount in decision making than the earlier information is provided then there is a greater probability of knowing – with confidence – the wishes and decisions of the patient. Moreover, be speaking early the patient has the opportunity to ask questions of her physicians that she deems important. All this is lost by waiting. When a patient loses capacity the physicians are forced to turn to the surrogate decision maker who may be reluctant to express the wishes of the patient or unable to face the harsh realities of the situation and delay decisions.

1 A surrogate cannot be permitted to cause a delay in decision making which will harm the patient by causing unnecessary suffering and costly delays.

2 If a surrogate cannot or will not be fully informed and understand the diagnosis and prognosis, he or she may not continue as surrogate

3 If a surrogate cannot or will not decide – find a new surrogate, or move to a best interest standard.

Often the surrogate is a family member suffering from fear and grief, often at odds with the views of other family members and friends. There is an understandable empathy for people in this position and the desire to help them through such a hard time in their lives is great. Yet, it is not the job of a physician or nurse or bioethicist to become involved with the surrogate to the point that the surrogate’s feelings seem more important than the need to uncover by the most reliable means possible under the circumstances to know the true perspective and intentions of the patient.

It must be of crucial importance to maintain focus on the patient’s wishes and not see the surrogate and family as a filter or as an easier method to arrive at a decision. The surrogate must make a decision, not based on a consensus of the family or the advice of the doctor or nurse, but on the best and clearest representation of the wishes of the patient.

From "Waiting for Godot" Samuel Beckett

VLADIMIR:

Let's wait till we know exactly how we stand.

ESTRAGON:

On the other hand it might be better to strike the iron before it freezes.

VLADIMIR:

I'm curious to hear what he has to offer. Then we'll take it or leave it.

ESTRAGON:

What exactly did we ask him for?

VLADIMIR:

Were you not there?

ESTRAGON:

I can't have been listening.

VLADIMIR:

Oh . . . Nothing very definite.

ESTRAGON:

A kind of prayer.

VLADIMIR:

Precisely.

ESTRAGON:

A vague supplication.

VLADIMIR:

Exactly.

ESTRAGON:

And what did he reply?

VLADIMIR:

That he'd see.

ESTRAGON:

That he couldn't promise anything.

VLADIMIR:

That he'd have to think it over.

ESTRAGON:

In the quiet of his home.

VLADIMIR:

Consult his family.

ESTRAGON:

His friends.

VLADIMIR:

His agents.

ESTRAGON:

His correspondents.

VLADIMIR:

His books.

ESTRAGON:

His bank account.

VLADIMIR:

Before taking a decision.

ESTRAGON:

It's the normal thing.

VLADIMIR:

Is it not?

ESTRAGON:

I think it is.

VLADIMIR:

I think so too.

Failing to Follow Best Practices - Ovarian Cancer

Bernard W Freedman, JD, MPH — Mon, 18 Mar 2013 22:24:58 -0800

At the 2013 annual meeting on Women’s Cancer by The Society of Gynecologic Oncology (March 9 2012 – Los Angeles) Dr. Robert Bristow, the director of Gynecologic Oncology at the University of California – Irvine presented a retrospective review of the medical records of 13,321 women with ovarian cancer, diagnosed from 1999 through 2006 in California. The study determined that only 37% of the care provided to this cohort adhered to the guidelines set forth by the National Comprehensive Cancer Network setting forth specific surgical procedures and chemotherapy. In women that received the specified protocol, 35% survived at least five years where as only 25% of those survived, where the guidelines were not followed.

More than 80% of the woman, as reported in the New York Times today, where cared for by what was labeled as “low volume” surgeons, who operated on 10 or fewer cases a year and hospitals with 20 or fewer cases per year.

The ethical and moral issues here arise out of the legal requirements of obtaining an informed consent. Consent is only deemed “informed” if it provides all material information - information that would be deemed important by the average reasonable person.

It is, therefore, legally required and ethically and morally mandated that patients be told by the physician that:

“I do not follow the medical and surgical guidelines recommended by the National Comprehensive Cancer Network that have a statistically significant better outcome in terms of life expectancy. Do you want me to treat your ovarian cancer or refer you to a physicians who follows these other guidelines?”

Not a likely scenario. Any physicians caring for the patients with ovarian cancer are required to keep abreast be aware of all up-to-date medical literature, and follow best practices and evidenced based medical guidelines for this devastating disease. Failure to provide such information to every similarly situated patient would be unethical, immoral, and a breach of the standard of care. That may also go further into the realm of fraud if it could be shown that the physician knew of this information, but failed to disclose it for purposes of his or her own financial gain, or the gain of the hospital.

Autonomy: the Basis of Respect and Dignity

Bernard W Freedman, JD, MPH — Mon, 11 Mar 2013 16:08:01 -0800

“Be a good girl and take your medicine.” Part 1

This statement was made to a 60 year old end stage leukemia patient who demanded to be discharged from the hospital. The patient refused the prescribed medications. No attempt was made to discuss the risks attendant in not taking the prescribed medication. The patient was cogent and articulate - able to make medical decisions for herself. The physician walked out of the patient’s room in the ICU. No social worker, bioethicist had been called to assist. Patient Jane was merely told, “Be a good girl and take your medicine.”

What can we say about the physician who made this statement? One might speculate that perhaps the physician was elderly – old school, etc. He was not. Early forties, well trained, and well respected. Could it be a socioeconomic impasse in communication? Possibly, the pt was poor and black. There was family or friends to advocate on her behalf. Nevertheless the statement breached medical ethics and legal responsibilities. A patient has a fundamental right to determine what medical care she will accept. To ignore these requests constitutes battery and possibly false imprisonment.

The patient reported that she never really spoke with her doctor. He would come into the room briefly, she said, early in the morning. He spent a short time examining her. Often he was interrupted by cell phone calls. He would say he had to run. The pt reported that the nurses were giving her little attention, save saying that she should take the medicine the doctor proscribed. She told the ICU nurses she was refusing meds and wanted to be discharged. She called me.

I found her curled up in a fetal position shivering with no blanket calling for help. She told me her wishes; her refusal of meds and request to be discharged. She had voluntarily admitted herself to the hospital and saw no reason that she should be kept “like a prisoner” and with her “Constitutional Rights violated." She implored me to help her; she said she had a brief time to live and did not want to remain in this hospital to wait out her days. She was feeling better and "wanted out." I contacted the primary treating physician who said she was not competent to make decisions. I recommended a psychiatric consult to confront this issue. The psychiatrist responded within a few hours and found that Jane was clearly competent to make decisions for herself, but placed her on an involuntary 72 hour hold because he found her to be paranoid that people would not listen to her.

This was a misapplication of the purpose of the 72-hour psychiatric hold statute, used for the protection of a who may cause harm to herself or others. I contacted then psychiatrist to inquire why he felt she might cause harm to herself or others. He did not think she would but did not want to cause "a problem" for the primary treating physician.

Nanotechnology: Who does the EPA Serve?

Bernard W Freedman, JD, MPH — Fri, 01 Feb 2013 17:14:17 -0800

The 9^th Circuit Court of Appeals recently heard oral argument in the case of NATURAL RESOURCES DEFENSE COUNCIL,( NRDC), vs. ENVIRONMENTAL PROTECTION AGENCY, Case# 12-70268, regarding the EPA’s conditional approval of a nano-silver product made by a Swiss company HeiQ Materials. The Amicus briefs describe it as:

“ the EPA’s unprecedented decision to conditionally register the nano-silver pesticide products HeiQ AGS-20 …as unsupported by substantial evidence. EPA has failed to show that the conditional registration will not cause any unreasonable adverse effect” on human health and the environment. The limited studies to this point have raised significant red flags about nano-silver.”

The Product is HeiQ AGS-20, as described by its manufacturer, provides antimicrobial protection for textiles (e.g. blankets) and medical products … (wound dressings, implants) with unique durability and effectiveness… contribute to healing, increased safety and faster recovery.

The issue in this case is the legality of the EPA’s interpretation that the interest of the public and of business trumps the EPA’s administrative mandate to first determine the safety of pesticides and to affirmatively determine that a product does not have “unreasonable adverse effects.” In this case infants and children under 2 have not been studied regarding fabrics containing nano-silver if chewed by infants or children 1 or 2 years of age. The fear is an increased risk of injury or death. Although the EPA is required to evaluate risk, they did not do so in the group most likely to ingest nano-silver - infants and children 1 to 2 years old who chew on materials available to them.

During oral argument in the Court of Appeal, one Justice questioned counsel for the NRDC as to whether we should do away with stairs because babies fall down the stairs all the time - isn’t there a risk in everything that we do?

This joking cynicism fails to appreciate the unknown risks of nanotechnology and perhaps parallels the ignorance of the majority of the public as to dangers of working with substances of unknown nature. According to an amicus brief filed on behalf of various organizations, both private industry and governments are spending billions of dollars on research and development of nano technology. Nano-silver is the largest area with the greatest amount of new products at the present time. To date, however, no labeling with respect to unknown risks is required.

The EPA regulates nano-silver products, as pesticides because the intended purpose is antibacterial and antimicrobial. The risks involve potential toxicity from individual one time exposure to dose related effects from the aggregate expose to numerous products such as, sunscreens, food packaging, children’s toys and pacifiers, laundry detergent, personal hygiene products, jeweler, bedding and furniture, underwear, hair brushes, creams, lotions, pillows, and toothbrushes.

Nano materials can be absorbed into the brain (able to get across the blood brain barrier), liver, heart, kidney, spleen, bone marrow as well as the nervous system.

It is the EPA’s job, its burden of proof, to determine before registering a pesticide, that it will not cause any “unreasonable adverse effects” on human health and the environment. That is the EPA’s affirmative duty and thus cannot be delegated to the manufacturer or anyone else. The EPA has in this instance chosen to give a conditional approval permitting the manufacturer to market it for 4 years – and then see what happens.

The justification for giving HeiQ conditional approval, as stated by the EPA: “the Agency has considered the nature and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of HeiQ AGS-20 during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is, in the public interest. “

Whether this is a sufficient predicate to conditionally approve the product, or whether the EPA is shirking its duty under its administrative mandate, should be at the core of the Court of Appeals’ decision. The statute requires that “ The Agency will approve an application only if:… The Agency has determined that the product will perform its intended function without unreasonable adverse effects …"

What's wrong with Romney's Plan to just send more people to Emergency Rooms: Ethnic and racial disparities in Health Care - All Patients are Not Created Equal

Bernard W Freedman, JD, MPH — Fri, 21 Sep 2012 07:22:36 -0800

All patients are not created equal

Many emergency departments and hospitals in low socioeconomic areas, sometimes referred to as “safety net hospitals,” have closed, resulting in serious problems for poor and minority populations due to reduced or no access to emergency care. This results in exacerbating illness or injury due to either waiting time to get, or failing to seek, medical attention. When patients later become desperate, ambulance calls increase; emergency rooms in distant hospitals become overcrowded; all resulting in further delayed emergency room care.

Medical specialists have become more reluctant to be on-call out of concern for overburdened emergency departments and perceived increased risks of liability. Loren Johnson, M.D., director of emergency services at Sutter Davis Hospital in California says that the problem of obtaining on-call coverage has grown worse over time based on the growing demand for emergency services.

In 2002, the California Senate office of Research published a report “Stretched Thin: Growing Gaps in, California’s Emergency Room Backup System.”

“Problems with access to emergency room on-call services and specialties in many areas of the state are adversely impacting the quality of patient care and forcing hospitals, physicians, patients and in some cases, medical groups and health plans to incur significant costs.”

University of Pennsylvania News Release March 2009 showed that longer stays in the ER, referred to as “boarding” result in poor pain control and avoidable medical complications. Judd Hollander MD, at the University of Pennsylvania noted that:

“Even prior to the economic downturn, some institutions had actually begun prioritizing hospital beds for insured patients having lucrative elective procedures. These measures will only worsen disparities for minorities. Congress needs to make certain that ‘not for profit’ hospitals do not compromise patient care in pursuit of greater profits.”

A correlation has been found between increasing poverty levels and the absence of hospitals in the area with increasing rates of ambulance use. Rates of use of emergency medical services are most dependent on age and cause, but use is also correlated with increasing levels of poverty.

For example, In 2005 State University of New York published a study finding that high poverty areas are relatively underserved by hospitals. In the 100 largest cities high poverty areas made up 44 percent of the total suburban population in 2000, but accounted for only 20 percent of total admissions, inpatient days, and outpatient and emergency visits in 2002.

Some have argued that by 2020 one third of hospitals will be gone.

Ambulance diversion exacerbates the problem and is most prominent in emergency rooms that serve poor populations. One way for ERs to ease overcrowding in emergency departments is to divert ambulances to other hospitals. This, however, does not help anyone. In a study recently published in the journal of “Health Affairs” delayed care in emergency room affect marginalized populations and declared that 50% of black patients in the ICU spent more than six hours waiting for an inpatient bed, compared to 37 percent of patients of other races.

The Journal of the American Medical Association in June 2011 addressed the question of ambulance diversion and survival among patients with acute Myocardial infarctions, finding that delays increased mortality rate for 30-day, 90-day, 9 months, and one-year mortality rates.

Delays in seeking care for acute myocardial infarctions were greatest in Asian and Latino populations due to the fact that Latinos and Asians utilized private transportation rather than emergency ambulance services the majority of the time (70% for Latinos, 83% for Asians).

Kaiser Foundation research found that approximately 30% of Hispanics and 20% of Black Americans lack a usual source of healthcare compared with less than 16% whites. Blacks are 13% less likely to undergo coronary angioplasty and one third less likely to undergo bypass surgery than are whites. A study in Boston found that the quality of care for Blacks at non-teaching hospitals was lower than in teaching hospitals.

FCC adopts rules for Medcial Body Area Networks

Bernard W Freedman, JD, MPH — Tue, 29 May 2012 06:32:47 -0800

The FCC adopted rules for Medical Body Area Networks (MBANs), with multiple body-worn sensors “MBAN” that monitor blood glucose, pressure monitoring, electrocardiogram readings, and even neonatal monitoring systems. The monitors can be used in the hospital setting, nursing facilities to identify life-threatening symptoms before they reach critical levels.

Under Part 95 of Medical Device “MedRadio” Service no application will be required to use body area networks

According to a study by the Institute for Healthcare Improvement, a monitored hospital patient has a 48% chance of surviving a cardiac arrest—this number plummets as low as 6% without monitoring.

The challenge has been security. FCC chairman Julius Genachowski told a press conference at George Washington University Hospital (GWUH) in Washington, D.C that the move would “represent a multi-industry effort to foster innovation in the spectrum band by allowing distinct but compatible users to share these airwaves.”FCC will permit a wireless electromagnetic spectrum, the 2.36-2.40 gHz band to be used with interference from WiFi transmissions or other wireless consumer devices and , hopefully, significantly reduce the risk of hacking.

Federal agencies are calling for increased surveillance of medical device cybersecurity, fearing that newer generations of products with wireless internet connectivity are vulnerable to "malicious tampering." Some government bodies are asking federal regulators to establish medical device software security protocols as part of the FDA's regular review of medical devices.

The U.S. Dept. of Homeland Security joined the Information Security & Privacy Advisory Board of the National Institute of Standards & Technology in calling for heightened review of medical devices, citing security weaknesses that may leave them vulnerable to "malicious tampering."

It is predicted that the global wireless sensor network market for all healthcare applications will reach $3.6 billion in 2012

Withdrawing Life Sustaing Treatment - Termial Extubation: Hassan Rasouli Part II

Bernard W Freedman, JD, MPH — Sun, 20 May 2012 07:54:50 -0800

Hassan Rasouli, previously diagnosed as being in a permanent vegetative state, has now been diagnosed to be in a minimally conscious state. The reason for the change - his physicians noted that he is able to give a thumbs-up when asked by his wife and able to track with his eyes. His physicians are Drs. Brian Cuthbertson and Gordon Rubenfeld, two critical care specialists at Sunnybrook Health Science Center in Toronto Canada, one of the largest trauma centers in Canada, who have petitioned the Canadian Supreme Court for the authority to withholding life sustaining treatment without the consent or approval of the patient’s wife and family and without the review and consent by the Canadian Consent and Capacity Board – as the law requires of them.

We now know that his doctors, who where adamant about terminally extubating him without the consent of the family, were wrong in their assessment that his was in a vegetative state was permanent, (assuming that it was a vegetative state to begin with). Not only did they want to extubate him without the consent of his wife and family, they also wanted to do so without review by an ethics committee, or Consent and Capacity Act of Canada that the law required of them, nor, most curiously, would they provide the Court with a copy of the Mr. Rasouli’s medical records. The doctors argue that no consent is needed because ending someone's life is "not treatment." In short, they wanted to proceed without any questions, oversight or ethically required transparency.

When questioned about this originally, Drs. Cuthbertson and Rubenfeld posited that if they were wrong, they would bear the responsibilities and consequences of their unilateral decision. This was a fatuous statement because if Rasouli was terminally extubated, there would be no evidence or basis to question their decision and thus impossible for them to be held responsible for anything.

In bringing this case to the Canadian Supreme Court they wish to set a precedent that any physician may terminally extubate without consent of the surrogate decision makers nor be subjected to any questions, oversight or ethically required required transparency.

In the United States it has been made clear by the courts, that the critical distinguishing factor between terminal extubation and physician assisted suicide or euthanasia is the patient’s clearly established rejection of artificial life sustaining treatment. Therefore, unambiguous documentation must make this clear. Only by being forthright about these factors can real transparency reflecting respect and dignity for the patient’s life truly exist.

In France, at the Centre Hospitalier Universitaire, Henri Mondor, just outside Paris, they follow a standardized collective decision-making process, noting that “… terminal extubation, very common in the United States, but much less so in France, reinforces the transparency of end-of-life decisions in intensive care units.” They explain:

“This process included three stages. In the initial phase, withdrawal of ventilator support was discussed at a department staff meeting.

The meeting's conclusions were transcribed into the medical file, and the possibility of extubation was raised with the family during a planned interview.

At least a 24-hour period of reflection was necessary before a new interview, and any opposition, hesitation or lack of understanding by the family at this first interview resulted in suspending the decision.” …

It is a fundamental right and requirement for a patient, to consent to terminal extubation, and only after all risks have been explained and all options presented. In the case of Hassan Rasouli his wife, as surrogate decision maker must consent,

It is this rejection of treatment that distinguishes respecting the patient’s decisions from assisting in a patient’s suicide.

Even in circumstances where consent has been given, physicians must be extremely reluctant and guarded to end a patient’s life, especially in cases where the patient is not suffering from a terminal disease. Surrogate decision makers often have an incentive, personally, emotionally and financially that may make their “consent” to the withdrawal of life sustaining treatment, suspect.

Must consent to treat, as well as consent to withdraw treatment, be required?

None of this should be interpreted that Drs. Cuthbertson or Rubenfeld are acting in bad faith and do not have the interests of the patient as paramount. Whether or not that are mistaken in Mr. Rasouli's case does not mean that they will not be correct in the next hundred cases. The issue is whether on not consent is a prerequisite to ending someone's life. Stated otherwise, must consent to treat as well as consent to withdraw treatment required.

Wearing two hats is always dangerous - filled with conflict of interest. Drs. Brian Cuthbertson and Gordon Rubenfeld however, seem to want to wear two hats: deciding what the best medically and when it is best to end a patient’s life. Cuthbertson and Rubenfeld must have concluded that a patient’s personal beliefs – their personal life history and experiences, religious beliefs, and cultural customs should be subjugated to their personal beliefs. Yet, their expertise is as critical care physicians, not as oracles. In areas other that critical care medicine they have no more ability than anyone else and should not hold sway over other peoples decisions.

Can late stage abortions be murder ?

Bernard W Freedman, JD, MPH — Tue, 10 Jan 2012 23:36:46 -0800

Dr. Nicola Riley is being held without bail in Utah following her arrest on December 28. 2011. She worked for Dr. Steven Brigham in New Jersey, who owns abortion clinics. Both of them have been charged with the crime of murder for performing late-term abortions in Maryland. Their apparent modus operandi was to “start” abortions in New Jersey and complete them in Maryland where abortion laws are less stringent.

Maryland has a Fetal Homicide Law that permits murder charges to be brought against people who “intend to cause the death of a viable fetus, yet specifically excludes physicians carrying out abortions. Section 2-103(e) Murder or manslaughter of viable fetus states:

Inapplicable to medical professionals administering lawful care. -- Nothing in this section subjects a physician or other licensed medical professional to liability for fetal death that occurs in the course of administering lawful medical care.

Reuters News reported on January 9^th that : Cecil County State's Attorney Ellis Rollins said the case could be the first of its kind to test Maryland's 2005 fetal homicide law, under which murder charges can be brought against people who intend to cause the death of a viable fetus. The charge of murder could only stand if the medical treatment – the abortion – was found to be unlawful medical care.

About 38 other states have similar statutes and for the most part, these statutes have been applied, as the legislature intended, in criminal cases where an intentional injury to a pregnant woman that kills a fetus would result in a charge for murder.

The cases against Drs. Riley and Bingham are seemingly intended to test the use of this statute in cases of abortion. This case is especially egregious, as 35 and 36 week term fetuses are alleged to have been found in the doctors’ freezer.

Charges include both first and second degree murder.

In 2003, the United States Congress passed the partial birth abortion ban act defining defined as any abortion where the death of the fetus occurs when the “entire fetal head or any part of the fetal trunk passed the naval is outside of the mother’s body.”

(a) Any physician who…, knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both.

In the 2007 case of Gonzalez versus Planned Parenthood, the United State Supreme Court in a five to four decision held that the congressional ban on partial birth abortion was not unconstitutionally vague and did not impose an undue burden on the right to have an abortion.

Under this federal statute, the penalty:

Any physician who, … knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both.

It is unclear at this point what type of abortion was performed by Drs. Riley and Brigham.

Withdrawing Life Sustaing Treatment - Rasouli Decision: We don't need permission to withdraw life sustaining care

Bernard W Freedman, JD, MPH — Tue, 27 Dec 2011 13:35:58 -0800

On December 22, 2011, the Supreme Court of Canada agreed to hear the case of Cuthbertson and Rubenfeld versus Hassan Rasouli. The appellants, Drs. Brian Cuthbertson and Gordon Rubenfeld) are Mr. Rasouli’s physicians.

The question before the court is whether physicians must seek approval from a legislatively created board of review before withdrawing a patient from life sustaining treatment. The statue was passed for a variety of reasons, including establishing a uniform standard of practice for the protection of patients across the country.

The review by the Consent and Capacity Board is only required if there is some objection by the surrogate decision maker. If the decision maker objects, he or she is required to follow principles of acting in the patient’s best interest as set forth in the “Health Care Consent Act.”

http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_96h02_e.htm

“...a health practitioner … may believe that the SDM (substitute decision maker) is not following these principles. If this happens, that person may apply to the board for a determination as to whether the principles have been followed and order to the SDM to comply with the act. Use of this application is limited to the health care provider of the incapable person (e.g. family members cannot apply to the board). Whenever an application of this type is received, the law provides that the patient is deemed to have applied for a review of his or her capacity to make the relevant decision…”

Purpose of the Health Care Act:

As a set forth in the appellate decision, the purpose of the Health Care Act is to establish rules that can be used consistently in all settings; provide and facilitate treatment, admissions, and other assistance for persons who lack capacity; and ensure a significant participation of family members when the person lacks capacity to make decisions.

The Consent and Capacity Board is an independent provincial tribunal created to adjudicate issues of consent in capacity and whether or not the substitute decision maker is acting in accord with the patient’s wishes or in his or her best interest.

There is no charge to the participants
Any party may attend
Family members and friends are also encouraged to attend.
Each party may have a lawyer, call witnesses and bring documents.
Each party, and the board members, may ask questions of each witness.
Thereafter, the board meets in private to make a decision.
The board will issue its decision within one day.
Written reasons will be issued if any of the parties request them.

Drs. Cuthbertson and Rubenfeld argue that the patient is in a persistent vegetative state and other physicians have examined Mr. Rasouli and agreed with this assessment.

They want to take him off life support and provide palliative care until he dies.

The decision maker argues that he is minimally conscious and remains aware of his surroundings and that if the physicians do not want to follow her wishes that they should apply to the Consent and Capacity Board and let the board decide whether the proposed course of action is in the respondents best interest.

A three day hearing was held in the Canadian Superior Court of Justice in February and March of 2011. The court found in favor of the respondent (Rasouli) and against the appellants Cuthbertson and Rubenfeld.

The court ordered that the question of continued life sustaining treatment must be referred to the Consent and Capacity Board, and, pending that decision the physicians were not permitted to withdraw or withhold life sustaining treatment nor place the patient in palliative care.

Rather than doing so, Cuthbertson and Rubenfeld brought their case to the Court of Appeals (Court of Appeal for Ontario, original case Rasouli versus Sunnybrook Health Science Center, 2011 docket number C53442).

Indeed, if they are wrong the patient will be dead.

Cuthbertson and Rubenfeld make two arguments to avoid compliance with the law:

1. “…if it is found that their decision to withhold or withdraw treatment falls below the requisite standard of care, they may be held accountable.” (Page 7 of the appellate decision). Indeed, if they are wrong the patient will be dead. The standard as set for the by the Canadian legislature, is to seek approval from the Board. The legislation protects physicians from being held liable:

If a treatment is withheld or withdrawn in accordance with a plan of treatment and with a consent to the plan of treatment that a health practitioner believes, on reasonable grounds and in good faith, to be sufficient for the purpose of this Act, the health practitioner is not liable for withholding or withdrawing the treatment.

2. Cuthbertson and Rubenfeld argue that withdrawing life sustaining care and prescribing a shift to palliative care is not “treatment” and that, therefore, no consent is needed to withdraw life sustaining care. Putting Mr. Rasouli on life support was a treatment decision and taking him off life support is a treatment decision, just as much as prescribing a medication for a patient and stopping the medication because it is not working.

Part 2 of this article will discuss the relevant ethical basis, legal reasoning and competing moral viewpoints.

Withdrawing Life Sustaing Treatment - Early Withdrawal of Life Sustaining Treatment in Severe Traumatic Brain Injuries, by Bernard W. Freedman JD, MPH

Bernard W Freedman, JD, MPH — Fri, 02 Sep 2011 08:49:33 -0800

CDC Statistics Traumatic Brain Injuries

On August 29, 2011 the Canadian Medical Association published the findings of a multicenter cohort study evaluating the withdrawal of life-sustaining treatment for patients who had suffered a traumatic brain injury. This study is of particular interest because by the nature of the injury patients cannot make decisions for themselves and generally such decisions in patients in end-of-life care have a variety of comorbidities which make an evaluation of the efficacy of the decisions to withdraw life sustaining care difficult.

720 patients were evaluated from six different major medical centers. Of the 720, 228 patients did not survive. 160 patients had life sustaining treatment withdrawn in the first three days of hospitalization.

In approximately 50% of the patients, deaths occurred within the first three days of admittance to the ICU. Most of the deaths were associated with withdrawing life-sustaining care (64%) yet the proportion varied significantly across the six medical centers, from 30.4% to 92.9%

Considering deaths due to withdrawal of life-sustaining care within the first three hospital days, an overall average of 45.6% occurred. However examining the outcomes from the six medical centers, the range of deaths due to withdrawal of life-sustaining care ranged from 22.2% to 59.1%.

According to the “medical teams” and who participated in the care, the reason given for withdrawing life-sustaining care was:

1. Poor chance of survival. (54.4%).

2. Prognosis was incompatible with the patient’s wishes. (33.8%)

3. A poor long-term neurologic prognosis. (28.5%)

These stated justifications are suspect because of the rapidity that decisions to withdraw life-sustaining care were arrived at. As the authors of this study indicate:

“in this specific population of patients, the decision to withdraw life-sustaining therapy made by patients’ relatives and medical teams is mainly based on prognostic information. Our findings are particularly concerning because many decisions to withdraw life-sustaining therapy were made early in our study: 64% of the patients who died within three days of admission to an ICU had life-sustaining therapy withdrawn. In some instances, this may be too early for accurate neuroprognostication.”

1. “Poor chance of survival. (54.4%)”

Means: She is probably going to die soon anyway, so let’s not wait and see, waste our time and costs, and extubate now.

This is a, " She is probably going to die soon so let's not wait and see and waste time and costs and extubate now" type of argument.

Yet, if the patient is going to die “soon” anyway, why not let her die without withdrawing the ventilator - for example. Waiting can only help us have a clearer picture of the degree of the damage and whether or not the patient will show any improvement in her neurologic status?

2. “Prognosis was incompatible with the patient’s wishes. (33.8%)”

This is a “He wouldn’t want to live this way” kind of reasoning. If the physicians for this patient could say to the family, something like: “I can tell you with authority that your son will never be able to have any modicum of awareness, he will never eat on his own, …” If this could be established then the “He wouldn’t want to live this way” reasoning may be an ethically sufficient decision, if in fact the wishes of the patient are clear. However, without such a established prognosis, how can we arrive at a reasonable assessment as to what, exactly, the patient would want. There is little ability to actually assess whether decisions to withdraw life support are genuinely the patient wishes or the wishes of others.

The question that must be posed is whether or not waiting will clarify the prognosis of the patient. If so, then it is indeed premature to withdraw. The fact that, as determined in this study, most patients die after withdrawal from ventilation support, serves to emphasize the need to wait.

“A poor long-term neurologic prognosis. (28.5%)”

This is a: “he probably will survive, but, …” argument. This is the worse excuse of the three listed. It states that: “he probably will survive and if we do not remove life support while he still needs it, someone will probably have to take care of him later. This is tantamount to homicide. We have a non-terminal patient with undetermined future neurologic status who we are going to withdraw life sustaining care to end his life. The total number of patients studied in this cohort was 720. 492 patients did survive, with considerable variability between the participating medical centers. The authors’ state:

“This raises the concern that differences in mortality between centers may be partly due to variation in physician’s perceptions of long-term prognosis and physicians practice patterns for recommending withdrawal of life-sustaining therapy.”

It is the job of the physicians to treat the patient, not satisfy the needs of the family. Hence, great care must be taken to determine and effectuate the wishes of the patient.

Patient Access to Cancer Care and Proposed Medicare Budget Cuts - Press Release

Bernard W Freedman, JD, MPH — Wed, 27 Jul 2011 15:12:59 -0800

July 27, 2011

ASCO Urges Policymakers to Protect Patient Access to Cancer Care from Debt Ceiling Negotiation Package

The American Society of Clinical Oncology (ASCO ) is deeply concerned about the proposed $3 billion in cuts to Medicare reimbursement as part of a debt ceiling negotiation package. If the cuts are put into place, patient access to cancer care will be threatened as previous cuts to Medicare have already caused oncology practices to close, consolidate and turn away Medicare patients.

ASCO is closely monitoring the situation, and advocating on behalf of oncology practices and patients. This week, ASCO placed print and online advertisements in Capitol Hill publications including Politico, The Hill, Roll Call and CQ. To learn more about all of ASCO's efforts on this issue, visit www.asco.org/protectaccess.

Withdrawing Life Sustaing Treatment - End of Life Care: the Doctor-Patient Relationship A Refusal to Communicate

Bernard W Freedman, JD, MPH — Thu, 23 Jun 2011 17:05:56 -0800

The New England Journal of Medicine recently published an article entitled: “ The Palliative Care Information Act in Real Life,” (NEJM 364;No.20 May 2011), regarding a New York statute that requires a physician to have discussions of end of life treatment options with the patient when the patient is “terminally ill.” Alan Astrow MD and Beth Popp, MD, the authors of the article, are troubled by the phrase terminal illness. They argue that the definition in the statute is vague and an improper interference with the physician-patient relationship. The fact that they find the phrase, “terminal illness” troublesome, is troublesome.

The authors fail to understand basic concepts in clinical bioethics as well as case law as to the duties of physicians dealing with critically ill patients and the provision of information on all relevant and alternative methods of treatment. Perhaps they think like so many others, that end of life care planning is reduced, basically, to one question: If you are close to death and your brain is in a persistent vegetative state do you want us to remove you from life support or not resuscitate you if you go into cardiac arrest? This is not the case. A variety of options are available to patients who are critically ill. It is foolhardy to wait until a patient is unable to actually explain their wishes to the physician and allow an adversarial situation to be created between family members, friends, physicians and other medical staff, as well as possibly leading to referring the matter to the ethics committee, the hospital administration, or hospital attorneys.

A variety of options should be addressed as early as possible and relative to the disease trajectory. In addition to discussing the anticipated medical course, differing degrees of brain injury or damage, the likelihood of recovery and anticipated risks and treatment options and related issues of quality of life. The following are some suggested talking points:

a. The selection of one person who will act as surrogate decision-maker: the patient must understand that the surrogate decision maker only has any say if the patient cannot speak for herself. It should be made clear that the purpose of the surrogate is to effectuate the wishes the patient, not the wishes of the surrogate. Additionally it should be made clear that the surrogate does not have to be limited to a family member.

b. A patient has the right to know (subject to the therapeutic exception) applicable Evidence-Based Medical (EBM) information to help the patient understand and evaluate risks and benefits of various treatment options (including lack of treatment) based on clinically significant research, such as: cohort studies, double-blind clinical research, meta-analysis, etc.

c. Discussion with family and clergy should be encouraged;

d. Advise that he or she may seek a second opinion. Aside from the fact that the patient may or may not want a second opinion, offering to arrange one will often provide a sense of confidence in the physicians treatment plan.

e. At some point in time the patient may want to be transferred home on hospice and die peacefully with his or her family rather than in the ICU. Thus, palliative care needs to be explained and the probabilities presented to the patient with respect to longevity and quality of life.

f. Does the patient have any religious requirements that they wish to follow with respect to receiving pain medication that may or may not hasten death? Many patients are willing to receive pain medication but not to the point where it may hasten death. Others may want to receive all necessary pain medication and sedation should be kept as pain free and comfortable as possible.

g. Does the patient have religious convictions with respect to receiving blood or blood products?

And so on.

The rights of patients to make their own medical decisions create reciprocal duties on the part of their physicians to respect and uphold these rights.

The authors argue that there is a “standard of care” that dictates when physicians must tell their patients all relevant medical information. This is not true.

The standard is not determined by the medical community, but rather, by the patient him or her self. It is not a medical question; it is a personal, individual and unique decision by the patient, of which can only be made if all medical information and options or explained.

As one commentator advises physicians: “If you don’t speak early, you lose your voice.” Carol Taylor, RN, PhD advises patients: “For someone who sits with families trying to make these life and death decisions, I can say that planning is the greatest gift to your family.”

What is it that stands in the way of early discussion for many physicians?

The authors of the article, Drs, Astrow and Pope, claimed that:

“… physicians need to feel comfortable communicating their values and experiences and providing non authoritarian guidance and support while expressing interest in and respect for the experiences and values of patients and families.”

This statement is ignorant of the law, foolish and, moreover, it is surprising that the NEJM would publish this misguided advice.

Physicians do not have to feel comfortable. What difference does it make if the physician “feels comfortable” or not when carrying out his or her responsibilities. Many physicians, if not most, will never feel comfortable in such situations. What is important is that the patient is not “comfortable” and may be fearful, confused and in need of all necessary information. (Without the provision of all relevant information, there cannot be any informed consent and the physicians may be found civilly liable in addition to incurring state imposed fines).

Secondly, it is clearly inappropriate for a physician to convey his or her values to the patient. A physician’s values are of no moment whatsoever. It is, on the contrary, the patient's values alone that should guide decision. Indeed, physicians’ values should not even be discussed or mentioned. If so, the patient would receive different guidance dependent upon which physician’s door she walks through.

Thirdly, the physician is always in a position of authority. The author’s suggestion that they can counsel a patient in a non-authoritarian manner will not work. That cannot be avoided. So, any suggestions, as to a physician’s values must be avoided. The values of the physician are not in issue.

The decisions of the patient should as John Stuart Mill once describe, be a product of “…free, voluntary and undeceived consent and participation…”

The authors provide us with a scenario of an 85-year-old man with gastrointestinal cancer that had metastasized to the lung.

“… when his cancer and its spread were diagnosed two years ago,

he was already frail.”

At this point, if not long before, the patient should have been given the opportunity to consider many of the types of questions listed above.

The patient may have benefited from the knowledge, for example, that in a recent study of the 151 patients with metastatic non-small cell carcinoma, early palliative care led to significant improvement in quality of life and mood and that patients receiving earlier palliative care and less aggressive care often had longer survival rate.” If this 85-year-old patient with metastatic lung cancer was not presented with these and like information from applicable and relevant and authoritative studies, then the patient lost the opportunity to have longer survival and improved quality of life.

Finally, Drs, Astrow and Pope are concerned with the interference of the state into the practice of medicine. I agree that interference of the state into the practice of medicine is something that must be vigorously challenged. In this situation, however, the statute refers to the necessity of ensuring the rights of patients rather than medical practice

Rationing "scarce medical resources" and lying to the patient - do these go hand in hand? 7 comments

Bernard W Freedman, JD, MPH — Thu, 19 May 2011 16:20:13 -0800

Rationing "scarce medical resources" and lying to the patient - do these go hand in hand?

7 comments

Claudia Ruiz M.D • I don't think so, I'm from Mexico, and I have worked plenty with the mayan communities, they really don't have any acces to medicines o medical attention. We did our best to get them what they need, but sometimes it is impossible. Anyways, I never lie to my patients, they deserve to know the truth always. Maybe it is a different situation in the United States and the HMOs, but in principle, I don't think it is ethical to lie and withhold information to people, specially if that information is for the best of the patient.

Henry Levenson,M.D. • No, rationing health care does not equal lying to patients. It is better to explain to the best of your ability why referrals were declined or not authorized. Patients seem to assume that physicians are responsible for the reasons why health care is rationed.

M. Sara Rosenthal • In the U.S., rationing is usually not done according to an ethical framework (such as beneficence); it is usually done according to "ability to pay": if we were transparent about THAT -- we wouldn't have opposition to universal healthcare in the U.S. by the very people who could benefit from it. Transparency about access is really the issue.

Bernard Freedman, JD, MPH • Follow up Comment: Rationing : Withholding Medical Care by Lying to the Patient   "Rationing" of medical care and “triage” are different.   Triage prioritizes the use of limited medical resources when sufficient resources are not available.   Rationing is the withholding of available care for political/economic reasons.  With respect to rationing, therefore, it must be decided whether or not the patient is going to be told the truth.   The ethical question here is whether patients must be told that medical care is being withheld, or if a standard practice will sanction lying to their faces.  In his book “Pricing Life” Dr. Peter Ubel provides us with his definition of rationing. He says that the clinician must,  (1) Withhold, withdraw or fail to recommend a service that, in the clinician’s best judgment, is in the patient’s best medical interests;  (2) Act primarily to promote the financial interest of someone other than the patient, including an organization, society at large, or the clinician himself or herself, and  (3) Have control over the use of the medically beneficial service” (Pricing Life – why it is time for health care rationing, Peter A. Ubel, M.D., MIT Press, Cambridge Massachusetts 2000).  The phrase “withhold, withdraw or fail to recommend” defines rationing as outright dishonesty with the patient – violative of the legally required fiduciary role in physician-patient relationships.  So, I agree with Dr. Rosenthal that, indeed, transparency is the real issue

Marie Cartwright • Withholding, withdrawing or failing to recommend a service does not imply, in any way, dishonesty. It rather describes an informed attitude a physician will take towards a patient regarding a particular procedure and their candidacy for that procedure. A physician, for instance, can withhold a procedure from a patient while still being honest about the reasons for doing so, and rightly so.   In the UK, for instance, candidates for hip replacement surgeries are (or were several years ago) denied the surgery until they brought their BMIs down to a healthy level. In other words, obese candidates were denied hip replacements based solely on their weight. I initially struggled with this particular topic because it seemed to have a tone of infinite regression- patients who required hip replacements would have a much easier time reaching a healthy weight if they had a healthy hip! However, if the supply is far less than the demand, we must also take into account that obese patients who received a hip replacement would also probably need another replacement sooner than those within a healthy weight range.   In terms of honestly, however, the patient-doctor relationship cannot exist without trust. Lying should never be present, under any circumstances.

Bernard Freedman, JD, MPH • Thanks for the discussion. This is a growing quandary that calls for clarity from medical, ethical and public policy points of view. There is a difference between withholding or withdrawing efficacious treatment and telling a patient what you are doing and why, and “failing to recommend” an efficacious treatment and keeping it a secret under the guise of having what you call an “informed attitude.” So, I must ask, what is it that informs a physician’s attitude that justifies keeping the decision hidden? In other words lying to the person you have the highest duty to be honest with. Yet, you say in the next sentence of your comment that it is ok to” withhold the treatment while still being honest about the reasons for doing so.” I am unclear whether you are really saying that withholding the truth, lying, is acceptable.  You give the example of the obese patient who needs a hip replacement but is denied the surgery unless he or she loses the weight. The denial may be justified, but is the patient told the reason for the denial? Do you tell your patient that they must lose weight before the hip replacement will be permitted? Of course, I believe, you do. Otherwise there would be no incentive for the patient to lose the weight.  It is the trust aspect, the moral imperative of truth telling between physician and patient that is, I believe, at risk when rationing truly scarce resources.

Marie Cartwright • I think we are on the same page in many respects here. But, if I may clarify a possible misunderstanding- You said, "So, I must ask, what is it that informs a physician’s attitude that justifies keeping the decision hidden?" I definitely didn't intend to imply that physicians should keep their decisions, or reasons for their decisions, hidden. I believe quite the opposite. By informed attitude, I meant to refer to the physicians as "gatekeepers" who decide who can have what procedure, and when, and their decisions, or attitudes, are informed by factors solely about the patient. Physicians, after all, are the experts that we rely upon to help us better our health and in some circumstances, "save" us. In essence, and hopefully to answer your question, withholding a treatment and withholding the truth are two entirely different things. In my previous comment, I said that withholding a particular treatment is in no way dishonest. However, withholding a treatment without justifying or explaining it to the patient goes against the patient-doctor relationship and also is counter productive for any patient's treatment.   Regarding the hip replacement patients, I believe the the denial must, in all situations, be explained to the patient. I don't really believe that truth telling is at risk in any situation, much less the rationing situation. A patient must be told why he/she is no longer a candidate for a particular procedure. Even when supply is scarce, to be dishonest serves no purpose.

Rationing Medical Care Part II

Bernard W Freedman, JD, MPH — Mon, 28 Feb 2011 11:00:43 -0800

Efforts to encourage (or compel) physicians to lie to their patients were faced years ago when “gag clauses” were inserted into contracts between HMO’s and contracted physicians. The gag clause established a contractual obligation on the part of the physician to withhold information regarding treatment modalities that were not within the HMO protocol of allowable categories of care.

Contractually, it is common to exclude specific types or categories of care - “We will pay for this, we won’t pay for that.” Every contract of insurance has exclusions. Gag clauses, however, go further. They contractually bar physicians from fulfilling their fiduciary duties to the patient from making clear what relevant treatments are available in the medical community. If there were more effective treatments available, the physician nevertheless had to withhold such information. Physicians, therefore, had to choose whether to breach their fiduciary duty to their patient, or breach their contractual duty to the HMO if they revealed the availability of superior care for the patient.

For a patient, there was no real choice. No information that would enable a comparison between alternative treatments, nor any opportunity to confer with other physicians regarding alternative treatments.

This, to be clear, is fraud: purposeful misrepresentation and intentional withholding of critical information by a fiduciary and relied upon by the patient to his or her detriment, namely serious injury or death.

In 1990s, the AMA asked managed care organizations to withdraw gag clauses from their contracts with physicians. Though gag clauses have drifted, we hope, out of existence, medical rationing resurrects the same fraudulent behavior and, again, attempts to persuade or compel physicians to participate in the entire charade.

Patients will have to be told the truth unless our moral foundations of democracy are to be drastically diminished. If the informed consent process is genuine it must reveal to the patient all alternative methods of treatment – whether they can afford it or not. Patients are accustomed to being told that certain categories of treatments, though needed, may not covered by their insurance. If the policy is ambiguous then that issue of coverage can be legally and rapidly challenged.

Protocols to ration health care, if they surreptitiously contribute to the worsening of illness or death, will once again be an attempt by those who make policy to encourage or compel physicians to change from their absolute loyalty to their patient to become coerced agents of fraudulent socioeconomic policy.

Part III to follow: Efforts to Ration Care and Value Based Medicine

Clinical Bioethics - Rationing - the Ethics of Lying to the Patient - Part I

Bernard W Freedman, JD, MPH — Wed, 15 Dec 2010 08:55:44 -0800

Rationing : Withholding Medical Care by Lying to the Patient

Rationing of medical care and “triage” are different.

Triage prioritizes the use of limited medical resources when resources are insufficient for immediate treatment.

Rationing is the withholding of available care for political/economic reasons.

With respect to rationing, therefore, it must be decided whether or not the patient is going to be told the truth.

The requirement of informed consent cannot cease to exist because of political/economic policy. Nevertheless the degree of informed consent may vary with the degree and type of risk. Informed consent for a blood pressure medication may not require any specific discussion if the medications are reasonably the same in term of efficacy of treatment.

The physician has an affirmative duty to raise the question and answer such questions by describing all “available” treatment.

On the other end of the spectrum, withholding information about hemodialysis in a patient with multi-organ failure requires an explanation of all risks of treatment and non-treatment alike. Life expectancy, quality of life, prolongation of the process of dying and so on must be discussed in specific detail. Religious considerations may come into play as well. For example, some religious doctrines draw a line between “ordinary” and “extraordinary” care – ordinary care being required, where extraordinary care is not.

Nor can a physician simply wait to see if the patient inquires about other treatment that may be available. The physician has an affirmative duty to raise the question and answer such questions and breaking down “available” methods of treatment.

Part II will address policy considerations and legal ramifications of rationing medical care.

Withdrawing Life Sustaing Treatment -From Conscious, Non Terminal, Incompetent Part II

Bernard W Freedman, JD, MPH — Thu, 09 Dec 2010 17:52:56 -0800

Physician Liability: Withdrawing and Withholding Life Sustaining Care From Conscious, Non Terminal, Incompetent Patients – Part II

There are different standards that must be appreciated and respected before a physician can support a decision to withdraw life sustaining treatment from a non terminal and incompetent patient.

This scenario requires the highest degree of protection for the patient. Our fundamental rights are the most important when we are the most vulnerable. Patients in this category are weak, often confused and subject to the effect of bias and undue influence. When illness requires life sustaining treatment family members may experience sympathy for the patient as well as opportunity to end their burden of caring for the patient. Some family members have said to others: "you have done so much, your life has been put on hold, how can we afford to pay for this care, etc. This can result in a request to withdraw or withhold artificial life support for what may be seen as being in every one's best interest. This often occurs in adult children caring for an elderly parent or spouse.

This responsibility for caring for patients at home falls predominantly on women. Women often care for both an elderly parent and their young children at the same time. Many, as well, must work to support the family. Yet, this understandable burden cannot be used as a justification or rationale for the termination of life sustaining treatment. Physicians must never allow themselves to place the needs of the family above the best interests of the patient. Physicians must not allow family interests to become a guide to decision making – even if it results in volatile or abusive confrontations with, or threats by, family members.

Withdrawing life sustaining care from a conscious, non-terminal patient, even if competent who refuses artificial life support, is thwart with risk for the treating physician. In a California case that was ultimately decided be the State Supreme Court, barred withdrawing artificial nutrition and hydration from a minimally conscious, non-terminal patient when there was not clear and convincing evidence that refusing treatment would be what the patient would want if able to speak for himself.

The function of a standard of proof is to instruct the fact finder concerning the degree of confidence our society deems necessary in the correctness of factual conclusions for a particular type of adjudication, to allocate the risk of error between the litigants, and to indicate the relative importance attached to the ultimate decision…. Thus, “the standard of proof may depend upon the ‘gravity of the consequences that would result from an erroneous determination of the issue involved. …courts have applied the clear and convincing evidence standard when necessary to protect important rights.

The legislature in Pennsylvania dealt with this dilemma by specifically codifying a limitation on physicians precluding the withdrawal of life sustaining treatment in non-terminal patients whether competent or not.

Health care necessary to preserve life shall be provided to an individual

who has neither an end-stage medical condition nor is permanently

unconscious,… 20 Pa.C.S. §5462(c)(1).

If a demand is made by a surrogate decision maker to terminate life sustaining care in a non terminal, conscious and incompetent patient, physicians, as a matter of customary practice, should request immediate review by the ethics committee as well as an experienced clinical bioethicist, followed by written recommendation which should be placed in the patient's chart. This will provide support and protection against liability risk for all physicians on the case, and protect the patient. Thereafter, if there is any disagreement between the physicians, ethics committee member, bioethicist, or surrogate decision makers, or other family members or close friends, consideration should be given to petition the court for review.

Survival in Hospital Cardiac Arrest - Challenges for Hospitalists

Bernard W Freedman, JD, MPH — Thu, 07 Oct 2010 04:25:58 -0800

The September 2010 publication of “The Hospitalist” reviews the overall survival rates for cardiac arrest patients.

This article reports that patients frequently have unrealistic expectations and overestimate their chances of survival. Patients predict post-arrest CPR survival at 64%, while the rate is 17%. Most important is that in nearly half of the patients who initially expressed the desire for CPR, once they were informed of the actual estimates, they changed their minds and code status was changed.

It is difficult for many hospitalists to discuss DNR orders with patients. There is not a trusting relationship formed over time. Therefore it is often difficult to broach the subject with patient's or their surrogate decision makers.

For an in-depth and legitimate conversation leading to an informed consent to take place there must be a serious and comprehensive discussion of the patient's history and resuscitation statistics to the degree that they are reliable and clinically significant. The article notes that the “presence of hepatic insufficiency, acute stroke, immunodeficiency, renal failure, or dialysis were associated with lower survival rates.” The authors also note that survival rates are lower with metastatic disease and other malignancies.

Age and a history from prior skilled nursing facilities were associated with poorer survival rates and racial statistics also play a part in survival rates. This article discusses a study that reviewed the medical records of 433,985 Medicare patients 65 years and older who underwent in-hospital CPR. Patients 85 and older had a 6% chance of surviving hospital discharge. This, however, is a statistic and cannot be provided to patients without a detailed discussion of their specific medical condition. Survival rates tend to be lower in patients who are black/nonwhite. Blacks and nonwhites are reported to use CPR at a higher rate but with lower survival rates.

Most importantly, any discussion must include a description of the probable quality of life with post arrest survival. The authors take note that in post resuscitation survivors, in 86% of patients with pre-arrest cognitive abilities remain the same on discharge. Please note that a boilerplate prediction of survival will not pass legal muster.

A Cautionary Note: We should also be alert to the fact that some patients may tend to have a grimmer perspective of survival because of a diagnosis of a malignancy, albeit the cancer is in early stages and not immediately life-threatening. Fear of “cancer” does frighten patients to the point where they will opt for a DNR order prematurely when it may result in an unnecessary early death. Hospitalists, therefore, must include a detailed description of cancer staging, and in such instances take a wait and see position to allow the discussion to continue with the patient’s primary treating physician.

Letting the Conscious Non-Terminal, Incompetent, Patient Die: Hold On a Minute - Not So Fast - Part I

Bernard W Freedman, JD, MPH — Tue, 31 Aug 2010 11:23:22 -0800

It is an injustice to cause patients to unnecessarily prolong the process of dying. Actual futile care must be avoided. But it is equally an injustice to easily acquiesce to patient’s demands that my result in unnecessary death.

On August 17, 2010 the Supreme Court of Pennsylvania decided a case involving a non-terminal, profoundly mentally retarded patient. The patient was conscious and non-terminal. David is 53 years old. David's parents were the guardians.

His parents argued that putting him on the ventilator was not in his best interest and requested terminal extubation. The hospital refused. After several weeks his condition improved and he was successfully weaned from the vent.

David was diagnosed as having aspiration pneumonia and was put on a mechanical ventilator. His parents argued that putting him on the ventilator was not in his best interest and requested terminal extubation. David's physicians and hospital properly refused to follow these demands. After several weeks his condition improved and he was weaned from the ventilator.

Notwithstanding arguments that this case is moot, the court went ahead and rendered an opinion The Pennsylvania Supreme Court was asked to review the case to clarify the statutory scheme regarding the right of individuals to make their own decisions and to clarify the procedures for decision-making when a patient is incompetent.

The applicable statute required all things “… necessary to preserve life shall be provided to an individual who has neither an end-stage medical condition nor is permanently unconscious”

An attorney was assigned to David who argued that a Guardian's decision-making abilities should be consistent with the medical recommendations where the life of an incapacitated person is at stake.

What, we must ask, was the basis for the parent’s demands. What is it that was not in his best interest? It was not their fear that he would be forced to remain on the vent permanently which would cause him anxiety and confusion, because he was responding to treatment for his pneumonia and was weaned off the vent in a few weeks. He would, as presumably they were told, return to his normal base line. If this was the case, the reason for withdrawing the vent early would have been a decision to to end his life (kill him) notwithstanding his improving condition.

The level of proof required to justify terminal extubation as being in the patient’s best interest is the legal standard of clear and convincing evidence.

The trial court determined that there was no clear and convincing evidence to justify terminal extubation. The hospital argued that life preserving medical care must be provided and, no consent from a third party is required. Nor must any objection by a guardian or surrogate decision maker be honored.

The Supreme Court of Pennsylvania made clear that there is a public policy to preserve life in circumstances of a non-terminal conscious patient.

Moreover, the court noted that in this instance David never had the ability to appoint a surrogate decision-maker in situations where he did not suffer from an end-stage condition or permanent unconsciousness and his parents were precluded from making a decision to end his life unless there was clear and convincing evidence that he was in end stage disease or permanently unconscious.

Even in the situation of a conscious cognitively able patient we must appreciate that a request to withhold life sustaining treatment in a patient with a non terminal condition, still requires a showing of clear and convincing evidence that the patient has the capacity to make such a decision.

We should allow some time to pass, have a psychiatric consult; neurologic consult to evaluate any potential underlying injury or insult that might affect the decision-making capacity.

As a patient’s condition improves and the risk of death is diminished the greater the need for a more paternalistic plan of approach when the patient’s or surrogate's demand may result in unnecessary death.

Many patients with mental illness may have capacity to make medical decisions for themselves and many normal cognitively functioning patients may not have capacity. We should not refuse an autonomous decision by a patient, yet we cannot blindly accept a decision by a patient who could return to a reasonable quality of life if treated for a short time.

Physicians must be free to fully evaluate the patient without fear of liability for “refusing” the patient’s demands. As a patient’s condition improves and the risk of death is diminished the greater the need for a more paternalistic plan of approach when the patient’s demand may result in unnecessary death. In this instance the medical record should reflect that the physicians are not refusing the patient’s demands, but first, fully evaluating the patient’s condition before the demands can be accepted. Involvement of bioethics consults and ethics committees will help to protect both the patient from harm and physicians and hospital from claims of liability.

Withdrawing Life Sustaing Treatment - Betancourt v Trinitas - Appellate Court Decision

Bernard W Freedman, JD, MPH — Tue, 17 Aug 2010 16:00:16 -0800

The New Jersey Superior Court–Appellate Division dismissed the appeal in Betancourt v Trinitas finding the appeal moot. The court stressed it's concern over the “sparse record” presented at the time of the original hearing in the trial court as well as on appeal and found that the evidence was not “conclusive in several areas necessary to fully adjudicate the substantial issues raised.” This is sometimes referred to as insufficiency of evidence. If the person or entity bringing the case does not provide sufficient evidence the court will dismiss the claim. In this case Tinitas Hospital's request to withdraw the ventilator.

Ruben Betancourt, 72 years old, was unconscious following the dislodging of a ventilator breathing tube after surgery at Trinitas Medical Center, which resulted in anoxic encephalopathy. He was readmitted to Trinitas in July 2008 with a diagnosis of renal failure. He received dialysis treatments, remained on a ventilator, and feeding tube. The physicians at Trinitas diagnosed Mr. Betancourt as being in a persistent vegetative state and told the family of their intention to stop dialysis and allow him to die.

“We do not decide the issue but raise it to emphasize why the “thin” and disputed record is so critical to a full analysis.”

The Superior Court in New Jersey (trial court) held a two day hearing and thereafter enjoined the hospital from withdrawing life support without the consent of Betancourt's daughter, Jacqueline, who was appointed his guardian. Mr. Betancourt remained at Trinitas, on the ventilator, receiving dialysis and on a feeding tube until his death in May 2009. The case nevertheless went forward because the attorneys argued that this dilemma is a common occurrence and needs to be clarified by the court.

What this court clarified is that insufficient evidence was presented to consider the issues of withdrawing life-sustaining treatment. As I pointed out in my previous post:

“… the physicians caring for this patient are required to place before the surrogate all medical evidence.

1. CT and MRI scans,

2. EEGs,

3. All respiratory records and any potential to wean him from the ventilator.

4. Does he have a tracheostomy?

5. Are his serious bed sores being tended to or ignored?

6. What infectious disease is he suffering from?

7. Is he responding to antibiotics?

8. To what degree was his brain damaged due to anoxic encephalopathy?

9. Has the physicians and or hospital discussed the events leading up to the hypoxic event, or hid from it because of concern of liability.

10. Has all evidence been preserved, provided to the surrogate

11. Has the ethics committee reviewed the case? If so where is their written report, findings and recommendations?

12. Have bioethicists and or lawyers participated in conferences with surrogate?

13. ETC.

The surrogate cannot perform the job of a surrogate in the dark. This is where detailed records of the conversations and meeting held with the surrogate, family and physicians and reports from the ethics committees are critical to the surrogate’s understanding the issues in order to make a legitimate decision.”

"The uncertainty and lack of true consensus as to Rubin's condition may generate a result that will not only apply to a patient in a non-cognitive, vegetative state, but to a patient who is impaired and in possession of some level of awareness.”

Attorneys representing the hospital chose not to bring necessary evidence. Attorneys pick and choose what evidence they wish to disclose as favorable to their client’s position. We can only surmise that the evidence not produced was not favorable. It is often said that bad facts make bad law. A case of great importance to so many must be decided on clear findings of fact.

“…the judge concluded that Ruben was unconscious and in a persistent vegetative state. As it was not necessary to the decision that he reached, the judge made no specific findings, however, concerning Rubin's ability to perceive pain or react to his surroundings. The uncertainty and lack of true consensus as to Rubin's condition may generate a result that will not only apply to a patient in a non-cognitive, vegetative state, but to a patient who is impaired and in possession of some level of awareness.”

The absence in evidence of the usual procedures when an impasse is reached between physicians and patients is to call for help – from consulting bioethicists and ethics committees who will bring to bear physicians of various specialties, lawyers, lay people and clergy from the community. The surrogate decision maker would then have the benefit of views - and the reasons therefore – to consider facts outside any adversarial proceeding.

There was no indication that this review or participation of the bioethics consultant, or even be ethics committee, was involved in the attempt to resolve the dispute between the patient's surrogate and be patient's physician.

Thus, the attorneys representing the hospital did not give to the trial court sufficient facts to make a decision to the grant the withholding of life-sustaining treatment to Mr. Betancourt. . As the court said in the opinion in this case: “We do not decide the issue but raise it to emphasize why the “thin” and disputed record is so critical to a full analysis.”