SUPERIOR COURT OF WASHINGTON
IN AND FOR JEFFERSON COUNTY
CM, a minor child, individually,
and
Dakota McBride, his natural mother,
Robert McLain, his natural father,
individually, and as guardians of their child,) PLAINTIFFS,

Annc Biedel, personally,
and DBA Dr. Anne Biedel & Associates,
DEFENDANTS

NO. 03-2-00329-7

AFFIDAVIT OF
PEDIATRICIAN and
ASSOCIATE PROFESSOR of
PEDIATRICS AND ETHICS
DOUGLAS S. DIEKEMA, M.D., M.P.H.

I, DOUGLAS DIEKEMA, M.D., M.P.H., being duly sworn, do attest and affirm the following:

1.) I hold an M.D. degree as well as a Masters in Public Health, and I am a physician licensed in the state of Washington. I am board certified in pediatrics and pediatric emergency care and have practiced as a physician for 15 years. I am also an Associate Professor of Pediatrics, as well as an Attending Physician, Emergency Services & Pediatrics, and Interim Director of the Center for Pediatric Bioethics at Children's Hospital & Regional Medical Center.

2.) I am also Adjunct Professor in the University of Washington Department of Medical History and Ethics and I am the current Chair of the Committee on Bioethics of the American Academy of Pediatrics.

3.) I live at ............ in the state of Washington.

4.) I have published numerous articles on medical ethics. I regularly consult with parents and health care providers on issues of informed consent for pediatric patients. My CV is attached herein.

5.) I have been asked for my professional opinion, to the best of my training, knowledge, and experience as a physician about the difference between the informed consent document (and its associated discussion with the parents), and the physician's entirely independent ethical duty to the child to conform to the standard of care. I am willing and able to so testify on this point, and do so here:

All medical procedures and practices are guided by bioethical principles, and they are especially important where the child-patient cannot express his or her preferences:

1. PRINCIPLE OF BENEFICENCE - To conform to the standard of care, all surgical or other interventions must be in the best interests of the patient, and have some reasonable prospect of providing a tangible benefit to him. In general, parents cannot subject a child to medical procedures that place the child at significant risk of serious harm unless there is a corresponding benefit that is likely to outweigh the potential harms. Non-therapeutic procedures that involve excessive risk should be avoided. An appendectomy on a healthy child, who has rio history or symptoms of an appendicitis and who is not undergoing an abdominal surgery for other therapeutic reasons, for instance, would not be ethically justifiable because the absence of benefit to the child would not justify the surgical risks.
   
   
2. PRINCIPLE OF NON- MALEFICENCE or avoiding the infliction of unnecessary harm to the patient - The patient must, individually, be a clinically suitable candidate for any proposed intervention so that no unjustifiable harm is caused. Infliction of harm is only justified when the harm will be offset by a greater benefit from the procedure or test. For example, the harm of pain from drawing blood is only justified if there is a valid reason for obtaining blood and the results of testing are likely to benefit the patient. Similarly, a surgical procedure can only be justified when the benefits likely to accrue to the patient outweigh the harms that might arise fiom surgery - pain, possibility of death or complications. In justifying a surgical procedure, contraindications like anatomical or congenital anomalies, allergies, bleeding disorders must be considered carefully in order to determine whether the risks of a particular surgical intervention do not exceed the possible benefit. In order to minimize harms, the physician should use anesthesia and analgesia that is approriate to the procedure to avoid unnecessarv pain to, or suffering of, the child.
   
   
3. PRINCIPLE OF PROPORTIONALITY - In the case of minors. good medical practice that minimizes risk to the patient and maximizes the likelihood of benefit should not be overridden or abandoned simply because of requests from the patient's [gu]ardians. All proposed surgical interventions must meet clinical and bioethical standards and fall within acceptable medical practice. A surgical procedure should not be performed solely because a parent requests it. It must offer some benefit to the child. If other less risky but equally beneficial treatment options are available, they should be considered instead of surgery. In some cases in my practice, parents might seek an intervention that offers no benefit to the child - for instance, demanding antibiotics to treat a simple viral upper respiratory infection (a cold). It is reasonable in those cases to refuse to write the prescription on the grounds that it offers no benefit to the child and poses some risks (including the risk of severe allergic reaction). The physician's duty is to always consider primarily the welfare of the child.
   
   
4. Thus the request of a parent or surrogate decision-maker is never sufficient to justify a particular clinical intervention. All clinical interventions must consider primarily to good of the child - carefully weighing the potential burdens and risks of therapy against the benefits of the therapy. To be justifiable, the potential benefits must compare favorably to potential harms.
   
   
5. Thus it is my opinion that physicians should always examine the clinical rationale behind a particular intenrention on a particular patient, and corisider carefully whether the proposed intervention promises benefits that are proportionate to the risk of ham. That inquiry is independent of the wishes of those who offer a proxy consent for a child. All medical care can and should be evaluated by whether is is good medicine for the particular patient. In the absence of a court order or an emergency situation, parental permission is required before a physician can embark upon a course of therapy. However, the range of decisions a parent can make are limited to those which conform to reasonable clinical practice, and for which the benefits are Iikelv to justify any potential harms. [underlined in the original]

Ethical medical practice keeps the good of the patient as the primary focus. Physicians should in most cases begin with measures that offer the prospect of benefit without associated harms before moving to more aggressive measures that increase the likelihood of harms. For example, in caring for patients with certain kinds of infection that can be treated surgically but that can also in most cases be treated successfully with antibiotics, we often begin by treating with antibiotics and reserve surgery only for those cases that do not improve with the less invasive and less potentially harmful therapy (antibiotics). In those cases, surgery would not be considered the appropriate standard of care without first attempting antibiotics. A parent or proxy decision-maker would not be offered surgery as an option until the less harmful therapy had been attempted and demonstrated to be unsuccessful.
[How much less appropriate would surgery be when the child patient is not suffering from any infection!]

I fully agree with the Bioethics Committee of the American Academy of Pediatrics when they state:

A proxy consent is necessary in all cases involving a child-patient. But analyzing the care provided the child, and assessing his or her clinical needs at the moment is an entirely different matter. Indeed, the clinical assessment, the diagnosis, and the treatment plan is usually and properly done WELL BEFORE any proxy consent for a procedure or intervention is presented to the parents.

The clinical analysis typically involves the careful consideration of the following questions:

1. What are the child's apparent problems?
2. What is a good working diagnosis?
3. What is indicated by the clinical assessment?
4. What would be a good treatment plan?
5. What is the least intrusive, most conservative means of achieving a good result?
6. Are there any contraindications to a proposed medication or procedure?
7. Is the anticipated benefit of the medication or procedure worth the risk of harm or poor result?

Parents can often provide valuable information about the child's problems, but their proxy consent only gives the physician permission to treat the child in the best clinical way possible. A proxy consent is NOT a carte blanche to demand any therapy they may desire for a child, but rather to choose from among those that fall within the standard of care at that point in time. A proxy's request does not compel the physician to perform a procedure that is contraindicated, has no clinical value to the child, or falls below the standard of care.

Thus proxy consents and clinical analyses are two entirely different, separable issues, and may be analyzed separately from each other.

FURTHER YOUR AFFIANT SAYETH NOT,

[signature]

1/17/06

Date

1 American Academy of Pediatrics Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 1995;95(2):3 14-7.