Lawyer analyzes informed consent issues
Classification: Law
GENERAL DISCUSSION OF LEGAL
ISSUES AFFECTING SEXUAL ASSIGNMENT OF INTERSEX INFANTS BORN WITH AMBIGIOUS
GENITALIA
Glenn M. Burton, Esquire
Florida Board Certified Trial Attorney
Burton, Schulte, Weekley, Hoeler, Robbins & Beytin,
P.A.
Post Office Box 1772
Tampa, Florida 33601-1772
GBURTON@LAW-BURTON.COM
Telephone: (813) 221-0955
Facsimile: (813) 490-0182
style='font-size:12.0pt'>INTRODUCTION
The foregoing is a general discussion
of various laws that may impact
style='font-size:12.0pt;text-decoration:none;text-underline:none;font-weight:
normal'>physicians and their patients in their determination of whether and when
to assign a sex to an individual born with sexual ambiguity. The
ambiguity may arise based upon chromosomal abnormalities or genital abnormalities. This
article is aimed to assist the healthcare practitioner in identifying legal
issues in hopes of improved patient care and avoiding liability. It
is not the intent of this author to �choose sides� on the debate, but rather
to illustrate legal practices and thinking. There are several assumptions
that have been made in the production of this material. This author
assumes that between one and two percent of all children born today may
be intersexual. That term implies either abnormal chromosomes or
genitalia sufficient to create a genital ambiguity. It is furthermore
assumed that these abnormalities are recognized either at birth or during
the early childhood of the individual. It is assumed that the child
has either parents or another legal surrogate whom are in agreement as
to whatever course of action is decided by them to pursue. They have
sought medical advice, first from the child�s pediatrician and then probably
thereafter, a pediatric urologist or general pediatric surgeon. This
article does not address the actual surgical issues and it is presumed
that the surgeon possesses the requisite skill and expertise to properly
perform any surgery required. Rather, this article focuses on the
issues of consent, whom makes the decision as to the type of surgery and
when it is going to be performed, and adherence to the applicable standard
of care for the healthcare individual.
INFORMED
CONSENT ISSUES FOR INTERSEX CHILDREN
I. style='font:7.0pt "Times New Roman"'> Who
Decides? Determining the Decision-Maker
style='color:black'>A. The Parents
Under
Florida law, unless there is a judicial decree to the contrary, the decision-maker
for a minor�s health care decisions are the minor�s natural parents. A �minor� is
defined by Florida Statute as �any person who has not attained the age
of 18 years.� � 1.01(13), Fla. Stat. (2001). A natural parent
has the right to the custody of his or her child absent conduct or conditions
that justify a deprivation of the right in the interest of the welfare
of the child and such a legal right should not be lightly regarded. Torres
v. Van Eepoel, 98 So.2d 735 (Fla. 1958). The right to consent
to medical treatment will typically reside in the parents who have the
legal responsibility to maintain and support their child. O�Keefe
v. Orea, 731 So.2d 680 (Fla. 1st DCA 1998). Although the parents� right
to determine their child�s health care decisions is not absolute and there
is some judicial authority to override the parents� authority, the courts
have repeatedly held that it is the parents and their medical advisors
that generally must make these decisions. In re Guardianship of
Barry, 445 So.2d 365 (Fla. 2d DCA 1984). The love and affection
of another person, no matter how great, is insufficient to deprive a fit
and proper parent of the decision-making authority over his or her child. Modacsi
v. Taylor, 104 So.2d 664 (Fla. 1st DCA 1958). In situations where
there has been an adoption or a dissolution of marriage, the judicial decree
will typically assign the decision-making authority to the adoptive parents
or custodial parent. See generally Ch. 61, 63, Fla. Stat.
(2001).
style='color:black'>B. Non-Parent
Decision-Makers and the Doctrine of Parens Patriae style='color:black'>
As noted above, the parents� right to make the health
care decisions for their child is not an absolute right. Under very
rare circumstances, the parents� right can be overridden by a state court
circuit judge. In these rare instances, the courts rely upon the doctrine
of parens patriae style='font-style:normal'> or �substituted judgment� to justify judicial intervention. Occasionally,
the courts find that their intervention is necessary on the basis that the
parents have �abandoned� their child. This nomenclature is archaic
and has given way to the more modern finding that the parents� decision,
oftentimes based upon religious beliefs, is outweighed by the state�s public
policy of preserving life or the overriding concern for the ultimate welfare
or best interest of the child. See C.E.S. v. State, Dept.
of Health and Rehabilitative Services, 462 So.2d 1160 (Fla. 2d DCA 1984). Medical
care may also be furnished in the absence of parental consent if the parents
have refused to give permission because of religious beliefs. J.V.
v. State, 516 So.2d 1133 (Fla. 1st DCA 1987); see also M.N.
v. Southern Baptist Hospital of Florida, Inc., 648 So.2d 769 (Fla. 1st
DCA 1994); In re Barry, 445 So.2d 365 (Fla. 2d DCA 1984).
In M.N., the parents challenged an �order
by which medical treatment was authorized for their eight-month old child
B.N., without their consent.� M.N., 648 So.2d at 770. The
child was admitted by the parents at the hospital, where she was diagnosed
with acute monocytic leukemia, severe anemia and a low platelet count. Chemotherapy
was then recommended as the most appropriate treatment for the child�s
life-threatening condition, which necessitated blood transfusions. The
parents refused to consent to this procedure based on their religious beliefs. M.N.,
648 So.2d at 770. The hospital filed an emergency petition requesting
an order as to whether chemotherapy and blood transfusions might be administered
to the child without parental consent. In addition to their religious
objections, the parents expressed concern that the proposed medical treatment
would cause undue suffering to their child. After an evidentiary
hearing, the trial judge entered an order authorizing the proposed medical
treatment. M.N., 648 So.2d at 770. The parents then
appealed the order to the First District Court of Appeal.
The First District then stated the law to be applied
setting out the obligations of the trial court in applying the law.
style='font-size:12.0pt'> Ordinarily, decisions regarding the care and
upbringing of minor children will be left to the parents. This parent-child
relationship is a fundamental liberty interest which is constitutionally
protected. Padgett v. Department of Health and Rehabil-itative
Services, 577 So.2d 565 (Fla.1991); In Re R.W., 495 So.2d 133
(Fla.1986); see In Re Dubreuil, 629 So.2d 819, 827 n. 11
(Fla.1993). But the parents' rights are not absolute, as the state
has parens patriae authority to ensure that children receive reasonable
medical treatment which is necessary for the preservation of life. J.V.
v. State, 516 So.2d 1133 (Fla. 1st DCA 1987). And as between
parent and child, the ultimate welfare of the child is the controlling
factor. State v. Reeves, 97 So.2d 18 (Fla.1957). Indeed,
the policy of advancing the best interests of the child is well rooted
in this state and guides the courts in many diverse contexts. See,
e.g., Department of Health and Rehabilitative Services v. Privette,
617 So.2d 305 (Fla. style='font-size:12.0pt'>1993); Padgett; Dinkel v. Dinkel, 322 So.2d 22
(Fla.1975).
style='font-size:12.0pt'> The state may override the fundamental liberty
interest in the parent-child relationship only when there is a sufficiently
compelling state interest. In Re Guardianship of Browning,
568 So.2d 4 (Fla.1990); Dubreuil. Furthermore, the state's
action must be narrowly tailored so as to produce the least intrusive interference
with individual rights, although the preservation of life has been described
as the most significant state interest. Browning. As
with the parent-child relationship, the state's parens patriae authority
is thus not entirely unfettered. Rather, the state's interest diminishes
as the severity of an affliction and the likelihood of death increase:
style='font-size:12.0pt'>[T]here is a substantial distinction in the State's
insistence that human life be saved where the affliction is curable, as
opposed to the State interest where ... the issue is not whether, but when,
for how long and at what cost to the individual ... life may be briefly
extended.
style='font-size:12.0pt'>Satz v. Perlmutter, 362 So.2d 160 (Fla. 4th DCA
1978), approved, 379 So.2d 359 (Fla.1980) (quoting Superintendent
of Belchertown v. Saikewicz, 373 Mass. 728, 370 N.E.2d 417 (1977)); see
also Browning; John F. Kennedy Hospital v. Blud-worth,
452 So.2d 921 (Fla.1984); In Re Guardianship of Barry, 445 So.2d
365 (Fla. 2d DCA 1984).
style='font-size:12.0pt'> The constitutional right of privacy may afford
an individual suffering from a terminal illness the right to refuse medical
treatment. Satz v. Perlmutter, 379 So.2d 359 (Fla.1980); see
also Public Health Trust v. Wons, 541 So.2d 96 (Fla.1989). This
right has been extended to incompetent persons and to infants. John
F. Kennedy Hosp.; Barry. As Barry indicates, courts sometimes
rely on the doctrine of substituted judgment in effectuating the privacy
right of incompetent patients. Under this doctrine the court attempts
to ascertain the choice which would have been made by the patient, if competent. However, Barry recognizes
the inherent difficulty in applying this concept to young children.
style='font-size:12.0pt'> There is no brightline rule or presumption that
applies to the dispute here at issue. An illustrative listing of
cases addressing this problem can be found in Newmark v. Williams,
588 A.2d 1108 (Del. 1991). But the courts must carefully consider
the facts and circumstances of each individual case as it arises, in weighing
the various competing interests. Medical treatment may thus be rejected
when the evidence is not sufficiently compelling to establish the primacy
of the state's interest, or that the child's own welfare would be best
served by such treatment. See Barry; Newmark. On
the other hand, the parents' wishes may be overcome when there is sufficient
medical evidence to invoke the state's parens patriae authority, and to
establish that the child's welfare will be best served by the disputed
treatment. See, e.g., In Re Cabrera, 381 Pa.Super.
100, 552 A.2d 1114 (1989); In Re Wilmann, 24 Ohio App.3d 191, 493
N.E.2d 1380 (1986); In Re Hamilton, 657 S.W.2d 425 (Tenn.App.1983); Custody
of a Minor, 375 Mass. 733, 379 N.E.2d 1053 (1978).
style='font-size:12.0pt'>M.N., 648 So.2d at 770-771.
The First District then concluded that �in the
present case it is not entirely clear whether the court fully considered
all of the competing interests involved.� M.N., 648 So.2d
at 771. �Given the nature of this dispute, we conclude that the matter
should be remanded so as to ensure a balanced weighing of the various interests.� M.N.,
648 So.2d at 771. �This necessitates [the] consideration of the parents� interest
in making fundamental decisions regarding the care of their child, the
state's interest in preserving human life, and the child's own welfare
and best interests, in light of the severity of the child's illness, the
likelihood as to whether the proposed treatment will be effective, the
child's chances of survival with and without such treatment, and the invasiveness
and nature of the treatment with regard to its effect on the child.� M.N.,
648 So.2d at 771. Accordingly, it remanded the case to the trial
court for a further evidentiary hearing on these issues. M.N.,
648 So.2d at 772. In view of the considerations set out by the First
District, and the past history of the Florida courts in these types of
cases, it appears quite evident that the majority of trial judges will
authorize the medical treatment for minors in such circumstances.
C. Legal
Standing
The state may have several interests in the issue of
whether a patient may forego medical treatment. See In re
Dubreuil, 629 So.2d 819, 822 (Fla. 1993); In re Guardianship of Browning,
568 So.2d 4, 11 (Fla. 1990); In re Guardianship of Schiavo, 780 So.2d
176 (Fla. 2d DCA 2001). The health care practitioner or provider, however,
may not have standing to assert these interests in a petition to require
medical treatment for a patient. See In re Dubreuil. At
least for blood transfusion cases, the Florida Supreme Court removed standing
from the health care practitioner and provider on grounds that there was
a potential conflict of interest in requiring health care practitioners and
providers to contest the wishes of their own patients. In re Dubreuil; Harrell
v. St. Mary's Hospital, Inc., 678 So.2d 455 (Fla. 4th DCA 1996). Nevertheless,
in the case of M.N., the hospital successfully brought a petition
against the parents. If the health care provider does not have standing,
the issue then becomes who does have standing. The answer to this question
may lie in Rule 5.900, Florida Probate Rules.
D. Judicial
Review
In 1989, the Second District Court
of Appeal issued a lengthy decision describing in dicta a method for judicial
review of a surrogate�s decision regarding the substituted judgment of
an incapacitated elderly patient. In re Guardianship of Browning,
543 So.2d 258 (Fla. 2d DCA 1989). After the Florida Supreme Court
reviewed the Second District�s decision, it realized the importance of
creating an expedited judicial procedure for these types of decisions and
requested the Probate Rules Committee to submit to it a proposed rule. In
re Guardianship of Browning, 568 So.2d 4 n. 17 (Fla. 1990). In
1991, the court created Rule 5.900, Florida Probate Rules, to assist this
legal procedure. Rule 5.900, on its face, is not limited to situations
involving elderly patients and appears to apply to all cases involving
expedited judicial intervention concerning medical treatment procedures. It
allows any �interested person� to file a petition. Rule 5.900 cautions
attorneys to �note that the criteria and standards of proof contained in Browning differ
from the criteria and standards of proof presently existing in chapter
765, Florida Statutes.� Fla.Prob.R. 5.900. Accordingly, a careful
review of Rule 5.900 is critical.
style='font-size:12.0pt;color:black'>Rule 5.900. Expedited Judicial Intervention
Concerning Medical Treatment Procedures
style='font-size:12.0pt;color:black'>** (a) Petition.** style='font-size:12.0pt;color:black'> Any proceeding for expedited judicial
intervention concerning medical treatment procedures may be brought by
any interested adult person and shall be commenced by the filing of a verified
petition which states:
style='font-size:12.0pt;color:black'> (1) the name and address of
the petitioner;
style='font-size:12.0pt;color:black'> (2) the name and location of
the person who is the subject of the petition (hereinafter referred to
as the "patient");
style='font-size:12.0pt;color:black'> (3) the relationship of the
petitioner to the patient;
style='font-size:12.0pt;color:black'> (4) the names, relationship
to the patient, and addresses if known to the petitioner, of:
style='font-size:12.0pt;color:black'> (A) the patient's spouse and
adult children;
style='font-size:12.0pt;color:black'> (B) the patient's parents (if
the patient is a minor);
style='font-size:12.0pt;color:black'> (C) if none of the above, the
patient's next of kin;
style='font-size:12.0pt;color:black'> (D) any guardian and any court-appointed
health care decision-maker;
style='font-size:12.0pt;color:black'> (E) any person designated by
the patient in a living will or other document to exercise the patient's
health care decision in the event of the patient's incapacity;
style='font-size:12.0pt;color:black'> (F) the administrator of the
hospital, nursing home, or other facility where the patient is located;
style='font-size:12.0pt;color:black'> (G) the patient's principal
treating physician and other physicians known to have provided any medical
opinion or advice about any condition of the patient relevant to this petition;
and
style='font-size:12.0pt;color:black'> (H) all other persons the petitioner
believes may have information concerning the expressed wishes of the patient;
and
style='font-size:12.0pt;color:black'> (5) facts sufficient to establish
the need for the relief requested, including, but not limited to, facts
to support the allegation that the patient lacks the capacity to make the
requisite medical treatment decision.
style='font-size:12.0pt;color:black'>** (b) Supporting Documentation.** style='font-size:12.0pt;color:black'> Any affidavits and supporting documentation,
including any living will or designation of health care decision-maker,
shall be attached to the petition.
style='font-size:12.0pt;color:black'>** (c) Notice.** style='font-size:12.0pt;color:black'> Unless waived by the court, notice
of the petition and the preliminary hearing shall be served on the following
persons who have not joined in the petition or otherwise consented to the
proceedings:
style='font-size:12.0pt;color:black'> (1) the patient;
style='font-size:12.0pt;color:black'> (2) the patient's spouse and
the patient's parents, if the patient is a minor;
style='font-size:12.0pt;color:black'> (3) the patient's adult children;
style='font-size:12.0pt;color:black'> (4) any guardian and any court-appointed
health care decision-maker;
style='font-size:12.0pt;color:black'> (5) any person designated by
the patient in a living will or other document to exercise the patient's
health care decision in the event of the patient's incapacity;
style='font-size:12.0pt;color:black'> (6) the administrator of the
hospital, nursing home, or other facility where the patient is located;
style='font-size:12.0pt;color:black'> (7) the patient's principal
treating physician and other physicians believed to have provided any medical
opinion or advice about any condition of the patient relevant to this petition;
style='font-size:12.0pt;color:black'> (8) all other persons the petitioner
believes may have information concerning the expressed wishes of the patient;
and
style='font-size:12.0pt;color:black'> (9) such other persons as the
court may direct.
style='font-size:12.0pt;color:black'>** (d) Hearing.** style='font-size:12.0pt;color:black'> A preliminary hearing on the petition
shall be held within 72 hours after the filing of the petition. At
that time the court shall review the petition and supporting documentation. In
its discretion the court shall either:
style='font-size:12.0pt;color:black'> (1) rule on the relief requested
immediately after the preliminary hearing; or
style='font-size:12.0pt;color:black'> (2) conduct an evidentiary
hearing not later than 4 days after the preliminary hearing and rule on
the relief requested immediately after the evidentiary hearing.
style='font-size:12.0pt;color:black'>Fla.Prob.R. 5.900.
While
Rule 5.900, Florida Probate Rules, which is designed for expedited cases,
may not be the most optimum avenue to seek judicial relief for cases of surgical
intervention of intersex children with genital abnormalities, it may provide
some guidance to attorneys and physicians of how to proceed. Most likely,
if such a case were brought in Florida, the person disagreeing with the parents� decision
would file a petition for injunctive relief in a state circuit court. He
or she would then have the initial burden of establishing standing as well
as the very heavy burden of establishing that the parents were unfit to make
such a decision for their minor child. There are no reported cases
in Florida involving this situation.
II. style='font:7.0pt "Times New Roman"'> Informed
Consent Issues
A. Introduction
The legal doctrine of informed consent is well
accepted in the health care profession and the law. By now, generally
limited by only their own financial constraints and resources, almost all
patients understand that they have the right to make their health care decisions. This
right, of course, exists even if the patients� health care provider knows
better. As set out above, in the case of a minor, the minor�s parents
typically make the minor�s health care decisions. In the case of an
incompetent person, a guardian or surrogate or proxy makes the health care
decisions after determining what health care is in the best interest of the
incompetent person. The right to make a health care decision, of course,
rests upon an informed basis for the decision, hence the term �informed consent.� Informed
consent has been enumerated in several different sources of law, including
the federal constitution, state constitutions, federal statutes, state statutes,
and of course, the common law. As a general rule, a health care provider
must obtain the informed consent of a patient for treating, examining, or
operating on that individual. � 766.103(3), Fla. Stat. (2001). A
failure to do so may result in liability for negligent treatment. An
exception exists for emergency medical treatment that falls within the �Good
Samaritan Act.� � 768.13, Fla. Stat. (2001).
B. The
United States Constitution
In Cruzan v. Director,
Missouri Department of Health, 497 U.S. 261, 110 S.Ct. 2841, 111
L.Ed.2d 224 (1990), the United States Supreme Court made clear that �a
competent person has a constitutionally protected liberty interest
in refusing unwanted medical treatment.� Cruzan, 497 U.S.
at 278. �This notion of bodily integrity has been embodied in
the requirement that informed consent is generally required for medical
treatment.� Cruzan, 497 U.S. at 269. �The informed
consent doctrine has become firmly entrenched in American tort law. Cruzan,
497 U.S. at 269. �The logical corollary of the doctrine of informed
consent is that the patient generally possesses the right not to consent,
that is, to refuse treatment.� Cruzan, 497 U.S. at 270. Although Cruzan involved
the right to refuse life-sustaining treatment issue due to �the advance
of medical technology capable of sustaining life well past the point
where natural forces would have brought certain death in earlier times,� Cruzan,
497 U.S. at 270, its holding on informed consent applies with equal
force to any issue involving informed consent. In fact, most
of the early cases that discussed informed consent involved the right
to refuse medical treatment based upon a patient�s religious beliefs. When
the courts base decisions on the federal constitution, it typically
means that the federal government or a state government has enacted
a statute that encroached upon or limits a patient�s right to consent
to a health care procedure or treatment or the right to receive information
in order to make an informed consent.
�But determining that a person has
a �liberty interest� under the Due Process Clause does not end the inquiry.� Cruzan,
497 U.S. at 279. Rather, the issue of �whether [a person�s] constitutional
rights have been violated must be determined by balancing his liberty interests
against the relevant state interests.� Cruzan, 497 U.S. at
270. Thus, although a competent person may have the right to refuse
unwanted medical treatment, the Supreme Court recognized that there are
situations where that liberty right may not be violated by a state that
prohibits the exercise of that right under certain circumstances. The
Supreme Court then reviewed the factual circumstances involving Ms. Cruzan,
an incompetent, where Missouri had a statute that �requires that evidence
of the incompetent�s wishes as to the withdrawal of treatment be proved
by clear and convincing evidence.� Cruzan, 497 U.S. at 280. �The
question, then, is whether the United States Constitution forbids the establishment
of this procedural requirement by the State.� Cruzan, 497
U.S. at 280. The Supreme Court held that it did not. Cruzan,
497 U.S. at 280.
Petitioners go on
to assert that an incompetent person should possess the same right in this
respect as is possessed by a competent person. . . . The difficulty with
petitioners' claim is that in a sense it begs the question: An incompetent
person is not able to make an informed and voluntary choice to exercise
a hypothetical right to refuse treatment or any other right. Such
a "right" must be exercised for her, if at all, by some sort
of surrogate. Here, Missouri has in effect recognized that under
certain circumstances a surrogate may act for the patient in electing to
have hydration and nutrition withdrawn in such a way as to cause death,
but it has established a procedural safeguard to assure that the action
of the surrogate conforms as best it may to the wishes expressed by the
patient while competent. Missouri requires that evidence of the incompetent's
wishes as to the withdrawal of treatment be proved by clear and convincing
evidence. The question, then, is whether the United States Constitution
forbids the establishment of this procedural requirement by the State. We
hold that it does not.
Whether or not Missouri's
clear and convincing evidence requirement comports with the United States
Constitution depends in part on what interests the State may properly seek
to protect in this situation. Missouri relies on its interest in
the protection and preservation of human life, and there can be no gainsaying
this interest. As a general matter, the States--indeed, all civilized
nations--demonstrate their commitment to life by treating homicide as a
serious crime. Moreover, the majority of States in this country have
laws imposing criminal penalties on one who assists another to commit suicide. We
do not think a State is required to re-main neutral in the face of an informed
and voluntary decision by a physically able adult to starve to death.
But in the context
presented here, a State has more particular interests at stake. The
choice between life and death is a deeply personal decision of obvious
and overwhelming finality. We believe Missouri may
legitimately seek to safeguard the personal element of this choice through
the imposition of heightened evident-iary requirements. It cannot
be disputed that the Due Process Clause protects an interest in life as
well as an interest in refusing life-sustaining medical treatment. Not
all incompetent patients will have loved ones available to serve as surrogate
decision-makers. And even where family members are present, "[t]here
will, of course, be some unfortunate situations in which family members
will not act to protect a patient." In
re Jobes_,_ 108 N.J. 394,
419, 529 A.2d 434, 447 (1987). A State is entitled to guard against
potential abuses in such situations. Similarly, a State is entitled
to consider that a judicial proceeding to make a determination regarding
an incompetent's wishes may very well not be an adversarial one, with the
added guarantee of accurate factfinding that the adversary process brings
with it. See style='font-size:12.0pt'>Ohio v. Akron Center for Reproductive style='font-size:12.0pt'>Health_,_ 497 U.S. 502, 515-516, 110 S.Ct. 2972, 2981-2982, 111 L.Ed.2d 405 (1990). Finally,
we think a State may properly decline to make judgments about the "quality" of
life that a particular individual may enjoy, and simply assert an unqualified
interest in the preservation of human life to be weighed against the constitutionally
protected interests of the individual.
* * *
We think it self-evident
that the interests at stake in the instant proceedings are more substantial,
both on an individual and societal level, than those involved in a run-of-the-mine
civil dispute. But not only does the standard of proof reflect the
importance of a particular adjudication, it also serves as "a societal
judgment about how the risk of error should be distributed between the
litigants." Santosky, supra, 455 U.S. at 755,
102 S.Ct., at 1395; Addington, supra, 441 U.S., at 423, 99
S.Ct., at 1807-1808. The more stringent the burden of proof a party
must bear, the more that party bears the risk of an erroneous decision. We
believe that Missouri may permissibly place an increased risk of an erroneous
decision on those seeking to terminate an incompetent individual's life-sustaining
treatment. An erroneous decision not to terminate results in a maintenance
of the status quo; the possibility of subsequent developments such as advancements
in medical science, the discovery of new evidence regarding the patient's
intent, changes in the law, or simply the unexpected death of the patient
despite the administration of life-sustaining treatment at least create
the potential that a wrong decision will eventually be corrected or its
impact mitigated. An erroneous decision to with-draw life-sustaining
treatment, however, is not susceptible of correction.
Cruzan,
497 U.S. at 279-283.
Significantly, in addition to the
clear and convincing evidence standard, the United States Supreme Court
also held that states are not constitutionally required to accept the �substituted
judgment� of a patient�s close family member absent substantial proof that
their views reflected the views of the incompetent patient. Cruzan,
497 U.S. at 286.
It is also worth noting that most, if not all,
States simply forbid oral testimony entirely in determining the wishes of
parties in transactions which, while important, simply do not have the consequences
that a decision to terminate a person's life does. At common law and
by statute in most States, the parol evidence rule prevents the variations
of the terms of a written contract by oral testimony. The statute of
frauds makes unenforceable oral contracts to leave property by will, and
statutes regulating the making of wills universally require that those instruments
be in writing. See 2 A. Corbin, Contracts � 398, pp. 360-361
(1950); 2 W. Page, Law of Wills �� 19.3- 19.5, pp. 61-71 (1960). There
is no doubt that statutes requiring wills to be in writing, and statutes
of frauds which require that a contract to make a will be in writing, on
occasion frustrate the effectuation of the intent of a particular decedent,
just as Missouri's requirement of proof in this case may have frustrated
the effectuation of the not-fully-expressed desires of Nancy Cruzan. But
the Constitution does not require general rules to work faultlessly; no general
rule can.
Cruzan,
497 U.S. at 284. Thus, the Cruzan decision also impacts the
determination of �who� may make a minor�s health care decision.
C. The
Florida Constitution
Separate
from the United States Constitution, the Florida Supreme Court has recognized
that the Florida Constitution �guarantees that �a competent person has the
constitutional right to choose or refuse medical treatment, and that right
extends to all relevant decisions concerning one�s health.�� In
re Dubreuil, 629 So.2d 819, 822 (Fla. 1993); In re Guardianship of
Browning, 568 So.2d 4, 11 (Fla. 1990); Public Health Trust of Dade
County v. Wons, 541 So.2d 96 (Fla. 1989). The Florida Supreme Court
premised this right upon a person�s right to privacy under Article I, section
23, of the Florida Constitution. It recognized, however, that where
the issue involves a blood transfusion, the privacy right �overlaps with
the right to freely exercise one�s religion.� In re Dubreuil,
629 So.2d at 822. In a prior decision, the court held that a terminally
ill incompetent person�s right to refuse medical treatment is the same as
a competent person�s right to refuse medical treatment. John F.
Kennedy Memorial Hospital, Inc. v. Bludworth, 452 So.2d 921 (Fla. 1984). In
so doing, the court recognized the doctrine of �substituted judgment� under
certain circumstances. Bludworth. Should there be any
doubt in the determination of the patient�s wishes about living or dying,
the default position favors life. In re Guardianship of Schiavo,
780 So.2d 176 (Fla. 2d DCA 2001).
Perhaps
the most controversial of the right to refuse medical treatment cases are
the ones where the patient refuses blood transfusions based upon religious
reasons. In re Dubreuil, Wons, Harrell
v. St. Mary's Hospital, Inc., 678 So.2d 455 (Fla. 4th DCA 1996); M.N.
v. Southern Baptist Hospital of Florida, Inc., 648 So.2d 769 (Fla. 1st
DCA 1994); St. Mary�s Hospital, Inc. v. Ramsey, 465 So.2d 666 (Fla.
1985). The Florida Supreme Court has clearly held that a health care
provider must comply with the wishes of a patient who refuses a blood transfusion
unless otherwise ordered by a court of competent jurisdiction. See In
re Dubreuil, Wons. The issue is clouded where the patient
is a parent of a young child. Wons. The state has an interest
in seeing that the child is not abandoned by the parent. In In re
Dubreuil and Wons, the Florida Supreme Court held that there was
insufficient evidence of child abandonment because the patient had a spouse
or an extended family member that would care for the child. In view
of the fact that the Florida Supreme Court decided the issue of informed
consent on an express �right of privacy,� a right that was created in the
state constitution after the creation of the right of informed consent, many
of the court�s decisions look to Florida�s common law for its reasoning.
D. The Florida Statutes
The Various Informed Consent Statutes
The
�Florida Medical Consent Law�
It is the most
widely employed statute for informed consent, but is typically relied upon
in cases involving competent adults making decisions about their ordinary
medical care. It states in part:
(3) No recovery shall be allowed
in any court in this state against any physician licensed under chapter
458, osteopathic physician licensed under chapter 459, chiropractic physician
licensed under chapter 460, podiatric physician licensed under chapter
461, or dentist licensed under chapter 466 in an action brought for treating,
examining, or operating on a patient without his or her informed consent
when:
style='font-size:12.0pt;color:black'> (a)1. The action of the physician,
osteopathic physician, chiropractic physician, podiatric physician, or
dentist in obtaining the consent of the patient or another person authorized
to give consent for the patient was in accordance with an accepted standard
of medical practice among members of the medical profession with similar
training and experience in the same or similar medical community; and
style='font-size:12.0pt;color:black'> 2. A reasonable individual,
from the information provided by the physician, osteopathic physician,
chiropractic physician, podiatric physician, or dentist, under the circumstances,
would have a general understanding of the procedure, the medically acceptable
alternative procedures or treatments, and the substantial risks and hazards
inherent in the proposed treatment or procedures, which are recognized
among other physicians, osteopathic physicians, chiropractic physicians,
podiatric physicians, or dentists in the same or similar community who
perform similar treatments or procedures; or
style='font-size:12.0pt;color:black'> (b) The patient would reasonably,
under all the surrounding circumstances, have undergone such treatment
or procedure had he or she been advised by the physician, osteopathic physician,
chiropractic physician, podiatric physician, or dentist in accordance with
the provisions of paragraph (a).
style='font-size:12.0pt;color:black'> (4)(a) A consent which is evidenced
in writing and meets the requirements of subsection (3) shall, if validly
signed by the patient or another authorized person, raise a rebuttable
presumption of a valid consent.
style='font-size:12.0pt;color:black'> (b) A valid signature is one
which is given by a person who under all the sur-rounding circumstances
is mentally and physically competent to give consent.
style='font-size:12.0pt;color:black'>� 766.103(3)-(4), Fla. Stat. (2001).
b. style='font:7.0pt "Times New Roman"'> The "Florida
Patient's Bill of Rights and Responsibilities"
The Florida Patient�s
Bill of Rights and Responsibilities law provides in relevant part:
style='font-size:12.0pt;color:black'> (4) RIGHTS OF PATIENTS. Each
health care facility or provider shall observe the following standards.
style='font-size:12.0pt;color:black'> (b) Information.--
style='font-size:12.0pt;color:black'> 1. A patient has the right
to know the name, function, and qualifications of each health care provider
who is providing medical services to the patient. A patient may request
such information from his or her responsible provider or the health care
facility in which he or she is receiving medical services.
style='font-size:12.0pt;color:black'> 2. A patient in a health care
facility has the right to know what patient support services are available
in the facility.
style='font-size:12.0pt;color:black'> 3. A patient has the right
to be given by his or her health care provider information concerning diagnosis,
planned course of treatment, alternatives, risks, and prognosis, unless
it is medically inadvisable or impossible to give this information to the
patient, in which case the information must be given to the patient's guardian
or a person designated as the patient's representative. A patient
has the right to refuse this information.
style='font-size:12.0pt;color:black'> 4. A patient has the right
to refuse any treatment based on information required by this paragraph,
except as otherwise provided by law. The responsible provider shall
document any such refusal.
style='font-size:12.0pt;color:black'> 5. A patient in a health care
facility has the right to know what facility rules and regulations apply
to patient conduct.
style='font-size:12.0pt;color:black'> 6. A patient has the right
to express grievances to a health care provider, a health care facility,
or the appropriate state licensing agency regarding alleged violations
of patients' rights. A patient has the right to know the health care
provider's or health care facility's procedures for expressing a grievance.
style='font-size:12.0pt;color:black'> 7. A patient in a health care
facility who does not speak English has the right to be provided an interpreter
when receiving medical services if the facility has a person readily available
who can interpret on behalf of the patient.
� 381.026(4)(b), Fla. Stat. (2001). As with the
state constitution right of privacy, the statutory bill of rights for patients
was created well after the common law doctrine of informed consent. Thus,
it too will most likely be interpreted in accordance with Florida�s common
law.
style='font-size:12.0pt;color:black'> E. The
Operation of the Informed Consent Provisions
1. The
Duty to Obtain the Patient�s Informed Consent
Generally, unless the patient�s
treating physician is a hospital employee, a hospital cannot be held liable
for the physician�s failure to obtain his or her patient�s informed consent
because the duty falls upon the physician, not the hospital, to obtain
the patient�s informed consent for the care and treatment being provided. Hospitals
are not listed in the Florida Medical Consent Law, and in fact, are specifically
excluded from this provision. � 766.103, Fla. Stat. (2001). The
reasons for this exclusion are that: (1) in most situations, only a qualified
physician has the training, experience and skill to obtain the patient�s
informed consent for whether any particular medical procedure should be
performed, (2) the physician is in a superior position to know the patient
as well as the patient�s medical history, and (3) requiring only the physician
to obtain the patient�s informed consent eliminates any potential conflict
between the physician and the hospital. Thus, it appears to be Florida�s
stated policy to protect hospitals from liability for obtaining a patient�s
consent for a medical procedure performed at its facility by a non-employee
physician. Cedars Medical Center, Inc. v. Ravelo, 738 So.
2d 362 (Fla. 3d DCA 1999), review denied, 751 So.2d 1253 (Fla. 2000); Valcin
v. Public Health Trust of Dade County, 473 So.2d 1297 (Fla. 3d DCA
1984), approved in part disapproved in part, 507 So. 2d. 596 (Fla.
1987).
In a medical malpractice action
based upon the failure to obtain a patient�s informed con-sent, the informed
consent requirement is met where the following elements are established.
style='font-size:12.0pt;color:black'> (1) The action of the health
care practitioner in obtaining the consent of the patient or of a person
authorized to give consent for the patient, was in accordance with the
accepted standard of medical practice among members of the medical profession
with similar training and experience in the same or similar medical community.
style='font-size:12.0pt;color:black'> (2) From the information furnished
by the health care practitioner, a reasonable individual would have a general
understanding of the procedure, the medically acceptable alternative procedures
or treatments, and the substantial risks and hazards inherent in the proposed
treatment or procedures.
� 766.103(3)(a),
Fla. Stat. (2001). Ritz v. Florida Patient�s Compensation Fund,
436 So.2d 987 (Fla. 3d DCA 1983), review denied, 450 So.2d 488 (Fla.
1984). If these two elements are not satisfied, the physician may
still nonetheless avoid liability if it can be shown that �the patient
would reasonably, under all the surrounding circumstances, have undergone
such treatment or procedure had he or she been advised by the physician,
osteopathic physician, chiropractic physician, podiatric physician, or
dentist in accordance with� paragraph (a). � 766.103(3)(b), Fla.
Stat. (2001). Proof of a violation of the standard of care for the
lack of an informed consent requires expert medical testimony. Valcin
v. Public Health Trust of Dade County, 473 So.2d 1297 (Fla. 3d DCA
1984), approved in part disapproved in part, 507 So. 2d. 596 (Fla.
1987); Meretsky v. Ellenby, 370 So.2d 1222 (Fla. 3d DCA 1979).
2. The
Scope of Consent
A
physician is not under a duty to explain all of the risks associated with
a procedure, but only those risks that are substantial and inherent in
the proposed treatment. A substantial risk inherent in a procedure
or treatment is one that is recognized among other medical professionals
with similar training and experience in the same or similar medical community. Public
Health Trust of Dade County v. Valcin, 507 So. 2d. 596, 598-599 (Fla.
1987); Ritz. Accordingly, in a case where the physician failed
to inform the patient who underwent a tubal ligation that an ectopic pregnancy
was a risk of the surgery, the patient was required to produce expert testimony
as to the necessity of informing her of the risk of ectopic pregnancy. Faced
with the medical expert witness testimony, the physician was required to
rebut it with qualified expert witness testimony establishing that the
risk of ectopic pregnancy was insubstantial or the failure to inform was
still in accordance with accepted medical practice within the medical community. Valcin.
** 3. The
Presumption of a Valid Consent**
�A
consent which is evidenced in writing and meets the requirements of subsection
(3) shall, if validly signed by the patient or another authorized person,
raise a rebuttable presumption of a valid consent.� � 766.103(4)(a),
Fla. Stat. (2001). �A valid signature is one which is given by a
person who under all the surrounding circumstances is mentally and physically
competent to give consent.� � 766.103(4)(b), Fla. Stat. (2001). The
Florida Supreme Court has ruled that this presumption of validity arising
from a signed informed consent does not violate due process. Parikh
v. Cunningham, 493 So.2d 999, 1001 (Fla. 1986). In determining
the application of the statutory presumption of the validity of a signed
written consent, all of the circumstances must be taken into consideration. These
include the medical procedure itself, the inherent risks of the medical
procedure and the adequacy and reliability of the physician�s means to
communicate the medical information to the patient taking into account
known language difficulties. Dandashi v. Fine, 397 So.2d 443
(Fla. 3d DCA 1981).
F. Informed
Consent for Minors
Generally, the physician must obtained the informed
consent from a parent or guardian in those situations where the patient
is a minor, i.e., a person less than 18 years of age. � 743.01, Fla.
Stat. (2001). A minor who has had the disability of non-age removed
pursuant to the various provisions of chapter 743 may consent to his or
her own treatment. There are exceptions to the general rule. Emergency
medical care or treatment may be provided to a minor by a physician without
parental consent if delaying treatment would endanger the health or physical
well-being of the minor. � 743.064(1), Fla. Stat. (2001). Notification
to the parents, however, �shall be accomplished as soon as possible after
the emergency medical care or treatment is administered.� � 743.064(1),
Fla. Stat. (2001). As set forth above, in rare instances, the courts
have held that it may be proper to intervene to preserve a minor�s life. See J.V.
v. State, 516 So.2d 1133 (Fla. 1st DCA 1987); see also M.N.
v. Southern Baptist Hospital of Florida, Inc., 648 So.2d 769 (Fla.
1st DCA 1994); In re Barry, 445 So.2d 365 (Fla. 2d DCA 1984).
G. style='font:7.0pt "Times New Roman"'> The
Ultimate Issue.
The ultimate issue presented at this conference rests upon a decision with
respect
to
the timing of surgical intervention. It is the informed consent and
specifics of the information provided that will ultimately determine whether
or not the healthcare provider has adhered to the applicable standard of
care in dealing with the situation. Recent events and studies have
raised some concerns about the traditional of early surgical intervention
and the psychological ramifications. It is the recommendation of
this author that these issues be communicated to the patients and/or their
parents. Thus, the recommendation is for a more expansive informed
consent that has traditionally been given when confronting these issues. This
author recognizes that there is not legal decision in this country squarely
on point. However, the emergence of peer reviewed literature suggesting
potential harm for early surgical treatment to patients creates a situation
where the healthcare practitioner must take these matters into account. Therefore,
the more cautious approach should be to at least notify the decision-maker
of the issues. It is recommended that this additional component be
incorporated into the more traditional informed consent document, so that
there is a clear written record that the information was in fact communicated. Of
course, the precise information and language of the informed consent will
be determined based upon the specifics of the individual set of patient
circumstances.
style='font-size:12.0pt;text-decoration:none;text-underline:none'>III. style='font:7.0pt "Times New Roman"'> Liability Issues.
style='font-size:12.0pt;text-decoration:none;text-underline:none'>A. Standard
of Care
As discussed above, a healthcare provider may have some liability
to an
style='font-size:12.0pt;text-decoration:none;text-underline:none;font-weight:
normal'>individual based upon the failure to obtain an appropriate informed consent. Additionally,
healthcare professionals risk exposure to suit if their conduct in providing
medical care falls below the applicable standard of care. Issues
concerning the technical aspects of rendering medical care are not addressed
in this article but instead negligence issues would center upon the advice,
recommendation, providing of information, and referral issues. As
a professional, the healthcare practitioner is imposed under the law of
the State of Florida with the duty to perform requested services in accordance
with the standard of care used by similar professionals in the community
under similar circumstances. style='font-size:12.0pt;font-weight:normal'>Moransails vs. Heathman style='font-size:12.0pt;text-decoration:none;text-underline:none;font-weight:
normal'>, 744 So.2d 973 (Fla. 1999). It is likewise defined in standard
jury instructions as the failure to use reasonable care. �Reasonable
care on the part of the physician is that level of care, skill, and treatment
which, in light of all relevant surrounding circumstances, is recognized
as acceptable and appropriate by similar and reasonably careful physicians.� Florida
Standard Jury Instruction 4.2(a). The healthcare professionals are
therefore expected to conduct themselves in accordance with the practices
that are generally accepted amongst the medical community.
It
appears to be generally accepted that at the present time, physicians
style='font-size:12.0pt;text-decoration:none;text-underline:none;font-weight:
normal'>reassign the sex of infants with ambiguous genitalia at birth or as soon
thereafter as is practical, but in any event within the first two years
of the child�s life. This appears to be based upon the initial research
and opinions set forth by Dr. John Money. Additionally, support for
early intervention has been set forth by the American Academy of Pediatrics
in a policy statement issued April 1996. American Academy of Pediatrics
Volume 97, Number 4, April 1996. In the policy statement, the academy
recommended surgery for orchidopexy and hypospadias to be performed between
six and 12 months of age. This policy statement helps define the
standard of care with respect to the timing of elective surgery on the
genitalia of children born with genital abnormalities. It should
be noted that the American Board of Pediatrics issued an addendum to their
1996 position as published in Pediatrics 2000; 106:138-142. The Academy
stated �the 2000 policy on Developmental Anomalies of the External Genitalia
acknowledges the considerable recent debate about the appropriate general
assignment of newborns with the most extremes forms of genitalia ambiguity,
and notes that some have suggested that the current early surgical treatment
be abandoned in favor for allowing the affected person to participate in
gender assignment at a later time.� Recent studies and literature
suggests that there is an emerging issue with regard to the appropriate
timing of surgical intervention. As greater and more expansive studies
are undertaken, the standard of care with respect to the timing of surgical
intervention may in fact evolve. It is during this interim time period
that the practitioner faces a true gray area.
Where
the standard of care in this country is to surgically intervene within
style='font-size:12.0pt;text-decoration:none;text-underline:none;font-weight:
normal'>the first year of the infant�s life, the standard would also require
that the medical advice given to parents be in accordance with this early
intervention. It can be argued that falling out side the main stream
and recommending to parents that they delay surgical intervention does
pose some potential risk to the healthcare practitioner.
It
is the recommendation of this author that the practitioner avoid this
pitfall by disclosing both schools of thinking to the parents. In
this rather unusual set of circumstances, greater time and effort should
be spent with a more extensive discussion and consent process than as traditionally
undertaken.
These
issues would certainly be much simpler if a legislature or a court of
style='font-size:12.0pt;text-decoration:none;text-underline:none;font-weight:
normal'>competent jurisdictions were able to define the rights, responsibilities,
and standards with respect to these individuals. At the present time
however, this author has not located any legislature or court within the
United States that has directly addressed these issues and the responsibilities
of the healthcare practitioner with respect to them. There has been,
however, one case decided in Columbia that has considered the issues.
B. Columbia�s
Decision
The Columbian Constitution Court issued two decisions. One
on May 12, 1999 and the other on August 2, 1999 which addressed issues
of surgical intervention in sexually ambiguous infants. The Court
found that �parents cannot give consent on a child�s behalf on surgeries
intended to determine sexual identity.� The Court indicated that
children older than five (5) years of age are the appropriate persons to
consent to surgeries to determine their sex. Additionally, in the
other Order the Court found the Informed Consent given to parents of a
child under the age of five (5) to be insufficient. At the present
time I have been unable to obtain an English translation of these decisions. Assuming,
however, that the English articles are accurate several questions come
immediately to mind. First, a comparison of the Constitution of Columbia
would need be compared to our own. There are perhaps some fundamental
differences which could have a bearing upon the basis of the decision. Secondly,
it is virtually impossible to imagine a scenario where a United States
Court would allow a minor to consent to a surgical procedure. As
stated previously in this article minors do not have the ability to enter
into a legally binding contract. Since a medical consent is in fact
a binding agreement minors would lack capacity to enter into it. One
final thought on the Columbia case centers on their displeasure with the
Informed Consent. As stated again it is likely that any decision
in the United States will turn upon the issue of Informed Consent. Therefore,
the issue that is presented in the Columbia case may be relevant to demonstrate
to healthcare professionals Courts general attitude towards an adequate
Informed Consent.
C. Related Cases
There are a number of related cases that although they
are not authoritative on the issues at hand are none the less illustrative
of the Court�s attitude towards a variety of issues respecting surgical
sex changes. I include the Littleton v. Prange case cited
in the 288th Judicial District Court, Bexar County, Texas, Case
No. 98-CI-15220. This case did not involve an intersex issue but
instead involved an individual who as an adult had surgery to transform
themselves from a man to the physical characteristics of a woman. As
a woman Ms. Littleton married Jonathan Littleton where they lived as husband
and wife for seven (7) years. Jonathon Littleton died in 1996 allegedly
as a result of malpractice of his treating physician. Ms. Littleton
attempted to file an action under the Texas Wrongful Death Statute as a
surviving spouse. The Defendant�s alleged that since Mrs. Littleton
was in fact born a man and Texas did not recognize same sex marriages that
she did not have standing to bring the action under the Wrongful Death
Statute. The Trial Court agreed, granting Summary Judgment, and the
issue was affirmed on appeal. Despite the fact that Christy Littleton
had her birth certificate changed to reflect her as a female, the Texas
Court looked beyond the ministerial act of the change of a birth certificate
and found that since she was born a male she was unable to bring the action.
style='font-size:12.0pt'>There are also a series of cases that discuss whether
transsexuals are in fact capable of marrying members of the same sex as
defined at the time of their birth. There are some conflicting cases
which may be more properly based upon that states a set of individual laws. These
cases include Baehr v. Lewin, 852 P.2d 44 (Hawaii, abbr. 1993); MT
v. JT, 355 A. 2d 204 Superior Court of New Jersey (1976); and In
re: Ladrach, 513 N.E.2d 828 (Ohio, 1987); Anonymous v. Anonymous,
325 N.Y.S.2d 499 S.C. Queens County, New York (1971); Baker v. Nelson,
191 N.Y.2d 185 Minnesota, abbr. (1971) and Jones v. Halahan, 501
S.W. 2d 588 Kentucky abbr. (1973).
style='font-size:12.0pt'>Several of these cases have been discussed in various
Law Review articles. They would include an article titled �Sex Changes
and Opposite Sex Marriages: Apply the Full Faith and Credit Clause to Comply
Interstate Recognition of Transgendered Persons Amended Legal Sex for Marital
Purposes.� 38 San Diego Law Review 1113 Fall, 2001 and �The Transsexual
and the Damage Done: The Fourth Court of Appeals Opens Pandora�s Box by
Closing the Door on Transsexuals Right to Marry.� 9 Law in Sex No. 1, 199-2000.
style='font-size:12.0pt'>Other articles of interest include �Race, Sexual Orientation,
Gender and Disability,� Ohio State Law Journal, 1985; �First do no Harm-
The Fiction of Legal Parental Consent to Genital Normalizing Surgery
on Intersexed Infants,� 19 Yale Law and Policy Review, 2001 and �An Emerging
Ethical and Medical Dilemma; Should Physicians Perform Sex Assignment Surgery
on Infants with Ambiguous Genitalia,� 7 Michigan Journal of Gender and
Law, 2000.
D. Conclusion
While there presently exists a great deal of concern
for the well-being of the individuals involved and the professionals
continue to search for the answers, the focus for the health care professionals
seem to have two rather clear pathways. The first is the pathway of
inquiry and testing designed to determine whether or not the majority of
persons treated by early surgical intervention derived a benefit or a harm
from the surgery. At the present time it appears that there is a good
faith effort on-going to arrive at sound conclusions in this regard.
The parallel path is the path of the health care
professional who is proceeding in accordance with the well established standard
of care for surgical treatment of these individuals within the first year
of their life. While these two paths may appear to be inconsistent
with one another, in reality they may both be standard of care, if the standard
is defined as such by the medical community. While it is certainly
logical to assume that the standard of care cannot or should not be changed
until the results of the on-going studies are known there does none the less
arise a concern that the results may differ from the traditional recommendation
course of action. As such perhaps the only prudent way to proceed is
to outline to the decision-maker the present state of medicine and its potential
evolution. Only in this manner can a reasonably prudent health care
practitioner proceed with either treatment or delay with any degree of comfort. Because
of this scenario a traditional Consent Form may not be legally adequate. It
is recommended that a Consent Form contain not only the traditional risks
of surgery and anesthesia but should include the potential future mental
or emotional component in the event the chosen sex becomes inappropriate. In
this regard there is attached as an addendum hereto a proposed Consent Form
for treatment. It is hoped that either this Consent or one revised
in accordance with the wishes of the participants herein becomes utilized.
style='font-size:14.0pt'>MEDICAL CONSENT
style='font-size:12.0pt'>Comes now Mr. and Mrs.
both individually and as the parents and natural guardians of
and hereby execute this Consent Agreement on this day of .
20 at a.m./p.m. This Consent is entered into pursuant to the
Florida Medical Consent Law which requires our health care practitioners
to advise us of the general nature of the treatment or procedures and the
medically acceptable alternative procedures and treatments and the substantial
risks and hazards inherent in the proposed treatment or procedures. We
understand that our child has been diagnosed with a developmental anomaly
of the external genitalia. We understand and acknowledge that this
is not a life threatening condition and it is therefore not an emergency
procedure. We recognize that the child faces potential mental or
emotional harm from this condition. I have been informed that this
procedure may be urgently needed in order to reduce or eliminate the potential
harm to our child. It has been recommended to us by our health care
providers that surgical intervention is in the best interest of our child
based upon the current status of medical thinking. We have been informed
that presently the American Academy of Pediatrics recommends surgery for
this condition to be conducted within the first twelve (12) months of the
infants life. We have likewise been informed that although the present
standard of care is to operate within the first twelve (12) months on the
infant for these conditions, there is presently an on-going debate as to
whether or not it is in the best interest of the child. We have been
informed that studies are on-going in an effort to determine the long term
effects of surgical intervention on children born with genital abnormalities. These
studies have not yet been completed, however, several individuals have
come forward suggesting that surgery was not appropriate for their circumstances. Since
the individuals that have come forward represent a minority of those who
have undergone surgery of this type, greater research is needed in order
to fully understand the ramifications.
style='font-size:12.0pt'>We have been informed that we have the right to obtain
other opinions to those expressed by our health care provider and have
been encouraged to do so. We have been made aware of the Intersex
Society of North America and the information from them that is available
both on the internet and through other means. We are satisfied that
we have been properly educated and informed about the status of medicine
as it presently exists concerning our child�s medical condition. Therefore,
we hereby enter into this Agreement as follows:
style='font-size:12.0pt'>1. We
hereby consent and authorize Dr. and such assistants
as may be selected by him, to perform upon our minor child the following
procedure:
style='font-size:12.0pt'>2. If
any unforeseen conditions arise during the course of the procedure, we
do hereby authorize and request our health care providers to take whatever
steps necessary and perform whatever procedures they deem advisable even
though they may be different from those procedures now planned.
style='font-size:12.0pt'>3. Our
doctor and/or other members of his staff have explained to us the purpose
of the procedure(s). They also explained to us the risks and potential
complications of this surgical procedure and we understand that there are
always certain risks and consequences that are associated with any procedure,
which may include but are not limited to allergic reactions and/or damage
to blood vessels, nerves, internal organs and/or infections, bleeding,
failure of healing or death. We also specifically recognize that
these abnormalities may take more than one procedure to correct and may
in fact involve multiple procedures. We also specifically recognize
that our child may in the future have conflict with their chosen sex and
therefore may require further medical care in this regard.
style='font-size:12.0pt'>4. The
alternative to these procedures have been fully explained to us and we
have been informed that one of the alternatives to is that we refuse surgical
options all together.
style='font-size:12.0pt'>5. We
hereby consent to the administration of such anesthetics as may be considered
necessary or advisable by a member of the Anesthesia Medical Staff, we
further request and authorize the person(s) administering the anesthetic
to do whatever they deem advisable and necessary under the circumstances
including but not limited to the insertion of blood pressure and blood
volume monitoring devices.
style='font-size:12.0pt'>6. We
hereby consent to the disposal by (HOSPITAL)
of any tissue or part which may be removed from our child.
style='font-size:12.0pt'>7. We
hereby consent to the taking of photographs or video taping in the course
of this procedure for the purposes of advancing medical education as may
be authorized by physician and to the admittance of the qualified observers
to the operating room as determined by (HOSPITAL).
style='font-size:12.0pt'>8. We
understand and read the English language and/or adequate interpretation
and have had the procedure adequately explained and have not had any mind-altering
medications prior to signing this document. Any and all questions
regarding this procedure have been answered to our satisfaction. We
understand that any existing Do Not Resuscitate (DNR) status is voided
upon entering the Surgical Department and will remain void until discharge
from the Surgical Department.
style='font-size:12.0pt'>9. WE
ACKNOWLEDGE THAT NO GUARANTEE OR ASSURANCE HAS BEEN MADE TO US AS TO ANY
OF THE RESULTS OR RISKS, AND THAT WE SPECIFICALLY ASSUME SUCH RISKS.
style='font-size:12.0pt'>10. In
signing this document we hereby acknowledge that we have read and understand
all of the terms contained within this document and to the extent we did
not understand any aspect we have inquired and our inquiries have been
answered to our satisfaction. As of the time of our entering into
this Consent, we maintain and believe that this procedure is in the best
interests of our child. As of the timing of the signing of this agreement,
any and all blanks located within this document have been filled in.
Signature
of Parent Date/Time Witness
to Signature Date/Time
Signature
of Parent Date/Time Witness
to Signature Date/Time
Signature
of Guardian Date/Time Witness
to Signature Date/Time
If not a
natural parent
Relationship
to Patient
WE CERTIFY
THAT I HAVE INFORMED THE PATIENT OF THE PRESENT STATUS OF MEDICINE CONCERNING
SURGICAL TREATMENT OF THE PATIENT�S CONDITIONS. I ALSO CERTIFY THAT
I HAVE INFORMED THE LEGAL REPRESENTATIVE OF THE PATIENT OF THE AVAILABLE
ALTERNATIVES WITH RESPECT TO THE PROPOSED SURGICAL PROCEDURE AND OF THE
INHERENT POTENTIAL SURGICAL RISKS, COMPLICATIONS AND RESULTS WHICH I CONSIDER
LIKELY TO OCCUR AS A RESULT OF SAID PROCEDURE.
style='font-size:12.0pt;font-weight:normal'> M.D.
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