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CHAPTER 33

Medicolegal Issues in
Obstetric Anesthesia
Mark S. Williams, MD, MBA, JD • Joanna M. Davies, MBBS, FRCA

CHAPTER OUTLINE

LAWSUITS INVOLVING CLAIMS AGAINST DISCLOSURE OF UNANTICIPATED OUTCOMES


HEALTH CARE PROVIDERS AND MEDICAL ERRORS
Importance of Effective Communication CONTEMPORARY RISK MANAGEMENT
Theories of Liability STRATEGIES
Establishing Medical Malpractice
LIABILITY PROFILES IN OBSTETRIC ANESTHESIA:
Establishing Lack of Informed Consent
THE AMERICAN SOCIETY OF
THE LITIGATION PROCESS ANESTHESIOLOGISTS CLOSED-CLAIMS PROJECT
Sources of Law Anesthesia-Related Injuries
Initiation of a Lawsuit Precipitating Events Leading to Injuries
Discovery Payments
Trial Lessons Learned
INFORMED CONSENT PROFESSIONAL PRACTICE STANDARDS
Process and Documentation
POTENTIAL RISK MANAGEMENT PROBLEM
Capacity to Consent/Mental Competence AREAS
Minor Patients Support Persons during Labor
Consent for Labor Analgesia Videotaping
REFUSAL OF CARE
Documentation
Conflicts Arising out of the Maternal-Fetal
Relationship

Childbirth is a natural process in which unexpected and of a real or perceived adverse outcome. Adverse outcomes
potentially severe adverse events can occur. Responses to may profoundly affect families and health care providers.
such events require timely and collaborative efforts Patients and their families must adjust to the reality of
among all caregivers. Obstetric anesthesia providers have an unanticipated adverse outcome as well as potentially
a challenging role. Some women have high expectations overwhelming and long-term financial costs. Physicians
about the availability and effectiveness of anesthesia ser- and other caregivers also may be profoundly affected
vices for labor and vaginal or cesarean delivery; these emotionally by an adverse outcome. Medicolegal claims
expectations may be influenced by the experiences and associated with such events (regardless of the merit of the
biases of family members and friends. By contrast, other claim) may compound such emotions, raise the costs of
women may view anesthesia for labor as an intrusion liability coverage, and ultimately impact the availability
upon the natural labor process; yet, some of these women and overall cost of health care services.
may ultimately need or request anesthesia services. The Anesthesia providers should possess an understanding
informed consent and decision-making process is funda- of basic medicolegal issues and should proactively
mental to securing a woman’s understanding and support. embrace risk management strategies that support optimal
The effectiveness of this process is subject to cultural and patient care and minimize both patient dissatisfaction
socioeconomic influences as well as the pain of labor. and the legal consequences of an unanticipated adverse
The degree to which patients and their families possess outcome. Insights and opportunities for promoting safer
a realistic understanding of the benefits and risks associ- and more effective anesthesia and obstetric care are
ated with childbirth and obstetric anesthesia may influ- rapidly evolving and are gaining support among payers,
ence the decision to pursue legal remedies in the event governmental agencies, and others.
764
33 Medicolegal Issues in Obstetric Anesthesia 765

LAWSUITS INVOLVING CLAIMS standard is applied to the particular facts of the plaintiff’s
AGAINST HEALTH CARE PROVIDERS situation in a malpractice action.
A mistake or a bad result does not necessarily denote
Importance of Effective Communication negligence. Similarly, unless a physician contracts other-
wise with the patient (i.e., makes a promise of a specific
The ability to effectively communicate information in a outcome), the provision of medical care alone does not
manner that is understood by the patient is fundamental warrant or guarantee that an illness or disease will be
to securing patient understanding and cooperation. cured. A physician is liable for a misjudgment or mistake
Lapses in communication may preclude obtaining truly only when it is proved to have occurred through a failure
informed consent and may lead to patient dissatisfaction, to act in accordance with the care and skill of a reasonably
lapses in patient safety, and inadequate explanation of an prudent practitioner.
unanticipated adverse outcome. Claims of medical malpractice must be filed within a
Communication failures are frequent elements in mal- certain period after the alleged incident of medical mal-
practice claims; these failures include lack of informed practice. Most jurisdictions in the United States have
consent, poor patient rapport, language barriers, and enacted statutes of limitations that are specifically
inadequate discharge instructions, among others.1 There applicable to malpractice claims. Recognizing that a sig-
is an increasing recognition that limited health literacy nificant time may elapse before symptoms or injury mani-
interferes with effective communication.2 Health literacy fest, many states have established discovery rules that
is defined as the “degree to which individuals have the apply to situations in which the patient has no way of
capacity to obtain, process, and understand basic health knowing that the injury was caused by wrongdoing or
information and services needed to make appropriate negligence. One example of an unknown injury is sterility
health decisions.”3 Providers should strive to adopt that is discovered only when the patient attempts to con-
methods and approaches that encourage patient engage- ceive. Another example is the Rh-negative mother who
ment, reduce risk, and improve treatment compliance.4 delivers an Rh-positive child and does not receive Rho(D)
immune globulin (RhoGAM). Such an injury would be
Theories of Liability apparent only when the mother has another child with
Rh-positive blood. Other exceptions to—or extensions
Every physician has a duty to provide professional ser- of—the statutes of limitations might involve situations of
vices that are consistent with a minimum level of compe- fraudulent concealment, an undiscovered foreign object,
tence. This is an objective standard based on the situations involving long-term continuous treatment, and
physician’s qualifications, level of expertise, and the cir- issues involving infants or minors.
cumstances of the particular case.5 The failure to meet
this objective standard of care may give rise to a cause of
action for medical negligence. The standard of care for
Establishing Medical Malpractice
medical practice is dynamic and changes as the profession In most malpractice cases, the following four elements
adopts new treatments and approaches for patient care. are required for proving medical negligence:
Therefore, changes in accepted medical practice may 1. Duty. It must be shown that a duty to provide care
create additional professional obligations and, in turn, existed (i.e., a health care provider–patient relation-
additional legal responsibilities for physicians. ship existed). This may apply to situations in which
Although the specific medical malpractice laws vary the provider renders medical advice over the tele-
from state to state, several different causes of action may phone to a patient never seen in the office or through
be brought against a physician. Patients may sue for inju- a “curbside” consult with another physician.
ries resulting from the provision of health care by using 2. Breach. It must be shown that the health care pro-
one or more of three different theories (or causes of vider failed to meet his or her duty to provide
action): (1) medical malpractice, (2) breach of contractual reasonable care (i.e., the health care provider was
promise that injury would not occur, and (3) lack of negligent).
informed consent.6 Plaintiffs (patients) commonly file 3. Injury. It must be shown that the patient experi-
lawsuits that allege improper care on the basis of more enced an injury that resulted in damages.
than one of these theories (e.g., alleging both a violation 4. Proximate cause. It must be shown that the neg-
of the standard of care and a lack of informed consent for ligence of the health care provider proximately
the medical treatment rendered). Medical malpractice caused the patient’s injury (i.e., there must be a
may involve failure to make the diagnosis, failure to sufficiently direct connection between the negli-
obtain informed consent, surgical errors, drug prescrip- gence of the health care provider and the injury
tion and administration errors, and other mistakes. For a experienced by the patient).7
plaintiff to prevail with regard to a medical malpractice If any one of these elements is missing, the plaintiff
claim, he or she must prove that the injury resulted from cannot establish medical malpractice. The plaintiff has
the failure of the health care provider to follow the the burden of proof to establish each of these elements
accepted standard of care. The standard of care may be by a “preponderance of the evidence.” This quantum of
defined as “that degree of care, skill, and learning expected proof means that a proposition is more probably true
of a reasonably prudent health care provider at that time than not true (i.e., > 50% certainty).
in the profession or class to which he belongs…acting If the malpractice claim involves the issue of whether
in the same or similar circumstances.”7 This objective a physician used a proper method of treatment, the
766 PART VIII Anesthetic Complications

plaintiff must use expert testimony to establish that the disclosure of the risk would have led a reasonable patient
defendant physician violated the standard of care and that in the plaintiff’s position to reject the medical procedure
such violation probably caused the plaintiff’s injury.7 or choose a different course of treatment, and (4) a causal
Expert testimony to establish how a reasonably prudent connection between the failure to inform the plaintiff of
health care practitioner would act under similar circum- the risk and the injury resulting from the occurrence of
stances typically must be provided by an expert with the the nondisclosed risk.10
same educational background and training as the defen- Expert testimony is typically required to establish at
dant physician. least some of the elements of an informed consent claim,
In certain cases, the plaintiff may not be required to especially the materiality of the risk. However, expert
present expert testimony to prove negligence, and the testimony is not essential if an issue falls within the
burden of proof may shift to the defendant. This repre- general knowledge of lay persons or if the doctor failed
sents the doctrine of res ipsa loquitur (i.e., the thing speaks to give the patient any information about the risks
for itself). This doctrine has the following three condi- involved, because a lay person can conclude that in the
tions: (1) the injury ordinarily does not occur in the absence of any information, informed consent is not
absence of negligence, (2) the injury must be caused by possible.
an agency or instrumentality within the exclusive control The obligation to obtain informed consent lies with
of the defendant, and (3) the injury must not have been the physician.11 Ordinarily, the hospital or other organi-
a result of any voluntary action or contribution on the zation has no independent duty to obtain a patient’s
part of the plaintiff.5 Claims involving injuries sustained informed consent. Likewise, a consultant physician who
during administration of anesthesia have been made advises the treating physician has no such duty. A refer-
under this doctrine. In one case, a patient complained of ring physician is not required to obtain informed consent
pain that he described as a “strong electric shock” after a unless he or she actually participates in or controls the
spinal block was administered. The patient subsequently subsequent treatment by the other physician.12
lost all sensation below that spinal level and became There are differences of opinion as to the perspective
incontinent. Because one would not ordinarily expect a to be embraced when a physician is disclosing the nature
permanent sensory loss from a spinal anesthetic, the and likelihood of a given risk. Specifically, should it arise
verdict was upheld at the appellate level.8 from the patient’s or the physician’s point of view? Theo-
retically, both would desire the same scope of disclosure.
Often, the pivotal issue is the determination of which
Establishing Lack of Informed Consent party’s viewpoint should dictate the standard for judging
Lack of informed consent is a common cause of action in the physician’s conduct.13 Most jurisdictions use a “rea-
medical malpractice claims. Within the context of the sonable person” or “prudent patient” standard. Under
physician-patient relationship, the doctrine of informed this rule, a physician is expected to disclose to the patient
consent is based in English common law, by which in lay terms all material information that a prudent or
doctors could be charged with the tort of battery if they reasonable patient would consider significant to making
had not gained the consent of their patient before the his or her decision.14 This approach concerns itself with
performance of surgery or another procedure. In the the patient’s needs, rather than the physician’s judgment;
United States, the New York Court of Appeals estab- this approach follows the rationale that the physician
lished the legal principle of informed consent in 1914.9 should neither impose his or her values on the patient
In this case, the plaintiff, Mary Schloendorff, was admit- nor substitute his or her level of risk aversion for that of
ted to a New York hospital and consented to examination the patient.15 Under this standard, the jury determines
under ether anesthesia to determine whether a fibroid whether a reasonable person in the plaintiff’s position
tumor was malignant, but she withheld consent for its would have considered the risk significant in making his
removal. The physician examined the tumor, found it or her decision. The issue is not what a particular patient
to be malignant, and removed it—in disregard of the would want to know but rather what a reasonable person
patient’s wishes. The Court found that this operation in the patient’s condition would want to know, taking into
constituted medical battery. Writing on behalf of the account factors such as the individual’s medical condition,
Court, Justice Benjamin Cardozo wrote, “Every human age, and risk factors.16 This objective standard protects
being of adult years and sound mind has a right to deter- physicians from potentially self-serving testimony of
mine what shall be done with his own body; and a surgeon plaintiffs, who inevitably assert that they would have
who performs an operation without his patient’s consent refused a given procedure if they had been properly
commits an assault for which he is liable in damages. This informed of the risk.
is true except in cases of emergency where the patient is The materiality of risk is an issue under this “reason-
unconscious and where it is necessary to operate before able” or “prudent” patient standard. It is generally
consent can be obtained.”9 accepted that a physician is not required to present every
This principle remains embedded in modern medical possible risk of a proposed treatment. If the probability
ethics and has been adopted by most state legislatures in of its occurrence is practically nonexistent, then the risk,
the form of informed consent statutes. To establish neg- no matter how severe, is not material. Conversely, even
ligence for failure to obtain informed consent, a plaintiff a small risk for occurrence may be significant to a patient’s
must prove (1) the existence of a material and reasonably decision if the potential consequences could be severe.17
foreseeable risk unknown to the patient, (2) a failure of Disputes concerning the proper scope of disclosure tend
the physician to inform the plaintiff of that risk, (3) that to center on whether the risk was foreseeable or remote.
33 Medicolegal Issues in Obstetric Anesthesia 767

Some jurisdictions still adhere to the professional stan- Constitutions are the fundamental laws of a nation or
dard of disclosure. This approach assumes the perspec- state, which establish the role of government in relation
tive of the physician and is concerned with what to the governed. Constitutions act as philosophical touch-
information a reasonable practitioner would share with a stones for the society, from which other ideas may be
patient under the same or similar circumstances.18 drawn. One example is the “right to privacy” established
Even in circumstances in which the health care provid- in case law, which flows from the constitutional recogni-
ers acknowledge their failure to provide important infor- tion of individual liberty.21 Statutes are the laws written
mation to the patient or the patient’s legally authorized and enacted by elected officials in legislative bodies. Reg-
surrogate decision-maker, the jury is still asked to decide ulations are written by government agencies as permitted
whether the patient or the patient’s decision-maker would by statutory delegation. Although regulations have the
have consented to such a course of treatment despite the force and effect of law, they must be consistent with their
risk. For example, in Barth v. Rock, a 5-year-old patient enabling legislation. Case law refers to written opinions
suffered a cardiac arrest (and eventual death) after receiv- or decisions of judges that arise from individual lawsuits.
ing general anesthesia by mask with sodium thiopental, Case law that may be cited as legal authority (precedent)
nitrous oxide, and a succinylcholine infusion for open is limited to cases at the appellate court level (i.e., cases
reduction of an arm fracture. Both the surgeon and the appealed from trial court decisions). The vast majority of
nurse anesthetist admitted that they failed to inform the lawsuits settle before trial, and only a small percentage of
minor patient’s parents about the risks of general anes- trial court decisions result in appeal; thus, case law reflects
thesia. The appellate court held that the jury should have a very small portion of actual litigation. Like medicine,
been instructed that, as a matter of law, there was no the practice of law is dynamic and changes as new legisla-
informed consent; the jury then should have decided tion and regulations are adopted or new case law is
whether the parents would have consented to the anes- created. In addition, any one or several of these sources
thesia had they been adequately informed of the risks.19 of law may be relevant to a particular case.
If a plaintiff establishes the four elements for a cause When creating new laws or applying the law in decid-
of action based on lack of informed consent, the burden ing the proper result for a particular case, a legislative
shifts to the physician to establish a defense that justifies body or a court may also consider other information
why the material information was not provided (e.g., the about standards for health care providers’ conduct. For
insignificant nature of the risk) or why disclosure would example, the court may give strong weight to The Joint
not have altered the chosen course of treatment. In addi- Commission standards and find that a provider acting in
tion, the health care providers may claim that the case accordance with The Joint Commission requirements
was a medical emergency. State laws generally supply a was adhering to his or her professional obligations.22 In
defense of “implied consent” for provision of necessary writing legislation or court decisions, lawmakers also may
emergency treatment when the patient is unable to defer to standards and practice guidelines adopted by
provide his or her own consent and no legally authorized professional organizations, such as the American Society
surrogate decision-maker is immediately available.20 If of Anesthesiologists (ASA). The adoption of professional
the health care providers’ treatment was authorized under standards and practice guidelines strengthens the influ-
a medical emergency, the providers should carefully doc- ence of professional organizations in the lawmaking
ument their determination of same. The documentation process because lawmakers often are willing to defer to
in the patient’s medical record should contain a descrip- professional organizations’ statements on standards of
tion of the patient’s presenting condition, its immediacy, care and professional ethics.
its magnitude, and the nature of the immediate threat of Some experts have suggested that the value of
harm to the patient. It is advisable for at least two health “evidence-based” guidelines within the venue of medical
care providers to document this information, because the malpractice has been disappointing, primarily because of
documentation would support their actions if a lack-of- a lack of scientific evidence supporting the guidelines.23
informed-consent lawsuit were filed. The “emergency A 2009 analysis of guidelines issued by the American
treatment” rule is limited in two respects. First, the College of Cardiology and the American Heart Associa-
patient must require immediate care to preserve life or tion determined that “the significant increase in the
health. Second, the physician may provide only the care quantity of scientific literature concerning cardiovascular
that is reasonable in light of the patient’s condition. disease published in recent years (along with the number
of technical and medical advances)—if aimed to address
unresolved issues confronting guideline writers—should
THE LITIGATION PROCESS have resulted in guideline recommendations with more
certainty and supporting evidence.”24 Recent federal reg-
It is helpful for health care providers to have a basic ulation dictates the funding of some comparative effec-
understanding of sources of law, how lawsuits are initi- tiveness studies that may provide additional evidence on
ated, and typical steps in the litigation process. which to base clinical guidelines.25 It will be several years
before the merit of these investments can be assessed.
Sources of Law
Legal authority has multiple sources, including federal
Initiation of a Lawsuit
and state constitutions, federal and state statutes, federal Medical malpractice lawsuits are typically initiated when a
and state regulations, and federal and state case law. plaintiff files a complaint with the court. Some states have
768 PART VIII Anesthetic Complications

enacted statutes that impose certain conditions (including trial testimony, (5) closing arguments, (6) jury instruc-
notification of the defendant physician) before a com- tions given by the judge, and (7) delivery of the jury’s
plaint is filed.26 The physician receives notice of the legal verdict. There also may be post-verdict proceedings and
action when he or she is served with a copy of the summons motions. The lawyers for all parties file briefs with the
and the complaint. In the complaint, the plaintiff alleges court in advance of the trial to outline the case for
the facts giving rise to the cause(s) of action against the the trial judge. The lawyers also prepare and argue over
physician. The complaint requires a written answer to be the content of jury instructions, seeking the best language
filed (by the attorney representing the physician) with the to support their theories of the case. The judge decides
court within a specified period. If a timely answer is not which jury instructions will be given and reads them to
filed, a default judgment may be entered against the physi- the jurors immediately prior to jury deliberation. Attor-
cian (i.e., a judgment is allowed because no response may be neys commonly file motions about significant trial pro-
treated as no defense against the allegations). ceedings, such as the scope of admissible evidence. The
In civil actions against health care providers, plaintiffs trial judge rules on these motions outside the presence of
are frequently motivated to sue for an award of monetary the jury.
damages. Medical malpractice lawsuits may involve mul- A jury verdict does not necessarily end the case. If a
tiple defendants, such as the treating physician, the verdict in favor of the plaintiff(s) is reached, defense
hospital, manufacturers of health care equipment, and counsel may file a motion (1) asking the court to set aside
pharmaceutical companies. Defense counsel evaluates its the verdict and grant a new trial, (2) asking the court to
client’s potential liability exposure (i.e., any aspect of care change the verdict and enter a judgment in the defen-
arguably not meeting the standard of care). Both plaintiff dant’s favor, or (3) asking for a reduction in the amount
counsel and defense counsel weigh the perceived risks if of damages awarded to the plaintiff(s). Defense counsel
the case proceeds to trial and then determine how much also may seek to reopen settlement negotiations or may
they think the case is worth. The valuation of a case may choose to appeal the case. The plaintiff(s) may take
include more than the estimated dollar value; it may also similar post-verdict steps if the jury renders a verdict in
include considerations such as setting a potential prece- favor of the defendant(s).
dent or maintaining a business relationship. The vast majority of medical malpractice cases never
go to trial. A 1991 study showed that only 2% of persons
Discovery injured by physicians’ negligence ever file a lawsuit.27
Subsequently, only 10% of all medical malpractice claims
Discovery refers to the early phase of litigation after a go to trial. Settlement negotiations result in the disposal
lawsuit is initiated. During this phase, the litigants on of many cases. Other cases are withdrawn by plaintiffs or
both sides research the strengths and weaknesses of their are dismissed by the court on legal grounds such as
cases by obtaining and examining medical records, summary judgment, whereby a judge may rule that a
reviewing medical literature, and interviewing and depos- plaintiff’s case is legally insufficient. Defendants win
ing witnesses, including the plaintiff(s), the treating approximately 71% of medical malpractice claims.28
health care provider(s), and potential expert witnesses. In seeking alternatives that might speed the litigation
During discovery, certain methods of gathering infor- process and reduce the overall costs, a number of states
mation are generally used. The methods include inter- have created medical pretrial screening panels. As an
rogatories and depositions. Interrogatories are written alternative to a full trial, a medical screening panel is
questions that are served on one party from an opposing typically comprised of several physicians and an attorney,
party. Interrogatories must be answered in writing, under who determine whether the defendant met the appropri-
oath, within a prescribed period. Failure to respond as ate standard of care and if the injury was proximately
required may result in the court’s issuing sanctions against caused by a failure to meet that standard. The findings
the nonresponding party. Depositions involve testimony of the group are then submitted to the court for further
given under oath that is recorded by a court reporter. In adjudication.29 The effectiveness of this model is subject
a deposition taken for the purpose of discovery, the attor- to considerable debate. Other alternatives include arbi-
neys representing all opposing litigants participate and tration, mediation, and other types of alternative dispute
ask questions of the witness. The purposes of discovery resolution.
depositions are (1) to obtain facts and other evidence, (2)
to encourage the other side to commit to a position “on
the record” (i.e., in preserved testimony), (3) to discover INFORMED CONSENT
the names of other potential witnesses, (4) to assess how
strong a witness the deposed individual may make, (5) to Process and Documentation
limit facts and issues for the lawsuit, (6) to encourage the
other side to make admissions against its own interests in A patient’s right of self-determination lies at the root of
the lawsuit, and (7) to evaluate the case for its dollar (or informed consent. A patient can make an informed deci-
other) value and potential for settlement. sion only after (1) a discussion of the diagnosis and the
indications for the procedure or therapy; (2) disclosure
of material risks, benefits, and alternatives; and (3) provi-
Trial sion of an opportunity for questions and answers. This
A trial typically consists of (1) jury selection, (2) opening process is neither accomplished nor affirmed solely by
statements, (3) plaintiff’s trial testimony, (4) defendant’s having the patient’s or the patient surrogate’s signature
33 Medicolegal Issues in Obstetric Anesthesia 769

on a document asserting informed consent. Evidence of individual or group settings, and they may be presented
this process and the physician’s involvement in the process in a variety of formats, such as print, video, the Internet,
may be found among office notes, informational aids and interactive devices.33 In essence, this approach
shared with patients, hospital notes, and signed forms attempts to address the weaknesses in both the “reason-
acknowledging informed consent. able patient” and the “professional standard” approaches
The necessity of having a specific process is not only to disclosure, and it becomes even more valuable as the
an ethical obligation but also a requirement of various diversity of practitioners and patients increases.
state and federal agencies. For example, the U.S. Centers Formal documentation of informed consent has other
for Medicare and Medicaid Services (CMS) have Condi- advantages. Adequate documentation helps health care
tions of Participation that define the requirements that providers defend their actions if patients subsequently
facilities must satisfy to participate in the Medicare and challenge their consent for health care. In some jurisdic-
Medicaid programs. Specifically, the Patients’ Rights Con- tions, a valid consent form signed by the patient may
ditions of Participation contain the following interpretive provide a direct means of defense and actually shift the
guidelines: “Hospitals must utilize an informed consent burden of proof to the plaintiff who wishes to make a
process that assures patients or their representatives are claim of lack of informed consent.34 Some large medical
given the information and disclosure needed to make an liability insurance providers have strongly recommended
informed decision about whether to consent to a proce- that the clinician responsible for providing anesthesia
dure, intervention, or type of care that requires consent.”30 care should obtain a separate written consent.35 Further,
Further, the interpretive guidelines for the CMS Surgical some anesthesia organizations have recommended not
Services Conditions of Participation specifically state the only that an anesthesia-specific form should be used but
following31: also that practitioners should highlight specific risks that
may be present.36 A separate anesthesia consent form that
The primary purpose of the informed consent process is highlights specific risks demonstrates a meaningful effort
to ensure that the patient, or the patient’s representative, to engage patients in a full discussion of relevant issues
is provided information necessary to enable him/her to and may help establish the basis of a potential defense
evaluate a proposed surgery before agreeing to the against a medical malpractice claim. It may also reinforce
surgery. Typically, this information would include the importance and significance of anesthesia services and
potential short and longer term risks and benefits to the choices in the obstetric setting.
patient of the proposed intervention, including the In discussing anesthetic options for a given procedure,
likelihood of each, based on the available clinical evidence, anesthesia providers should consider several aspects,
as informed by the responsible practitioner’s professional including the best options given the skill set of the pro-
judgment. Informed consent must be obtained, and the vider, the comorbidities of the patient, and the prefer-
informed consent form must be placed in the patient’s ences of the surgeon. In a review of anesthesia consent
medical record, prior to surgery, except in the case of procedures, O’Leary and McGraw37 recommended that
emergency surgery. an explanation of the relevant risks and benefits of alter-
native techniques as well as the likelihood and details of
The interpretive guidelines note that there is no specific a backup plan should be included in informed consent.
requirement for informed consent governing anesthesia The investigators recommended that anesthesia provid-
services but also state that “given that surgical procedures ers adopt a separate, written consent form for the admin-
generally entail the use of anesthesia, hospitals may wish istration of anesthesia services. A form that clearly
to consider specifically extending their informed consent delineates common risks but allows documentation of
policies to include obtaining informed consent for the patient-specific risks should be used. Ideally, the anesthe-
anesthesia component of the surgical procedure.”31 sia provider should obtain the patient’s consent for anes-
As patients have become more engaged in their health thesia and should not rely on other professionals who are
care and are reaching out to nontraditional sources of not competent to explain the risks and benefits of anes-
information, other approaches to ensuring informed thesia options.
consent have been proposed. Studies have demonstrated
that standard counseling often results in inadequate deci-
sion quality.32 Some patients may have an incomplete
Capacity to Consent/Mental Competence
understanding of the risk and benefits of a treatment, and Physicians are bound by ethics and required by law to
clinicians are often poor judges of patients’ values; con- obtain a patient’s informed consent before initiating
sequently, there may be overuse of treatments that treatment. This premise assumes that a patient is compe-
informed patients would not choose or value.33 Thus, tent and/or has the capacity to successfully participate in
decision-making aids are used to improve the quality of this process. Competence generally refers to the patients’
informed consent and to reduce unnecessary practice legal authority to make decisions about their health care.
variations by (1) providing facts about the condition, Adult patients, typically 18 years of age or older, are
options, outcomes, and risks; (2) clarifying patients’ eval- presumed to be legally competent to make such decisions
uations of the outcomes that are most meaningful to unless otherwise determined by a court of law. Capacity
them; and (3) guiding patients in the steps of deliberation typically focuses on the clinical situation surrounding the
and communication so that a choice can be made that informed consent process. For example, an otherwise
reflects their informed values. These decision-making normal patient who has been given sedation may be
aids may be used by practitioners and/or patients in either legally competent but temporarily incapacitated and
770 PART VIII Anesthetic Complications

therefore unable to give informed consent.38 The deter- determination made by the health care providers that the
mination as to whether a patient has the capacity to minor is mature and emancipated for consent purposes,
provide informed consent generally is a professional and (3) by a judicial determination of emancipation.
judgment made by the treating health care provider. Parental involvement in a minor’s health care deci-
However, if a court has made a judgment regarding a sions is usually desirable. For most health care decisions,
patient’s capacity to make such decisions, the health care a parent is required to provide consent for medical treat-
provider(s) should obtain a copy of the court order, ment of a minor patient.42 However, many minors will
because it may delineate whether the patient is consid- not take advantage of some available medical services if
ered able to make his or her own health care decisions. they are required to involve their parents.43 The list of
For example, a guardianship is a type of court proceeding services for which minors can legally give consent has
that may have an impact on the informed consent process. recently expanded to include (1) sexual and reproductive
If a patient has a legal guardian with the authority to health care, (2) mental health services, and (3) alcohol and
make health care decisions on behalf of the patient, that drug abuse treatment. The majority of states also permit
guardian should be consulted about the patient’s care and minor parents to make important health care decisions
is the person legally authorized to provide consent. A regarding their own children.
failure to recognize a lack of capacity may expose a physi- In most states, consent laws apply to minors 12 years
cian to liability for treating a patient without valid of age and older. For example, 26 states and the District
informed consent. of Columbia allow minors (12 years of age and older) to
The legal standards for decision-making capacity vary consent to contraceptive services. All states and the Dis-
among jurisdictions but generally encompass the follow- trict of Columbia allow minors to consent to treatment
ing criteria: The patient must be able to (1) understand for sexually transmitted infections. Thirty states and the
the relevant information, (2) appreciate the situation and District of Columbia allow minor parents to consent to
its consequences, (3) reason about treatment options, and medical care for their children. For some medical treat-
(4) communicate a choice.39 When the patient is unable to ment, including contraception and obstetric care, case
do so, surrogate decision-makers may be sought. In emer- law has generally held that minors have rights of privacy
gency situations, physicians can provide necessary care and autonomy that are fundamental and equivalent to the
under the presumption that a reasonable person would rights of adults.44
have consented to the anticipated treatment.40 Most states In addition to statutes and case law regarding a minor’s
have laws that delineate who is legally authorized to ability to provide consent, there also exists a broader legal
provide consent for health care decisions on behalf of concept—the emancipated or mature minor doc-
an incapacitated individual. State laws vary, but they typi- trine.45 This doctrine allows health care providers to
cally provide a list of persons (in order of priority) who determine whether a minor is emancipated for providing
may give consent. These laws assume that legal relatives medical consent. Case law may not give a precise defini-
are the most appropriate surrogate decision-makers. tion of an emancipated minor, but it may list criteria that
However, the competent patient is free to select any com- health care providers should consider. Such criteria may
petent adult to act as his or her health care decision-maker include the minor’s age, maturity, intelligence, training,
by executing a durable power of attorney for health experience, economic independence, and freedom from
care, which appoints that person as his or her agent. parental control. When a minor is deemed emancipated
Health care providers are required to make reasonable for medical consent, the health care provider should
efforts to locate a person in the highest possible category document the objective facts that support the emancipa-
to provide consent. If there are two or more persons in tion decision, consistent with institutional policies and/
the same category (e.g., adult children), then the medical or other legal guidance.
treatment decision must be unanimous among those Some states have adopted emancipation statutes that
persons. These surrogate decision-makers generally are permit minors to file for emancipation status in court.46
required to make “substituted judgment” decisions on Typically, a minor is required to be a minimum age to file
behalf of the patient (i.e., they are obligated to decide as for emancipation. Once the court grants emancipation
they believe the patient would, not as they may prefer). status, a minor generally has the right to give informed
If what the patient would want under the circumstances consent for health care. A signed copy of the court’s
is unknown, then the surrogate must make a decision emancipation order should be placed in the patient’s
consistent with the patient’s “best interests.”41 The sur- medical record.
rogate decision-maker has the authority to provide Emancipation per se does not alter the requirement
consent for medical treatment, including nontreatment. that a patient provide informed consent for medical treat-
ment, including nontreatment. Emancipation status
affords the minor patient rights (for providing consent)
Minor Patients that are equal to those of an adult patient. The emanci-
Existing laws regarding the ability of minors to provide pated minor (like any adult patient) must have the ability
their own consent for medical care may be viewed as to weigh the risks and the benefits of the proposed treat-
a patchwork quilt. Statutes and case law differ from ment or nontreatment.
state to state. There are three ways in which a minor In summary, health care providers typically should
may be deemed able to give his or her own consent for obtain consent from the minor’s parents before providing
medical care: (1) by state law that permits the minor to nonemergency treatment unless the minor is emanci-
consent for the specific type of care, (2) by a clinical pated (by either a clinical or judicial determination) or
33 Medicolegal Issues in Obstetric Anesthesia 771

the minor is permitted by statute to give consent to the written consent was obtained. The verbal-plus-written
type of health care sought. consent group had significantly higher median (range)
recall scores (90 [80-100]) than the verbal-only group (80
[70-90]). Only two women (both in the verbal group)
Consent for Labor Analgesia believed that they were unable (because of either inade-
It is common practice for surgical patients to sign a pre- quate information or situational stress) to give valid
operative consent form, which often includes a statement consent. The investigators concluded that “the high
giving consent for anesthesia. The situation in obstetrics recall scores achieved by the women in both groups
is somewhat different in that not all laboring women suggest that the majority of laboring women are at least
require operative delivery. Several years ago, an unpub- as mentally and physically competent to give consent as
lished survey of obstetric centers in the greater Seattle, preoperative cardiac patients.”
Washington, area revealed that approximately half of the Clark et al.52 randomly assigned hospital inpatients
institutions did not require a signed consent form for to receive either an oral anesthesia discussion alone
obstetric procedures other than cesarean delivery. At or both an oral anesthesia discussion and a preprinted
many of these institutions, a separate written consent anesthesia consent form. In contrast to the results of
signed by the patient is not obtained before administra- Gerancher et al.,51 these investigators found that “patients
tion of anesthesia. A 1995 survey of obstetric anesthesi- remembered less of the information concerning anes-
ologists in the United States and the United Kingdom thetic risks discussed during the preoperative interview
indicated that 52% of U.S. anesthesiologists (but only if they received a preprinted, risk-specific anesthesia
15% of U.K. anaesthetists) obtained a separate written consent form at the beginning of the interview.” They
consent for epidural analgesia during labor.47 In a survey speculated that “patients who see an anesthesia consent
performed in the United Kingdom in 2007,48 only 7% of form for the first time during the preoperative interview
obstetric units routinely obtained written informed may try to read and listen simultaneously, and with their
consent for epidural analgesia during labor. In a 2004 attention divided, may remember less of the preoperative
survey from Australia and New Zealand,49 less than 20% discussion.”
of anesthesia providers obtained written consent before Anesthesia providers have expressed concern about the
initiating neuraxial labor analgesia. adequacy of the informed consent process when women
Some health care facilities and organizations have are experiencing the severe pain of active labor. A 2005
begun using a consent form for obstetric and anesthetic study evaluated whether labor pain and neuraxial fentanyl
procedures that may be desired or necessary during labor administration affect the intellectual function of laboring
and delivery. The process of reviewing and signing the women.53 The Mini-Mental Status Examination (MMSE)
consent form provides a specific opportunity for the was used to evaluate orientation, registration, attention,
patient to ask questions. It also provides additional docu- calculation, recall, and language both before and after
mentation that consent was obtained. The combined initiation of analgesia in 41 laboring women. There was
form has the additional advantage of not requiring the no difference in MMSE scores before and after adminis-
patient to sign multiple medicolegal documents. Although tration of neuraxial analgesia.
a signed consent form is not necessary, it should be stan- In summary, it seems reasonable for the patient to
dard practice for anesthesia providers to document that provide her signature as evidence of her consent, if her
verbal informed consent was obtained before administra- condition permits. This consent can be furnished on a
tion of anesthesia. separate anesthesia consent form or as part of a consent
Ideally, the anesthesia provider will discuss anesthetic form for all obstetric care, including anesthesia. A signed
options before the patient is in severe pain and distress. consent form is preferable, but it should be standard
Unfortunately, the anesthesia provider often first encoun- practice for the anesthesia provider to explain the intended
ters the patient when she is in severe pain. Although the procedure, risks, and alternatives and to document this
provider may tailor the consent process to the circum- discussion in the medical record.
stances, the presence of maternal pain and distress does
not obviate the need for a frank discussion of the risks of
anesthesia as well as the alternatives. A survey of Cana- REFUSAL OF CARE
dian women revealed their strong preference to be
informed of all possible complications of epidural anes- Documentation
thesia, especially serious ones, even when the risk was
quite low.50 This study and others have emphasized that Competent adult patients may refuse medical treatment,
parturients desire to have these discussions as early in including life-saving care.42 Health care providers gener-
labor as possible. ally determine whether a patient is capable of making
Gerancher et al.51 performed a study to evaluate the medical treatment choices (see earlier discussion). In
ability of laboring women to recall the details of a pre- theory, the health care providers’ clinical judgment about
anesthesia discussion and to determine whether verbal a patient’s capacity to provide informed consent is the
consent alone or a combination of verbal and written same regardless of whether the patient approves or disap-
consent provided better recall. The investigators ran- proves the treatment plan. In practice, however, these
domly assigned 113 laboring women to one of two situations are often handled differently. When a patient
groups, those from whom verbal consent alone was consents to the recommended medical treatment,
obtained and those from whom verbal consent plus minimal scrutiny of his or her decision-making capacity
772 PART VIII Anesthetic Complications

is typically made. However, when a patient refuses poten- infant died approximately 2 hours after delivery, and the
tially life-saving treatment, a higher level of scrutiny is mother died 2 days later.
applied to the patient’s ability to understand and make a This case spawned extensive debate as to whether
choice for nontreatment. Determination of a patient’s coercive intervention to protect the fetus is ever morally
capacity to give informed consent is typically a clinical and legally justifiable.56 With the assistance of the Ameri-
judgment. State law may provide some definitions as to can Civil Liberties Union, Angela’s parents sued the hos-
when a person may not be competent. pital, 2 administrators, and 33 physicians for claims
If a patient refuses potentially life-saving treatment, including battery, false imprisonment, discrimination,
the health care providers should carefully assess the and medical malpractice. These civil lawsuits were settled
patient’s capacity to provide informed consent. It may be after several years of litigation, and as part of this process,
advisable to obtain a psychiatric consultation as part of the hospital adopted a written policy concerning decision-
this clinical determination. It is important to document making for pregnant patients.57 The court later reversed
the determination of capacity and the objective facts sup- its initial decision authorizing the surgical delivery and
porting the decision. If a patient is deemed able to provide ultimately issued an opinion setting forth the legal prin-
consent, he or she is able to either choose or reject the ciples that should govern the doctor–pregnant patient
recommended treatment plan. Institutional policies may relationship.58 The court stated, “In virtually all cases the
require the patient (or health care provider if the patient question of what is to be done is to be decided by the
refuses) to sign an “Against Medical Advice” form for a patient—the pregnant woman—on behalf of herself and
non–medically approved discharge. If a patient is deemed the fetus. If the patient is incompetent…her decision
unable to consent, the health care providers should obtain must be ascertained through substituted judgment.” In
consent from a legally authorized surrogate decision- affirming that the patient’s wishes, once ascertained, must
maker on the patient’s behalf. If an incompetent patient be followed in “virtually all cases” unless there are “truly
needs emergency medical care, it may be provided extraordinary or compelling reasons to override them,”
consistent with an “emergency exception” (see earlier the court did not foreclose the possibility of exceptions
discussion). to this rule.
Many contemporary medical ethicists agree that a
Conflicts Arising out of the Maternal- pregnant woman’s informed refusal of medical interven-
tion should prevail as long as she has the capacity to make
Fetal Relationship medical decisions.59 Newer legislation and some high-
Almost all pregnant women consider the welfare of their profile legal cases (some involving criminal prosecution)
unborn child to be of utmost importance. However, there have challenged this notion and have raised the question
may be situations in which maternal and fetal interests of whether there are circumstances in which a pregnant
appear divergent or, potentially, in conflict. One example woman’s rights to informed consent and bodily integrity
is when a pregnant woman refuses a diagnostic proce- may be subordinated to protect her unborn child. In
dure, a medical treatment, or a surgical procedure that is 2004, Amber Rowland, a woman who had given birth
intended to enhance or preserve fetal well-being. Another vaginally to six children (with birth weights up to 12
may arise when the pregnant woman’s behavior is con- pounds), was told by her treating physicians at a Penn-
sidered harmful to the fetus.54 Physicians who care for sylvania hospital that she should undergo a cesarean
pregnant women may confront challenging dilemmas delivery on the basis of an ultrasonographic examination
when their patients reject medical recommendations, use that suggested an estimated birth weight of 13 pounds.
illegal drugs, or engage in other behaviors that may When she refused, the hospital obtained a court order
adversely affect fetal well-being. for a “medically necessary” cesarean delivery. She and her
Appellate court decisions typically have held that a husband left the hospital against medical advice and went
pregnant woman’s decisions regarding medical treatment to another facility, where she uneventfully delivered a
take precedence over the presumed fetal consequences of healthy 11-pound daughter.60
the maternal decisions.55 One case illustrates the evolu- Other cases have focused on the pregnant woman’s
tion of this judicial approach. Angela Carder was a potentially harmful behavior. In 1991, Regina McKnight,
26-year-old married woman who had had cancer since who was pregnant at the time, began using cocaine after
age 13 years. At 25 weeks’ gestation she was admitted to her mother’s death. She had a stillbirth, and the state of
George Washington University Hospital, where a massive South Carolina charged her with homicide by child
tumor was found in her lung. Her physicians determined abuse, claiming that her drug use caused the stillbirth.
that she would die within a short time. Her husband, her She became the first South Carolina woman to be con-
mother, and her physician agreed with her expressed victed of this crime, for what both the defense and pros-
wishes to be kept comfortable during her dying process. ecution agreed was an unintentional stillbirth, and she
Ultimately, the hospital sought judicial review of this spent nearly 8 years in jail. In 2008, the South Carolina
course of action. The hospital asked whether a surgical Supreme Court unanimously reversed her conviction on
delivery should be authorized to save the potentially the grounds that she did not receive a fair trial, primarily
viable fetus. The situation was presented to a judge, who on the basis that her attorney failed to challenge the
authorized an emergency cesarean delivery without first science that was used to convict her.61
ascertaining (using the principle of substituted judgment) Also in 2008, the Southern Poverty Law Center, along
the patient’s wishes. A cesarean delivery was performed with 25 medical, public health, and health advocacy
without full consideration of the patient’s wishes, the groups, filed an amicus curiae brief against the prosecution
33 Medicolegal Issues in Obstetric Anesthesia 773

of pregnant women in Covington County, Alabama, sub- resolution, a 1999 ACOG opinion offered the following
sequent to the following event. Shekelia Ward delivered three options: (1) respect the patient’s autonomy and not
an infant on January 8, 2008. Both she and her newborn proceed with the recommended intervention regardless
tested positive for cocaine during their hospital stay, and of the consequences, (2) offer the patient the option of
the facility reported it to authorities for possible child obtaining medical care from another individual before
abuse.62 The following day she was arrested, imprisoned, conditions become emergent, and (3) request that the
and charged with a felony—chemical endangerment of a court issue an order to permit the recommended treat-
child. The state statute at issue was passed by the Alabama ment.68 In 2004, the ACOG addressed the situation in
legislature in 2006, for the purpose of prosecuting parents which health care providers may consider this last option
who exposed children to the toxins associated with meth- (i.e., legal intervention against a pregnant woman).54 Spe-
amphetamine production; the statute did not mention cifically, the ACOG stated that the following criteria
pregnant women or their fetuses.63 should be satisfied: (1) “there is a high probability of
These statutes reflect the concept that a fetus can and serious harm to the fetus in respecting the patient’s deci-
should be treated as separable and legally, philosophically, sion”; (2) “there is a high probability that the recom-
and essentially independent from the mother.55 The mended treatment will prevent or substantially reduce
refinement of techniques of intrauterine fetal imaging, harm to the fetus”; (3) “there are no comparably effective,
testing, and treatment prompted the view that fetuses are less intrusive options to prevent harm to the fetus”; and
independent patients who can be treated directly while (4) “there is a high probability that the recommended
in utero.64 The prominence of some ethical models that treatment [will] also benefit the pregnant woman or that
have asserted that physicians have moral obligations to the risks to the pregnant woman are relatively small.”
fetal patients separate from their obligations to pregnant The ACOG opinions assume the presence of compe-
women also contributed to these developments.65 Finally, tency and informed consent. Thus, if a pregnant patient
a number of laws (primarily passed at the state level) were is believed to be incompetent and incapable of providing
enacted with the aim of defining fetal rights separate from informed consent, the health care providers may not be
a pregnant woman’s rights. In 2011, the American College required to respect the patient’s refusal of care. Moreover,
of Obstetricians and Gynecologists (ACOG) Committee if the patient is deemed incompetent and/or a medical
on Health Care for Underserved Women issued a state- emergency exists, care may be provided with consent
ment addressing the issue of substance abuse reporting from a legally authorized surrogate decision-maker or as
and the role of the obstetrician.66 This document an “emergency exception.”
described a “disturbing trend” in legal actions and poli- In summary, two approaches are available to the
cies that criminalized drug abuse during pregnancy when practitioner dealing with maternal-fetal conflict. One
such abuse is thought to be associated with fetal harm or approach is to honor a competent pregnant patient’s
adverse outcomes. Noting that women seeking obstetric refusal of care. The other approach (which appears least
care should not be exposed to criminal or civil penalties favored by many medical ethicists and the ACOG) is to
and that few treatment facilities are available to effectively seek judicial authorization of treatment, which overrides
treat drug abuse in pregnancy, the ACOG concluded that a competent pregnant woman’s refusal of care.69
the use of the legal system to address alcohol and sub- In honoring a competent patient’s desires to refuse
stance abuse issues is inappropriate and urged that policy treatment, the health care providers should carefully
makers and legislators instead focus on strategies to document the woman’s competency and ability to provide
address the needs of pregnant women with addictions. informed consent. Every attempt should be made to
The American Medical Association (AMA) has taken counsel her to follow the treatment recommendations.
a similar position, stating that (1) drug addiction is a Documentation should include how, when, and what
disease amenable to treatment, rather than a criminal information was provided to the patient and family
activity, and (2) there is a pressing need for maternal drug regarding the significant risks to both the patient and the
treatment and supportive child protective services.67 Any unborn child if the recommended care were not pro-
legislation that criminalizes maternal drug addiction or vided. If time permits, the treatment options should be
requires physicians to function as agents of law enforce- reevaluated with the patient at frequent intervals, with
ment will be opposed by the AMA.67 detailed documentation in the patient’s medical record.
During the past two decades, practitioners have only Additionally, legal counsel for the health care providers
infrequently resorted to court-ordered interventions and medical facility may wish to prepare an “assumption
against the wishes of the pregnant woman. In overturning of risk” form for the patient (and, if possible, her husband)
the previous court’s decision in the Angela Carder case to sign. This form represents another level of documen-
(mentioned earlier), the Washington, DC, Court of tation (beyond the detailed notes in the patient’s medical
Appeals noted that if a pregnant woman makes an informed record) demonstrating that the patient was fully informed
decision, “her wishes will control in virtually all cases.”58 about the risks associated with her refusal of treatment
The court added, “We do not foreclose the possibility that and that she voluntarily elected to accept those risks.
a conflicting state interest may be so compelling that the However, such a release signed by the parents may not
patient’s wishes must yield, but we anticipate that such protect the physician and medical facility from a claim
cases will be extremely rare and truly exceptional.”58 brought on behalf of the child who suffers an injury as a
Medical ethicists and practitioners agree that clear result of nonintervention. In some cases the court has
communication and patient education represent the found that physicians have a duty to provide care to the
best means to address maternal-fetal conflict. Failing unborn child.70
774 PART VIII Anesthetic Complications

Patient “assumption of risk” does not release a health 44,000 to 98,000 patients each year.73 In December 2006,
care provider from his or her obligations to provide other the Institute for Healthcare Improvement (IHI) initiated
treatment within the accepted standard of care. For the 5 Million Lives Campaign.74 At that time, the IHI
example, in Shorter v. Drury,71 a case that involved a estimated that 15 million incidents of harm occurred
patient’s refusal of blood transfusion because of religious in U.S. hospitals each year (40,000 per day). Since that
preferences, the court upheld the validity of an “assump- time, the prevalence of medical errors remains unac­
tion of risk” (i.e., release) that relieved the physician from ceptably high and continues to draw the focus of the
liability for compliance with the patient’s refusal of blood public, regulators, and health care providers.75 Large-
transfusion before and after surgery but nonetheless held scale efforts are underway to improve the safety in health
him partially responsible for her death because of his care, and many organizations have achieved remarkable
negligent performance of the surgery.71 improvements.76
Before deciding whether to seek court review, health Most practitioners strive to provide the highest quality
care providers should identify what issue they want the of care, but even with the growing focus on patient safety,
court to resolve. Is it whether the pregnant woman is unintended consequences—including patient injury and
competent? Is it whether there is a superior state interest death—do occur. Unfortunately, most physicians remain
in preserving the life of the viable fetus and/or the preg- largely unprepared to engage patients and their families
nant woman despite the (competent) patient’s desire to in a timely, truthful, and candid manner in the aftermath
refuse recommended care? Health care providers also of such events. In 1984, David Hilfiker wrote candidly
should consider whether a court is the proper forum for of a life-altering mistake that he had made as a family
resolving those issues or whether another forum (e.g., an physician treating a young woman in a small town in
institutional ethics committee) may be a better choice. If Minnesota.77 Hilfiker was caring for a young woman
a patient care dilemma is put before a judge, the health named Barb Daily whom they both believed to be preg-
care providers give up a large amount of control over the nant. He had delivered Barb and Russ Daily’s first child,
disposition of the case. Nonetheless, if a patient’s com- Heather, 2 years earlier, and he had been a friend of the
petency is at issue and there is adequate time, court review couple for some years. After several months of care, her
to settle the patient’s competency may be beneficial and serial urine pregnancy test results remained negative and
is supported by both the ACOG guidelines54 and the In her uterus was only slightly enlarged. Concluding that
re: A.C. decision.58 It is beneficial to obtain authorization she may have experienced a missed abortion, Hilfiker
for the provision of medically recommended care without scheduled her for a dilation and curettage. The procedure
waiting until the situation becomes an emergency. If the was performed, but it became apparent that the diagnosis
patient is deemed incompetent, the court may either was incorrect and the procedure had been carried out
appoint a surrogate decision-maker or directly authorize with a live fetus. In his reflections on the event, Hilfiker
(by court order) the provision of medically indicated care. wrote of a physician’s expectations of perfection, the lack
It is not unusual for physicians to disagree with their of training in dealing with unexpected outcomes and mis-
patients’ health care decisions, and such differences are takes, and the damaging effects of these conditions on
expected. In some cases, physicians conclude that provid- physicians.77
ing the requested care would present a personal moral Disclosure of errors and unanticipated outcomes is a
problem—a conflict of conscience, which prompts them key component in the national patient safety movement.
to refuse to provide the requested care. Conscientious It is also an ethical mandate and a regulatory require-
refusals have become especially prevalent in the practice ment. The ethical imperative is captured in the following
of reproductive medicine, an area characterized by deep passage from the Charter on Medical Professionalism, pub-
societal divisions regarding the morality of contraception lished by the American Board of Internal Medicine
and pregnancy termination. The ACOG Committee on (ABIM) Foundation78:
Ethics72 has acknowledged that “respect for conscience is
one of many values important to the ethical practice of Physicians should also acknowledge that in health care,
reproductive medicine.” The ACOG stated that when medical errors that injure patients do sometimes occur.
conscience implores physicians to refuse to perform Whenever patients are injured as a consequence of medical
abortion, sterilization, and/or provision of contracep- care, patients should be informed promptly because failure
tives, “they must provide potential patients with accurate to do so seriously compromises patient and societal trust.
and prior notice of their personal moral commitments.” Reporting and analyzing medical mistakes provide the
The ACOG committee opinion also emphasized that basis for appropriate prevention and improvement
providers have an obligation to provide medically indi- strategies and for appropriate compensation for injured
cated care in an emergency that threatens the patient’s parties.
health, in which referral is not possible.72
The AMA’s Code of Medical Ethics contains the follow-
ing statement: “It is a fundamental ethical require­
ment that a physician should at all times deal honestly
DISCLOSURE OF UNANTICIPATED and openly with patients…. Concern regarding legal
OUTCOMES AND MEDICAL ERRORS liability, which might result following truthful disclosure,
should not affect the physician’s honesty with a patient.”79
In 1999, the Institute of Medicine (IOM) estimated that The Joint Commission standard RI.2.90 requires that
preventable medical errors in the hospital setting kill “patients and, when appropriate, their families, are
33 Medicolegal Issues in Obstetric Anesthesia 775

informed about the outcomes of care, treatment, and


services that have been provided, including unantici­ CONTEMPORARY RISK
pated outcomes.”80 Many states require reporting of MANAGEMENT STRATEGIES
medical errors, and some have legislated “apology” laws
that encourage practitioners to be empathetic and honest Prevention of medical errors and adverse outcomes
with patients by allowing certain statements of sym­ frequently focuses on the safety culture of the organiza-
pathy to be made without fear of admitting medical tion, communication and teamwork, and the intelligent
liability.81 use of protocols and checklists (see Chapter 11). The
Physicians and other health care providers should concept of a safety culture originated in organizations
undergo disclosure training to help them provide prompt outside of health care sometimes referred to as high reli-
and honest communication with patients and families and ability organizations (e.g., nuclear industry, aircraft
to help manage the risks of legal liability. Many untoward carrier operations).85 A culture of safety is characterized
outcomes do not represent malpractice; they may simply by an institution-wide commitment to minimize adverse
reflect risks or complications of procedures that may or events despite the performance of intrinsically complex
may not have been adequately discussed with patients and and hazardous work.86 The key features of a “culture of
their families before the procedure or treatment. Ade- safety” are:
quate informed consent is an essential element of an • An acknowledgment of the high-risk nature of an
effective disclosure program. Iatrogenic injuries, obvious organization’s activities and the pursuit of consis-
mistakes, wrong-site surgeries, medication errors, and tently safe operations.
similar events that harm the patient should clearly be • A “blame-free” environment that encourages indi-
disclosed. A failure to disclose such an error may lead the viduals to report errors or near misses without fear
patient (or the attorney) to conclude that health care of reprimand or punishment.
providers made a deliberate effort to “cover up” the error. • Encouragement of collaboration across levels and
Furthermore, nondisclosure after such an event can lead disciplines of the organization to seek solutions to
to a charge of fraud. In most situations in which a pro- the prevention of errors.
vider conceals an error, the law provides that the statute • Organizational commitment of resources to address
of limitations “clock” for filing a malpractice claim does the safety concerns.
not begin to run until the fraudulent concealment is Safety culture has been defined and can be measured;
discovered. poor safety culture has been linked to increased error
In 2006, the Harvard teaching hospitals and their asso- rates and adverse outcomes. Achieving a culture of safety
ciated Risk Management Foundation developed a docu- in health care is daunting, because a culture of individual
ment entitled, “When Things Go Wrong: Responding blame remains dominant and traditional. An issue that
to Adverse Events.”82 This white paper acknowledged the often arises is balancing the twin concepts of “no blame”
presence of many barriers to disclosure, including the and appropriate accountability. This is a particular strug-
fear of being sued, but the authors insisted that commu- gle with physicians, given that few organizations have
nication with patients and their families must be timely, implemented meaningful systems of accountability that
open, and ongoing. In addition to stressing the impera- apply to the physicians.87
tive of providing support for the patient and/or family Communication and teamwork lapses are one of the
involved in the unexpected outcome, the paper empha- primary causes of sentinel events identified by The Joint
sized the need to provide support to the health care Commission from 2009 to 2011.88 A 2010 review of
providers involved. This concern is reflected in a 2008 obstetric malpractice risks by a major insurer found that
survey that indicated that as many as 75% of obstetricians 65% of the malpractice cases involved high-severity inju-
felt that caring for a patient with a stillbirth exacted a ries, including maternal and infant deaths.89 The most
large toll on them, with almost 10% of those affected frequent contributing factors were substandard clinical
considering giving up their obstetric practice.83 judgment (77% of claims) and miscommunication (36%
Organizations that have adopted robust disclosure of claims). The report specifically noted that “at the
policies often have early settlement or “offer” programs, intersection of individual decision making and team com-
with the goals of reducing the overall costs of claims and munication, teamwork training fosters development of a
speeding the resolution process. Recognizing the long- culture and structure for effective communication and
standing gridlock over tort reform, this and other decisive action. Its hallmarks—development of shared
approaches may provide a better balance between the mental models, broad situational awareness, and clear
interests of health care providers and their patients. Not communication among team members—facilitate clini-
only is it an opportunity to reform the process of com- cians’ ability to timely identify signs of distress and take
pensating those who may have been injured, but it can appropriate action.”89
also be linked to improvements in patient safety. A dis- There is also increasing recognition of the value of
tinguishing feature of “disclosure and offer” models is smart checklists and protocols. Checklists may simplify
that information and insights generated from the inves- complex procedures and make them less prone to error.
tigative process can be shared and analyzed for the pur- Checklists may reduce the mental flaws inherent in human
poses of implementing interventions that improve patient behavior.90 The ACOG has issued an opinion noting that
safety.84 Physicians have a unique opportunity to lead “protocols and checklists have been shown to improve
such efforts, and their participation promotes the buy-in patient safety through standardization and communica-
of other staff members. tion. Standardization of practice to improve quality
776 PART VIII Anesthetic Complications

outcomes is an important tool in achieving the shared 80


vision of patients and their health care providers.”91
70

Claims by decade (%)


Some health care organizations and liability insurers
60
are now adopting strategies to specifically promote these
goals (e.g., offering financial incentives to providers for 50
completing disclosure training, participating in multidis- 40
ciplinary didactic training programs to support accurate 30
interpretation of electronic fetal heart rate tracings, the 20
adoption of other safe practices). Federal agencies, 10
working with health care organizations and liability pro- 0 N=724
viders, are also supporting similar initiatives.92 1970s 1980s 1990s 2000s
n=60 n=290 n=264 n=110

General Neuraxial
LIABILITY PROFILES IN OBSTETRIC
ANESTHESIA: THE AMERICAN SOCIETY FIGURE 33-1 ■ The percentage of claims in which the anesthetic
technique for cesarean delivery was either neuraxial or general.
OF ANESTHESIOLOGISTS CLOSED- Data are shown as the percentage of the total number of claims
for the indicated decade. (Data from the ASA Closed-Claims
CLAIMS PROJECT Project database, N = 9536, December 2010.)

In 1985 the ASA Committee on Professional Liability


began an ongoing study of insurance company liability We can ask such questions as: What injuries are most
claims involving anesthesiologists. Cases that are closed common in obstetric anesthesia claims? What is the rela-
(i.e., no longer active) are reviewed by practicing anes- tionship between the type of anesthesia and the presumed
thesiologists, abstracted, double-checked by the ASA injury? What are the precipitating events that lead to the
Closed-Claims Committee, and entered into a computer injuries? How do payment rates compare between obstet-
database. In 1991 and 1996 comprehensive analyses of ric and nonobstetric claims?
obstetric anesthesia claims were published, based on a Approximately 12% of the 9536 claims in the ASA
total database of 1541 and 3533 claims, respectively.93,94 Closed-Claims Project database involve anesthesia care
In 2009, another publication compared obstetric claims for patients undergoing vaginal or cesarean delivery. Of
from 1990 to 2003 with those before 1990.95 As of these obstetric claims, 66% involve cesarean delivery.
December 2010, some 9536 claims (excluding those for The anesthesia workforce surveys conducted in 1981,
dental injuries) from more than 35 insurance companies 1992, and 2001 revealed a significant increase in the pro-
across the country have been reviewed and entered into portion of cesarean deliveries performed under neuraxial
the ASA Closed-Claims Project database. The analysis anesthesia and a corresponding decrease in those per-
reported in this chapter focuses specifically on the 640 formed with general anesthesia.97 An analysis of the ASA
obstetric claims in the ASA Closed-Claims Project data- Closed-Claims Project database illustrates a similar trend
base between 1990 and 2010. in the claims for cases involving neuraxial and general
It is important to recognize the limitations of this kind anesthesia for cesarean delivery (Figure 33-1).
of study. A closed-claims study cannot determine the
incidence of a complication, for a number of reasons.
First, the denominator is unknown. Neither the total
Anesthesia-Related Injuries
number of anesthetics given each year in each category Table 33-1 lists all injuries or complications that had a
nor the actual number of injuries per year is known. frequency of 3% or greater in the obstetric claims that
Second, not all injuries result in a claim of malpractice, occurred in 1990 or later, as well as the type of anesthesia
and the anesthesiologist may not be named in a claim that resulted in the injury. Maternal nerve damage and
resulting from an anesthesia-related injury. This latter neonatal brain damage were the most common injuries.
category may comprise a significant population of In contrast to previous analyses, the proportion of nerve
patients, which may make the relationship between cause damage claims is now greater than maternal death claims.
and injury impossible to construct.96 Conversely, anesthe- This finding likely reflects the increased use of neuraxial
siologists may be named in claims in which there was no anesthesia (with a corresponding decrease in the use of
anesthesia-related adverse event. general anesthesia) in obstetric anesthesia practice over
The claims that have been reviewed are not a random the past two decades. A significantly greater proportion
sample of such data. However, given the large number of nerve damage claims were associated with vaginal
of participating insurance carriers, they are likely to be delivery compared with cesarean delivery. Although
broadly representative of liability claims involving obstet- nerve damage in obstetric patients is more likely second-
ric anesthesia care in the United States. ary to obstetric causes (e.g., vaginal delivery, fetal position
Despite the significant limitations of closed-claims during pelvic descent, maternal position during the
studies, such efforts do provide information that cannot second stage of labor [see Chapter 32]) than directly
be obtained in other ways. For example, claims involving attributable to neuraxial anesthesia, the obstetric claims
obstetric anesthesia care can be compared with those analysis published in 2009 found that nearly two thirds
from other types of anesthesia practice to determine of the nerve damage claims may be directly linked to a
whether different patterns of injury and outcome emerge. neuraxial procedure.95 Unfortunately, in many cases it is
33 Medicolegal Issues in Obstetric Anesthesia 777

TABLE 33-1 Most Common Injuries in Obstetric Anesthesia Claims*


Type of Anesthesia Type of Delivery
Obstetric Claims NEURAXIAL ANESTHESIA GENERAL ANESTHESIA CESAREAN VAGINAL
Injury (n = 640) (n = 489) (n = 123) (n = 387) (n = 286)
Maternal nerve damage 19% (119) 24% (117)‡ 2% (2) 13% (49)‡ 29% (69)
Neonatal brain damage 16% (102) 13% (58)‡ 29% (33) 21% (74)‡ 13% (28)
Maternal death 15% (94) 10% (49)‡ 36% (44) 18% (69)‡ 7% (17)
Headache 11% (72) 15% (72)‡ 0% (0) 7% (27)‡ 19% (45)
Back pain 10% (62) 13% (62)‡ 0% (0) 5% (20)‡ 17% (42)
Neonatal death 9% (60) 6% (26)‡ 24% (27) 13% (46)‡ 4% (9)
Emotional distress 8% (54) 9% (46) 6% (7) 11% (41)† 5% (13)
Maternal brain damage 7% (44) 7% (34) 7% (8) 9% (36)† 3% (8)
Pain during anesthesia 6% (38) 7% (32) 3% (4) 9% (34)‡ 2% (4)
Aspiration pneumonitis 1% (5) < 1% (2) 2% (3) 1% (4) < 1% (1)

*The most common injuries in the obstetric group of claims that occurred in 1990 or later are shown as % (n). Percentages are based on
the total claims in each group. Some claims indicated more than one injury and are represented more than once. Claims involving brain
damage include only patients who were alive when the claim was closed. Claims for which type of anesthesia or form of delivery were
unknown are excluded.
†P ≤ .01; ‡P < .001 compared with general anesthesia or vaginal delivery.
Data from the American Society of Anesthesiologists Closed-Claims Project database, N = 9536, December 2010.

almost impossible to differentiate between an anesthetic


or obstetric cause for the nerve injury; appropriate neu- TABLE 33-2 Maternal Injuries Compared
rologic consultation and investigation improves the like- with Similar Injuries in
lihood of a correct diagnosis in these patients. Nonobstetric Claims*
Some obstetric patients are reluctant to accept neur- Maternal Nonobstetric
axial anesthesia because of the fear of nerve injury. Injury Claims Injury Claims
Because such injuries are uncommon, anesthesia provid- Type of Injury (n = 640) (n = 4410)
ers often minimize the risks of neurologic injury in their Maternal/patient nerve 19% (119) 20% (868)
discussions with patients. An ASA Closed-Claims analysis damage
of injuries associated with neuraxial anesthesia in the Maternal/patient death 15% (94)‡ 30% (1325)
1980s and 1990s found that a significantly greater pro- Headache 11% (72)‡ 1% (44)
portion of obstetric neuraxial claims were associated with Back pain 10% (62)‡ 1% (62)
temporary and low-severity injuries than nonobstetric Emotional distress 8% (54)‡ 5% (201)
claims.98 Epidural abscess accounted for a greater propor- Maternal/patient brain 7% (44)† 10% (442)
tion, and epidural hematoma a significantly smaller pro- damage
portion, of obstetric neuraxial claims than nonobstetric Pain during anesthesia 6% (38)‡ 1% (45)
neuraxial claims. Combining both epidural abscess and Aspiration pneumonitis 1% (5)‡ 4% (164)
meningitis claims, infection was the leading cause of
*The most common maternal injuries in the obstetric anesthesia
obstetric neuraxial complications (46%).98 claims occurring 1990 or later are shown as % (n). Percentages
A nonreassuring fetal heart rate tracing and urgent or are based on the total claims in each group. Some claims had
emergency cesarean delivery were found to be factors in more than one injury and are represented more than once.
nearly three fourths of neonatal death/brain damage Claims involving brain damage include only patients who were
claims in 1990 or later.95 Determining whether a causal alive when the claim was closed.
†P ≤ .01; ‡P < .001 compared with nonobstetric claims.
link exists between the anesthetic care (negligent or oth- Data from the American Society of Anesthesiologists Closed-
erwise) and the injury to the neonate is often difficult. A Claims Project database, N = 9536, December 2010.
closer analysis of neonatal brain damage cases in the
1990s found that anesthesia care may have contributed
to adverse fetal outcome in less than a fourth of cases; in satisfactory anesthesia during cesarean delivery, as do
half of these cases, some delay in anesthesia care was patients undergoing other types of surgery. It is also
alleged.95 The payment rate on behalf of the anesthesiolo- interesting that headache and back pain are relatively
gist was 21% in the claims involving neonatal death/brain more common in the claims involving vaginal delivery.
damage, which was significantly lower than the payment This may result, in part, from factors unique to labor and
rate of 60% for maternal death/brain damage claims.95 vaginal delivery (e.g., back strain from assuming unnatu-
Some injuries (e.g., headache, pain during anesthesia, ral positions during childbirth, increased risk for post–
back pain) were almost exclusively associated with neur- dural puncture headache after bearing down during the
axial anesthetic techniques. Most claims involving pain second stage of labor).99,100
during anesthesia were associated with cesarean delivery Table 33-2 lists the most common injuries identified
(see Table 33-1). This finding suggests that inadequate after eliminating those involving only the neonate. This
analgesia for labor and vaginal delivery is rarely a source allows comparison of the profiles of maternal injury with
of liability risk. However, women expect to have those among the nonobstetric population. The most
778 PART VIII Anesthetic Complications

TABLE 33-3 Most Common Precipitating Events in Obstetric Anesthesia Claims*


Type of Obstetric
Anesthesia
Nonobstetric Claims Obstetric Claims NEURAXIAL GENERAL
Event (n = 4410) (n = 640) (n = 489) (n = 123)
Respiratory system events 22% (959)§ 5% (29) 1% (7)§ 16% (20)
Difficult intubation 6% (250)§ 2% (15) < 1% (1)§ 11% (14)
Aspiration 3% (149)§ 1% (5) < 1% (1)† 2% (3)
Inadequate ventilation/oxygenation 5% (202)§ 1% (7) 1% (5) 1% (1)
Premature extubation 2% (109)§ < 1% (1) 0% (0) 1% (1)
Airway obstruction 2% (72)§ < 1% (1) 0% (0) 1% (1)
Block-related events 11% (473)§ 41% (265) 54% (265)§ 0% (0)
High spinal/epidural 1% (30)§ 6% (41) 8% (41)§ 0% (0)
Dural puncture headache < 1% (20)§ 6% (40) 8% (40)§ 0% (0)
Inadequate analgesia < 1% (11)§ 5% (35) 7% (35)§ 0% (0)
Retained catheter < 1% (6)§ 4% (25) 5% (25)‡ 0% (0)
Neuraxial cardiac arrest 1% (43)† 2% (13) 3% (13) 0% (0)
Other block-related** 5% (240)§ 16% (101) 21% (101)§ 0% (0)
Surgical events/patient condition 9% (416)§ 25% (158) 19% (95)§ 38% (47)
Cardiovascular system events 15% (682)‡ 11% (69) 7% (35)§ 26% (32)
Hemorrhage 3% (126)§ 6% (38) 3% (15)§ 18% (22)
Pulmonary embolism 1% (49)§ 4% (23) 3% (15) 7% (8)
Medication events 8% (351)§ 4% (27) 4% (18) 6% (7)

*The most common damaging events occurring 1990 or later are shown as % (n). Chronic pain claims are excluded. Percentages are
based on the total claims in each group. Specific precipitating events were not identified in all claims. Some claims indicated more than
one damaging event, but only the most significant event is listed. Columns do not sum to 100% as minor events are not listed.
Statistical comparisons are made between obstetric and equivalent nonobstetric claims as well as between obstetric neuraxial and
obstetric general anesthetics.
†P < .05; ‡P < .01; §P < .001 compared with obstetric claims or general anesthesia.
**Of the 101 other block-related claims, 2% (12) were epidural abscess, 1% (5) were epidural hematoma, 2% (13) were other permanent
disabling nerve injuries, 7% (43) were temporary or minor nerve injuries, 1% (5) were meningitis, and 4% (23) were other
miscellaneous block-related events.
Data from the American Society of Anesthesiologists Closed-Claims Project database, N = 9536, December 2010.

striking finding is that the maternal claims contain a obstetric claims, and pulmonary aspiration was the pre-
much higher proportion of relatively minor injuries such cipitating event in 5 (1%) of the obstetric claims. Among
as headache, pain during anesthesia, back pain, and emo- the five aspiration claims, three were related to general
tional distress (35%) than do the nonobstetric claims anesthesia but only one was associated with a difficult
(8%). Obstetric patients may be at greater risk for some intubation; the other two occurred during the preinduc-
of these complications.98 For example, the popularity of tion period. In a fourth case, the patient was sedated with
neuraxial anesthetic techniques in obstetric anesthesia an unprotected airway and aspirated after vomiting. The
combined with the greater risk for post–dural puncture final case was unrelated to anesthesia.
headache in young females may account for the greater Several reports have suggested that difficult intubation
number of headache claims in the obstetric group. Pain and pulmonary aspiration are the leading causes of
during anesthesia is almost always associated with cesar- anesthesia-related maternal mortality.101-103 Interestingly,
ean delivery conducted with neuraxial anesthesia. These a study of anesthesia-related maternal deaths in the state
claims may have resulted from a reluctance by the anes- of Michigan between 1985 and 2003 found that no deaths
thesiologist to convert to general anesthesia because of occurred during induction of anesthesia; all cases related
the risk for aspiration or anticipated difficult airway man- to airway obstruction or hypoventilation (> 50% of
agement. In some cases claims may have resulted from anesthesia-related deaths) occurred postoperatively, often
other factors, such as unrealistic expectations or general when monitoring and supervision were inadequate.104
dissatisfaction with the care provided. Despite the reduction in the proportion of claims for
respiratory events in the past two decades,95 these data
reemphasize that (1) all obstetric patients are at risk for
Precipitating Events Leading to Injuries airway complications (e.g., difficult intubation, aspira-
Perhaps even more important than the injuries and com- tion); (2) anesthesia providers should be familiar with
plications that may result in claims are the precipitating protocols such as the ASA difficult airway algorithm; (3)
events that lead to the injuries (Table 33-3). Critical equipment should be immediately available for the man-
events involving the respiratory system were the most agement of patients in whom tracheal intubation proves
common anesthesia-related events in both the obstetric difficult; and (4) obstetric patients require the same stan-
and nonobstetric claims involving general anesthesia. dard of postanesthesia care as nonobstetric patients (see
The proportion of difficult intubation and aspiration ASA “Guidelines for Neuraxial Anesthesia in Obstetrics”
claims in the obstetric claims was found to be signifi- [Appendix A]).
cantly less than that in the nonobstetric claims. Difficult Obesity increases the risk for both obstetric105 and
intubation was the precipitating event in 15 (2%) of the anesthetic106,107 complications in pregnant women (see
33 Medicolegal Issues in Obstetric Anesthesia 779

Chapter 50). In the ASA Closed-Claims Project database, diagnosis and intervention (by both surgical and anesthe-
damaging events related to the respiratory system were sia providers), and the use of major obstetric hemorrhage
significantly more common among claims involving protocols to streamline response systems and improve
obese parturients (18%) than in the claims involving non- availability of blood products, have been shown to reduce
obese parturients (8%) (P < .05). However, the rates of major hemorrhage rates and improve outcomes (see
other injuries were not significantly different in obese Chapter 38).109
and nonobese parturients.93 An embolic disorder was the second most common
With the increasing use of neuraxial anesthesia for cardiovascular event related to maternal death in the ASA
both vaginal and cesarean deliveries, it is not surprising Closed-Claims Project database. Of the 23 embolic dis-
that neuraxial blockade–related events are the most order claims, 20 cases were due to amniotic fluid embo-
common precipitating events in the obstetric population, lism; only 3 cases were due to venous thromboembolism.
accounting for a significantly greater proportion of cases This finding may reflect the effectiveness of peripartum
than found among the nonobstetric claims. The use of thromboprophylaxis measures that have been widely
an effective epidural test dose, the incremental injection introduced over the past decade.
of the therapeutic dose of local anesthetic, the availability
of ropivacaine and levobupivacaine, and the use of pencil-
point spinal needles (leading to a greater rate of spinal
Payments
anesthesia) have undoubtedly contributed to a reduction The practice of obstetrics is associated with high medi-
in the incidence of serious adverse outcomes associated colegal risk. The obstetric anesthesia provider may also
with epidural anesthesia in obstetric patients.102 However, be named in a malpractice suit, in an attempt to increase
the database includes several claims for neuraxial payments beyond policy limits. This belief is reinforced
anesthesia–associated cardiac arrest (predominantly sec- by well-publicized cases involving huge monetary awards.
ondary to unintentional intrathecal injection of drug) and However, the ASA Closed-Claims Project database pro-
for high spinal or epidural neuroblockade. Ironically, the vides a somewhat different perspective. For the purposes
number of claims for inadequate analgesia during neuro- of this discussion, a payment is considered to be any
blockade, usually during cesarean delivery, has also expenditure by the insurance carrier in the form of a
increased. settlement or award. Obstetric claims constitute 12% of
The proportion of cardiovascular events in the obstet- the ASA Closed-Claims database. Similarly, the obstetric
ric claims has increased over time; maternal hemorrhage claims account for 11% of the total number of payments
was the most common precipitating event (6%). More made and 14% of the total dollars expended in payments.
than half of the cases were associated with abnormal Clearly, the payments for obstetric claims were not dis-
placentation (placenta accreta or percreta); in several proportionately frequent or large. Table 33-4 provides
cases the abnormal placentation was not diagnosed before additional payment information. For claims in which
delivery. Inability or failure of the anesthesia provider payments were made, the median payment was greater in
to adequately resuscitate the patient was a factor in the the obstetric group. This is not surprising, considering
majority of cases. Delayed diagnosis of hemorrhage, that there are two patients at risk in obstetric anesthesia
poor communication among providers, unavailability of cases, and both the mother and her infant are younger
blood products, and inappropriate blood product replace- than the average age of patients in the nonobstetric files.
ment were other contributing factors. Death secondary Although the obstetric claims contained a lower propor-
to maternal hemorrhage is believed to be the most tion of deaths (either maternal or newborn), there was a
common preventable cause of maternal mortality.108 Early greater proportion of brain injuries (either maternal or

TABLE 33-4 Payment Data for Obstetric Anesthesia Claims Compared with Nonobstetric
Anesthesia Claims*
Type of Practice Type of Obstetric Anesthesia Type of Delivery
NONOBSTETRIC CLAIMS OBSTETRIC CLAIMS NEURAXIAL GENERAL CESAREAN VAGINAL
(n = 4410) (n = 640) (n = 489) (n = 123) (n = 387) (n = 241)
Payment 53% (2227) 45% (274)‡ 43% (198)† 55% (65) 49% (180) 39% (87)†
Made
Median 254,000 398,250‡ 284,375‡ 1,237,500 557,500 172,000‡
Payment ($)
Range ($) 129 to 33.96M 1293 to 19.65M 1293 to 19.65M 8000 to 11.55M 6223 to 19.65M 1293 to 8.33M

M, million.
*Payment frequency, shown as % (n), and dollar amounts (adjusted to 2011 values). Percentages are based on the total number of
claims occurring 1990 or later in each group with payment data. Statistical comparisons are made between obstetric and nonobstetric
claims, between obstetric neuraxial and general anesthetics, and between vaginal and cesarean deliveries. Claims with missing
payment data were excluded from the analysis.
†P ≤ .01
‡P ≤ .001.
Data from the American Society of Anesthesiologists Closed-Claims Project database, N = 9536, December 2010.
780 PART VIII Anesthetic Complications

newborn) than in the nonobstetric claims. Such injuries closed-claims studies is that they reflect the consumer
typically result in higher payments for projected lifelong perspective.
care requirements. To some extent the large proportion of relatively
minor injuries in the obstetric claims may reflect a higher
incidence of such problems among obstetric patients.
Lessons Learned However, it is clear that many of these patients were
The obstetric anesthesia claims reveal a risk profile that unhappy with the care provided and believed that they
differs from that of the nonobstetric anesthesia claims. had been ignored or mistreated. It has been suggested
Surprisingly, since 1990, problems involving airway man- that malpractice litigation serves the purposes not only
agement, especially difficult intubation and pulmonary of reparation of injury and deterrence of substandard care
aspiration, are disproportionately represented in the but also of emotional vindication.112,113 Anesthesia care
nonobstetric claims. The continuing decrease in the use providers should give attention to conducting themselves
of general anesthesia in obstetric cases, and the wide- in such a manner that patients will not be motivated to
spread use of difficult airway algorithms, may be factors bring suit for an unexpected outcome.114 The importance
that have contributed to improvements in obstetric of establishing good rapport with patients cannot be
patient safety. The incidence of systemic local anesthetic overemphasized. Whenever possible, anesthesiologists
toxicity has diminished. However, the ASA Closed- should involve themselves in the prenatal education
Claims Project database continues to receive information process. A careful preanesthetic evaluation is very impor-
on claims for severe adverse outcome resulting from tant and should occur as early in labor as possible. Special
neuraxial anesthesia–associated cardiac arrest (primarily care should be taken to provide patients with realistic
owing to unintentional and unrecognized intrathecal expectations and knowledge of potential major and minor
injection of drug). The data suggest that we need to risks associated with anesthetic procedures.
continue our efforts to reduce the risks of major compli-
cations of both general and neuraxial anesthesia. The
large number of claims for pain during neuraxial anesthe- PROFESSIONAL PRACTICE STANDARDS
sia for cesarean delivery, however, suggests that general
anesthesia should not be delayed or avoided if a patient One beneficial effect of closed-claims analyses has been
has inadequate anesthesia from neuraxial blockade. the greater attention to steps to minimize the occurrence
Unfortunately, anesthesiologists frequently are inap- of severe adverse outcomes. On the basis of an analysis
propriately named in lawsuits involving “bad baby” out- of malpractice claims in 1985, the Harvard University–
comes, despite increasing evidence that cerebral palsy is affiliated medical institutions adopted a set of minimal
associated with birth asphyxia in only 6% to 8% of cases, monitoring standards within their system. Since that time
and even in these children, prevention may not be pos- the malpractice losses (normalized for the number of
sible.110 In 2003, an ACOG task force published criteria anesthetics given) have declined by more than 50%.115
to help define the causal relationship between acute intra- In 1986, the ASA became the first professional medical
partum events and cerebral palsy (see Chapter 10).111 society to promulgate professional standards of care.
Among cases in the ASA Closed-Claims Project database The introduction of the ASA “Standards for Basic Intra-
from 1990 and later, anesthesia-related events contribut- Operative Monitoring” was accompanied by a decrease
ing to newborn death and brain damage were uncom- in the number of anesthesia-related liability claims.
mon; a payment was made on behalf of the anesthesiologist Although it is difficult to prove a cause-and-effect rela-
in only 21% of claims for newborn death/brain damage.95 tionship between the introduction of these standards and
Potentially preventable anesthetic causes of newborn fewer claims and payments, the arguments seem compel-
injury included delays in anesthetic care (primarily due ling.115 Better monitoring, especially the greater use of
to the anesthesiologist being away from the hospital or pulse oximetry and capnography, has undoubtedly con-
poor choice of anesthesia technique), substandard anes- tributed to the decrease in severe complications and asso-
thesia care, and poor communication between the obste- ciated large awards.116
trician and the anesthesiologist (often related to the The ASA also has directed its efforts at improving
urgency of cesarean delivery).95 obstetric anesthesia care in this country through a
Perhaps the most surprising finding of the analysis of variety of position statements. In 1986, the ASA House
the obstetric cases in the ASA Closed-Claims database is of Delegates and the ACOG approved a joint statement
the large proportion of relatively minor injuries in the entitled “Optimal Goals for Anesthesia Care in Obstet-
obstetric claims. This proportion markedly contrasts to rics” (see Appendix C). This policy-oriented document
that in the nonobstetric claims, suggesting that efforts to recognized the need for (1) appropriately trained physi-
reduce the incidence of major injuries will not solve the cians to provide anesthesia care, (2) a qualified obstetri-
medical malpractice problem in obstetric anesthesia. cian to be readily available during the administration
Clearly, factors other than major injury must motivate of anesthesia, and (3) equipment, facilities, and support
patients to bring a claim. It is overly simplistic to equate personnel for labor and delivery units equal to that
lawsuits with injury. A 1991 study found that the propor- provided in the surgical suite. The document served as
tion of patients harmed by negligent care who actually the basis for the ASA “Standards for Conduction Anes-
file a claim is only 2%.94 However, a lawsuit does not thesia in Obstetrics,” which was approved by the ASA
occur unless someone perceives that he or she or a loved House of Delegates in 1988. Unfortunately, unlike the
one has been wronged. One of the unique advantages of widely acclaimed “Standards for Basic Intra-Operative
33 Medicolegal Issues in Obstetric Anesthesia 781

Monitoring,” these obstetric anesthesia practice stan- Compared with the operating room environment, the
dards generated immediate and widespread controversy. typical obstetric service is less familiar and more chaotic.
In part, this was because they had implications with The role and responsibility of the anesthesia provider is
regard to nursing, obstetric, and pediatric practices and less clearly defined. Anesthesia services may be urgently
were considered too restrictive and too difficult to meet, requested in a situation in which there is little informa-
especially for smaller or rural obstetric facilities. Conse- tion available about the patient and the patient is unable
quently, in 1991, the document was revised and renamed or unwilling to answer questions. Laboring women typi-
“Guidelines for Regional Anesthesia in Obstetrics.” The cally are not sedated and calm when they request neur-
current document was revised in 2010 and renamed axial anesthesia. Rather, women in active labor may be
“Guidelines for Neuraxial Anesthesia in Obstetrics” (see uncooperative and even combative during the adminis-
Appendix A). tration of neuraxial anesthesia. The anesthesia provider
In October 1998, the ASA House of Delegates may need to provide care for multiple patients simultane-
approved a document developed by the ASA Task Force ously and may need to entrust some monitoring respon-
on Obstetrical Anesthesia. This evidence-based docu- sibilities to nurses. In some situations the choice of
ment, titled “Practice Guidelines for Obstetrical Anes- anesthesia may be dictated by others, and anesthesia pro-
thesia,” is more clinically oriented than the aforementioned viders may feel that they are little more than technicians.
guidelines and was last amended in 2007 (see Appendix Perhaps it is not surprising that many anesthesia provid-
B). It synthesizes a large body of published studies “to ers are uncomfortable in this environment and prefer to
enhance the quality of anesthesia care for obstetric minimize their liability and discomfort by limiting their
patients, reduce the incidence and severity of anesthesia- time practicing obstetric anesthesia.
related complications, and increase patient satisfaction.”
The document provides systematic analyses and meta- Support Persons during Labor
analyses of specific anesthetic techniques and practices,
along with general recommendations. Unique to obstetric anesthesia care is the presence of the
It is hoped that these practice guidelines will positively patient’s partner or other support persons during anes-
affect the quality of care and the liability profiles in thesia care. In the past it was considered a privilege for a
obstetric anesthesia practice. Practice guidelines suggest husband or relative to be present during a cesarean deliv-
a standard of care and are based on both evidence and ery, and often there were preconditions such as documen-
expert opinion. As such they often are used as evidence tation of attendance at prenatal classes. Today, in many
in cases of medical malpractice. Such documents can be obstetric centers, it is taken for granted that one or more
used for exculpatory purposes (i.e., to exonerate a defen- support persons will be present for virtually any type of
dant physician) or as inculpatory evidence (i.e., to impli- delivery. Undoubtedly, this trend has resulted in part
cate a defendant physician). A two-part study surveyed from a sincere desire to facilitate a more family-centered
960 randomly selected malpractice attorneys and 259 experience. A second motivation may be to attract patients
open and closed claims from two malpractice insurance in a competitive, market-oriented environment.
companies.117 The claims were opened during a 2-year We are not aware of specific case law regarding issues
period (1990 to 1992) and included all claims involving involving support persons. However, the topic does raise
obstetric and anesthetic cases. Practice guidelines played a number of risk management questions. What are the
a pivotal role in 17 cases. In 12 cases they were used as parturient’s rights with regard to having support person-
inculpatory evidence and in 4 as exculpatory evidence (in nel present during labor and delivery? What are the
1 case the use of practice guidelines could not be classi- rights of the institution and health care providers? The
fied). Similarly, the surveyed attorneys responded that presence of a support person often helps reassure and
guidelines were used to implicate malpractice more than calm the parturient, but this is not always true. In some
twice as often as they were used to defend against a claim cases the presence of a support person can adversely
of malpractice (54% versus 23%). The ACOG guidelines affect patient care. Melzack118 found that women have
were used most frequently in these claims, but the ASA higher pain scores during labor when the husband is
guidelines were used rarely. The authors speculated that present. Similarly, Orbach-Zinger et al.119 found that
the simplicity and clarity of the ASA guidelines may make parturient anxiety and pain during the epidural procedure
compliance easier. Clearly, practice guidelines may act as were higher in parturients randomized to the partner’s
a double-edged sword in medical litigation. Nonetheless, presence during the neuraxial procedure compared with
guidelines may reduce litigation expenses by dissuading the partner’s absence from the labor room.
plaintiffs’ attorneys from pursuing cases in which guide- Many anesthesia providers are not accustomed to
lines have been met or by encouraging early settlement having lay observers present during anesthesia proce-
by the defense in cases in which guidelines were not fol- dures. Their presence can distract the provider’s atten-
lowed without good reason. tion and adversely affect judgment and performance. It
is helpful, especially in obstetrics, for the anesthesiologist
to develop a close physician-patient relationship. The
POTENTIAL RISK MANAGEMENT presence of a support person often distracts the patient’s
PROBLEM AREAS attention away from the conversation and activities of the
anesthesiologist. In some cases this is helpful, but in
Obstetric anesthesia often is an unpredictable, difficult, others that distraction interferes with the provision of
and high-stress environment for the anesthesia provider. anesthesia care.
782 PART VIII Anesthetic Complications

The support person also may be at risk for unantici-


pated injury.120 We are aware of a number of instances in KEY POINTS
which a father suffered an injury as a consequence of a
• Effective communication with the parturient and
vasovagal episode. In one case the father dropped the
her family is an important component of obstetric
newborn on the floor as he lost consciousness. Although
anesthesia practice.
there was no legal action in any of these cases, the poten-
tial liability issues are self-evident. • Honest, caring, and comprehensive discussion
In some cases, support persons may request that they with the patient before the administration of
be present during the delivery even when the patient anesthesia meets legal and ethical standards,
receives general anesthesia. At the University of improves the image of the anesthesiologist, and
Washington we do not allow support persons in the oper- reduces the likelihood of dissatisfaction and
ating room during administration of general anesthesia; possible litigation after unanticipated
the patient undergoing general anesthesia does not complications.
require “support” in the traditional sense, and the pos- • Informed consent may be either verbal or both
sibility for complications is ever present. Even under the verbal and written. Written consent provides
best of circumstances, the presence of such a person documentation that the consent process has
makes it more difficult for the anesthesia provider to give occurred. If possible, it is best to obtain consent
full attention to the patient. Routine anesthesia practices early in labor, before the onset of severe pain.
and procedures during general anesthesia may be fright- • Refusal of care by pregnant patients may raise
ening and misunderstood by laypersons. No matter how unique legal and ethical concerns. In such
well intentioned and well prepared, the sight of a loved situations, the woman’s competency or ability to
one who is unresponsive, intubated, and mechanically make an informed medical decision may be an
ventilated can be traumatic emotionally. issue. When the patient is competent, the health
care providers should attempt to resolve
Videotaping treatment conflicts through additional patient
education and discussion. Rarely, it may be
Physicians and hospitals also should consider policies advisable to seek a court order to resolve
regarding the use of audio/video equipment in the deliv- competency and/or medical treatment issues.
ery room. Clearly all patients have a right to refuse to be • Maternal nerve injury was the most common
photographed, filmed, or videotaped. However, a woman damaging event in obstetric anesthesia claims in
often wants a photographic record or videotape of events the American Society of Anesthesiologists (ASA)
surrounding her delivery. Such a record can provide Closed-Claims Project database from 1990
dramatic documentation of unfortunate interactions or onwards. Detailed neurologic examination,
suboptimal medical care. Courts typically allow video- involvement of neurologic specialists, and
tapes to be entered into evidence and permit videotapes appropriate investigations can assist in making an
to be edited reasonably.121 The visual impact of delivery accurate diagnosis.
room events can have a profound impact on a jury, • Critical events involving the respiratory system
regardless of whether the videotape has been edited to were the most common anesthesia-related
the advantage of the plaintiff. After the presentation of
events leading to adverse outcome in both
such evidence, it may be difficult to convince a jury of
obstetric claims and nonobstetric claims involving
the appropriateness of treatment.
general anesthesia in the ASA Closed-Claims
A survey of 35 members of the American College of
Project database. Use of a difficult airway
Legal Medicine identified nine cases in which an obstet-
algorithm, availability of specialized equipment
ric videotape was used as evidence.121 In response to such
(e.g., a video laryngoscope), and high-quality
cases, some hospitals have instituted policies to limit the
postoperative care after general anesthesia may
use of video equipment in their labor and delivery suites.
help reduce the incidence of these events.
Such policies may antagonize patients and prompt them
to seek care elsewhere. A balanced approach may be the • Obstetric claims include a much higher
best solution (i.e., it may be reasonable to allow use of proportion of relatively minor injuries (e.g.,
video equipment but to establish clear, fair, and unam- headache, pain during anesthesia, back pain,
biguous policies regarding its use). The policies must be emotional distress) than nonobstetric claims.
understood by all members of the staff and should be • Guidelines for obstetric anesthesia practice have
made known to patients and their families, preferably been published by the ASA, and a joint
before the patient is admitted to the hospital. Prenatal statement has been published by the ASA and
classes can serve as a means to disseminate such informa- the American College of Obstetricians and
tion. One approach is to have informational material and/ Gynecologists.
or specific consent forms for patients and their families.
Another option is to combine such policy statements with
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PA RT I X

OBSTETRIC
COMPLICATIONS
Donald Caton, MD

The philosophy of obstetric management changed in the undamaged, then you will have to agree with me that
early decades of the twentieth century, and this change labor is pathogenic, because experience has proved such
had a profound effect on the use of obstetric anesthesia. ideal results exceedingly rare.”2 Other physicians agreed
Until 1900, obstetricians considered childbirth a physi- with DeLee. Austin Flint asked how a “process that kills
ologic process best left to proceed without interference thousands of women each year, leaves a quarter of all
by physician or midwife. They criticized “meddlesome cases more or less invalidate, is attended by severe pain
practices” for normal deliveries. Then a new generation and tearing of tissues, and kills three to seven percent
of obstetricians, concerned about the high rate of com- of all babies, can be called a normal or physiologic
plications associated with routine deliveries, began to function?”3
advocate more active management of childbirth. They The change in the philosophy of obstetric manage-
envisioned the practice of obstetrics as a form of preven- ment was further stimulated by early feminists. In the
tive medicine. Leaders of this movement, such as Joseph United States, but especially in Great Britain, feminists
DeLee of Chicago, became strong advocates for the formed a coalition with obstetricians to improve teach-
routine use of episiotomy, forceps delivery, and manual ing, build new facilities, and fund better care for women
removal of the placenta. Of course, these measures also in hospitals. They also demanded better anesthesia cov-
necessitated greater use of anesthesia.1 erage and even funded research to develop new anesthetic
DeLee acknowledged that his method “interferes techniques. In response to this movement, physicians
much with Nature’s process,” but he felt justified. With developed many new techniques for laboring patients.
conservative management, he said, a dismal outcome was Many of the anesthetic methods now favored for normal
so common that he “often wondered whether Nature did deliveries are a direct outgrowth of public support for
not deliberately intend women should be used up in the innovation and improvement that began during this time.
process of reproduction, in a manner analogous to that
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