Practice

Epilepsy and Pregnancy:

A Practical Approach to
Mitigating Legal Risk
Joseph S. Kass, MD, JD

ABSTRACT

Address correspondence to
Dr Joseph S. Kass, Baylor
College of Medicine,
Department of Neurology,
1 Baylor Plaza NB-302,
Houston, Texas 77030,
kass@bcm.edu.
Relationship Disclosure:
Dr Kass reports no disclosure.
Unlabeled Use of
Products/Investigational
Use Disclosure:
Dr Kass reports no disclosure.
* 2014, American Academy
of Neurology.

Women with epilepsy are at increased risk of obstetric complications and poorer
cognitive outcomes for their offspring. This article aims to provide neurologists with
a practical framework for understanding, identifying, and managing legal risk when
treating pregnant women with epilepsy.
Continuum (Minneap Minn) 2014;20(1):181185.

Seizures may injure both the mother and her fetus through several mechanisms, including trauma, hypoxia, and complications of status epilepticus.
Minimizing seizures in pregnant patients improves outcomes for both the
pregnant woman and her unborn offspring. Antiepileptic drugs (AEDs),
however, carry risks of causing major congenital malformations, and the US
Food and Drug Administration (FDA) has rated AEDs no safer than pregnancy
class C. AEDs also can cause adverse reactions, which, even in the absence of
teratogenesis, may negatively impact the pregnancy.
Recognizing the challenges of managing epilepsy safely in pregnant women,
the American Academy of Neurology (AAN) issued three practice parameter
updates in 2009 specific to pregnant women with epilepsy. These focused on
obstetric complications and changes in seizure frequency;1 teratogenesis and
perinatal outcomes;2 and vitamin K, folic acid, AED blood levels, and breastfeeding.3 As reflected in the practice parameters, considerable uncertainty remains
in the high-stakes environment of the obstetric care of women with epilepsy.
Although the vast majority of medical injuries are not due to medical
malpractice,4 physicians understandably perceive themselves as vulnerable to a
lawsuit whenever a patient experiences an adverse outcome. As the AAN
practice parameters underscore, women with epilepsy are at increased risk of
obstetric complications and poorer cognitive outcomes for offspring. This
article aims to provide neurologists with a practical framework for understanding, identifying, and managing legal risk when treating pregnant women with
epilepsy.
The four hypothetical clinical scenarios below are ones in which the treating
neurologist may be exposed to legal liability if medical outcomes are poor. All
presume that the woman has chosen not to terminate her pregnancy and
considers herself and her fetus as the neurologists patients. The discussion that
follows is not intended to substitute for appropriate legal or institutional riskmanagement counsel and does not guarantee mitigation of legal risk.

Continuum (Minneap Minn) 2014;20(1):181185

www.ContinuumJournal.com

Copyright American Academy of Neurology. Unauthorized reproduction of this article is prohibited.

181

A Practical Approach to Mitigating Legal Risk

Practice Case 1
A 28-year-old primiparous woman who is 16 weeks pregnant is transported
by ambulance to the hospital in status epilepticus. She stopped divalproex
sodium (which she has been taking for 12 years because of her juvenile
myoclonic epilepsy) without consulting her physician when she and her
husband began trying to conceive 5 months ago. She was given IM
diazepam and intubated in the field but continues to experience
convulsive seizures. The neurologist on call implements a standard
status epilepticus treatment protocol, administering IV fosphenytoin and
midazolam to achieve seizure control in a medically reasonable period of
time. The patient awakens without obvious sequelae but is concerned
about the impact of the treatment on her pregnancy.

Practice Case 2
A 28-year-old woman with juvenile myoclonic epilepsy has been treated
for many years with divalproex sodium. She has been seizure free for more
than 5 years and now wishes to become pregnant. She consults with her
neurologist before attempting conception because she is concerned about
the effects of divalproex sodium on her ability to get pregnant and on
the fetus. She is also worried about losing seizure control and the
implications that such loss of control may have for her quality of life
and the outcome of her pregnancy.

Practice Case 3
A 28-year-old woman with juvenile myoclonic epilepsy successfully
managed on divalproex sodium for the past 5 years discovers that she
is approximately 8 weeks pregnant. She seeks information from her
long-standing neurologist about the effects of this medication on her
pregnancy and developing fetus.

Practice Case 4
A 28-year-old woman presents for follow-up of her symptomatic
localization-related epilepsy with increased seizure frequency despite
being on high doses of levetiracetam. Oxcarbazepine is added to her
seizure regimen to improve seizure control. Two months later, she informs
her neurologist that she is pregnant. The patient does not understand
how she became pregnant while taking oral contraceptive pills with 100%
compliance. She is worried about the potential teratogenicity of her AEDs.

DISCUSSION
In a medical malpractice claim, the plaintiff alleges that the providers care
deviated from accepted norms, resulting in injury. Since medical malpractice
claims are a type of negligence claim, the plaintiff must demonstrate by the
preponderance of the evidence (51% certainty) each of four elements of a
negligence claim in order to prevail.5

182

www.ContinuumJournal.com

Copyright American Academy of Neurology. Unauthorized reproduction of this article is prohibited.

February 2014

First, the plaintiff must show that a physician-patient relationship existed,

creating in the neurologist a duty to care for the plaintiff at the nationally
accepted standard. The physician-patient relationship inherently imposes this
duty on the neurologist. Second, the plaintiff must establish that the
neurologists actions deviated from the acceptable professional standard. The
plaintiff must generally provide expert testimony to demonstrate that a
reasonably prudent neurologist would have acted differently under the same
circumstances. The deviation from the standard of care is specialty specific and
based on a national, not a local, standard in most jurisdictions. The alleged
deviation from professional standards can take the form of poor-quality medical
care, unprofessional behavior, or failure to provide the patient (or surrogate)
with enough information to make an informed decision about whether to
accept or reject the proposed intervention. Cases in which the quality of
informed consent is in dispute may rely on either a reasonably prudent
medical professional or a reasonably prudent layperson standard, depending
on the jurisdiction.6 The plaintiff in a jurisdiction operating under the first
standard must demonstrate that the defendant neurologist failed to disclose
what reasonably prudent neurologists typically disclose to patients under similar
circumstances. Plaintiffs in jurisdictions employing the second, more common
standard must demonstrate that the defendant failed to disclose what a
reasonably prudent patient would want to know in order to assess the risks and
benefits adequately. Third, the plaintiff must demonstrate injuryVphysical,
emotional, or financial. Fourth, the plaintiff must establish that the negligent
actions were the proximate cause of the injury (ie, but for the providers behavior,
the patient would not have been injured). Neurologists who care for adult
patients should also keep in mind an important technical issue regarding the
statute of limitations for medical malpractice lawsuits that may be different in
obstetric cases, in which injury to a minor is involved: in most states, the statute of
limitations for injuries to minors may extend the statute of limitations for bringing
a medical malpractice lawsuit well beyond what is allowed with adult plaintiffs.
In Practice Case 1, although the neurologist exposed the developing fetus to a
potential teratogen, the neurologist properly followed the standard of care for status
epilepticus, a life-threatening emergency. In following a generally accepted status
epilepticus protocol, the neurologist used best evidence to manage the emergency
and minimize harm to the patient. Without achieving rapid seizure control, both the
mother and the fetus may have been irreversibly injured. This case highlights that in
emergency situations, what is best for the pregnant woman is generally accepted to
be best for the fetus. Although fosphenytoin is a category D medication and may
not be ideal for long-term management of epilepsy during pregnancy,2 it met the
standard of care in the treatment of this neurologic emergency. This case also
highlights that informed consent for treatment during a medical emergency, when
the patients decision-making ability is impaired, is implied consent. Therefore, the
neurologists first duty to the patient was to manage the status epilepticus properly.
The neurologist was not obligated to obtain explicit consent for the use of
fosphenytoin, despite its category D status, because it was used for treatment of
the patients time-sensitive medical emergency.
Neurologists recognize that no AED is perfect for use during pregnancy. Certain
AEDs, especially valproate-containing medications, present a particularly heightened
risk of adverse effects to the developing fetus.2 Because the patient in Practice Case 2
Continuum (Minneap Minn) 2014;20(1):181185

www.ContinuumJournal.com

Copyright American Academy of Neurology. Unauthorized reproduction of this article is prohibited.

183

A Practical Approach to Mitigating Legal Risk

is consulting with her neurologist before conception, the neurologist and the
patient have time to explore the therapeutic options thoroughly before exposing
the fetus to risk. The neurologist can fulfill the ethical and legal obligations of
informed consent thoroughly because of the patients prudent choice to plan in
advance. The neurologist must discuss with the pregnant patient the risks and
benefits of treating versus not treating epilepsy. Furthermore, the discussion must
include a disclosure of medication-specific risks to the health of both the woman
and the fetus, as well as an explanation of why a particular medication is being
recommended over other medically appropriate choices. The neurologist must also
realize that the degree of detail a reasonable patient would want to know in
weighing treatment options may be greater than usual when pregnancy outcome is
at stake. The neurologist must also ensure that the patient truly understands the
risks and benefits of the proposed treatment plans. The neurologist should use one
of the standard communication techniques for assessing a patients comprehension,
such as asking the patient to explain back what she understands about the
treatment options. The patient should also be asked to explain why she is choosing
or rejecting the particular treatment options. The neurologist must then document
thoroughly the entire informed consent process in the medical record, including
this verification of understanding based on the patients clearly articulated
understanding of the risks and benefits of the treatment options. This thorough
weighing of options, disclosing of risks and benefits, ensuring a meaningful
informed consent process, and properly documenting the informed consent
process in the medical record should satisfy the neurologists ethical obligations
and mitigate the risk of a successful negligence claim based on failure to obtain
meaningful informed consent.
In Practice Case 3, if the fetus suffers an adverse outcome, the neurologists
liability exposure will depend on the thoroughness of the prepregnancy informed
consent process. When initially prescribing potentially teratogenic medications to a
woman of childbearing potential, the neurologist should disclose this teratogenicity
in the process of reviewing the risks and benefits of the medication. The neurologist
may believe that divalproex sodium is the most appropriate medication to treat this
patients epilepsy; however, just as a reasonable patient would want to know about
the potential metabolic, cosmetic, and hepatic risks with valproate-containing
medications, she would also want to consider the potentially deleterious effects of
this medication on a developing fetus when deliberating the appropriateness of this
medication for her situation. As part of the informed consent process, the
neurologist should recommend effective contraception and consider prescribing
folic acid.3 Although not responsible for birth control failure in this case, the
neurologist may be liable depending on the quality of the initial informed consent.
In Practice Case 4, the neurologists liability exposure depends on how the
neurologist counseled the patient about the potential effect of oxcarbazepine
on the efficacy of oral contraceptive pills. If the neurologist either (1) performed
proper medication reconciliation and failed to realize that oxcarbazepine
reduces oral contraceptive efficacy or (2) failed outright to perform adequate
medication reconciliation, the neurologist may be found negligent for having
provided substandard care. This case, and to some extent Practice Case 3, also
raises the issue of how and when to apologize for a medical error.
Although a thorough review of the topic of apologies for medical error is
beyond the scope of this article, neurologists should be aware that the

184

www.ContinuumJournal.com

Copyright American Academy of Neurology. Unauthorized reproduction of this article is prohibited.

February 2014

admissibility of apologies during a medical malpractice lawsuit varies from state

to state; while some have no law in this area, the majority of states have apology
laws. Apology laws typically protect only the actual expression of sympathy but
not the expression of fault that may accompany the expression of sympathy. A
minority of states have disclosure laws. These laws mandate disclosure of
certain unanticipated outcomes and may protect the communication from
being used against the physician in a legal or administrative action.7 Knowing
the law and working with local risk management personnel is advisable in these
difficult situations when a medical error has been made.
CONCLUSION
Neurologists managing pregnant women with epilepsy face a number of challenges
in their attempt to optimize pregnancy outcome and fetal wellbeing. Minimizing
legal liability requires communicating and documenting the risks and benefits of
treatment clearly to the patient and acknowledging the imperfect state of evidencebased medicine in this field. Neurologists can mitigate risk by discussingVand
documenting the discussion ofV pregnancy-related issues with their nonpregnant
epileptic female patients of childbearing age. Furthermore, neurologists should keep
informed of their local informed consent and apology laws and seek the advice of
legal counsel and risk management professionals in appropriate circumstances.
REFERENCES
1. Harden CL, Hopp J, Ting TY, et al. Practice parameter update: management issues for women with
epilepsyVfocus on pregnancy (an evidence-based review): obstetrical complications and change
in seizure frequency : report of the Quality Standards Subcommittee and Therapeutics and
Technology Assessment Subcommittee of the American Academy of Neurology and American
Epilepsy Society. Neurology 2009;73(2):126Y132.
2. Harden CL, Meador KJ, Pennell PB, et al. Practice parameter update: management issues for
women with epilepsyVfocus on pregnancy (an evidence-based review): teratogenesis and
perinatal outcomes: report of the Quality Standards Subcommittee and Therapeutics and
Technology Assessment Subcommittee of the American Academy of Neurology and American
Epilepsy Society. Neurology 2009;73(2):133Y141.
3. Harden CL, Pennell PB, Koppel BS, et al. Practice parameter update: management issues for
women with epilepsyVfocus on pregnancy (an evidence-based review): vitamin K, folic acid,
blood levels, and breastfeeding: report of the Quality Standards Subcommittee and Therapeutics
and Technology Assessment Subcommittee of the American Academy of Neurology and American
Epilepsy Society. Neurology 2009;73(2):142Y149.
4. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized
patients results of the Harvard Medical Practice Study 1. 1991. Qual Saf Health Care
2004;13(2):145Y151.
5. Kapp MB. The interface of law and medical ethics in medical intensive care. Chest 2009;136(3):
904Y909.
6. Nepps ME. The basics of medical malpractice: a primer on navigating the system. Chest 2008;
134(5):1501Y1555.
7. Mastroianni, Mello MM, Sommer S, et al. The flaws in state apology and disclosure laws dilute
their intended impact on malpractice suits. Health Affai (Millwood) 2010;29(9):1611Y1619.

Continuum (Minneap Minn) 2014;20(1):181185

www.ContinuumJournal.com

Copyright American Academy of Neurology. Unauthorized reproduction of this article is prohibited.

185