Epilepsy and Pregnancy a Practical Approach to.20

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Epilepsy and Pregnancy:A Practical Approach toMitigating Legal Risk

Joseph S. Kass, MD, JD

ABSTRACT

Women with epilepsy are at increased risk of obstetric complications and poorercognitive outcomes for their offspring. This article aims to provide neurologists witha practical framework for understanding, identifying, and managing legal risk whentreating pregnant women with epilepsy.

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

Seizures may injure both the mother and her fetus through several mecha-

nisms, 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 breast-

feeding.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 understand-ing, 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 risk-

management counsel and does not guarantee mitigation of legal risk.

Address correspondence toDr Joseph S. Kass, BaylorCollege of Medicine,Department of Neurology,1 Baylor Plaza NB-302,Houston, Texas 77030,[email protected].

Relationship Disclosure:Dr Kass reports no disclosure.

Unlabeled Use ofProducts/InvestigationalUse Disclosure:Dr Kass reports no disclosure.

* 2014, American Academyof Neurology.

181Continuum (Minneap Minn) 2014;20(1):181185 www.ContinuumJournal.com

Practice

Copyright American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
mailto:[email protected]:[email protected]


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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

Practice Case 1

A 28-year-old primiparous woman who is 16 weeks pregnant is transportedby ambulance to the hospital in status epilepticus. She stopped divalproexsodium (which she has been taking for 12 years because of her juvenilemyoclonic epilepsy) without consulting her physician when she and herhusband began trying to conceive 5 months ago. She was given IMdiazepam and intubated in the field but continues to experienceconvulsive seizures. The neurologist on call implements a standardstatus epilepticus treatment protocol, administering IV fosphenytoin andmidazolam to achieve seizure control in a medically reasonable period oftime. The patient awakens without obvious sequelae but is concernedabout the impact of the treatment on her pregnancy.

Practice Case 3A 28-year-old woman with juvenile myoclonic epilepsy successfullymanaged on divalproex sodium for the past 5 years discovers that sheis approximately 8 weeks pregnant. She seeks information from herlong-standing neurologist about the effects of this medication on herpregnancy and developing fetus.

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

Practice Case 4A 28-year-old woman presents for follow-up of her symptomaticlocalization-related epilepsy with increased seizure frequency despitebeing on high doses of levetiracetam. Oxcarbazepine is added to herseizure regimen to improve seizure control. Two months later, she informsher 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.

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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 thisduty 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, dependingon 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 oflimitations for injuries to minors may extend the statute of limitations for bringing

a medical malpractice lawsuit well beyond what is allowed with adult plaintiffs.

InPractice 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 alsohighlights 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




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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 ofinformed 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 thetreatment 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 awoman 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 theneurologist 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

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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 butnot 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 evidence-based medicine in this field. Neurologists can mitigate risk by discussingVand

documenting the discussion ofVpregnancy-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.

REFERENCES1. 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 epilepsyV

focus on pregnancy (an evidence-based review): teratogenesis andperinatal outcomes: report of the Quality Standards Subcommittee and Therapeutics and

Technology Assessment Subcommittee of the American Academy of Neurology and American


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


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.


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