Four significant issues have converged to impact and heighten concern about
the potential for more malpractice litigation related to psychopharmacology:
- Psychiatric malpractice lawsuits frequently include allegations of negligence related to the use of psychotropic medications because these drugs are vital to the treatment of mental disorders.
- A host of controversies about the safety of psychotropic medications has been widely publicized, debated and considered in various realms (e.g., regulatory, research, clinical, drug industry, medical
profession, patient advocacy).
- Adverse drug events (ADEs) are a focus of attention by the patient safety movement in an effort to
decrease medical errors.
- Historically, advances in medical treatment tend to increase medical malpractice litigation.
This article will review sources of professional liability risk related to
psychopharmacology and make some suggestions for preventing and reducing risk.
Advances in psychopharmacology have provided therapeutic options that were
unavailable just a short time ago. This has resulted in an increase in the use
of psychotropic medications in all age groups. The efficacy and safety of
psychotropic medications, especially in pediatric patients, is an ongoing issue
in clinical practice and psychopharmacological
research (Curtis et al., 2005). Specific concern about the off-label use of
psychotropic medications has been voiced by consumers and, in some instances,
These issues have received more attention lately. This is due in part to the
March 22, 2004, Public Health Advisory from the U.S. Food and Drug
Administration about worsening depression and suicidality
in patients treated with antidepressants and with the FDA's directive for a
black box warning about this risk on the package labeling of antidepressants
(FDA, 2004). Moreover, research findings and reports in the media about various
serious side effects and risks of psychotropic medications often emphasize the
problems and not the benefits of these drugs. Announcements such as the FDA
Public Health Advisory of April 11 (FDA, 2005) regarding increased mortality in
elderly patients with behavioral disturbances prescribed atypical antipsychotics have added to the escalating national debate about post-approval safety of prescription medications.
Patient safety research and initiatives, in large part stimulated by the
1999 Institute of Medicine report "To Err
Is Human: Building a Safer Health System" (Kohn et al., 2000), point to the
prevalence of adverse medication events in causing patient injuries. In a 2002
study, Rothschild and colleagues found that "[a]dverse
drug events associated with malpractice claims were often severe, costly, and
preventable." Prevention of ADEs is one of four
priority areas approved by the American Psychiatric Association Board of
Trustees for patient safety activities to be directed in psychiatric practice
(APA, 2002). Increased awareness of the problem at the early stages of the
patient safety movement may prompt more attention to ADEs
with a subsequent impact on litigation. However, in the longer-term, patient
safety initiatives hold the promise of decreasing ADEs
and related malpractice actions. (See Liang
 for a discussion on the impact of tort and contract law on patient safety
High-profile legal actions against physicians related to prescribing
scheduled controlled substances periodically cause
concern for physicians about professional liability risk and even criminal risk
in this heavily regulated area of practice. Historically, innovations in
medicine have often been followed by an increase in medical malpractice
lawsuits. These innovations usually add to the complexity of treatment and may
simultaneously increase patients' unrealistic expectations for positive treatment
outcomes (Sage, 2003). Against this background, psychiatrists' prescribing
decisions will be scrutinized more than ever, increasing the risk of
Sources of Liability
Medical malpractice actions involving psychopharmacology usually allege
negligence in prescribing, administering and monitoring medication(s), and/or
failure to obtain informed consent or adequate informed consent (Table 1).
Allegations about negligent prescribing encompass the adequacy of assessment/evaluation
of the patient (including history-taking, physical findings, obtaining past
treatment history/records), diagnostic formulations and the decisions regarding
medication(s) (including which to prescribe, dosage, frequency
of dose and management of refills) (Table
Off-label prescribing is a widespread and well-accepted part of medical
practice and is not, in and of itself, a professional liability risk. Off-label
uses range from the clearly controversial to those considered the established
standard of care. Typical off-label uses include prescribing for a condition
not indicated on the FDA-approved labeling, prescribing at a different dosage
than indicated or a different patient population.
Physicians are entitled to prescribe FDA-approved medications for off-label
use (Arbitblit and Fleishman, 2005; FDA, 1982; O'Reilly
and Dalal, 2003). The American Medical Association
(AMA, 2004) (emphasis added)
confirms its strong support for the autonomous clinical decisionmaking authority of a physician and
that a physician may lawfully use an FDA approved drug product or medical device for an unlabeled indication when such use is based upon sound scientific evidence and sound medical opinion.
Critical issues in the evaluation of professional liability risk associated
with off-label prescribing are: 1) whether the decision to prescribe off-label
is evidence-based; and 2) whether supporting documentation reflect the
psychiatrist's clinical judgment and decision making for prescribing this drug
in this instance for this patient. Should a lawsuit arise with allegations that
the off-label use injured a patient, these two elements provide evidence that
will help defend the case.
Despite some recent high-profile media reports, criminal prosecution of
physicians based on allegations of prescribing controlled substances for other
than legitimate purposes is rare. Becoming the subject of a malpractice lawsuit
and/or administrative (i.e., medical licensure) action alleging inappropriate
prescribing is the greater risk. Examples of cases involving scheduled
controlled substances include: 1) a patient death with allegations that the
amount of methadone (Dolophine, Methadose)
prescribed caused methadone toxicity and; 2) a patient death with allegations
that methadone was prescribed for narcotic addiction treatment outside a
specialized opioid treatment program in violation of
federal and state law. Sometimes these cases are brought with allegations that
the patient became addicted to the controlled substance due to the physician's
All aspects of prescribing and dispensing controlled substances are highly
regulated. Knowledge of and compliance with the federal, state and local laws
and regulations, and applicable state medical board guidelines and position statements
about prescribing scheduled controlled substances, along with utilizing the
standard medication safety practices used for prescribing any drug, are
critical to avoiding professional liability risk when prescribing scheduled
controlled substances. (For more information and resources, see Federation of
State Medical Boards [2005, 2002]).
1. AMA (2004), Patient access to treatments prescribed by
their physicians. H-120.988. Available at: www.ama-assn.org/apps/pf_new/pf_online.
Accessed Aug. 25, 2005.
2. APA (2002), Patient safety and psychiatry: Recommendations to the Board of
Trustees of the American Psychiatric Association. Available at: www.psych.org/psych_pract/
Accessed Aug. 25, 2005.
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in data on the absence or presence of unintended harm? Psychiatr
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T et al. (2005), Prevalence of atypical antipsychotic drug use among
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Available at: www.fsmb.org. Accessed Aug. 25, 2005.
7. Federation of State Medical Boards (2005), Pain policy
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antidepressants/AntidepressanstPHA.htm. Accessed Aug. 25, 2005.
10. FDA (2005), Public health advisory: deaths with antipsychotics
in elderly patients with behavioral disturbances. Available at:
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on Quality of Healthcare in America,
Institute of Medicine (2000), To Err Is Human:
Building a Safer Health System. Washington,
D.C.: National Academies Press.
Available at: www.nap.edu/books/0309068371/html/. Accessed
Aug. 25, 2005.
12. Liang BA (1999), Error in medicine: legal
impediments to U.S.
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13. O'Reilly J, Dalal A (2003),
Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.
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14. Rothschild JM, Federico FA, Gandhi TK et al. (2002), Analysis of
medication-related malpractice claims: causes, preventability, and costs. Arch
Intern Med 162(21):2414-2420 [see comments].
15. Rozovsky FA (2004), The
rules for consent to treatment. In: Consent to Treatment: A Practical Guide,
3rd ed. New York: Aspen Publishers, pp1:1-1:128.
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