Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks

• Author: Troyen A. Brennan,Russell L. Gruen,David M. Studdert,Michelle M. Mello,E. John Orav,Marin K. Levy,Edward J. Dunn
• Published date: 01 March 2007
• Date: 01 March 2007
• DOI: http://doi.org/10.1111/j.1740-1461.2007.00083.x

Geographic Variation in Informed

Consent Law: Two Standards for

Disclosure of Treatment Risks

David M. Studdert, Michelle M. Mello, Marin K. Levy,

Russell L. Gruen, Edward J. Dunn, E. John Orav, and

Troyen A. Brennan*

We analyzed 714 jury verdicts in informed consent cases tried in 25 states in

1985–2002 to determine whether the applicable standard of care (“patient”

vs. “professional” standard) affected the outcome. Verdicts for plaintiffs

were significantly more frequent in states with a patient standard than in

states with a professional standard (27 percent vs. 17 percent, P=0.02). This

difference in outcomes did not hold for other types of medical malpractice

litigation (36 percent vs. 37 percent, P=0.8). The multivariate odds of a

plaintiff’s verdict were more than twice as high in states with a patient

standard than in states with a professional standard (odds ratio =2.15, 95%

confidence interval =1.32–3.50). The law’s expectations of clinicians with

respect to risk disclosure appear to vary geographically.

*Address correspondence to David M. Studdert, Melbourne Law School, University of

Melbourne, Victoria, Australia; email: d.studdert@unimelb.edu.au. Studdert is Professor and

Federation Fellow in the Faculties of Law and Medicine, Dentistry, and Health Sciences at the

University of Melbourne. Mello is Associate Professor of Health Policy and Law in that depart-

ment. Levy is a J.D. candidate at Yale Law School. Gruen is Associate Professor of Surgery in the

Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne, Australia.

Dunn is Director of Policy & Clinical Affairs, Veterans Affairs National Center for Patient Safety.

Orav is an Associate Professor in the Department of Biostatistics at the Harvard School of Public

Health. Brennan is Chief Medical Officer of Aetna, Inc.

This work was supported by general institutional funds; Studdert was also supported in part

by Grant KO2HS11285 from the Agency for Healthcare Research and Quality. The authors

thank Carly Kelly and Tony Yang for legal research assistance, and David Mooney, Amanda

Cavicchio, and Doug Smink for assistance with the verdict reviews. Atul Gawande and Alan

Meisel provided helpful comments on an earlier draft of the article.

Journal of Empirical Legal Studies

Volume 4, Issue 1, 103–124, March 2007

©2007, Copyright the Authors

Journal compilation ©2007, Cornell Law School and Blackwell Publisher, Inc.

103

I. Introduction

Every human being of adult years and sound mind has a right to determine what shall be

done with his own body; and a surgeon who performs an operation without his patient’s

consent, commits an assault, for which he is liable in damages.1

Beginning in 1914 with Justice Cardozo’s now-famous pronouncement in

Schloendorff v. Society of New York Hospital, the legal doctrine of informed

consent has matured through a series of important court decisions.2Early

cases alleging failure to obtain consent for medical care were tried as cases of

battery—literally, unconsented touching.3Eventually, courts moved toward

evaluating informed consent claims using negligence law.4A “professional”

standard applied, meaning that the question of whether the defendant’s

behavior had breached the standard of care was determined by reference to

what the defendant’s professional peers characterized as reasonable or cus-

tomary medical practice, drawing informed consent doctrine into line with

other forms of medical malpractice litigation.5

The most significant development in the law of informed consent

during the last 40 years has been a reformulation of the negligence standard

in circumstances involving disclosure of treatment risks.6Two 1972 cases,

Canterbury v. Spence7and Cobbs v. Grant,8shifted the focus of the inquiry from

physician to patient by creating a “lay” or “patient” standard. According to

this standard, allegations of failure to disclose are to be judged according to

jury assessments of what a reasonable patient in the plaintiff’s position would

expect to be told prior to making a decision about treatment (patient

1Schloendorff v. Society of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).

2Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); Cobbs v. Grant, 502 P.2d. 1 (Cal. 1972);

Natanson v. Kline, 186 Kan. 393 (Kan. 1960); Salgo v. Leland Stanford Jr. Univ. Bd. of Trs., 317

P.2d 170 (Cal. Ct. App. 1957).

3Mohr v. Williams, 95 Minn. 261 (Minn. 1905).

4Jay Katz, The Silent World of Doctor and Patient 65–69 (2002).

5William P. Keeton et al., Prosser & Keeton on the Law of Torts 189 (5th ed. 1984).

6Ruth Faden & Thomas Beauchamp, A History and Theory of Informed Consent (1986).

7464 F.2d at 781–88.

8502 P.2d at 10–12.

104 Studdert et al.