An Empirical Analysis of the Medical Informed Consent Doctrine- S
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An Empirical Analysis of the Medical Informed Consent Doctrine- S
RISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Sedical Informed Consent Doctrine: Search for a standard of DisclosureJon F. MerzFollow this and additional works at: https://scholars.unh.edu/nsk Ó* Part of the Medicine and Health Sciences CommonsRepository CitationJon F Merz, An Empirical Analysis of the Medical Informed Consent Doctrine: Search f An Empirical Analysis of the Medical Informed Consent Doctrine- Sor a Standard of Disclosure. 2 RISK 27 (1991).This Article is brought to you for free and open access by the University of Nev/ Hampshire - Franklin PAn Empirical Analysis of the Medical Informed Consent Doctrine- S
ierce School of Law at University of New Hampshire Scholars Repository. It has been accepted for inclusion in RISK: Health, Safety & Environment (1990RISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- SEmpirical Analysis of the Medical Informed Consent Doctorine:Search for a “Standard” of Disclosure*Jon F. Merz**IntroductionInformed consent is the legal embodiment of the concept that each individual has the right to make decisions affecting his or her wellbeing. It is generally accepted that indiv An Empirical Analysis of the Medical Informed Consent Doctrine- Siduals should consider — that is, ttade-off — the risks and potential benefits flowing from their decisions. To do so, decision-makers must have knowlAn Empirical Analysis of the Medical Informed Consent Doctrine- S
edge of those risks and potential benefits. The law protects the individual’s right to give informed consent by requiring the disclosure of informatioRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Scommunity right-to-know, and medical informed consent In each case, issues regarding the disclosure of risks are similar.Risk may be defined as “exposure to a chance of an injury or loss.”1 It embodies two distinct factors: (1) chance relates to* Support for this research was provided by the Nationa An Empirical Analysis of the Medical Informed Consent Doctrine- Sl Science Foundation, under contract with SES-8715564-02 with the Department of Engineering and Public Policy of Carnegie Mellon University. Also, theAn Empirical Analysis of the Medical Informed Consent Doctrine- S
author wishes to thank Barusch Fischoff, Joel Greenhouse, Cindy Atman, Marcie Merz, Thomas Field and anonymous reviewers for their helpful comments oRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Smber, bar of the Commonwealth of Pennsylvania; and doctoral candidate, Engineering and Public Policy, Carnegie Mellon University.1Morgan, Probing the Question of Technology-Induced Risk, IEEE spectrum2 RISK - Issues in Health & Safety 27 [Winter 1991]28uncertain events — those that are not predictab An Empirical Analysis of the Medical Informed Consent Doctrine- Sle in any single case, but for which a probability that an event will occur in any one case may be estimated; and (2) injury or loss includes any consAn Empirical Analysis of the Medical Informed Consent Doctrine- S
equence for which the decision-maker has disutility. In each of the three areas identified above, the law places on one party a positive obligation toRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Sntecedent basis of these laws is the same, but theừ implementation has diverged. In each case, what it means to be informed and how consent is given varies.Products liability law holds manufacturers and sellers of goods liable for damages resulting from the intended or foreseeable use of “unreasonab An Empirical Analysis of the Medical Informed Consent Doctrine- Sly dangerous” — and therefore defective — products that they put into the stream of commerce. An “unreasonably dangerous” product is one for which theAn Empirical Analysis of the Medical Informed Consent Doctrine- S
benefits are outweighed by the risks, or one which does not meet reasonable consumer expectations of safety.* 2 As a means of safety regulation, thisRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Sict liability for the marketing of a defective product and manufacturer negligence in creating or failing to discover a manufacturing flaw in a product is the failure to give adequate warning of risks inherent in the use of an otherwise useful product.4 Generally, manufacturers and resellers have a An Empirical Analysis of the Medical Informed Consent Doctrine- Sduty to warn of risks known to them, or risks they58, 59 (Nov. 1981).2See generally Prosser and Keeton on Torts (5th Ed. 1984).3See G. CALABRESI, TheAn Empirical Analysis of the Medical Informed Consent Doctrine- S
Cost of Accidents: Legal & Economic Analysis (1970); Keeton, Products Liability — Some Observations About Allocations of Risks, 64 Mich. L. Rev. 1329 RISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Sons and Misconceptions, 1968 Wis. L. REV. 228, 234 (1968).Merz: Empirical Analysis of Informed Consent 29 should have been aware of through the exercise of reasonable care, at the time the product left theừ control.5In failure to warn cases, juries are empowered to determine whether a risk that tran An Empirical Analysis of the Medical Informed Consent Doctrine- Sspừed in that case was known and whether the warning, if any, was adequate to enable the reasonable consumer to avoid the risk either by not using theAn Empirical Analysis of the Medical Informed Consent Doctrine- S
product or by taking appropriate precautions.6 The scope of the disclosure obligation is uncertain, and, as two preeminent commentators noted:7This gRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Scial solution to latent design defects labor under a naive belief that one can warn against all significant risks. Too much detail can be counterproductive. A warning to be effective must be read and understood.As in all other substantive areas of tort law, there must be a causal link between the de An Empirical Analysis of the Medical Informed Consent Doctrine- Sfendant’s failure to disclose the risk and the injury suffered by a plaintiff. In products cases, the law creates a rebuttable presumption that, had tAn Empirical Analysis of the Medical Informed Consent Doctrine- S
he warning been adequate, the plaintiff would have taken precautionary measures to avoid the risk — that is, it is presumed that the plaintiff would nRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the Me An Empirical Analysis of the Medical Informed Consent Doctrine- Sy5See generally Keeton, Products Liability — Inadequacy of Information, 48 Tex. L. Rev. 398 (1970); Twerski, Weinstein, Donaher & Piehler, The Use and Abuse of Warnings in Product Liability—Design Defect Litigation Comes of Age, 61 CORNELL L. Rev. 495 (1976).6See, e.g., Borel V. Fibreboard Paper Pro An Empirical Analysis of the Medical Informed Consent Doctrine- Sducts Corp., 493 F.2d 1076 (5th Cừ. 1973).RISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the MeRISK: Health, Safety & Environment (1990-2002)Volume 2ArtiHn ANumber 1 RISK: Health, Safety & EnvironmentAri c e o33239An Empirical Analysis of the MeGọi ngay
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