Introduction to Informed Consent in Torts and Medical Research

Edward P. Richards

Harvey A. Peltier Professor of Law

Louisiana State University

https://biotech.law.lsu.edu

Sources of Law

Federal Standards for IRBS

State Statutes

State Common Law

What is the Remedy?

Federal Law

Federal Government Can Sanction Investigator

Federal Government Can Cut off Funds to the Investigator and the Institution

No Private Remedy for the Patients/Subjects

State Tort Law

Battery

Negligence – Failure of Informed Consent

Battery

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.
Schloendorff v. Society of New York Hospital, 105 N.E. 92 (N.Y. 1914)

Battery

Classic Intentional Tort

Elements

Intent

Harmful or Offensive Touching

Damages

Still Important if No Consent

Rejected if there is Consent

Generally not Insured

When Consent is Not Necessary

Emergency Exception

Patient Cannot Consent

A Reasonable Person would have Consented

Cannot Use the Emergency Exception if the Patient Refuses Care

Consent by a Guardian or Parent

Court Ordered Care

Some Public Health Treatments

Informed Consent

Negligence

Elements

Duty

Breach

Causation

Damages

Duty

Person with the Legal Duty to Obtain Consent

Usually the Treating Physician

Letting the Nurse Get the Forms Signed does not Shift the Duty

Cannot Say, “It is the Nurse’ Fault”

Hospital Can Assume Duty, but Physician is Still Liable

Breach of Duty

Standard of Care

Must Have Expert Testimony on What Patient Should Have Been Told

Reasonable Physician Standard

Reasonable Patient Standard

LA 1299.40 E(2)(a)

In a suit against a physician or other health care provider involving a health care liability or medical malpractice claim which is based on the failure of the physician or other health care provider to disclose or adequately to disclose the risks and hazards involved in the medical care or surgical procedure rendered by the physician or other health care provider, the only theory on which recovery may be obtained is that of negligence in failing to disclose the risks or hazards that could have influenced a reasonable person in making a decision to give or withhold consent.

Causation

Must show that a reasonable person could have refused the treatment had there been adequate disclosure

Hard to do for life-saving or emergency care

Easy to do for cosmetic and other elective care

Damages

Must be damaged by the consented to care

No recovery for dignitary injury

Doc does not disclose risks, but you do not suffer the risk

No recovery if you suffered a disclosed risk, even if there were lots of undisclosed risks

LA Cases

Lugenbuhl v. Dowling, 701 So.2d 447 (La. 1997)

Fortier v. Dehne, 804 So.2d 819 (La.App. 4 Cir. 2901)

Baham v. Medical Center of Louisiana at New Orleans, 792 So.2d 85 (La.App. 4 Cir. 2001),