Wednesday, February 11, 2015

INFORMED CONSENT IN WISCONSIN: PAST AND PRESENT

By
Hon. John J. DiMotto

     Section 448.30 of the Wisconsin Statutes sets forth the requirement that a physician obtain the informed consent of his/her patient before performing a medical procedure.  It addresses what a reasonable patient would want/need to know in order to make an intelligent decision with respect to treatment or diagnosis as well as the obligations of the physician in providing the information.  In this blog, I will first look at case law which first addressed the concept of informed consent at common law.  Next, I will look at the informed consent statute that was enacted in 1982 and then look at it the informed consent statute as revised in 2013.

PRE-1982 CASE LAW

        In Wisconsin, common law has long recognized the need for the consent of a patient to a medical procedure.

In Throne v. Wandell, (1922), 176 Wis. 97, the Court held that a person in possession of his faculties and in sufficient physical health to be consulted about his condition, must be so consulted in nonemergency situations.

In Paulsen v. Gundersen, (1935), 218 Wis. 578, the Court held that the plaintiff had the burden of proving that that the operation performed was done without his consent.

In Trogun v. Fruchtman, (1973), 58 Wis.2d 569, the Court recognized that a patient had a right to know of significant potential risks involved in proposed treatment or surgery so that he could make a rational and informed decision of whether he would undergo the proposed procedures. 

In Scaria v. St. Paul Fire and Marine Ins. Co., 68 Wis.2d 1 (1975), the Court stated that the duty of a doctor is to make such disclosures as appear reasonably necessary under circumstances then existing to enable a reasonable person under the same or similar circumstances confronting the patient at the time of the disclosure to intelligently exercise his right to consent or refuse treatment or procedure proposed.  The Court further stated that a doctor need not disclose technical information that a patient will not likely understand or extremely remote risks that might only cause alarm.

CHAPTER 375, LAWS OF 1981

     On May 6, 1982, the Wisconsin legislature enacted the first "Informed Consent" law in Section 448.30.  It was entitled: "Information on alternate modes of treatment."  In essence, it codified what had been discussed in case law.  It set forth:

"Any physician who treats a patient shall inform the patient about the availability of all alternate, viable medical modes of treatment and about the benefits and risks of these treatments.  The physician's duty to inform the patient under this section does not require disclosure of:

(1)  Information beyond what a reasonably well-qualified physician in a similar medical classification would know.
(2)  Detailed technical information that in all probability a patient would not understand.
(3)  Risks apparent or known to the patient.
(4)  Extremely remote possibilities that might falsely or detrimentally alarm the patient.
(5)  Information in emergencies where failure to provide treatment would be more harmful to the patient than treatment.
(6)  Information in cases where the patient is incapable of consenting.

     Over the years, appellate courts have had numerous opportunities to address the issue of informed consent in 448.30.

In Staudt v. Froedert Memorial Lutheran Hospital, 217 Wis.2d 773 (Ct. App. 1998), the Court held that the duty to get informed consent rests with the physician not the hospital.  Medical decisions on how to treat patients rests with physicians who are subject to liability for their malpractice.

In Mathias v. St. Catherine's Hospital Inc., 212 Wis.2d 540 (Ct. App. 1997), the Court stated that the duty of a doctor to ensure a patient gives informed consent to any medical treatment is codified in 448.30 and that the legislature limited the application to treating physicians.

In Schreiber v. PICWIS, 223 Wis.2d 417 (1999), The Court held that: 

(1)  A patient does not have the right to demand any treatment she desires.  
(2)  A doctor is not required to perform procedures that he/she does not consider medically viable; procedure for which he/she lacks appropriate expertise or procedures he/she is morally opposed to do.
(3)  Consent, once given, is not immutable.  It can be withdrawn.
(4)  The onset of the procedure does not foreclose a patient's withdrawal of consent though at some point in time in virtually every medical procedure a patient reaches a point of no return but this point need not be arbitrarily created at the commencement of the procedure.  It varies with the nature of the individual procedure and continues so long as there are alternative viable modes of medical treatment.
(5)  An objective test applies to whether the failure to again conduct an informed consent discussion was a cause of injuries.  (Objective test -- would a reasonable patient want to know the information and would a reasonable patient have acted differently than they did without the information.)
(6)  Where informed consent is withdrawn, a subjective test is applied to another informed consent discussion.

In Montalvo v. Barkovec 256 Wis.2d 472 (Ct. App. 2002), the Court indicated that what a physician must disclose is what a reasonable person in the patient's position would need to know in order to make an intelligent and informed decision.

In Martin v. Richards, 192 Wis.2d 156 (1995), the Court indicated that: 
(1) The doctrine of informed consent comes from common law and stems from the fundamental notion of the right to bodily integrity.  
(2) 448.30 requires a physician who treats a patient to inform the patient of availability of "all alternate, viable" modes of treatment and benefits and risks of them except in six circumstances.
(3) The standard for informed consent cannot be defined by the medical profession.  It is not a medical decision, it is a patient's decision.
(4) Diagnostic procedures as well as medical procedures are included in 448.30.
(5) Informed consent applies to noninvasive procedures as well invasive procedures.

In Johnson v. Kokemoor, 199 Wis.2d 614 (1996), the Court indicated that in order to insure that a patient gives informed consent: 
(1) A physician has the duty to provide the patient with such information as may be necessary under the circumstances then existing to assess significant potential risks the patient confronts.  
(2) The information must be material to the decision.
(3) The patient cannot make an informed consent unless the physician gives the patient all of the viable alternatives and risks information.
(4)  There is no bright line rule as to what a patient needs to know.  It varies case by case.
(5) Disclosures that would be made by doctors in good standing, under the same or similar circumstances, are certainly material and relevant.

In Brown v. Dibbell, 227 Wis.2d 28 (1999), the Court indicated that:
(1)  A patient's duty to exercise ordinary care in an informed consent case includes a patient's duty to tell the truth and give complete and accurate information about personal family and medical histories to a doctor's request for such information.
(2) A patient's duty to exercise ordinary care in an informed consent case generally does not impose on a patient an affirmative duty to ascertain the truth or completeness of the doctor's information, to ask the doctor questions or independently seek information when a reasonable person would want such information.  Usually a patient has to rely on the professional skills and knowledge of the doctor.
(3) Informed consent doctrine focuses on the reasonableness of the doctor's disclosure. 
(4) The standard of what a doctor must disclose is described as "the prudent patient's standard."

In Hageny v. Bodensteiner, 316 Wis.2d 240 (Ct. App. 2008), the Court indicated that a physician need not disclose absolutely every fact or remote possibility that could theoretically accompany a procedure.  What must be disclosed is what a reasonable person in the patient's position would want to know.

In Bubb v. Brusky, 321 Wis.2d 1 (2009), the Court indicated that:
(1) Any physician who treats a patient must inform the patient about the availability of all alternate, viable medical modes of treatment, including diagnosis, as well as benefits and risks of such treatments.
(2) The patient's right of self decision is the measure of the physician's duty to reveal.
(3) A physician's duty to inform is not boundless but must give information of risks, known to a reasonably well qualified practitioner or specialist commensurate with his/her classification in the medical profession.  This is a reasonableness standard.

In Jandre v. PICWIS, 340 Wis.2d 31 (2012), the Court held:
(1) A physician's duty is to inform the patient about diagnostic procedures about which a reasonable patient would want to know to make an informed, voluntary decision about his or her medial care, even if those diagnostic procedures are aimed at conditions that are unrelated to the condition that was the final diagnosis.
(2) Though the final diagnosis in this case was non negligent one of Bell's Palsey, the earlier differential diagnosis involving stroke required the physician to inform the patient of the test for stroke.
(3) Martin and Bubb did not hold that a physician has duty to inform a patient only of information about the final diagnosis and related condition.
(4) The physician must make disclosures as appear reasonably necessary under the circumstances then existing to enable a reasonable person under the same or similar circumstances confronting the patient at the time of the disclosure to intelligently exercise informed consent regarding the treatment or procedure proposed.

2013 WISCONSIN ACT 111

     In response to the Jandre decision, on December 12, 2013 the Wisconsin Legislature enacted 2013 Wisconsin Act 111 which effectively limits the scope of 448.30. The legislation revised 448.30 as follows: 
(1) Eliminating the requirement that a physician inform the patient of "all alternate, viable medical medical modes of treatment" and replacing it with "reasonable medical modes of treatment."
(2) Setting forth a "reasonable physician standard" for informing a patient.  This standard requires disclosure only of information that a reasonable physician in the same or a similar medical specialty would know and disclose under the circumstances.
(3)  Setting forth that disclosure is not required about alternate medical modes of treatment for any condition that physician has not included in his/her diagnosis at the time the physician informs the patient.

     448.30 has been retitled:  Informed consent.  It sets forth:

"Any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.  The reasonable physician standard is the standard for informing a patient under this section.  The reasonable physician standard requires disclosure only of information that a reasonable physician in the same or similar medical specialty would know and disclose under the circumstances.  The physician's duty to inform the patient under this section does not require disclosure of:

(2)  Detailed technical information that in all probability a patient would not understand.
(3)  Risks apparent or known to the patient.
(4)  Extremely remote possibilities that might falsely or detrimentally alarm the patient.
(5)  Information in emergencies where failure to provide treatment would be more harmful to the patient than treatment.
(6)  Information in cases where the patient is incapable of consenting.
(7)  Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.

CONCLUSION

     The revisions to 448.30 limit the disclosure obligations of a physician. The questions to be answered in future cases are: 

(1) Does the "reasonable physician standard" of 448.30 that requires disclosure only of information that a reasonable physician in the same or similar medical specialty would know and disclose under the circumstances trump the "reasonable patient standard" in Wisconsin law that requires a physician disclose information necessary for a reasonable person to make an intelligent decision with respect to choices of treatment or diagnosis? 

(2) Does the "reasonable physician standard" of 448.30 run contrary to the "fundamental notion of the right to bodily integrity?