Legislative Changes Re-Define Wisconsin's Informed Consent Statute

WDC Journal Edition: Spring 2014
By: Nadya E. Shewczyk, Hinshaw & Culbertson LLP

In 2012, the Wisconsin Supreme Court revisited the doctrine of informed consent and examined whether the law required a physician to advise a patient about tests and treatments for possible alter- native health problems that were unrelated to the diagnosed condition. In Jandre v. Wisconsin Injured Patients and Families Compensation Fund, the court’s decision broadened the scope of informed consent and raised questions about how much in- formation physicians need to provide to patients to obtain their informed consent.1

There was concern that the decision would result in physicians practicing “defensive medicine” which would in effect increase the cost of healthcare in a time when healthcare providers were trying to increase their efficiency. Therefore, individuals and organizations took action and the legislature made significant changes to the informed consent statute, Wis. Stat. § 448.30. This Article will discuss (1) the Wisconsin Supreme Court’s analysis of the former statute; (2) the legislative changes made to the statute; and (3) the practical effect of the changes on attorneys who are defending informed consent claims.

I. Discussion of the Jandre Decision

On June 13, 2003, the coffee Mr. Thomas Jandre was drinking came out of his nose.2 He began drooling and slurring his speech, and the left side of his face drooped.3 For an additional 20 minutes, he was dizzy and had weakness in his legs.4 Mr. Jandre was taken to the emergency room, triaged by a nurse, and then examined by a physician specializing in emergency medicine.5

The physician’s differential diagnosis included multiple syndromes, including Bell’s palsy, transient ischemic attack, hemorrhagic and ischemic stroke, tumors, and multiple sclerosis.6 Her findings led her to order a CT scan, which could rule out a hemorrhagic stroke and brain tumor.7 The results were normal.8

To determine whether Mr. Jandre had any form of ischemic stroke—e.g., transient ischemic attack,reversible ischemic neurological deficit, or a “full- blown ischemic stroke”—the physician listened to the patient’s carotid arteries with a stethoscope.9 This test had little diagnostic value because if nothing was heard through the stethoscope, an artery could still be severely blocked.10 A carotid ultrasound is another non-invasive test that can be used to check the status of a patient’s carotid arteries and determine if a patient is having any form of ischemic stroke.11 It is a better diagnostic tool than listening through a stethoscope, but a carotid ultrasound was not performed on Mr. Jandre.12

Based on the CT scan and the physical exam, the physician concluded that Mr. Jandre had a mild form of Bell’s palsy, although his symptoms were atypical for this condition.13 “Bell’s palsy is a ‘diagnosis of exclusion,’ which means there is no affirmative test for Bell’s palsy. The only way to diagnose Bell’s palsy is to rule out all other potential conditions.”14 The physician explained her diagnosis to Mr. Jandre, prescribed him medication, and sent him home with instructions to see a neurologist for additional care.15

Three days later, Mr. Jandre saw his family practitioner, who concluded that Mr. Jandre’s Bell’s palsy was resolving.16 On June 24th, Mr. Jandre experienced a full-blown ischemic stroke.17 A carotid ultrasound showed his right carotid artery was 95% blocked.18 Mr. Jandre sued.

At trial, the physician explained that she did not tell Mr. Jandre about the potential of an ischemic stroke or the option of performing a carotid ultrasound because she considered the risk of stroke “very unlikely” and a “remote” possibility.19 Two expert witnesses testified that they would have ordered a carotid ultrasound during the initial examination in the emergency room which would have revealed the blockage, and that surgery could have reduced the likelihood of a full blown stroke.20

The jury concluded the physician met the standard of care in treating Mr. Jandre; her diagnosis of Bell’s palsy and treatment of Mr. Jandre was reasonable, even though the diagnosis turned out to be wrong.21However, the jury also concluded that the physician failed to disclose to Mr. Jandre information regarding an alternative medical treatment—i.e., a carotid ultrasound—which was necessary for him to make an informed decision.22 Additionally, they concluded that a reasonable person made aware of the necessary information would have undertaken the alternative medical treatment, and the failure to disclose the information was a cause of Mr. Jandre’s physical and cognitive impairments.23 The jury awarded approximately $2,000,000 in damages.24

The jury’s conclusion regarding the disclosure of information to Mr. Jandre was appealed. In a 4-3decision, the Wisconsin Supreme Court affirmed the lower court’s decision and held that “the circuit court could not determine, as a matter of law, that the physician had no duty to inform the patient of the possibility that the cause of his symptoms might be a blocked artery, which posed imminent, life-threatening risks, and of the availability of alternative, non-invasive means of ruling out or confirming the source of his symptoms.”25 The supreme court also held the verdict was consistent even though the jury found the physician not

negligent in misdiagnosing and treating Mr. Jandre, but found her negligent in failing to obtain informed consent.26 In affirming the lower court’s decision, the supreme court relied on the doctrine of stare decisis, applied the “reasonable patient standard,” and concluded the lower court’s decision was based on well-established precedent.27

Under the reasonable patient standard, “Wisconsin law ‘requires that a physician disclose information necessary for a reasonable person to make an intelligent decision with respect to the choices of treatment or diagnosis.’”28 The court reiterated that a physician has the duty to “disclose to the patient the existence of any methods of diagnosis or treatment that would serve as feasible alternatives to the method initially selected by the physician to diagnose or treat the patient’s illness or injury.”29

The court held the physician had a duty to inform Mr. Jandre of “the availability of an alternative, viable means of determining whether he had suffered an ischemic stroke event rather than an attack of Bell’s palsy.”30 And, a jury could have determined that the physician “should have known” that information about another available, non-invasive diagnostic tool—i.e., a carotid ultrasound—was information a reasonable patient in Mr. Jandre’s position would want to know in order to decide whether to follow the physician’s instructions.31

There was more than one reasonable diagnostic procedure available to diagnose Mr. Jandre’s condition. The physician was not at liberty to fail to disclose the availability of a recognized alternative procedure, especially where, as here, the alternative procedure was noninvasive and more conclusive than the diagnostic tool actually selected by the physician.32

The supreme court focused on the need to inform the patient of diagnostic options for identifying a cause of unique symptoms, rather than on discussing treatment options for the condition diagnosed. The decision raised questions regarding the scope of informed consent and how much information physicians need to provide to their patients for

undiagnosed conditions. In effect, it required physicians to inform their patients about medical tests and treatments that may be appropriate for the patient’s symptoms, even if the doctor does not believe the patient has the underlying condition or disease.

Many believed the decision pushed Wisconsin physicians away from providing “efficient care” and towards practicing defensive medicine which would increase healthcare costs by requiring a discussion of unnecessary tests which would in turn result in the performance of those tests.33 They also believed the court’s ruling would cause physicians to share unnecessary health information with their patients, which would overwhelm the patient with irrelevant information and create patient confusion.34 Therefore, healthcare providers, lawyers, lobbyists, and organizations, including the Wisconsin Medical Society, Wisconsin Hospital Association, and the American College of Emergency Physicians- Wisconsin Chapter, played an active role in seeking an amendment to the law.

II. Legislative Changes to the Doctrine of Informed Consent

The collaborative effort of lawyers, lobbyists, healthcare providers, and several organizations resulted in the Wisconsin Legislature passing Assembly Bill 139, which modified Wisconsin’s informed consent statute, Wis. Stat. § 448.30. The bill was signed into law by Governor Scott Walker on December 13, 2013. The revised statute applies to physicians required to inform patients about modes of treatment beginning on or after December 15, 2013, the effective date of the legislation.

The statute changed in many ways. First, it is now titled “Informed consent,” rather than “Information on alternate modes of treatment.”35 Second, the law requires physicians to inform patients about “the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”36 Previously, the law required physicians to inform patients about “the availability of all alternate, viable medical modes of treatment and about the benefits and risks of these treatments.”37

Third, the law alters the standard for assessing whether a doctor properly obtained a patient’s informed consent for medical care and treatment. Specifically, the statute previously required “a physician to disclose information necessary for a reasonable person to make an intelligent decision with respect to the choices of treatment or diagnosis.”38 Under the revised statute, a physician is now required to disclose information which a “reasonable physician” in the same or similar medical specialty would know and disclose to a patient under the circumstances.39

The final revision to the statute was set forth in the exceptions to the duty to inform. Under the former statute, a physician was not required to disclose:

(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; and

(6) Information in cases where the patient is incapable of consenting.40

Under the revised statute, exception (1) above is repealed, and under the new standard the following does not need to be disclosed: “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.”41

The law is in the process of being expanded to apply to chiropractors, dentists, podiatrists, and optometrists.42 As a result of the statutory revisions, the Wisconsin Civil Jury Instructions regarding informed consent are also being amended.43 The new instructions will be published in the near future.

The hope is that the revisions will help prevent physicians from presenting an endless amount of information to a patient regarding conditions that the provider does not believe the patient has. The revised law should also help stop healthcare providers from having to order unnecessary tests and procedures to avoid a lawsuit.

III. Practical Effect of the Legislative Amendments

In anticipation of patients filing informed consent claims for treatment occurring on or after December 15, 2013, the following sections outline the effect of the legislative changes:

A. Informed Consent Must Be Pleaded.

Under Wisconsin law, negligence in failing to abide by the professional standard of care and negligence in failing to obtain a patient’s informed consent are two separate and distinct forms of malpractice.44Typically, patients who file claims alleging the physician failed to meet the standard of care in treating the patient also allege the physician failed to obtain the patient’s informed consent. The revisions to the law will not change this approach. Patients’ complaints will likely contain the same allegations, and thus the healthcare providers’ answers and affirmative defenses to the complaints will be the same.

Further, it will remain the case that patients who fail to plead informed consent cannot pursue such claims.45 Medical malpractice cases frequently take years to prepare for trial. As the cases move through discovery, the patient’s theory for liability often evolves. Initially, the patient may not have raised an informed consent claim, but later realize that such a claim has merit. If an informed consent claim was not pleaded, it cannot be on the special verdict.46

B. Most Cases Will Require the Patient to Present Expert Testimony.

The revisions to the informed consent statute alter the patient’s burden of proof. Under the revised statute, the “professional standard of care” that applies to a claim alleging the physician failed to meet the standard of care in treating the patient will also apply to a claim alleging the physician failed to obtain the patient’s informed consent. In both claims, the physician will be held to the level of a hypothetical, reasonable physician of the same or similar medical specialty working under the same or similar circumstances.

In an informed consent claim, the patient will have to prove that alternative treatments were available at the time the physician cared for the patient and that the physician did not disclose information that is customarily disclosed by other medical professionals.47 In most cases, patients will be required to elicit expert testimony to meet the burden of proof.48 In the past, informed consent claims sometimes included expert testimony. Now it will usually be required.49 An exception to the requirement for expert testimony may be made in a case where a physician is silent and makes no disclosure at all regarding the risks involved in the medical treatment. If expert testimony is not provided to support an informed consent claim, it will be prudent to consider a motion to preclude the claim.

C. Impact on Defense Expert Testimony

Like in the past when a patient brought an informed consent claim, defense attorneys will continue to obtain information regarding the discussions that took place between the physician and patient prior to providing the treatment, as well as any pamphlets and brochures that were given to the patient, and any documents the patient signed consenting to treatment. Now, a defense attorney should also consider retaining an expert to testify regarding the information that is customarily disclosed by physicians under the same or similar circumstances presented in the case.

The patient carries the burden of proof, so expert testimony is not required by the defense. However, it may help the defense at trial to have an expert that can counter the patient’s expert’s opinions. As a matter of efficiency, the expert that is called to testify regarding the commonly discussed treatments and the risks and benefits of those treatments may be the same expert who testifies regarding the applicable standard of care relating to the physician’s care and treatment of the patient.

D. The Patient Must Prove that the Failure to Inform Was a Cause of Injury.

Under the prior informed consent law, the patient had the burden of proving that the failure to disclose information about alternative medical diagnoses or treatments was a cause of injury.50 The statutory amendments do not affect the patient’s obligations in this regard. The jury instructions that are being revised in response to the legislative amendments to Wis. Stat. § 448.30 will provide additional guidance on this issue.

IV. Conclusion

The expansion and speculation created by the supreme court’s decision in Jandre has been reeled in through a collaborative effort of the knowledgeable and dedicated healthcare providers, organizations, lawyers, and lobbyists who brought about legislative change. Hopefully, the amendments will ease the minds of healthcare providers, reduce the practice of defensive medicine, and decrease the number of informed consent claims.

References

1 2012 WI 39, 340 Wis. 2d 31, 813 N.W.2d 627. 2 Id., ¶ 39.
3 Id.
4 Id.
5 Id., ¶¶ 40-41.
6 Id., ¶ 41.
7 Id., ¶ 43.
8 Id.
9 Id., ¶ 45.
10 Id.
11 Id., ¶ 46.
12 Id.
13 Id., ¶¶ 47, 49.
14 Id., ¶ 49.
15 Id., ¶ 50.
16 Id., ¶ 53.
17 Id., ¶ 54.
18 Id.
19 Id., ¶ 52.
20 Id., ¶ 54.
21 Id., ¶ 56.
22 Id., ¶ 58.
23 Id.
24 Id., ¶ 59.
25 Id., ¶ 10.
26 Id., ¶¶ 91-93.
27 Id., ¶¶ 7, 34.
28 Id., ¶ 8 (citations omitted).
29 Id., ¶ 17 (citations omitted).
30 Id., ¶ 38.
31 Id.
32 Id., ¶ 98.
33 https://www.wisconsinmedicalsociety.org/news/society-testifies-in-support-of-bills-clarifying-informed-consent-law/.
34 https://www.wisconsinmedicalsociety.org/news/society-applauds-signing-of-informed-consent-law/.
35 Wis. Stat. § 448.30 (Eff. 12/15/13).
36 Id.
37 Wis. Stat. § 448.30 (repealed 2013) (emphasis added).
38 Id.; see also Jandre, 340 Wis. 2d 31, ¶¶ 7-8 (citations omitted).
39 Wis. Stat. § 448.30 (Eff. 12/15/13).
40 Wis. Stat. § 448.30 (Repealed 2013).
41 Wis. Stat. § 448.30 (Eff. 12/15/13).
42 See 2013 Senate Bill 518, which would create a new Wis. Stat. § 446.08 (setting forth the “reasonable chiropractor standard”), Wis. Stat. § 447.40 (setting forth the “reasonable dentist standard”), Wis. Stat. §448.697 (setting forth the “reasonable podiatrist standard”), and Wis. Stat. § 449.29 (setting forth the “reasonable optometrist standard”).
43 The jury instructions that relate to informed consent and which will be amended are: Wis. JI-CIVIL 1023.1 “Professional Negligence: Medical: Informed Consent: Special Verdict”; Wis. JI-CIVIL 1023.2 “Professional Negligence: Medical: Informed Consent”; Wis. JI-CIVIL 1023.10 “Professional Negligence: Chiropractor: Informed Consent”; and Wis. JI-CIVIL 1023.11 “Professional Negligence: Chiropractor: Informed Consent: Special Verdict.”
44 Jandre, 340 Wis. 2d 31, ¶ 93; Hannemann v. Boyson, 2005 WI 94, ¶ 40, 282 Wis. 2d 664, 698 N.W.2d 714; Finley v. Culligan, 201 Wis. 2d 611, 628, 548 N.W.2d 854 (Ct. App. 1996) (citing Knief v. Sargent, 40 Wis. 2d 4, 8, 161 N.W.2d 232 (1968)); Wis. JI-CIVIL 1023.
45 Hannemann, 282 Wis. 2d 664, ¶ 54 (A claim of informed consent “requires amendment of the pleadings or the implied consent of the parties to try the issue when the plaintiff pleads only negligence in treatment.”) (citing Finley, 201 Wis. 2d at 629).
46 Id.
47 Martin v. Richards, 192 Wis. 2d 156, 171, 531 N.W.2d70 (1995) (citing Sharon Nan Perley, From Control Over One’s Body to Control Over One’s Body Parts: Extending The Doctrine of Informed Consent, 67 N.Y.U. L. Rev. 335, 339-340 (1992)).
48 Wis. Stat. § 907.02 (“If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.”).
49 See Fain v. Smith, 479 So.2d 1150, 1152 (Ala. 1985) (applying the professional medical standard, expert testimony is required “to establish what the practice is in the general community”); Barriocanal v. Gibbs, 697 A.2d 1169, 1172 (Del. Super. 1981) (The burden of proof is on the plaintiff to demonstrate through expert testimony that the health care provider failed to supply information “customarily given” by other “licensed health care providers with similar training and/or experience in the same or similar health care communities as that of the defendant at the time of treatment, procedure or surgery.”); Neb. Rev. Stat. § 44-2816 (Reissue 2010); Curran v. Buser, 711 N.W.2d 562, 568 (Neb. 2006) (Adopting the professional standard, patients must “prove by expert testimony that doctors in similar locations and situations would ordinarily disclose [the information].”); Rodriguez v. New York City Health & Hospitals Corp., 50 A.D.3d 464, 465 (N.Y. 2008) (citations omitted) (“Where a plaintiff fails to adduce expert testimony establishing that the information disclosed to the patient about the risks inherent in the procedure is qualitatively insufficient, the cause of action for medical malpractice based on lack of informed consent must be dismissed.”); Wilkerson v. Mid-Am. Cardiology, 908 S.W.2d 691, 696 (Mo. Ct. App. 1995) (“To prove nondisclosure, the plaintiff is required to produce expert testimony to show what disclosures a reasonable medical practitioner would have made under the same or similar circumstances. Stated another way, a plaintiff must show that the disclosures made by the defendant do not meet the standard of what a reasonable medical practitioner would have disclosed under the same or similar circumstances.”) (citing Aiken v. Clary, 396 S.W.2d 668, 675 (Mo.1965)); Culbertson v. Mernitz, 602 N.E.2d 98 (Ind. 1992) (applying the “reasonably prudent physician” standard of care to informed consent cases, expert medical testimony is necessary to establish whether a physician has complied with the standard of a reasonably prudent physician except in those cases where deviation from the standard of care is a matter commonly known by lay persons); Melton v. Medtronic, Inc., 698 S.E.2d 886, 894 (S.C. App. 2010) (“‘An informed consent action is no different from any other action for professional malpractice.’ A plaintiff must ordinarily establish the professional standard governing the scope of a physician’s duty to inform a patient of the material risks inherent in a proposed treatment or procedure by expert medical evidence.”) (citing Hook v. Rothstein, 316 S.E.2d 690, 696-97 (S.C. App.1984)).
50 Wis. JI-CIVIL 1023.3 and 1023.12; Martin v. Richards, 192 Wis. 2d 156, 182-194, 531 N.W.2d 70 (1995); Fischer v. Wis. Patients Compensation Fund, 2002 WI App 192 ¶¶ 6-18, 256 Wis. 2d 848, 650 N.W.2d 75; Hannemann, 282 Wis. 2d 664, ¶¶ 50-56.