INFORMED CONSENT:  NOT JUST A PIECE OF PAPER

I.  INTRODUCTION – VALID CONSENT VS. INFORMED CONSENT

• Valid consent refers to the health care provider’s obligation to obtain the patient’s express or implicit authorization prior to the performance of any sort of invasive procedure.

• Informed consent refers to the health care provider’s obligation to inform the patient of the nature of the proposed treatment, its risks, and alternatives.

• A plaintiff does not need to prove that a physician was negligent in the treatment of the patient in order to prevail on an informed consent claim or a claim of battery based on failure to obtain a valid consent.

• These concepts have been intertwined due to the belief that a consent to treatment should not be considered valid unless it is preceded by a certain degree of explanation by the physician concerning the treatment.

II.  VALID CONSENT

• Failure to obtain a patient’s valid consent before performing an invasive procedure will subject the health care provider to liability for battery.

*  Karp v. Cooley 493 F,2d 408 (1974)  The Court held that a wife’s consent to her husband’s operation has no significance under Texas law she is legally authorized to give consent.  The relationship of husband and wife does not create such a relationship.

• A battery may occur where the scope of the consent is exceeded by the physician.

*  Guin v. Sison 552 So. 2d 60 (1989)  The defendant physician obtained consent from the plaintiff to perform exploratory surgery and a colonoscopy in an attempt to discover the source of abdominal pain.  During the exploratory surgery, it was discovered that the plaintiff had an inflamed ovary and fallopian tube which had grown together.  The physician removed both organs.  The Court held that the defendant physician committed medical battery by removing the organs without consent when the plaintiff was not in immediate danger by the condition.

• Valid consent by a patient to medical treatment may be either express or implied.

• Express consent may be either oral or in writing.
• Implied consent may arise from the conduct of the patient in submitting to the proffered treatment.

• Valid consent requires that the patient have the capacity to consent to the treatment.  A person may lack capacity due to minority, mental illness, or intoxication.  A consent may not be valid where the patient is mistaken as to the essential character of the treatment due to a misrepresentation by the health care provider.

• EXCEPTIONS TO VALID CONSENT REQUIREMENTS:

1. EMERGENCY SITUATIONS

• An exception to the requirement of a valid consent arises when a patient is in need of immediate treatment and is unable to consent to that treatment.

• Consent may be implied where the patient is unconscious or otherwise incapable of consenting to treatment.  However, the potential harm to the patient must outweigh any harm threatened by the proposed treatment.

• Where the patient is unable to consent, consent should be obtained from a relative or a guardian if possible.

• Consent to a particular treatment or procedure may be implied when an emergency develops during the course of surgery.  Implied consent may not, however, be used to circumvent a patient’s right to refuse medical treatment.  Thus, a physician must not wait until a patient lapses into unconsciousness in order to provide a treatment which has been previously refused by the patient.  A sudden emergency may also exempt a physician from the duty to disclose to the patient the risks and alternatives to the disputed treatment.

1. MINORS

• Historically, at common law, minors could not give valid consent to medical treatment involving a serious risk of harm.

• A physician is ordinarily required to obtain consent from the minor’s parent or guardian prior to commencing medical treatment.  A parent, however, may not deprive a child of lifesaving treatment.

• The consent of a parent or guardian has not been required where immediate treatment is required to prevent serious mental or physical harm to the minor, and no parent or guardian is readily available.

• In most jurisdictions, statutes provide that parental consent is not necessary where a minor is emancipated, such as when he is married or financially independent and living away from home.

1. INCOMPETENT PATIENTS

At common law, a mentally incompetent person could not ordinarily consent to medical treatment involving a serious risk of harm.  Duly appointed guardians and the next of kin, typically a spouse or an adult child, have capacity to consent to a medical procedure to be performed on an incompetent.  Treatment of an incompetent patient may also be required by court order.

III.  INFORMED CONSENT

1. INTRODUCTION

In recent years, court decisions have significantly expanded the duty of physicians to disclose the risks of proposed treatments and alternatives.  At common law, a physician could be held liable to a patient for battery if he did not obtain valid consent to an invasive procedure.  In 1957, the Supreme Court of California first recognized the concept of “informed consent” in Slago v. Leland Stamford Jr. University Board of Trustees 317 P. 2d 170 (Cal. Ct. App. 1957).  Prior to Slago, there was no general duty to inform the patient of the risks of a proposed treatment or possible alternatives.  Under the traditional paternalistic approach that prevailed up to that point, physicians were viewed as experts who should direct the treatment of their patients without interference by the patient or his family.  Since physicians were deemed authoritative, there was little reason to cause the patient additional anxiety by disclosing risks or alternatives.

1. MODERN TREND

• The modern doctrine of informed consent represents the ascendancy of the

value of patient autonomy over the value of physician beneficence.  The doctrine has achieved nearly universal recognition.

• Cases recognizing the doctrine of informed consent have relied on the

fiduciary relationship between the physician and the patient, and the patient’s right to control his own body.

• Many courts have quoted with approval from Justice Cardozo’s opinion in

Schloendorff v. Society of New York Hospitals wherein it was stated: ”[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body.”  Thus, it has been recognized that the ultimate decision as to whether to undergo treatment lies with the patient.

1. THE ELEMENTS OF INFORMED CONSENT – LOGAN V. GREENWICH HOSPITAL 191 Conn. 282 (1983)

• FACTS OF THE CASE

The patient, Mary Logan, was referred to Dr. B, a urologist, by Dr. N, her internist, for a kidney biopsy to determine the extent of lupus involvement in her kidneys.  Dr. B met with the patient in her hospital room the evening before the scheduled surgery.  He told her that there might be some bleeding and that there was a risk of hemorrhaging and of losing a kidney.  Dr. B did not discuss the alternative of an open biopsy procedure under general anesthetic, although he had performed such operations previously and conceded it was a more controlled procedure in terms of visualizing the kidney.  He did not discuss the risk of puncturing the gallbladder.  Dr. B testified that he did not consider this procedure to be a “viable alternative” for the plaintiff, however, because there was a greater risk of complication especially involving general anesthesia.  During the procedure and after there was a puncture to the patient’s gallbladder, which ultimately had to be removed.  The court charged the jury on the issue of informed consent as follows, “now the duty to warn of alternatives exists only where there are feasible alternatives available.  An alternative that is more hazardous is not a viable alternative”.  The Connecticut Supreme Court found that the trial judge’s charge on informed consent was in error and remanded the case for a new trial.

• THE LAW OF INFORMED CONSENT

1.  “THE REASONABLE PATIENT STANDARD”

The court in Logan adopted what has been called the “lay” or “reasonable patient” standard of disclosure in informed consent cases.  This standard imposes a duty on the physician to disclose such information as a reasonable patient would consider material to the decision whether or not to undergo treatment or diagnosis.

2.  MATERIALITY

“Materiality may be said to be the significance a reasonable person, in what the physician knows or should know is the patient’s position, would attach to the disclosed risk or risks in deciding whether to submit or not to submit to surgery or treatment.  Wilkinson v. Vesey 110 R.I. 606 (1972); “Logan v. Greenwich Hospital” 191 280 Conn. 282, 291 (1983)

“These decisions require something less than full disclosure of all information which may have bearing however remote upon the patient’s decision.”  Canterbury v. Spence 464 F. 2d 772 (1972).

3.  ELEMENTS OF INFORMED CONSENT

The following elements which must be included in a physician’s disclosure:

1. the nature of the procedure
2. the risks and hazards of the procedure
3. the alternatives to the procedure
4. the anticipated benefits of the procedure

4.  INFORMATION THAT IS NOT REQUIRED TO BE DISCLOSED

“Obviously, there is no need to disclose risks that are likely to be known by the average patient or that are in fact know to the patient usually because of past experience with the procedure in question”.  Wilkinson v. Vesey at 627 quoted in Logan at 292.

5.  THERAPEUTIC PRIVILEGE

Some limited recognition has been given also to the therapeutic privilege of a physician to withhold information where a disclosure might jeopardize a course of therapy.

• CONCLUSION

The court concluded that the trial court erred in charging the jury that an alternative that is more hazardous is not a viable alternative.  In discussing the issue, the court stated the following:

“The incongruity of making the medical profession the sole arbiter of what information was necessary for an informed decision to be made by a patient concerning his own well-being has led to various judicial and legislative attempts within the last decade to define a standard tailored to the needs of the patient, but not unreasonably burdensome upon the physicians or wholly dispensing with the notation that “doctor knows best” in some situations.  While the essential ambivalence between the right of the patient to make a knowledgeable choice and the duty of the doctor to prescribe treatment is professional judgment deems best for the patient has not been fully resolved the outline has begun to emerge.”

IV.  OTHER SIGNIFICANT CONNECTICUT CASES

A.  Mason v. Walsh 26 Conn. App. 225 (1991)

• THE FACTS

The plaintiff consulted with the defendant, a urologist, for treatment of an infection caused by a hydrocele, which ultimately required surgical treatment.  Before the plaintiff’s admission to the hospital, the defendant informed the plaintiff of his recommendation that general anesthesia be employed during surgery.  The patient suffered atrial fibrillation shortly after general anesthesia was administered and the surgery was aborted.  Several days later the surgery was performed successfully using local anesthesia and the plaintiff claimed that he suffered from an irregular heart beat and was unable to exert himself as he had before the atrial fibrillation.  At trial, plaintiff offered no expert testimony to establish that the urologist had an obligation to obtain the informed consent of the patient with respect to the use of general anesthesia during the procedure.  The jury rendered a verdict against the urologist and he appealed.  The appellate court reversed the case and directed judgment on behalf of the urologist.

• COURT’S DECISION

The court in Walsh found that in order to establish a duty to inform, the plaintiff must show through expert testimony that the customary standard of care of physicians in the same practice is that of the defendant was to obtain the patient’s consent prior to performing any operation.  Once the existence of the duty to inform had been established, the degree or extent of disclosure necessary to satisfy the duty must be proven in accordance with the reasonable patient’s standard.

• ANALYSIS

The plaintiff does not have to offer expert testimony to prove or establish what information must be given to a patient in order to meet the requirements of informed consent.

B.  Duffy v. Flagg 88 Conn. App. (April 2005)

• THE FACTS

Plaintiff became pregnant with her second child and during her course of obstetrical care, was informed by the defendant that although her first child had been delivered through cesarean section, her second child could be delivered via VBAC procedure.  Dr. Flagg advised the patient that statistically there were risks associated with the procedure, including uterine rupture and even a small chance of death of the child.  He also assured the plaintiff that all necessary steps would be taken to minimize or eliminate the risk to the patient or the patient’s child and that the risk was “very very small”.  While discussing the risks of the VBAC procedure, the plaintiff asked Dr. Flagg about her personal experience with VBACs and whether Dr. Flagg has had any negative outcomes.  In response, Dr. Flagg stated that one of her previous patients had suffered a uterine rupture as a result of a VBAC delivery.  However, she did not mention that the uterine rupture had caused the infants death and had placed the mother’s health at risk.  Trial court precluded the plaintiff from offering evidence of Dr. Flagg’s past experience with the procedure which also precluded her from introducing evidence that she was not given adequate informed consent.

• COURT’S DECISION

The court reversed the trial court’s decision precluding the plaintiff from offering the plaintiff does not have to offer expert testimony to prove or establish what evidence of Dr. Flaggs’ past experience with VBACs and stated: “in the present case we are not called upon to decide generally whether a physician has an affirmative duty to disclose her prior experience with a particular procedure as part of the required underlayment for informed consent.  Rather, we consider whether in conjunction with an informed consent claim, a physician’s failure to answer fully and completely a patient’s direct question related to an anticipated procedure is probative of a claim that a physician did not obtain informed consent.  Duffy v. Flagg 88 Conn. App. 484 App. 491

In addition, the court stated that the jury might reasonably have concluded that the lay standard for informed consent required Dr. Flagg to answer the plaintiff’s questions regarding her prior experience with VBAC procedure completely and accurately.  Thus, informing the plaintiff, not only that a prior patient’s uterus had ruptured, but also that the patient’s infant had died as a direct result.

“Although we do not state that prior experience information need always be disclosed in order to obtain a patient’s informed consent, we believe that when a patient directly asks for such information and when the requested information could be relevant to the choices made by a reasonable patient, a jury as fact finder and not the court as gate keeper should be able to determine whether the failure to provide such information on request supports the plaintiff’s claim regarding informed consent.”  The court reversed the case in part and ordered a new trial in which evidence of Dr. Flagg’s past experience with VBACs would be admitted on the issue of informed consent.

• ANALYSIS

A physician must be careful, thorough and completely honest in responding to a patient’s questions regarding a contemplated procedure including providing full disclosure regarding a physician’s experience with a contemplated procedure.

C.  DeGennaro v. Tandon 59 Conn. App. 183 (May 2005)

• THE FACTS

The plaintiff in this case sought treatment for a tooth ache from the defendant dentist who had just purchased the dental practice from the patient’s prior dentist.  Defendant used 25 year old equipment to drill the patient’s affected tooth.  The defendant had ordered new equipment for the office, but this equipment had not arrived by the time of this procedure.  The defendant did not inform the plaintiff that she had not used this equipment before nor did she inform the plaintiff that she usually had an assistant present when she performed this type of surgery.  The defendant also acknowledged that she could not recollect having any training or previous experience with the unit she was using to perform the procedure.  During the procedure, the bur from the drill came in contact with the plaintiff’s tongue which caused the plaintiff to lose sensation in the area, loss of taste, and developing a lisp and occasional drooling out of the left side of her mouth.  Plaintiff brought an action in two counts, including a count alleging that the defendant had failed to obtain the plaintiff’s informed consent prior to the procedure.  The plaintiff’s lack of informed consent claim rested on the defendant’s failure to inform the plaintiff of her lack of experience with the equipment she used, her lack of readiness to treat the plaintiff and her lack of staff to aide her in the procedure.  The jury found in favor of the plaintiff, awarding her $50,000 in economic and non-economic damages.  The dentist appealed.

• COURT’S DECISION

The court cited the dentist’s obligation to provide the patient with information which a reasonable patient would have found material for making a decision whether to embark upon a contemplated course of therapy and concluded that a patient centered duty to inform necessarily counsels against excluding from that duty to inform information that a reasonable person in the patients position would need to know in order to make an intelligent informed decision simply because the information was provider specific as opposed to procedure specific.  DeGennaro v. Tandon 89 Conn. App. 183 191 (2005)

The court concluded that “if the facts and circumstances of a specific case indicate that provider specific information would be material to a reasonable patient in deciding whether to embark on a course of therapy, a provider has the duty to disclose that information to the patient in order to obtain the patient’s informed consent.”  The court concluded that the evidence introduced at trial, which was that the defendant was understaffed, using equipment with which she was not familiar and was using an office that was not ready for business is the type of “provider specific information” that a reasonable person in the plaintiff position would consider material in weighing the risk of a dental procedure and in deciding whether a viable alternative was to seek a different provider to perform the procedure.”

• ANALYSIS

It now appears that it may be necessary in certain circumstances to provide the patient with provider specific information if it be material to a patient decision to pursue the contemplated treatment.  The difficulty will be to determine when those circumstances exist.  However, arguably, a physician may have to disclose the fact that he or she have very little or no experience in performing such a procedure.

The Court in DeGennaro cited three out of state cases in support of their decision which could have implications for future informed consent cases in Connecticut.  These three decisions could open the door to informed consent claims based on a physician’s failure to inform the patient of their level of experience in performing the contemplated procedure; their morbidity and mortality rates as compared to other surgeons; the alternative of having the surgery performed at another facility with more experienced surgeons and the role of a resident in performing the surgery.

• Johnson v. Kokernoor, 199 Wis. 2d 615 (1996).  The Supreme Court of Wisconsin upheld a trial court’s decision to admit into evidence that the defendant surgeon in undertaking his duty to obtain the plaintiff’s informed consent for a basilar bifurcation aneurysm surgery had failed to divulge the extent of his experience in performing this type of surgery and to disclose his morbidity and mortality rates for this type of surgery as compared to other surgeon’s in the area.  In addition, the court overruled the trial court’s decision to preclude evidence that the defendant physician failed to refer the plaintiff to a tertiary care center staffed by physicians more experienced in performing the same surgery.

• Barricanel v. Gibbs 697 A. 1169 (1997)  The Supreme Court of Delaware reversed the trial court’s decision to exclude evidence that the defendant physician had failed to disclose that he had not performed the brain aneurysm surgery at issue recently, that the hospital would be thinly staffed the day of surgery and that there are other hospitals nearby that specialized in the surgery.

• Dingle v. Belen 358 Md. 354 (2000)  The Court of Appeals of Maryland affirmed trial court’s decision dismissing a breach of contract for the defendant physician’s alleged failure to abide by a verbal agreement to perform the laparoscopic cholecystectomy himself as opposed to having a resident perform the primary parts of the surgery.  The defendant physician admitted that a resident performed the dissections and removed the gallbladder.  During the surgery, the resident dissected and clipped the common bile duct.  The defendant physician denied he ever agreed to perform the primary aspects of the surgery and prevailed on the informed consent claim.  However, the court stated in its decision:

In the context of this case, it will suffice to say that a doctor who partially abandons his or her patient by improperly delegating to other professional tasks that the doctor was engaged personally to do and agreed personally to do may be liable for traditional professional negligence, lack of informed consent, and breach of contract, depending in part on the nature of the consequences that flow from that abandonment.  Dingle at p. 157.

V.  HOW MUCH INFORMATION TO PROVIDE?

1. IN GENERAL –

• “The scope of disclosure required of physicians defies simple definition and must therefore be measured by the patient’s needs, and that need is whatever information is material to the decision.”  Cobb v. Grant 8 Cal. 3^rd 502 (1972)

• “The amount of disclosure can vary from one patient to another because what is reasonably disclosure in one instance may not be reasonable in another.”  Wilkinson v. Vesey 110 R.I. 606 (1972)

• “It seems obviously prohibitive and unrealistic to expect physicians to discuss with their patients every risk of proposed treatment – no matter how small or remote.”  Canterbury v. Spence

• A physician is required to disclose only those risks which he knows or reasonably should know are associated with the proposed treatment.  A physician is not required to inform the patient of inconsequential risks or those which are extremely remote or those which are commonly known.

• Typically, courts will require disclosure of statistically significant risks of serious injuries.

*  In an article investigating patient’s preference for risk disclosure and role in decision making for invasive medical procedures, the authors determined that patients preferred shared decision making (68.1%).  42.7% of the patients preferred qualitative descriptions of risks.  35.7% preferred quantitative descript of risks.  9.8% indicated a preference for both and 8.4% indicated that either would be fine.  The authors recommend rising a combination of qualitative and quantitative formats or simply quantitative terms.

Mazur, D.J., & Hickam, D.H. (1997).  Patient’s Preferences for Risk Disclosure in Decision Making for Invasive Medical Procedures J. Gen. Intern Med. 12(2)-114-7.

• When the statistical risk is remote and the severity is not great, the physician is not bound to disclose the risks to the patient.

• A physician is ordinarily required to inform a patient that a proposed procedure is experimental.

B.  NOTABLE CASES

• It has been held that a physician may be liable for failure to inform the patient of the availability of a diagnostic procedure.

Berman v. Allen 80 NJ 421 (1979)  Court held that the doctor had a duty to inform the parents of a defective child of the availability of prenatal testing for the defect.

• It has also been held that a physician may be liable for failing to inform a patient of the risks of refusing preferred diagnostic test.

• In some instances, the doctrine of informed consent has been to require disclosures of a physician’s research and economic interest unrelated to the patient’s health where that interest may affect physician’s medical judgment.

• Howard v. University of Medicine and Dentistry of New Jersey (172 NJ 537 (2001)  Court held that a patient had a cause of action for lack of informed consent against a surgeon who misrepresented his experience and credentials.

• DeGennaro v. Tandon 89 Conn. App. 183(2005)  Physicians may have duty to disclose “provide specific information” to the patient in certain circumstances when it be material to the reasonable patient in deciding whether to embark on a course of therapy.

V.        WHERE, WHEN AND HOW TO SECURE AND DOCUMENT INFORMED CONSENT

• Informed consent is a patient physician dialogue.  It is important for the physician to encourage and invite the participation of this patient in the discussion and decision.

*  The recommended or best practice regarding information sharing and decision making is one of sustained partnership.  It has been recommended that from the first interview, physicians should make it clear that decisions are a shared responsibility.

Brody, D.S. (1980) The Patient’s Role in Clinical Decision Making Am. Intern Med. 93(5) 718-22.

*  Physician’s role is to provide the patient with information they need to understand the problem at hand, the treatment alternatives, the risks and benefits.

*  Patient’s responsibility is to disclose the information about their health that the physician requests as well as disclosing their own values and beliefs.

*  Together the physician and patient will negotiate a decision about treatment.

*  Ultimately, physicians should provide patients with the information they need, to the depth they desire and in a form that they can understand.

• Informed consent is best obtained in the office rather than the hospital (unless the patient’s condition changes or in an emergency).  The office is more relaxed and is a less threatening environment.  Office staff can serve as a witness.

• Informed consent for a procedure should be given to the patient officially before the procedure so the patient will have time to absorb the information.  Patient may want to discuss options with their family and return later once the decision has been made.

• The physician performing the procedure is responsible for discussing the procedure, alternatives, material risks and complications and obtaining consent.  This responsibility should not be delegated.

• Use lay terms easily understandable by the patient to describe the procedure.  In some cases it may helpful to draw a diagram or illustration to explain a procedure.  All diagrams or illustrations should  be dated and kept in the patient’s file.

• The physician’s progress notes should clearly document the consent process.

• At a minimum the note should specifically state that the procedure, alternatives, material risks and complications were discussed and the patient’s questions were answered.  In some cases, physician will have the patient sign the office record indicating that they have been provided with the information indicated.  While the note need not be a verbatim transcript of the discussion, key elements especially regarding risks should be noted, as well as any specific questions raised by the patient and answers provided by the physician.

• As appropriate, include the family in the consent progress, documenting in the progress notes their present and having them sign off on any consent form as witnesses.

• If there is a language barrier, the name and relationship of the interpreter should be documented on the consent form and in the progress note.

• In an emergency, where consent cannot be obtained, the progress notes should clearly document why consent was not possible.

• Hospital of St. Raphael consent to surgery form and interpretive guidelines (see attached)

VI.  WHO SHOULD DISCLOSE INFORMED CONSENT?

• The existence of a duty to disclose information to a patient depends upon the existence of a “sufficiently close” physician patient relationship.  Generally, the responsibility for making the proper disclosure rests with the attending physician.  In the case of surgical procedures, generally it is the principal surgeon rather than those assisting who is responsible for obtaining informed consent.  For example, absent proof of an accepted practice to the contrary, it has been held to be the responsibility of the surgeon rather than the anesthesiologist to obtain a patient’s informed consent to the use of anesthesia.