Risk Management Compliance

– Informed Consent –

Maryland Chiropractic Association

Continuing Education Seminar
October, 2010

Presented by:
Marc K. Cohen, Esquire
Ober, Kaler, Grimes & Shriver
100 Light Street
Baltimore, Maryland 21202
410.685.1120

www.ober.com

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 INFORMED CONSENT

ORIGINS of INFORMED CONSENT

The Common Law

Civil and Criminal Battery

Since all established English law as it existed in 1776 was
incorporated into Maryland law, it has been a tort for a doctor to
perform a procedure, including any examination procedure, without
first obtaining the patient’s permission. Battery is an intentional tort
and liability for battery subjects a physician to both punitive and
compensatory damages and may be excluded from coverage under
insurance.

Failure to obtain informed consent is negligence not battery.

Civil Negligence
Breach of the standard of care compared to breach of the duty to
obtain informed consent.

Breach of the Standard of Care

Failure to provide care consistent with the standard of care that
would be provided by a similarly qualified reasonable and prudent
provider and resulting injury to the patient.

The standard of care is established by testimony of similarly

qualified experts stating their opinion of what a reasonable and
prudent would have done or the care that would have been
provided given the conditions presented by the patient.
The standard of care may also be established by reference to
authoritative treatises, studies, and professional society
publications.

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 Breach of the Duty to Obtain Informed Consent
Maryland, through the development of its common law, imposes a
separate and substantial obligation on doctors to obtain informed
consent prior to providing any care to patients.

Sard v. Hardy
The seminal and still most fundamental exposition of the law of
informed consent was developed in Sard v. Hardy (1977). This
case was brought by a patient when she became pregnant despite
the tubal ligation she had received.

The patient claimed that the doctor was negligent in failing to

advise her that the procedure had a 2% failure rate and that there
were alternative methods of sterilization and birth control.

The Court of Appeals agreed, and clearly established the

physician’s duty to obtain a patient’s informed consent prior to
providing any particular treatment.

This duty was held to be separate and distinct from the tort of
battery (an unpermitted touching or act upon a patient) and from
negligence in the selection and administering of a particular
treatment.

There was no breach of the standard of care provided Sard. The

recommendation was reasonable and the ligation was carefully
performed meeting all elements of the standard of care. However,
there was a breach of the separate duty to obtain her informed
consent to the procedure because she was not provided

The Court stated that this duty is founded on the patient’s right to
make an informed choice about a particular therapy, so that a
physician does not substitute his judgment, no matter how
appropriate, for that of the patient.

Meeting the duty of informed consent, the Court held, required

providing the patient with information and advice regarding: (1)
the nature of the patients ailment or diagnosis; (2) the nature of the
proposed treatment; (3) the probability of success and material
risks, complications and outcomes and; (3) alternatives.

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 Material risks are those “which a physician knows or ought to
know would be significant to a reasonable person in the patient’s
position” in making a decision about whether to submit to a
particular treatment. Maryland’s Civil Pattern Jury Instructions
adopted this exposition of informed consent, but made clear that
whether the patient would have consented to the procedure if
informed of the risk, is a relevant factor, but is not conclusive and
that only information regarding those risks which would be
material to an intelligent decision by a reasonably prudent patient
need be provided.”

McQuitty v. Spangler
In McQuitty v Spangler (2009) the Court of Appeals revisited the
law of informed consent as stated in Sard and both reaffirmed and
amplified it.

This case was brought by a patient who gave birth to a child who
sustained substantial neurological damage during gestation. The
patient claimed that she was not given sufficient information to
permit her to give her informed consent as to whether to continue
carrying her child closer to term or have had a sooner Cesarean
delivery. The physician’s defense was that since he had the
patient’s initial consent to continue to carry the child and never
proposed a sooner Cesarean delivery, he had no duty to obtain her
informed consent to that procedure.

The Court disagreed and in deciding this case amplified the law of
informed consent. Under the holding in McQuitty it now appears
that a doctor has a duty to inform a patient of risks and available
alternative treatments related to all material changes in her
condition. Informed consent is no longer limited to those
circumstances where a patient is asked to decide whether to submit
to a specifically proposed procedure. Informed consent now
requires provision of all information material to a patient in
determining his course of care (“what shall be done with his own
body and when”). The information must be sufficient to permit the
patient involvement in the healthcare choices and treatment
alternatives pertinent to his condition. In general determinations of
which course of treatment to follow are for the patient to decide

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 assisted by as much information and advice the doctor may
reasonably be able to furnish.

Summary
Informed consent requires advising the patient of:

1. The patient’s condition or diagnosis

2. The nature of the proposed treatment

3. All reasonable alternative treatments, including, if appropriate,

no treatment and lifestyle changes

4. The probability of success and the risks of the proposed

treatment and all reasonable alternatives.

5. All material changes in the patient’s condition, all reasonable

changes treatment options implicated by the change in
condition.

6. All material information needed for a reasonably prudent

patient to make decisions determining his course of care.

But there is no stated requirement as to how the patient is to be

informed. Information may be provided through written, oral or
any combination of communications. A written acknowledgement
is not required.

Statutes, Regulations and Administrative Rulings

Health Occupations Article

The Maryland legislature has, with but one exception, declined over
the years to set standards or create guidelines regarding informed
consent.

However, for social workers the legislature did enact Sec 19-318 of
the Health Occupations Article. It requires social workers to inform
their patients of the services which may be provided, the cost for each
service, and “sufficient information for a patient to give informed

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 consent regarding the service to be provided.” The informed consent
requirements must be documented by notation in the patient record or
a form signed by the patient.

Code of Maryland Regulations (COMAR)

Only the Board of Chiropractic Examiners has undertaken to
promulgate specific rules for providing informed to consent to
patients by its licensed doctors. COMAR 10.43.14.06 sets out, in
more detail than the standards of any other healthcare profession, the
informed consent obligations imposed on chiropractors.

Chapter 14 specifically requires:

D. Provide sufficient information to a patient to allow the patient to

make an informed decision regarding treatment, including:

1. The purpose and nature of an evaluation or treatment regimen;

2. Alternatives to treatment;

3. Side effects and benefits of a treatment regimen proposed and

alternatives to that treatment;

4. The estimated cost of the treatment and alternatives to treatment;

5. The right of the patient to withdraw from treatment at any time,

including the risks associated with withdrawing from treatment;
and

6. The patient’s right to decline to participate in treatment if an

aspect of the treatment will be recorded, documented,
photographed, observed, or otherwise used in an educational
program;

Chapter 10.43.15.03, Record Keeping included the additional

requirement that:

(3) The chiropractor shall include the following information in the

patient record:

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 (k) The signed consent of the patient or the parent or guardian of the
minor patient or incompetent patient.

Summary of the Chiropractic Regulatory Requirements:

Patient to be provided:

Sufficient information to give an informed consent to treatment

Reason and description of each proposed procedure

Benefits, side effects, complications and alternatives

Estimated cost of treatment and cost of alternative treatments

Right to withdraw at any time and possible risks

To decline any observation, recording or non-therapeutic use of

treatment

Patient’s signed consent

Maryland Professional Board Pronouncements and Rulings

Rulings requiring more detailed and signed informed consents
1. Maryland Board of Physicians, as a condition of probation or
corrective action may require specific items in a written informed
consent document. Board of Physicians v Barbara Solomon,
2. Board of Chiropractic Examiners, in disciplinary actions has
indicated specific limitations and information in extended course
of care contracts with patients

Professional Associations, Specialty Boards and Hospitals

In General
The standard of care and a determination of that “which a physician
knows or ought to know would be significant to a reasonable person
in the patient’s position” will likely find an evidentiary foundation in
the standards of professional associations.

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 The American Chiropractic Association
The American Chiropractic Association guidelines on Informed
Consent recommend a doctor:
1. As in McQuitty, treat informed consent as an “ongoing
discussion throughout the patient’s course of care.
2. Advise and describe the recommended course of action and
discuss the benefits, risks and reasonable and alternatives
3. Determine that the patient reasonably understands the
discussion
4. Provide and opportunity to ask questions
5. Note any refusal to follow recommendations
6. Document the elements of informed consent in the patient
record.

International Chiropractic Association

The International Chiropractic Association guidelines and Informed
Consent form recommend a doctor:
1. Obtain a written informed consent signed by the patient and doctor
2. Provide an opportunity to discuss the nature and purpose of
purposed treatment and answer the patient’s questions.
3. Results are not guaranteed and a doctor must use professional
judgment during the course of care.
4. Advise of possible complications, including stroke.
Note: The ICA citing a study published in the journal Spine states that
stroke is not material risk of cervical manipulation.

The AMA Guidelines

The American Medical Association guidelines recommend a doctor-
not a delegated associate:
1. discuss the diagnosis, if known
2. nature and purpose of treatment or procedure
3. risks and benefits of proposed procedure and of alternatives,
including no treatment.
4. provide opportunity to ask questions to ensure understanding
5. document discussion and agreement in the patient record.

CMS Interpretive Hospital Guidelines (Sec 842.24)

CMS states hospital medical record must contain a document
recording the patient’s informed consent for procedures and
treatments specified in the hospital by-laws and federal and state laws.

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 The consent form must contain:
1. The name of the patient
2. The name of the facility
3. The specific procedure
4. The name of the responsible doctor for the procedure and the
practitioner who conducted the informed consent discussion.
5. The signature of the patient
6. Date and time executed
7. Indication or listing of the material risks
7. Identification of physicians or other non-physician practitioners
who may participate in procedure
8. Statement that the procedure, its benefits, material risks and
alternatives was explained to the patient.

Note: CMS states that “Material risks could include risks with a high
degree of likelihood but a low degree of severity, as well as those with
a very low degree of likelihood but high degree of severity.”

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INFORMED CONSENT IN OTHER STATES

A. Connecticut
Like Maryland, Connecticut has adopted the “material risk” or “reasonable
patient” standard of informed consent.1 Under this approach, informed
consent requires disclosure of the nature of the procedure, the risks,
alternatives, and the anticipated benefits.2 However, the full scope of the
required disclosure is determined by what information would be material to
a reasonable person in the patient’s position faced with the decision of
whether to embark upon a contemplated course of therapy.3

The Connecticut Board of Chiropractic Examiners recently issued a

Declaratory Ruling in which it discusses which risks are considered to be
material in the practice of chiropractic.4 The Board stated that the materiality
of a risk is determined by weighing the benefits of a procedure against the
frequency and severity of the potential harm. Under this standard, the Board
held that the scientific evidence is sufficient to establish that a stroke or
cervical dissection is not a risk or side effect of a joint mobilization,
manipulation, or adjustment of the cervical spine performed by a
chiropractor.

B. Georgia
Georgia does not recognize the common law doctrine of informed consent.5
Instead, informed consent is governed by statute in Georgia. 6 The informed
consent statute does not impose a general requirement of disclosure upon
physicians.7 It enumerates a limited number of specific factors that must be
disclosed by a physician prior to performing surgery or a diagnostic
procedure.8 Significantly, chiropractic treatment is not included among the
matters for which informed consent is required by statute.9 Thus,
chiropractors in Georgia do not have a common law or statutory duty to

1 Logan v. Greenwich Hospital Association, 191 Conn. 282, 292-93 (1983); Duffy v. Flagg, 279 Conn. 682, 687-
88 (2006).
2 Id.
3 Duffy v. Flagg, 279 Conn. at 692.
4 Available at
http://www.ct.gov/dph/lib/dph/phho/chiropractors/declaratory_rulings/declaratory_ruling_regarding_informed_co
nsent_6_10_2010.pdf
5 Blotner v. Dorieka, 285 Ga. 481 (2009).
6 Informed Consent Doctrine, OCGA § 31-9-6.1
7 Id.
8 Id.
9 Blotner v. Dorieka, 285 Ga. 481 (2009) (citing OCGA § 31-9-6.1).

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inform patients of the material risks of a proposed treatment or procedure.10
Physicians merely have a duty to truthfully answer questions from a patient
regarding the risks associated with a treatment or procedure.11

C. Florida
Informed consent in Florida is governed by the Florida Medical Consent
Law.12 Unlike Maryland, Florida has adopted the professional community
standard of informed consent, providing that an action for lack of informed
consent is barred if

“1. The action of the [physician] in obtaining the consent of the

patient…was in accordance with an accepted standard of medical
practice among members of the medical profession with similar
training and experience in the same or similar medical community;
and
2. A reasonable individual, from the information provided by the
physician…would have a general understanding of the procedure, the
medically acceptable alternative procedures or treatments, and the
substantial risks and hazards inherent in the proposed treatment or
procedures.”13

The statute also provides that an action for lack of informed consent must
fail if the jury determines that the patient would reasonably have undergone
a treatment or procedure had she been fully advised by the physician.

Courts applying Florida’s Medical Consent Law have held that a physician
has a duty to advise his patient of the material risks of undergoing a medical
procedure14 and that consent is informed when the patient knows the dangers
and degree of danger of the procedure to be performed.15

D. New Jersey
Like Maryland, New Jersey has adopted the “material risk” or “reasonable
patient” standard of informed consent.16 Under this approach, both case law

10 Blotner v. Dorieka, 285 Ga. 481 (2009); Albany Urology Clinic v. Cleveland, 272 Ga. 296, 528 S.E.2d 777
(2000).
11 Id.
12 § 766.103(3), Fla. Stat. (2005).
13 Id.
14 Thomas v. Berrios, 348 So.2d 905, 907 (Fla. 2d DCA 1977).
15 Valcin v. Pub. Health Trust of Dade County, 473 So.2d 1297, 1302 (Fla. 3d DCA 1984).
16 Largey v. Rothman, 110 N.J. 204, 211-12, 540 A.2d 504 (1988).

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and statute indicate that informed consent requires disclosure of the
available medical options, the medically significant risks associated with
those options, the nature of the proposed treatment, and the significance of
giving informed consent.17 However, the full scope of the required
disclosure is determined by what information would be material to a
reasonable person in the patient’s position faced with the decision of
whether to submit to the medical treatment at issue.18

E. California
Like Maryland, California applies the “material risk” or “reasonable patient”
standard of informed consent.19 Under this approach, informed consent
requires disclosure of the available alternatives to the proposed therapy and
the dangers inherently or potentially involved in each treatment. 20 However,
the full scope of the required disclosure is determined by what information
would be material to a reasonable person in the patient’s position faced with
the decision of whether to submit to the medical treatment at issue.21

F. Virginia
Unlike Maryland, Virginia employs the professional community standard of
informed consent.22 Accordingly, a physician’s duty to disclose is defined
with reference to the degree of skill and diligence exercised by a reasonably
prudent practitioner in the same specialty in Virginia.23 This generally
entails a disclosure of the dangers of, possible negative consequences of, and
alternatives to the proposed treatment or procedure.24 To recover against a
physician for lack of informed consent, the patient must establish by expert
testimony whether and to what extent any information should have been
disclosed.25

17 Howard v. Univ. of Med. & Dentistry of N.J., 172 N.J. 537, 548, 800 A.2d 73 (2002); N.J. Stat. Ann. §
26:2H-12.8 (2000).
18 Largey v. Rothman, 110 N.J. 204, 211-12, 540 A.2d 504 (1988).
19 Cobbs v. Grant, 8 Cal. 3d 224, 502 P.2d 1, 104 Cal. Rptr. 505 (1972).
20 Id.
21 Id.; Wilson v. Merritt, 142 Cal.App.4th 1125, 1133-34, 48 Cal.Rptr.3d 630, 637 (2006).
22 Tashman v. Gibbs, 263 Va. 65, 73, 556 S.E.2d 772, 777 (2002).

23 Bryan v. Burt, 254 Va. 28, 34, 486 S.E.2d 536, 539 (1997); Pierce v. Caday, 244 Va. 285, 291, 422
S.E.2d 371, 374 (1992).
24 Rizzo v. Schiller, 248 Va. 155, 158, 445 S.E.2d 153, 155 (1994).
25 Moates v. Hyslop, 253 Va. 45, 48, 480 S.E.2d 109, 111 (1997); Tashman v. Gibbs, 263 Va. 65, 73, 556 S.E.2d
772, 777 (2002).

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MALPRACTICE INSURANCE REQUIREMENTS
Suggested Forms

WHAT TO SAY AND HOW TO INFORM

Too much, too little, video, materials, Q&A

SENSITIVE ISSUES
Diagnosis

Alternatives

Care plans

Costs

Stoke

INFORMED UNDER HIPAA

Notice of Privacy Practices

Right to health care information

A STANDARDIZED FORM
Attached for discussion

QUESTIONS AND ANSWERS

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 CONSENT TO CHIROPRACTIC EXAMINATION AND CARE

I hereby authorize ____________ (“the Practice”) and its licensed doctors and assistants,
based on my complaints and the history I have provided, to undertake an examination and
provide an evaluation and treatment plan which may include chiropractic adjustments and
other tests and procedures considered therapeutically appropriate. I also wish to rely on
the Practice doctors to make those decisions about my care, based on the facts then
known, that they believe are in my best interest.

The nature and purpose of the chiropractic examination and evaluation, the chiropractic
adjustments and the other procedures that may be recommended during the course of my
care have been explained and described to my satisfaction.*

Based on current findings, Practice doctors have discussed my diagnosis and treatment
plan, the benefits and expected improvement with the proposed treatment and the
reasonable alternatives to the proposed treatment.** They have also explained the cost of
my proposed care (or provided me with a current fee schedule) and to the extent
practicable the costs of reasonable alternatives to the proposed treatment.*

To aid the understanding of my condition and the reasons for the proposed course of care,
the Practice has provided me with specific pamphlets and other literature (and videos)
and Practice doctors have answered my questions regarding the planned treatments and
course of care that I will receive.* Practice doctors have also explained that my diagnosis
and treatments may change during the course of care and that they will advise me of
material changes in my diagnosis and treatment options and answer any additional
questions that I may have at any time.**

I have also been advised that although the incidence of complications associated with
chiropractic services is very low, anyone undergoing adjusting or manipulative
procedures should know of rare possible hazards and complications which may be
encountered or result during the course of care. These include, but are not limited to,
fractures, disk injuries, strokes, dislocations, sprains, and those which relate to physical
aberrations unknown or reasonably undetectable by the doctor.*

I understand and accept that:

1. I have the right to withdraw from or discontinue treatment at any time and that the
Practice doctors will advise me of any material risks in this regard.*
2. That neither the practice of chiropractic nor medicine is an exact science and that
my care may involve the making of judgments based upon the facts known to the
doctor during the course of my care.
3. That it is not reasonable to expect the doctor to be able to anticipate or explain all
risks and complications or an undesirable result does not necessarily indicate an
error in judgment or treatment.

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4. The Practice does not guarantee as to results with respect any course of care or
treatment.
5. My care and treatment will not be observed or recorded for any non-therapeutic
purpose without my consent.*

I have read this Consent (or have had it read to me) and have also had an opportunity to
ask questions about the Consent and understand to my satisfaction the care and treatment
I may receive. My signature below acknowledges my consent to the examination,
evaluation and proposed course of care and treatments by the Practice.

_____________________ _____________________________
Witness Patient’s Printed Name

______________________________
Patient’s Signature

Doctor’s Notes:
Patient counseled by:
Discussion __________________________________
Provision of chiropractic pamphlet _______________
Viewing video _______________________________

____________________________
Signature of doctor

* Denotes Maryland Board of Chiropractic Examiners regulatory

requirements.

** Denotes additional requirements of Maryland common law as

discussed and amplified in McQuitty v. Spangler

Note: Inclusion of the above consent elements, except in unusual

circumstances, will concurrently meet those standards published by the
American Chiropractic Association and the International Chiropractic
Association.

© Marc K. Cohen, Ober:Kaler

Licensed for use by all MCA Members

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