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Orthopaedics and the Law
Abstract
Understanding the relevant legal context is critical to the safe and
successful practice of orthopaedic surgery. Specifically, three areas
of liability are relevant to most physicians: medical malpractice,
products liability, and the liability of health care organizations.
Medical malpractice encompasses the professional physician-
patient relationship with its implied contract, consent, fiduciary
responsibilities, and duty to provide the standard of care, as well as
certain common-law duties pertinent in special circumstances.
Orthopaedic surgeons who design implants or who have a
relationship with a device manufacturer are at risk for liability for a
failed product. In general, the hospital entity is responsible for the
actions of its physician-employees. Still unclear is the degree to
which a physician is obligated to appeal to a third-party payor on
behalf of a patient. Physicians should remember that, above all
else, common sense with regard to the treatment, informed
consent, and advocacy of patients is essential to avoiding many
medical-legal pitfalls.
U
nderstanding the legal system
as it relates to the practice of
orthopaedic surgery has become
essential. As one author recently
noted:
The interaction between physi-
cians and the US legal system is
one of the most fascinating and
dynamic areas of law, encom-
passing not only classic ques-
tions of professional liability but

also the very heart of how the
modern medical enterprise is or-
ganized, financed, overseen, and
held accountable for both busi-
ness conduct and its broader so-
cial obligations.
1
For this reason, it is not merely law-
yers who need to understand health
law.
Before 1840, medical malpractice
was virtually unheard of in the
United States.
2
The evolution of the
medical-legal interface has grown in-
creasingly complex, overlapping in
virtually all aspects of the law. For or-
thopaedic surgeons, an understand-
ing of liability is especially relevant
to how one practices, the arena in
which one practices, and the tools
one uses (Tables 1 and 2). A broad
overview of professional liability as
it specifically relates to orthopaedic
surgery can serve as a foundation for
understanding challenges in the prac-
tice of medicine. Such an overview
also can provide an incentive for in-
creasing one’s role in shaping and re-

forming the professional environ-
ment. Specifically, three aspects of
medical liability are important in
this regard: professional liability (or
medical malpractice), orthopaedic
products liability, and the liability of
health care organizations.
Michael Suk, MD, JD, MPH,
Ann Marie Udale, EdM, JD, and
David L. Helfet, MD
Dr. Suk is Assistant Professor, University
of Florida College of Medicine, and
Director, Orthopaedic Trauma Service,
Shands Medical Center, Jacksonville,
FL. Ms. Udale is Attorney, Nutter,
McClennen & Fish, LLP, Boston, MA.
Dr. Helfet is Professor, Weill College of
Medicine at Cornell University, and
Director, Orthopaedic Trauma Service,
Hospital for Special Surgery, New York,
NY.
None of the following authors or the
departments with which they are
affiliated has received anything of value
from or owns stock in a commercial
company or institution related directly or
indirectly to the subject of this article:
Dr. Suk, Ms. Udale, and Dr. Helfet.
Reprint requests: Dr. Suk, University of
Florida – Shands Jacksonville, ACC

Building, 2nd Floor/Ortho, 655 West
Eighth Street, Jacksonville, FL 32209.
J Am Acad Orthop Surg 2005;13:397-
406
Copyright 2005 by the American
Academy of Orthopaedic Surgeons.
Volume 13, Number 6, October 2005 397
Professional Medical
Liability
The Physician-Patient
Relationship
The legal concept of the
physician-patient relationship com-
bines elements of contract law with
those of fiduciary law. Although the
legal relationship is initially estab-
lished by contract or agreement, the
law also recognizes the imbalance in
bargaining power between physician
and patient. Therefore, the law de-
mands that the physician uphold the
patient’s trust by acting in the pa-
tient’s best interest. Medical mal-
practice is a breach of a duty to the
patient, a duty created within a
physician-patient relationship. This
concept of the physician-patient re-
lationship thus sets the framework
for malpractice actions.
Contract

A physician enters into a profes-
sional relationship when a patient
seeks treatment and the physician
agrees to treat the patient. Although
typically no written contract forms
Table 1
Claims by 10 Most Prevalent Patient Conditions
Patient Condition
Total No. of
Claims
Percent Paid to
Closed Claims
Total Indemnity
($)
Fracture of femur 879 31.83 29,531,365
Fracture of tibia or fibula 760 29.61 31,533,639
Displacement of intervertebral disk 734 30.47 46,086,474
Osteoarthrosis, generalized or localized 699 31.26 24,338,270
Fracture of radius or ulna 636 29.81 12,618,199
Disorder of joint, not including arthritis 556 27.29 13,436,002
Fracture of medial malleolus, closed 466 35.42 19,184,075
Tear of medial cartilage or meniscus of knee 452 29.83 14,581,003
Back disorders, including lumbago and sciatica 426 23.75 18,458,511
Fracture of humerus 357 31.60 11,671,591
Total 5,965 30.23* 221,439,129
* = mean
Reprinted with permission from Fountain S, Brooks D, Butler D, et al: Managing Orthopaedic Malpractice Risk: Committee on
Professional Liability. Rosemont, IL: American Academy of Orthopaedic Surgeons, 2000, pp 3-78.
Table 2
Comparative Claim Payment*

Specialty
Total No. of
Closed Claims
Percent Paid to
Closed Claims
Total Indemnity
($)
Average Indemnity
($)
Largest Payment
($)
Obstetrics and
gynecology
20,725 36.47 1,671,380,657 221,141 4,000,000
Internal
medicine
19,274 27.40 846,741,532 160,307 2,900,000
General and
family practice
17,034 37.12 801,544,914 126,767 2,500,000
General surgery 16,195 36.12 856,453,215 146,402 2,000,000
Orthopaedic
surgery
14,979 30.19 603,418,371 133,441 2,000,000
* See also: www.aaos.org/wordhtml/bulletin/jun03/fline5.htm, citing average indemnity paid to successful claimants as $196,500 in
cases with error and $79,700 in cases without. These unpublished data take into account a study of Eastern seaboard states by the
AAOS in 2002.
Reprinted with permission from Fountain S, Brooks D, Butler D, et al: Managing Orthopaedic Malpractice Risk: Committee on
Professional Liability. Rosemont, IL: American Academy of Orthopaedic Surgeons, 2000, pp 3-78.
Orthopaedics and the Law

398 Journal of the American Academy of Orthopaedic Surgeons
the relationship, the law views this
agreement as an implied contract.
As in most contracts, this original
agreement to treat gives both parties
some latitude to define and limit the
relationship. For example, a physi-
cian may agree to perform only
specific procedures. However, be-
cause of the special nature of the
physician-patient relationship, there
are limits to the kinds of contractu-
al terms that courts will enforce. To
elaborate, a court usually will find a
contract that completely releases
the physician from all malpractice
liability to be unconscionable and
thus unenforceable. Some courts
have found physician-patient rela-
tionships to be formed through phy-
sicians’ contractual duties to hospi-
tals or health plans, even when the
physicians themselves have never
met the patients in question.
3
Consent
The physician-patient relation-
ship is consensual in that both the
physician and the patient are free to
refuse to enter into the relationship.

The relationship cannot be formed
without the assent of both parties. It
is important to note that, although
the patient has agreed to entrust his
or her care to the physician, in-
formed consent still must be ob-
tained for each specific diagnostic or
treatment procedure.
Fiduciary Responsibilities of
the Physician
A fiduciary is a person in a posi-
tion of confidence or trust who un-
dertakes a duty to act for the benefit
of another in a given set of circum-
stances (eg, a director of a corpora-
tion or the trustee of a trust). As
mentioned, the law recognizes that
the physician and the patient are not
equals in their dealings because the
physician has superior medical
knowledge and skills. Because of
this asymmetry, the patient is forced
to trust the physician, who in turn
has a special legal duty to honor that
trust and to act in the best interests
of the patient. It is this fiduciary as-
pect of the relationship that gives
rise to the limitations on contracts.
Fiduciary law is especially impor-
tant when a physician’s personal in-

terests conflict with a patient’s best
interests. For example, California
law requires physicians whose re-
search or economic interests might
affect their professional medical
judgment to disclose that fact to the
patient.
4
Special Situations
In certain situations, even in the
absence of the traditional physician-
patient relationship, special factors
or certain common law duties, based
on case law rather than on statute,
may apply. In some states, attending
physicians can be held liable when
substandard care is rendered by
residents under their supervision,
even when no traditional physician-
patient relationship exists between
the attending physician and the pa-
tient.
5
In these states, courts have
found that physicians owe a com-
mon law duty to patients because it
is foreseeable that negligent supervi-
sion could cause harm to patients.
To show that the supervision was
negligent, a plaintiff must demon-

strate that the surgeon’s supervision
fell short of the standard of care for
such supervision.
6
Physicians who merely consult
with a patient’s treating physician
via telephone will not usually be
found to have entered into a
physician-patient relationship with
that patient. However, when a phy-
sician evaluates patient medical in-
formation provided by a nurse and
makes a medical decision as to the
patient’s status or treatment, a rela-
tionship may be found.
7
An Arizona
court found that when a physician
was paid to cover the emergency de-
partment on an on-call basis, and the
hospital bylaws required that it treat
all patients admitted to the emer-
gency department, this contractual
agreement established a physician-
patient relationship and a resulting
duty to an emergency department
patient.
3
However, there are limits
to this contractual responsibility. A

New York court, for example, found
this duty to treat is created by con-
tract only in cases in which hospital
rules require that on-call physicians
treat patients or those in which phy-
sicians have undertaken to treat the
patient in question.
8
On-call physicians also may have
legal duties that are independent of
the physician-patient relationship.
For example, or thopaedic surgeons
who are on call for certain hospital
emergency departments may have a
legal duty under the Emergency
Medical Treatment and Active Labor
Act of 1986 (EMTALA, colloquially
known as the Patient Anti-Dumping
Act) to screen and stabilize patients
presenting with emergency medical
conditions, whether or not a phys-
ician-patient relationship exists.
This act provides for civil penalties
against certain “responsible” phy-
sicians who negligently violate
EMTALA.
9
In practice, there is little
risk of penalty to an on-call physi-
cian who examines the patient and

who, when preparing to transfer the
patient, provides needed stabiliza-
tion. The on-call physician also
would accurately certify (according
to EMTALA guidelines
10
) that the
benefits of transfer outweigh the
risks. However, EMTALA obliga-
tions on hospitals also can affect or-
thopaedic surgeons in that such ob-
ligations sometimes lead hospitals
to require physicians to provide on-
call services, in some cases without
compensation. The American Acad-
emy of Orthopaedic Surgeons has
published a position statement urg-
ing hospitals and orthopaedic sur-
geons to negotiate guidelines for
appropriate on-call coverage expec-
tations and compensation.
11
Another special situation arises
when the physician is an employee
of an organization that has contract-
ed with the patient to provide care.
In the Texas case Hand v Tavera,
12
Lewis Hand, a Humana Health Care
Michael Suk, MD, JD, MPH, et al

Volume 13, Number 6, October 2005 399
Plan beneficiary, presented at a hos-
pital emergency department report-
ing a 3-day headache. Dr. Tavera was
responsible for authorizing admis-
sions of Humana patients to the hos-
pital that evening. Without seeing
the patient personally, and despite
the recommendation of the treating
emergency department physician,
Dr. Tavera denied the patient admis-
sion. Shortly after discharge, Hand
suffered a debilitating stroke. The
Texas Court of Appeals found that
Dr. Tavera had a duty to treat that
patient as he would any other pa-
tient, according to the contract be-
tween Humana and Dr. Tavera’s
medical group. Because of this stip-
ulation in the contract, the court
found that a physician-patient rela-
tionship existed between Tavera and
Hand. Although this decision has
not been followed extensively out-
side Texas, it does suggest that a
medical group that contracts with
insurers to provide services should
consider whether the terms of the
contract might be found to create a
physician-patient relationship with

beneficiaries of the plan.
Finally, in addition to the duties
of physicians under EMTALA, there
may be other duties to patients out-
side a traditional physician-patient
relationship. The Supreme Court of
New Jersey recently held that a phy-
sician performing preemployment
physical examinations had a duty to
tell a patient of a potentially serious
health problem that was discovered,
although their relationship was not
a traditional physician-patient rela-
tionship.
13
Generally, courts have
found that physicians examining pa-
tients on behalf of insurers or em-
ployers have at least a duty not to in-
jure the patients; however, courts
have differed on the extent of the du-
ty.
14
Termination
Once a relationship has been cre-
ated, there are several ways in which
that relationship may be terminated.
The simplest is when the physician’s
services are no longer needed.
15

A
physician-patient relationship will
not be assumed to continue after the
episode of illness has concluded.
16
The relationship also may be termi-
nated by mutual agreement while
treatment is ongoing. Finally, the
physician may legally choose to ter-
minate the relationship while treat-
ment is still needed but only if done
in a manner that does not constitute
abandonment.
Medical Malpractice
A medical malpractice action is a
type of tort action. A tort is a civil
wrong for which a remedy may be
obtained, usually in the form of
damages.
17
Because tort law is large-
ly a common law doctrine that var-
ies by state, the specifics of each el-
ement of a tort claim likewise var y
according to state law. The underly-
ing doctrine, however, is fairly uni-
form. To succeed in a malpractice
suit, a plaintiff generally must show
that the physician had a duty to him
or her, that the physician breached

this duty, and that the breach caused
injury to the plaintiff.
Duty
Once a physician-patient rela-
tionship is established, the physician
has a legal duty to provide care that
meets the professional standard of
care. Holding physicians to this
standard of care requires that they
exercise the same care that a reason-
ably prudent physician would have
exercised under similar circum-
stances. The standard of care varies
according to specialty: an ortho-
paedic surgeon will be held to the
standard of care of a reasonably pru-
dent orthopaedic surgeon, which
will be different from that of a gener-
al practitioner.
The courts disagree about the ap-
plicable standard of care for resident
physicians. Some courts have held
residents to a standard of care specif-
ic to resident physicians; others have
held residents to the standard for
practicing physicians. Even when
residents are held to a “lower” stan-
dard of care, the cour t may find that
the resident’s responsibilities includ-
ed the duty to obtain the guidance of

an attending physician when faced
with a situation that the resident
physician knew to be beyond his or
her skills and training. Thus, negli-
gence may be found despite being
held to a resident’s standard of care.
For resident physicians training
in a specialty, a related question the
courts have reviewed is whether to
hold them to a general practitioner’s
or to a specialist’s standard of care.
The Pennsylvania Superior Court
has ruled that an orthopaedic resi-
dent is to be held to an intermediate
standard of care, higher than that of
a general practitioner but not that of
a fully trained orthopaedic special-
ist.
18
In general, interns or first-year
resident physicians with less spe-
cialized training have been more
likely to be held to a generalists’
standard of care, whereas residents
with further training are more like-
ly to be held to the standard of their
specialty.
An attending physician who su-
pervises residents may possibly be li-
able for negligent supervision if the

plaintiff can show that the supervi-
sion fell short of the standard of
care.
19
In some states, evidence also
must be offered showing that the at-
tending physician had control over
the acts of the resident physician.
20
Although the standard of care is
objective, it is not fixed. A jury de-
termines the standard of care in each
case, usually after hearing expert tes-
timony. The patient (plaintiff) bears
the burden of establishing the gov-
erning standard of care. If relevant
clinical practice guidelines exist,
they may be used by either side as
persuasive evidence of the standard
of care; however, expert testimony
typically will be offered in addition.
Therefore, the clinical practice
guidelines are not necessarily deter-
minative. State statutes stipulate the
qualifications a physician must pos-
sess to qualify as an expert witness
Orthopaedics and the Law
400 Journal of the American Academy of Orthopaedic Surgeons
in a medical malpractice case. To
testify with regard to the standard of

care for a specialist, it is commonly
required that a physician have some
knowledge of the specialty. For ex-
ample, a general practitioner would
not ordinarily be allowed to testify
as an expert on the standard of care
for orthopaedic surgeons. If resident
physicians have the required qualifi-
cations, they usually are allowed to
testify as expert witnesses.
21
The
standard of care is not intended to
identify one specific best practice
but rather to encompass a range of
treatments considered to be accept-
able practice in terms of sound med-
ical judgment and the care used by
the physician.
Traditionally, the standard of
care was deter mined relative to lo-
cation. For example, to determine
whether a general practitioner in ru-
ral Kentucky fulfilled the standard
of care, one would ask what a rea-
sonable general practitioner in the
same or a similar location would
have done. However, because infor-
mation about new medical knowl-
edge and techniques has become

more widely available, many states
now hold physicians to a national
standard of care, and most courts
have abandoned this “locality rule.”
(In Sheeley v Memorial Hosp.,
22
for
example, the Rhode Island Supreme
Court discusses its explicit decision
to join the growing number of states
which are discarding the locality
rule.) Specialists are especially
likely to be held to a national stan-
dard, although this continues to dif-
fer among states.
23
Holding to a na-
tional standard can be of strategic
importance in a lawsuit because it
gives both sides the opportunity to
use experts from outside the locality
in question.
Breach of Duty
Negligence is a necessary ele-
ment of most torts. In a malpractice
case, the physician’s conduct will be
judged as negligent if it falls below
the professional standard of care. In
addition to bearing the burden of es-
tablishing the standard of care, the

patient in malpractice cases also
bears the burden of proving to the
jury that the physician departed
from the standard.
An example of a common breach
of duty is misdiagnosis.
24
In a recent
case, a New York court awarded a
plaintiff $2.5 million because an or-
thopaedic surgeon misdiagnosed and
treated reflex sympathetic dystrophy
(complex regional pain syndrome) as
de Quervain’s disease and thereby
caused complete loss of use of her
dominant hand and arm as well as
chronic pain. The plaintiff ’s expert
in this case testified that the defen-
dant surgeon breached the standard
of care by failing to read the patient’s
complete medical record and by
“failing to conduct further tests fol-
lowing the surgical procedure of De-
Quervain release and discovery of
normal tendons.”
25
As illustrated by the Nebraska
Court of Appeals’ opinion in Coran
v Board of Regents of the Universi-
ty of Nebraska, evidence of breach of

the applicable standard of care is
generally necessary for misdiagnosis
to rise to the level of negligence.
Here, the court affirmed dismissal of
the patient’s action because, while
alleging that the defendant surgeon
had failed to diagnose thoracic spinal
stenosis, the plaintiff did not offer
evidence that the surgeon’s conduct
breached the standard of care.
26
Res Ipsa Loquitor
In some cases, an injury may oc-
cur during treatment that is unlike-
ly to have occurred other than by
negligence but for which no specific
evidence of such negligence is avail-
able. An example is when a patient
awakens from anesthesia with an in-
jury that was not a known risk of the
procedure. Recognizing the difficul-
ties patients face in this situation,
courts have sometimes applied the
legal doctrine of res ipsa loquitor;
which literally means “the thing
speaks for itself.” In Ybarra v Span-
gard,
27
the patient (plaintiff) under-
went an appendectomy and awoke

with paralysis of one arm. The court
found negligence on the part of the
medical staff in this case, even
though the patient could not pro-
duce a witness or describe the negli-
gent act, because upper extremity
paralysis does not normally occur
during an appendectomy.
Over time, however, the doctrine
of res ipsa loquitor has become less
popular because of concern by the
courts that physicians might be held
liable for rare bad outcomes even in
the absence of negligence.
28
In states
in which res ipsa loquitor continues
to be used, the plaintiff must show
that he or she was injured (1) in an
occurrence that ordinarily does not
happen in the absence of negligence,
(2) by an agency or instrumentality
within the defendant’s exclusive con-
trol, and (3) that he or she did not
contribute to the injury. In some ju-
risdictions, the first element—the ex-
traordinary nature of the occur-
rence—must be discernible by lay
persons; that is, the use of experts is
not required. Other jurisdictions al-

low or even require the use of experts
to prove this element. When the pa-
tient can show all three of these el-
ements, the burden shifts to the phy-
sician to show that the injury was
not caused by his or her negligence.
Causation
Even if it is proved that a physi-
cian has violated the standard of
care, the physician will not automat-
ically be held liable. The plaintiff
must establish that this breach of
the standard of care caused an inju-
ry suffered by the plaintiff. Legal
cause traditionally has been com-
posed of two elements: cause in fact
and proximate cause. To meet the
cause-in-fact test, an act must have
been necessary for the outcome,
even if the act was not the only
cause of the outcome.
29
Thus, if a
patient with severe osteopenia
sustains a wrist fracture during an
unrelated surgery, the orthopaedic
Michael Suk, MD, JD, MPH, et al
Volume 13, Number 6, October 2005 401
surgeon can be liable for the fracture,
even if it was partly the result of the

preexisting condition.
However, even when a physi-
cian’s action was the factual cause of
a patient’s injury, liability may be
limited by the doctrine of proximate
cause. In cases in which the type of
injury is not foreseeable, the doc-
trine of proximate cause recognizes
that liability might contravene pub-
lic policy. An example is when a pa-
tient has a rare and unforeseeable
disease that causes a poor reaction to
a given treatment. Although the
treatment may have caused the reac-
tion, courts may find the resulting
injury too remote to have been fore-
seeable.
Contributory Negligence
One defense a physician can raise
is that the patient’s own negligence
contributed to the injury. For exam-
ple, if a patient neglected to disclose
important information regarding his
or her medical history or neglected
to follow discharge instructions, the
jury may find contributory negli-
gence. In some cases, patient negli-
gence may alleviate the physician’s
liability entirely; in other cases, such
negligence may be deemed to be

only a partial cause of the injuries
and therefore may decrease the dam-
ages awarded only by a percentage
relative to the patient’s contribu-
tion.
Damages
A primary purpose of damages in
a tort action is to make the plaintiff
“whole.” When a plaintiff cannot ac-
tually be made whole in cases of
physical or emotional damage, the
legal system compensates the pa-
tient with a monetary award. Com-
pensatory damages reimburse the in-
jured party for the injury sustained,
and nothing more. Special damages,
which are part of compensatory
damages, are for the actual out-of-
pocket losses incurred by the plain-
tiff, such as medical expenses and
lost earnings. Noneconomic damag-
es, also part of compensatory damag-
es, are awarded for nonfinancial loss-
es, such as pain and suffering.
In addition to compensatory dam-
ages, courts sometimes award puni-
tive damages when a physician’s ac-
tions have been egregious. Punitive
damages are unusual in medical
malpractice cases and often cannot

be awarded unless some other type
of damages is awarded for actual in-
jury. Nominal damages are awarded
when there is no harm other than to
the patient’s dignity or integrity. The
award of nominal damages may
sometimes serve as the prerequisite
to an award of punitive damages.
Informed Consent
Failure to procure informed con-
sent is a claim often brought with a
malpractice claim. To be truly in-
formed, consent must be given by a
patient who understands the infor-
mation presented, is capable of mak-
ing a decision, and makes that deci-
sion voluntarily. Informed consent
should include discussion by the
physician and patient of the follow-
ing information: (1) the diagnosis or
medical problem for which the phy-
sician is recommending treatment;
(2) a description of the proposed
treatment or procedure, including its
purpose, duration, methods, and im-
plements used, as well as the proba-
bility of success; (3) all material risks
of the procedure or treatment; (4)
any reasonable alternatives to the
proposed procedure; and (5) the risks

of not being treated.
30
Optimal informed consent is a
process usually obtained through a
combination of written and oral
communication. To ensure that the
patient is in fact adequately in-
formed, a surgeon is best advised to
review the form with the patient, at-
tempt to gauge the patient’s under-
standing of the information, and ad-
dress questions and concerns.
Some states have enacted statutes
mandating specific disclosures for
certain procedures, although this
level of statutory specificity is still
uncommon. In designing an in-
formed consent procedure, physi-
cians should first investigate state
statutory requirements for disclo-
sure. Where there are no specific dis-
closure requirements, an adequate
informed consent procedure should
generally include the five types of in-
formation previously discussed.
Patients who do not know what is
being asked or who are unable to
comprehend the nature of the treat-
ment and the consequences of their
treatment decision may be incom-

petent to give consent. Although
capacity is a legal standard, it is us-
ually physicians who make the ini-
tial determination. In many situa-
tions, determining capacity is fairly
straightforward—for example, when
the patient is unconscious or severe-
ly mentally retarded. When a physi-
cian has doubts about a patient’s
ability to comprehend what is being
explained, an alternative is to ask
another physician with appropriate
expertise to consult.
20
If the situa-
tion is not an emergency, a final re-
sort is to refer the question of capac-
ity to a court.
When a patient lacks capacity to
consent, it can be obtained through
a surrogate. If a legal guardian has
been appointed, his or her decision is
authoritative. When no legal guard-
ian has been appointed, the common
practice is to rely on the consent of
a family member or next of kin. This
practice has explicit legal support in
some states; in others, it does not.
One practitioner’s guide counsels
that reliance on the consent of a

family member generally carries
negligible risks when (1) the decision
is in favor of treatment that is med-
ically indicated and is the treatment
recommended by the patient’s physi-
cian; (2) the treatment does not in-
volve the patient’s reproductive ca-
pacity; (3) no family member objects
to the decision; and (4) the patient
does not object.
20
However, i f one of these factors is
missing, the legal risks of relying on
family consent without some sort o f
Orthopaedics and the Law
402 Journal of the American Academy of Orthopaedic Surgeons
authorization increase considerably.
State statutes establish an age at
which a child is permitted to con-
sent to medical treatment, usually
age 18 years. Before that age, in most
circumstances, parental consent
must be obtained.
Generally, for patients to prevail
in court on a theory of lack of in-
formed consent, they must prove
that they would not have consented
to the procedure had they been
aware of the particular risk of the
complication or complications in

question. In deciding whether a risk
was “material,” courts in most
states have looked to a physician-
centered standard and asked wheth-
er a reasonable physician would
have disclosed this risk to the pa-
tient. However, the modern trend is
for courts to adopt the general or
patient-centered standard. States
that use this patient-centered stan-
dard ask whether information re-
garding the risk would be important
to a reasonable patient in making
the decision to accept treatment. In
some states, the court also may ask
whether the risk would have been
material to the particular plain-
tiff.
31
Because of this, a physician in
one of these states should take the
time to get a sense of the patient’s
values and of those risks that may be
especially important to the patient.
Good informed consent and com-
munication practices may help pre-
vent malpractice claims. One study
has shown that physicians who es-
tablished rapport with patients and
more effectively explained the inju-

ry and treatment plan experienced
fewer malpractice claims.
24
Abandonment
Abandonment refers to the phy-
sician’s breaching a legal duty by
unilaterally terminating the phy-
sician-patient relationship without
reasonable notice at a time when the
patient still has need of medical at-
tention. This concept is an old one,
and judicial decisions often quote
the court in the 1935 Utah case
Ricks v Budge in describing physi-
cians’ duties with regard to the
physician-patient relationship:
The obligation of continuing at-
tention can be terminated only
by the cessation of the necessity
which gave rise to the relation-
ship, or by the discharge of the
physician by the patient, or by
the withdrawal from the case by
the physician after giving the pa-
tient reasonable notice so as to
enable the patient to secure oth-
er medical attention. A physi-
cian has the right to withdraw
from a case, but if the case is
such as to still require further

medical or surgical attention, he
must, before withdrawing from
the case, give the patient suffi-
cient notice so the patient can
procure other medical attention
if he desires.
32
Abandonment is most easily
found when a physician expressly
tells a patient that he or she will no
longer treat the patient. If the physi-
cian terminates the relationship in
this manner without allowing the
patient time to find a suitable re-
placement, and if the patient is still
in need of care, the physician likely
will be found to have abandoned the
patient. When there is an existing
physician-patient relationship and a
physician refuses to perform a proce-
dure, the abandonment inquiry be-
comes slightly more complicated. In
this situation, there is a question of
fact as to whether the physician in-
tended to maintain the relationship,
even though refusing to perform this
procedure. In general, if there is no
intent to abandon, there is no aban-
donment. One caveat to this is that
when a physician’s employment

with a management organization is
terminated, the physician may still
be under a duty to provide care to the
organization’s patients until suitable
substitute care is found. However, in
many cases, the management orga-
nization will undertake to provide
substitute care. Additionally, notice
of termination is often provided far
enough in advance to allow the pa-
tients ample time to find substitute
care.
A surgeon also can be liable for
abandonment when he or she fails to
ensure proper postsurgical care.
Even in situations in which the phy-
sician and patient agree that the
surgeon’s services are limited to
perfor ming surgery, a court may
view this to include ensuring imme-
diate necessar y aftercare. The fail-
ure to provide for proper follow-up
is a leading cause of malpractice
actions against or thopaedic sur-
geons.
24
However, if the physician
arranges for an attending physician
or hospital staff member to provide
aftercare and explains the follow-up

recommendations clearly to the pa-
tient, the physician usually is seen
as having fulfilled his or her duty not
to abandon.
A doctor who discharges a patient
prematurely may be considered to
have abandoned the patient. Similar-
ly, abandonment may occur when a
physician discharges a patient with-
out giving suitable discharge in-
structions, and the patient is there-
by injured.
The abandonment doctrine does
not mean that physicians have no le-
gal right to terminate the physician-
patient relationship. A physician can
terminate the relationship if suffi-
cient notice is given to allow the pa-
tient to find a substitute. The physi-
cian also can avoid abandonment
liability by providing a competent
substitute; however, usually it is re-
quired that the patient receive no-
tice of this substitution. Finally, the
patient has an obligation to cooper-
ate and return. If the patient does not
cooperate with the physician, the
physician may first warn the patient
of the intent to terminate care, and
then do so. Furthermore, if the pa-

tient fails to comply with proper
follow-up instructions, the physi-
cian may be justified in terminating
the relationship.
Michael Suk, MD, JD, MPH, et al
Volume 13, Number 6, October 2005 403
Orthopaedic Products
Liability
Advances in orthopaedic surgery,
perhaps more than any other surgi-
cal subspecialty, hinge on changes in
technology. Progress in understand-
ing mechanical disease has spurred
innovation in all aspects of ortho-
paedic surgery, most notably in joint
arthroplasty and spine and ortho-
paedic trauma surgery . Under special
circumstances, orthopaedic sur-
geons may be subject to the risk of
product liability litigation because,
to facilitate biologic healing, they
commonly use implants and nonbi-
ologic materials created by manufac-
turing processes.
33
Definition
Products liability refers to the li-
ability of any or all parties along the
chain of manufacture for damage
caused by that product or inherent

defects in the product. This liability
may extend to the implant manufac-
turer, the distributor, and the indi-
vidual orthopaedic surgeon.
Legal Theory
Manufacturers, distributors, and
orthopaedic surgeons who harm pa-
tients through the use of allegedly
defective products are sued under
the theory of strict liability, not neg-
ligence. Unlike medical malpractice,
the concept of strict liability elimi-
nates the need to prove negligence
for an injury caused by a defective
product. Strict liability wrongs do
not depend on the level of care exer-
cised by the defendant. Translated
into products liability terms, a de-
fendant is liable simply when it is
shown that the product is defective.
Driven by the public policy interest
in consumer protection, liability for
manufacturing defects places the
burden of proving safety on the man-
ufacturer.
Two types of defects are subject to
products liability: manufacturing de-
fects and design defects. Products
with manufacturing defects are
those that deviate from their intend-

ed original design and usually are
easy to identify in that the product
itself is flawed. Although flaws are
often the result of some form of neg-
ligence during the assembly process,
suits involving these types of defects
are subject to the strict liability stan-
dard without regard to the manufac-
turer’s care in protecting its process
from er ror. The test used is the con-
sumer expectation test. Because the
consumer expects a product to be
free of defects, this test weighs
whether a product is unreasonably
dangerous beyond that danger con-
templated by the ordinary consum-
er.
34
The leading orthopaedic example
involved the recall in 2000 of the
Inter-Op acetabular cup manufac-
tured by Sulzer Orthopedics (Austin,
TX). After reported failures of the
cup, Sulzer noted that there had
been an unacceptable level of miner-
al oil–based lubricant left on the cup
during the final cleaning process of
the porous coating. This residue act-
ed to prevent adequate bone in-
growth to the acetabular cup, result-

ing in premature loosening and its
ultimate failure.
35
A claim based on a design defect
alleges that a product is inherently
unsafe despite meeting all design
and manufacturing specifications.
An example of the design defect is
the production of the Hylamer Dur-
aloc acetabular liner manufactured
by DuPuy (Warsaw, IN). Hylamer
was introduced by DuPuy in 1990 as
a modified implant-grade polyethyl-
ene developed to reduce wear in to-
tal joint arthroplasty components.
Initially, all Hylamer components
were sterilized by gamma radiation
in air. As a result of surprising early
failures in the Hylamer liners, an in-
vestigation revealed that the pres-
ence of oxygen during gamma steril-
ization and storage of sterilized
components caused a progressive de-
generative oxidation that was associ-
ated with decreased wear resistance
and increased brittleness. Patients
with failed Hylamer liners ultimate-
ly required revision total hip arthro-
plasty.
36

Although this set of events
presented a new standard for investi-
gation in total joint arthroplasty and
dramatically increased knowledge of
polyethylene cross-linking, the ini-
tial product was made according to
manufacturer guidelines.
Individual orthopaedic surgeons
are at risk for liability for a failed
product in several ways: as the de-
signer of the implant or product, or
as a consultant or clinical investiga-
tor whose responsibility is to pro-
mote the device under investigation.
Where the link between indepen-
dent practitioner and employee ex-
ists is the subject of much litiga-
tion.
33
Liability of Health Care
Organizations
Historically, physicians in the prac-
tice of medicine were often indepen-
dent of the hospital environment in
which they often practiced. Begun
as charitable institutions, hospitals
typically enjoyed immunity from
lawsuits for the actions of the profes-
sionals working within their walls.
Today, however, the hospital no

longer has this immunity as a result
of the increasing application and
acceptance of two legal doctrines:
respondeat superior and corporate or
enterprise liability.
Respondeat Superior
In medical malpractice actions,
the physician is typically individual-
ly liable for negligent acts that cause
a patient harm. However, in special
circumstances, that physician may
be shielded from personal liability
under the doctrine of respondeat su-
perior (literally, “let the master an-
swer”). Under this doctrine, the hos-
pital entity is responsible for the
actions of its employees or agents,
and the physician is considered an
employee of the health care organi-
zation. When the negligent act per-
formed by the physician-employee is
Orthopaedics and the Law
404 Journal of the American Academy of Orthopaedic Surgeons
found to have occurred within the
scope of his or her duties, the health
care organization may be held joint-
ly or ultimately responsible.
A physician may be considered to
be an employee of a hospital in two
ways: as a direct employee under

contract with defined duties, or indi-
rectly, when circumstances are such
that an “employment-like” relation-
ship can be construed. Determining
the connection between the physi-
cian and hospital can be difficult; it
often rests on the level of suppor t
the hospital provides to the individ-
ual physician (eg, billing services,
ancillary services, uniforms). For ex-
ample, if a hospital represents to the
patient that a physician is a hospital
employee although in fact the physi-
cian is an independent contractor, a
court may still hold the hospital lia-
ble for the physician’s acts. Under
this legal theory, known as ostensi-
ble or apparent agency, the patient is
viewed as relying on the hospital
through its physician agents to pro-
vide reasonable and safe health care.
A plaintiff relying on the ostensible
agency theory need only show that
he or she looked to the hospital for
treatment and that the assigned at-
tending physician negligently in-
jured the patient during treatment.
Enterprise Liability
Under the theory of corporate or
enterprise liability, the hospital it-

self is viewed as having a nondelega-
ble duty to its patients to ensure the
proper selection, retention, and su-
pervision of its medical staff. Negli-
gent acts that might arise from a
lapse in these duties can result in the
direct liability of the health care in-
stitution. To hold a hospital liable
based on the theory of corporate neg-
ligence, a plaintiff must show that
the hospital knew or should have
known that the physician was pro-
viding substandard care.
In the watershed decision Dar-
ling v Charleston Memorial Hospi-
tal, the court held that a hospital
owed a duty to the patient for the
proper supervision of a physician
covering the emergency department.
In Darling, a physician in general
practice close-reduced an injured pa-
tient’s tibia-fibula fracture and
placed it into a circumferential cast.
The patient subsequently developed
a compartment syndrome and re-
quired a below-knee amputation.
Apart from the physician’s individu-
al negligence, the court determined
that the hospital failed in its duty to
require the physician to obtain the

appropriate orthopaedic consulta-
tion for diagnosis and manage-
ment.
37
The legal basis for its deci-
sion was the hospital’s direct
responsibility to see that indepen-
dent practitioners obtain the appro-
priate specialist consultation and act
on the specialist’s recommenda-
tion.
Third-Party Liability
On occasion, physicians and pa-
tients are faced with an insurer’s de-
cision to deny coverage for a recom-
mended procedure. Many states
have passed laws that guarantee the
right to appeal these decisions in the
form of a n independent review. Most
recently, the United States Supreme
Court in Rush Prudential HMO, Inc
v Moran
38
upheld an Illinois law that
guaranteed patients the right to an
external review of denial of cover-
age. When confronted with this sit-
uation, physicians should encourage
patients to pursue every avenue of
appeal and to document the entire

appeal process.
There is some debate about the
extent to which a physician is ethi-
cally or legally obligated to be in-
volved in the appeal process on be-
half of the patient. A California
Court of Appeals suggested in Wick-
line v State that a physician who dis-
charged a patient against his or her
medical judgment because the insur-
er refused to authorize a longer inpa-
tient stay could be held liable for
negligence because he or she did not
challenge the denial of authoriza-
tion.
39
However, this precedent has
been limited by a later California de-
cision
40
and has not been followed
by any other state. Further, the Fed-
eral Court of Appeals for the Third
Circuit expressly found that there
was no duty to advocate for a patient
under New Jersey law.
41
Many states have passed laws
that protect physicians who do advo-
cate for their patients from retalia-

tion by the managed care organiza-
tions that employ the physicians. In
addition, some state laws assume
that physicians will present evi-
dence on behalf of their patients be-
fore the review committee, but no
state law directly mandates that
physicians must appeal decisions on
behalf of their patients. Given the
current state of the law, a physician
will fulfill his or her legal duty by
giving accurate information to a re-
viewer when called on to do so.
However, the American Medical As-
sociation Code of Ethics states that
in certain circumstances, physicians
have an ethical obligation to initiate
appeals on behalf of their patients
when a managed care organization
denies care that, in the physician’s
judgment, would “materially bene-
fit” the patient.
42
According to the
Code, in some instances, physicians
should advocate against particular
denials of coverage or against guide-
lines that operate unfairly.
Summary
Understanding the relevant legal

context is critical for the safe and
successful practice of orthopaedic
surgery. Confronted with legal situ-
ations that challenge the ortho-
paedic environment, the prudent
physician may use this information
to develop a risk-management strat-
egy. Particularly in regard to medical
malpractice and products liability,
practicing orthopaedic surgeons
should be aware of the areas of po-
tential liability inherent in the
physician-patient relationship and in
relationships with device manufac-
turers. In general, however, common
Michael Suk, MD, JD, MPH, et al
Volume 13, Number 6, October 2005 405
sense with regard to the treatment,
informed consent, and advocacy of
patients is paramount and essential
to avoiding many medical-legal pit-
falls.
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Orthopaedics and the Law
406 Journal of the American Academy of Orthopaedic Surgeons