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Medical malpractice encompasses the professional physician-patient relationship with its implied contract, consent, fiduciary responsibilities, and duty to provide the standard of care,

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

Understanding 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.2The 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.

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 ($)

* = 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

Internal

medicine

General and

family practice

Orthopaedic

surgery

* 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.

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.7An 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.3However, 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, orthopaedic 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.9In 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 guidelines10) 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

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.17Because 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 vary 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 physspecif-icians; others have held residents to the standard for practicing physicians Even when

residents are held to a “lower” stan-dard of care, the court 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.18In 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.19In 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

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 determined 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.,22for

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.23Holding 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.24In 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,27the 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.28In 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

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 popub-licy 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

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

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 mentalsevere-ly 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, if one of these factors is missing, the legal risks of relying on family consent without some sort of

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.31Because 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 Budgein 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 performing surgery, a court may view this to include ensuring imme-diate necessary aftercare The fail-ure to provide for proper follow-up

is a leading cause of malpractice actions against orthopaedic sur-geons.24However, 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

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 dede-fects 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 error 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 loosenresult-ing 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.36Although 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 superiorand 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

found to have occurred within the

scope of his or her duties, the health

care organization may be held

joint-ly or ultimatejoint-ly 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 support

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.37The 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 an independent review Most recently, the United States Supreme

Court in Rush Prudential HMO, Inc

v Moran38upheld 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 Statethat a physician who dis-charged a patient against his or her medical judgment because the

insur-er refused to authorize a longinsur-er inpa-tient stay could be held liable for negligence because he or she did not challenge the denial of authoriza-tion.39However, this precedent has

been limited by a later California de-cision40and 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.42According 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

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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