Overview of Legal and
Ethical Issues Related to
Health-Care Malpractice for
Prosthists and Orthotists
Ron Scott, JD, PT, OCS
ABSTRACT
The malpractice litigation crisis affects
all clinical health -care professionals.
Providers are sued by patients for
professional (treatment-related) negligence, injury from defective products,
breach of contract, and/or intentional
acts and omissions. Because orthotics
and prosthetics (O&P) focuses on both
professional product and service delivery, prosthetists and orthotists are
particularly vulnerable to professional
negligence and product liability claims.
While it is vital to maintain an altruistic
focus in care delivery, clinicians and
managers also must practice effective
malpractice risk management. Of particular importance is the generation of
legally acceptable incident reports when
patients are injured during evaluation or
treatment.
Introduction
All health-care professionals (HCPs)
are justifiably concerned about the potential risk of exposure to situations in
their clinical practices that could result
in malpractice liability. The United
States is clearly experiencing a serious
"litigation crisis," evidenced by the
more than 19 million new civil lawsuits
filed in 1992, the latest year for which
statistics are available (1). The healthcare malpractice crisis," although a
small component of the litigation crisis
(2), poses a formidable threat to the
participants in health-care delivery-
providers, facilities, product manufacturers, suppliers, insurers, and patients and their families
Although more and more patients
with adverse treatment outcomes are
resorting to the legal system for redress, not all health-care malpractice
claims can fairly be labeled as frivolous.
Evidence suggests a significant number
of inadvertent adverse incidents associated with clinical health-care delivery
results from malpractice.
The Harvard Medical Practice Study
(3) involved a retrospective review of
31,000 New York City inpatient medical records from 1984. The authors reported an adverse incident rate of nearly 4 percent among the patients whose
records were evaluated; 1 percent of
the patients studied were injured as a
result of professional negligence on the
part of health-care providers, according
to the professional judgment of the reviewers. However, between 2,967 and
3,888 health-care malpractice claims
were filed from the 31,000 patients
studied; this indicates many more patients (or their survivors) filed claims or
lawsuits than were deemed by professional reviewers to have been injured
as a result of malpractice.
Health-care malpractice litigation
exacts a devastating toll on provider defendants and their families, just as it
does on patient-plaintiffs. Some of the
potential adverse consequences of being sued include psychological stress,
the prospect of an adverse money judgment in settlement or at trial, the
mandatory reporting of the names of licensed HCPs to the National Practitioner Data Bank, and the potential for
adverse employment consequences associated with merely being named a defendant in a malpractice action.
Bases for Health-Care Malpractice
Legal Actions
Patients cannot successfully sue HCPs
simply because they experience "bad"
outcomes. Most adverse outcomes result from normal complications of
pathology. Many more occur due to
non-negligent errors in professional
judgment.
To succeed in health-care malpractice litigation, a patient must prove to a
judge or jury a legitimate basis exists
for imposing monetary liability. The legal bases of health-care malpractice liability are professional negligence, intentional misconduct, breach of contract, strict product liability for injury
from providing dangerously defective
products and strict liability incident for
abnormally dangerous activities. One
or more of these legal bases of liability
must be present in addition to an adverse patient outcome (i.e., physical
and/or psychological injury to the patient) for a patient to prevail in a healthcare malpractice legal action (4).
Health-care facilities may be named
as malpractice defendants in lawsuits
initiated by patients, either for their
own conduct (primary liability) or as
entities vicariously (indirectly) liable
for the conduct of HCP employees acting within the scope of employment (5).
Individual HCP defendants are normally patient care providers legally recognized as "health-care professionals."
This group of potential individual defendants includes physicians, dentists,
registered nurses, physical and occupational therapists, and prosthetists and
orthotists, among other licensed and
certified HCPs. O&P was formally recognized by the American Medical Association as an allied health profession
in 1992 (6).
Professional Negligence
The vast majority of health-care malpractice claims and lawsuits are
grounded exclusively in allegations of
professional negligence or substandard
care. Because O&P is unique among
the health professions as a co-primary
product and service profession (7), the
incidence of product-liability malpractice legal actions is greater than in other disciplines such as physical therapy,
nursing or medicine.
A patient-plaintiff in a professional
negligence health-care malpractice legal action must prove four elements by
a preponderance of evidence (8). These
elements of proof are as follows:
- The HCP owed the patient a legal
duty of care.
- The HCP violated or breached the
duty owed in some way.
- The breach of duty caused injury to
the patient.
- The patient sustained the kinds of
losses for which a court may award
compensation in the form of monetary
"damages."
When is a duty owed to a patient?
Normally, a specific duty of care is
owed only when an HCP agrees to provide professional treatment-related
services or products to a patient. That
special duty is breached if the HCP fails
to provide professional service or a
product that at least comports with
minimally acceptable standards of
practice and care.
There is no legal requirement that a
professional service or product be superior to other similarly situated HCPs'
work products or even of average quality. The legal standard is measured at
"floor-level," not at the "ceiling" of
comparative quality. "State-of-the-art'
technology is not necessary for compliance with the standard as long as what
the HCP under inquiry did for a patient
falls within acceptable standards of
practice.
How is the standard of care established? With only a few isolated exceptions representing judicial activism in
the legal literature, every health-care
profession has exercised the right to establish its own standard of care. What is
acceptable practice usually is determined by the testimony of expert witnesses or those professionals from the
same discipline as a defendant-HCP or
from a related discipline (provided the
nonpeer possesses sufficient knowledge, training and experience in the
area under inquiry).
To qualify as an expert, a witness
must: 1) possess in-depth knowledge
about the product or service in issue
and 2) be familiar with the standard of
care in the jurisdiction in which the patient was injured at the time the injury
occurred.
With these conditions in mind, physicians, physical and occupational therapists, nurses, and others may or may not
be legally competent in a malpractice
case brought by a patient against a
prosthetist- or orthotist-defendant to
testify about the standard of care. Prosthetists and orthotists who are the subjects of legal claims should ensure their
attorneys (personal legal counsel and/
or professional liability insurance attorneys) investigate and, when appropriate, challenge the competence of nonpeers to testify on the standard of care
or O&P.
The legal standard of care also can
be established by introducing into evidence authoritative works such as textbooks and peer-reviewed professional
journals (including the Journal of Prosthetics and Orthotics). Profession-wide
or institutional practice standards also
may be used to establish the legal standard of care.
In addition, professional codes of
ethics can serve as reference documents
for the standard of care. For O&P professionals, for example, certain provisions in the Canons of Ethical Conduct
(9) constitute practice standards that
can be introduced in a legal proceeding
to establish the legal standard of care. Section 2.1 enunciates two standards: 1)
the diagnosis of patients' pathologies is
considered to be outside the scope of
O&P professional practice, and 2) the
making of a prosthesis or orthosis requires a prescription from an appropriate licensed HCP. Section 2.3 states another practice standard: When requested to do so by the referring entity, prosthetists and orthotists "shall monitor
and observe a patient's physical condition in connection with orthotic and
prosthetic care...to make certain the patient is responding appropriately." Section 2.5 spells out practice parameters
for necessary modifications by prosthetists and orthotists of prescribed devices. Section 3.2 employs another practice standard that fixes primary (legal)
responsibility for O&P evaluation and
care delivery on prosthetists and orthotists once they accept patients for care.
Intentional Conduct, Breach of
Contract and Product Liability
Cases alleging intentional (mis)conduct
are frequently highlighted by the media
and include such claims as battery (inappropriate touching of a patient without patient consent), sexual battery
(battery intended to arouse or gratify
sexual desires) and invasion of patient
privacy. Allegations of impropriety
lodged against HCPs may give rise to
legal actions in several venues: civil
court for malpractice, criminal court for
felonious misconduct or an administrative setting for adverse licensure or certification action. For example, the intentional wrong of publicizing private
information about a patient (invasion
of privacy) also constitutes an ethics violation (Section 3.1 [Confidential Information], Canons of Ethical Conduct) for prosthetists and orthotists, potentially giving rise to both a civil legal
action for malpractice and an adverse
administrative action that could affect
certification.
Courts historically have been reluctant to permit patients to sue and win
against HCPs for breach of contract or
injury from defective products because
the legal system views the HCP/patient
relationship as something more than
just an ordinary arms-length business
relationship. The courts traditionally
view this relationship as special-akin
to parent/child, attorney/client and
minister/parishioner relationships.
The problem with this quasi-immunity from product liability for prosthetists
and orthotists is the creation of a product is coequal in importance to professional service in the O&P profession.
Still, to minimize imposition of product
liability, prosthetists and orthotists who
are claimed against or sued for product
liability-related malpractice should ensure their attorneys argue forcefully
that their physical work products are
integral components of professional
health-care service delivery.
Liability for Failing to Obtain
Patient-Informed Consent
A special case of professional negligence liability involves failure to obtain
patient-informed consent for evaluation and treatment. Out of respect for
patient autonomy, every HCP treating
patients has the legal and ethical duty
to obtain informed consent from every
patient (or surrogate decisionmaker)
before beginning treatment. Failure to
make informed disclosure and obtain
patient consent to care is a breach of
the duty of care owed to the patient. If
the patient is injured and can prove he
or she would have declined treatment
had informed disclosure been made,
the patient has an actionable healthcare malpractice case.
The Patient Self-Determination Act
(10), a consumer-education federal
statute that reiterates patient rights
(but does not create new ones), requires that federally funded healthcare facilities inform patients of their
rights to make advance directives and
to control the treatment decision-making process generally. These facilities
must provide patients with written information about facility policies on patient-informed decision-making and advance directives, including living wills
and durable powers of attorney for
health-care decisions consistent with
state law.
Although the exact requirements for
patient-informed consent vary from
state to state, the following is a general
checklist of disclosure elements that
prosthetists and orthotists should impart to patients:
- the nature of the intervention ordered;
- whether any material (decisional)
risks of serious injury or complications
are associated with the proposed plan
of care;
- expected benefits of the proposed
intervention, i.e., goals of treatment;
and
- reasonable alternatives, if any, to
the proposed course of treatment.
After disclosure of these consent elements, the O&P professional must solicit and satisfactorily answer patient
questions about the proposed care plan
and then formally ask for patient consent to proceed. Only after this process
is complete has the patient given informed consent to O&P intervention.
Ordinary Negligence
("Premises Liability")
One other form of negligence that can
result in patient injury is "ordinary"
negligence. Ordinary negligence involves non-treatment-related negligence that results in patient injury, such
as when a patient slips and falls on a wet
floor in the dressing room before or after evaluation or treatment. The type of
ordinary negligence described here also
is called "premises liability" (11), the
same kind of liability that can affect any
landowner or occupant of business or
residential property. While there is a significant number of claims filed by patients for ordinary negligence, this legal
action does not equate "malpractice"
and should not result in the same kinds
of adverse administrative and employment consequences for HCPs as professional negligence often does.
Clinical Liability Risk Management
What steps in daily clinical practice can
O&P professionals take to minimize
the risk of being claimed against or
sued by patients for health-care malpractice or ordinary negligence? Simple everyday practice patterns, including effective communication, friendliness and empathy for patients' problems, go a long way toward preventing
health-care-setting claims and lawsuits.
So does careful interpretation of physician and other HCP orders in patient
records as well as ongoing coordination
with referring entities and co-providers.
Prosthetists and orthotists, like other
HCPs privileged to document inpatient records, must ensure their documents are accurate, clear, concise,
objective and timely (11). Failure to
document in this manner is another
form of professional negligence if other
providers need vital information concerning the patient and either fail to receive it in a timely manner or cannot
decipher what is contained therein.
Clinicians and clinic and facility
managers must know the proper course
of action following patient injury in the
clinic area. The first steps after patient
injury are stabilizing the patient and
calling for medical assistance. An objective description of patient injuries
and treatment should be recorded in
the patient's progress notes in the treatment record. A separate document-an
incident report-should then be generated and filed, through the clinic manager, with the facility risk manager.
In the narrative section of an incident report, an objective description
of everything the report writer perceived should be documented, including relevant statements made by others about the incident. Statements
made by others (called "hearsay") are
enclosed in quotes so there is never a
later question about who said what. An
incident report must never contain
speculation as to the cause(s) of patient injury, nor should it attribute
blame to any specific HCP.
The dual purposes of an incident report are: 1) to alert management to
possible safety deficiencies requiring
immediate attention, and 2) to create
an objective administrative and legal
record of the incident for use in quality
improvement programs and as possible
evidence in a legal proceeding. To ensure immunity from disclosure, the generation of the incident report should
not be mentioned nor should a copy of
the report be filed in the patient's
treatment record (11).
Conclusion
Despite the recent health-care malpractice litigation crisis in the United
States, prosthetists and orthotists have
fared relatively well in minimizing liability exposure through effective clinical risk management. The purpose of
this article is to introduce clinicians and
managers to legal concepts related to
health-care malpractice; so they will
understand the nature of their legal
and ethical practice obligations and
fine-tune, as necessary, their practices
for the protection of the patients, themselves, their professions and the healthcare delivery system.
The information conveyed is not intended to foster defensive health-care
delivery because that kind of practice
focus increases, rather than diminishes.
liability risk exposure. HCPs, clinic
managers and administrators, and
health policymakers face the formidable task in coming months and years old
redesigning health-care delivery to cut
costs while simultaneously striving to
maintain the system's patient-welfare
focus that dampens liability exposure.
The information contained in this
article is intended to be informational
only and should not be construed as
specific advice for any HCP Prosthetists, orthotists and clinical managers must coordinate with risk management personnel and/or facility and
personal legal counsel in the event of
potentially compensable event involving a patient.
RON SCOTT JD, PT, OCS, is associate professor and interim chair at the physical therapy department of the University of Texas
Health Science Center at San Antonio.
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Note 2, 10, 27-9.
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1994.
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42 U.S.C. Section 1395cc(f).eff. Dec. 1.1991.
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