LEGAL ISSUES IN MEDICAL
SCREENING 2014
James B. Haddow, Esquire
DISCLAIMER
The information provided in this presentation
is intended for educational purposes only. It is
not legal advice. If you encounter legal issues
in the course of your work, you should consult
with a qualified attorney.
Legal Issues with Potential Impact on
Prenatal Screening Professionals
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Liability for personal injury
Liability for infringement of intellectual property rights
Liability for breach of contract
Liability for violation of specific state / federal statutes
or regulations:
– Americans with Disabilities Act (“ADA”)
– Age Discrimination in Employment Act (“ADEA”)
– Equal Employment Opportunity Act of 1972
– Health Information Portability and Accountability
Act (“HIPAA”)
• Responsibility for violation of penal law
LIABILITY FOR PERSONAL INJURY
• Professional Liability
• “Slip-and-fall” liability
PROFESSIONAL LIABILITY - ELEMENTS
• Breach of the standard of care
• Injury caused by the proven breach
• Damages
STANDARD OF CARE IN PROFESSIONAL
NEGLIGENCE
• Plaintiff must provide evidence in the form of expert
testimony to establish the standard of care.
• The standard applied in any case must be by reference
to the actual practice of health professionals in the
same field as the defendant nationally.
• No health professional is required to use more than
the degree of care and skill expected of a reasonably
competent practitioner in the same field, working
under similar circumstances.
STANDARD OF CARE IN PROFESSIONAL
NEGLIGENCE
The standard “is not that of the most highly skilled,
nor is it that of the average member of the profession
or trade, since those who have less than median or
average skill may be competent and qualified. Half
of the [health care practitioners] of America do not
automatically become negligent in practicing . . . at
all, merely because their skill is less than the
professional average.”
Restatement (Second) of Torts §299A
SPECIFIC APPLICATIONS OF PROFESSIONAL
NEGLIGENCE PRINCIPLES TO PRENATAL SCREENING:
WRONGFUL BIRTH / WRONGFUL LIFE
Roe v. Wade and the right to legal abortion
OB/GYN Specialists Of The Palm Beaches, P.A. v. Mejia
Florida 2014
• Mother of child born with significant birth defects
awarded $2.5MM against sonographer who failed to
detect defects during Level II ultrasound conducted on
first day of third trimester.
• Florida statute prohibits abortion during third trimester.
• Trial judge did not allow sonographer to present
evidence that abortion was not a legal option.
OB/GYN Specialists Of The Palm Beaches, P.A. v. Mejia
Florida 2014
ON APPEAL
• Plaintiff can prevail only if she can prove that she would have
obtained an abortion if the doctor had not been negligent.
• Plaintiff's ability to undergo such a procedure, medically, legally,
and logistically, is relevant to the issue of causation.
RESULT: JUDGMENT VACATED
SPECIFIC APPLICATIONS OF PROFESSIONAL
NEGLIGENCE PRINCIPLES TO PRENATAL SCREENING:
WRONGFUL BIRTH / WRONGFUL LIFE
• Decision to offer screening
• Informed consent
• Technical conduct of screening
• Treatment of results
THE DECISION TO OFFER SCREENING
The standard of care in deciding to offer (or not
offer) prenatal screening is based on the actual
practice of health professionals who regularly
treat pregnant women.
THE DECISION TO OFFER SCREENING
What screening would a reasonably competent
practitioner in the same field offer to a similarly
situated patient in materially similar
circumstances?
THE DECISION TO OFFER SCREENING
Would a competent practitioner recognize
characteristics in a patient that would cause the
practitioner to conclude that a fully informed
patient in similar circumstances could reasonably
determine that the risk posed by screening is
likely to be outweighed by the advantage of
having a more accurate measurement of the risk
that the fetus she is carrying is affected by a
disorder?
INFORMED CONSENT – BASIC RULE
Before conducting any test or procedure, a health
care professional must secure her patient’s
consent after providing the patient with enough
information about the risks and benefits of the test
or procedure to allow the patient to make a
reasoned choice about whether to go ahead with
it.
INFORMED CONSENT – THE STANDARD
What information would a competent practitioner
provide in similar circumstances?
vs.
What information would a reasonable patient want
to know in order to make an informed decision
about her care?
The Screening Test
What are the duties owed by a laboratory in conducting tests?
Miller v. Redwood Toxicology Laboratory, Inc., 688 F.3d 928 (8th Cir. 2012)
To act with reasonable care in:
• collecting the sample or specimen to be tested;
• testing the sample or specimen; and
• reporting accurately and intelligibly the results of the test.
The Screening Test
A laboratory generally does not owe to a patient whose sample or
specimen is submitted to it for testing a “general duty of
reasonable care” nor a duty to warn about the risk of erroneous
results inherent in any test.
The Screening Test
Securing samples:
• Standard of care as established by practitioners
• Clinical Guidelines
The Screening Test
Testing Samples:
• Standard of care as established by professionals
• Practice guidelines
• CLIA
• CAP Checklist
• ACOG Standards and Guidelines for Clinical Genetics
Testing
Liability Risks in Multiple Factor
Screening
What are the responsibilities and potential
liabilities for a testing laboratory that aggregates
and analyzes data, some of it collected elsewhere,
and reports an overall result for use by a physician
and/or a genetic counselor in advising a patient
about risk, further testing, and possible pregnancy
termination?
Liability Risks in Multiple Factor
Screening
• Does the laboratory know or have reason to know
that any of the data coming from outside sources are
unreliable?
• Does the laboratory know or have reason to know
that the use of potentially unreliable data could have a
material effect on the overall risk assessment it will
report?
Handling Screening Test Results
• Communication from laboratory to physician:
– Attention to accurate communication
– Attention to reliability of information communicated
– Attention to confidentiality issues
• Communication from physician / counselor to patient:
– Attention to accurate communication
– Attention to reliability of information communicated
– Attention to confidentiality issues