LLEGALEGAL I ISSUESSSUES ININ M MEDICALEDICAL SSCREENINGCREENING 2014 2014

James B. Haddow, EsquireJames 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 Legal Issues with Potential Impact on Prenatal Screening ProfessionalsScreening Professionals

• 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 - PROFESSIONAL LIABILITY - ELEMENTSELEMENTS

• 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 STANDARD OF CARE IN PROFESSIONAL NEGLIGENCENEGLIGENCE

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. MejiaFlorida 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. MejiaFlorida 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 SPECIFIC APPLICATIONS OF PROFESSIONAL NEGLIGENCE PRINCIPLES TO PRENATAL NEGLIGENCE PRINCIPLES TO PRENATAL

SCREENING:SCREENING:WRONGFUL BIRTH / WRONGFUL LIFEWRONGFUL 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 SCREENINGTHE 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 INFORMED CONSENT – BASIC RULERULE

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 INFORMED CONSENT – THE STANDARDSTANDARD

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 TestThe 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 TestThe 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 TestThe Screening Test

Securing samples:

• Standard of care as established by practitioners

• Clinical Guidelines

The Screening TestThe 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 Liability Risks in Multiple Factor ScreeningScreening

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 Liability Risks in Multiple Factor ScreeningScreening

• 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 ResultsHandling 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