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Informed Consent: Premature Births

Posted on August 20th, 2013 by Oddo & Babat, P.C.

In 2010, the New England Journal of Medicine published the details of a 2004-2009 study of 1,300 severely premature infants at 23 medical institutions across the United States. The study, called the Surfactant, Positive Pressure and Oxygenation Randomized Trial (SUPPORT), was designed to address a longstanding issue in the care of premature babies: Oxygen, considered a crucial component in preemie care, administered to an infant in too high a dose can result in blindness while too low a dose can cause severe brain damage or death. Doctors hoped to discover what level of oxygen administration was best to prevent blindness without increasing the risk of neurological damage or death by randomly assigning the infants involved to receive different levels.

Considered ethically flawed by a number of federal officials, the study resulted in much negative feedback and a 2013 lawsuit against overseers of the study at the University of Alabama at Birmingham. The suit by parents of five Alabama children claims negligence and failure to properly inform the family of the risks involved. Along with questions about the ethics of medical experimentation, publicity around the study has raised the issue of informed consent processes as they pertain to premature infants.

Informed consent is a legal procedure to ensure that patients and caregivers are aware of all the potential risks involved in a particular medical treatment.

In the case of SUPPORT, the US Department of Health and Human Services acknowledged many of the parents would not have allowed their newborns to undergo the oxygen level tests had they been aware of the potential for serious harm or fatality.

It is a doctor’s responsibility to notify pregnant patients of the risks associated with carrying and delivering a baby – including factors that may increase their chances of premature labor. Some of the most common conditions that make a mother high risk for a premature birth are:

• Multiple babies including twins and triplets
• History of premature birth
• Short intervals between pregnancies
• Smoking, drinking and/or drug abuse during pregnancy
• Poor nutrition
• Infections of the amniotic fluid or lower genital tract
• High blood pressure and diabetes
• Stress
• Unusual shape of the uterus
• Physical injury or trauma
• Age of the mother, with heightened risk for those under 18 or over 35

With 500,000 cases of premature birth in the US each year, it is not always possible for a doctor to arrest early labor and prevent injury to the infant. During and post-delivery, the premature child may experience bleeding in the brain, low blood sugar, infections, severe lung damage and breathing problems that require close post-birth monitoring in neonatal intensive care units. As the baby develops, they are more likely to show signs of cerebral palsy, intellectual disability, vision and hearing problems and learning difficulties.

Failure of hospital personnel to fully disclose the treatment options
available and the risk factors involved in premature birth
may be grounds for a medical negligence claim.

While it is up to the parents to assess the quality of life their child will lead and determine if further operations and life-sustaining treatment should be administered, it remains the doctor’s responsibility to help them make educated decisions in the child’s best interest and obtain their informed consent before carrying out or withholding treatment.

When a baby is born with unexpected brain damage or physical defects, it will alter the course of their life and create significant hardship for the family. According to a report published by the Institute of Medicine in 2006, the cost of medical care in the first year of life for premature babies is 10 times higher than for full-term infants. The resulting disabilities can cost millions of dollars over a lifetime in rehabilitation fees and special education. Failure of hospital personnel to fully disclose the treatment options available and the risk factors involved in premature birth may be grounds for a medical negligence claim. If a doctor fails to notify a patient of risk factors or performs a procedure without informed consent of the patient, they may be liable for damages sustained as a result.

Oddo & Babat specializes in Medical Malpractice and Medical Negligence claims. Contact us today or call or call us at 212-642-0950 to arrange an appointment with one of our experienced New York attorneys.

Sources & Resources:
www.nejm.org/doi/full/10.1056/NEJMe1304996
www.ahrp.org/cms/content/view/921/81/
www.cdc.gov/reproductivehealth/MaternalInfantHealth/PretermBirth.htm
www.marchofdimes.com/mission/the-economic-and-societal-costs.aspx
www.mayoclinic.com/health/premature-birth/DS00137/DSECTION=risk-factors

_{Article by Shea Bergesen for Lavery Design Associates, Ltd.
copyright 2013. This article may not be reproduced without permission from the author.}