Parents Sue Doctor Who Gave Child Propulsid
July 9, 2001
When Gage Stevens was born he brought joy into the lives of his parents. Unfortunately, their happiness was short lived. Gage was constantly irritable, so his parents took him to a doctor to determine the cause of his irritability. Dr. Susan Orenstein of Pittsburgh's Children's Hospital diagnosed Gage with acid reflux disease, also known as heartburn. Dr. Orenstein blamed Gage's fussiness on the condition. The doctor informed Gage's parents that she was conducting a study of the heartburn drug Propulsid and suggested that Gage participate. Gage was enrolled and died a few months later.
Gage's parents never knew that Propulsid was not approved for use in children, in fact, the consent form they signed at the request of Dr. Orenstein specifically stated that the drug was FDA approved for pediatric use. In addition, at the time they signed the consent form, at least one child had already died after taking Propulsid.
An FDA investigation into Dr. Orenstein's study found that she failed to follow good clinical practices, violated Federal regulations, kept poor records, and failed to use informative consent forms. Why would a doctor knowingly put a patient, especially a helpless child, into harm's way? Dr. Orenstein's critics claim that she was having difficulty enrolling patients into her Propulsid study. As such, she may have been tempted to bend, if not break rules in order to entice participation. Dr. Orenstein's quest for notoriety may have killed young Gage Stevens. Gage's parents are suing the doctor, Johnson and Johnson (Propulsid's maker), and Pittsburgh's Children's Hospital.
Propulsid has subsequently been removed from the market. The drug had a tendency to increase the heart's QT interval. The QT interval measures the time it takes the heart muscle to expand and contract. A healthy QT interval is around 4/10 of a second. A slight increase in that time can interrupt the heartbeat and cause an arrhythmia, resulting in immediate death. Propulsid has caused at least 300 deaths.
-- Article Courtesy of InjuryBoard.com
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