Recent 5th Circuit Court of Appeals Decision Regarding Failure to Administer t-PA

The 5th Circuit recently decided a case dealing with the failure to administer t-PA to a stroke patient, Young v. Memorial Hermann Hospital System. The plaintiffs alleged that Randall Young should have been given t-PA and that the failure to receive proper treatment, t-PA is now the standard of care in most stroke patients, caused Mr. Young harm. The Court decided that the Youngs did not meet their burden of proof on the issue of causation.

In Young, the plaintiffs were trying to show that a stroke victim who is given t-PA has a greater likelihood of survival without morbidity than one who does not receive the medication. The Court used a study cited by Plaintiff to show that patients in the Plaintiff’s age group have a less than 50% chance of survival without morbidity (42%) if they do not timely receive t-PA and they have a greater than 50% chance of survival (59%) if they are given the drug timely. Nonetheless, since the plaintiff did not demonstrate that the benefit is double the positive outcome without the drug; the Court held that Plaintiff failed to prove causation. “[T]he requirement of a more than 50% probability means that epidemiological evidence must show that the risk of an injury or condition in the exposed population was more than double the risk in the unexposed or control population,” opined the Court looking to the principals of Havner.

The Court expanded what a plaintiff is required to prove in terms of causation, misapplying the Havner analysis. In Havner, a leading case on medical causation, the plaintiffs were attempting to prove that a drug, Bendectin, caused birth defects. The Texas Supreme Court held in Havner, that it has to be shown epidemiologically that there was a doubling of the risk over the normal population, the population of those who were not given Bendectin. A risk based claim, rather than a benefit based claim. The Texas Supreme Court in deciding Havner did not indicate that its holding would be applicable to a benefit based analysis as well.

The 5th Circuit has greatly changed the quantum of proof necessary to show that the failure to administer t-PA reduces the risk of survival below 50%. The study cited by the plaintiffs and used by the Court clearly indicated that a plaintiff would have a greater than 50% chance of survival (59% versus 42%) if given t-PA timely. It appears that the 5th Circuit is now requiring that the timely administration of t-PA would have to be double the rate of survival with t-PA or 84%. I question whether this is statistically possible.