2009

In this medical device products liability case defended by Dina M. Cox, a minor child died of an accidental overdose of acetaminophen with codeine while recuperating from surgery. The cup used to administer the medicine was a plastic, translucent cup with a capacity of 30 milliliters. Just 15 milliliters was prescribed. The facts were undisputed that the administering nurse was familiar with the cup, and that the autopsy showed more than twice the prescribed level of medication in the minor's bloodstream. The nurse testified that she had filled the cup approximately half-way, although the minor's father testified that he witnessed the nurse administer a full cup of the medicine.

The minors' parents sued on the theory that the cup was not suitable for precision measurement, and that there should have been a corresponding warning. This argument was supported by the affidavit of an expert who testified that the cup had a 20 to 30% margin for error, but no warning with respect to that margin.

In this multi-defendant case, Dina was the first to move for summary judgment before the trial court on behalf of her product distributing clients; the other manufacturing defendants then followed suit.  Dina deposed plaintiffs' pharmacy expert who was identified to defeat summary judgment; and, thereafter, she moved to exclude his opinions in concert with the other defendants.  Dina coordinated the joint summary judgment reply on behalf of the defense, and she participated in oral argument before the trial court.  Summary judgment was granted in favor of the cup defendants.  When this ruling was appealed by plaintiffs, Lewis Wagner led appellate briefing efforts before the Indiana Court of Appeals.  Although the Court of Appeals revised the trial court ruling, the Indiana Supreme Court (on transfer) agreed that summary judgment was appropriate for the cup defendants.

In affirming summary judgment for the cup defendants, the Indiana Supreme Court reversed the Indiana Court of Appeals opinion which stood for the proposition that omitted warnings create a presumption of causation that defeats summary judgment; and, in such cases, plaintiffs are not required to show that they would have read and heeded an adequate warning.

According to the Indiana Supreme Court, although cause-in-fact is typically a factual question reserved for determination by the jury, it becomes a question of law for the court where reasonable minds cannot differ.  The Supreme Court held that summary judgment was appropriate based upon the cause-in-fact issue because the minor was administered more than twice the prescribed dose of the medication, whereas the plaintiffs' expert testified that the cup had just a 20 to 30% margin for error.  Thus, even a warning about the cup’s purported 20-30% margin of error would not prevented the harm caused by a presumed double-dose.  As stated by the Court, "the 'read-and-heed' presumption does not completely dispose of the causation issue in a failure-to-warn case. The most the presumption does is establish that a warning would have been read and obeyed. It does not establish that the defect in fact caused the plaintiff's injury.”  The Kovach opinion has since been cited numerous times in subsequent appellate opinions expounding upon the causation requirement in tort cases. 

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