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ATTORNEYS FOR APPELLANTS Stephen B. Caplin Indianapolis, Indiana Mark W. Sniderman Indianapolis, Indiana ATTORNEYS FOR AMICUS CURIAE INDIANA TRIAL LAWYERS ASSOCIATION William E. Winingham Christopher G. Stevenson Indianapolis, Indiana

ATTORNEY FOR APPELLEES CALIGOR MIDWEST Dina M. Cox Indianapolis, Indiana ATTORNEYS FOR APPELLEES PREMIUM PLASTICS, INC. John D. Nell Maureen E. Ward Matthew M. Adolay Indianapolis, Indiana ATTORNEYS FOR APPELLEES MEDEGEN HOLDING, LLC MEDEGEN MEDICAL PRODUCTS, LLC MEDEGEN VOLLRATH GROUP VOLLRATH GROUP Jason L. Kennedy Keith J. Hays Nancy S. Woodworth Jill M. Felkins Chicago, Illinois Karl L. Mulvaney Nana Quay-Smith Indianapolis, Indiana ATTORNEY FOR APPELLEES DYNAREX CORPORATION Edward F. Harney, Jr. Indianapolis, Indiana ATTORNEYS FOR AMICUS CURIAE DEFENSE TRIAL COUNSEL OF INDIANA Kevin C. Schiferl Melanie D. Margolin Daniel M. Long Lucy R. Dollens Indianapolis, Indiana James D. Johnson Evansville, Indiana

______________________________________________________________________________

FILED
of the supreme court, court of appeals and tax court

Indiana Supreme Court
_________________________________ No. 49S04-0902-CV-88 JIM KOVACH AND JILL KOVACH,

In the

Sep 08 2009, 11:12 am

CLERK

INDIVIDUALLY AND ON BEHALF OF DECEASED MINOR CHILD, MATTHEW KOVACH, Appellants (Plaintiffs below), v. CALIGOR MIDWEST, ET AL., Appellees (Defendants below). _________________________________ Appeal from the Marion Superior Court, No. 49D11-0407-PL-001227 The Honorable John F. Hanley, Judge _________________________________ On Petition To Transfer from the Indiana Court of Appeals, No. 49A04-0707-CV-406 _________________________________ September 8, 2009

Boehm, Justice. The plaintiffs allege their son was given a fatal overdose of pain medication by a nurse after a surgical procedure. The plaintiffs sued the manufacturers and distributors of the medicine cup used to administer the medication, alleging defects in design of the cup and failure to warn that the cup was not suitable for precision measurement. We affirm summary judgment in favor of these defendants because these claimed defects did not cause the death. The undisputed facts establish that if an overdose caused the death it was due to a quantity of drug essentially double the prescribed amount. None of the claimed defects in the cup would have caused an overdose of that magnitude. Facts and Procedural History Nine-year-old Matthew Kovach was diagnosed with an enlargement of nasal tissue causing congestion, mouth-breathing, and impaired dental development. In August 2002

Matthew underwent surgery and was prescribed 15 milliliters (mL) of acetaminophen with codeine for pain following the procedure. In the post-anesthesia care unit of the surgical center, a nurse administered a dosage of the medication, a light red liquid, using a medicine cup made of 2

flexible, translucent plastic with a volume of just over 30 mL. The interior of the cup bore translucent markings to measure its contents, and graduations delineated both 15 and 30 mL. The nurse had used that type of cup frequently both at this surgical center and at other hospitals, and she had no difficulty reading its markings. The nurse testified she filled the cup

approximately half-way and administered 15 mL of medication to Matthew. According to Matthew's father, who was present when the drug was administered, the nurse gave Matthew a full cup of medicine. Matthew was discharged from the recovery unit and sent home with his mother. He took no additional medication after leaving the surgical center. That afternoon Matthew went into respiratory arrest and was brought to Bloomington Hospital where he was later pronounced dead of asphyxia. An autopsy identified the cause of death as an opiate overdose, and revealed that Matthew had between 280 and 344 nanograms/mL of codeine in his bloodstream, more than twice the recommended therapeutic level. Matthew's parents sued, among others, the manufacturers1 and a distributor of the medicine cup (collectively the "Cup Defendants"). Their complaint set forth several causes of action against the Cup Defendants including strict liability and negligence under the Products Liability Act, breach of implied warranty of fitness for a particular purpose, and breach of implied warranty of merchantability. The thrust of these counts was that Matthew's overdose was caused by an imprecise measurement of codeine resulting from defects in the medicine cup. The Cup Defendants moved for summary judgment on all claims, arguing among other things that the undisputed facts revealed no causal connection between the cup's alleged defects and Matthew's overdose. The Kovachs responded to the Cup Defendants' motion for summary judgment by designating the affidavit of Dr. James O'Donnell, a pharmacist and associate professor of pharmacology. Dr. O'Donnell analyzed the physical characteristics of the medicine cup, found it was not suitable for precision measurement, and concluded that the cup should have provided a
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The manufacturer defendants argue that they are entitled to summary judgment because the Kovachs cannot identify the manufacturer of the cup at issue in this case. The Kovachs respond that their complaint alleged these defendants were "manufacturers" under the Product Liability Act, and that the defendants failed to designate any evidence to refute the allegations. In light or our resolution of this case in favor of the defendants, we need not address this issue.

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corresponding warning. For purposes of his affidavit, Dr. O'Donnell assumed that the cup "was full when [the nurse] administered Capital with Codeine to Matthew." He opined that Matthew's overdose was "a medication error caused by Codeine being administered at a wrong dose" and the overdose "[r]esulted from using the [c]up as a volume measuring device for [p ]recision [m]easurement." The Cup Defendants deposed Dr. O'Donnell after receiving his affidavit. He elaborated on the contents of his affidavit and also estimated that measurements performed using the medicine cup posed a 20% to 30% margin of error. The Cup Defendants moved to exclude Dr. O'Donnell's testimony as unfounded and irrelevant. They also submitted a joint reply brief in support of summary judgment in which they cited portions of Dr. O'Donnell's deposition. The trial court denied the motion to exclude but nonetheless granted summary judgment in favor of the Cup Defendants. The Kovachs appealed the summary judgment ruling, and the Cup Defendants crossappealed the denial of their motion to exclude. The Court of Appeals reversed in part, holding that (1) the trial court did not abuse its discretion in admitting Dr. O'Donnell's affidavit, and (2) genuine issues of fact precluded summary judgment on the Kovach's claims against the Cup Defendants. Kovach v. Alpharma, Inc., 890 N.E.2d 55, 72 (Ind. Ct. App. 2008). On the issue of proximate cause relevant to all theories of liability, the Court of Appeals held that "the missing warning is in essence a presumption of causation." Id. at 71 (citing Ortho Pharm. Corp. v. Chapman, 180 Ind. App. 33, 55, 388 N.E.2d 541, 555 (1979)). In addition, the court expressly refused to consider Dr. O'Donnell's deposition testimony in connection with the summary judgment motion, stating that the evidence was never designated to the trial court during the summary judgment proceedings. Id. at 65. Chief Judge Baker dissented, finding that the Kovachs had failed to establish that the cup's alleged defects were the proximate cause of Matthew's death. Id. at 72. We granted transfer. Standard of Review We review a summary judgment order de novo. Atterholt v. Herbst, 902 N.E.2d 220, 222 (Ind. 2009), clarified on reh'g, 907 N.E.2d 528 (Ind. 2009). Considering only those facts supported by evidence that the parties designated to the trial court, we must determine whether there is a "genuine issue as to any material fact" and whether "the moving party is entitled to a 4

judgment as a matter of law." Ind. Trial Rule 56(C); Dreaded, Inc. v. St. Paul Guardian Ins. Co., 904 N.E.2d 1267, 1269

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