Title: Jim and Jill Kovach v. Caligor Midwest, et al

State: indiana

Issuer: Indiana Supreme Court

Document:

ATTORNEYS FOR APPELLANTS 
 
 
 
 
ATTORNEY FOR APPELLEES 
Stephen B. Caplin 
 
 
 
 
 
CALIGOR MIDWEST 
Indianapolis, Indiana 
 
 
 
 
 
Dina M. Cox 
 
 
 
 
 
 
 
 
 
 
 
 
Indianapolis, Indiana 
Mark W. Sniderman 
Indianapolis, Indiana 
 
 
 
 
 
ATTORNEYS FOR APPELLEES 
 
 
 
 
 
 
 
 
PREMIUM PLASTICS, INC. 
ATTORNEYS FOR AMICUS CURIAE  
 
 
 
John D. Nell 
INDIANA TRIAL LAWYERS ASSOCIATION 
 
 
 
Maureen E. Ward 
William E. Winingham 
 
 
 
 
 
Matthew M. Adolay 
Christopher G. Stevenson  
 
 
 
 
Indianapolis, Indiana 
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 
 
______________________________________________________________________________ 
 
In the 
Indiana Supreme Court  
_________________________________ 
 
No. 49S04-0902-CV-88 
 
JIM KOVACH AND JILL KOVACH, 
FILED
CLERK
of the supreme court,
court of appeals and
tax court
Sep 08 2009, 11:12 am
2 
 
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 
3 
 
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 
                                                 
1 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. 
4 
 
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 cross-
appealed 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 
5 
 
judgment as a matter of law.”  Ind. Trial Rule 56(C); Dreaded, Inc. v. St. Paul Guardian Ins. Co., 
904 N.E.2d 1267, 1269–70 (Ind. 2009).  We construe all factual inferences in the non-moving 
party’s favor and resolve all doubts as to the existence of a material issue against the moving 
party.  Id. 
Discussion 
 
The Kovachs assert four claims against the Cup Defendants, described as strict products 
liability and negligent products liability under the Indiana Product Liability Act (“PLA”), and 
breach of implied warranty of merchantability and breach of implied warranty of fitness for a 
particular purpose under the Uniform Commercial Code (“UCC”).  The Court of Appeals 
concluded that the UCC and PLA provide “alternative remedies,” and it therefore entertained all 
four of the Kovachs’ claims as separate theories.  Kovach v. Alpharma, Inc., 890 N.E.2d at 67.  
This Court has never addressed whether the PLA preempts warranty-based theories of recovery 
for physical harm, but several federal district courts and other panels of the Court of Appeals 
have held that tort-based breach-of-warranty claims have been subsumed into the PLA.  See, 
e.g., Cincinnati Ins. Cos. v. Hamilton Beach/Proctor-Silex, Inc., No. 4:05 CV 49, 2006 WL 
299064, at *3 (N.D. Ind. Feb. 7, 2006); N.H. Ins. Co. v. Farmer Boy AG, Inc., No. IP 98-0031-
C-T/G, 2000 WL 33125128, at *3 (S.D. Ind. Dec. 19, 2000); Condon v. Carl J. Reinke & Sons, 
Inc., 575 N.E.2d 17, 18 (Ind. Ct. App. 1991).  To the extent they are separate theories, the 
plaintiffs’ claims all require proof that the injury sustained was proximately caused by the 
alleged product defect.  Ford Motor Co. v. Rushford, 868 N.E.2d 806, 810 (Ind. 2007) (as to 
strict liability and negligence in products liability); James J. White & Robert S. Summers, 
Uniform Commercial Code § 9-7 (5th ed. 2000) (as to breach of implied warranty of 
merchantability); 63 Am. Jur. 2d Products Liability § 724 (1997) (as to implied warranty of 
fitness for a particular purpose).  We find the causation issue in this case dispositive as to all 
causes of action.  We therefore do not resolve the relationship between the PLA and the UCC 
today, as that issue is directly raised only by amici, and presented obliquely, if at all, by the 
6 
 
parties.  We also do not address several collateral issues that the parties have raised in this 
appeal.2 
“Proximate cause” has two components:  causation-in-fact and scope of liability.  City of 
Gary ex rel. King v. Smith & Wesson Corp., 801 N.E.2d 1222, 1243–44 (Ind. 2003).  To 
establish factual causation, the plaintiff must show that but for the defendant’s allegedly tortious 
act or omission, the injury at issue would not have occurred.  Id.  The scope of liability doctrine 
asks whether the injury was a natural and probable consequence of the defendant’s conduct, 
which in the light of the circumstances, should have been foreseen or anticipated.  Id. at 1244.  
Liability is not imposed on the defendant if the ultimate injury was not reasonably foreseeable as 
a consequence of the act or omission.  Id.  Causation-in-fact is ordinarily a factual question 
reserved for determination by the jury.  Id. at 1243–44.  However, where reasonable minds 
cannot disagree as to causation-in-fact, the issue may become a question of law for the court.  
Peters v. Forster, 804 N.E.2d 736, 743 (Ind. 2004). 
The plaintiffs argue that if the medicine cup had been better suited as a precision 
measuring device or had contained a warning that it was not suitable for precision measurement, 
Matthew would not have received an overdose.  We agree with Chief Judge Baker that the 
undisputed facts establish that there is no such causal connection.  There is a dispute as to 
whether the 30-mL cup was full or half-full, but the following facts are not contested.  Matthew 
was prescribed 15 mL of codeine after surgery.  The nurse used a medicine cup to dispense the 
medication.  She had extensive experience with the cup and had no difficulty in identifying its 
markings.  A half-cup of medication would have contained approximately 15 mL.  A full cup 
                                                 
2 There are several collateral issues in connection with Dr. O’Donnell’s affidavit and deposition 
testimony.  The defendants moved to exclude Dr. O’Donnell’s testimony as unreliable, unspecialized, 
speculative, and irrelevant.  At the same time, they apparently cited several portions of Dr. O’Donnell’s 
deposition in various subsequent filings.  The Kovachs purport to stand by their expert and the 
competence of his opinions, yet they insist that Dr. O’Donnell’s deposition testimony was not properly 
designated to the trial court and is off limits for purposes of summary judgment.  Our analysis of the 
proximate cause issue in this case moots the defendants’ motion to exclude.  As for the O’Donnell 
deposition, we are unable to evaluate the sufficiency of the defendants’ designation, as no party has 
included the pertinent summary judgment materials in the appellate appendix.  In any event, we are able 
to decide this case on the basis of evidence that was undisputedly designated, and we reach the same 
result whether or not the O’Donnell deposition is considered as well. 
 
 
7 
 
would have contained approximately 30 mL or slightly more.  The cup was translucent, and 
acetaminophen with codeine is a red liquid.  The nurse knew that she was supposed to administer 
a half-cup of medication, and anyone observing her could see whether the cup was half full or 
completely full.  Matthew’s father asserts that he was present and saw that it was in fact full.  
The Kovachs contend Matthew’s death was caused by a full, 30-mL cup of codeine.  The results 
of the autopsy revealed that Matthew had more than twice the recommended therapeutic level of 
codeine in his blood stream.  The undisputed evidence thus demonstrates that if there was an 
overdose in this case, it was not caused by an imprecise measurement of medication attributable 
to less than readily discernible marks.  Rather, if the codeine was the cause of Matthew’s death, 
it was due to an erroneous double dosage of 30 mL of codeine when Matthew was supposed to 
receive 15 mL.  The accident therefore cannot be attributed to any alleged defects in the cup 
itself. 
For the foregoing reasons, we need not consider Dr. O’Donnell’s deposition to resolve 
this case.  We note, however, that our conclusion is further supported by Dr. O’Donnell’s 
testimony.  Dr. O’Donnell estimated that the cup’s imprecision could result in up to a 20% to 
30% margin of error.  But Matthew had over twice the recommended level of codeine in his 
bloodstream when he died.  So even if we assume the nurse administered the correct 15-mL 
dosage of codeine, the cup’s imprecision would at most result in an overdose of only 30% and 
could not account for the 100% excess level of codeine discovered in the autopsy.   
The Kovachs also assert a failure to warn against the cup’s use for precision 
measurement.  We do not address whether any such warning is required in this or any other 
circumstance because, even if given, it would not have prevented the injury here.  Any claimed 
failure to warn that the cup was unsuitable for use in “precise” measurements had no effect on a 
double dose which was known to be improper.  In holding that the cup’s missing warning created 
“a presumption of causation,” the Court of Appeals relied primarily on language from Ortho 
Pharmaceutical Corp. v. Chapman, 180 Ind. App. at 55, 388 N.E.2d at 555.  In Ortho, the 
plaintiff developed thrombophlebitis after taking an oral contraceptive manufactured by the 
defendant and prescribed by her doctor.  Id. at 58, 388 N.E.2d at 557.  She sued the manufacturer 
alleging negligence, strict liability, and breach of warranty.  Id. at 35–36, 388 N.E.2d at 544.  
The plaintiff claimed that the manufacturer published inadequate and misleading warnings about 
8 
 
the relationship between the contraceptive and development of thrombophlebitis.  Id. at 52, 388 
N.E.2d at 554.  In the course of discussing the issue of proximate cause, the Court of Appeals 
explained that there exists “a presumption that an adequate warning would be heeded.  This 
operates to the benefit of a manufacturer where adequate warnings in fact are given.  Where 
warnings are inadequate, however, the presumption is in essence a presumption of causation.”  
Id. at 55, 388 N.E.2d at 555 (citing Restatement (Second) of Torts § 402A cmt. j (1965)). 
 
Ortho was merely following the prevailing view that in a failure-to-warn case, the 
plaintiff is not required to establish that he would have read the warning and taken the steps to 
avoid injury.  See Nissen Trampoline Co. v. Terre Haute First Nat’l Bank, 332 N.E.2d 820, 826–
27 (Ind. Ct. App. 1975), rev’d on procedural grounds, 265 Ind. 457, 358 N.E.2d 974 (1976); 2 
Dan B. Dobbs, The Law of Torts § 367 (2001) (“Perhaps the best ground for invoking the 
presumption is that the plaintiff could seldom prove convincingly that he would have read a 
warning, so that the manufacturer’s duty to warn would be effectively avoided in almost all 
cases.”).  But 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 plaintiff invoking the presumption must still show that the danger that would have 
been prevented by an appropriate warning was the danger that materialized in the plaintiff’s case.  
See 2 Dobbs, supra, § 367 (“The plaintiff who is not properly warned that asbestos can cause 
respiratory disorders must show . . . that she in fact has such a disorder resulting from asbestos 
exposure. . . . [T]he injury suffered must be within the class of injury that the warning 
requirement was meant to avoid.”); 1 David G. Owen, M. Stuart Madden & Mary J. Davis, 
Madden & Owen on Products Liability § 9:11 (3d ed. 2000) (even where the read-and-heed 
presumption applies, “pivotal to the successful maintenance of plaintiff’s claim of actionable 
failure to warn is the demonstration that the seller’s failure to warn adequately of the hazard was 
a cause-in-fact and a proximate cause of the injury”). 
Here, the Kovachs claim that the medicine cup should have borne a warning that it was 
not designed for precision measurement.  If we apply the read-and-heed presumption, then we 
must assume the nurse would have read such a warning and chosen a precision applicator to 
administrate the codeine.  But as explained above, Matthew’s overdose was not the result of 
9 
 
imprecise measurement.  If the overdose was the cause of death, it was due to mistaken 
dispensation of a full cup, a 30-mL double dosage, by a nurse who knew that a half cup, 15 mL, 
was the proper dosage.  Matthew’s death was not factually caused by the danger that a warning 
against use of the cup for precision measurement would have addressed, and the accident would 
not have been avoided if any such warning had been given. 
 
Conclusion 
 
For the foregoing reasons, the Cup Defendants have established that Matthew’s death 
was not caused by the alleged defects in their product.  The judgment of the trial court granting 
summary judgment in favor of the Cup Defendants is affirmed. 
Shepard, C.J., and Dickson, Sullivan, and Rucker, JJ., concur.