ROBB, Chief Judge.
Natalie A. Miller, individually and as administratrix of the estate of Alexis J. Ritch, deceased; Christian J. Miller, a minor, by and through his mother and next friend Natalie A. Miller; and Daniel J. Ritch, individually (collectively, "Plaintiffs"),
Alexis Ritch was the daughter of Natalie Miller and Daniel Ritch and the sister of Christian Miller. Alexis had a history of chronic respiratory and gastrointestinal health problems, which required numerous medications, surgeries, and periods of hospitalization. On March 19, 2002, four-year-old Alexis sustained a fever and was prescribed Omnicef for an ear infection at King's Daughters' Hospital and Health Services (the "Hospital") in Madison, Indiana. Natalie returned home and refrigerated the Omnicef consistent with a note on its label, but before administering the medicine to Alexis thought that it "didn't look right." Appellant's [sic] Appendix at 219. Natalie called the Hospital to inquire, and a pharmacist told her that the medicine should not have been refrigerated and was "no good anymore." Id. Alexis's fever continued, and on March 24, Natalie took Alexis to the Hospital emergency room with a high fever, where Alexis was prescribed Omnicef again. The next morning, Natalie was alarmed by Alexis's coughing, choking, and diarrhea, and took her to the Hospital emergency room.
Dr. L. Barrett Bernard diagnosed Alexis with a stomach virus, prescribed Phenergan, ordered a 12.5 milligram dose of Phenergan at the Hospital, and instructed Natalie to also administer Kaopectate to Alexis. Phenergan is the trade name of an antihistamine drug that provides sedative and anti-nauseam effects through its active ingredient, promethazine hydrochloride. Appellant's [sic] Brief at 5.
Natalie filled the prescription for Phenergan at a local CVS branch, which gave Natalie the generic version manufactured by MGP: Promethazine Syrup Plain. That evening, March 25, Natalie administered to Alexis a dose, and Alexis soon became extremely drowsy. Natalie called the Hospital emergency room out of concern, but a nurse told her that drowsiness was an expected side effect, so she put Alexis to bed. A few hours later, Natalie checked on Alexis, found that she was not breathing, and called paramedics. Alexis
Several post-mortem laboratory tests were conducted to determine the cause of Alexis's death, including the extent to which the Promethazine Syrup Plain may have contributed to her death. First, the Jefferson County Coroner (the "Coroner") received Alexis's body, medical records, and a total body x-ray from the Hospital, and sent all on to the Kentucky Medical Examiners' Office for a complete autopsy.
AIT also tested the bottle of Promethazine Syrup Plain from which Natalie gave Alexis a dose. The Coroner requested AIT "QUANTITATE AND DETERMINE CONCENTRATION OF RX MED." Id. at 262. AIT tested the medicine using an instrument referred to as a gas chromatography electron capture detector ("GC/ECD"),
Two years later, in March 2004, National Medical Services ("NMS") tested Alexis's bottle of Promethazine Syrup Plain to determine the concentration of promethazine hydrochloride in the substance. NMS conducted its testing differently from AIT, following federal Food and Drug Administration
In April 2004, Dr. Evans completed an affidavit commenting on the AIT test results, in which he stated:
Id. at 107-08.
In a deposition, Dr. Evans was asked whether AIT's test results were scientifically reliable in determining the concentration of medication in the bottle. Dr. Evans explained that AIT "do[es] testing for pharmaceutical industries, ... [so] the whole process is different from the very— very beginning. So this was not done on GMP—USP standards." Id. at 284.
Cheryl Blume, Ph.D., President of the Pharmaceutical Development Group, Inc., reviewed the AIT test results, the autopsy report of Dr. Hunsaker, the Hospital's records of Alexis, the affidavits of Vickery and Dr. Evans, professional reference documents, and FDA regulatory materials, and concluded:
Dr. George Nichols, II, M.D., explained that both a forensic method of testing substances and a USP method of testing substances are scientifically reliable, and that in "layman's" terms, this case involves two scientifically reliable procedures or methods of testing that have produced different results. Id. at 66-67. Dr. Kenneth Kulig, M.D., was deposed at length on at least
Plaintiffs filed suit in 2003 against Dr. Bernard, the Hospital, MGP, and CVS and amended their complaint in 2006.
In 2009, Defendants again moved for summary judgment and to exclude
We review a trial court's summary judgment order de novo. Kovach v. Caligor Midwest, 913 N.E.2d 193, 196 (Ind.2009). We apply the same standard as the trial court: whether the designated evidence
A genuine issue of material fact exists where facts concerning an issue which would dispose of the litigation are in dispute, or where undisputed facts are capable of supporting conflicting inferences on such an issue. Briggs v. Finley, 631 N.E.2d 959, 963 (Ind.Ct.App.1994), trans. denied. We may affirm a trial court's grant of summary judgment upon any theory supported by the designated materials. Sims v. Barnes, 689 N.E.2d 734, 735 (Ind. Ct.App.1997), trans. denied. Additionally, we "may determine in the context of summary judgment a mixed question of law and fact." Ebbinghouse v. FirstFleet, Inc., 693 N.E.2d 644, 647 n. 2 (Ind.Ct.App.1998), trans. denied.
Plaintiffs request our review of the trial court's decision to grant Defendants' motion to exclude the testimony of Dr. Loeb. In their list of expert witnesses, Plaintiffs introduced and described Dr. Loeb as follows:
Appellant's [sic] App. at 89.
In an affidavit, Dr. Loeb expressed his opinion "to a reasonable degree of medical certainty, as to the cause of Alexis Ritch's death." Id. at 137. Specifically:
Id. at 138.
The admission or exclusion of expert testimony lies within the sound discretion of the trial court, and will not be reversed absent an abuse of that discretion. Hannan v. Pest Control Servs., Inc., 734 N.E.2d 674, 679 (Ind.Ct.App.2000), trans. denied. Indiana Evidence Rule 702, governing expert testimony, contains two requirements for a witness to qualify as an expert: "(1) the subject matter is distinctly related to some scientific field, business or profession beyond the knowledge of the average lay person; and (2) the witness is shown to have sufficient skill, knowledge or experience in that area so that the opinion will aid the trier of fact." Bacher v. State, 686 N.E.2d 791, 800 (Ind.1997). Further, "[e]xpert scientific testimony is admissible only if the court is satisfied that the scientific principles upon which the expert testimony rests are reliable." Evid. R. 702(b). "The focus of the admissibility test must remain on the methodology of the theory or technique, not on the conclusions generated." Ollis v. Knecht, 751 N.E.2d 825, 829 (Ind.Ct.App.2001) (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)), trans. denied.
The trial court did not determine whether Dr. Loeb qualifies as an expert, but granted Defendants' motion to exclude Dr. Loeb's opinion because Defendants were unable to participate in the Medical Review Panel proceedings, and those proceedings did not concern them and only concerned Dr. Bernard.
At the outset, we note that it is unclear which opinion by Dr. Loeb Plaintiffs sought to enter as designated evidence and the trial court excluded. Plaintiffs do not intend to enter into evidence Medical Review Panel opinions regarding the liability of Dr. Bernard or the Hospital, and the panel did not opine on the liability of Defendants.
Accordingly, this intended evidence would be admissible so long as it constitutes expert testimony. It would not matter that Dr. Loeb relied on evidence that might not be admissible (i.e., for the sake of argument, evidence presented during the Medical Review Panel to which Defendants were not a party), because experts "may testify to opinions based on inadmissible evidence, provided that it is of the
Nor would it matter that Dr. Loeb was part of the panel and expressed an opinion regarding the liability of Dr. Bernard and the Hospital. The following analogy demonstrates the error of concluding otherwise. Suppose an expert is to testify regarding cause of death in two related criminal trials. In the first trial, as to Defendant A, the expert testifies that the victim died as a result of a gunshot wound. In the second trial, as to co-Defendant B tried separately, the expert can certainly testify again that the victim died as a result of a gunshot wound (although the transcript of Defendant A's trial would be inadmissible). Defendant B could not exclude the expert's testimony solely because the expert first offered his opinion in the trial of Defendant A. Similarly here, Defendants cannot exclude Dr. Loeb's testimony solely because he first offered his opinion as a member of the Medical Review Panel.
The trial court abused its discretion in excluding Dr. Loeb's affidavit on the grounds that he participated in the Medical Review Panel and Defendants were not parties to those proceedings.
But Defendants articulate other reasons why the trial court's exclusion of Dr. Loeb's opinion was proper. First, Defendants contend that Dr. Loeb's opinion was inadmissible because "the information relied on by the panel is the same flawed data [Plaintiffs] ha[ve] relied on throughout this litigation." Appellees/Cross-Appellants' Br. at 27. Specifically, Defendants note that Dr. Loeb's participation in the panel is governed by statute, and that his opinion as to claims "unrelated to the provision of medical care or treatment," would be beyond the scope of his legal authority as a panel member. Id. at 28 (quoting H.D. v. BHC Meadows Hosp., Inc., 884 N.E.2d 849, 855 (Ind.Ct.App. 2008) (quotation omitted), trans. denied). Given our analysis above, this argument is unpersuasive because Plaintiffs do not intend to enter into evidence Dr. Loeb's or the panel's opinion regarding the Hospital or Dr. Bernard. Further, to the extent Defendants challenge the reliability of Dr. Loeb's opinion because most of the evidence before him as a panel member likely pertained to the liability of Dr. Bernard and the Hospital and not the liability of Defendants, Defendants challenge the weight and not admissibility of the evidence. See Dorsett v. R.L. Carter, Inc., 702 N.E.2d 1126, 1128 (Ind.Ct.App.1998) ("[T]he admissibility of expert testimony does not hinge on the expert's disclosure of the facts and reasoning that support his opinion. The lack of facts and reasoning, which may be brought out on cross-examination of the expert, goes to the weight to be given the expert's opinion, not its admissibility.") (interpreting Evid. R. 705), trans. denied.
Defendants next contend, similarly, that the items of evidence upon which Dr. Loeb based his opinion, the medical examiner's report and the AIT test results, are inherently inadequate as a basis because: 1) he is unqualified to determine the reliability of the AIT test results, 2) he has not reviewed evidence regarding defective manufacturing of the MGP product, and 3) the trial court found that the medical examiner's report and the AIT results are insufficient to satisfy the Plaintiffs' burden to show a genuine issue of material fact.
As to Dr. Loeb's qualification to determine the reliability of the results, that is for the trial court to determine in accordance with Evidence Rule 702. As to his review of the evidence regarding MGP's purported defective manufacturing, we agree that it is not completely clear whether the evidence Dr. Loeb reviewed warrants
The trial court erred in excluding Dr. Loeb's opinion solely because Defendants were unable to participate in the Medical Review Panel proceedings which formed part of the basis for Dr. Loeb's opinion. Defendants' other reasons for excluding Dr. Loeb's opinion are also unpersuasive. For these reasons, we reverse the trial court's decision to exclude Dr. Loeb's opinion and remand for the trial court to determine whether Dr. Loeb satisfies the requirements of Evidence Rule 702. This reversal and remand alone could be sufficient to reverse the trial court's entry of summary judgment because the designated evidence supplemented by Dr. Loeb's opinion might demonstrate a genuine issue of material fact. However, in the interest of judicial economy, we address the other issues as well even without considering Dr. Loeb's opinion.
The next issue is whether the rebuttable presumption contained in the Indiana Product Liability Act applies to MGP and the Promethazine Syrup Plain that is the subject of this case. Indiana Code section 34-20-5-1 provides, in pertinent part:
Plaintiffs contend the trial court erred in concluding that the presumption applies because MGP concedes it cannot identify the specific lot from which Alexis's medication came. Defendants have explained that the lot number was on the label of the stock bottle at the CVS branch in Madison, and the remaining Promethazine Syrup Plain contained in that bottle was sold and the bottle discarded. However, MGP has determined from its records that there were only twenty-six potential lots of Promethazine Syrup Plain that could have been used to fill Alexis's prescription in March 2002, and that before the sale or even distribution of these lots by MGP, each were tested using HPLC to quantify the promethazine hydrochloride therein. App. of Appellees/Cross-Appellants at 719-20.
MGP's HPLC test results show that each lot conformed to the FDA-approved strength of promethazine hydrochloride: 5.625 to 6.875 milligrams per 5 milliliters, with a labeled concentration of 6.25 milligrams per 5 milliliters. Id. The designated evidence is clear that HPLC is the method recommended by the USP and approved by the FDA for quantitative
Contrary to Plaintiffs' appellate argument, the designated evidence is clear that an earlier formulation of Promethazine Syrup Plain, of which the concentration of promethazine hydrochloride was less stable and more likely to be defective, was out of circulation and could not have been included in Alexis's bottle. Id. at 720. Although Plaintiffs strenuously argue to the contrary, they designate no evidence in support of such argument. Thus, the rebuttable presumption contained in Indiana Code section 34-20-5-1 applies.
We now turn to the question of whether Plaintiffs designated admissible evidence to rebut the statutory presumption of Indiana Code section 34-20-5-1. This presumption may be rebutted, at least for purposes of summary judgment, if the designated evidence demonstrates a question of fact remains as to whether the product was defective. See Schultz v. Ford Motor Co., 857 N.E.2d 977, 985 (Ind. 2006).
Here, the voluminous designated evidence focuses on whether the Promethazine Syrup Plain was defective. The long list of conflicting designated evidence includes the following that at least arguably support Plaintiffs' position: the autopsy report and opinion of Dr. Hunsaker, the AIT test results, the affidavit and testimony of Dr. Evans, the affidavit of Dr. Blume, and the opinions of Dr. Kulig and Dr. Nichols. Defendants' challenge to the AIT test results and any expert opinions interpreting or based on those results is a challenge to the weight of the evidence inappropriate at the stage of summary judgment. Therefore, although the statutory presumption applies, Plaintiffs designated admissible evidence to rebut this presumption for purposes of summary judgment.
The trial court concluded that Plaintiffs failed to rebut the presumption for several reasons. First, the trial court found the tests by Dr. Hunsaker and AIT to be unreliable because neither considered or factored into their tests the difference between blood and plasma or serum, and neither considered the principle of post-mortem redistribution. Other experts testified regarding the importance of these concepts, and the trial court independently recalculated the promethazine level in Alexis's blood to be within the therapeutic range.
Plaintiffs next challenge the trial court's finding that Alexis's death was not, as a matter of law, caused by MGP's production of Promethazine Syrup Plain and CVS's distribution of the same. "Only in plain and indisputable cases, where only a single inference or conclusion can be drawn, are the questions of proximate cause and intervening cause matters of law to be determined by the court." Peters v. Forster, 804 N.E.2d 736, 743 (Ind.2004). "When an event is the reasonably foreseeable, natural and probable consequence of an act or omission, the act or omission is a proximate cause of the event. There may be more than one proximate cause of an event." Board of Comm'rs of Adams Cnty. v. Price, 587 N.E.2d 1326, 1333 (Ind. Ct.App.1992) (citations omitted), trans. denied.
At this point, we deem it helpful to describe how Indiana's summary judgment procedure "abruptly diverges" from federal practice. Jarboe v. Landmark Cmty. Newspapers of Indiana, Inc., 644 N.E.2d 118 (Ind.1994). In federal practice, a defendant seeking summary judgment is not required to negate an plaintiff's claim, but need only indicate the basis for its motion and designate evidence to show that the plaintiff failed to establish an essential element of its claim. Dennis v. Greyhound Lines, Inc., 831 N.E.2d 171, 173 (Ind.Ct.App.2005), trans. denied. The burden then rests upon the non-moving party to make a showing sufficient to establish the existence of each challenged element upon which the non-movant has the burden of proof. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
In Indiana, however, "[m]erely alleging that the plaintiff has failed to produce evidence on each element" of its claims is insufficient to sustain summary judgment for defendants. Jarboe, 644 N.E.2d at 123. Rather, "the party seeking summary judgment must demonstrate the absence of any genuine issue of fact as to a determinative issue, and only then is the non-movant required to come forward with contrary evidence." Id.; accord Kennedy
At oral argument, Defendants repeatedly made statements to the effect of "we produced evidence, but Plaintiffs have not produced any evidence."
Nevertheless, consistent with the process for seeking summary judgment in Indiana courts, Defendants have designated evidence tending to suggest the absence of an issue as to causation. Namely, the most significant evidence in support of this position includes MGP's test results of the Promethazine Syrup Plain before MGP distributed the drug to CVS, which suggests that at one point the drug was not defective and therefore it could not have— via a defect—caused Alexis's death. Defendants also produced the NMS test results and an affidavit by Dr. Barbieri, in which he meticulously explains why the NMS test results are accurate and the AIT test results should not be given much weight.
Finally Defendants point to Dr. Evans's affidavit and deposition testimony commenting on the AIT test results. Defendants contend Dr. Evans's comments undermine the AIT test results and all expert opinions relying on it. This contention is based on our court's opinion in Hagerman Constr., Inc. v. Copeland, 697 N.E.2d 948, 957 (Ind.Ct. App.1998), trans. denied, in which we stated that "[w]hile any scientific test is subject to error, [a prior Indiana appellate opinion] cannot extend so far that evidence becomes admissible where even the laboratory conducting the test provides testimony questioning the test's reliability." In Hagerman, the issue was whether a well-recognized method of testing blood was sufficiently reliable for test results to be admissible when used to test a blood sample that was not properly cared for. The parties disputed whether the laboratory's results could be admissible when the laboratory staff discredited their results by describing improper care for the sample.
Here, however, the parties do not dispute whether the scientific test was reliable—all agree that AIT's test results are scientifically reliable "for the purpose of which it was intended." Appellant's [sic] App. at 456. The dispute, on which conflicting designated evidence was provided, is over what precise purpose AIT tested the materials, and to some extent whether the test results may also be reliable as to other data produced by the test. On one hand, Dr. Evans agreed at a deposition that the Coroner "wanted to know what the concentration of the medication was in the bottle." Id. at 457. Based on this statement and others, Plaintiffs and their experts point to the AIT test results as evidence of super-potency of the Promethazine Syrup Plain, and draw a direct causal link to Alexis's death. On the other
Consequently, because Dr. Evans's deposition testimony does not render the AIT test results inadmissible and does not significantly undercut the reliability or admissibility of other experts relying on the AIT test results, there is ample designated evidence to support Plaintiffs' contention that the Promethazine Syrup Plain caused or was at least a significant contributing factor to Alexis's death. This includes the report of Dr. Hunsaker and opinion of Dr. Blume. Therefore, even if we did not consider the opinions of Drs. Loeb, Kulig, and Nichols, and considered the NMS test results and the opinions of Vickery and Dr. Barbieri as persuasive evidence negating causation, we are left with conflicting evidence and a genuine issue of material fact. Sharply conflicting designated evidence exists as to whether the Promethazine Syrup Plain manufactured by MGP and distributed by CVS contributed to Alexis's death. This case is anything but plain and indisputable, thus, summary judgment is inappropriate.
We next address Defendants' issues on cross-appeal because we reverse the trial court's order granting summary judgment to Defendants. On cross-appeal, Defendants contest the trial court's denial of their motion to exclude the expert opinions of Dr. Kulig and Dr. Nichols because Defendants' challenges were aimed at the weight and not admissibility of the experts' opinions. The following principles guide our review of this issue:
City of Gary v. McCrady, 851 N.E.2d 359, 363 (Ind.Ct.App.2006) (citations omitted).
Defendants argue the opinions by Drs. Kulig and Nichols are inadmissible because they do not agree with each other, and are therefore unreliable. But for the same reason that a disagreement of opinion
In Saliba v. State, 475 N.E.2d 1181 (Ind.Ct.App.1985), trans. denied, this court reviewed whether a trial court erred in excluding the criminal defendant's expert opinion regarding an opinion poll he took, after an expert of the State testified to his view of flaws in how the poll was conducted. We noted that expert opinion cannot be excluded for merely technical inadequacies, and concluded that the trial court erred in excluding the defendant's expert. Id. at 1190. Although the experts in Saliba did not testify in support of the same party, so the trial court's error may seem more obvious than here, the following explanation from Saliba in the context of the experts' disagreement as to proper methodology is analogous to the issue here.
Id. at 1189 (quoting Martin v. Roberts, 464 N.E.2d 896 (Ind.1984)) (emphasis original to Saliba) (citation omitted). This court then stated:
Id.
The disagreement that Defendants highlight is that Drs. Kulig and Nichols hold different theories on how promethazine caused Alexis's death. This is immaterial at the summary judgment stage, as is Defendants' claim that Drs. Kulig and Nichols "employ backward reasoning" in arriving at the same conclusion. Appellees/Cross-Appellants' Br. at 29.
Defendants next contend the opinions of Drs. Kulig and Nichols are unreliable and inadmissible because the data upon which they rely—the AIT test results—are unreliable. However, the AIT test results were only part of the basis for the opinions of Drs. Kulig and Nichols, and even if the AIT test results are inadmissible, experts may base their opinions on inadmissible evidence. See Evid. R. 703. Defendants argue that Plaintiffs' experts "should be precluded from offering any opinions that have AIT's test results as their foundation (or the Autopsy Report as it is based on the AIT test results)[.]" Appellees/Cross Appellants' Br. at 33. Evidence Rule 703 precludes this general exclusion of expert opinions based on arguably inadmissible evidence.
Defendants next argue Dr. Kulig is not qualified to testify as an expert that the Promethazine Syrup Plain at issue was super-potent because he appeared relatively unfamiliar with AIT testing procedures. But Dr. Kulig was not called on to critique AIT's testing procedures; his opinion refers to Alexis's cause of death, for which he relied in part on AIT's test results. Dr. Kulig's unfamiliarity with various laboratory testing procedures is irrelevant to his expertise in evaluating test results, and therefore does not render him unqualified
Defendants then piece together portions of Dr. Kulig's testimony to emphasize the presumptions and estimates in his opinion. Dr. Kulig admitted he made estimates for the purpose of demonstrating in simplified terms his conclusion that Alexis received a super-potent dosage of promethazine. Although his testimony is somewhat confusing, Dr. Kulig appears to contend that AIT's test results of extraordinarily high levels of promethazine are not so unreasonable that they must be dismissed out of hand (a position he presumes Defendants take). He bases this contention on his estimates and calculations that are not intended to determine the specific level of concentration, but to demonstrate that the AIT results are within the realm of the scientifically accurate. So long as the trial court agrees with Dr. Kulig that his assessment is beyond the knowledge of the average lay person, that it will aid the trier of fact in understanding the evidence, and that the scientific principles upon which he bases his estimates and calculations are reliable, then the trial court may allow Dr. Kulig's opinion. See Evid. R. 702. Defendants also challenge Dr. Kulig's calculations that account for post-mortem redistribution, but this argument also focuses on the weight and not admissibility of his opinion. The same goes for Defendants' challenges to Dr. Kulig's opinion as to causation because he did not rule out other possible causes of death.
Yang v. Stafford, 515 N.E.2d 1157, 1162 (Ind.Ct.App.1987) (quotation and citation omitted), trans. denied.
Defendants challenge Dr. Nichols's testimony as establishing only a temporal relationship between Alexis taking Promethazine Syrup Plain and her death, but this challenge is not supported by Dr. Nichols's deposition testimony. He based his opinion on the AIT test results and his medical expertise, to ultimately opine that Alexis's dehydration was due to water loss sufficient to cause her death, and that the concentration of promethazine found in her blood was a significant and contributing factor to her dehydration. App. of Appellees/Cross-Appellants at 417. Dr. Nichols also opined that the level of promethazine in Alexis's blood led to her sedation, leaving her unable to ask her mother for fluids or rehydrate herself. Defendants contend this is not supported by facts (because Natalie was instructed to put Alexis on a liquid diet for twenty-four hours) or scientific literature. But this amounts to another attack on the weight of Dr. Nichols's opinion, and does not affect its admissibility. See Yang, 515 N.E.2d at 1162. In sum, the trial court did not err in allowing the expert opinions of Drs. Kulig and Nichols.
The trial court erred in excluding the opinion of Dr. Loeb. Defendants are entitled to the statutory rebuttable presumption that the Promethazine Syrup Plain was not manufactured defectively, but whether Plaintiffs rebutted and overcame this presumption remains a genuine issue of material fact. The causal connection
Reversed in part, affirmed in part, and remanded.
RILEY, J., and SULLIVAN, S.J., concur.
Appellant's [sic] App. at 43.
It is not completely clear whether the trial court recalculated this number independently, relying on the Baselt text, or relied on some expert's opinion that for some reason was not highlighted in the record. Regardless, the trial court erred by weighing conflicting evidence.