Miller v. Bernard

957 N.E.2d 685, 2011 Ind. App. LEXIS 1928, 2011 WL 5931997
CourtIndiana Court of Appeals
DecidedNovember 29, 2011
Docket39A05-1009-PL-546
StatusPublished
Cited by12 cases

This text of 957 N.E.2d 685 (Miller v. Bernard) is published on Counsel Stack Legal Research, covering Indiana Court of Appeals primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Miller v. Bernard, 957 N.E.2d 685, 2011 Ind. App. LEXIS 1928, 2011 WL 5931997 (Ind. Ct. App. 2011).

Opinion

OPINION

ROBB, Chief Judge.

Case Summary and Issues

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, “Plain *688 tiffs”), appeal the trial court’s entry of summary judgment to Morton Grove Pharmaceuticals, Inc. (“MGP”) and CVS Pharmacy, Inc. (“CVS”) (collectively, “Defendants”). Plaintiffs raise three issues for our review, which we reorder and restate as: 1) whether the trial court erred in excluding the testimony of Dr. Kevin Loeb; 2) whether Defendants were entitled to the statutory rebuttable presumption that Promethazine Syrup Plain was not manufactured defectively, and if so whether Plaintiffs failed as a matter of law to rebut the same; and 3) whether Alexis’s death was not caused, as a matter of law, by MGP’s production and CVS’s distribution of Promethazine Syrup Plain. On cross-appeal, Defendants request we review whether the trial court erred in denying their motion to exclude other expert testimony in support of Plaintiffs. We conclude that 1) the trial court erred in excluding the testimony of Dr. Loeb; 2) Defendants were entitled to the statutory rebuttable presumption of no defect, but whether Plaintiffs have rebutted this presumption remains a question of fact; and 3) whether MGP’s production and CVS’s distribution of Promethazine Syrup Plain caused Alexis’s death is also a question of fact. We further conclude that the trial court did not err in denying Defendants’ motion to exclude other expert testimonies in favor of Plaintiffs. Accordingly, we reverse in part, affirm in part, and remand.

Facts and Procedural History 1

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 Phener-gan, 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 Phen-ergan 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 *689 was taken to the Hospital and pronounced dead soon thereafter.

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. 2 Appellant’s [sic] App. at 206. Dr. Donna Hunsaker, M.D., 3 performed an autopsy on March 26, 2002, the date of death. To that end, the Coroner requested a forensic toxicology analysis from AIT Laboratories (“AIT”). As to Alexis’s blood, AIT’S report included a finding of a “[cjoncentration” of 295 nanograms per milliliter of promethazine, and noted that the therapeutic level is 5 to 150 nanograms per milliliter. Id. at 216-17; see id. at 234-85 (stating that a blood sample included 295.5 nanograms per milliliter of promethazine). To analyze the blood, AIT used an instrument referred to as “GC/NPD.” Id. at 234.

AIT also tested the bottle of Prometha-zine 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”), 4 and reported that the contents contained 3.35 milligrams per milliliter of promethazine. 5 Id. at 218, 236. These reports were signed by Michael Evans, Ph.D., the Director of Clinical and Forensic Operations, President, and CEO of AIT. Id. at 217, 237. Dr. Evans noted that the testing of the Promethazine Syrup Plain was performed according to Forensic Laboratory Guidelines, but not in accordance to “GMP ... [or the] USP Method (HPLC),” and the “[r]esults are not certified to GMP.” Id. at 237. Dr. Evans later explained that GMP stands for Good Manufacturing Practices, which is recognized worldwide for the quality control testing of pharmaceutical products, and that the USP, U.S. Pharmacopeia, sets forth a process to test and evaluate prescription and non-prescription medications. Appel-lees/Cross-Appellants’ Morton Grove Pharmaceuticals, Inc. and CVS Pharmacy, Inc.’s Appendix (“App. of Appellees/Cross-Appellants”) at 201. Based on AIT’s test results of Alexis’s blood and the bottle of medication, Dr. Hunsaker concluded that Alexis “died of dehydration secondary to body volume loss as a result of acute diar-rheal enteritis.... Promethazine intoxication is a significant factor contributing to her death....” Id. at 215.

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 Adminis *690 tration (“FDA”) requirements regarding testing and analytical procedures of the pharmaceutical preparation of prometha-zine hydrochloride, under a method known as high-performance liquid chromatography (“HPLC”).

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Bluebook (online)
957 N.E.2d 685, 2011 Ind. App. LEXIS 1928, 2011 WL 5931997, Counsel Stack Legal Research, https://law.counselstack.com/opinion/miller-v-bernard-indctapp-2011.