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FOR PUBLICATION
ATTORNEY FOR APPELLANT: J. ANTHONY GOEBEL Eckert Law Firm Madison, Indiana ATTORNEY FOR APPELLEE/CROSS APPELLANT CVS PHARMACY, INC. ROBERT BARLOW Barlow Law Office Madison, Indiana ATTORNEYS FOR APPELLEE/CROSS APPELLANT MORTON GROVE PHARMACEUTICALS, INC., FREDERIC X. SHADLEY JEFFREY F. PECK LINDA E. MAICHL MARY LYNN TATE Ulmer & Berne LLP Cincinnati, Ohio

FILED
Nov 29 2011, 9:01 am
of the supreme court, court of appeals and tax court

CLERK

IN THE COURT OF APPEALS OF INDIANA
NATALIE A. MILLER, Individually and as Administratrix of the Estate of Alexis J. Ritch, deceased, CHRISTINA J. MILLER, a minor by and through the mother and next friend Natalie A. Miller, and DANIEL J. RITCH, Individually, Appellants-Plaintiffs, vs. L. BARRETT BERNARD, M.D., THE BETHANY CIRCLE OF KING'S DAUGHTERS HOSPITAL AND HEALTH SERVICES, CVS PHARMACY, INC., and MORTON GROVE PHARMACEUTICAL, INC., Appellees-Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

No. 39A05-1009-PL-546

APPEAL FROM THE JEFFERSON CIRCUIT COURT The Honorable Roger Duvall, Special Judge Cause No. 39C01-0304-PL-182

November 29, 2011

OPINION - FOR PUBLICATION

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, "Plaintiffs"), 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

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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 History1 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

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We heard oral argument on August 24, 2011 at the Indiana Court of Appeals Courtroom in

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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 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

Indianapolis. We thank counsel for their capable advocacy.

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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

"[c]oncentration" 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 234-35 (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 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"),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

It is unclear from the record why this was sent to Kentucky and not Indiana. Although we note that Madison, Indiana is near the Indiana/Kentucky border.
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Dr. Donna Hunsaker also went by the name of Dr. Donna Stewart during this case.

Cf. Appellees/Cross-Appellants' Appendix at 203 (Dr. Evans stating that although the report states AIT used an instrument referred to as a gas chromatography nitrogen phosphorous detector (GC/NPD), AIT actually used a gas chromatography electron capture detector (GC/ECD)).
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3.35 milligrams equals 3,350,000 nanograms. Neither the appellate record nor appellate briefs suggest that 3.35 milligrams is a typographical error.

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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. Appellees/CrossAppellants' 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 diarrheal 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 Administration ("FDA") requirements regarding testing and analytical procedures of the pharmaceutical preparation of promethazine hydrochloride, under a method known as high-performance liquid chromatography ("HPLC"). William Vickery of NMS stated NMS tests found the concentration of promethazine hydrochloride was 6.21 milligrams per 5 milliliters.6 Edward Barbieri, Ph.D., a Forensic Toxicologist and Assistant Laboratory Director at NMS, explains in a thirteen-page affidavit what he views as flaws in AIT's

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6.21 milligrams per 5 milliliters equals 1,242,000 nanograms per milliliter.

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testing of the materials in this case, and accordingly expresses his disagreement with AIT's test results. See Appellant's [sic] App. at 326-38. In April 2004, Dr. Evans completed an affidavit commenting on the AIT test results, in which he stated: 3. [AIT] received a request to perform a forensic toxicology analysis of the contents of a prescription bottle bearing a label describing the contents as promethazine syrup, prescription number . . . regarding Alexis Ritch. 4. The assay method employed by AIT to test that specimen was performed according to Forensic Laboratory Guidelines. The purpose of the assay was to identify the contents of the bottle. 5. The assay method AIT employed was not intended to reliably report the concentration of promethazine in the specimen under GMP conditions. 6. The assay performed by AIT was not performed according to GMP, and the results are not certified to GMP. Further, the assay was not performed according to the USP method for testing promethazine, which is HPLC. 7. Accordingly, the assay results from my testing at AIT cannot be used to determine, within a reasonable degree of scientific certainty under FDA Guidelines, the concentration of promethazine in Specimen . . . . 8. The opinions in this affidavit are stated to a reasonable degree of scientific certainty. 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

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