Miller vs Bernard - Indiana promethazine case


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MILLER v. BERNARD 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, AppellantsPlaintiffs, v. 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. Court of Appeals of Indiana. Novemb
  MILLER v. BERNARDNATALIE A. MILLER, Individually and as Administratrix of theEstate of Alexis J. Ritch, deceased, CHRISTINA J. MILLER, aminor by and through the mother and next friend Natalie A.Miller, and DANIEL J. RITCH, Individually, Appellants-Plaintiffs,v.L. BARRETT BERNARD, M.D., THE BETHANY CIRCLE OF KING'SDAUGHTERS HOSPITAL AND HEALTH SERVICES, CVSPHARMACY, INC., and MORTON GROVE PHARMACEUTICAL,INC., Appellees-Defendants.No. 39A05-1009-PL-546.Court of Appeals of Indiana.November 29, 2011.  J. ANTHONY GOEBEL, Eckert Law Firm, Madison, Indiana, ATTORNEYFOR APPELLANT.ROBERT BARLOW, Barlow Law Office, Madison, Indiana, ATTORNEY FORAPPELLEE/CROSS APPELLANT CVS PHARMACY, INC.FREDERIC X. SHADLEY, JEFFREY F. PECK ,LINDA E. MAICHL,MARY LYNN  TATE, Ulmer & Berne LLP, Cincinnati, Ohio, ATTORNEYS FORAPPELLEE/CROSS APPELLANT MORTON GROVE PHARMACEUTICALS,INC. ROBB, Chief Judge.Case Summary and IssuesNatalie 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 friendNatalie A. Miller; and Daniel J. Ritch, individually (collectively, Plaintiffs ), appealthe 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 thatPromethazine 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'sdeath was not caused, as a matter of law, by MGP's production and CVS'sdistribution of Promethazine Syrup Plain. On cross-appeal, Defendants requestwe 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 thestatutory rebuttable presumption of no defect, but whether Plaintiffs haverebutted this presumption remains a question of fact; and 3) whether MGP'sproduction and CVS's distribution of Promethazine Syrup Plain caused Alexis'sdeath 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 gastrointestinalhealth problems, which required numerous medications, surgeries, and periodsof hospitalization. On March 19, 2002, four-year-old Alexis sustained a fever andwas prescribed Omnicef for an ear infection at King's Daughters' Hospital andHealth Services (the Hospital ) in Madison, Indiana. Natalie returned home andrefrigerated the Omnicef consistent with a note on its label, but beforeadministering 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 toldher that the medicine should not have been refrigerated and was no goodanymore. Id. Alexis's fever continued, and on March 24, Natalie took Alexis tothe Hospital emergency room with a high fever, where Alexis was prescribedOmnicef 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, prescribedPhenergan, ordered a 12.5 milligram dose of Phenergan at the Hospital, andinstructed Natalie to also administer Kaopectate to Alexis. Phenergan is the tradename of an antihistamine drug that provides sedative and anti-nauseam effectsthrough its active ingredient, promethazine hydrochloride. Appellant's [sic] Brief at 5.Natalie filled the prescription for Phenergan at a local CVS branch, which gaveNatalie the generic version manufactured by MGP: Promethazine Syrup Plain.That evening, March 25, Natalie administered to Alexis a dose, and Alexis soonbecame extremely drowsy. Natalie called the Hospital emergency room out of concern, but a nurse told her that drowsiness was an expected side effect, soshe put Alexis to bed. A few hours later, Natalie checked on Alexis, found thatshe was not breathing, and called paramedics. Alexis was taken to the Hospitaland 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 mayhave contributed to her death. First, the Jefferson County Coroner (the Coroner ) received Alexis's body, medical records, and a total body x-ray fromthe Hospital, and sent all on to the Kentucky Medical Examiners' Office for acomplete 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, theCoroner 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 5to 150 nanograms per milliliter. Id. at 216-17; see id. at 234-35 (stating that ablood sample included 295.5 nanograms per milliliter of promethazine). Toanalyze 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 gaveAlexis a dose. The Coroner requested AIT QUANTITATE AND DETERMINECONCENTRATION OF RX MED. Id. at 262. AIT tested the medicine using aninstrument 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 MichaelEvans, Ph.D., the Director of Clinical and Forensic Operations, President, andCEO of AIT. Id. at 217, 237. Dr. Evans noted that the testing of the PromethazineSyrup Plain was performed according to Forensic Laboratory Guidelines, but notin accordance to GMP . . . [or the] USP Method (HPLC), and the [r]esults arenot certified to GMP. Id. at 237. Dr. Evans later explained that GMP stands for Good Manufacturing Practices, which is recognized worldwide for the qualitycontrol 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/Cross-Appellants' Morton GrovePharmaceuticals, Inc. and CVS Pharmacy, Inc.'s Appendix ( App. of Appellees/Cross-Appellants ) at 201. Based on AIT's test results of Alexis's bloodand 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 ) testedAlexis's bottle of Promethazine Syrup Plain to determine the concentration of promethazine hydrochloride in the substance. NMS conducted its testingdifferently from AIT, following federal Food and Drug Administration ( FDA )requirements regarding testing and analytical procedures of the pharmaceuticalpreparation of promethazine hydrochloride, under a method known as high-performance liquid chromatography ( HPLC ). William Vickery of NMS statedNMS tests found the concentration of promethazine hydrochloride was 6.21milligrams per 5 milliliters. 6 Edward Barbieri, Ph.D., a Forensic Toxicologist andAssistant Laboratory Director at NMS, explains in a thirteen-page affidavit whathe views as flaws in AIT's testing of the materials in this case, and accordinglyexpresses his disagreement with AIT's test results. See Appellant's [sic] App. at326-38.In April 2004, Dr. Evans completed an affidavit commenting on the AIT testresults, in which he stated:3. [AIT] received a request to perform a forensic toxicology analysis of thecontents of a prescription bottle bearing a label describing the contents aspromethazine syrup, prescription number . . . regarding Alexis Ritch.4. The assay method employed by AIT to test that specimen was performedaccording to Forensic Laboratory Guidelines. The purpose of the assay was toidentify the contents of the bottle.  5. The assay method AIT employed was not intended to reliably report theconcentration of promethazine in the specimen under GMP conditions.6. The assay performed by AIT was not performed according to GMP, and theresults are not certified to GMP. Further, the assay was not performed accordingto the USP method for testing promethazine, which is HPLC.7. Accordingly, the assay results from my testing at AIT cannot be used todetermine, within a reasonable degree of scientific certainty under FDAGuidelines, the concentration of promethazine in Specimen . . . .8. The opinions in this affidavit are stated to a reasonable degree of scientificcertainty.Id. at 107-08.In a deposition, Dr. Evans was asked whether AIT's test results were scientificallyreliable in determining the concentration of medication in the bottle. Dr. Evansexplained that AIT do[es] testing for pharmaceutical industries, . . . [so] thewhole process is different from the very — very beginning. So this was not doneon 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'srecords of Alexis, the affidavits of Vickery and Dr. Evans, professional referencedocuments, and FDA regulatory materials, and concluded:6. It is my preliminary opinion based on the limited data that I have reviewed thatthe Promethazine Syrup Plain manufactured by [MGP] given to Alexis J. Ritch onthe day of her death . . . was defective, that this defect caused an overdose of promethazine hydrochloride in the bloodstream of Alexis J. Ritch, and that suchoverdoses have been associated with pediatric fatalities. Id. at 188.Dr. George Nichols, II, M.D., explained that both a forensic method of testingsubstances and a USP method of testing substances are scientifically reliable,and that in layman's terms, this case involves two scientifically reliableprocedures 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 two occasions.Because NMS did not complete testing until about two years after Alexis died,the rate of degradation of samples became an issue of contention amongexperts. At one point, Dr. Kulig stated that he does not know the rate of degradation of MGP's Promethazine Syrup Plain, and asserted that a test for concentration of a sample can only indicate the concentration at the time of thetesting. Id. at 388-92. Dr. Barbieri came to the opposite conclusion, and opinedthat MGP's stability test results shows otherwise. Id. at 338.Plaintiffs filed suit in 2003 against Dr. Bernard, the Hospital, MGP, and CVS andamended their complaint in 2006. 7 Dr. Bernard and the Hospital were the subjectof a medical review panel hearing per Indiana law regarding allegations of medical malpractice, and are not parties to this appeal. 8 As to Defendants,parties to this appeal, Plaintiffs allege negligence, product liability, strict liability,misrepresentation, breach of express warranty, breach of implied warranty,negligent infliction of emotional distress, intentional infliction of emotionaldistress, and negligent distribution by CVS. 9 These allegations are based uponthe defective manufacture of the medication [(Promethazine Syrup Plain)] which
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