Adams v. Proctor & Gamble Distributing LLC, 012214 OHCP, A1204223

Docket Nº:A1204223
Opinion Judge:Ethna M. Cooper, Judge
Party Name:SHERRY L. ADAMS, et. al., Plaintiffs, v. THE PROCTOR & GAMBLE DISTRIBUTING, LLC, et. al., Defendants
Attorney:Frank C. Woodside, III, Esq., Eric K. Combs, Esq., Mary-Jo Pullen, Esq., Counsel for Defendants The Proctor & Gamble Distributing LLC, and The Proctor & Gamble Company, and The Proctor & Gamble Manufacturing Company. Raymond C. Silverman, Esq., Counsel for Plaintiffs.
Case Date:January 22, 2014
Court:Court of Common Pleas of Ohio
 
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SHERRY L. ADAMS, et. al., Plaintiffs,

v.

THE PROCTOR & GAMBLE DISTRIBUTING, LLC, et. al., Defendants

No. A1204223

Court of Common Pleas of Ohio, Hamilton

January 22, 2014

          Frank C. Woodside, III, Esq., Eric K. Combs, Esq., Mary-Jo Pullen, Esq., Counsel for Defendants The Proctor & Gamble Distributing LLC, and The Proctor & Gamble Company, and The Proctor & Gamble Manufacturing Company.

          Raymond C. Silverman, Esq., Counsel for Plaintiffs.

          ENTRY GRANTING DEFENDANTS' MOTION TO EXCLUDE OPINIONS OF DRS. ASKARI, GRAINGER, GREENBERG, LAUTENBACH, AND SMITH

          Ethna M. Cooper, Judge

         This case is before the Court on Defendants The Proctor & Gamble Distributing LLC, The Proctor & Gamble Company and the Proctor & Gamble Manufacturing Company's Motion to Exclude the Opinions of Drs. Askari, Grainger, Greenberg, Lautenbach and Smith, Plaintiffs' Memorandum in Opposition to Defendants' Motion to Exclude the Opinions of Drs. Askari, Grainger, Greenberg, Lautenbach and Smith, and Defendants' Reply thereto. Oral argument was held on Thursday, December 19, 2013 at which time the Court heard extensive arguments of counsel with respect to Defendants' Motion.

         II. BACKGROUND

         This case arises from Plaintiffs' allegations that Sherry Adams' (" Adams") chronic use of Fixodent resulted in neurological injuries. Plaintiffs contend that when Fixodent is swallowed and exposed to the gastrointestinal tract in excess amounts, the zinc in Fixodent is subsequently absorbed by the body, causing depleted copper levels ultimately resulting in the development of a " constellation of neurological symptoms generally referred to as neuropathy as well as other hematologic complications." 1

         Plaintiffs have submitted the reports of several experts in support of their theories of both general and specific causation. Defendants seek to exclude the opinions of Plaintiffs' expert as unreliable under Valentine v. PPG Industries.2

         III. ANALYSIS

         In order for Plaintiffs to succeed on their claims, they must establish that: 1) Fixodent is capable of causing Adams' condition (general causation); and 2) Fixodent in fact caused Adams' medical condition (specific causation).3 Ohio Rule of Evidence 702 sets forth that,

" A witness may testify as an expert if all of the following apply:

(A) The witness' testimony either relates to matters beyond the knowledge or experience possessed by lay persons or dispels a misconception common among lay persons; (B) The witness is qualified as an expert by specialized knowledge, skill, experience, training, or education regarding the subject matter of the testimony; (C) The witness' testimony is based on reliable scientific, technical, or other specialized information. To the extent that the testimony reports the result of a procedure, test, or experiment, the testimony is reliable only if all of the following apply: (1) The theory upon which the procedure, test, or experiment is based is objectively verifiable or is validly derived from widely accepted knowledge, facts, or principles; (2) The design of the procedure, test, or experiment reliably implements the theory; (3) The particular procedure, test, or experiment was conducted in a way that will yield an accurate result."

          It is Plaintiffs' burden to show that its expert evidence is admissible.4

         Defendants do not take issue with the first two requirements under Rule 702. Rather Defendants contend that Plaintiffs' experts' opinions are " methodically flawed and scientifically unreliable, " thus implicating the third requirement under Rule 702. The U.S. Supreme Court in Daubert 5 set forth several factors to aid in the determination of whether an expert's opinion is reliable. These factors are: 1) whether the theory or technique has been tested; 2) whether it has been subjected to peer review; 3) whether there is a known or potential rate of error; and 4) whether the methodology has gained general acceptance.6 While the " inquiry is flexible, " the focus remains " solely on principles and methodology, not on the conclusions that they generate." 7

         Ohio law on the admissibility of expert mirrors, the Supreme Court's holding in Daubert. Under Valentine , Plaintiffs' experts must proceed in a " stepwise fashion" to: 1) establish the characteristic of the alleged medical condition; 2) carefully define the nature and amount of the alleged toxic exposure; 3) demonstrate that the medical and scientific literature provides reliable evidence that in some circumstances the exposure can cause the outcome, and 4) reach a reasonable conclusion applying general knowledge to the specific circumstances of the case, taking into account mitigating circumstances and competing causes.8

         Plaintiffs have offered the opinions of five experts to establish that Fixodent caused Adams' myelopathy. Defendants argue that Plaintiffs' experts' opinions are flawed because they: " 1) are based upon hypothesis-generating case reports and unsupported extrapolation; 2) lack any reliable epidemiological data demonstrating a causal relationship between Fixodent and neurological injuries; 3) fail to establish the characteristics of the medical condition at issue (i.e. there is no case definition); and 4) fail to establish the amount and duration of exposure necessary to cause the alleged injury (i.e. the dose/response relationship)."

          Under Ohio law, " scientific evidence and expert testimony must have traceable, analytic basis in objective fact before it may be considered." 9 It is the Court's function to determine whether the proposed expert testimony has a " reliable basis in the knowledge and experience of the discipline." 10 To do this, there must be a valid connection between an expert's opinion regarding causation and the scientific research.11

         Plaintiffs do not dispute the applicable legal standard but rather, spend much of their time arguing that the scientific principles relied upon by its experts are " generally accepted." However, as Defendants point out, in Ohio, " general acceptance" of a methodology is only one factor for a court to consider in determining reliability, but it is not a prerequisite to admissibility.12 In this respect, Ohio does not follow the standard announced in Frye v. United States , which held that an expert's opinion is inadmissible unless it has gained " general acceptance" in the relevant scientific community.13

         Epidemiological Evidence

         Epidemiology explores " the causes of diseases in humans as inferred from observations of humans." 14 Epidemiological studies are therefore the " primary generally accepted methodology for demonstrating a causal relation between the chemical compound and a set of symptoms or disease." 15 According to Dr. Lautenbach, before identifying the possible causes of a disease, " one must first quantify the frequency with which the disease occurs... the most commonly used measures of disease frequency in epidemiology are prevalence and incidence." 16 None of Plaintiffs' experts have identified, or are able to identify, the incidence of myelopathy or neuropathy in the general population in order to form a baseline (or background risk) for such.17 As the court in Chapman opined,

Some people use denture cream and some people have a myelopathy; it is possible (and depending on the incidence of myelopathies, likely) that some denture-cream users have an idiopathic myelopathy simply due to the background distribution of that disease. Without a baseline, any incidence may be coincidence. Accordingly, the absence of this data is a substantial weakness in Plaintiffs' experts' causal reasoning.18

         There has been no baseline offered with respect to the disorders which comprise CDM and there is no available data with respect to the incidence of elevated zinc in the blood or copper deficiency within the general population, denture users or Fixodent users. Indeed Dr. Smith admits that this data is unavailable.19 Moreover, no other expert has produced such data. As a result, there is no reliable way to establish whether Fixodent use increases the risk of neurological disorders. According to the court in Chapman , the lack of a baseline is just one of the analytical gaps which, standing alone, mandates the exclusion of Plaintiffs' experts.20

         Case Definition

         Under Valentine , in order to show that a chemical substance can cause a specific medical condition, the expert " must establish the characteristics of the medical condition.21 This is commonly referred to as a " case definition." According to the Center for Disease Control (" CDC"), a case definition includes " information on symptoms, laboratory findings, and limitations of time, place and person." 22 A case definition allows an investigator to exclude individuals with illnesses unrelated to the potential toxic substance.23 Copper deficiency myeloneuropathy (" CDM") has never been defined by a specific set of signs or symptoms. It's been described in various publications as a " myelopathy with peripheral neuropathy of varying severity." Of particular note is that symptoms allegedly resulting from copper deficiency commonly manifest themselves through blood abnormalities such as anemia and neutropenia.24 However, some case studies have occasionally linked CDM to MRI findings.25 Once again, the court in Chapman , noted that " [a] number of different terms have been used -- more or less as synonyms, regardless whether that is medically accurate -- in the course of the litigation to refer to the constellation of neurological injuries allegedly caused by long-term use of Fixodent. Those terms include...

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