Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims

In the spring of 2012, Judge Sandra Mazer Moss granted summary judgment to Proctor & Gamble, after excluding, on Frye grounds, plaintiff’s expert witnesses who opined that plaintiff suffered zinc neurotoxicity from his use of FixodentJacoby v. Rite Aid Corp., 2012 Phila. Ct. Com. Pl. LEXIS 208 (2012).  SeePhiladelphia Plaintiff’s Claims Against Fixodent Prove Toothless” (May 2, 2012).  Judge Moss’s exclusion of plaintiff’s expert witnesses involved a careful analysis of the evasive, hand-waving tactics of the witnesses.  Among the plaintiff’s team of expert witnesses was Dr. Martyn Smith, the chief hand waver and obscurantist in Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012).

On Monday, December 9, 2013, after a careful review, the Pennsylvania Superior Court affirmed summary judgment for Proctor & Gamble in the Jacoby case. Jacoby v. Rite Aid Corp., Pa. Super. Ct. No. 1508 EDA 2012 (Dec. 9, 2013) [Slip op.]  The Superior Court panel, consisting of Judges Stevens, Lazarus, and Colville, largely adopted Judge Moss’s analysis and affirmed in a signed, but unpublished, opinion by Judge Lazarus. 

Like Judge Moss before them, the Panel saw through the attempt to pass off “Weight of the Evidence” (WOE) and “Totality of the Evidence” (TOE) as scientific methodologies.  The witnesses, Martyn Smith and others, failed to specify what evidence they weighed, how they weighed the evidence, and what the weights supposedly were.  Another expert witness vaguely pointed to the “Naranjo scale” in support of interpreting case reports to show causal association, but this scale was similarly incompetent other than as a crude “plausibility” scale for assessing case reports.

The Superior Court’s decision in Jacoby is noteworthy on several important issues. There was no material issue as to whether zinc at some dose and duration of exposure can cause neuropathies.  The Court saw, however, that the important issue was whether zinc in the form, dose, and duration ingested by plaintiff can cause the outcome he experienced, and whether his exposure to zinc in Fix-o-dent actually caused his alleged injury.  The Superior Court re-affirmed Pennsylvania’s case law that makes extrapolation from different doses, different durations, and different biological circumstances, a “novel” claim that is subject to the gatekeeping by the so-called Frye standard. Slip op. at 11.

The Superior Court’s opinion astutely observed that the issue was not whether WOE and TOE are accepted scientific methodologies, but whether expert witness Martyn Smith can “evade a reasoned Frye inquiry merely by making reference to accepted methods in the abstract.”  Id. at 12 (citing Betz, at 58).  When pressed, Martyn Smith’s invocation of WOE amounted to little more than a distortion and abridgment of the Bradford Hill factors.  The Superior Court recognized, however, that the Bradford Hill guidelines provide an evaluative process to consider whether an association, after first being shown to be clear cut and not attributable to chance, is causal or spurious.  Id. at 13.  As Bradford Hill postulated the question that arises before his famous nine factors come into the analysis:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965) (emphasis added).

In this case, Smith never got off the dime with his evasive tactics.  He did not identify a quantified association that could be assessed for the play of random variation, or bias and confounding.  Smith tried to suggest that a mere possibility of an association was sufficient to invoke the Bradford Hill guidelines, but the Superior Court rejected this attempt to invent a new-age scientific method. Slip op. at 13.

The Superior Court acknowledged that the scientific literature describes WOE as varying from nothing more than “seat-of-the-pants qualitative assessment” to “aggregating diverse modalities.”  Id. at 14.  In Smith’s hands, WOE was little more than a personal, subjective opinion, an ipse dixit dressed as a scientific opinion.  Smith never defined his WOE approach, and the other witnesses never defined their TOE approach.  The plaintiffs’ witnesses in Jacoby failed to offer an accepted methodology when they failed to identify the forms of evidence they considered, and how they went about weighing the evidence upon which they had relied.  Id. at 15.

In a brief discussion, the Panel also embraced another basic evidentiary principle to dismiss a common tactic in specious claiming. The plaintiffs’ challenged defendants’ pharmokinetic study and tried to suggest that their deconstruction counted as affirmative evidence to support their own theory of biological fate and distribution. Id. at 16.  The Superior Court saw through the ruse; the plaintiffs had not created affirmative evidence for their theory by arguing that the defendants’ study was flawed. 

The Superior Court squarely confronted the limitations and inadequacy of relying upon descriptive, anecdotal case reports. Case reports provide a narrative and temporal history of events with respect to exposure and outcome, but they cannot fully account for confounding by known and unknown factors.  Case reports represent post hoc assessments that were not planned, and therefore lack data that would permit distinguishing coincidence from causality.  Id. at 17 (citing Dr. Lorene Nelson’s report).  See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345 (S.D. Fla.2011).

Proctor & Gamble had the good fortunate to have obtained a good ruling in the MDL litigation in the Southern District of Florida, which no doubt helped focus the gatekeeping process in Pennsylvania state court. Unfortunately, the Superior Court Panel chose not to publish its decision.  This decision is regrettable for its inconsistency with the transparency and due process expected of all courts.  See Erica Weisgerber, “Unpublished Opinions: A Convenient Means to an Unconstitutional End,” 97 Georgetown L.J. 621 (2009).

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