Philadelphia Plaintiff’s Claims Against Fixodent Prove Toothless

In Milward, Martyn Smith got a pass from the First Circuit of the U.S. Court of Appeals on his “weight of the evidence” (WOE) approach to formulating an opinion as an expert witness.  Last week, Smith’s WOE did not fare so well.  The Honorable Sandra Mazer Moss, in one of her last rulings as judge presiding over the Philadelphia Court of Common Pleas mass tort program, sprinkled some cheer to dispel WOE in Jacoby v Rite Aid PCCP (Order of April 27, 2012; Opinion of April 12, 2012).

Applying Pennsylvania’s Frye standard, Judge Moss upheld Proctor & Gambles challenge to Dr. Martyn Smith, as well as two other plaintiff expert witnesses, Dr. Ebbing Lautenbach and Dr. Frederick Askari.  The plaintiff, Mr. Mark Jacoby, used Fixodent for six years before he first experienced parasthesias and numbness in his hands and feet.  Jacoby’s expert witnesses claimed that Fixodent contains zinc compounds, which are released upon use, and are absorbed into the blood stream.  Very high zinc levels suppress copper levels, and cause a copper deficiency myeloneuropathy.  Finding that the plaintiffs’ causal claims were toothless in the face of sound science, Judge Moss excluded the reports and proffered testimony of Drs. Smith, Askari, and Lautenbach.

Although Pennsylvania courts follow a Frye standard, Judge Moss followed the lead of a federal judge, who had previously examined the same body of evidence, and who excluded plaintiff’s expert witnesses, under Federal Rule of Evidence 702, in In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345 (S.D. Fla. 2011).  Without explication, Judge Moss stated that Judge Altanoga’s reasoning and conclusions, reached under federal law, were “very persuasive” under Frye.  Moss Opinion at 5.  In particular, Judge Moss appeared to be impressed by the lack of baseline incidence data on copper deficiency myeloneuropathy, the lack of exposure-response information, and the lack of risk ratios for any level of use of Fixodent.  Id. at 6 – 10.

Judge Moss accepted at face value Martyn Smith’s claims that WOE can be used to demonstrate causation when no individual study is conclusive.  Her Honor did, however, look more critically at the component parts of Smith’s particular application of WOE in the Jacoby case.  Smith used various steps of extrapolation, dose-response, and differential diagnosis in applying WOE, but these steps were woefully unsound.  Id. at 9.  There was no evidence of how low, and for how long, a person’s copper levels must drop before injury results.  Having attacked Proctor & Gamble’s pharmacokinetic studies, the plaintiffs’ expert witnesses had no basis for inferring levels for any plaintiff.  Furthermore, the plaintiffs’ witnesses had no baseline incidence data, and no risk ratios to apply for any level of exposure to, or use of, defendant’s product.

Predictably, plaintiffs’ invoked the pass that Smith received in Milward, but Judge Moss easily distinguished Milward as having involved baseline rates and risk ratios (even if Smith may have imagined the data to calculate those ratios).

Another plaintiff witness, Dr. Askari, used a method he called the “totality of the evidence” (TOE) approach.  In short, TOE is WOE is NO good, as applied in this case.  Id. at 10 -11.

Finally, another plaintiff’s witness, Dr. Lautenbach applied the Naranjo Adverse Drug Reaction Probability Scale, by which he purported to transmute case reports and case series into a conclusion of causality.  Actually, Lautenbach seems to have claimed that the lack of analytical epidemiologic studies supporting an association between Fixodent and myeloneuropathy did not refute the existence of a causal relationship.  Of course, this lack of evidence hardly supports the causal relationship.  Judge Moss assumed that Lautenbach was actually asserting a causal relationship, but since he was relying upon the same woefully, toefully flawed body of evidence, Her Honor excluded Dr. Lautenbach as well.  Id. at 12.

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