We saw the movie “Whiplash” last weekend. In this Oscar contender, a drum student at a prestigious music conservatory seeks the approval of a harsh and punishing conductor, as well as a berth in the conductor’s competition jazz band. The film is so tense and so consistently painful to watch that it would not be accurate to say that we “enjoyed” it, but we wouldn’t have missed it for the world.
“New,” but Not Improved
Physiological Process Involved/ Clinical Studies
To validate their argument that the zinc in Fixodent dissociates and becomes bioavailable, Plaintiffs relied upon a new Fixodent Blockade Study and two new sets of in vitro studies.
Defendants challenged “serious methodological flaws in the design, conduct and analysis of the Fixodent Blockade study, as well as the overall relevance of the study’s findings to the question of general causation, because the study does not address dose − the amount, frequency or duration of Fixodent use needed to cause a copper deficiency, much less a myeloneuropathy.” Id. at *57 (internal quotation marks and citations omitted). The Court agreed. describing mid-stream changes in the statistical analysis that deviated from the approved protocol and “[made] the data fit Plaintiff’s hypothesis,” id. at *60-61, “[turning] a ‘not significant’ study result into a ‘quite impressive’ study result,” Id. at *63-64. The Court concluded that the methodological flaws, “taken together,” demanded a finding that “the Fixodent Blockade Study is not “good science” and is not admissible.” Id. at * 68 (citation to Daubert omitted).
The Court next analyzed Plaintiffs’ in vitro studies. With regard to the first, the Court commented, “In place of details and analysis, [the] one page in vitro report consists of conclusory statements . . . devoid of factual or analytical support.” Id. at *72 (citations omitted). Among other methodological flaws, the report failed “to explain the relevancy of the in vitro studies to humans or to account for factors needed to make a proper extrapolation . . . .” Id. The Court concluded that the report was unreliable, based on its “severe inadequacies” and its failure to consider how the in vitro release of zinc “correlated to actual zinc ion release in the human body.” Id. at *74. The second set of in vitro studies failed to support plaintiff’s bioavailability argument and actually demonstrated “that taking more and more Fixodent may not expose a person to more and more zinc.” Id. at *91. “In short,” the Court concluded, “Plaintiffs are not much better off than they were at the time of Chapman.” Id.
Epidemiological Evidence and Background Risk of Disease
In sum, the Court held that Plaintiffs’ general causation experts possessed “no analytical epidemiological evidence, no evidence of background risk, and no knowledge of dose-response.” Id. at *141. As such, the Court granted P & G’s motions, concluding, “To admit the Plaintiffs’ evidence, the Court would have to make several scientifically unsupported ‘leaps of faith’ in the causal chain. The Daubert rule requires more.” Id. at *142-43 (citation omitted).In Whiplash, after repeating the same mistake too many times, the young student narrowly avoids a chair the irate conductor has thrown at his head. In this case, the Denture Cream Plaintiffs forgot to duck.