Proctor & Gamble Averts Suit From Fixodent User

(CN) - A woman suffering from a severe neurological disease cannot prove that her condition stems from use of the denture adhesive Fixodent, the 11th Circuit ruled.

Marianne and Daniel Chapman sued Proctor & Gamble (P&G) in 2009, claiming that Marianne's use of its Fixodent product caused her to develop a copper deficiency.

Fixodent improves adhesion with a zinc compound that the Chapmans claimed can enter a user's digestive tract where it blocks copper assimilation into the body.

Marianne's symptoms included a loss of feeling in her hands and feet, replaced by a burning pain in her extremities requiring pain medication; low red- and white-blood-cell counts; and a progressively unsteady gait caused by the loss of muscle control that ultimately confined her to bed.

The Chapmans supported their case with testimony of four expert witnesses, but a federal judge in Florida's Southern District excluded the experts' testimony one week before trial as unreliable.

Although "the relationship between dose and effect (dose-response relationship) is the hallmark of basic toxicology," and "is the single most important factor to consider in evaluating whether an alleged exposure cause a specific adverse effect," the Chapmans' experts could not inform the court "how much Fixodent must be used for how long to increase the risk of a copper-deficiency, or for how long a copper-deficiency must persist before an individual is at an increased risk of developing a myelopathy," the lower court's ruling said.

The court also faulted the experts' failure to opine as to Marianne's risk of developing myelopathy without exposure to excess zinc.

The 11th Circuit affirmed Thursday, effectively dismissing plaintiffs' suit.

"Given the deposition admissions of Dr. [George J.] Brewer, Dr. [Ebbing] Lautenbach, and Dr. [Joseph R.] Landolph regarding their lack of knowledge of dose-response, epidemiological evidence, and background risk of disease, methodologies this circuit has recognized as indispensable to proving the effect of an ingested substance, we conclude that the testimonies of these proffered experts could not establish general causation of myelopathy by Fixodent," Judge Peter Fay wrote for the three-judge panel. "Because these experts have failed to demonstrate the primary methods for proving the zinc in Fixodent causes myelopathy, their secondary methodologies, including plausible explanations, generalized case reports, hypotheses, and animal studies are insufficient proof of general causation."

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