## Facts

- Marianne Chapman alleged severe neurological injury (myelopathy) with symptoms including sensory loss, gait ataxia, burning pain, blood-count abnormalities, and wrist/finger drop.
- The Chapmans attributed her condition to long-term, heavy use of a zinc-containing denture adhesive (Fixodent) manufactured and distributed by Procter & Gamble.
- They alleged zinc exposure caused copper-deficiency myelopathy and relied on developing medical literature, including case reports hypothesizing a connection between denture-adhesive zinc and copper deficiency.
- Fixodent had been reformulated to include a calcium–zinc compound; the zinc compound was described as less bioavailable than other zinc compounds.
- The Chapmans asserted state-law claims including design defect, failure to warn, negligence, implied warranty, fraud/misrepresentation, FDUTPA, and loss of consortium.
- The action was removed to federal court on diversity grounds and proceeded in consolidated multidistrict litigation in the Southern District of Florida.
- To prove causation, the Chapmans offered expert testimony on general causation (that Fixodent can cause the alleged condition) and specific causation (that Fixodent caused Marianne Chapman’s condition).

## Issues

1. Whether the district court abused its discretion under Federal Rule of Evidence 702 and *Daubert* by excluding the Chapmans’ causation experts as methodologically unreliable.
2. Whether, after exclusion of the causation experts, summary judgment for Procter & Gamble was required because the Chapmans lacked admissible evidence of causation.

## Decision

- The Eleventh Circuit affirmed the exclusion of the Chapmans’ general-causation experts under Rule 702 and *Daubert*.
- The court agreed that the experts’ reliance on case reports, animal studies, biological plausibility, and extrapolation from other zinc exposures did not reliably establish that Fixodent, as formulated and used, is capable of causing copper-deficiency myelopathy in humans.
- The court accepted the district court’s product-specific concern that Fixodent’s zinc compound was less bioavailable, weakening inferences drawn from other zinc compounds or exposure contexts.
- The Eleventh Circuit affirmed exclusion of the treating neurologist’s specific-causation opinion because it depended on an unproven general-causation premise.
- The court affirmed summary judgment for Procter & Gamble because causation was an essential element of all claims, and without admissible expert causation testimony there was no genuine dispute of material fact.

## Legal Principles

- Under Rule 702 and *Daubert*, expert testimony must rest on reliable methods and sufficient supporting data, and district courts act as gatekeepers to exclude unreliable opinions.
- In toxic-tort/product cases, general causation ordinarily requires reliable expert proof that the product and exposure levels at issue are capable of causing the alleged injury in humans.
- Case reports and other non-controlled observations, standing alone, generally do not establish causation; extrapolation from dissimilar exposure data must be reliably justified and fit the product-specific facts.
- A specific-causation opinion is inadmissible where it assumes general causation that has not been reliably shown.
- When a plaintiff lacks admissible expert evidence on causation for claims that require it, summary judgment for the defendant is proper.

## Conclusion

The Eleventh Circuit held that the district court permissibly excluded the Chapmans’ causation experts under Rule 702 and *Daubert* due to unreliable methodology and lack of product- and exposure-specific support, and that summary judgment for Procter & Gamble followed because the Chapmans could not prove causation with admissible evidence.


Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir. 2014)