In Re Denture Cream Products Liability Litigation
795 F. Supp. 2d 1345
S.D. Fla.2011Background
- Chapman suffers copper-deficiency myelopathy allegedly caused by long-term zinc exposure from Fixodent denture adhesive.
- Plaintiffs proffer multiple experts (Brewer, Landolph, Lautenbach) asserting general causation; Greenberg offers specific causation linking Chapman to Fixodent.
- Defendant moves to exclude expert testimony under Daubert; court considers reliability of methodologies and data.
- Plaintiffs’ evidence centers on case reports, mechanistic explanations, and limited clinical data; pharmacokinetic and regulatory analyses are debated.
- Court finds substantial gaps: no reliable dose-response, no analytic epidemiology, uncertain background risk, and questionable case-study support.
- Result: court grants motions to exclude plaintiffs’ general and specific causation testimony; other related expert testimony barred.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether plaintiffs' general causation methods are reliable | Brewer/Landen/ Lautenbach apply epidemiology to show causation. | Methods rely on case reports; no dose-response or analytic epidemiology. | General causation methods deemed unreliable; Daubert satisfied for exclusion. |
| Whether there is a valid dose-response basis for Fixodent-induced copper deficiency | Dose-response supports zinc causing copper deficiency and myelopathy. | Pharmacokinetics show uncertain exposure-dose relation; no reliable threshold established. | No reliable dose-response evidence; plaintiffs’ theory rejected. |
| Whether epidemiological evidence supports causation | Descriptive/analytical epidemiology show association. | Analytical epidemiology lacking; reliance on descriptive case reports is insufficient. | Epidemiological evidence deemed insufficient to prove general causation. |
| Whether Greenberg’s differential diagnosis provides reliable specific causation | Differential diagnosis identifies Fixodent-induced copper-deficiency myelopathy. | Differential diagnosis is not reliable when premisses lack valid basis and broader causation not established. | Greenberg’s differential diagnosis excluded; specific causation rejected. |
| Whether FDA notice or other regulatory references can establish causation | FDA notice indicates a compelling signal of association. | FDA association does not prove causation and relies on adverse-event reports. | FDA notice not admissible to establish causation. |
Key Cases Cited
- McClain v. Metabolife Int'l., Inc., 401 F.3d 1233 (11th Cir. 2005) (epidemiology as best evidence in toxic torts; need reliable method)
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (Supreme Court, 1993) (gatekeeping reliability of expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Supreme Court, 1999) (flexible Daubert standard for non-scientific expert testimony)
- Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183 (11th Cir. 2010) (three-part inquiry for admissibility of expert testimony)
- Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010) (epidemiology as best evidence; caution on background risk)
- Joiner v. General Elec. Co., 522 U.S. 136 (Supreme Court, 1997) (connection between data and opinion must be scientifically valid)