In Re Stand 'N Seal, Products Liability Litigation
623 F. Supp. 2d 1355, 2009 U.S. Dist. LEXIS 75370, 2009 WL 1606543 (2009)
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Rule of Law:
Expert testimony on causation in a toxic tort case is admissible under Federal Rule of Evidence 702 if it is based on reliable principles and methodology, such as the Bradford Hill criteria, even if it lacks a definitive dose-response relationship or contains other arguable flaws, as such critiques generally go to the weight of the evidence rather than its admissibility.
Facts:
- Stand ‘n Seal is a consumer product marketed as a 'Spray-On' Grout Sealer for use in areas like kitchens and bathrooms.
- The product was originally manufactured with a fluoropolymer chemical known as Zonyl 225.
- From April to May 2005, and again in July 2005, the manufacturer switched from Zonyl 225 to a different fluoropolymer chemical, Flexipel S-22WS.
- Immediately following this change, users of Stand ‘n Seal with Flexipel began to report experiencing respiratory problems, including chemical pneumonitis.
- By August 31, 2005, the manufacturer recalled all Stand ‘n Seal products containing Flexipel S-22WS from the market.
Procedural Posture:
- Consumers across the country filed personal injury lawsuits in various federal courts against the manufacturers, distributors, and sellers of Stand ‘n Seal with Flexipel.
- On January 5, 2007, the Judicial Panel on Multidistrict Litigation transferred the federal cases to the U.S. District Court for the Northern District of Georgia for consolidated pretrial proceedings (MDL).
- Following extensive discovery, the Defendants filed a Motion for Summary Judgment on the issue of general causation.
- Defendants also filed motions to exclude the testimony and affidavits of Plaintiffs’ expert witnesses David Hurst, Henry Spiller, and Roger Wabeke under the Daubert standard.
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Issue:
Does expert testimony asserting that a chemical product causes respiratory harm meet the reliability requirements of Federal Rule of Evidence 702 when it is based on pre-litigation clinical analysis, strong temporal association, and analogy to similar chemicals, even without a definitive dose-response relationship?
Opinions:
Majority - Thomas W. Thrash, Jr.
Yes. The expert testimony meets the reliability requirements of Rule 702 because the experts employed methodologies with sufficient intellectual rigor, consistent with standards in their respective fields. The court functions as a gatekeeper to exclude unreliable testimony, not to resolve factual disputes or decide which of two competing scientific theories is correct. The court found that Plaintiffs' experts—a chemist (Hurst) and two toxicologists (Spiller and Wabeke)—were qualified and based their opinions on sufficient data, including chemical tests, clinical patient data from the outbreak, and the broader scientific literature. The court rejected Defendants' arguments that the testimony was unreliable, finding that the experts' methodologies were sound. For example, the toxicologists' reasoning was consistent with the established Bradford Hill criteria for assessing general causation. The court determined that the absence of a dose-response relationship was adequately explained and that reliance on case reports and analogies to similar fluoropolymers was appropriate given the strong temporal association between product use and injury. Any alleged concessions or flaws in the experts' work were deemed matters affecting the weight of the evidence for the jury to consider, not grounds for exclusion.
Analysis:
This order provides a clear application of the Daubert standard for expert testimony in the context of a complex toxic tort multidistrict litigation (MDL). It reinforces the principle that the trial court's gatekeeping role is to ensure methodological reliability, not to usurp the jury's function of weighing evidence and assessing credibility. The decision highlights that a lack of a definitive dose-response relationship is not fatal to a general causation opinion if its absence is scientifically justified. By finding the plaintiffs' experts' methodologies reliable, particularly their alignment with the Bradford Hill criteria, the court allows the case to proceed past the critical summary judgment stage, setting a precedent for how similar causation challenges may be handled in future mass tort cases.
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