Allen v. Pennsylvania Engineering Corp., 96-30209

• Decision Date: 31 December 1996
• Docket Number: No. 96-30209,96-30209
• Citation: 102 F.3d 194
• Parties: , 46 Fed. R. Evid. Serv. 215, Prod.Liab.Rep. (CCH) P 14,832 Walter Mixon ALLEN, Jr., et al., Plaintiffs, Mattie Gayle Allen, Barry Lane Allen, Plaintiffs-Appellants, v. PENNSYLVANIA ENGINEERING CORP., et al., Defendants, American Sterilizer Company, Defendant-Appellee.
• Court: U.S. Court of Appeals — Fifth Circuit

Page 194

102 F.3d 194

65 USLW 2488, 46 Fed. R. Evid. Serv. 215,

Prod.Liab.Rep. (CCH) P 14,832

Walter Mixon ALLEN, Jr., et al., Plaintiffs, Mattie Gayle Allen, Barry Lane Allen, Plaintiffs-Appellants, v. PENNSYLVANIA ENGINEERING CORP., et al., Defendants, American Sterilizer Company, Defendant-Appellee.

No. 96-30209.

United States Court of Appeals, Fifth Circuit.

Dec. 31, 1996.

Edward J. Walters, Jr., Keith Patrick Richards, Moore, Walters, Shoenfelt & Thompson, Baton Rouge, LA, for plaintiffs-appellants.

Thomas E. Balhoff, Judith R. Atkinson, Roedel, Parsons, Hill & Koch, Baton, Rouge, LA, Bert L. Wolff, Skadden, Arps, Slate, Meagher & Flom, New York City, for American Sterilizers Co.

Appeal from the United States District Court for the Middle District of Louisiana.

Before WISDOM, JONES and WIENER, Circuit Judges.

EDITH H. JONES, Circuit Judge:

Walter Allen died of a brain cancer known as glioblastoma multiforme after having been a maintenance worker at Baton Rouge General Hospital for over 20 years. During that time, he occasionally replaced cylinders containing ethylene oxide ("EtO"), a chemical that has been widely used in this country to sterilize heat and moisture sensitive medical and surgical devices. Allen's widow and son (the "Allens") filed suit against numerous defendants, including American Sterilizer Company, the manufacturer of EtO sterilizers. On motions for judgment as a matter of law, the district court held both that two of the Allens' three expert witnesses were not qualified to render opinions that exposure to EtO caused Allen's fatal cancer and that the opinions of all three experts were inadmissible in federal court for lack of sufficient scientific grounding.

We affirm. Where, as here, no epidemiological study has found a statistically significant link between EtO exposure and human brain cancer; the results of animal studies are inconclusive at best; and there was no evidence of the level of Allen's occupational exposure to EtO, the expert testimony does not exhibit the level of reliability necessary to comport with Federal Rules of Evidence 702 and 703, the Supreme Court's Daubert decision, ¹ and this court's authorities. Moreover, under the circumstances of this case This court reviews the judgment as a matter of law on two levels. First we must evaluate the trial court's evidentiary ruling under the manifest error standard, and then, with the record defined, we review de novo the order granting judgment as a matter of law. Christophersen v. Allied-Signal Corp., 939 F.2d 1106, 1109 (5th Cir.1991) (en banc), cert. denied, 503 U.S. 912, 112 S.Ct. 1280, 117 L.Ed.2d 506 (1992). If the trial court has excluded evidence essential to maintain a cause of action, the propriety of summary judgment depends, as here, entirely on the evidentiary ruling. Id.

the fact that EtO has been classified as a carcinogen by agencies responsible for public health regulations is not probative of the question whether Allen's brain cancer was caused by EtO exposure.

In Daubert, the Supreme Court meticulously explained the criteria for admitting expert scientific testimony pursuant to Federal Rule of Evidence 702:

Proposed testimony must be supported by appropriate validation--i.e., "good grounds," based on what is known ... [T]he requirement that an expert's testimony pertained to "scientific knowledge" establishes a standard of evidentiary reliability. (footnote omitted) Daubert, 509 U.S. at 590, 113 S.Ct. at 2795.

Further, the Court held that a trial court has a duty to screen expert testimony for both its relevance and reliability. Id. An expert's opinion must have a "reliable basis in the knowledge and experience of his discipline." Id. at 592, 113 S.Ct. at 2796. Specifically, the court must determine that the reasoning and methodology underlying the testimony is scientifically valid and that the reasoning and methodology can properly be applied to the facts in issue. Id. at 592-93, 113 S.Ct. at 2796.

The Court added that under Rule 703, an expert must base his opinion on facts and data of a type reasonably relied on by experts in the field. Id. at 595, 113 S.Ct. at 2797-98.

Although the trial court wrote a cursory opinion on the admissibility of Allen's expert evidence, the parties developed a considerable record, and the court heard oral argument before rendering a decision that the experts' evidence, testimony and opinions did not satisfy the standards set forth in Daubert or relevant authorities of this Court. Those standards may readily be applied to the evidence before us.

Appellants produced three expert witnesses, Dr. Page, Dr. Kelsey and now--Dr. LaMontagne, ² whose opinions may be summarized as follows. First, human epidemiological evidence "suggests" an association between EtO exposure and an increased risk of brain cancer. Second, scientific studies conducted on rats have shown EtO capable of causing tumors in certain of those animals. Third, EtO is known as a mutagen and genotoxin. Consequently, these witnesses theorize, EtO reaches brain tissue, alkylates DNA and "clearly" causes animal brain tumors. The experts employ a "weight of the evidence" analysis used by organizations such as the World Health Organization's International Agency for Research on Cancer (IARC), OSHA, and the EPA to rate the carcinogenicity of various substances in humans. We will examine each of the types of evidence on which appellants' experts rely: epidemiological studies, animal studies, cell biology, and health organization conclusions. We must also consider the "weight of the evidence" methodology.

First, although occupational exposure to EtO has been studied for many years, not a single scientific study has revealed a link between human brain cancer and EtO exposure. In fact, numerous reputable epidemiological studies covering in total thousands of workers indicate there is not a correlation between EtO exposure and cancer of the human brain. See, e.g., L. Stayner, et al., Exposure-Response Analysis of Cancer Mortality in a Cohort of Workers Exposed to Ethylene Oxide, 138 Am.J.Epid. 787, 797 (1993) (concluding that the study's "findings do not provide evidence for a positive association between exposure to [EtO] and cancers of the ... brain...."). The National Institute for Occupational Safety and Health ("NIOSH") conducted this study. This analysis follows the prior published epidemiological study by the same NIOSH researchers. See K. Steenland, et al., Mortality Among Workers Exposed to Ethylene Oxide, 324 N.E.J.Med. 1402 (1991). Evidence has been found that suggests a connection between EtO exposure and human lymphatic and hematopoietic cancers, but this is not probative on the causation of brain cancer. ³ This court has said that:

Undoubtedly, the most useful and conclusive type of evidence in a case such as this is epidemiological studies. Brock v. Merrill-Dow Pharmaceuticals, Inc., 874 F.2d 307, 311 (5th Cir.1989), modified by 884 F.2d 166 (5th Cir.1989), cert. denied, 494 U.S. 1046 [110 S.Ct. 1511, 108 L.Ed.2d 646] (1990).

While appellants' experts acknowledge the lack of statistically significant epidemiological evidence, they rely on certain studies as "suggestive" of a link between EtO exposure and brain cancer. "Suggestiveness" is not by the experts' own admission statistical significance, nor did the appellants' experts show why and how mere "suggestiveness" scientifically supports a causal connection; this basis for their scientific opinion must be rejected. ⁴

Second, the experts rely on two studies that found brain tumors in F-344 rats exposed to inhaled EtO, and on other animal studies that have found EtO-associated increases in the rodents' various solid and hematopoietic cancers. In Brock, this court noted "the very limited usefulness of animal studies when confronted with questions of toxicity." Brock, 874 F.2d at 313. Brock goes on to outline a number of reasons why studies of the effects of chemicals on animals must be carefully qualified in order to have explanatory potential for human beings. So it is here. Although in these particular studies, F-344 rats contracted brain cancer after being exposed to EtO, Allen's experts concede that the same effect did not occur in mice studies. As an expert for appellee concludes:

Thus, the lack of capacity for the F-344 rat to predict how even the mouse model responds necessarily undercuts confidence that the rat will predict accurately how other species including humans will respond [to EtO exposure].

Reliance on these animal studies furnishes at best speculative support for appellants' causation theory. ⁵

Third, the cell biology data show only that EtO has mutagenic and genotoxic capabilities in living organisms, not that it necessarily causes brain cancer in humans or in Allen's particular case. That EtO may have these effects on living cells or genes is the beginning, not the end of the scientific inquiry and proves nothing about causation without other scientific evidence.

On examination, none of the scientific data on which appellants' experts rely furnishes a scientifically valid basis for the conclusion they would draw. The paucity of epidemiological evidence, the unreliability of animal studies, and the inconclusiveness of cell biology combine to undercut the expert testimony.

We are also unpersuaded that the "weight of the evidence" methodology these experts use is scientifically acceptable for demonstrating a medical link between Allen's EtO exposure and brain cancer. Regulatory and advisory bodies such as IARC, OSHA and EPA utilize a "weight of the evidence" method to assess the carcinogenicity of various substances in human beings and suggest or make prophylactic rules governing human exposure. This methodology results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances. The agencies' threshold of proof is reasonably lower than that appropriate in tort...