BRIGHT, Senior Circuit Judge.
Kristofer and Katrina Sorensen have suffered from mental retardation since birth, allegedly caused by their parents' ingestion, prior to the children's conception, of alfalfa health food tablets produced and distributed as a Shaklee product by defendant Shaklee Corporation (Shaklee). Some of these alfalfa tablets had been treated with the chemical ethylene oxide (EtO), leaving on some a chemical residue of ethylene chlorohydrin (ETCH) and ethyl glycol. Defendant Union Carbide Chemicals & Plastics Company, Inc. (Union Carbide) produced EtO.
Kristofer and Katrina, through their mother, Laura E. Dunbar, claimed their birth defects had been caused by the chemical treatment residue on the alfalfa tablets ingested by the parents, Laura and her former husband Nord Sorensen. After reviewing discovery materials including disputed and contradictory medical and scientific evidence presented by the parties, the district court granted defendants' motions for summary judgment for failure of proof of causation. Plaintiffs Kristofer and Katrina appeal.
The principal question presented by this appeal is whether, in light of the Supreme Court's 1993 opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc., ___ U.S. ___, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), plaintiffs presented relevant admissible evidence to establish a jury question on causation. We agree with the district court
I. BACKGROUND
A. Factual History
Alfalfa tablets are among the products distributed by defendant Shaklee. In 1974, Shaklee's in-house microbiological staff isolated a batch of alfalfa tablets that showed traces of salmonella. Shaklee sent those tablets to Griffith Laboratories U.S.A., Inc. (Griffith) for purification.
An outside laboratory subsequently tested the tablets for EtO residue and found traces of ETCH at a maximum level of 3000 parts per million (ppm).
Following discovery of the bacteria-contaminated tablets, Shaklee issued a specification in 1975 to its alfalfa supplier, Cal-Leaf Health Products, Inc. (Cal-Leaf), requiring a zero tolerance level for salmonella and E. coli microorganisms. To meet this requirement, Cal-Leaf sent its raw alfalfa powder to Griffith for EtO sterilization. Based upon independent testing, no EtO residues were detected during 1975 and 1976. In 1977, however, testing by the WARF Institute, Inc. (WARF) indicated the presence of ETCH ranging from 20-24 ppm in the alfalfa tablets and 153-459 ppm in the alfalfa powder. In its reports to Shaklee following recitation of the test results, WARF made the following recommendations:
App. at 1335 (September 20, 1977 report).
Id. at 1369 (October 14, 1977 report).
In an internal memorandum dated September 27, 1977, having previously consulted with in-house legal counsel, Shaklee disputed WARF's characterization of the alfalfa as falling outside the ambit of the Code of Federal Regulations' "spice" category. Id. at 1320. Notwithstanding this dispute, Shaklee decided to destroy its on-hand supply of alfalfa tablets and powder treated with EtO. Further, during the summer of 1977, Shaklee began developing a non-chemical, heat sterilization process. From August 1977 to February 1978, Shaklee did not distribute any alfalfa tablets.
Shaklee employees conducted an analysis of the company's use of EtO, culminating in a memorandum dated October 6, 1977, comprised of notes from interviews of various Shaklee employees conducted on October 4. Some of the employees recalled that at least one Shaklee official, including George Lieberman, Vice President of Operations and in charge of Research & Development, was unconcerned with checking for residuals from the EtO fumigating and did not want to know how Cal-Leaf eradicated the bacteria. Id. at 1344-45, 1349-50.
Nord Sorensen and Laura Dunbar began using Shaklee products, including alfalfa tablets, in late 1975 or early 1976, after Nord's mother (Janet) told them about the products and averred to their considerable health benefits. Nord and Laura obtained Shaklee products from a local distributor in Iowa, as well as Janet's remaining supply in June or July of 1977 (purchased sometime prior to her death in September 1976). Nord estimated that the supply obtained from his mother lasted until June of 1978.
From the summer of 1977 through the birth of Kristofer on June 17, 1978, Laura took an average of two to four alfalfa tablets a day; Nord took about six to eight tablets a day. During that same period, Laura also smoked approximately a half a pack or less of cigarettes a day and drank only one alcoholic beverage. Thereafter, prior to learning she was again pregnant, Laura took about one to two alfalfa tablets per day. From the end of 1978 through the birth of Katrina on December 14, 1979, Laura took approximately two to four alfalfa tablets a day. The record does not indicate Nord's daily use of the tablets between the time of Kristofer's birth and Katrina's conception. Laura smoked almost a pack of cigarettes a day during her pregnancy with Katrina. Both Kristofer and Katrina were born severely mentally retarded, and have similar physical attributes. Laura and Nord discontinued the alfalfa tablets sometime after Katrina's birth. A third child fathered by Nord was unaffected by any genetic or developmental disability. Subsequently, Nord and Laura divorced, Laura remarried and she and Gary Dunbar had a healthy child in January 1987.
Laura provided the following family medical history. She had an uncle who was "probably mildly retarded," id. at 751, a second cousin who had cerebral palsy, a nephew with emotional reaction-induced epileptic seizures, a brother who died shortly after birth who had hydrocephaly, and a fifth cousin with meningitis. The record does not indicate the presence of genetic or developmental disabilities in Nord's family.
B. Procedural History
Plaintiffs, Kristofer and Katrina Sorensen, initially brought suit by and through their parents and next friends, Nord Sorensen and Laura Dunbar, against Shaklee, Union Carbide, Cal-Leaf, Griffith, and several individual defendants in Iowa state court. Prior to the state court's resolution of Shaklee's motion for summary judgment, plaintiffs dismissed their action, see Sorensen v. Shaklee Corp., 461 N.W.2d 324 (Iowa 1990) (upholding plaintiffs' dismissal of their state action prior to the resolution of defendant's summary judgment motion), and refiled their claims in federal district court.
C. Evidence Presented
(1) Plaintiffs' experts
The following general observations derive from our review of the record pertaining to the testimony of plaintiffs' experts. As amply stated by the district court:
Dist.Ct.Op. at 4.
Plaintiffs' most supportive expert was Henry T. Lynch, M.D., a professor of medicine and chair of the Department of Preventative Medicine/Public Health at Creighton University School of Medicine. Dr. Lynch considers himself to be an expert in "medical genetics, internal medicine and medical oncology." App. at 1043. A review of Dr. Lynch's curriculum vitae indicates that he has written extensively on genetics and cancer. Id. at 1254-96.
In his affidavit dated March 27, 1989, Dr. Lynch opined,
Id. at 1247. Dr. Lynch identified two specific mechanisms emanating from the exposure to EtO or ETCH as "highly probable" as the cause of the Sorensen children's mental retardation:
Id. at 1248. Further, Dr. Lynch did not believe it necessary, "in order to render an opinion within a reasonable degree of scientific certainty, on the etiology of a given disorder to understand the mechanism." Id. at 1249.
Dr. Lynch expressed similar opinions in his January 13, 1989 deposition. In addition, he stated that the amount consumed was not critical to his opinion and that, with genotype susceptibility, a small amount could cause
At both his July 6, 1992 and December 16, 1992 depositions, however, Dr. Lynch was unable to testify with the same degree of certainty. Instead, he agreed that given the absence of research into the effects of ingested EtO and ETCH, the most he could testify to was that EtO or a by-product thereof could possibly have caused the mental retardation of the children by virtue of the susceptibility of the fetal tissue. Id. at 1220-21. He also conceded that Nord and Laura were probably exposed to other sources of EtO and/or ETCH during the relevant time period, id. at 1233, and that with two sources of EtO-exposed material, there is no way of differentiating which molecule caused the effect, id. at 1169. Finally, Dr. Lynch could not identify any "statistically significant epidemiological proof that ethylene oxide or ethylene chlorohydrin causes mental retardation," id. at 292, and he was unaware of "any studies that have shown mutagenesis from exposure to ethylene oxide or ethylene chlorohydrin in humans at a dose lower than her [Laura Dunbar's] predicted [mutagenic] dose," id. at 295.
Matthew J. Severin, Jr., J.D., Ph.D., an epidemiologist and clinical microbiologist, opined at his January 1, 1988 deposition that
Id. at 302.
In his March 27, 1989 affidavit, Dr. Severin stated "to a reasonable degree of scientific certainty, that the mental retardation of the children in this case was a result of point mutation caused by the exposure of Laura Dunbar and/or Nord Sorensen to alfalfa tablets produced by Shaklee which were treated by ETO and contained degredation [sic] products of ETO." Id. at 1299-1300.
Subsequently, however, Dr. Severin testified at his June 24, 1992 deposition that he could say only that EtO was a "possible cause," id. at 1004, and that, due to lack of information, he could not testify "that there is any relationship between [EtO] and mental retardation in this case," id. at 315-16, 320. In rejecting the alternative explanation that the children's mental retardation was nonspecific as to causation, Dr. Severin based his opinion upon their "almost identical symptomatology." Id. at 1032.
William Kimberling, M.D., a geneticist and division director of the Center for Hereditary Communication Disorders at Boys Town National Research Hospital, also testified on behalf of the plaintiffs. At his September 2, 1992 deposition, he stated that "[g]iven exposure, ... it is reasonable to presume that the ethylene oxide caused a mutation and that that mutation resulted in the children's problems."
Carol Remmer Angle, M.D., a physician, professor of pediatrics and director of the clinical toxicology program at the University of Nebraska, assumed exposure at 3000 ppm per tablet "ECH" (based upon the highest level of ETCH detected from the 1974 batch of fumigated tablets) in concluding that Laura had consumed .24 milligrams "ECH" per kilo per day. Id. at 617. Dr. Angle later conceded that there was no evidence that the compounds contained ethylene oxide. Id. at 842.
Dr. Angle testified that she was unaware of human oral toxicity from ethylene oxide-sterilized foods, id. at 328, or that ethylene oxide-sterilized foods caused teratogenic effects, id. at 329. While stating that "it is not scientifically unreasonable to consider that [EtO] is a possible cause of the mental retardation of these children," id. at 1493-94, Dr. Angle did not have an opinion as to what actually caused plaintiffs' mental retardation, and averred she did not have enough information to eliminate other possible causes, id. at 347. She agreed that in the field of toxicology, normally one would require some experimental evidence, the ability to replicate experimental results, and a reasonable mechanism to explain the effect before a scientific conclusion of causation is justified. Id. at 578.
One study relied upon by plaintiffs' experts summarizes the following effects relative to EtO exposure
Additionally, Dr. Angle reviewed translations from two Russian studies, one on the question of mutation effect of ethylene oxide in mammals, and the other on the maximal permissible concentration of ethylene chlorohydrin in water sources. Dr. Angle did not review the studies for their methodological or evaluative accuracy. The studies reported that both ethylene oxide and ethylene chlorohydrin are mutagenic in rats at considerably less than at lethal doses. See id. at 300. Dr. Angle thereby concluded that "These estimated intakes of ECH by both the mother and father are, respectively, 4.8x and 3.4x the human mutagenic dose predicted by animal data. The data support the probability that the oral doses of ECH ingested by the parents of the Swanson [sic] children were mutagenic." Id.
(2) Defendants' experts
Defendants presented affidavits from four witnesses who were experts in their respective fields of toxicology and pharmacology, epidemiology, clinical psychiatry and pediatrics. All of these experts concluded, to a reasonable degree of scientific certainty, based on the facts and scientific methodology appropriate to their respective disciplines, that the parents' ingestion of ethylene oxide or ethylene chlorohydrin, via the Shaklee alfalfa tablets, could not have caused plaintiffs' mental retardation. Id. at 409-10, 440, 461, 496.
Further, William Wadell, M.D., an academic toxicologist and pharmacist, testified at his February 14, 1989 deposition concerning EtO as an alkylating agent in cigarette smoke and of the alkylating agent in alcohol.
D. District Court Opinion
In determining that plaintiffs' proffered expert testimony did not make a case to establish causation, the district court stated:
Dist.Ct.Op. at 7.
The district court further observed the inadequacies of Dr. Lynch's testimony, probably plaintiffs' witness with the most applicable testimony in plaintiffs' favor:
Dist.Ct.Op. at 10 (emphasis in original).
II. ADMISSIBILITY OF THE SCIENTIFIC EVIDENCE
This case is controlled by Daubert v. Merrell Dow Pharmaceuticals, Inc., ___ U.S. ___, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). As interpreted by Daubert, Rules 702 and 703 of the Federal Rules of Evidence
In the Daubert litigation, two minor children born with limb reduction birth defects
The Ninth Circuit agreed with the district court, basing its affirmance on its adherence to the "general acceptance test" of the so-called Frye Rule
The Supreme Court granted certiorari to determine the appropriate standard for admission of expert testimony. Daubert, ___ U.S. at ___, 113 S.Ct. at 2792. In its decision, the Court unanimously rejected the Frye Rule, stating:
Daubert, ___ U.S. at ___, 113 S.Ct. at 2794 (footnote omitted).
Although the opinion might have ended at that point, as the dissent in Daubert noted, id. at ___, 113 S.Ct. at 2799 (Rehnquist, C.J., and Stevens, J., dissenting), the Blackmun opinion, joined by six other justices, also presented standards and goals to aid federal judges in their consideration of the admissibility of scientific evidence. Since Daubert, federal and state courts have applied Justice Blackmun's discussion to a broad range of expert testimony in considering or resolving whether to admit the expert opinion evidence.
Several propositions discussed by the Blackmun opinion in Daubert apply directly to our resolution of the admissibility issue. Initially, the Court observed:
___ U.S. at ___ - ___, 113 S.Ct. at 2794-95 (footnote omitted) (emphasis added). In explaining the "relevancy" prong, the Blackmun opinion relates:
___ U.S. at ___, 113 S.Ct. at 2795-96. The Court continued:
Id. at ___, 113 S.Ct. at 2796 (footnotes omitted).
The expert testimony proposed by plaintiffs in this case fails to qualify for admissibility as "relevant." Plaintiffs produced no evidence showing or providing a reliable inference that the Shaklee alfalfa tablets taken by their parents contained any EtO residue.
We also need to consider the "scientific validity" of the submission — as put in Daubert:
Id. at ___, 113 S.Ct. at 2797 (footnote omitted).
Daubert sets out a list of non-exhaustive factors relevant to, but not necessarily determinative of a district judge's determination whether the expert will testify to relevant,
1. Whether the theory can be and has been tested.
Here, neither of Dr. Lynch's potential causal mechanisms, "a germ line mutation," or "a multi-factorial induced phenomenon," App. at 1247-48, or Dr. Severin's theory of "a point mutation," id. at 1299-1300, due to the ingestion of EtO residue, have been studied. While plaintiffs' experts understandably state that conducting such a study on humans would be unethical, they fail to address the absence of animal studies demonstrating the incidence of EtO-sterilized food products and mental retardation.
2. Whether the theory has been subjected to peer review and publication.
Plaintiffs' experts have not subjected their theories to peer review
3. As to a particular scientific technique, the court should consider the known rate of error.
This principle does not apply here because the testimony advanced involved theories and not any particular technique.
4. Generally, acceptance can yet have a bearing on the inquiry.
No evidence has been presented of any general acceptance of either the theory or methodology presented by the plaintiffs' experts.
Here, the hypotheses presented by plaintiffs' experts follow no scientific principles. Those opinions reason that, because Kristofer and Katrina sustained birth defects (mental retardation) and their parents used Shaklee's alfalfa tablets, and because some alfalfa tablets had contained an EtO residue, the parents must have ingested the EtO residue tablets. That inference turns scientific analysis on its head. Instead of reasoning from known facts to reach a conclusion, the experts here reasoned from an end result in order to hypothesize what needed to be known but what was not.
While it may be that this sort of reasoning could pass muster in some cases where the obvious result explains the etiology (for example, where a fractured bone accompanied by bruised outer skin and flesh demonstrate that some type of physical contact caused the injury) such reasoning cannot apply here where several possible causes could have produced one effect. As the district court noted:
Dist.Ct.Op. at 10.
The Seventh Circuit dealt with a somewhat similar scientific inference in O'Conner v. Commonwealth Edison Co., 13 F.3d 1090 (7th Cir.1994). There the plaintiff's medical expert opined that plaintiffs cataracts had
Id. at 1107 (footnotes omitted).
A similar result was obtained in Porter v. Whitehall Laboratories, Inc., 9 F.3d 607 (7th Cir.1993), which involved a product liability action for damages allegedly caused by ingesting ibuprofen. Plaintiff, while awaiting surgery on a toe he injured at work, received samples of Motrin, a prescription form of ibuprofen, and Vicoden, a form of acetaminophen, from his internist's nurse practitioner. Plaintiff took the Motrin, as well as over-the-counter strength ibuprofen, for pain relief. Subsequently plaintiff returned to his internist's office, experiencing kidney failure that required a transplant. The experts provided two theories to explain plaintiff's kidney failure: (1) rapidly progressive glomerulonephritis (RPGN), due to anti-glomerular basement membrane glomerulonephritis (anti-GBM), or (2) unspecified RPGN, either caused by the process of anti-GBM or membranoproliferative glomerulonephritis (MPGN). Applying Daubert, the Seventh Circuit affirmed the district court's grant of summary judgment in favor of the defendant pharmaceutical companies, holding that the expert testimony was properly excluded for lack of grounding in the scientific method. Porter, 9 F.3d at 614.
In this case the district court made pertinent observations that the plaintiffs' experts addressed none of the considerations relating to scientific validity. The testimony proffered by plaintiffs was not derived from the application of any reliable methodology or principle. Despite plaintiffs' protestations to the contrary, we conclude that the district court properly held the testimony inadmissible irrespective of the experts' conclusions.
Daubert does not require proof with certainty. It does require that expert testimony be relevant and reliable. ___ U.S. at ___, 113 S.Ct. at 2795. We note two cases, one clearly in the scientific area, the other in the general area of expert evidence, which illustrate difficult admissibility questions under the rubric of Daubert.
In Cantrell v. GAF Corporation, 999 F.2d 1007 (6th Cir.1993), plaintiffs presented expert testimony that their injuries (both had asbestosis and Cantrell had laryngeal cancer as well) resulted from exposure to asbestos. The expert based his opinion on examination of the plaintiffs, previous diagnoses of three individuals with laryngeal cancer out of 150 workers at the same plant (where in the general population the incidence rate is about 4 per 100,000 individuals per year) and that, in regard to Cantrell, the combination of his cigarette smoking and asbestos exposure worked in a synergistic fashion. The Sixth Circuit majority upheld the admission of plaintiffs' expert testimony, concluding that Rules 702 and 703 and Daubert do not prohibit an expert "from testifying to confirmatory data, gained through his own clinical experience, on the origin of a disease or the consequences of exposure to certain conditions." Cantrell, 999 F.2d at 1014. Reluctantly Judge Wellford concurred, though he considered plaintiffs' expert's testimony erroneously admitted as challenged. Plaintiffs' expert testified
Id. at 1019.
In Robinson v. Missouri Pacific Railroad Company, 16 F.3d 1083 (10th Cir.1994), the
The application of Daubert to difficult admissibility questions concerning expert testimony, such as those illustrated by the above cases, remains subject to development in the courts.
Finally, the Daubert opinion reminds district judges that when necessary they may themselves seek expert assistance in their "gatekeeper" functions by resorting to Rule 706 which "allows the court at its discretion to procure the assistance of an expert of its own choosing." ___ U.S. at ___, 113 S.Ct. at 2798.
III. SUFFICIENCY OF THE EVIDENCE
Viewing the evidence in the light most favorable to the non-moving party, we agree that plaintiffs' evidence is insufficient as a matter of law to establish the requisite element of causation. Plaintiffs fail to establish that the alfalfa tablets consumed by Nord Sorensen and/or Laura Dunbar contained EtO residue, or that human consumption of EtO-sterilized products causes mental retardation.
IV. CONCLUSION
For reasons stated by the district judge and supplemented by this opinion, we affirm the summary judgment of dismissal.
FootNotes
Fed.R.Evid. 703 provides:
"In vivo experiments test the effects of ingesting a suspect drug during pregnancy on fetuses of animals thought to be similar to humans." Id. at 20 (footnote omitted). Because of the dose-response differential between animals and humans, however, extrapolating to humans from animal studies is problematic.
Comparative studies are generally referred to as structure-activity or chemical structure comparisons. The problem with the structure-activity hypothesis is that "[m]olecules with minor structural differences can produce very different biological effects." Id. at 19 (footnote omitted).
As the citations above illustrate, Daubert's rationale has been applied to both scientific evidence and technical issues calling for expert opinions. The Supreme Court has also suggested a broad application of Daubert. See Rincon v. United States, ___ U.S. ___, 114 S.Ct. 41, 126 L.Ed.2d 12 (1993) (vacating case below, 984 F.2d 1003 (9th Cir.), and remanding for a determination of the admissibility of expert testimony on the issue of the reliability of eyewitness identification, in light of Daubert), appeal after remand, 28 F.3d 921, (9th Cir.1994).
We note that recent amendments to the federal discovery rules, e.g., Fed.R.Civ.P. 16 and 26, require an early and full evaluation of these evidentiary problems.
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