Sorensen By and Through Dunbar v. Shaklee Corp.

• Decision Date: 02 August 1994
• Docket Number: No. 93-3454,93-3454
• Citation: 31 F.3d 638
• Parties: 40 Fed. R. Evid. Serv. 475 Kristofer SORENSEN, a Minor, By and Through his Parent and Next Friend, Laura E. DUNBAR; Katrina Sorensen, a Minor, by and through her Parent and Next Friend Laura E. Dunbar, Appellants, v. SHAKLEE CORPORATION, also known as Shaklee Products, Inc.; Union Carbide Chemicals & Plastics Company, formerly known as Union Carbide Company, Inc., Appellees.
• Court: U.S. Court of Appeals — Eighth Circuit

Page 638

31 F.3d 638

40 Fed. R. Evid. Serv. 475

Kristofer SORENSEN, a Minor, By and Through his Parent and Next Friend, Laura E. DUNBAR; Katrina Sorensen, a Minor, by and through her Parent and Next Friend Laura E. Dunbar, Appellants, v. SHAKLEE CORPORATION, also known as Shaklee Products, Inc. Union Carbide Chemicals & Plastics Company formerly known as Union Carbide Company Inc., Appellees.

No. 93-3454.

United States Court of Appeals Eighth Circuit.

Submitted June 15, 1994.

Decided Aug. 2, 1994.

James R. Welsh, Omaha, NE, argued, for appellants.

Dennis M. Gray, Council Bluffs, IA, argued, for appellee Shaklee.

Rex A. Rezac, Omaha, NE, argued (Scott J. Rogers, John E. Carne, Ezra Hendon, Adrienne Larkin, Joseph K. Meusey, Marjorie L. Fine, and Robert F. Rossiter, Jr., on the brief), for appellee Union Carbide.

Before BOWMAN, Circuit Judge, BRIGHT, Senior Circuit Judge, and LOKEN, Circuit Judge.

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 ¹ and affirm.

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. ² Griffith sterilized the tablets with EtO manufactured by Union Carbide. Since the 1930s, EtO has been used as an antimicrobial agent in the sterilization of medical instruments, pharmaceutical products, spices, tobacco and other botanical products. ³

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). ⁴ The testing revealed no traces of EtO. Shaklee's records fail to reveal the disposition of the 1974 fumigated tablets--whether the entire batch was destroyed, whether the tablets were both partially destroyed and partially distributed or whether the batch was distributed in toto. Shaklee asserts that if these finished alfalfa tablets were sold, they would have been consumed by April 1975, well before the conception of either plaintiff.

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:

Ethylene Chlorohydrin is a known mutagen and teratogen, and has recently appeared on the suspect carcinogen list....

The levels found in the ingredients tested are not of great concern from the acute toxicological standpoint but certainly of concern in a chronic situation. Our generation may never be affected by these levels as there is no human evidence to support the data. Future generations could quite probably be affected with long term use by our generation.

According to the Code of Federal Regulations, there are no tolerances for Ethylene Oxide in anything but walnut meats, spices and copra. The ingredients we tested are unlikely to fall into any of the above categories. It therefore may be wise according to Warf's expert judgment to consider a possible recall of all products containing ingredients which have been fumigated with Ethylene Oxide.

App. at 1335 (September 20, 1977 report).

A toxicological panel evaluated the data produced and concluded that ETO fumigation of food products should be halted immediately based on the levels of residue found in the products.

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. ⁵

Plaintiffs' federal action, based upon diversity of citizenship, claimed, inter alia, misrepresentation, negligence, strict liability, breach of warranty, fraud and res ipsa loquitur against Shaklee, and negligence, strict liability and res ipsa loquitur against Union Carbide. Subsequently, all of the defendants but Shaklee and Union Carbide either settled or were otherwise dismissed from the case. The district court thereafter granted defendants' motions for summary judgment. Sorensen v. Shaklee Corp., No. 1-91-CV-70007 (S.D.Iowa Sept. 28, 1993).

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:

No published scientific literature reports mental retardation in...