Korte v. Mead Johnson & Co.
| Decision Date | 30 July 2010 |
| Docket Number | No. 4:09–cv–00063–JAJ–CFB.,4:09–cv–00063–JAJ–CFB. |
| Citation | 824 F.Supp.2d 877 |
| Parties | Patrick KORTE and Michelle L. Korte, Individually and as Parents of D.J.K., Plaintiffs, v. MEAD JOHNSON & COMPANY, A Delaware Corporation, d/b/a Mead Johnson Nutritionals and Mead Johnson Nutrition Group, Defendants. |
| Court | U.S. District Court — Southern District of Iowa |
OPINION TEXT STARTS HERE
William R. King, Michele L. Warnock, Scott M. Brennan, Davis Brown Koehn Shors & Roberts PC, Des Moines, IA, Andrew Weisbecker, Bruce T. Clark, Marler Clark LLP PS, Seattle, WA, for Plaintiffs.
Anthony J. Anscombe, Julie L. Simpson, Sedgwick Detert Moran & Arnold LLP, Chicago, IL, Mark L. Tripp, Jason T. Madden, Jason C. Palmer, Bradshaw Fowler Proctor Fairgrave, Des Moines, IA, Karen E. Woodward, Sedgwick Detert Moran & Arnold LLP, Los Angeles, CA, for Defendants.
This matter comes before the Court pursuant to Defendant Mead Johnson & Company, LLC's (“Mead Johnson”) April 5, 2010 Motion for Summary Judgment. [Dkt. No. 31.] Plaintiffs Patrick Korte and Michelle L. Korte, individually and as Parents of D.J.K. filed a response to Mead Johnson's motion for summary judgment with the Court on April 29, 2010. [Dkt. No. 44.] The Court granted Mead Johnson's May 5, 2010 resisted motion for extension of time to file a reply to its motion for summary judgment, which Mead Johnson filed on June 8, 2010. [Dkt. Nos. 47, 48, 49, 50, 51 & 65.]
The Court held a hearing on this matter on May 24, 2010. [Dkt. No. 62.] The Court grants summary judgment in its entirety to Mead Johnson.
Premature infants often need enhancements or supplements added to breast milk. Breast milk for premature infants can be nutritionally insufficient because they require additional calories, proteins, vitamins, and minerals in order to achieve growth and development comparable to what they would have achieved in utero. Mead Johnson's Enfamil ® Human Milk Fortifier (“EHMF”) is one such product used to supplement breast milk. EHMF is a powdered formula that permits supplementation of breast milk without displacing breast milk volume. In other words, a doctor can maximize the amount of breast milk in a feeding because the powdered formula is mixed into the breast milk, whereas a liquid formula added to breast milk reduces the volume of breast milk fed to an infant.
The batch of EMHF at issue here, Batch No. BMO05C, was manufactured in late 2006 and early 2007. Beginning in 2002, Mead Johnson had made manufacturing and quality control testing changes to its products in order to make it difficult for bacteria to enter and propagate. But because EHMF is not a sterile product, there is an inherent risk that Enterobacter sakazakii 2 (“ E.sak ”) bacteria will be present and medical professionals must weigh the risk of infection when deciding to use EHMF. To completely sterilize EHMF would otherwise destroy the nutritional quality of the product.
EHMF is made at the Zeeland Specialty Products manufacturing plant in Zeeland, Michigan (“ZSP Plant”). Mead Johnson manufactures EHMF in three phases. The first phase involves a “wet blending” process. In this “wet blending” process, Mead Johnson formulates the base mix by pasteurizing and then drying the milk-based component of the product. In the second phase, other dry ingredients of vitamins and minerals from outside suppliers are blended with the base mix in a dry process and on equipment that curtails microbial growth. These suppliers are audited by Mead Johnson to make sure they have manufactured the ingredients under hygienic conditions. The residual moisture content of the finished product is less than 3%. The blending stage for Batch No. BMO05C was finished by December 27, 2006. Lastly, Mead Johnson packages the EHMF for sale on dedicated equipment in individual tubular sachets. Each sachet weighs .71 gram and every box contains 100 sachets. The total amount of finished product for Batch No. BMO05C was 204.5 kilograms or 204,500 grams.
Mead Johnson tests the product during each phase for E. sak and Batch No. BMO05C passed all three phases of product testing. If any batch tests positive for E. sak, then the entire batch is rejected. In January 2007, Mead Johnson tested 999 grams of Batch No. BMO05C between the base mix, its prepackaged blend, and all the ingredients, and all tests were negative for E. sak. Seventy-five grams of Batch No. BMO05C were also tested with a negative result for the more general bacterial family of Enterobacteriaceae.3 This testing consisted of three separate tests of twenty-five grams each for the base, blend, and final product of Batch No. BMO05C. According to Mead Johnson, Batch No. BMO05C was manufactured pursuant to its “proper recipe” and was made on equipment that was contemporaneously noted to be clean and in good working order.
Daniel March, Director of Food Safety at Mead Johnson, states that the testing protocols “give a high measure of assurance that even if E. sak were to enter the [E]HMF, it would be in very low concentrations, and, to a near statistical certainty, would not exceed one CFU per any one feeding.” If a sample tests positive for E. sak, then the results would be “reported as the number of [CFU] per weight of product.” Of course, there is no way to confirm whether amounts not tested did not have E. sak present in excess of one CFU per feeding. But product contamination by a bacteria like E. sak is a “non-uniform event” and “testing protocols do not exist to confirm the complete absence” of E. sak in a finished product. Further, Plaintiffs assert that it is possible for E. sak to exist as a biofilm and biofilms, by definition, “can contain many individual cells.” 4
A pathogen like E. sak can also contaminate and become established in powdered formula manufacturing plants, with such harbourage sites serving as a source of future contamination. E. sak may remain in low levels in an otherwise highly hygienic environment if there is an inadequate separation of wet and dry areas and/or by poor control over the movement of employees, equipment and goods.” There is no evidence that Mead Johnson had any harbourage sites in the production area of EHMF. Before January 2007, Mead Johnson had some positive tests for the presence of E. sak in certain finished powdered products. 5
In summary, all samples of Batch No. BMO05C that Mead Johnson tested were negative for E. sak and all related documents to Batch No. BMO05C indicate the batch was in compliance with the manufacturing specifications.
Because powdered infant formulas are not sterile, there is the risk of E. sak contamination. Any infection in an infant can have significant consequences. Premature infants have immature or not fully developed gastrointestinal, immune, and blood-brain barriers. As a result, neonates are extremely susceptible to rapid and destructive invasion and growth by infections, including E. sak. Premature infants do have some defensive physiological and immune mechanisms that can prevent or slow bacterial growth.
In 2002, the FDA informed health care professionals of certain precautions they should take when using powdered infant formulas:
As background information for health professionals, FDA wants to point out that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile.
Additionally, the Food and Agricultural Organization and the World Health Organization (“FAO/WHO”) convened panels of experts in 2004, 2006, and 2008 to “evaluate and develop strategies to reduce risks of infection due to E. sak and other bacteria.” In its studies, the FAO/WHO determined that E. sak in formula has caused illness and that epidemiological evidence associates powdered infant formula with E. sak. But the FAO/WHO literature does not conclude that every E. sak case can be causally linked to powdered infant formula, or more specifically, EHMF.
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