Does powdered infant formula (PIF) contaminated with Cronobacter sakazakii nee Enterobacter sakazakii constitute a design defect? The district court in The Security National Bank of Sioux City, Iowa v. Abbott Laboratories thinks so.
Creating (we think) a design defect dichotomy the court distinguished between "intended design", here PIF designed to specification but without bacteria and (apparently) "unintended design" – PIF designed to specification but with bacteria. Unintended design defects sound suspiciously like manufacturing defects since the bugs are picked up in the manufacturing process but the court held otherwise. Turning defendant’s argument that bacterial contamination is common in any food not specifically sold as sterile into an assertion that the PIF was thereby meant incorporate E. sakazakii the court wrote: "[a]ny assertion that Defendant’s intended design included the presence of E. sakazakii strains credulity."
Hammering away at defendant’s claim that the microbial world’s ancient and relentless assault on humanity and its works aren’t part of the design of PIF the court continued: "the implication is clear: their product is intended to contain E. sakazakii, as well as other potentially harmful bacteria. First, if 75% of a product does not contain a bacteria and 25% of a product does, elementary statistics dictates that the 75% without the bacteria constitutes the norm while the 25% with the bacteria constitutes a deviation therefrom. Second, a common defect, such as the persistent contamination of a food product with bacteria, if generally unknown and proven harmful, should increase a manufacturer’s total liability, rather than eliminate it." Finally, holding that plaintiff’s proposed alternate designs of adding a biocide to the unintentionally designed but on spec PIF, or of adding water so that PIF becomes IF, the court concluded that plaintiff’s design defect claims survived defendant’s motion to dismiss.
So, when a food company’s designs don’t include E. sakazakii’s does that constitute an "unintended design defect"? Even when its product is on spec? And is adding e.g. antibiotics or soaps or chlorine to PIF a valid alternate design of PIF? How about claiming that PIF can be changed to IF without somehow losing the P?
A half dozen other claims by plaintiff also survived the motion to dismiss including manufacturing defect and breach of implied warranty. Those we get but the design defect claim is a head-scratcher. Perhaps the court didn’t understand that we’re all in continuous contact with potentially harmful bacteria. In fact, we’re full of and crawling with countless numbers of them though we only notice if say one that lives peacefully on our skin winds up in our lungs. Or maybe the court understood and is imposing a duty to incorporate nature’s designs into our own. We’ll let you know if further light is shed on the matter.
For more about PIF, E. sakazakii and the devastating meningitis that caused severe and permanent brain damage in plaintiff see this very informative PowerPoint from the CDC: "Enterobacter sakazakii meningitis and death associated with powdered infant formula." and last December’s press release from the FDA, "Investigation of Cronobacter Bacteria Illness in Infants".