Health Law Daily Wrap Up, FOOD SAFETY—N.D. Ill.: Infant formula maker wins dismissal of claims in bacterial contamination case, (Jun 11, 2024)

By Pankhuri Bhatnagar, B.A. LL.B.

A father failed to establish that the product he purchased was contaminated or that his daughter contracted a disease linked to that bacterium.

In a suit brought against a baby formula manufacturer by two individuals whose infants fell ill after consuming formula allegedly contaminated by harmful bacteria, a federal district court in Illinois dismissed, without prejudice, an Illinois resident's claims for lack of causation and a Connecticut resident’s claims for lack of general and specific personal jurisdiction. However, the manufacturer’s motion to strike the class allegations against it was denied as the proposed class representatives had standing and the manufacturer’s objections were better suited for a class certification inquiry (Harden v. Mead Johnson & Co., LLC, No. 24 CV 108 (N.D. Ill. June 7, 2024)).

Background. Mead Johnson & Company, LLC (Mead or manufacturer) was a leading manufacturer and seller of infant formula, including Enfamil-brand Nutramigen Powder. In August 2023, the Food and Drug Administration (FDA) issued a warning letter to Mead stating that FDA inspections conducted at Mead’s manufacturing facilities in Zeeland, Michigan, and Wanamingo, Minnesota, had revealed the presence of Chronobacter sakazakii bacterium in various Enfamil products. The bacteria can cause several illnesses, including meningitis. The Israeli Ministry of Health also concluded that Nutramigen Powder produced at the Zeeland facility tested positive for the bacteria. By December 2023, Mead recalled its Nutramigen Powder products that were manufactured in June 2023 and had a “use by” date of January 1, 2025, due to the possibility of contamination. Two Illinois and Connecticut residents who purchased the powder for their infant daughter and son, respectively, filed a putative class action suit against Mead after their infants fell ill after consuming the powder. They sought relief for themselves, their children, and several classes based on various legal theories. The manufacturer moved to dismiss the complaint and to strike the class allegations.

Standing. The manufacturer first sought to dismiss under Rule 12(b)(1) for lack of Article III standing, which requires proof of (1) an injury in fact that is (2) fairly traceable to the defendant’s challenged action and (3) is likely to be redressed by a favorable decision. Mead challenged the second element, but the court found that the complaint’s allegations that the infants fell ill after consuming Nutramigen and that Mead recalled that product due to bacterial contamination, were sufficient to show standing at this stage. Unlike Mead’s cited precedents, standing did not depend on third-party conduct or a chain of contingencies, and the alleged injuries were fairly traceable to Mead’s conduct of negligently producing the baby formula. The manufacturer pointed out that there was no proof that the products purchased by the residents were actually contaminated since the residents did not allege that their purchased products were subject to the recall, the recalled products did not test positive for the bacteria, and the recall was only due to a “possibility of contamination.” The court held that these arguments went to the merits, not standing, and that traceability only requires causal connection as opposed to a proximate cause, Pit Row, Inc. v. Costco Wholesale Corp., 101 F.4th 493, 502 (7th Cir. 2024). Thus, the motion was denied as to subject matter jurisdiction.

Jurisdiction. Mead next sought to dismiss the Connecticut mother’s claims under Rule 12(b)(2) for lack of personal jurisdiction. States may exercise general jurisdiction over a company if that company is incorporated or has its principal place of business in that forum. Mead explained that it was organized under Delaware law, was formerly headquartered in Illinois, but had shifted its headquarters from Illinois to Indiana. The mother countered that general personal jurisdiction could exist over Mead if it had continuous and systematic contacts with Illinois, and she requested jurisdictional discovery. The court denied her request, noting that the resident failed to make a prima facie showing of personal jurisdiction. As for specific jurisdiction, the allegation that Mead sold and marketed contaminated Nutramigen Powder products in Illinois was sufficient to satisfy the first prong of purposeful availment of the forum, but there was no proof that the mother’s alleged injury “arose out of” these forum activities. Thus, her claims were dismissed, and only the Illinois father’s claims proceeded due to the court’s specific personal jurisdiction over his claims.

Causation. Mead asserted that the father’s claims failed for lack of causation since his entire theory rested on the assumptions that (1) the Nutramigen Powder was contaminated because FDA inspections in late 2022 and early 2023 found other Enfamil products (not Nutramigen) to be contaminated; (2) Nutramigen produced months later must have also been contaminated; and (3) Nutramigen testing positive for C. sakazakii in Israel meant that domestic Nutramigen was also contaminated. The court opined that the FDA’s August 2023 letter found Mead’s remediation efforts inadequate, leading to an inference that the conditions that led to the bacterial contamination in late 2022 and early 2023 persisted later. Israel’s ministry’s positive results were of Nutramigen products made domestically, at the Zeeland facility. Thus, the claims were viable. However, the father did not claim that his purchased product came from Zeeland, that it had a January 1, 2025, use-by date, or that his daughter contracted a disease linked to C. sakazakii. Thus, the complaint did not connect the alleged contamination to the infant’s injuries, and was accordingly dismissed.

Warranty. Mead claimed that the Illinois resident failed to give pre-suit notice of his breach of warranty claim. The resident responded that the manufacturer was already on notice of the defect because it issued the recall and that he was exempt from the notice requirement as he alleged a personal injury. The first exception did not apply because a defendant must be apprised of the trouble with the particular product purchased by a particular buyer; awareness of problems in a product line is not sufficient. As for the second exception, the court agreed with Mead that the resident did not allege that he suffered an injury and failed to connect his daughter’s injury to the powder’s contamination. Thus, this claim was also dismissed with leave to amend.

Motion to strike. Finally, Mead asserted that the three proposed classes lacked Article III standing and that differences in class members’ injuries and differences in applicable state law meant that common questions would not predominate over individual questions, precluding certification under Rule 23(b)(3). The court explained that the class representatives had standing as they each had children who were physically injured by the subject product and that the infants’ illnesses met the injury-in-fact requirement. The court declined to strike the class allegations at this stage, noting that it was possible for states with similar legal requirements to be grouped together in subclasses or for the class to litigate discrete issues together, with individual proceedings to follow, Bennett v. Dart, 53 F.4th 419, 420 (7th Cir. 2022) (per curiam).

The case is No. 24 CV 108.

Judge: Jenkins, L.

Attorneys: Jeffrey Daniel Blake (Zimmerman Law Offices, PC) for M.H., Jessica Tan and Dion Harden. James William Mizgala (Tucker Ellis LLP) for Mead Johnson & Co., LLC.

Companies: Mead Johnson & Co., LLC

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