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From Health Law Daily, April 28, 2014

Phantom recall theory does not support standing in claims of tainted Tylenol causing infant’s death

By Melissa Skinner, JD

Certain parties that were accused of having participated in a phantom recall of children’s Tylenol® were dismissed from a lawsuit for lack of standing. The suit was brought by the parents of the minor who died after ingesting the Tylenol. Because these entities were found not to have sufficient influence over the manufacturers of the tainted Tylenol and their decisions regarding the recall of the product, the court found the element of causation was lacking with respect to the parents’ claims against these entities (Sherfey v Johnson & Johnson, April 25, 2014, Kelly, R).

Background. Stacy and Neil Sherfey, the parents of Tracen Sherfey, brought suit against Johnson & Johnson (J&J), McNeil-PPC, Inc. (McNeil), Johnson & Johnson Sales & Logistics Company, LLC, Wal-Mart Stores, Inc., and individuals and executives of McNeil. They filed suit after Tracen Sherfey, who was two-weeks old, suffered from acute liver failure and died after ingesting the recommended dosage of allegedly tainted children’s Tylenol. The suit was also brought against Inmar, Inc., Carolina Supply Chain Services, LLC, and Carolina Logistics, LLC (collectively Inmar). Inmar filed a motion to dismiss the claims against it for lack of standing.

Phantom recall theory. The Sherfeys claimed that Inmar was involved in a “phantom recall” of children’s Tylenol, which entailed Inmar’s market assessment of defective products. In particular, the Sherfeys alleged that, at J&J and McNeil’s direction, Inmar traveled across the country visiting retail stores and measuring the amounts of tainted products on the shelves rather than alerting the FDA or the public. According to the Sherfeys, the requirements of standing were met because “without the clandestine assistance of Inmar, J&J and McNeil could not have concealed for so long the manufacturing defects of its pediatric medicines;” in turn, Inmar’s behavior played a part in causing Tracen’s death.

Motion to dismiss. The court reviewed holdings in similar matters with similar allegations and found that the similar types of entities that were alleged to be involved with a phantom recall had been dismissed for lack of standing. It then granted Inmar’s motion to dismiss based on standing. As in the previously reviewed matters, the court found that the Complaint did not “support a causal connection between the injury and the conduct complained of… and the death of Tracen is not fairly traceable to the challenged actions,” of Inmar. The court based this determination on the fact that Inmar did not have sufficient influence over J&J and McNeil to affect their decisions in regard to the recall. The court also noted that the pleadings were conclusory in regard to how Inmar conducted the market assessments of the product and that the alleged ratification of the market assessments by McNeil occurred after the death of the infant.

The case number is 12-4162.

Attorneys: Irene M. McLafferty (Messa & Associates PC) for Stacy Sherfey. Melissa A. Graff (Drinker, Biddle & Reath LLP) for Johnson & Johnson, McNeil-PPC, Inc., Johnson & Johnson Sales & Logistics Co., LLC and Wal-Mart Stores, Inc. Cyrus Y. Chung (Hogan Lovells US LLP) for Inmar, Inc., Carolina Supply Chain Services, LLC, Carolina Logistics, LLC.

Companies: Johnson & Johnson; McNeil-PPC, Inc.; Johnson & Johnson Sales & Logistics Co., LLC; Wal-Mart Stores, Inc.; Inmar, Inc.; Carolina Supply Chain Services, LLC; Carolina Logistics, LLC

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