We write today fresh from a short cruise to celebrate a milestone birthday of the Drug and Device Law Dowager Countess. We view cruising, and the limitations of its inevitable confinement, as the perfect antidote to the often-unrelieved breakneck pace of our daily lives. And this cruise was no exception. We eschewed shore excursions in favor of endless trivia contests, raucous piano bar sing-alongs, and sitting on our balcony with a book. Nevertheless, rough seas, and sequelae on which we will not elaborate, provoke a first-time-ever equivocal response to “how was the trip?”
We are also ambivalent about today’s case, but only a tiny bit. In Desranleau v. Hyland’s, Inc., 2019 WL 5304860., –_ P.3d — (Wash. Ct. App. Oct. 21, 2019) the plaintiff claimed that her infant son died after ingesting the defendant’s homeopathic cold remedy, which, she alleged, contained toxic levels of certain chemical components. (As an aside, we were surprised to see a “toxic concentration” claim in the context of a homeopathic preparation, because active ingredients in such products are generally diluted to the point of non-existence. You can read another post about homeopathic products here.) The decedent was found dead in his bed after a couple of days of suffering from a cold. His caregiver reported that she had given him a dose of the defendant’s infant cold remedy the night before and had given him several other doses during the time that he displayed cold symptoms. An autopsy failed to reveal the cause of the infant’s death, which was therefore deemed a “sudden unexpected infant death.”
Two years earlier, as the court explained, the FDA had informed the defendant that it was concerned about the process by which the defendant manufactured a category of its products (not the cold medication), because the process by which products’ ingredients were diluted to the correct concentration could lead to so called “batch stratification;” in other words, parts of a batch could have significantly higher concentrations of a given ingredient than those contained in other parts of the batch. Though the FDA had not raised concerns related specifically to the cold medication, the medication was manufactured through a process that was substantially similar to the manufacturing process for the implicated product. Three years after her son’s death, and five years after the FDA’s inquiry, the plaintiff sued the defendant, alleging that an alkaloid in the cold medication killed the infant because batch stratification caused it to be concentrated at a toxic level in the batch of medication the child ingested. The defendant moved for summary judgment, arguing that the plaintiff had no admissible evidence that the decedent had ingested the defendant’s cold medication, and the trial court granted the motion. On appeal, the Court of Appeals affirmed the trial court’s ruling that the caregiver’s account of the medication she had given to the decedent was hearsay, not saved by any exception to the hearsay rule. But, the court held, “[E]ven though the trial court correctly identified [the caregiver’s] testimony as hearsay, [it] did not provide [the plaintiff] with the benefit of all reasonable inferences.” Desranleau, 2019 Wl 5304860 at *4. The court reversed the trial court’s decision, holding that, because it was undisputed that the baby had had a cold for a few days before he died, and because an open bottle of the defendant’s product was found in the home in a different location from products prescribed for other members of the household, “there was enough circumstantial evidence, viewed in the light most favorable to [the plaintiff], for a jury to find that [the infant] ingested [the defendant’s] cold medicine.” Id. at *5.
We have sympathy, of course, because we understand the proof problem and because the decedent was a baby. But mostly we are unhappy about the prospect of “product identification” being deemed adequate in other cases in the absence of toxicological (or any) evidence, simply because the product — among numerous other products — was on the scene. We fear a slippery slope that muddies the burden of proving the most basic element of any product liability suit: the plaintiff’s use of the defendant’s product. And we wonder how far “permissible inferences” can go. We will watch for decisions on similar facts, and we will keep you posted.