Drug & Device News

In the case of In re Tylenol (Acetaminophen) Markting, Sales Practices, and Products Liability Litigation, the court overseeing the multi-district litigation claiming Tylenol use can cause liver failure has determined that the plaintiffs' experts may base their opinions on a disputed study, and that three proposed defense experts' testimony, which seeks to counter the validity of the disputed study, is not admissible because it does not meet scientific reliability standards. In re Tylenol (Acetaminophen) Markting, Sales Practices, and Products Liability Litigation, 2016 U.S. Dist. LEXIS 92334 (E.D. Pa. 7/14/16).

A key issue in the litigation is the question of whether the drug acetaminophen, which is found in Tylenol products, can cause acute liver failure (ALF) at or just above the recommended dose. To establish the causal link between acetaminophen at recommended doses and ALF, the plaintiff proposed to offer the testimony of several experts, all of whom formed their opinions, at least in part, by relying on one published study titled “Acetaminophen-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study” (Larson, et al., Hepatology, Vol. 42, No. 6, 2005). This article states, among other things, that at the maximum daily recommended dose of acetaminophen ' 4 grams ' ALF can occur. This conclusion was based on the cases of 19 of the 600+ cases observed by the researchers; these 19 had apparently taken the recommended maximum daily dose (or less) of acetaminophen and no more, yet they developed ALF.