Drug & Device News

A settlement was reached Feb. 10 between McNeil Consumer Healthcare (a subsidiary of Johnson & Johnson) and more than 200 plaintiffs who claim liver damage from taking the drug maker's product, Tylenol. Details of the settlement were not made public, but according to court documents filed in the U.S. District Court for the Eastern District of Pennsylvania, the agreement “establishes a global private settlement program to resolve Tylenol claims (whether filed or unfiled) of the claimants against the McNeil defendants and through which the claimants have agreed to settle their Tylenol claims.”

The defendant drug maker had been unsuccessful last summer in trying to block the testimony of one plaintiff's proposed expert witness, gastroenterologist and hepatologist Dr. Neil Kaplowitz, who was tapped to testify that Tylenol's active ingredient, Acetaminophen, can cause liver damage. U.S. District Judge Lawrence F. Stengel said of Dr. Kaplowitz at that time: “In rendering his general causation opinions, Dr. Kaplowitz considered the totality of the evidence and weighed the available information about acetaminophen-induced” by relying on “his own clinical experience, case reports, [U.S. Food and Drug Administration] documents including an analysis of the FDA's adverse event reports (AERs) database, published clinical studies and case series involving acetaminophen (including a study he coauthored in 2006), and animal studies.” The doctor was thus deemed qualified to offer his expert opinion at trial.