October 13, 2015 — Court documents have shed light on a previously-undisclosed lobbying campaign aimed at preventing the FDA from imposing strict safety regulations on over-the-counter Tylenol.
ProPublica reports that executives at McNeil Consumer HealthCare, led by company president Peter Luther, launched an aggressive campaign to “influence the FDA”. In an email to other executives in August 2009, he wrote:
“We’re being too nice and too worried about stepping on FDA’s toes. It may be time to get members of Congress to put some pressure on FDA. We have to make this our top priority and pull out all stops.”
Six years after that email went out, the FDA still has not taken action on over-the-counter Tylenol products. The agency has only taken action on prescription acetaminophen drugs like Vicodin and Percocet
McNeil is now in trial against Regina Jackson, a woman from New Jersey who was hospitalized with elevated liver enzymes after taking over-the-counter Extra Strength Tylenol for a few days. She accuses McNeil of negligence for downplaying the drug’s narrow margin of safety.
There are currently more than 200 lawsuits pending in a centralized federal Multi-District Litigation (MDL No. 2436) in Pennsylvania.
All of the lawsuits claim that over-the-counter Tylenol products can cause liver damage, including liver failure, even when taken as directed. Acetaminophen is by far the leading cause of acute liver failure in the United States, responsible for about 150 accidental deaths per year.