Vermont Business Magazine The Attorneys General have reached a$33 million settlementwith Johnson & Johnson Consumer Inc. and Johnson & Johnson (“Defendants”), the settlement resolves claims that Defendants, through subsidiary McNeil-PPC, Inc, unlawfully promoted over-the-counter drugs as complying with federal current Good Manufacturing Practices (cGMP) when they did not comply. Under the terms of the settlement agreement Vermont will receive $377,832.59 for costs and fees associated with the litigation.
“It is vital that the over-the counter-drugs Vermonters take be safe and unadulterated, especially those given to children,” said Attorney General Donovan. “We want to be sure our consumers are fully protected. This settlement requires McNeil to follow appropriate policies to prevent adulteration of drugs, and to ensure that its future marketing practices will not unlawfully promote OTC drug products.”
McNeil was a division of Johnson & Johnson Consumer Inc. that manufactured and distributed OTC drugs. During the period 2009 through 2011, the FDA found that McNeil manufacturing facilities did not comply with cGMPs. Under federal law, a drug is “adulterated” if the methods used to manufacture it or the facilities in which it is are manufactured do not meet required quality standards.
TheComplaintfiled today by the State of Vermont alleges that Defendants, acting through McNeil, violated Vermont’s consumer protection law by misrepresenting their cGMP compliance and the quality of their OTC drugs. McNeil’s alleged quality control lapses resulted in recalls of drugs manufactured between 2009 to 2011including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops, several of which are indicated for pediatric use.
Vermont AG: May 24, 2017