Forty-three states, including Delaware, reached a settlement with Johnson & Johnson Consumer over allegations that the manufacturers inaccurately promoted their over-the-counter drugs as complying with federally mandated current Good Manufacturing Practices despite some manufacturing facilities did not comply.
The state alleged that between 2009 and 2011, McNeil Consumer Healthcare Division, now a division of Johnson & Johnson Consumer Inc., violated state consumer protection laws by misrepresenting the current Good Manufacturing Practices (cGMP) compliance and the quality of their OTC drugs, and represented that these OTC drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that they did not have.
McNeil’s alleged quality control lapses resulted in recalls of drugs manufactured between 2009 to 2011 including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops, several of which are indicated for pediatric use.
The settlement also requires Johnson & Johnson to pay $629,569.51 to the Delaware Consumer Protection Fund, which funds work on consumer fraud and deceptive trade practice matters and other consumer-oriented investigations and legal actions. Johnson & Johnson will pay a total of $33 million to states as part of the settlement.
Delaware sat on the executive committee of the multi-state group that investigated the allegations and reached the settlement.