Attorney General Fox Joins 42 Other State Attorneys General in a $33 Million Settlement with Johnson & Johnson Concerning Representations of Over-The-Counter Drug Quality
Montana Attorney General Tim Fox joined 42 other state attorneys general last Wednesday in reaching a $33 million settlement with Johnson & Johnson Consumer Inc. and Johnson & Johnson. Montana’s share of the settlement is $634,130.
The settlement resolves allegations that Johnson & Johnson, acting through McNeil Consumer Healthcare Division, unlawfully promoted their over-the-counter drugs as complying with federally mandated current Good Manufacturing Practices (cGMP), even though the Food and Drug Administration found that some McNeil manufacturing facilities did not comply with current Good Manufacturing Practices between 2009 and 2011. Moreover, some McNeil OTC drugs were deemed adulterated as a matter of federal law.
“This settlement is a reminder to all companies operating in Montana that they must follow the rules if they are going to do business here,” said Attorney General Tim Fox. “Cutting corners is never acceptable, especially when doing so could adversely affect consumers’ health. This settlement is a victory for Montana consumers, and I’m glad my office helped take the lead on this case.”
The complaint, filed by the state attorneys general, alleged that Johnson & Johnson, acting through McNeil, violated state consumer protection laws by:
(1) Misrepresenting the current Good Manufacturing Practices compliance and the quality of their OTC drugs; and
(2) Representing that these OTC drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that they did not have.
According to the complaint, McNeil marketed certain batches of OTC drugs that failed to comply with federal standards, and as such, were deemed adulterated. McNeil’s alleged quality control lapses resulted in recalls of drugs manufactured between 2009 and 2011.
The settlement requires McNeil to ensure that its marketing and promotional practices do not unlawfully promote OTC drug products. Specifically, McNeil shall not:
- Represent on its websites that McNeil’s OTC Drug Product facilities meet current Good Manufacturing Practices (cGMP) as outlined by the FDA if McNeil has had a Class I or Class II Recall of OTC drug products within the last twelve months; (Class I recalls involve situations in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death. Class II recalls involve situations in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote;)
- Fail to follow its internal standard operating polices regarding whether to open a Corrective Action/Preventive Action plan (CAPA) during the manufacture of an OTC drug; and
- Fail to provide information to participating Attorneys General within sixty days of a written request regarding the identity of wholesalers or warehouses to which any OTC drugs that were subject to a recall were distributed in their State.
Pennsylvania and Texas led the Executive Committee for the multi-state settlement, which also includes Attorneys General from Montana, Arizona, Delaware, District of Columbia, Florida, Kentucky, Maryland, Massachusetts, New Jersey, and Ohio.
Also participating in the settlement are Alaska, Arkansas, California, Colorado, Connecticut, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Washington, West Virginia, and Wisconsin.
McNeil-PPC, Inc. was a wholly-owned subsidiary of Johnson & Johnson that manufactured and distributed over-the-counter (OTC) drugs. McNeil Consumer Healthcare Division formerly a division of McNeil-PPC. Inc., is now a division of Johnson & Johnson Consu mer Inc. (“McNeil”).