By Joseph Arshawsky, J.D.
Pennsylvania Attorney General Josh Shapiro and 42 other Attorneys General reached a $33 million settlement with McNeil-PPC, Inc. ("McNeil"), the maker of Tylenol®, to resolve allegations that the company distributed contaminated over-the-counter drugs and unlawfully promoted its product, according to a complaint and consent decree filed for approval with a Pennsylvania court (Commonwealth of Pennsylvania v. Johnson & Johnson Consumer Inc., May 24, 2017).
McNeil operated several plants throughout the U.S. and recalled hundreds of millions of packages of drugs it manufactured between 2009 and 2011, including many for pediatric use. The recalls came amid reports of product oddities, including strange odors and particles found in liquid medicines that the company produced. The recalled drugs included Tylenol, Motrin®, Benadryl®, St. Joseph Aspirin®, Sudafed®, Pepcid®, Mylanta®, Rolaids®, Zyrtec® and Zyrtec eye drops. A prior investigation by the U.S. Department of Justice into McNeil’s quality control issues resulted in a misdemeanor guilty plea that included a criminal fine of $20 million and the forfeiture of an additional $5 million.
State Attorneys General. The state Attorneys General launched an investigation into claims that McNeil’s marketing of some of its drugs was false, misleading and deceptive because the drugs were not manufactured in compliance with current Good Manufacturing Practices ("cGMP") regulations promulgated by the FDA. The states’ settlement resolves claims that McNeil unlawfully promoted its over-the-counter drugs as compliant with federal cGMP. The settlement includes investigative and reporting requirements that are intended to create additional safeguards to consumers. In the event of a future recall, the settlement requires McNeil to provide information to the Attorneys General regarding the identity of the wholesaler and warehouses where the over-the-counter drugs subject to the recall were distributed. Pennsylvania’s share of the settlement, just over $1.4 million, will be used to fund future consumer protection efforts.
Advertising restriction. The settlement restricts inappropriate advertising. In particular, it orders that McNeil shall not represent on www.mcneil-consumer.com or any other McNeil-operated website that McNeil’s OTC drug product manufacturing facilities meet cGMP if McNeil has had a Class I or Class II recall of OTC drug products within the prior twelve months caused by cGMP noncompliance at its Fort Washington, Pennsylvania or Las Piedras, Puerto Rico manufacturing facilities.
The case is No. 2017 cv 4007 EQ.
Companies: McNeil-PPC, Inc.
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