TRENTON – Attorney General Christopher S. Porrino announced today that New Jersey will receive more than $1 million as a result of its participation in a multi-state civil settlement with Johnson & Johnson Consumer Inc. and Johnson & Johnson. The settlement resolves allegations that McNeil-PPC, a Johnson & Johnson company, made false or misleading representations about its over-the-counter products and distributed some products that were adulterated as a matter of federal law.
“This is an important settlement for New Jersey consumers, because it imposes requirements on the company designed to prevent similar misconduct going forward,” said Attorney General Porrino.
“The products at issue in this case are well-known over-the-counter medications – pain relievers, decongestants, antacids and other remedies commonly found in people’s medicine cabinets,” Porrino said. “It’s essential that people who buy and consume these products be able to do so with confidence, and without fear that they may be tainted in some way, or manufactured in substandard facilities. “
Under terms of the multi-state settlement, McNeil will pay a total of $33 million to 42 participating states and the District of Columbia.
New Jersey was part of the 10-state Executive Committee that investigated the McNeil allegations, and will receive approximately $1.04 million.
Based in Fort Washington, PA., McNeil-PPC was a wholly-owned subsidiary of Johnson & Johnson that has since been absorbed by Johnson & Johnson Consumer, Inc., another Johnson & Johnson subsidiary. The company manufactures a variety of brand-name, over-the-counter drugs including Tylenol, Motrin, Benadryl and St. Joseph Aspirin.
The settlement announced today resolves allegations that McNeil and Johnson & Johnson falsely promoted these and other products as having met federal standards when, in fact, the Food and Drug Administration (FDA) cited some McNeil facilities between 2009 and 2011 for failing to meet a federal standard known as current Good Manufacturing Practices (cGMP). In addition, some over-the-counter drugs marketed by McNeil were deemed adulterated as a matter of federal law.
A Complaint filed in court today along with the settlement agreement alleges that McNeil violated state consumer protection laws by (1) misrepresenting the quality and compliance level of their over-the-counter drugs and (2) falsely representing that the products at issue had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities or qualities they did not have.
McNeil’s alleged quality control lapses resulted in more than 1,800 product lot recalls between 2009 and 2011, including product lots of: Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops, several of which are indicated for pediatric use.
The product recalls were related to inspections by the FDA at three company manufacturing facilities – two in Pennsylvania and one in Puerto Rico. In those inspections, the FDA flagged multiple violations of the current good Manufacturing Practice standard. A Consent Judgment filed today requires McNeil to ensure that its marketing and promotional practices do not unlawfully promote over-the-counter drug products.
Specifically, McNeil shall not:
- Represent on its Web sites that McNeil’s over-the-counter drug product facilities meet the current good Manufacturing Practice standards as outlined by the FDA if McNeil has had a Class I or Class II recall of over-the-counter drug products within the prior 12 months. (A Class I recall involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product would cause serious adverse health consequences or death. A Class II recall involves a situation in which use of or exposure to a violative 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 policies regarding whether to open a Corrective Action/Preventive Action plan during the manufacture of an over-the-counter drug
- Fail to provide information to participating Attorneys General within 60 day of a written request regarding the identity of wholesalers or warehouses to which any over-the-counter drugs that were subject to a recall were distributed in their state.
Deputy Attorney General Patricia A. Schiripo, Assistant Section Chief of the
Division of Law’s Consumer Fraud Prosecution Section, handled the Johnson & Johnson matter on behalf of the State.
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