AG, DCP: State Joins $33M Multistate Settlement with
Johnson & Johnson on Representations of OTC Drug Quality
Attorney General George Jepsen and state Department of Consumer Protection Commissioner Michelle H. Seagull today announced that Connecticut has joined with 41 other states and the District of Columbia in a $33 million settlement with Johnson & Johnson and Johnson & Johnson Consumer, Inc. to resolve allegations that the companies engaged in unfair or deceptive trade practices in the marketing of certain over-the-counter (OTC) medications.
McNeil-PPC, Inc. was a wholly owned subsidiary of Johnson & Johnson that manufactured and distributed OTC medications. The McNeil Consumer Healthcare Division, formerly a division of McNeill-PPC, Inc., is now a division of Johnson & Johnson Consumer, Inc.
Between 2009 and 2011, McNeil announced voluntary recalls of certain OTC medications. In March 2011, McNeil stipulated in a guilty plea and memorandum with the United States that some of its OTC drugs were not manufactured, processed, packed, labeled, held or distributed in conformance with federally mandated current Good Manufacturing Practices (cGMP).
Also in March 2011, McNeil entered into an agreement with the United States requiring it to destroy all recalled products from four manufacturing facilities and to hire an expert in current Good Manufacturing Practices to inspect three facilities and inform the federal Food and Drug Administration when the facilities were in compliance with guidelines.
The states alleged the McNeil's quality control lapses resulted in recalls of certain drugs manufactured between 2009 and 2011, including formulations of Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops, some of which are indicated for pediatric use. The states alleged that it was false, misleading or deceptive to offer for sale or sell certain OTC medications that were represented to be of a certain quality, and that complied with cGMPs, when in reality the medications did not.
"Consumers should be able to trust, when choosing an OTC medication for themselves or their children, that the product is of the quality that has been represented," said Attorney General Jepsen. "This case called into question the production of some of the most trusted and well-known brands available to consumers in Connecticut and across the country. This settlement helps to ensure that consumers are getting accurate representations when choosing these OTC products."
"When choosing OTC medication for their families, consumers should feel safe, and confident with their decision," said Commissioner Seagull. "Companies need to represent the products they're selling accurately so that we have safe products on the market that consumers can trust will work as advertised, especially when it comes to healthcare."
Connecticut share of the settlement funds is $531,816, which will be deposited into the state's General Fund. The settlement will not be final unless and until it is approved by the court.
In addition to the monetary payment, the settlement prohibits McNeil from representing on its Web sites that its facilities meet federal guidelines if McNeil has had a Class I or Class II recall of over the counter drug products within the prior 12 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 consequence or where the probability of serious adverse health consequences is remote.
McNeil is also required, under the settlement, to follow its internal standard operating policies regarding whether to open a Corrective Action/Preventative Action Plan during the manufacture of any OTC drug, and must provide information to participating attorneys general within 60 days of a written request about the identity of wholesalers or warehouses from which any OTC drugs subject to a recall were distributed within their state.
In addition to Connecticut, and led by the attorneys general of Texas and Pennsylvania, states participating in this settlement include Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the District of Columbia.
Assistant Attorney General Jeremy Pearlman assisted the Attorney General with this matter.
Office of the Attorney General:
Jaclyn M. Falkowski
Department of Consumer Protection:
Lora Rae Anderson