Rutledge Reaches $33 Million Settlement with Johnson & Johnson
May 24, 2017
Arkansas will receive nearly $500,000
LITTLE ROCK – Arkansas Attorney General Leslie Rutledge today announced that she has joined with 42 other attorneys general in a $33 million settlement with Johnson & Johnson to resolve allegations that the company, acting through McNeil-PPC Inc., a wholly-owned subsidiary of Johnson & Johnson, unlawfully promoted its over-the-counter drugs as complying with federally mandated current Good Manufacturing Practices (GMP) even though the Food and Drug Administration found that some McNeil manufacturing facilities did not comply with current GMPs between 2009 and 2011. Moreover, some McNeil over-the-counter drugs were deemed adulterated as a matter of federal law.
“Federal and state standards are put in place to safeguard consumers from harm but also to maintain quality,” said Attorney General Rutledge. “The deceitful actions of Johnson & Johnson resulted in recalls of some of the most common over-the-counter medicines that Arkansans use. Today 43 states are holding this company accountable for its negligence that flooded the market with phantom drugs while padding its bottom line.”
Today’s filing alleges that Johnson & Johnson acting through McNeil violated consumer protection laws by delivering for introduction into state markets certain batches of over-the-counter 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 including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops, several of which are indicated for pediatric use.
Arkansas will receive $499,138.58 of the $33 million settlement.
The consent judgment requires Johnson & Johnson to ensure that its marketing and promotional practices do not unlawfully promote over-the-counter products. Specifically, the company and its subsidiary shall not:
- Represent on its websites that the over-the-counter products manufacturing facilities meet current GMP 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. Class I recalls involve situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls involve situations 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 polices regarding whether to open a Corrective Action/Preventive Action plan during the manufacture of an over-the-counter drug; and
- Fail to provide information to participating attorneys general within 60 days 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.
Pennsylvania and Texas led the Executive Committee, which also included attorneys general from Arizona, Delaware, District of Columbia, Florida, Kentucky, Maryland, Massachusetts, Montana, New Jersey and Ohio.
Rutledge participated in today’s settlement along with attorneys general from Alaska, 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.