Delaware joins forty-three other states in a $33 million settlement with Johnson & Johnson over allegations that the company inaccurately promoted its over-the-counter drugs. The pharmaceutical giant presented the drugs […]
Delaware joins forty-three other states in a $33 million settlement with Johnson & Johnson over allegations that the company inaccurately promoted its over-the-counter drugs. The pharmaceutical giant presented the drugs as complying with federal Good Manufacturing Practices when the facilities that made those drugs were out of compliance.
Johnson & Johnson will pay $629,570 to the Delaware Consumer Protection Fund, which pays out to victims of fraud and deceptive trade practices.
The case against the company came out of a series of violations between 2009 and 2011 by McNeil Consumer Healthcare Division, now a division of Johnson & Johnson. A number of quality control lapses led to recalls of Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops.
A consent judgment entered into by the states and McNeil outline guidelines for marketing and promotional efforts of over-the-counter drugs, requiring that the company
Shall not represent on its websites that McNeil’s OTC Drug Product facilities meet cGMP as outlined by the FDA if McNeil has had a Class I or Class II Recall of OTC 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;
Shall not 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
Shall not fail to provide information to participating Attorneys General within sixty (60) 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.