Johnson & Johnson will pay $33 million to resolve charges that it violated
federal regulations governing the quality of over-the-counter (OTC) medicines.
The drug manufacturer misrepresented the safety of several OTC drugs,
including those used to treat children.
“It is reprehensible that any company would manufacture medicine
that could potentially harm children,” said California Attorney
General Xavier Becerra.
The settlement resolves charges brought by attorneys general for 42 states
and the District of Columbia. McNeil-PPC Inc., which is a wholly-owned
subsidiary of Johnson & Johnson Consumer Inc., manufactured and distributed
the OTC drugs at issue. The suit alleged that McNeil unlawfully promoted
drugs as complying with federally-mandated current Good Manufacturing
Practices, despite known compliance failures at several manufacturing
facilities between 2009 and 2011.
The OTC drugs that failed quality control standards included Tylenol; Motrin;
Benadryl; St. Joseph Aspirin; Sudafed; Pepcid; Mylanta; Rolaids; Zyrtec;
and Zyrtec Eye Drops. The medications emitted a musty odor, failed to
dissolve properly, and contained unwanted particulates and bacteria.
The manufacturing defects ultimately prompted the recall of millions of
packages of OTC medications. In some cases, the U.S. Food and Drug Administration
only became aware of the drug safety issues after obtaining an internal
memo that directed McNeil employees to conduct a “phantom recall,”
in which employees purchased affected drugs rather than notifying consumers
and conducting an official recall.
This is not the first time that McNeil has faced liability over its manufacturing
practices. In 2015, quality-control violations prompted the Department
of Justice (DOJ) to bring criminal charges. In that case, the DOJ alleged
that McNeil knowingly sold children’s liquid medications that were
contaminated with metal. The drug maker paid a fine of $20 million and
forfeited an additional $5 million.
Under the latest settlement, McNeil is prohibited from stating its facilities
meet federal standards within 12 months of a recall. In addition, the
company must follow standard operating procedures when manufacturing issues occur.
If you or someone you love has suffered serious harm due to a dangerous
or defective drug, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation.