Tylenol makers to pay $33 million in settlement

A generic image of Tylenol acetaminophen pills.

Pennsylvania will receive $1.4 million as co-leader of national settlement of allegations that contaminated drugs were distributed throughout the country

HARRISBURG — Announcing an effort led by Pennsylvania, Attorney General Josh Shapiro said today his office and 42 other Attorneys General have reached a $33 million settlement with McNeil-PPC, Inc., the maker of Tylenol, to resolve allegations that the company distributed contaminated over-the-counter drugs and unlawfully promoted its products.

The settlement with McNeil, previously a subsidiary of Johnson & Johnson, will result in a payment of $1.4 million to the Office of Attorney General, which will be used to fund future consumer protection efforts across the Commonwealth.

McNeil operated a plant in Fort Washington, Montgomery County and recalled hundreds of millions of packages of drugs it manufactured between 2009 and 2011, including many for pediatric use. The recalls came amid reports of product oddities, including strange odors and particles found in liquid medicines that the company produced. The recalled drugs included Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops.

“We’re proud Pennsylvania helped lead this national effort to ensure health care companies are held accountable when they mislead consumers about the quality of the products they put into the marketplace,” Attorney General Shapiro said. “It’s particularly troubling that many of the drugs that were found to be contaminated in this case were designed for infants and children.”

A prior investigation by the U.S. Department of Justice into McNeil’s quality control issues resulted in a misdemeanor guilty plea that included a criminal fine of $20 million and the forfeiture of an additional $5 million.

State Attorneys General launched an investigation into claims that McNeil’s marketing of some of its drugs was false, misleading and deceptive because the drugs were not manufactured in compliance with federal requirements. The states’ settlement resolves claims that McNeil unlawfully promoted its over-the-counter drugs as compliant with federal good manufacturing practices, a system that ensures products are consistently produced and meet quality standards.

The settlement restricts inappropriate advertising, and adds investigative and reporting requirements that will create additional safeguards to protect Pennsylvania consumers. In the event of a future recall, the settlement requires McNeil to provide information to the Attorneys General regarding the identity of wholesalers and warehouses where the over-the-counter drugs subject to the recall were distributed.

“This settlement requires safeguards to ensure states get the appropriate information they need to protect their citizens if they are any future recalls by this drug manufacturer,” Attorney General Shapiro said. “A large number of state Attorneys General worked diligently on this case to protect consumers, and that collaboration makes us safer. I want to commend Senior Deputy Attorney General Nicole VanOrder and our Health Care Section, who headed this effort for our office.”

If you have prescription drugs in your medicine cabinet or home and need to know if they were part of the tainted drugs recalled by McNeil, read the settlement linked below. All of the drugs recalled, with lot numbers, are listed in the document.

Pennsylvania and Texas headed an executive committee that led the states’ investigation of McNeil. The executive committee included Attorneys General from Arizona, Delaware, District of Columbia, Florida, Kentucky, Maryland, Massachusetts, Montana, New Jersey and Ohio. Click here to read the full settlement and a list of all states participating.

The Health Care Section protects the public and consumers from unfair health care practices. Pennsylvanians with problems involving a health care provider or health insurance company can call the Health Care Section at 877-888-4877 or file a complaint at www.attorneygeneral.gov.