Healthcare News & Insights

Major drug company sued for stealth recall of defective drug

Johnson & Johnson is being sued by at least one state attorney general over the failure to properly recall medications it knew to be defective.

The Oregon Attorney General is suing Johnson & Johnson and two of its subsidiaries, alleging 787 violations of state trade law for selling packs of the questionable products to consumers and another 27 violations for allowing retailers in the state to stock the item. State law allows for a fine of up to $25,000 per violation — leaving the companies on the hook for more than $20.3 million in potential fines.

The case stems from J&J’s handling of a bad batch of eight-capsule packs of Motrin. The company discovered in November 2008 that some Motrin pills produced at a McNeil Consumer Healthcare plant in Puerto Rico didn’t dissolve properly. (McNeil is a J&J subsidiary.)

J&J says the defect didn’t pose a health risk. But it’s likely that at least some consumers didn’t get the correct dose and experienced unnecessary inflammation and pain.

Rather than issue a recall, the company contracted mystery-shopper agencies to hire people to go to stores around the country and buy up any packs of the affected batch that were still on the shelves. According to records a whistle-blower turned over to the state attorney general, the mystery shoppers were expressly forbidden to mention any recall effort to the stores’ employees or to state why they were buying such large quantities of the over-the-counter painkiller.

The mystery-shopper buybacks occurred throughout 2009. Not until February 2010 — months after the FDA finally learned about the problem — did McNeil announce an “urgent” recall of the drug.

J&J’s CEO has admitted the company “made a mistake” in how it handled the situation, referring to it as a “phantom recall.”

It’s unclear at this point if other state attorneys general will take similar measures against the company. We’ll keep you posted as the story develops.

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  1. James Goldberg says:

    Good for Oregon!

    The fines, if imposed, however, a piss in the ocean for J&J.

    There should be a criminal consequence for knowingly allowing bad
    drugs into the market.

    You want to see change: throw the bastards in jail.
    THEN it will stop!

    Dr. James Goldberg