Sometime around the middle of 2009, McNeil Consumer Healthcare discovered that certain of its over-the-counter pediatric Motrin products did not dissolve properly. What followed thereafter in the manufacturer’s efforts to get the product off consumer shelves has led to an ever-growing battle between Johnson & Johnson and Congressional investigators, which hit a new pitch on Friday when new company documents were revealed.
These documents indicate that McNeil Consumer Healthcare, a division of Johnson & Johnson, sought to remove the defective products from targeted retail locations by having companies it hired ‘purchase’ the products to get them out of the stream of commerce. What was not done, however, was the issuance of a formal recall in cooperation with the FDA.
The details of this activity and the feud it has led to were reported in yesterday’s New York Times in an article by Natasha Singer. According to the Times –
One document on McNeil letterhead instructs contractors involved in the Motrin buyback program not to alert stores about their activities.
“Do not communicate to store personnel any information about this product,” the document says. A separate McNeil instruction said, “Just purchase all available product.”
Representative Edolphus Towns, a New York Democrat who is the chairman of the committee conducting the investigation, believes these documents show that “McNeil had directed surreptitious activity by its contractors. He has repeatedly referred to this incident as a “phantom recall.”
As you might expect, McNeil, through its spokesperson, Bonnie Jacobs, has a different ‘take’ on the events surrounding the removal of the pediatric Motrin products.
“Given that there was no safety risk, the objective was to remove the affected product from a unique distribution channel, mainly convenience stores and gas stations, with as little disruption and consumer confusion as possible,” Ms. Jacobs said on Friday.
What somewhat belies this proclaimed innocence is another document recently provided to Congress that reveals to a large degree the purpose and motive behind the conduct of McNeil’s contractors.
“Simply ‘act’ like a regular customer while making these purchases. There must be no mention of this being a recall of the product!” — when buying back the Motrin for McNeil.
How does Ms. Jacobs reply to this? She claims Johnson & Johnson and its subdivision McNeil had nothing to do with this subcontractor’s written communication.
So where was the FDA in all of this? Were they advised of this plan to ‘buy-up’ the defective Motrin and not issue a formal recall?
On the issue of informing the F.D.A. about its activities, Ms. Jacobs said McNeil had contacted the agency after it discovered that two lots of Motrin did not dissolve properly. The company informed the agency that it planned to retrieve the products from stores and kept the agency apprised of its progress, she said.
And the FDA’s response to this claim?
“It seems that your company is doing a recall even though you are calling it a ‘retrieval,’ ” Neisa M. Alonso, an investigator and recall coordinator with the F.D.A. in San Juan, P.R., wrote in a message date July 16, 2009, to an executive at McNeil. “The agency’s position is that your company should do a voluntary recall of the product since it appears to be that you are already doing a recall of the product.”
McNeil’s formal voluntary recall of “6 million bottles from over 40 different types of medicines including brands such as Children’s Tylenol, Infants’ Tylenol, Children’s Motrin, and Children’s Benadryl” (source: Committee on Oversight and Government Reform) occurred on April 30, 2010 – almost a year after McNeil discovered that it’s products ‘may not meet standards. It is unclear when McNeil first had knowledge of this problem; hopefully the Congressional investigation will make this known. ‘ Here is the language contained in the recall notice issued this year:
[T]hese products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children.
So what motivated this ‘re-purchase’ program of McNeil? They didn’t want to set-off a panic? I wonder if it had anything to do with making sure there wasn’t a dip in corporate profits if consumers learned that these products for children and infants on the retailers’ shelves and in their medicine cabinets “may not meet standards.”