FDA busts open a "phantom" caper run by a giant drug company

The Phantom Caper

At first it seems comical. Then you realize just how dangerous it might be.

Here’s the comical part…

Guy walks into a big box store, goes to the drug aisle, and clears out every box of a specific type of Motrin product. While standing in line for the cashier, he reviews his instructions…

“You should simply ‘act’ like a regular customer while making these purchases. There must be no mention of this being a recall of the product! If asked, simply state that your employer is checking the distribution chain of this product and needs to have some of it purchased for the project. With your purchase, ask for a bag for the product.”

Trying to act “regular,” he loads all the boxes onto the conveyor belt.

Then…trouble! The friendly cashier says, “Wow! Got a big headache?”

Guy freezes. What would a regular customer say?

Guy: “My employer is checking the distribution chain of this product and needs to have some of it purchased for the project.”

Cashier: “What project?”

Guy: “Uh…checking the distribution chain.”

Cashier: “What the heck is that?”

Guy: (Panics.) “It’s not a recall! And I need a bag for the product!”

It’s like an absurdly uncomfortable scene from Curb Your Enthusiasm. But HBO isn’t the producer of this one. This production comes from Johnson & Johnson, and their subsidiary, McNeil Consumer Healthcare.

Ring a bell?

McNeil is the company that runs the drug plant that was shut down last month after FDA inspectors found evidence that bacteria might have contaminated dozens of J&J products for children and infants, including Motrin, Tylenol, Zyrtec, and Benadryl.

That scandal prompted hearings from the House Committee on Oversight and Government Reform. And in the course of the hearings, someone spilled the beans about a problem with a Motrin product that wouldn’t dissolve properly.

Seems someone at J&J recognized this problem back in 2008. So distribution of the product was stopped and J&J execs told the FDA they would make random checks of store samples to see if the problem required a recall.

Instead, someone at J&J or McNeil apparently decided they’d like to avoid the humiliation and financial losses of a recall. So they cooked up this “phantom recall,” sending inventory workers out to stores to buy up all the product they could find.

Hilariously, a J&J rep told the House Committee, “There was never any intent to mislead or hide anything from anyone.”

But in a closing statement at the hearing, Edolphus Towns, chairman of the Committee, said, “We uncovered a J&J document showing that they told their contractor not to say this was a recall.” And that document is where the above quote about acting like a regular customer comes from.

But wait–it just gets more hilarious…

Committee chairman Towns also said, “It wasn’t until this caper was foiled by the FDA that McNeil did what it should have done in the first place and recalled the affected medication.”

A “caper”! FOILED by the FDA!

I think we may have a pitch for a new police procedural TV drama: “FDA–Caper Busters!”

The phantom recall occurred in 2008. But when FDA gumshoes blew the case wide open (sorry, I can’t resist), McNeil announced a genuine recall of the Motrin products in July 2009.

And that’s where the funny comes to a screeching halt.

In delaying the recall, J&J and McNeil allowed consumers who had already purchased the subpar Motrin to continue using it for MONTHS.

FDA officials have referred this case to their criminal investigation unit, so now we’ll see what the agency is really made of. Will they put the screws to J&J execs, or will they let McNeil take the fall, allowing J&J to save face?

Here’s a hint: J&J is one of the largest drug companies in the world. So if you were betting on this one, you’d have to play the odds: J&J will get off scot-free.

McNeil? Those guys better get good lawyers.

To Your Good Health,

Jenny Thompson

Sources:

“Congress Widens J&J Probe to Include Contractors” Ed Silverman, Pharmalot, 6/4/10, pharmalot.com
“FDA: Johnson & Johnson Concealed Motrin Recall” Scott Hensley, NPR, 5/27/10, npr.org

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