When is a Recall Not a Recall?

When you call it an "audit", of course.

In 2010, I wrote four posts about Johnson & Johnson's problems (most recently, here). At that time, I noted that J&J had issued nine product recalls over the course of the year, and that investment bankers were starting to wonder whether there was a systemic problem at J&J, and consumers were starting to wonder if there was any reason for paying a premium for a branded product.

And here we are, back again, talking about J&J.

Today's New York Times carries an article by Natasha Singer and Reed Abelson reporting on a suit filed by the state of Oregon against a "phantom recall" conducted by McNeil Consumer Healthcare in early 2009.

McNeil apparently "hired outside contractors to buy back vials of Motrin ... because the pills failed to dissolve properly, a problem that could diminish the product's effectiveness."

Note that McNeil did not initiate a public recall, but gave contractors the following instructions: "Do not communicate to store personnel any information about this product. Just purchase all available product. If you are questioned by store personnel, simply advise that you have been asked to perform an audit."

Oregon attorney general John R. Kroger said that the point of the suit is "to send a message to pharmaceutical companies and other companies that make medical products that they have to do proper recalls that give consumers real notice."

McNeil did eventually complete a formal recall of eight-count vials of Motrin in July 2009, after the FDA inquired into the matter. A recall of 24-count vials was announced in February 2010.

I think we are well past the point of saying that there's a quality problem at McNeil. There is clearly a systemic problem, and McNeil has made it clearer than any other division at J&J (as Singer and Abelson note, "McNeil recalled more than 200 million product units last year, including different kinds of Tylenol, Motrin, and Rolaids." Emphasis added.). That's not to say that it's a McNeil problem alone. As the parent company, J&J is responsible for setting the overall standards -- and for seeing to it that subsidiaries consistently meet those standards.

Here's hoping that 2011 will be a quality year.