The Johnson & Johnson recall scandal is threatening to envelope the healthcare giant in ways that, just a few months ago, no one could imagine. The latest twist involves a series of emails that appear to lend further credence to what a Congressional committee is calling a 'phantom recall,' which was allegedly undertaken to obscure serious problems with widely used over-the-counter pediatric medications. The episode is part of a long-running chain of events may prompt the FDA to consider criminal charges.
At issue are quality-control failures that forced J&J to recently recall tens of millions of bottles of such venerable brands as Tylenol and Motrin, among others, which had been found to contain too much active ingredient or metallic specks. But instead of issuing a recall, J&J hired an outside contractor to buy Motrin from stores, and its employees were instructed to act like "regular customers" and not discuss a possible recall (here is the memo here). This was disclosed at a May 27 Congressional hearing.
Since then, internal J&J documents obtained by Pharmalot would appear to undercut some of J&J's contentions, such as the notion that its contractor's assignment was limited and transparent. A J&J spokeswoman told The New York Times the contractor's memo was created without the knowledge of its McNeil Consumer Healthcare unit. But e-mails suggest J&J employees were aware, including Lily Vandermolen, an associate product director at McNeil, and Carolyn Parziale, a diretor of quality assurance at McNeil.
For instance, an April 1, 2009, email from Rob Small, director of field operations and transporation at Inmar, a J&J contractor, to various Inmar and J&J personnel, says: 'Some stores will not care, others will ask specifically what we are doing. Initially, we are going to buy all product as mystery shoppers. We will need to clarify to the field what the response will be if the store asks questions as we are reviewing products searching for specific lot codes.' Suggested reponses to curious retailers? Say you are conducting random quality packaging checks or looking for packaging changes and need to purchase samples. Later, though, Inmar employees were told to say they were conducting an audit, but nothing else. Small did not return a call for comment.
Recently, Peter Luther, McNeil's president, told the committee that McNeil - which recently closed its Fort Washington, Pa., plant after a scathing FDA inspection - didn't make children's meds for other companies, according to a source close to the investigation. Yet, a few days later, the FDA announced Blacksmith Brands was recalling various PediaCare products made for the company at the same plant (see this).
Meanwhile, J&J apparently was telling the FDA that its campaign was a product retrieval, not a recall. But in a July 16, 2009, e-mail from Neisa Alonso, an FDA investigator and recall emergency and coordinator, writes to Parziale that "your company is doing a recall even though you are calling it a retrieval." The FDA's position, she continued, is that J&J should do a recall, because it already appears that one is under way. A recent Motrin sampling, she added, failed a dissolution test and such failures "typically" result in recalls.