J&J lawyers assert FDA knew about Motrin recall
TRENTON, N.J. — Lawyers for Johnson & Johnson insist regulators knew the company was secretly pulling packets of ineffective Motrin from store shelves last year, rather than announcing a public recall.
But the lawyers, responding yesterday to demands from a congressional panel investigating the case, wrote they have no documents from the Food and Drug Administration approving what’s been dubbed the “phantom recall’’ of Motrin.
Documents the J&J attorneys turned over yesterday to the House Oversight and Government Reform Committee seem to show the FDA received two brief company reports about the effort to remove containers of Motrin caplets from convenience store shelves.
The committee has scheduled a hearing on the matter Sept. 30.
Neither report mentions that employees of the company J&J hired for the project were instructed to act like regular shoppers, buy up all containers of the two Motrin lots in question, and not tell store personnel what they were doing. Those instructions had been included in previously released e-mails circulated internally at J&J’s McNeil Consumer Healthcare unit.
What role, if any, the FDA played in the recall has become a central part of the committee’s probe.
That investigation is an offshoot of the panel’s review of numerous recalls since last September involving millions of bottles of Tylenol and other J&J nonprescription medicines. The reasons include potentially wrong doses of active ingredient and contamination with bacteria or tiny metal shards.
“FDA was unaware of McNeil’s ‘phantom recall’ when it was initiated. Any effort to suggest to the contrary is based on quoting documents selectively and out of context and ignores other evidence as to what occurred,’’ said Elaine Gansz Bobo, an FDA spokeswoman.
But J&J attorneys said the documents they submitted “make clear that McNeil kept the FDA apprised of its actions.’’
Johnson & Johnson declined to comment on the documents submitted yesterday, but a spokesman said the company would continue to cooperate with the House committee.