J&J lawyers: Company reports to FDA show it knew of secret recall; no proof FDA approved it

J&J lawyers: FDA knew of secret 2009 Motrin recall

TRENTON, N.J. — Lawyers for Johnson & Johnson insist government 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 Wednesday to demands from a congressional panel probing the case, wrote they have no documents from the Food and Drug Administration approving what’s been dubbed the “phantom recall” of Motrin in the first half of 2009.

Documents the J&J attorneys turned over Wednesday to the House Oversight and Government Reform Committee seem to show the FDA received two brief company reports about the effort to remove small containers of faulty Motrin caplets from convenience store shelves. The committee has scheduled a hearing on the matter Sept. 30.

The reports were obtained by The Associated Press. Neither 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 secret recall has become a central part of the committee’s probe.

That investigation is an offshoot of the panel’s probe of numerous recalls since last September involving tens of 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,” FDA spokeswoman Elaine Gansz Bobo said in an e-mail.

The J&J attorneys, Ethan M. Posner and Robert K. Kelner, wrote Wednesday that, “It would be highly unusual for the FDA to negotiate an ‘agreement’ regarding the conduct of a recall in a formal manner, let alone a “written agreement.”

The documents they submitted “make clear that McNeil kept the FDA apprised of its actions,” the attorneys added.

One of the documents, a “Field Alert Report” that McNeil apparently submitted to the FDA on March 23, 2009, states that J&J hired a third party to assess how many containers of the faulty Motrin were still available by visiting about 10 percent of convenience stores.

A final “Field Alert Report” dated April 21, 2009, states that about 1 percent of two Motrin lots that didn’t dissolve properly had been found during that assessment. The report adds that those containers had been bought up and the company would finish buying all other Motrin from the two lots at convenience stores across the country.

Three months later, an FDA investigator in Puerto Rico, Neisa M. Alonso, wrote to McNeil’s head of quality assurance, Carolyn Parziale, stating that “your company should do a voluntary recall of the product,” according to another document obtained by the AP.

Bobo said the FDA “then voiced its objections about McNeil’s ‘phantom recall’ activities to the senior leadership of Johnson & Johnson in a February 2010 meeting.”

Johnson & Johnson declined to comment on the documents submitted Wednesday, but a spokesman said the company would continue to cooperate with the House committee.

The lawyers’ letter stated, “Although the purchase of the Motrin products at issue complied with legal requirements, moving forward the company would handle things differently.”

The ranking Republican on the oversight committee, Rep. Darrell Issa, R-CA, wrote in an e-mail to The Associated Press, “We need to uncover the true extent of what the FDA knew and when they knew it and determine whether or not they acted appropriately and timely.”