Healthy Skepticism Library item: 18247

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Publication type: news

Head of Johnson & Johnson unit recommended buyback of recalled drug
NJ.com 2010 Jun 14
http://www.nj.com/business/index.ssf/2010/06/head_of_johnson_johnson_unit_r.html

Full text:

Johnson & Johnson’s McNeil Consumer Healthcare president recommended a recall of faulty Motrin pills without notifying regulators or consumers, according to a person familiar with a congressional probe of the company.
Peter Luther, whose unit produced the Motrin tablets in 2008, told McNeil employees in an e-mail to go ahead with a “market withdraw of Motrin,” writing, “Let’s make this happen ASAP.” The e-mail was obtained by Bloomberg from the person familiar with the investigation by the House Oversight and Government Reform Committee.
The probe into the Motrin tablets, which didn’t dissolve properly, began in May as part of an inquiry into children’s medicines recalled April 30 by McNeil because of manufacturing defects. Colleen Goggins, J&J’s consumer group chairman, told a May 27 committee hearing that the company hadn’t intended to mislead anyone about the Motrin incident. Contractors were hired to buy pills, emptying store shelves without announcing a recall, the person familiar with the investigation said.
“The FDA was kept fully informed of McNeil’s plans and actions throughout the process,” Bonnie Jacobs, a spokeswoman for J&J’s McNeil unit, said in a phone interview. “The memo you referenced is consistent with what we have stated previously.”
Luther has been McNeil’s president since January 2009, she said.

Go Ahead
A May 27, 2009, e-mail from Luther in response to a discussion among McNeil executives about whether to go ahead with the plan to buy the Motrin in stores expressed concern about the expense of the contractors hired by the company, the person said.
“Given our current financial situation, I hope we’re not going to really double our cost to do this,” Luther said in the e-mail to six McNeil employees, according to the person familiar with the investigation.
The e-mails show that senior McNeil executives were involved with the plan to buy back the defective Motrin in large quantities, the person said, and not just perform a sampling of whether the product made it into stores, as Goggins said in testimony.
There was no safety risk from the faulty Motrin tablets, J&J said.

‘Unique’ Outlets
“The objective was to remove the affected product from a unique distribution channel, namely convenience stores and gas stations, with as little disruption and consumer confusion as possible,” Jacobs said. “The FDA was kept informed of the survey and product retrieval, and after it was essentially complete, the FDA requested that we conduct an additional step, which was to conduct a formal recall, and we agreed.”
McNeil told the FDA it would “sample” from stores where the Motrin had been sent, Meghan Scott, a spokeswoman for the agency, said on June 11.
“They did not inform the agency that they would instruct contractors to go into stores, ‘act like a regular customer,’ and buy all of the product in question,” Scott said in an e- mail. The agency didn’t respond immediately today to a new request for comment.
J&J fell 4 cents to $58.42 in New York Stock Exchange composite trading. The shares have fallen 9.1 percent since the New Brunswick, New Jersey-based company announced the April 30 recall of 40 children’s medicines.