Contractor Questions Order to Remove Motrin From Shelves

Sept. 20, 2010 — -- For generations, parents have depended on Johnson & Johnson, trusting the company's medicines in the middle of the night.

Today, the gold-standard brand is in a tailspin and its quality is being questioned as Johnson & Johnson faces a second congressional hearing.

There have been eight recalls in the last year -- 136 million bottles of children's medicines including Children's Tylenol, Motrin Infant Drops, Children's Benadryl and Zyrtec -- and the company is apologizing for the largest over-the-counter children's medicine recall in history.

In November 2008, Johnson & Johnson and its subsidiary McNeil Consumer Healthcare discovered that some of its Motrin tablets were not dissolving properly -- meaning that if a consumer had a headache and took the medication, it might not work as expected.

Usually when there is a manufacturing problem, the product is recalled even if, as in this case, it does not pose a harm to consumers. In this case, contractors were sent to 5,000 convenience stores around the U.S. to quietly buy the faulty Motrin without alerting the public.

"I had been told not to say that this was a recall," said Lynn Walther who works for a Portland, Ore., inventory company. "I did not understand why I should be telling someone that this is not a recall when in my mind it was a recall."

In an exclusive interview with ABC News, Walther said that he was hired by a contractor to walk into convenience stores and quietly buy specific lots of Motrin IB caplet eight-count vials. Though he said his purchases often were met with puzzled looks from store owners, Walther said he had been told not to give the stores an explanation.

"Usually the only thing that was said was 'That's quite a bit of Motrin. What are you going to do with that?'" Walther said. "I just said, 'I'd like to purchase this Motrin.' I didn't make any conversation that I didn't feel was necessary."

He said he was following the instructions he'd been given. "You should simply act like a regular customer while making these purchases," the document said. "There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."

'I Wish ... I Hadn't Done It

"I wish to this day that I hadn't done it," Walther said. "But I did and I'm stuck with it."

Walther faxed the instructions to the Oregon Board of Pharmacy and the papers eventually reached Congress. The plan to buy back Motrin products was taking place all across the United States and 88,000 packages had been purchased.

At a hearing in May 2010, Colleen Goggins, head of the the company's consumer group, said that Johnson and Johnson wasn't behind the buyback and that it was doing an "audit" to find out where the faulty pills were being sold.

"I don't believe there was any intent to mislead or hide anything," she said during the hearing. Goggins resigned last week.

In June, company CEO William Weldon was issued a formal inquiry from Rep. Edolphus Towns, D-N.Y., chairman of the House Committee on Oversight and Government Reform.

The hearing looked at what Towns described as a "phantom recall" of certain Motrin caplets sold in eight-caplet vials carried out for the company in June 2009 by an outside contractor.

E-mails obtained by ABC News reveal that senior executives at Johnson & Johnson's McNeil subsidiary coordinated the $400,000 Motrin purchase program from the start. The e-mails read: "Do not communicate to store personnel any information about this product. Simply visit the store, locate the product and if any is found, purchase all of the product."

An e-mail shows McNeil president Peter Luther authorizing the program, saying: "Let's make this happen asap."

The Food and Drug Administration said it had no knowledge of plans to launch the program.

FDA officials said they told Johnson & Johnson to issue a recall before the buyback program had ended. In a statement to ABC News, the agency said: "When the FDA learned that McNeil had hired contractors to secretly purchase product off the shelves, the agency advised McNeil to do a full recall, which the company agreed to initiate in July 2009."

In July 2009, McNeil began officially recalling Motrin caplets thought to be dissolving improperly.

E-Mails Show FDA in Puerto Rico Knew of Plan

Though FDA officials said they did not know about a "phantom recall," in e-mails obtained by ABC News, senior McNeil employees congratulated each other on receiving support for their plan to withdraw product from the market, from the FDA in Puerto Rico where the faulty Motrin was made.

"Good news," one e-mail begins. The FDA director in San Juan "is in agreement with continuing to pull product from the rest of the stores and NOT consider this a National Recall." Another e-mail says that the FDA "is really bending the rules" by not automatically urging a recall, while another e-mail calls the buyback program "a major win for us as it limits the press that will be seen."

Johnson & Johnson declined a request for an interview; however, in a statement, the company said: "McNeil kept the FDA informed of its actions and removed the product from the market in a compliant manner. However, given the concerns highlighted by the congressional committee with respect to Motrin, moving forward we would like to handle things differently."