Secret Motrin recall

A Johnson & Johnson subsidiary took steps to pull a defective pain reliever off store shelves without alarming store employees or telling the public, according to a lawsuit filed by Oregon. It cites e-mail traffic and other documents:

Nov. 20, 2008:

McNeil Consumer Healthcare tests in Puerto Rico show a batch of Motrin failed standards.

Jan. 22, 2009:

McNeil notifies FDA that the Motrin flaw means consumers would be receiving less ibuprofen, which "may lead to a worsening of pain, fever or inflammation."

March 31, 2009:

McNeil executive writes about a plan to retrieve Motrin from stores without alerting store personnel, with "no reference to why we are auditing."

April 20, 2009:

McNeil executive writes that an FDA official in Puerto Rico agrees no national public recall is needed. Other company officials respond that this is "great news" and a "major win" that will "limit press."

June 2009:

Contractors are hired to retrieve the faulty Motrin from retailers across the country. One contractor's instructions tell field staff: "You should simply 'act' like a regular customer while making these purchases. THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THIS PRODUCT!"

June 2009:

An Oregon employee of one contractor notifies the Oregon Pharmacy Board about the retrieval. The agency alerts the FDA, which learns of the secret recall for the first time.

Feb. 17, 2010:

McNeil notifies retailers and distributors of the faulty Motrin: "URGENT – DRUG RECALL."

Lynn Walther was bothered by his instructions to secretly buy up faulty pain relievers from Salem-area stores.

So in June 2009, he faxed his employer's orders to Oregon pharmacy regulators. "Something was wrong," Walther said.

He never heard back from them, but the Oregon man's whistleblowing fax triggered a federal investigation into health care giant

.

This week,

sued the conglomerate and two subsidiaries, claiming they left eight-capsule packets of

on Oregon store shelves for months after learning the product was defective.

Citing e-mail traffic from the company and federal regulators, Kroger charged that the company deliberately withheld word of the defect from retailers and the public.

The pharmaceutical giant discovered at the end of 2008 that its Motrin caplets didn't dissolve properly and thus were ineffective in relieving pain, the suit says. But instead of ordering an official recall to alert consumers, the company hired a contractor to scour stores across the country and buy up the defective Motrin.

The company finally conducted a formal recall, but more than a year after discovering the faulty batch and then only under pressure from the U.S. Food and Drug Administration.

The Oregon complaint accuses the company of 787 violations of state trade law for packets sold to consumers, and another 27 violations for having retailers stock the product. Kroger didn't seek a specific penalty, but state law provides a fine of up to $25,000 per violation. Johnson & Johnson could be liable for more than $20 million.

Kroger last summer sought the company's voluntary compliance and a settlement of $725,000, but no deal was struck.

Johnson & Johnson officials said through its subsidiary

that "there was no health or safety risk to consumers associated with this limited recall." McNeil officials said Kroger's complaint had "no legal basis."

William Weldon, CEO of Johnson & Johnson, admitted in congressional testimony last September that the company had conducted a "phantom recall." He said the company didn't tell federal regulators it was buying its own product off the shelves.

"That was a mistake we made," Weldon testified. "We firmly admit that."

Congressional records and Kroger's complaint say the trouble started at a manufacturing plant in Puerto Rico. The company learned in November 2008 that a batch of Motrin tablets didn't dissolve as fast as expected, impairing how much ibuprofen a consumer would get. According to Kroger's complaint, the company reported to regulators that while this posed no health risk, consumers could experience "a worsening of pain, fever or inflammation."

The Oregon distributor, unaware of the problem, continued shipping the Motrin tablets for another four months, until March 2009.

That same month, McNeil officials notified federal regulators in a "field alert report" that the questionable Motrin tablets weren't "available at the store level." They said if a check at stores found the product, "a recall of these Motrin batches will be recommended."

The Oregon complaint cites e-mail traffic showing company officials worked to keep the top

official in Puerto Rico from triggering a full recall. Word that no national recall would be ordered led company officials to declare "great job" in one e-mail and a "major win" in another.

Kroger said the company then planned to "surreptitiously" remove Motrin tablets still in retailers, such as convenience stores and gas stations. Contractors were hired to send buyers into stores to identify by code any faulty batches and buy them.

One subcontractor said 33 stores in Nevada wouldn't be checked because secret shoppers there had to be licensed private detectives. Kroger said in a notice last August to Johnson & Johnson that the record wasn't clear whether the company "unlawfully shopped" in Nevada or "simply left remaining eight-packs on store shelves."

According to the complaint, 787 faulty Motrin packets were sold in Oregon. Secret buyers bought another 41 packets, checking 27 stores throughout the state.

Lynn Walther was one of those secret buyers, working for WIS International.

The Salem resident told The Oregonian he was assigned to go into local stores, look for certain batch numbers, and buy the offending packets with a credit card provided by his employer.

"Usually, the instruction sheets tell you what to do. They don't very often tell you what not to do," he said.

More

Documents outlinine the Motrin secret recall:

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In the Motrin buys, he was told to keep his true purpose secret. On June 23, 2009, he faxed the instruction sheet to the Oregon Board of Pharmacy. The board released a copy to The Oregonian Wednesday.

It said: "You should simply 'act' like a regular customer when making these purchases. THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THIS PRODUCT! "

Walther said he brushed aside questions from store clerks who quizzed him about the volume of his purchases.

Pharmacy Board officials forwarded the instruction sheet to the FDA.

By July 2009, federal regulators pressed Johnson & Johnson for a full public recall. Kroger's complaint said the company didn't do so until February 2010, notifying retailers then about an "urgent" drug recall.

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of The Oregonian contributed to this report.