Secret Recall of Children's Tylenol Sparks Lawsuit

By Joe Harris, Courthouse News Service

05 January 12

n a scorching complaint that cites internal company memos, parents say their child died because Johnson & Johnson issued a "phantom or stealth recall" of tainted Children's Tylenol, buying up the drugs from stores on the sly without issuing a recall, "so the general public, ignorant of the dangers, would continue buying and administering these brand name drugs to their children."

Daniel and Katy Moore say their 2-year-old son River died of liver failure in July 2010, the day after he took Children's Tylenol.

They sued Johnson & Johnson, McNeil Consumer Healthcare, Costco and a long list of others in the chain of supply and distribution, and third-party contractors who allegedly bought up the over-the-counter drugs in the "phantom recall."

"Defendant Johnson & Johnson, a Fortune 50 Company with $60 billion in annual sales, knew of defects, impurities and contamination in the children's drugs and, yet, embarked on a 'phantom' or 'stealth' recall of these drugs to hide these problems so the general public, ignorant of the dangers, would continue buying and administering these brand name drugs to their children," the complaint states.

Katy Moore says she gave Tylenol to her son River on July 22, 2010. Within 30 minutes, River was splitting up blood and he died the next day due to liver failure. River's parents claim the Tylenol destroyed his liver.

They claim the defendants ignored deplorable manufacturing conditions and had numerous recalls of its products, including its infants and children's Tylenol.

River's parents claim Johnson & Johnson and its McNeil subsidiary hired contractors to secretly go into stores that stocked the tainted products, buy up all the products and not mention the recall to anyone.

"This clandestine phantom/stealth recall was done without notification to the customers or the retailers to avoid the public shame, the financial impact and regulatory ramifications of a formal recall," the complaint states.

It continues: "the purpose of the phantom/stealth recall is evidenced in an internal email in which a McNeil executive said, 'We are just trying to prevent a recall and a lot of expended dollars.'

"In another email, a McNeil executive described the success of the phantom/stealth recall by saying, 'This was a major win for us as it limits the press that will be seen.'

"On May 27, 2009, defendant Peter Luther sent an email approving the unethical phantom/stealth recall and instructed, 'Let's make this happen ASAP.'

"Defendant Luther, who defendant Weldon praised as being a loyal J&J employee, was not fired for his intimate roll [sic] in the phantom/stealth recall."

Weldon is chairman and CEO of Johnson & Johnson, Luther the president of its McNeil subsidiary, according to the complaint.

The complaint continues: "At the direction of J&J and McNeil's third-party contractors, including [defendants] Inmar Inc., WIS International, and CSCS [Carolina Supply Chain Services], visited various retail outlets and purchased all of the Motrin IB in the store, acting like regular customers.

"J&J and McNeil directed their third-party contractors, including Inmar Inc., WIS International, and CSCS, not to discuss their purchases as being a recall of the product.

"Indeed, J&J's specific instructions to the contractors hired to perform the phantom recall indicated that they were to 'quickly enter each store, find ALL of the Motrin product described, make the purchase transaction, secure the receipt, and leave ... THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT!' [Ellipsis in complaint.]

"J&J and McNeil subsequently misrepresented to the FDA that their third-party contractors were merely performing an audit of retailers to determine whether McNeil should initiate a formal recall.

"The FDA eventually became aware of the phantom/stealth recall when it received a copy of an internal memo containing the above instructions and confronted McNeil regarding those activities.

"On July 9, 2009, as a result of the above, McNeil publicly recalled the Motrin IB, at a delay of approximately 8 months.

"This phantom/stealth recall, in part, spurred the House Committee on Oversight and Government Reform to conduct a congressional investigation and hold two separate congressional hearings in 2010."

But River's parents say it was too little, too late for their son.

"Johnson & Johnson and its highly compensated executive knew of the problems with their products, and instead intentionally decided to gamble with River Moore's life because they were more concerned with company profits and meeting the Wall Street analysts' earnings projections, than the health and safety of American children," the complaint states.

"As a result, the contaminated Children's Tylenol, which never should have been on the market in the first place, caused River Moore's liver failure and death."

River's parents seek punitive damages for product liability, recklessness, breach of warranty, negligent infliction of emotional distress, violation of consumer protection law, civil conspiracy and wrongful death. They are represented by Thomas Sweeney with Messa & Associates.

Defendants include Johnson & Johnson, McNeil-PPC Inc., McNeil Consumer Healthcare, McNeil Consumer & Specialty Pharmaceuticals - a division of McNeil PPC Inc., Costco Wholesale Corporation, Inmar Inc., Carolina Supply Chain Services, Carolina Logistics Services, WIS International and eight Johnson & Johnson officials.