Parents allege J&J's excess-API Tylenol killed son

An Ellensburg, WA, couple who suffered the loss of a 2-year-old to liver failure is suing Johnson & Johnson ($JNJ), saying that manufacturing problems leading to Tylenol recalls in 2010 are to blame. Parents Daniel and Katy Moore say in their complaint that 30 minutes after they gave Children's Tylenol to their son, River, he began spitting up blood. He died the next day.

The Moores' lawyer, Joseph Messa, said the family believes that it was "a super dose" of Tylenol, "containing excessive acetaminophen that damaged the child's liver, causing his death," reports The Associated Press. J&J in a statement said there were "various reasons" for the recalls, "but they were not related to serious adverse events." Excess API, however, is among those reasons.

Messa told the AP that an autopsy found that River's liver enzymes were "three times the normal level," which suggests that medication was the cause. In addition, "extensive testing done on River before and after his death ruled out viruses or other conditions," the AP quotes the lawyer as saying.

According to the U.K.'s Daily Mail, the lawsuit lists the lot number of the product allegedly taken by the boy, and it is among those recalled in April 2010. In the recall notice, J&J says that "some of the products included in the recall may contain a higher concentration of active ingredient than is specified," reports the Daily Mail.

The couple charges also that the so-called phantom recall of 2009, in which J&J's McNeil subsidiary is alleged to have hired contractors to buy up large quantities of substandard Motrin to avoid a formal recall, shows that the company tried to hide defective products.

According to reports in The Philadelphia Inquirer and Courthouse News Service, the Moores are suing in a Philadelphia court, about 20 miles from the troubled J&J/McNeil Fort Washington manufacturing plant shuttered in April 2010. The plant will remain closed until an estimated $100 million in remediation upgrades are made to the FDA's satisfaction, the Inquirer reports.

"Johnson & Johnson and its highly compensated executive knew of the problems with their products," the Moore complaint alleges, according to CNS. "They were more concerned with company profits and meeting the Wall Street analysts' earnings projections, than the health and safety of American children."

A large portion of the Moore complaint appears to be based on the phantom recall of Motrin, according to the press reports. However, the Motrin recalls—both the phantom and later the official one—were necessitated by pills that didn't dissolve as expected, much different than the manufacturing missteps that led to the excess-API, contamination, maintenance and nauseating-odor triggers of the Tylenol recalls.

The Moores took a supply chain view when choosing whom to sue. In addition to J&J, McNeil and 8 company officials, CNS reports that defendants include Costco and alleged phantom-recall agents Inmar, Carolina Supply Chain Services, and WIS International. 

- here's the Philadelphia Inquirer story
- see the CNS report
- here's more from the Associated Press
- and the Daily Mail report

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