Mothers and fathers worry about little boys with fevers, so Katy Moore gave her son Very Berry Strawberry Children's Tylenol. Within 30 minutes, he was spitting up blood. By the next day, he was dead from liver failure.
In a lawsuit filed last month in Philadelphia Common Pleas Court, Daniel and Katy Moore of Ellensburg, Wash., southeast of Seattle, blame Tylenol's manufacturer, Johnson & Johnson Inc., and its McNeil Consumer Healthcare subsidiary, which has a plant and headquarters in Fort Washington, Pa. J&J officials including Chief Executive Officer Bill Weldon and other companies in the supply chain also are named as defendants.
McNeil's Fort Washington plant was closed in March 2010 after dozens of reports of manufacturing problems and warnings from the U.S. Food and Drug Administration. It won't open again until $100 million in improvements are completed and the FDA and a federal judge give their approval.
"Johnson & Johnson makes statements about their credo of putting patients first, but it's simply not true," said Philadelphia attorney Joe Messa, whose firm represents the family. "It is lip service, a marketing tool to tell the public and shareholders how wonderful they are."
In response, J&J said in a statement that while it empathized with the Moores, it strongly disagreed with the lawsuit's contention that the company was hiding its product problems at the time of River's death.
"As the makers of Tylenol (acetaminophen), we are deeply concerned about all matters related to our medicines, and we remain committed to providing safe and effective pediatric medicines," the statement said.
"While we are sympathetic to the pain and hardships suffered by the Moore Family, we must correct several of the allegations being made against our company in this suit. When McNeil Consumer Healthcare initiated several recalls for children's products in 2010, it communicated that information to the FDA, consumers, retailers and health care professionals. There were various reasons for those recalls, but they were not related to serious adverse events, as alleged in this suit."
On April 30, 2010, McNeil announced a voluntary recall of more than 136 million bottles of liquid infants' and children's products. A congressional hearing, which got considerable media attention, took place in May 2010.
The following month, there were media reports of congressional committee staff members and the FDA saying they were investigating a so-called "phantom recall," in which J&J quietly hired a company to buy all the McNeil-made Motrin that could be found on shelves in 2009 without publicity.
In May 2010, an FDA official said the agency checked on reports of a 6-year-old dying after taking cold medicines made by McNeil, but could not tie the events together.
Former McNeil employees told the Philadelphia Inquirer that problems from that era were due to a combination of increased work, staff cuts, and a change in upper management's approach. The company denied there was such a change.
Whatever the cause of the product problems, they manifested themselves in metal particles and incorrect doses in medicines and musty-smelling pills, among other issues.
"Although the public-health risk from these quality problems is low, these problems should never have occurred," FDA Deputy Commissioner Joshua Sharfstein testified at a hearing in May 2010, adding that quality-control "failures at the facility that caused them were unacceptable."
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source: News Observer (Sell, 1/5)
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