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J&J to Face Failure to Warn Allegations over Children’s Motrin

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In 2010, Gary and Debra Newman, and their son Blane Newman as well as another child, Mariam Khawam, filed a lawsuit against McNeil Consumer Healthcare after the two children were diagnosed with Stevens-Johnson Syndrome (SJS), and a deadly form of the condition called Toxic Epidermal Necrolysis (TEN), following the use of over-the-counter children’s version of Motrin, to treat fever.

The lawsuit said that Motrin labels failed to adequately warn consumers that using the medication could cause injuries related to SJS and TEN, and that the labels should include symptoms of the conditions including blindness, extensive burns, massive scarring, massive skin loss, and organ damage.

J&J filed for summary judgment; however, U.S. Magistrate Judge Maria Valdez denied the motion, finding that federal law does not preempt the labeling claims.

McNeil has listed the possible SJS link on the labels of prescription Motrin since 1983, and the FDA required a TEN warning to the prescription dose in 2006. However, neither disease is mentioned on over-the-counter nor children’s versions of Motrin, as the FDA declined a consumer petition to require that OTC and Children’s Motrin carry the warnings regarding SJS and TEN in 2006.

“Plaintiffs have not alleged that the OTC Motrin warning label should use the terms ‘SJS’ or ‘TEN’,” Valdez wrote. “As opposed to terms like SJS and TEN, consumers are familiar with injuries like blindness and scarring; and including such information does not seem as if it would keep consumers from quickly and easily understanding the potential severity of an adverse reaction to ibuprofen.” The judgment continued, “ Obviously, McNeil knew that users of its product might be injured; therefore even if there is ‘unusual susceptibility’ in this case, it is not a complete defense to plaintiffs’ failure to warn claim,” Courthouse News reported. disclaimer: This article: J&J to Face Failure to Warn Allegations over Children’s Motrin was posted on Thursday, January 19th, 2012 at 8:21 pm at and is filed under Defective Drug Lawsuits.

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