Children’s Motrin Suit Seeks Compensation, New Label For Ibuprofen Product
This article was originally published in The Tan Sheet
Executive Summary
A lawsuit that alleges Children's Motrin with ibuprofen caused a girl's blindness wants McNeil Consumer & Specialty Pharmaceuticals to clearly list all potential serious adverse reactions on the product's label and compensate the child
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A lawsuit that alleges Children's Motrin with ibuprofen caused a girl's blindness wants McNeil Consumer & Specialty Pharmaceuticals to clearly list all potential serious adverse reactions on the product's label and compensate the child. Sabrina Brierton Johnson is suing McNeil, Johnson & Johnson, McKesson Corp., Save-On Drug Stores, Cardinal Health and Ralph's Grocery in Los Angeles Superior Court for selling Children's Motrin, which she claims caused her to develop Stevens-Johnson Syndrome and go blind in 2003 ("1 The Tan Sheet' Jan. 3, 2005, In Brief). Johnson's lawyer, Browne Greene with Greene Broillet & Wheeler, gave his opening statement June 13, and will argue in the case that McNeil must warn consumers on the product label that ibuprofen can cause blindness and death, he said. Greene said that McNeil knew Children's Motrin could cause SJS and even warned of the risk on the product's label when it was a prescription drug. Similar cases against McNeil are pending in at least six other states, he added. A spokesman said McNeil is "deeply concerned about all matters related to our products," but after reviewing the reports and scientific literature "we firmly believe that it is unlikely ibuprofen can cause Stevens-Johnson Syndrome and that Children's Motrin is safe and effective when used as directed and is labeled appropriately." Browne also said he hopes the case "sounds the alarm for why pre-emption is a bad idea." He argues pre-emption should not apply in this case because McNeil did not emphasize to FDA when requesting an OTC switch for Motrin in 1984 that some clinical trial participants developed SJS and Toxic Epidermal Necrolysis. Greene said the report was "hidden" in a stack of OTC-switch related documents and "not highlighted." A California judge previously denied McNeil's motion for pre-emption because it did not apply under state law, said Daniel Balaban, also of Santa Monica, Calif.-based Greene Broillet & Wheeler. - Elizabeth Crawford ([email protected]) |