A federal judge in Pennsylvania ruled that Johnson & Johnson (JNJ) may be liable for punitive damages if it displayed "implied malice" by failing to alert the FDA to two cases of a life-threatening condition associated with Children's Motrin.
The remote but serious danger for children who are given Motrin comes from Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (both conditions in which a patient's skin detaches from her body), and acute Vanishing Bile Duct Syndrome (which leads to liver failure).
In the case, 9-year-old Kiley Wolfe was given Children's Motrin by her parents in 1996. She contracted SJS and VBDS and had to have a liver transplant. Her lawyers claim that the Motrin box fails to warn parents of this risk, and that J&J didn't report to the FDA two cases of the condition in a study it had done on Motrin's safety. The judge wrote:
J&J senior medical consultant Anthony Temple told the court that the cases had been reported to the FDA but were left out of a massive 83,000-child study of Motrin because they were not linked to the drug:
Over the last two decades, Americans have annually purchased more than 6 billion doses of the drug.
... According to the FDA, there are an estimated one to six cases of SJS diagnosed per million people per year from all causes.Nonetheless, the consequences are so severe in the small number of children who contract the condition that Motrin is a potential 60 Minutes episode-in-waiting. In a separate California case it emerged that Motrin packets in Germany warn of the condition but the U.S. packet has never specifically warned of the disease. In fact, the specificity of the warnings -- and the likelihood that a parent would figure out that her daughter appears to be dying from Children's Motrin -- are at the heart of the Wolfe case.