The judge has ruled that Johnson & Johnson could be liable for punitive damages if the company was guilty of "implied malice" for failing to alert the US Food and Drug Administration (FDA) about two cases of Stevens Johnson syndrome that were associated with the use of Children's Motrin.
According to the Pittsburgh Post-Gazette (04/11/11), the lawsuit concerns Kiley Wolfe, a 9-year-old whose ordeal began when she was given Children's Motrin by her parents back in 1996 to treat a headache and fever. Following administration of the Children's Motrin, Kiley developed Stevens Johnson syndrome and Vanishing Bile Duct Syndrome, a condition that can cause liver failure. Kiley eventually required a liver transplant.
READ MORE STEVENS JOHNSON SYNDROME (SJS) LEGAL NEWS
In making his decision, the judge noted that Johnson & Johnson acknowledged receiving two reports of SJS but did not mention those reports in a Clinical Study Report. A senior medical consultant for Johnson & Johnson, however, said the cases were reported to the FDA but were excluded from the study because they were not linked to the drug.
The judge determined that it is up to a jury to decide whether Johnson & Johnson handled the reports properly. The judge further stated that if the jury finds that information about the reports of SJS was deliberately concealed from the FDA to win approval of over-the-counter Children's Motrin and to avoid adding a warning label, the defendant could face punitive damages.