In 2001, a 3-year-old girl was given eight doses of Children's Motrin to treat a fever and cough while she was in the hospital. Days later, the girl experienced reddening of the skin, rashes, and blisters and was later diagnosed with Stevens-Johnson Syndrome. Plaintiff's mother argued that the manufacturer of the drug, Johnson & Johnson, failed to warn of the associated risk, stating that at that time, the drug company had the authority to make changes to the label, not the FDA; she sued for product liability. These warnings were not placed on the packaging until 2005. Defense argued the labels were always adequate for the safe and effective use of the product, that even with the associated risks, the product's availability was in the interest of public health, that the girl's contraction of the syndrome could be attributed to other factors, and that even with a warning, the outcome likely would have been the same. The girl suffered loss of sight in one eye, permanent skin disfigurement, and damage to her reproductive system. The jury found Johnson & Johnson negligent for not providing an accurate warning on the label and that it was the factual cause of the girl's injuries.
Alicia E. Maya Donaldson v. Johnson & Johnson d/b/a McNeil Consumer Healthcare