Pennsylvania appeals court upheld a $10 million jury award to a 3-year old girl whose body was covered with blisters and a rash caused by a reaction to Children's Motrin, requiring her to get skin grafts and surgeries on her skin, eyes and vaginal wall.
McNeil-PPC, a maker of over the counter medicines, had been held liable on January 6, 2012 after a nine-week jury trial for negligent failure to warn. The company raised 10 evidentiary and procedure claims in its appeal, all of which were denied on July 22, 2014.
The child, now age 17, developed toxic epidermal necrolysis, described as an especially severe form of Stevens Johnson Syndrome. It caused blistering and sloughing off of skin to her mouth, eyes, throat, esophagus, lungs and complete fusion of both sides of the vaginal wall. She had 16 eye surgeries because of adhesions and scar tissue between her eyelid and eyeball.
McNeil: not required to warn
McNeil argued it was not required by the FDA to add "skin reddening," "rash," and "blisters" to the list of symptoms in the allergy alert on the label. The court opinion, dripping with scorn, said, "the manufacturer bears responsibility for the content of its label at all times."
The girl's mother testified that she checked the label, would not have bought the medication and would have stopped giving it to her daughter if it had warned of the devastating side effects.
On Saturday, November 25, 2000, the child came home from attending a play. She was coughing and felt slightly warm, and her mother gave her the first of many doses of Children's Motrin over several days.
On Tuesday morning she went to the first of several hospitals with a rapidly spreading rash over her entire body, her eyes red with discharge and blisters on her mouth, chest and groin. By Friday burn-like wounds covered 85% of her body.
She suffered a drop in blood oxygen and blood pressure, fluid had to be continually suction out of her lungs, and she needed multiple blood transfusions because of internal bleeding. Doctors sedated her to relieve the excruciating pain.
Nine days to diagnose
Nine days after the onset of the first symptoms, doctors determined that the cause was Children's Motrin, which is pediatric ibuprofen.
The damage to her reproductive system will prevent her from having normal intercourse and childbirth. She must stay out of sunlight, which can damage her eyes, and avoid strenuous activity due to her inability to perspire normally. Scarring in her lungs makes breathing difficult and increases the risk of asthmatic attacks.
When her mother checked the label and dosage instructions, the label warned only of hives, wheezing, facial swelling or shock and recommended "call your doctor" if symptoms persist.
The case is Alicia E. Maya v. Johnson and Johnson and McNeil-PPC, No. 3259 EDA 2011, 2014 Pa. Super 152, Superior Court of Pennsylvania.
