The Pennsylvania Superior Court recently supported a $10 million verdict issued against Johnson & Johnson subsidiary McNeil-PPC over a Children’s Motrin lawsuit. The suit involved a 3-year-old girl who suffered a severe, potentially fatal, allergic reaction known as Stevens-Johnson Syndrome (SJS) after taking Children’s Motrin for a slight fever and cold.
SJS and a similar condition known as Toxic Epidermal Necrolysis (TEN) are severe allergic reactions that are usually caused by prescription and over-the-counter medications. SJS and TEN may be caused by essentially any drug, but some present a higher risk than others. Over-the-counter painkillers containing ibuprofen, including Motrin and Children’s Motrin, may increase the likelihood of these conditions.
According to the lawsuit, the Motrin-induced SJS caused the girl to suffer blindness in one eye, permanent reproductive damage and permanent disfigurement of the skin. The suit alleges that the drugmaker was aware of the risks but did not adequately warn of them on the drug label. The jury agreed with this assertion, and awarded $10 million in compensatory damages to the girl’s family.
McNeil appealed to the Superior Court, and argued that it could not be found liable for failing to warn about early SJS/TEN symptoms because it was not required by the U.S. Food and Drug Administration (FDA) when the girl developed the condition. This argument was rejected by the Superior Court, who asserted that the manufacturer is responsible for creating an adequate warning label.
SJS and TEN cause a skin rash that result in blistering, peeling and open sores. SJS is a medical emergency; patients usually need be hospitalized for treatment. Unfortunately, in many cases this reaction is not diagnosed in time and the risk becomes life-threatening. According to Mayo Clinic, SJS patients may experience fever, sore mouth and throat, fatigue, cough and burning eyes several days before the rash. Symptoms of an SJS rash include swelling of the face or tongue, hives, skin pain, a red or purple rash that spreads within hours to days, blisters on the skin and the mucous membranes of the mouth, nose, eyes and genitals and shedding of the skin.