A San Francisco jury recently awarded a family $97,000 after their 5-year-old daughter died after being given Children’s Motrin, a popular child’s cold medicine.

The parents said that they bought Children’s Motrin from a local Wal-Mart and gave it to their daughter in accordance with the cold medicine directions. The girl’s condition quickly deteriorated and she was hospitalized. She was transferred to a children’s hospital the next day because her condition continued to worsen.

According to the parents’ lawsuit, their daughter developed a severe reaction to the cold medicine called erythema multiforme. This condition is a type of hypersensitivity reaction to medicine that is marked by fever, vision problems, itching, burning eyes and generalized pain. The most severe form of erythema multiforme is called Stevens-Johnson syndrome and is marked by mouth sores, skin lesions, lesions on internal organs, sepsis and shock.

The girl also eventually developed toxic epidermal necrolysis, commonly known as Lyell’s syndrome. This extremely rare life-threatening condition involves the detachment of the top and lower layers of skin throughout the body. The medical literature is mixed regarding how common toxic epidermal necrolysis is, but it is believed that cases are limited to 0.04 to 1.3 cases per million.

The parents alleged that clinical trials indicated that the drug could cause this deadly allergic reaction, but the drugmaker failed to warn about Stevens-Johnson syndrome/toxic epidermal necrolysis in the Children’s Motrin drug package insert.

Pharmaceutical companies have an obligation to warn consumers of the possible side effects of their products, including known allergic reactions. Drugmakers that fail to do so can be held liable for the damages that arise out of this failure, including medical expenses, loss of income and wrongful death. In this case, the parents alleged that they would never have given their daughter the cold medication had they known that Stevens-Johnson syndrome/toxic epidermal necrolysis was a possible risk.

In its response to the parents’ lawsuit, the drugmaker alleged that the child’s reaction was extremely rare, thereby alleviating its duty to inform the parents of the risk. The drugmaker also made a laundry list of other affirmative defenses, including assumption of risk, adequate warnings provided and that the child has a pre-existing condition.

A jury ultimately rejected the drugmaker’s claims and awarded the family $97,149 in medical expenses against McNeil Consumer & Specialty Pharmaceuticals. Wal-Mart stores Inc., which sold the cold medicine, was not held liable. It is unknown whether the family made any pretrial settlements with Wal-Mart or Johnson & Johnson in this case. Many large retailers and pharmaceutical companies often settle cases involving child death to avoid the possible financial exposure of a jury trial.

Source: Brakefield vs. McNeil Consumer & Specialty Pharmaceuticals, 5 Trials Digest 15th 22, 2011 WL 7091312