On January 19, 2016, the U.S. Supreme Court said it would not hear Johnson & Johnson’s appeal of a $140 million judgment in a lawsuit alleging the company failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition.
Johnson & Johnson and its McNeil-PPC Inc. subsidiary had asked the to decide whether it should be held liable because they claim federal drug regulators would not have approved adding warnings to the drug’s labels about the life-threatening conditions, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), Reuters reports.
In refusing to hear the appeal, the high court left intact one of the largest verdicts ever awarded by a Massachusetts jury.
The family that sued J&J and McNeil in 2007 claimed they were not warned about the link between ibuprofen—the active ingredient in Children’s Motrin—and Stevens-Johnson Syndrome and toxic epidermal necrolysis, rare and related skin conditions. The child developed toxic epidermal necrolysis when she was 7 years old after taking several doses of Children’s Motrin. She lost about 95 percent of the top layer of her skin and suffered other serious injuries, including heart failure, stroke, and an aneurysm, Reuters reports.
In Stevens Johnson Syndrome, the individual suffers blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. In toxic epidermal necrolysis, there is a similar blistering of mucous membranes. But in TEN, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening. SJS and TEN can be caused by non-steroidal anti-inflammatory drugs (NSAIDs) in both prescription and over-the-counter forms, sulfa drugs, antibiotics, barbiturates, anticonvulsants, anti-tuberculosis drugs, and the drug allopurinol, prescribed for gout.
A Massachusetts jury found J&J and McNeil liable for failing to warn about these serious side effects. The jury awarded the family $63 million, which, with interest, totals $140 million.
J&J said the case should have been dismissed because the Food and Drug Administration (FDA) had declined to grant a petition from several doctors and consumers seeking to mention SJS and TEN on the Children’s Motrin warning label because those conditions are unfamiliar to most consumers. Instead, the label references potential redness, rash and blisters that are symptoms of the conditions. The companies argued that if the FDA did not think a warning was necessary, they should not be liable for failing to warn consumers about that risk.
The company said the FDA’s decision not to change the warnings constituted “clear evidence” that such warnings were unnecessary, according to Reuters. But the Massachusetts Supreme Court, which upheld the award, disagreed, saying that past actions did not indicate how the FDA would rule on future proposed changes.