The U.S. Supreme Court has declined to an appeal of a $140 million judgment against hear Johnson for failing to warn that Children’s Motrin could cause a devastating skin condition.
Johnson & Johnson and McNeil-PPC Inc., a subsidiary, had asked the court 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.
Parents and their daughter sued J&J and McNeil in 2007, claiming they had not been warned about the link between ibuprofen-the active ingredient in Children’s Motrin pain and fever medication-and Stevens-Johnson and toxic epidermal necrolysis, rare and related skin conditions. The girl, then 7, developed toxic epidermal necrolysis after taking several doses of Children’s Motrin. She lost about 95 percent of the top layer of her skin and also suffered heart failure, stroke, and an aneurysm, Reuters reports.
Stevens Johnson Syndrome causes painful blistering of mucous membranes, typically in the mouth, eyes, and vagina, and areas of patchy rash. In toxic epidermal necrolysis, there is a similar blistering of mucous membranes, but in TEN, the top layer of skin peels off in sheets from large areas of the body. Both disorders can be life threatening and people who develop SJS or TEN often must be treated in a hospital burn unit. SJS and TEN can be caused by non-steroidal anti-inflammatory drugs (NSAIDs), both prescription and over-the-counter forms, sulfa drugs, antibiotics, barbiturates, anticonvulsants, tuberculosis drugs, and allopurinol, which is prescribed for gout.
The Massachusetts trial jury found J&J and McNeil liable for failing to warn about the possibility of SJS and TEN. The jury awarded the child and her parents $63 million. With interest, the award totals $140 million, according to Reuters.
J&J argued 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 add SJS and TEN to the warnings on the Children’s Motrin label. The petitioners said the conditions are unfamiliar to most consumers. Instead, the label refers to skin redness, rashes, and blisters, which are all symptoms of the two conditions. The companies argued that if the FDA did not think a warning was necessary, the companies should not be held liable for failing to warn consumers about that risk.
The companies 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 disagreed. That court upheld the award, saying that past actions by the FDA did not indicate how the agency would rule on future proposed changes.