NEW YORK (Reuters) - The U.S. Supreme Court said on Tuesday it will not hear Johnson & Johnson’s appeal of a $140 million judgment in a lawsuit alleging it failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition.
The decision leaves intact one of the largest verdicts ever awarded by a Massachusetts jury.
Johnson & Johnson and its McNeil-PPC Inc subsidiary had asked the high court to decide whether it should be held liable because they say federal drug regulators would not have approved adding warnings to the drug’s labels about the life-threatening condition suffered by the plaintiff, Samantha Reckis.
J&J’s petition had been closely watched by pharmaceutical industry trade groups.
They had urged the court to hear the case in order to clarify what constitutes “clear evidence” that the U.S. Food and Drug Administration (FDA) would have rejected a label warning about the diseases at issue in the lawsuit. If regulators did not think a warning was necessary, they argued, companies should not be liable for failing to warn consumers about that risk.
Reckis and her parents sued J&J and McNeil in 2007, claiming they were not warned about the link between the active ingredient in Children’s Motrin, ibuprofen, and Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, two rare, related skin conditions.
Reckis said she developed toxic epidermal necrolysis when she was 7 years old after receiving several doses of Children’s Motrin, leading her to lose 95 percent of the top layer of her skin and suffer other serious injuries, including heart failure, stroke and an aneurysm.
A Massachusetts jury found J&J and McNeil liable for failing to warn Reckis about those side effects and awarded her and her parents $63 million. With interest, the judgment totals $140 million.
J&J said the case should have been dismissed because the FDA had declined to grant a petition from several doctors and consumers seeking to add the names of those skin conditions to the warning label because they are unfamiliar to most consumers, and instead referenced potential redness, rash and blisters that are symptoms of those conditions.
The company said this constituted “clear evidence” that such warnings were unnecessary. But the Massachusetts Supreme Court disagreed, saying the FDA’s past actions did not indicate how it would rule on proposed changes from J&J, and affirmed the verdict last year.
A J&J spokeswoman said the company sympathized with the plaintiff but was disappointed with the high court’s decision not to hear the appeal. A lawyer for the Reckises, Michael Bogdanow, said they were grateful and relieved the Supreme Court had affirmed the judgment.
Reporting by Jessica Dye; Editing by Will Dunham, Alexia Garamfalvi and Jonathan Oatis