Johnson & Johnson ($JNJ) is oh-for-two at the U.S. Supreme Court this month.
Last week, the court refused to weigh its final appeal against a $124 million penalty in a Risperdal marketing case. Now, the high court has said the same about an even bigger judgment.
J&J and its McNeil subsidiary now face a $140 million judgment in a lawsuit over Children's Motrin side effects.
A Massachusetts jury found that the company failed to warn consumers about a rare but potentially fatal set of skin conditions, Stevens-Johnson syndrome and toxic epidermal necrolysis. The jury awarded the plaintiff, Samantha Reckis and her parents, $63 million in damages. With interest, the award amounts to $140 million.
J&J had argued that the FDA would not have approved adding warnings about the skin conditions to Children's Motrin labeling. The company cited a citizen petition asking that the label mention Stevens-Johnson syndrome and toxic epidermal necrolysis; the FDA didn't grant that request, saying that the names weren't familiar to most consumers.
As Reuters notes, J&J argued that the FDA's denial was "clear evidence" that the warnings weren't necessary. But the Massachusetts Supreme Court said the FDA might have acted differently if J&J itself had requested the change.
Trade groups had filed amicus briefs urging the Supreme Court to take up the case to offer greater clarity on just what "clear evidence" means, Reuters reports. The briefs argued that companies shouldn't be held liable for failing to warn about risks if regulators did not think a warning was necessary.
- see the Supreme Court docket in this case
- get the news from Reuters