The U.S. Supreme Court denied Johnson & Johnson’s petition to have a $140 million jury verdict reviewed in a failure-to-warn case involving a teenage girl who developed a serious skin reaction blamed on the company’s Children’s Motrin.
Johnson & Johnson had argued that claims made by Samantha Reckis and her parents that the over-the-counter painkiller gave her a painful and blistering skin condition should have been preempted by the 2009 Supreme Court decision in Wyeth v. Levine, which found that drug makers cannot be held liable for not including a label that “clear evidence” indicates the FDA would not have approved.
Reckis’ lawsuit claims that in 2003, when she was 7, she developed toxic epidermal necrolysis (TEN), the most serious form of Stevens Johnson Syndrome (SJS) after being treated with Children’s Motrin. The condition caused 90 percent of her skin to blister and peel off, leaving her susceptible to potentially fatal infections. She also developed blisters to the mucous membranes on her body, including the mouth and eyes. She lost 80 percent of her lung capacity and eyesight. Through the years she required multiple hospital stays and surgeries, and remains permanently disabled.
Reckis’ attorneys argued that the safety label of Children’s Motrin did not sufficiently warn consumers about the risk of SJS or TEN. A Massachusetts state jury found in favor of the family and awarded $50 million for their daughter’s injuries and damages, and $6.5 million to each of her parents for their losses stemming from her health issues.
Johnson & Johnson petitioned the Massachusetts Supreme Court to preempt Recesses’ claims, arguing there was “exceptionally clear evidence” that the FDA would have denied the warnings for SJS and TEN. The state’s high court in February 2013 upheld the decision.
The Supreme Court declined to review the ruling without comment. The verdict increased to $140 million when interest is factored.