The U.S. Supreme Court has declined to review a $140 million jury verdict over inadequate warnings on Johnson & Johnson’s Children’s Motrin in favor of a teenager who had developed a life-threatening skin condition. The verdict had been upheld by Massachusetts’ highest court. The pharmaceutical giant had argued in its petition for writ of certiorari that claims by Samantha Reckis and her parents that J&J’s Children’s Motrin gave the child a horrific skin condition, requiring multiple hospital stays and surgeries since she was 7 years old, should have been preempted by the Supreme Court’s 2009 decision in Wyeth v. Levine. That ruling, which held that U.S. Food and Drug Administration (FDA) approval of a medication does not shield its maker from liability. That opinion also held that manufacturers cannot be held liable for not including a label that “clear evidence” indicates the FDA would not have approved.
Industry groups, including the Biotechnology Industry Organization, the Consumer Healthcare Products Association and the Pharmaceutical Research and Manufacturers of America, had backed J&J’s contention that Reckis’ claims were preempted, contending in a pair of amicus briefs that the upheld verdict presents “a square challenge” to the FDA’s regulatory authority.
Plaintiff Reckis was represented in the state trial and appellate proceedings by Bradley M. Henry, Leo V. Boyle, Michael B. Bogdanow and Victoria Santoro of Meehan Boyle Black & Bogdanow PC. They did an excellent job in this case. The case is in the Supreme Court of the United States.
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