A drug manufacturer may be held liable for punitive damages on a theory of “implied malice,” a federal judge has ruled, where evidence suggests the manufacturer withheld information from the U.S. Food & Drug Administration that would have led to stronger warning labels.
In his 25-page opinion in Wolfe v. McNeil-PPC Inc. , Senior U.S. District Judge Jan E. DuBois said a jury must decide whether the manufacturer of Children’s Motrin withheld from the FDA reports of two instances in which patients developed Stevens-Johnson Syndrome, a rare and life-threatening condition affecting the skin in which cell death causes the epidermis to separate from the dermis.
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