U.S. High Court Asked To Clarify ‘Clear Evidence’ Of FDA Labeling Decisions
(October 27, 2015, 7:22 AM EDT) -- WASHINGTON, D.C. — Johnson & Johnson and McNeil-PPC Inc. on Oct. 8 asked the U.S. Supreme Court to decide if a Food and Drug Administration response to a citizen petition regarding a risk of Children’s Motrin constitutes “clear evidence” that the agency considered and rejected a stronger warning about the risk of toxic epidermal necrolysis (TEN) (Johnson & Johnson, et al. v. Lisa Reckis, et al., No. 15-449, U.S. Sup.).
(Johnson & Johnson brief available. Document #28-151029-015B.)
Samantha Reckis, the minor child of Lisa and Richard...