Janssen's Warning Letters Failed to Advise Physicians of Dangers Associated with Off-Label Use

NEW YORK -- A New York Supreme Court Justice denied Janssen Pharmaceutica's motion for summary judgment in a case filed by a woman claiming that her son's death was caused by Propulsid, after finding that the company's warning letters did not warn about the dangers of off-label use in children. Elizabeth M. Owens v. Janssen Pharmaceutica Products, L.P., et al., No. 12043/01 (N.Y. Sup. Ct.).

New York Supreme Court Justice John W. Burke ruled Dec. 3, 2003, that the woman presented a triable issue of fact as to whether Janssen misled potential consumers and physicians concerning the safety and efficacy …