Vonnie Cornett v. Johnson & Johnson and Cordis Corp. (A-88/89-10; 066671)
The Cornett complaint is time-barred. The failure to warn claim as to approved and off-label uses is preempted, except to the extent plaintiffs base the claim on allegations of deliberate non-disclosure or fraudulent representations of known adverse information apart from defendants’ failure to comply with FDA disclosure requirements or promotion of off- label uses outside the safe harbor. The breach of express warranty claim is also preempted, except to the extent plaintiffs allege defendants have made voluntary statements to third parties beyond and different from the information on the approved label or packaging.
