In a setback to Johnson & Johnson, the US Supreme Court yesterday declined to review a case in which a family successfully argued that the healthcare giant should have included sufficient warnings about the risks of Infant Tylenol. For its part, J&J had argued that state failure-to-warn claims involving over-the-counter drugs are preempted under a Supreme Court ruling last year that did immune generic drugs from such lawsuits. Preemption, you may recall, is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued three years ago before the Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. There are, however, exceptions in which preemption prevails.
