Clay Landa


Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally strengthen their warning without prior FDA approval under current regulations to head off any state tort claims for failure to warn. If the FDA ultimately determines not to approve the strengthened label, under explicit authority granted by Congress in the FDCA, drug makers have a strong argument that implicit conflict preemption now applies. As another avenue, drug makers may include a potential warning amounting to a prohibition of the drug's use or method of delivery when seeking initial approval of the warning label. Again, if the FDA explicitly rejects such a prohibitive warning, a drug maker may likely claim the FDA rejection preempts any state court requirement for the warning. In addition, drug makers may seek legislative action, both at the federal and state levels. In Congress, pharmaceutical companies could push for addition of an explicit preemption clause similar to one currently in the FDCA for medical devices. Finally, drug makers could take their case to state legislatures, seeking statutes that would not allow state tort claims for a failure to warn when the manufacturer complied with FDA regulations. Part II of this paper analyzes the history and background of federal preemption to give context to the current environment after Wyeth. Part III analyzes the Supreme Court's decision in Wyeth, holding that the FDCA and corresponding regulations do not preempt state tort claims. Finally, Part IV discusses and analyzes what drug makers may do now to continue to produce and market pharmaceuticals profitably while limiting their liability for state tort claims.