Last year, Professor Catherine Sharkey wrote that preemption is the “is the fiercest battle in products liability litigation today.” Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach,76 Geo. Wash. L. Rev. 449, 450 (2008) . Earlier this year, the Supreme Court stepped in and changed, or possibly ended entirely, that debate. In Wyeth, the Supreme Court rejected the drug maker’s claim that it would impossible for its drug Phergan to comply with the FDA’s warning label requirements and the implicit requirements of state failure to warn laws. See Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009) (“But absent clear evidence that the FDA would not have approved a change to Phergan’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements. Wyeth has offered no such evidence.”).
With future preemption claims likely to fail, drug makers and their allies may turn once again to state law to protect themselves against liability and allegedly frivolous lawsuits. Michigan is the model example because it is the only state that provides that compliance with FDA regulations is a complete defense to state tort suits. In Michigan, “a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration . . . .” Mich. Comp. Laws § 600.2946(5) (2008). This statute, though, is under attack. An attempt to repeal the provision has passed the Democratic-controlled state house but stalled in the Republican-controlled state senate, and gridlock appears likely to continue. Rather than accepting either side’s all or nothing approach, my note, When and How to Defer to the FDA: Learning from Michigan’s Regulatory Compliance Defense, advocates a middle of the road approach. Drugs that comply with the FDA’s regulations should still have a defense against liability, but a back-up in the form of state attorney general-lead litigation should be there to provide deterrence in situations where the FDA has failed to act and to provide compensation to legitimate victims. Hopefully legislators in Michigan, and other states considering a regulatory compliance defense, will read this paper.