MICHIGAN HOUSE RESCINDS FDA PREEMPTION LAW....AGAIN

Make Sense to You?

Today, the Michigan House voted to rescind (i.e., repeal) the state's thirteen-year-old drug industry immunity law....again. In 2007, the House voted similarly, but the bill was killed in the state Senate which has a thin majority favoring the 1996 statute. A difference this year is that a number of the Senators who favor Michigan's full preemption will be running for reelection in 2010. The issue made a significant difference in the 2006 and 2008 state elections.

The Michigan statute is unique, providing a full shield to any drug that is FDA approved. This is a far broader immunity than even the dissent imagined in Wyeth v. Levine. Justice Alito wrote in that dissent:

"To be sure, tort suits can peacefully coexist with the FDA's labeling regime, and they have done so for decades. But this case is far from peaceful coexistence."

The operative phrase is "this case"--the particular circumstances of the Levine case in which, the dissent argued, the FDA had fully reviewed the particular risk in question. In order to make that argument, the dissent itself fully reviewed the history of FDA's considerations of the Phenergan label. So the issue in Levine was not what was, or was not, on the label. It was the regulatory history of how it got there. (Indeed, writing for the majority in Levine, Justice Stevens wryly noted that the dissenting Justices had done a far more thorough job reviewing Phenergan's risks and benefits than the FDA ever did.)

In Michigan, the sheer fact that a drug and its label are "FDA-approved" is, in and of itself, the only criterion necessary to provide a full shield. Thus, in Michigan, there are _no_ situations in which tort suits "can peacefully coexist with the FDA's labeling regime." The fact that they "have done so for decades" is either entirely ignored or dismissed as a mistake.