FURTHER THOUGHTS ON WYETH V. LEVINE

Supreme Court Rejects FDA Preemption—Nine to Nothing.

I have now read the complete set of opinions in Wyeth v. Levine. While I cannot claim to have followed every nuance, and I’m sure I’ve missed much, certain conclusions seem warranted.

The most important one is this: None of the opinions, neither the majority finding nor the dissents, support anything remotely like the kind of broad preemption that has been argued in most of the pro-preemption positions—whether in amici, white papers, or in the Bush FDA’s own pronouncements. Indeed, the entire structure that the FDA put together to justify preemption—most specifically, the 2006 preamble and the 2008 CBE redefinitions—are missing from Justice Alito’s dissent (in which he was joined by Chief Justice Roberts and Justice Scalia). In this regard, the dissent is also strikingly unlike a number lower court decisions which did turn on these FDA assertions. Here, what is striking is that nothing turns on them at all. They are windblown leaves; the scattered remnants of a house of cards.

Instead, the dissent is framed quite narrowly. It makes the very specific argument that FDA extensively considered the risks of IV push injection of Phenergan, established considered and appropriate warnings, and that—given those specific facts and their similarity to other precedents (the Geier case is noted most prominently)—preemption should prevail in this instance. Again, this is a far more narrow support of preemption than almost everything that we have heard from preemption’s advocates. And that narrowness is made explicit in Justice Alito’s conclusion, which itself merits close attention:

“To be sure, state 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.” (26)

The operative language, it seems to me, is “this case.” To those who yearn for the day when FDA approval, in and of itself, inherently preempts failure-to-warn suits, they will find no comfort from Justice Alito. Instead, they will find definitive rebuttal. That, to me, is extraordinary. And it means that the Supreme Court has unanimously rejected FDA preemption in the form in which we have most often heard it articulated.

If the dissent is this narrow on preemption, the majority opinion and concurrences are devastating. Taking a strong federalist view, Justice Thomas asserts that FDA preemption is little less than tyranny. He quotes an 1869 case that “the preservation of the States, and the maintenance of their governments, are as much within the design and care of the Constitution as the preservation of the Union and the maintenance of the National Government.”(3) Later, invoking Justice Story in 1831, he asserts that such “invasions” from the center are “merely acts of usurpation, and will deserve to be treated as such.” (5) Justice Thomas makes no mention of the fact that only Michigan has an FDA preemption law based on precisely the doctrine that he calls "usurpation." And while he does not call on Michigan citizens to dump their tea in the harbor, the text certainly evokes such imagery.

Regarding FDA preemption specifically, Justice Thomas is definitive:

“Initial approval of a label amounts to a finding by the FDA that the label is safe for the purposes of gaining federal approval to market the drug. It does not represent a finding that the drug, as labeled, can never be deemed unsafe by later federal action, or as in this case, the application of state law.” (11)

And further:

“Nothing in the text of the statutory or regulatory scheme necessarily insulates Wyeth from liability under state law simply because the FDA has approved a particular label.” (12)

It is hard to be more clear than that. Or more rejecting of the preemption argument as we have heard it during the past seven years.

Not surprisingly, Justice Thomas also makes no mention of the recent preamble or CBE changes. They are, in his opinion, of no consequence. By contrast, they do appear in the majority opinion—as presumptions entirely without merit and worthy of no deference. Here, there is no reason to go into detail. In a rolling series of arguments and citations, the majority asserts that preemption, as we have heard it asserted in recent years, is little more than an aberration, fully out of touch with the past seventy years of both the FDA’s own understanding of its authority relative to tort law and Congressional intent on the same question. For those of us who agree with that view, the opinion is a treasure trove of relevant citations. But there is no need to reiterate those here.

So I return to my initial conclusion. At core, Wyeth v. Levine was not a 6-3 decision. With regard to the preemption defense as we have most often heard it articulated, it was a 9-0 rejection.

Send in the brooms.