Henry Greenspan

Supreme Court Rejects FDA Preemption Unanimously—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, it seems to me, is this: None of the opinions, either 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 definitions—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 support here. That, to me, is extraordinary. And it amounts to the fact 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) While he does not call on Michigan citizens to dump their tea in the harbor, the text certainly evokes such imagery.

Regarding the FDA issue 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 role relative to tort liability 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, this 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.

© H. Greenspan, 2009. All Rights Reserved.

Henry Greenspan: Author Bio | Other Posts
Posted at 3:38 PM, Mar 09, 2009 in Corporate Abuse | Corporate Lawsuit Amnesty | Federal Preemption | Preemption | Supreme Court Rulings
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The Rent Seeking Theory trumps all ideology and political affiliation in the lawyer. A statute is needed to ban the lawyer from all benches, all legislative seats, and all responsible policy positions in the Executive.

Posted by: Supremacy Claus | March 11, 2009 7:30 AM

@Supremacy Claus Did you forget to take your medication today? What does banning lawyers from holding office have to do with the FDA preemption? Why not ban anyone who is a plumber or a librarian or an IQ over 100? You're an idiot.

Posted by: ubuwalker31 | March 11, 2009 9:53 AM

Ubu: You must be young and healthy. Try to not age. Starting in your thirties, your body will become an endless source of entertainment as organ after organ fails every few years.

I am putting a curse on you. At some point, your doctor will say, "There is nothing more that can be done." The reason will be the lawyer and the left wing extremist nutjobs here will have destroyed our drug companies. The curse will be that you will remember this curse and nothing else at the time of the announcement. You will suffer a long time, then you will die treated with bogus, obsolete generics from Commie Care. You will suffer for months and seek the mercy of death. This curse will invade your mind with regret for your disrespect and your left wing hatred of our lawyer besieged nation.

I support morally and intellectually the formation of patient direct action groups. They will not kill the lawyer hierarchy. They will inflict painful, permanent injuries so they may understand the damage they are doing to our nation, and finally realize drug companies should be left alone to make medical progress.

Posted by: Supremacy Claus | March 11, 2009 11:31 PM

SC - If you read through all the pro-preemption briefs, you will only find one drug that is mentioned as having been pulled from the market as a result of lawsuits--Benedectin. At the time, both of Benedectin's active ingredients (one of which was Vitamin B6) were available over-the-counter.

What other drugs do you know of that were withdrawn as a result of suits?

Posted by: HG | March 27, 2009 12:32 AM

Here is more information on the recent Paxil settlement:

Posted by: Joshua | March 27, 2009 2:23 PM

Still I've been prevented from redress from harm done by the medical industry. The lawyers that I've contacted told me that it was because of the FDA preemption - and I have contacted a lot of lawyers. I was not seeking to sue the drug companies, I was seeking redress from the doctors that couldn't read my medical history, were definitely not afraid of harming me and could not see the adverse reactions that I was experiencing. Because of these heinous actions, I live in excruciating pain, I've been disfigured and I've been illegally fired from my job and barred from working for anyone, anywhere. I've lost all of my retirement, my life savings and I'm in abject poverty. The story is ending as I'm starving to death. Keep on poppin' them drugs, keep on watchin' them TV drug commercials, America. Population control. Yee ha! I know why don't we give America "free" drugs!

Posted by: Michael | November 16, 2009 4:55 AM