Sunday, March 8, 2009


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.


  1. Interesting comments - Thanks for the analysis Justice. Also, congratulations on the victory here.

    Justice Thomas's comments are interesting -- I certainly did not expect him to rule the way he did, but you're right that it make's sense in retrospect. Presumably, given his stand on state rights, Thomas would find Michigan's law perfectly acceptable: If the citizens (or elected government) of the State of Michigan WANT to defer authority to the FDA, then so be it. However, he seems most opposed to federal REQUIREMENTS that states to give up thier rights.

  2. Here's some interesting comments from "The Pink Sheet". Especially focus on the second section of the article. The authors here view that preemption is not dead -- individual drugs may well have preemption when the risks are well-studied by the FDA. Notice that they particularly point out suicidality for SSRI's as a possible class of drugs that may still be able to claim a "preemption defence".
    While the Supreme Court's landmark ruling in Wyeth v. Levine dashes pharmaceutical industry hopes for broad protection from product liability lawsuits, it will not trigger any sea change in litigation. Instead, the opinion seems likely to maintain the status quo and restrict the situations in which companies can claim they provided adequate warning of a drug's risks.

    The court ruled 6-to-3 in the case that FDA-approved labeling does not block individuals from pursuing personal injury claims under state law.

    The March 4 opinion, written by Justice John Paul Stevens, resoundingly rejected Wyeth's arguments that federal law pre-empts respondent Diana Levine's claims that the company did not adequately warn of the risks of IV-push administration of its anti-nausea drug Phenergan (promethazine). Levine, a musician, had her forearm amputated after the drug inadvertently went into an artery, causing gangrene.

    The court dismissed Wyeth's contention that FDA labeling regulations prevent companies from unilaterally adding warnings without prior FDA approval. It also concluded that Congress did not intend to pre-empt state failure-to-warn actions and that a 2006 FDA preamble to a drug labeling regulation is "inherently suspect" since it reversed FDA's own longstanding position that state law is a complementary form of drug regulation.

    The decision upholds a ruling by the Vermont Supreme Court, which upheld a $6.7 million jury verdict against Wyeth. Justice Samuel Alito wrote a dissenting opinion, joined by Chief Justice John Roberts Jr. and Antonin Scalia.

    While the decision is a blow for the pharmaceutical industry, which had hoped the Supreme Court would bolster its pre-emption defense in personal injury suits, lawyers on both sides of the issue agreed it maintains the status quo.

    "While it's disappointing this is not an earth-shattering change," said Arnold Friede, counsel at McDermott Will & Emery, "it will return things to where they were before 2006" when FDA issued the preamble to its drug labeling rule.

    FDA Views On Specific Drug Risks May Be Key

    Friede said the court did not lay out a standard for when industry can use the pre-emption defense but that one could infer it would be appropriate in situations where FDA has considered a drug's risks in depth. He said such a situation exists when FDA implements a Risk Evaluation and Mitigation Strategy requiring a company to do specific things to control for a drug's risks.

    A company should not be liable for an injury that the REMS was intended to address, Friede said. "If that's not pre-empted then there's nothing left to pre-empt and we might as well give it up."

    James Beck and Mark Herrmann, authors of the Drug and Device Law blog, also said companies might use the pre-emption defense in situations where FDA considered a particular risk in considerable depth and rejected adding a warning about the risk to the labeling. Suicidality claims related to selective serotonin reuptake inhibitors would be a good example of this kind of review, they said.

    "The court did not hold that there's no pre-emption at all, or no pre-emption without an express regulation, either of which it could have done," they wrote in a blog posting on the decision. "After Levine, it's pretty clear though that implied pre-emption is going to depend quite a bit on what the FDA has to say about specific drug risks, and not very much on what the FDA has to say about pre-emption."

    Brian Wolfman, director of Public Citizen Litigation Group and one of Levine's attorneys, agreed that the ruling will not change the terms of pharmaceutical product liability litigation.

  3. Hi Nathan--Thanks for these posts which definitely raise the right questions.

    Re: Michigan, it is a fascinating issue--whether a state can impose standards on itself that defer to the feds. This has actually been argued in the Mich. Supreme Ct. some years ago. It was a close decision in favor of our law. That was also a much more preemption-friendly court. So there is a reasonable chance a similar case will arise or the state legislature will rescind the law first.

    I think the Pink Sheet is saying pretty much what I wrote. The preempiton upheld by the _dissenters_ was a very narrow one--close to the Sharkey criteria. It does not resemble the broad preempton we've mostly heard. And this was the view of the minority three Justices. Not clear where the other six would go on that.

    As things stand, Wolfman sums it up at the end. As of now, nothing has changed one way or other.

  4. Justice – Thank you for this excellent review of Levine. Justice Thomas nailed it when he said FDA preemption “is little less than tyranny.” The FDA over-reached its power, forgot its mandate, and lacked respect for tort law. The Levine decision will help shine a bright light on Michigan’s un-just law and efforts to rescind it.

  5. One point in the quotes that Nathan provide that I don't understand. The quote -

    "Friede said the court did not lay out a standard for when industry can use the preemption defense but that one could infer it would be appropriate in situations where FDA has considered a drug's risks in depth."

    It seems that there are different levels of FDA studies? Some are "in depth" and some apparently are cursory. Of course that begs the question - what is in depth?

    Then citing SSRI's as an example of the type of drugs that might be preempted because of the FDA's "in depth" studies seems ridiculous. I would say that if it is true that these drugs have undergone in depth FDA study we can conclude that FDA in depth study should not be a qualification for preemption.

    Some of the main reasons for the outcry against preemption are facts that we all know:
    1. The FDA does not get all the facts about premarket studies, sometime they get half truths or outright lies.
    2. The capacity of the FDA does not meet the demand for drug/device safety.
    3. Post approval, real life drug usage often reveals previously unknown issues with drug/device safety.

    Given the nature of man to be both fallible and self centered (a nice way of putting it), preemption should not have any qualifiers for its existence. If it exists it can and will be abused eventually. If it exists much thought will be encouraged to exploit it for selfish purposes. Billions of dollars are riding on it.

    My conclusion -
    Sometimes deciding legal issues that we've made about as complicated as they can be, need to be boiled down to basics.

    Basically any time a product is provided to a consumer the consumer reserves the right to complain about the product to the producer. This should be encouraged. In the extreme the consumer reserves the right to take that complaint to litigation if he/she feels that they are justified. The consumer does this for two reasons. One - to be compensated for damages and two - to cause the producer to make their product safer for others.

    Let's leave the evil trial lawyer argument out of this, it's not a factor.

    So for me it's simple, you can not take away the right to complain and be compensated if justified. The court will decide what is justified.

    Any other issues that this right (even responsibility) to complain might cause need to be solve by means other than simply taking away the right of the consumer to complain. Here I refer to the presumption that litigation may cause a reduction in life saving drugs and devices or that some litigation may be abusive.

  6. Jaynesday writes: "So for me it's simple, you can not take away the right to complain and be compensated if justified. The court will decide what is justified."

    If it were that simple, then I would agree completely. The problem is that there is no universal standard of justice among jurors or judges. Who wins and who looses seems to be largely a crapshoot. Moreover, consumers don't have to pay anything to file a lawsuit -- it doesn't cost them a penny. (thanks to lawyers who only charge services when they win) Yet, if they happen to win, there will be major payouts. Pharma companies get no such free-lunch. We have to pay to defend each and every lawsuit brought against us - regardless of who wins and who looses.

  7. Nathan, I understand what you say. There are problems with litigation. My point is that these industry difficulties should not be solved by elimination of the right to complain in a court of law.
    Elimination of litigation certainly would solve the industry's issues with litigation but elimination of litigation from the consumer's point of view is not an option.

  8. Justice

    My must admit I had an initial Kneejerk response to the dissent, but after rereading their opinion I agree with your analysis. The Geier case was their starting and ending point. In Geier, the DOT allowed Auto Manufacturers a choice of passive restraints in the manufacture of automobiles. A suit was bought against Honda for failing to install a specific device (airbags) and the court ruled that the State Action supporting the plaintiff ususrped Federal Authority by mandating a specific restraint.
    This case is similar in manner and the fact that the dissent focused on the language of labeling available at the time of the incident focused on the inconsistency with Geier in the majority opinion. It’s just a guess on my part but had the FDA not issued the 2006 preamble and Wyeth presented their argument entirely on the issue decided in Geier they may have been successful.
    However that was not the issue pursued by Wyeth and the FDA; Wyeth and the FDA were requesting a broad restriction on preemption. Although I believe that Wyeth’s initial claim was only that under the then current FDA regulations they were powerless to change the existing language. The FDA through the Solicitor General sought to expand the argument to include broad preemption. The initial argument raised by Wyeth brought this case down to a very simple issue and it really boils down to does Wyeth’s argument hold water? And the majority’s answer was no; it does not.
    As far as broad preemption sought by the Bush Administration; I do not agree that the 2006 Preamble did not factor in the decision. Although the majority references the preamble and states the preamble is not entitled to the usual agency deference, I believe the fact is the majority took a negative inference from the existence of the preamble and used its very existence as a reason to justify their decision. In the opening statement, where the majority references the preamble, their language was essentially a “smack down” of over reaching by the FDA and a repudiation of Executive Authority.
    In closing, I have previously written that this was a poor case for opponents of preemption, turns out I was wrong. However, I believe, especially after reading the existing FDA approved label, that this case should not have survived Summary Judgment at the State level.

  9. Assargh. Just wrote a long comment that got lost in space.

    Anyway, most relevant part was that it will probably be difficult to determine what an "adequate" FDA review of a particular risk is. And, as FDA has argued, it will take a lot of their time/resources to maintain all the paperwork, not to mention appearing in court to back it up. Perhaps some of this would be decided in summary judgement were this to become a basis for limited preemption.

    This has been Sharkey's view, and criticized, in part, for the reasons above.

    Agree that the preamble served as provocation to the majority. Bias assumed, I think that the FDA Chief Counsel's office really did overreach themselves--the "power grab" aspect was almost asking for push back. And that's, of course, what they got.

  10. Question perhaps especially for Jim.

    Could case law and precedents serve to create "de facto" immunity if one could determine "adequate review" criteria, such that one didn't need the Supreme Court to formally back "preemption" under such circumstances?

  11. Justice

    To answer your question, I think Geier is a good starting point; however your question points to "adequate review" as the basis for immunity so I will have to get back to you. Unfortunately since my retirement I no longer have access to Lexis/Nexis so I am restricted to Findlaw and the Legal Research Institute, and the search engine in Findlaw has deteriorated significantly. However, I will see what I can find.

    Just a Hint: Write your comments in Word or WordPerfect and then copy them to the blog, if the comment gets lost you still have your original.

  12. Thanks, Jim. I'll do that for long things.

    I assume "adequate review" is not a term or art, but perhaps there is something equivalent that would clarify.

  13. "James Beck and Mark Herrmann, authors of the Drug and Device Law blog, also said companies might use the pre-emption defense in situations where FDA considered a particular risk in considerable depth and rejected adding a warning about the risk to the labeling. Suicidality claims related to selective serotonin reuptake inhibitors would be a good example of this kind of review, they said. "

    Interesting that ssri's are singled out, when in fact the FDA added the black box warnings LONG after the drug was on the market based on information that was overlooked/misrepresented at the time of approval.
    They are the perfect example of why preemption should not have applied.
    1. Studies proving the risk were suppressed/missed by pharma.
    2. The FDA chose not to raise the red flag back in 1991, when the risks became more widely reported directly from patients to the Medwatch system.
    3. The addition of the black box warnings in 2004 for suicidality, based on information available back in 1991 and not acted on for 13 years.

    To now state that this category of drugs is somehow different that other risky drugs and those who were harmed should be limited in their recourse is troubling.

  14. Adequate Review -
    I believe that this concept is what supporters of preemption have been claiming that the FDA already does. Therefore couldn't we assume that this qualifier for a possible future form of preemption will be abused, broadly defined and misleading?

    Who will define Adequate Reiview? An FDA/Industry committee who's under the table goal is to accelerate the introduction of new drugs/devices?

    Adequate Review is in essence the root of the original preemption preamble fiasco, just re-termed.

    Seems dangerous to me and seems likely that it would put us right back where we started.

  15. Product manufacturers of any sort can never be absolved from questioning and inspection directly by the consumer. I say no way, no how.

  16. Jaynesday==I think lsyorke defines the issue in her post above: "situations where FDA considered a particular risk in considerable depth and rejected adding a warning about the risk to the labeling."

    Yes, it will come down to definitions. But these are essentially Sharkey's criteria and far more narrow than "FDA appoval=preemption." They will have to demonstrate both the depth and the specific fact of rejecting, all premised on their having all the relevant information available.

    In a case in which all the above _genuinely_ applied, I would certainly encourage companies to use those facts at trial, and it is hard to imagine their losing, whether or not even this most narrow of preemption scenarios had some sort of sanctioning.

    In the meantime, FDA itself has argued against this model because they claim (maybe rightly) they don't have the resources or people to do that kind of record-keeping and, potentially, being deposed.

    If not, then no basis for seeking preemptive authority.

  17. Relevant news item from Law 360:

    "High Court Remands Cases In Light Of Wyeth
    Law360, New York (March 09, 2009) -- Just days after the U.S. Supreme Court ruled in the key product liability case Wyeth v. Levine, the high court vacated and remanded two cases that also center on the issue of preemption.

    In an order Monday, the high court sent Pennsylvania Employees Benefit Trust Fund v. Zeneca and Colacicco v. Apotex back to the U.S. Court of Appeals for the Third Circuit."

    The Colacicco case, in particular, had been considered extremely important re: refining degree of preempiton. I assume they were remanded because we now knew how the Court puts the boundaries.

    If we are essentially not in favor of preemption, I think it is still amazing that even the dissents support the narrowest versions of preemption that have been proposed by anyone. If that's where you start, and move back, this remains an enormous victory for people who have stood against FDA preemption in the drug arena.


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