Wyeth and Deference to Agencies:

One interesting aspect of the Supreme Court's Wyeth decision is its refusal to defer to the FDA's conclusion that state tort suits, of the sort at issue here, conflict with the FDA's regulatory scheme. While the Court does not foreclose deferring to similar agency determinations in the future, Justice Stevens makes clear that it is for courts, not agencies, to determine whether such a conflict exists. While this might not matter much in the immediate future, as I doubt the Obama Administation will be all that aggressive in urging preemption, it will raise the bar for future, pro-preemption administrations.

Here is a portion of the relevant language in the opinion.

In prior cases, we have given "some weight" to an agency's views about the impact of tort law on federal objectives when "the subject matter is technica[l] and the relevant history and background are complex and extensive." . . . Even in such cases, however, we have not deferred to an agency's conclusion that state law is pre-empted. Rather, we have attended to an agency's explanation of how state law affects the regulatory scheme. While agencies have no special authority to pronounce on pre-emption absent delegation by Congress, they do have a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an "obstacle to the accomplishment and execution of the full purposes and objectives of Congress." . . . The weight we accord the agency's explanation of state law's impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. . . .

. . . we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law. And the FDA's newfound opinion, expressed in its 2006 preamble, that state law "frustrate[s] the agency's implementation of its statutory mandate," . . . does not merit deference for the reasons we have explained. . . .

In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.

The folks at the Drug and Device Law blog have some initial thoughts on the decision here.

Related Posts (on one page):

  1. Wyeth and Deference to Agencies:
  2. Court Rejects Wyeth's Preemption Claim:
You might want to close that italics tag ...

I agree with Stevens -- the courts should defer to the FDA on matters related to the safety of food and drugs and the methods for determining same. Deference over a manifestly political matter is out of the question.
3.4.2009 6:21pm
Prof. S. (mail):
Can I close the tag for you? [/i]

Only this will tell....
3.4.2009 6:27pm
Larry Reilly (mail):
The FDA's policy on preemption has changed 180-degrees in recent years. To insist that the newest iteration, which displaced long-running policy statements going the other way, might be comparable to supporting that "living" Constitution that so-called strict constructionists detest.
3.4.2009 6:32pm
Bob Goodman (mail) (www):
Why wouldn't FDA's pre-emption of tort provisions violate the 5th Amendment?
3.4.2009 6:34pm
Chico's Bail Bonds (mail):
3.4.2009 6:38pm
Anderson (mail):
Weight and deference should be two different things, tho I'm not recalling a case to that effect.

*Weight* goes to the court's evaluation.

*Deference* substitutes the agency's evaluation for that of the court.
3.4.2009 6:50pm
Chevron requires deference to federal agencies' interpretations of federal law, but it says nothing about deferring to their interpretations of state law. Any claim that a state law conflicts with federal law necessarily requires an interpretation of state law. Moreover, federal agencies have no expertise in the question of how to resolve such a conflict, which is a constitutional, legal, and political question, not a technical one.
3.4.2009 10:03pm
dierk hirschel story (mail):
Raivo Pommer

EZB krise

"Zu spät, zu zögerlich"

Der DGB ging die EZB dagegen scharf an. "Sie reagiert zu spät und zu zögerlich auf die historische Wirtschaftskrise", sagte der Chefvolkswirt der Deutschen Gewerkschaftsbundes (DGB), Dierk Hirschel.

"Sie hätte sich ein Beispiel an den angelsächsischen Banken nehmen und die Zinsen schnell und drastisch senken sollen." In den USA liegt der Leitzins nahe null Prozent.

Vor der EZB hatte am Mittag bereits die Bank von England ihren Leitzins auf das historische Tief von 0,5 Prozent gekappt und den Ankauf von Staatsanleihen angekündigt um zusätzlich Milliarden in die Wirtschaft zu pumpen.
3.5.2009 8:54am
Mr. B:
The facts of Levine illustrated why the FDA's supposed 180 (I do not believe that it ever held a contrary position, but the Court found otherwise) was actually a change from an incorrect view of the law to the proper one. You have loads of evidence showing that the FDA was trying to balance consumer protection against efficacy, and you have a jury finding facts in favor of a Vermont celebrity saying "not good enough." It's very difficult to say that this does not interfere with the federal regulatory regime. Whether such tension amounts to preemption is for the courts to decide, but I think the FDA was clearly right in explaining that such re-weighing of evidence already considered interferes with its ability to do its job. The opposite conclusion makes FDA's considered judgments on these issues almost futile; it might as well just approve everything and then let juries dictate what the labeling should say. And how long do you think it will be before a plaintiff brings an action claiming the FDA-approved labeling was too restrictive, and if the labeling had been more permissive (such as by allowing higher dosages or more effective methods of administration), then the plaintiff would not have suffered for as long as he did?
3.5.2009 10:43am
loki13 (mail):
Mr. B has it exactly right.

While I am almost *always* pro-plaintiff, in this particular case, I cannot see why there wouldn't be a strong argument for preemption.

The FDA occupies the field as far as the labeling of pharmaceuticals goes. They dictate (either through rulemaking or indirect pressure) what goes on the labels. Pharmaceutical companies *must* comply or lose their license to manufacture/sell that drug.

In cases of a state tort action for failure to warn, the claim is based on labeling that is mandated by *federal law* (what the FDA requires the drug companies to place on the label). It's a matter of conflict preemption- the drug companies are forced to chose between the federal regulatory scheme and the state tort regimes.

To comply with the FDA scheme opens them up to state "failure to warn" claims. To comply with the state tort laws requires they do not comply with the FDA. Federal law should trump.
3.5.2009 1:27pm
senior status for you:
Stevens should take retirement status. It's obvious that Stevens tried to turn his dissent in Geier into the countervailing "interpretation" of the majority opinion, a move that was little more than sleight of hand. Alito has him dead to rights on the factual background of the case too. Stevens falsely claims that there was no specific warning and consideration of IV-push in Wyeth's FDA-mandated label when (1) the label repeatedly warns against "inadvertent intra-arterial injection" (it can only be "inadvertent" when the drug is accidentally injected intra-arterially instead of intravenously) and (2) the label counsels "extreme care" because of the proximity of arteries and veins "in the areas most commonly used for intravenous injection."

If a warning to take extreme care when using "intravenous injection" isn't a specific warning on the dangers of using IV-push, I don't know what is.
3.5.2009 3:50pm

The FDA occupies the field as far as the labeling of pharmaceuticals goes. They dictate (either through rulemaking or indirect pressure) what goes on the labels. Pharmaceutical companies *must* comply or lose their license to manufacture/sell that drug.

But the Supreme Court has just said that pharmaceutical companies don't have to comply -- they can put out labels with stronger warnings than the FDA approved. The Supreme Court said the FDA can't take action against them if they do this.

Are you suggesting the FDA will defy the Supreme Court's interpretation of the boundaries of its authorizing statute?
3.5.2009 9:03pm
To be more precise, The Supreme Court has said that pharmaceutical companies who put out labels with stronger warnings than the FDA approve are complying with the statute and hence the FDA would have no legal basis for declaring them out of compliance.
3.5.2009 9:05pm
anotherpsychdoc (mail):
Phenergan is a very commonly used drug. Are you more likely to read a manual pertaining to a device you know 'well' or on encountering a new device? I reviewed a case several years ago in which, to treat headache, an ER physician gave double the recommended Phenergan IM dose. He found the sedation listed as a side effect useful. On releasing the patient, ER staff asked who would be driving her home. She told them a family member and pointed to a car down in the parking lot. She was released. As it turned out, she was driving home alone, crashed her car in a culvert and the expected lifetime cost of her care was about $ 6 million for which the hospital was sued. Her side had very distinguished, thoughtful, supportive expert testimony. Should Wyeth have been sued? As I recall there is not a boldfaced warning.

Here, the label was quite clear on the danger of intra-arterial injection. It is most likely that hospital personnel had looked at the label years earlier, if they had at all, and had a standard practice of which this was a complication. Justice Stevens IMHO shows hubris in thinking that it is likely that an amendment as might have been suggested by Vermont regulations would have left the clinicians informed where otherwise they were not.
3.6.2009 11:30am
EagemoFoore (mail) (www):
all stars at
3.7.2009 4:23am
schloss (mail):
Raivo Pommer


Die Schweiz, Luxemburg und Österreich suchen einen Weg, wie sie einen Rest ihrer Bankgeheimnisse retten können

Vier Wochen vor dem Treffen der 20 wichtigsten Wirtschaftsnationen der Welt (G20) kommt Bewegung in die Riege der europäischen Steueroasen. Die Schweiz, größter Finanzplatz für internationale Privatvermögen, hat sich am Freitag offiziell zu einer weiteren Aufweichung ihres Bankgeheimnisses bereit erklärt. Ähnliche Signale werden von einem Treffen der Finanzminister der Schweiz, Österreichs und Luxemburg am Sonntag in Luxemburg erwartet.

"Wir wollen die internationale Zusammenarbeit bei Steuerdelikten verbessern", sagt der Schweizer Bundespräsident und Finanzminister Hans-Rudolf Merz nach einer Kabinettssitzung in Bern. Die Drohungen von Seiten großer Industriestaaten seien ungerechtfertigt, aber ernst zu nehmen. Für die Schweiz gelte es zu verhindern, dass sie von der G20 oder einem ähnlichen internationalen Forum auf eine Schwarze Liste gesetzt werde. "Auf Verträge einzugehen, die unter Sanktionen entstanden sind, wäre ganz schlecht", sagte Merz. Erwartet wird, dass Österreich und Luxemburg bei dem Treffen am Sonntag ein ähnliche Position einnehmen werden. Belgien und Luxemburg, so sagte der britische Botschafter in Bern jüngst, hätten ohnehin signalisiert, dass sie das Bankgeheimnis nach 2013 "nicht in dieser Form weiterführen werden". Ein Sprecher des Luxemburger Finanzministers wies diese Darstellung am Freitag jedoch zurück.
3.7.2009 9:15am

Post as: [Register] [Log In]

Remember info?

If you have a comment about spelling, typos, or format errors, please e-mail the poster directly rather than posting a comment.

Comment Policy: We reserve the right to edit or delete comments, and in extreme cases to ban commenters, at our discretion. Comments must be relevant and civil (and, especially, free of name-calling). We think of comment threads like dinner parties at our homes. If you make the party unpleasant for us or for others, we'd rather you went elsewhere. We're happy to see a wide range of viewpoints, but we want all of them to be expressed as politely as possible.

We realize that such a comment policy can never be evenly enforced, because we can't possibly monitor every comment equally well. Hundreds of comments are posted every day here, and we don't read them all. Those we read, we read with different degrees of attention, and in different moods. We try to be fair, but we make no promises.

And remember, it's a big Internet. If you think we were mistaken in removing your post (or, in extreme cases, in removing you) -- or if you prefer a more free-for-all approach -- there are surely plenty of ways you can still get your views out.