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Court Rejects Wyeth's Preemption Claim:

This morning, in Wyeth v. Levine, the Supreme Court held, 6-3, that federal approval of warnings on prescription drug labels does not preempt state law tort suits alleging that such warnings were inadequate. Justice Stevens wrote the majority opinion, joined by the usual suspects and Justice Kennedy. Justice Thomas concurred in the judgment. Justice Alito dissented, joined by the Chief Justice and Justice Scalia.

This is the second time this term in which the Court has rejected industry arguments that federal law preempts state tort law claims. The Court also rejected a preemption claim in Altria v. Good. This is interesting because preemption claims fared quite well during the first three years of the Roberts Court, lending support to the idea that this Court is "pro-business." Until this year, the only preemption claim the Roberts Court had rejected was the argument that the Clean Water Act preempts punitive damages in Exxon Shipping v. Baker, but this was not much of a loss for business as, in the same decision, the Court limited the extent of such damages under the federal common law of maritime. I don't think Wyeth and Altria signal a dramatic shift in the Court's jurisprudence, but I do believe these decisions are evidence that early proclamations that the Roberts Court is a "pro-business" court were premature.

Related Posts (on one page):

  1. Wyeth and Deference to Agencies:
  2. Court Rejects Wyeth's Preemption Claim:
sg:
Justice Roberts is one of the usual suspects?
3.4.2009 10:33am
sg:
Sorry, I meant Thomas.
3.4.2009 10:34am
Angus:
Interesting to see that the liberal Justices favor federalism in this case, while the most conservative judges favor federal preemption.
3.4.2009 10:42am
Roger __:
The concurrence in the judgment by Justice Thomas is fascinating, expressing skepticism about this whole implied preemption nonsense.
3.4.2009 10:54am
MCM (mail):
"Interesting to see that the liberal Justices favor federalism in this case, while the most conservative judges favor federal preemption."

Which fuels cynics who think that all judges are results-oriented, even those that claim to do otherwise.
3.4.2009 10:54am
ahendo10 (mail) (www):
@Angus :

Doesn't this highlight the inadequacy of such binary labels in this area? Just because it would be nice if things were so simple doesn't mean that they are.
3.4.2009 10:56am
pireader (mail):
Professor Adler --

I viewed Wyeth's position in this case as asking the Court for a broader construal of pre-emption than it had offered in past cases.

If you agree, then why interpret this as a shift by the Court? Why not see a "pro-business" Court importuned by business litigants with ever more extreme positions until the majority finally says 'enough'?
3.4.2009 11:19am
M. Gross (mail):
It looks like they kind of skirted the issue entirely by saying that it was possible to comply with both sets of regulations at once.

The suit is ridiculous on other matters, though, primarily dealing with issues of fact, and thus was the mistake of the Vermont Jury, not the SCOTUS.
3.4.2009 11:44am
lesser ajax (mail):
Am I a bad liberal law student if I find Justice Thomas's concurrence to be pretty compelling?
3.4.2009 11:46am
eric (mail):


The suit is ridiculous on other matters, though, primarily dealing with issues of fact, and thus was the mistake of the Vermont Jury, not the SCOTUS.


That has been the problem with this case from the start. I think the majority has the better view than the dissent and Justice Thomas has the correct view.

This jury made what I feel was a poor factual finding on causation. That is a hazard of the jury system, of course. I think the plaintiff's attorneys probably expected to lose this thing. I assume the malpractice case settled, it seems to me that it was pretty clearly malpractice.
3.4.2009 12:08pm
DiverDan (mail):
Having read the Opinions, I am convinced that the majority got it right on the law, even though I think that this result is, as a policy matter, a terrible result. This even though I am usually far more likely to be convinced by Scalia/Alito/Roberts/Thomas than almost anything said by Stevens or the liberal wing of the Court I did find Justice Thomas's concurrence very persuasive, though I think as a matter of form it's really odd that he uses a concurrence to rail against a theory, the broad-based and ill-defined "purposes and effects" preemption, that is really not necessary to the majority decision. I would have understood this if he had been using the concurrence to address more directly the Dissent, rather than differentiate his position from the Majority.

All that aside, is anyone else really offended that any rational jury (Does that Beast exist? Or is it like the mythical Unicorn?) could find causation in fact in this case? It seems to be admitted that if the physicians and physicians assistants had actually followed the warnings that were already ON the label used by Wyeth, the injury in this case would not have happened. It seems here that the Plaintiff's counsel simply bought himself access to a "deep pocket" by settling with the Hospital and health care professionals first in order to pursue Wyeth. Why didn't Wyeth join the health care providers in third party claims asserting a right of indemnification for their negligent violation of Wyeth's warning label? It might not have ultimately stuck, but I'd sure want to put those idiots in front of the jury and ask the question, "Who in this case is REALLY at fault?"
3.4.2009 12:25pm
Bob White (mail):

Am I a bad liberal law student if I find Justice Thomas's concurrence to be pretty compelling?


Yes. Did you need to ask?

I'm not sure what I think of his concurrence. If I liked him less, or found reading his opinions as taxing as I generally do those of his colleagues, I might be inclined to say unkind things about his ability to dispose of the issue in 1 or 2 pdf pages, then spend 20+ railing on his pet theory shared if few by any others with citations too often to one's own prior work on the issue. That way madness (and/or an awful blog post or comment) oft lies.
3.4.2009 12:34pm
Anderson (mail):
Am I a bad liberal law student if I find Justice Thomas's concurrence to be pretty compelling?

Stopped clock, twice a day, etc.

That way madness (and/or an awful blog post or comment) oft lies.

Interesting insight. "Clarence Thomas's Blog" would be a great satire, and maybe even funnier if it were the real thing.
3.4.2009 12:38pm
David Welker (www):

Who in this case is REALLY at fault?


This is a REALLY dumb question, because it assumes that multiple actors cannot be at fault.

It is pretty clear that the Wyeth warning label could have been much more clear. In most circumstances, it appears that the only reasonably safe way to administer this drug is through the IV-drip method, not the IV-push method: "even a careful and experienced clinician using the IV-push method will occasionally expose an artery to Phenergan" when this drug is used. After that the patient will get gangrene, which will in turn either kill the patient or require an amputation.

Despite this, there was no specific warning about the dangers of using the IV-push method. And no, this isn't the first time someone has gotten gangrene from the use of Phenergan. Given the severe consequences, it was negligent of Wyeth to not include a specific warning about a commonly used method to intravenously inject drugs.

Clearly, this drug is not appropriate for casual administration via the IV-push method in order to treat symptoms like nausea.

Now, was the physician assistant who administered this drug perfect? Absolutely not. If the physician assistant had been perfect, would this not have happened? No. But, Wyeth has a responsibility to provide warnings for the actual imperfect physician assistants that the public must rely on to actually administer these drugs. There should have been a specific warning advising of the dangers of using the IV-push method.

It should be emphasized that fault, in many situations, need not be considered a scarce commodity. That actor X is at fault or even relatively more blameworthy does not mean that actor Y cannot and should not also be held responsible. The world is much more complex than that assumed by your silly question, which assumes only one source of negligence and causation.

The jury intelligently saw this.
3.4.2009 1:30pm
Jonathan H. Adler (mail) (www):
pireader --

I am sorry that I wasn't clear. I agree that the preemption claim here was more ambitious than that in, say, Riegel v. Medtronic, so the result is not particularly surprising to me, nor do I think it is indicative of a trend. My point was that this decision (combined with Altria) shows that the current court is not reflexively pro-business in preemption cases, and that any claims to the contrary were premature.

JHA
3.4.2009 1:36pm
strech (mail):
David Welker:

The warning includes the text:

INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY


as well as a large block of text that the decision cites in footnote 1 and is pretty well on point, including a suggestion to use IV drip:


When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.


The warnings seemed pretty clear to me, and it was clear that the clinician didn't pay attention to the existing ones; adding more wouldn't have helped. I really can't blame Wyeth for any of this, especially given the blatant mistakes of the clinician. That said, that wasn't what was before the court.
3.4.2009 1:47pm
DiverDan (mail):
David Welker, I can only assume you are a personal injury plaintiff's lawyer, and therefore, IMHO, a completely untrustworthy source of "the truth". In short, I am completely unfazed by your poor opinion of me; I consider the source and find your opinion unworthy of credence.

As to your reasoning, it conveniently ignores (or expressly misrepresents) a number of facts, including the very specific warnings given by Wyeth, and the fact that the FDA, after much detailed review, found that there were situations where the IV-push method of administration was both necessary and safe. Contrary to your claim that the Physician's Assistant was simply "imperfect", she was NEGLIGENT, as was the Doctor who prescribed the IV-push of Phenergan in an inappropriate case and failed to adequately supervise the assistant so that she was aware of the very clearly disclosed risks. If Wyeth must design its labels for the "less than perfect" physicians and nurses in the world, in other words those who either don't read or willfully ignore the warnings ALREADY THERE, it will have to distribute a book the size of the PDR with each bottle, and even that will do no good, since the "less than perfect" doctors and nurses won't read those warnings either.

You also ignore the well established law on causation-in-fact, the so-called "but for" test: Would the injury complained of have occurred but for the act or omission of the Defendant? Since both the physician and physician's assistant in the present case ignored at least 6 separate warnings fully disclosed on the Phenergan Label they had in front of them, what makes ANYBODY (except perhaps a PI Plaintiffs' lawyer) think that they would have been slowed at all by a 7th Warning. The ONLY thing that MIGHT have saved the patient the pain and injury she suffered would have been a flat-out ban on administering Phenergan by IV Push (indeed, that was exactly what the Plaintiff's lawyer argued for at the trial), something the FDA, in its EXPERT and CONSIDERED opinion, refused to do. While I think the Supreme Court got it right on the law in this case, the ultimate decision on Wyeth's liability was the result of a jury pushed by emotion and sympathy for the Plaintiff to ignore who really caused the injury and lash out at the deep pocket. Does anybody really wonder why prescription drug prices are rising many times the rate of inflation?
3.4.2009 2:18pm
tragic facts make bad law:
lol, David Welker's credibility went into the sinkhole when he claimed there were no specific warnings on IV-push on the Wyeth label.
3.4.2009 4:11pm
TelecomRegLit (mail) (www):
I don't see this opinion as evidence of a "pro-business" or "anti-business" trend at all. I see it as evidence of the court's awareness that it has to refine its conflict preemption analysis in the context of administrative state.

The most interesting part of the decision, to me, was the majority's discussion of the Geier court's proposition that the regulatory agency's views on conflict preemption are to be given "some" weight.

In Wyeth, Stevens explained that, in the absence of statutory evidence that Congress intended to give the agency power to declare state law preempted on a subject, the agency's legal conclusion of preemption is not to be given much weight.

What IS to be given weight is the agency's expert analysis of HOW a state law might frustrate a federal regulatory scheme. This is actually very useful to "businesses" making preemption arguments in other cases, particularly those involving agencies regulating industries that are intrinsically interstate (like mobile wireless communicaitons).

So, my quick, preliminary, incomplete read of Wyeth is that it is not "pro" or "anti" any stakeholder such as "business" or "consumers." Rather, it reinforces and cabins the powers of Congress and executive agencies in their respective spheres. It reinforces the notion that in a federal system, the power to preempt a sovereign state's laws resides in Congress and thus can be exercised by an agency only where that power has actually been delegated to the agency. However, it also reinforces the obligation of courts to defer to agencies in their areas of expertise, which includes their determinations regarding when and how a state law would interfere with a federal regulatory scheme.

In sum, outside the pharma context, the decision helps all litigants (including federal agencies and state governments) by clarifying conflict preemption analysis.
3.4.2009 7:12pm
David Schwartz (mail):
Is Federal pre-emption justified solely on the grounds that a State has demonstrated that it's incompetent to administer the law?
3.4.2009 10:28pm
Dr Mengele:
Last I checked, the clinician responsible for Levine's necrotic arm is stll working at the clinic. The clinic settled for a few hundred $k but she still managed to keep her job. WTF?
3.5.2009 3:32am
Public_Defender (mail):

I do believe these decisions are evidence that early proclamations that the Roberts Court is a "pro-business" court were premature.

Hogwash. This case shows just how far toward the business side the Court is. This case would have effectively eliminated a huge swath of state court tort actions and prety much insulated drug makers from liability for wrongdoing. The fact that the issue was in play shows how deep the business lobby is onto its opposition's side of the field.
3.5.2009 5:55am
DiverDan (mail):

Is Federal pre-emption justified solely on the grounds that a State has demonstrated that it's incompetent to administer the law?


No. When a State demonstrates its incompetence in any field, the people responsible for either fixing the problem or suffering the consequences are the citizens of that State. In this case, if Wyeth and other pharmaceutical companies start adding a surcharge to the price of their drugs in Vermont (which they certainly must be allowed to do) to reflect the higher costs of liability insurance and costs of defense, then it becomes the problem of Vermont Citizens. Now, if Wyeth and other pharmaceutical companies begin raising prices nationwide, then it is ALL of our problem, and we can ask our Congressmen and Senators to fix it by making preemption explicit in the Food and Drug Act, effectively overruling this case.
3.5.2009 7:58am
David M. Nieporent (www):
DiverDan: the problem with your strategy, as attractive as it is, is that it's too easy to forum shop. There are various ways one can end up in a Vermont court applying Vermont law even if the drugs weren't actually purchased from Wyeth in Vermont.
3.5.2009 9:49am
meddlesome:
The phrase IV push scares me a lot. I prefer IV injection. The only time that IV push was used that I remember was with the iv injection of bile acids to time arm to tongue time to verify heart failure. Because the end point was the patient grimacing to the bilious taste in his mouth the injection had to be given fast in a bolus. This method is no longer used. Why? I do not know.

Everything else (excluding the injection of a blood pressure lowering iv drug) that is injected IV will serve just as well if it is injected slowly. It also gives one a warning if something is not right, pain,etc. and the injection can be stopped before the whole dose is given.
So the idea of a bolus of anything hitting hitting the heart always scares me, whereas if the medication is well mixed with a great deal of blood any deleterious effects will be minimized or obviated.

IMHO the warning was clear and the audience was professional so what better warning could have been concocted?
On the law, SCOTUS seems to me to be correct, although I don't see the distinction between medical devices and drugs. It seems that one cannot know everything about any drug.
3.5.2009 1:23pm
anotherpsychdoc (mail):
Offhand. It is not unusual in my practice as a consultation psychiatrist to be confronted with an unusual clinical circumstance and read the side effects of the drugs the patient is taking to find that clinical circumstance, cancel out that drug and have a problem solved. Reading the label is for dumbasses, like a psychiatrist. Marcus Welby read part of a label 5 years ago, 'nuff known from that source especially if it is a drug he commonly uses. One of the most interesting statements I heard in college was from a Mr. Sahtout, a differential equation teacher, 'we know little of what is to be known.' How do you know what you don't know?

A man went to a clinic about a headache. The treating PA or physician wanted to give him a shot of Toradol. he and the family repeaed, 'He is allergic to Aspirin. Please don't give him that or anything like that.' With perhaps a superior tone, they were told, 'It doesn't contain any Aspirin.' Shot given; man falls over dead. The label says 'Toradol is contraindicated in persons with an Asprin allergy.' Do you doubt that the Phenergan label could have said 'IV injection of Phenergan could cause priapism in you or a Supreme Court justice' and the frequency/ method of injections of Phenergan at that hospital wouldn't have gone up or down? Law is about process; but the label, read by any health care professional, should have been adequate warning.
3.5.2009 10:07pm