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Derek Lowe The 2002 Model

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Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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March 4, 2009

Wyeth v. Levine: Pre-emption Goes Away

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Posted by Derek

The idea of preemption in drug liability cases has been coming up a lot in recent years. If the FDA approves a drug, does that Federal-level approval stop liability suits at the state level, or not?

The Supreme Court has ruled today in the Wyeth v. Levine case, which directly addresses this issue. And pre-emption now appears to be a dead issue, at least in my first reading:

". . .State tort suits uncover unknown drug hazards and pro-vide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come for-ward with information. . .

. . .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.

We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA. Accordingly, the judgment of the Vermont Supreme Court is affirmed."

And that, I would say, is that.

Comments (12) + TrackBacks (0) | Category: Current Events | Regulatory Affairs


1. Hap on March 4, 2009 1:44 PM writes...

I thought that preemption was a bad idea in the first place - it puts an awful lot of power in the hands of the FDA with not so much control over it (it is controlled by the executive branch, although Congress could command it to do particular things or threaten to defund it, it can't really force it to actually enforce the law.) Having too many different conditions for drugs is not good, but it's probably better than putting all of the regulations in one basket, particularly when that basket is subject to political interference and regulatory capture. (The FDA has a lot of smart people, but sometimes judgements are altered by money or other interests - the last eight years seems to be a comprehensive explanation of why that might be a bad idea.)

If more justices such as Alito, Roberts, and Scalia are chosen, preemption might be resurrected but probably not. I'mm not seeing any reason to give Scalia (or Alito, or Roberts) any more respect than the little I had for him before. The dissent relies heavily on one particular case - Geier - to make its claims, and the rest of the dissent reads like a summary document of the PhMRA's position, as written as well in C+EN. It reads too much like someone trying to justify what he wants, rather than explaining why the wants are an inevitable consequence of the law. Thomas surprised me - I hadn't had much respect for him before, but skimming his sort-of-dissent, it actually seems to make a lot of sense. It leaves open the possibility of preemption, but seems to place its conditions closer to law rather than to what would do the relevant business interests the most good.

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2. Jakcie Wellbaum on March 4, 2009 1:52 PM writes...

Drug companies like Pfizer and Wyeth can run but cannot hide. It is simply untrue that, as Wyeth attorney Rein asserts in a written statement:

"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label."

Drug companies 'negotiate' vigorously with the U.S. Food and Drug Administration (FDA) over the text of the warning label which accompanies each drug to the marketplace. Drug companies such as Pfizer and Wyeth hold the results of their clinical trials close, keeping from the public AND the FDA analysis of clinical data which link the use of their drugs to serious adverse events and deaths. Is it still true that potential tragedies for a 'few' American consumers become the 'cost of doing business' for Pfizer and others as they have practiced a strategy of lobbying to dilute FDA enforcement while also hiding behind it's 'expertise' as an insulation against litigation? Answer before today's supreme court ruling: Yes! Today's supreme court decision upholding a cash award for Ms. Levine may be an early warning signal to pharmaceutical companies such as Pfizer and Wyeth to take far more responsibility for what is contained in AND omitted from their warning labels. These drug companies have failed in their attempt to lead the public into believing that a chronically hog-tied Food and Drug Administration maintains ultimate legal and moral responsibility for the safety of the American public from harmful and deadly side-effects. How long did Pfizer think it could succeed with this strategy knowing how many deaths and other serious side-effects are suffered by its 'customers?' To pharmaceutical companies everywhere: If your product maims and kills people, you will be exposed and will pay either in negative publicity or cash or both. And when will either Bush or Cheney, leaders of an failed and embarrassed American administration, finally suffer a drug-company-induced serious adverse event? Sooner rather than later is my fervent hope.

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3. J Bane on March 4, 2009 2:17 PM writes...

"If the FDA approves a drug, does that Federal-level approval stop liability suits at the state level, or not?"

This new ruling makes no sense. They took away the right to sue at the state level for medical devices approved by the FDA last year!!

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4. Becky on March 4, 2009 2:47 PM writes...

So if this ruling says that the states can have a voice in determining the label language, then what is to prevent every state from setting up its own version of the FDA to regulate drugs sold and administered within the state? And I don't understand the initial ruling, since this particular side effect was known and was described on the label?

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5. AliG on March 4, 2009 2:50 PM writes...

This lawsuit wasn't about a drug side effect. It was about the consequences of administering the drug improperly. It was medical error by the nurse/doctor. All this does by shifting the blame from the person responsible to the one with the deepest pockets is make warning labels even longer and less helpful. Now all warning labels will say if you administer the drug improperly it can lead to serious injury including loss of limbs or death. The warning labels are already a couple pages long, how does this help?

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6. CMC Guy on March 4, 2009 4:48 PM writes...

Although I am not really an advocate of preemption I think this was poor decision. If you read about the facts of the case as AliG suggests this was not about what Wyeth did/didn't do but shifting blame to the "deep pockets" (although Wyeth may be guilty of attempting to use a Sledge-hammer to drive a screw by claiming preemption). The trial lawyers are probably partying as they can continue to file questionable suits that would have been prevented by the opposite ruling. Makes one question the nature of the legal system (if did not already).

As I understand it the specific info warning against bolus injection was not an approved text by the FDA which is the 2nd issue that troubles me here. Preemption is only viable if the FDA does its job correctly. Having been party to several "Label Negotiations" it is a complex process that entails Clinical, Regulatory, Legal, Marketing, Executive and Technical people from the company side so reaching consensus is a chore before dealing with Agencies. The FDA is typically very hard-fisted in this stage and in the end they do control (final say) what labeling is provided for the drug. The process means even 'simple' changes aren't easy to make and although would expect FDA to be acutely responsive to potential problems they are so bureaucratic delays can be lengthy so a companies hands are tied. Unfortunately FDA seems to be broken lacking the personnel and proper expertise (which to counter Haps idiotic rant has resulted more from Congress's neglect and meddling than Industry coziness or Executive branch).

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7. Hap on March 4, 2009 6:29 PM writes...


You mean, like this? (You might ask the people over at EPA, if you have some free time, as well.)

Thanks for the input.

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8. medicamenta vera on March 4, 2009 8:54 PM writes...

Does anyone have access to the FDA-approved label at the time Ms. Levine suffered this tragedy?

I have found secondary information that the label stated "extreme care should be exercised to avoid ... inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection ... suggest that pain, severe chemical irritation ... and resultant gangrene requiring amputation are likely under such circumstances."

Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning," especially after it learned of at least 20 incidents before Levine's injury in which an injection led to gangrene and amputation.

The FDA label in the second paragraph, if accurate, seems explicit to me.

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9. Hap on March 4, 2009 9:07 PM writes...

Let's try an alternative line of reasoning.

This article describes the preemption policy at FDA as being initiated in 2005. Assuming that 1) there wasn't really any industry influence into that policy (as would likely have happened at EPA) and 2) that Congress underfunded the FDA and micromanaged them, why would you want preemption as policy? Making yourself the sole authority on aspects of drug policy would seem to imply that Congress would likely be more interested (not less) in the details of your policies and your people are going to have to be even more careful, because there would be no alternative means of regulating their output, and their mistakes could be even more costly. FDA's regulation would likely cost more, both in terms of political work (interference) and in financial terms.

So, why would you come up with the policy? Either 1) you expect a massive influx of authority and cash from Congress (to allow the FDA to effectively regulate with preemption) or 2) you don't really want anyone to regulate, because if FDA is not effective now they are unlikely to become more so with higher costs to their regulations, and preemption prevents anyone else from doing so. Congress has some influence, but FDA is under the executive branch, and while Congress can write them laws, if they don't execute them, Congress's options are limited (defunding FDA probably would counterproductive, for example). The latter option would seem to be consistent with the EPA experience (the other arena in which the Bush administration attempted to implement preemption). If the latter option is accurate, then who might be the likely beneficiaries of said policy? Perhaps you might ponder that.

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10. pete on March 5, 2009 11:22 AM writes...

re: Hap-1
..was a surprise to me too that Thomas parted ways with Scalia on this one. I know it's not the first time that's happened but still - it caught me off guard (in a good way) to see his spark of independence on this issue.

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11. philp on March 5, 2009 7:09 PM writes...

Re: AliG

The drug was not administered improperly, it was administered in a way that was approved by the FDA on the original label of the drug. The possible side effects were also listed on the label, and the FDA still gave its approval.

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12. srp on March 5, 2009 8:54 PM writes...

Even the New York Times, hardly a defender of big pharma, had a description of the case that makes you wonder about what the heck is going on in state courtrooms. What is Wyeth supposed to do, attach neon blinking signs to the medicine bottle? The nurse screwed up and the jury took it out on the drug manufacturer.

We know that putting on more and more warnings and stronger warnings quickly reaches the point of negative marginal returns because people can't process all the information and for rare problems it's like crying wolf.

From a legal basis, the Supremes sound like they got it right to me. The distinction with medical devices is that in the device case Congress supposedly put in explicit language allowing preemption in the regulatory legislation. Now the Waxmanites are, according to the NYT story, preparing to gut that as well so as to favor the plaintiffs' lawyers still further.

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