"Often those lawsuits add an unwanted deterrent against the sale of desperately needed drugs."

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In his latest Forbes.com column, Richard Epstein explains why the outcome of Wyeth v. Levine, which the Supreme Court heard this week, matters a very great deal:

Wyeth v. Levine…posed one simple question. Once the Food and Drug Administration has approved the warnings about drugs licensed for sale, may a plaintiff bring state law action for damages on the ground that those warnings are inadequate?

The principled answer to that question is a resounding "no." Concede—no insist—that the FDA is far from flawless. All too often, however, its extreme risk aversion keeps newer and safer drugs off the market—or requires strong, "black box" warnings that over-deter valuable use.

Against this backdrop, it is folly to act as if the private lawsuits attacking FDA warnings just backstop a porous and lax FDA. Often those lawsuits add an unwanted deterrent against the sale of desperately needed drugs. That risk is multiplied by hyperventilated state tort law that, in many instances, is lopsidedly pro-plaintiff.

[…]

The specter of heavy litigation expense and crushing liabilities by runaway juries could easily block the pharmaceutical industry from initiating life-saving changes.

Whole thing here. Ronald Bailey on "the FDA versus dying cancer patients" here, Todd Seavey on whether the FDA is even necessary here.

NEXT: The Third Way

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  1. The FDA isn’t going anywhere. Neither is the IRS. Niether is the LP, but that’s another story. Donate now!

  2. What is the point of a large and expensive “expert” bureaucracy if final policy is going to be made, on a ad hoc basis, in (or by) the courts.

  3. So if the FDA decides that chelation therapy is fine and dandy because someone bribed an official, nobody should be able to sue the therapist who lies to patients about its therapeutic properties and injures them?

    The problems caused by subornable court monopoly are not going to be solved by placing an relatively unaccountable bureaucrat in charge of preemptively making liability decisions.

  4. The FDA isn’t going anywhere. Neither is the IRS.

    Change is coming to Washington.

    Yeah, right.

  5. Well, tarran, in that case you could bring a lawsuit based on the bribery. No need to bring lawsuits based on compliance with valid rules.

  6. Epstein leaves out a crucial consideration.

    He writes: “Consider the particulars, Wyethinvolved the anti-nausea drug Phenergan, which has been around for over 50 years. Phenergan can be administered by either deep intramuscular (IM) or intravenous injection (IV). The mode of administration raises a delicate risk/reward tradeoff. Forget the common bromide that the FDA only approves drugs proven “safe and effective.” The stark truth here is that IM is both more safe and less effective than IV in treating nausea and similar conditions.”

    He leaves out the details of the “delicate tradeoff”. The reason IV administration is less safe is that, if the drug is injected into an artery, it causes UNTREATABLE GANGRENE.

    Hm. On the one hand, with IM injection we have a slightly less effective treatment for nausea. On the other hand, there’s a risk of permanent loss of extremities.

    Not a very delicate tradeoff, actually. A bit of an asshole move for Epstein to leave that out.

  7. Change is coming to Washington.

    Yeah, right.

    Not the kind of change you want, fuckface. Government intervention in the economy and tighter regulations on financial markets–that’s the change that’s coming to Washington. We’re going to return to a more Keynsian model and a broader prosperity. Free-market fundamentalist dogma is finished.

  8. The test of our progress is not whether we add more to the abundance of those who have much; it is whether we provide enough for those who have too little.

    Franklin D. Roosevelt

  9. “whether we provide”…?

    Who the hell appointed you God? Where do you get off forcing me to provide for anyone but myself and my family? Fuck you.

  10. “…thee.”

  11. Why “fuckface”?

    That isn’t reasonable or even remotely interesting. Just childish. Now you get time out.

  12. Free-market fundamentalist dogma is finished.

    Fortunately, the U.S. government is bankrupt and our foreign lenders are about to stop paying for your militarist and socialist fantasies – So while free-market dogma is dead, government of all forms is going to be on a massive decline!

    We are not entering the era of socialism or big government, we are going to see the collapse of the state on a massive scale.

  13. Rex,

    Don’t be so optimistic. Look at Somalia. The state ran that that place into the ground before it finally died.

    The early-1980s saw a temporary spike in government expenditures on items like
    education. But by the late 80s the weight of nearly 20 years of rampant corruption, repression, and state control had reduced Somali welfare to horrifically low levels. Well prior to the government’s collapse the agricultural economy was in a shambles, and malnutrition and starvation were common place (Samatar 1987). In the 1980s Somalia had one of the lowest per capita caloric intakes in the world (UNDP 2004). At the end of the decade government spent less than one percent of GDP on economic and social services, while military and administration consumed 90 percent of the state’s total recurrent expenditure (Mubarak 1997).

    Read the whole depressing litany of uneconomical actions taken by the government in the name of social policy.

    Parasites are generally too dumb to restrain themselves from killing their host.

  14. We are not entering the era of socialism or big government, we are going to see the collapse of the state on a massive scale.

    Guys like Lefiti see change coming – like the light turned from red to green. They don’t see the change which is the city bus careening through the intersection.

    I used to think that the economic collapse doom sayers were all hyperventilating. Events this year proved that massive collapse is possible – maybe even inevitable. Lefiti loves to taunt the LP – because it is not powerful. The only and best defense the weak have for the powerful is truth. The Keynesian left have earned their chance to try and right the wrongs of the crony capitalist Bush administration. The truth is that they will fail because their ideas are poor.

  15. This is precisely the wrong view that libertarians should be advancing and is the primary reason libertarians are justifiably seen by many as crony capitalists rather true advocates of liberty. The government should not at any point be acting to protect business, period. The point of the civil courts is to do exactly what Mr. Epstein is arguing against, which is to protect the consumers against dangerous products. Cost is irrelevant — what is he, some sort of cost-benefit ethicist? He could just as easily argue that lead paint would be cheaper and if the FDA said it was safe than it should be immune from lawsuits. In a free society, one without a FDA, it would be private arbitration courts, the equivalent of civil courts, who would provide this safety mechanism, and they would be more pervasive and aggressive, not less so — as should our civil courts today. Epstein should be arguing to eliminate the FDA and to have all such safety issues decided by jury in civil courts. That would be far closer to a true libertarian system than to whine that once government says something is safe that “cost” is a justification for exempting the manufacturer from liability. No one said a free society would be a cheaper one, or even a safer one — only that if would be a more moral one. If one can’t accept that, than perhaps “libertarian” isn’t the label one should be applying to oneself.

  16. The FDA isn’t going anywhere. Neither is the IRS. Niether is the LP, but that’s another story.

    And apparently neither are you. So, bitter pills all around…

  17. Paul,

    Just ignore him. At this point it’s impossible to tell which posts are by the original Edward and which ones are spoofs.

    They are also increasingly boring and redundant. He’s like the homeless guy who loudly argues with the subway station wall every morning. Everybody is happier if you just leave him to shout in peace and move on.

  18. He leaves out the details of the “delicate tradeoff”. The reason IV administration is less safe is that, if the drug is injected into an artery, it causes UNTREATABLE GANGRENE.

    Hm. On the one hand, with IM injection we have a slightly less effective treatment for nausea. On the other hand, there’s a risk of permanent loss of extremities.

    Golly. Too bad there isn’t a safe, inexpensive, effective anti-nausea medication out there.

    …Here to hoping Nancy Reagan, Bill Clinton, George W Bush, and John Walters suffer painful, painful demises filled with constant nausea as a small measure of retribution for the pain they have caused others.

  19. Jon H brings up the central point of this court case.

    He leaves out the details of the “delicate tradeoff”. The reason IV administration is less safe is that, if the drug is injected into an artery, it causes UNTREATABLE GANGRENE.

    Wyeth knew of this problem, yet did not put it on the warning label (which is read by those administering the drug). The crux of the court case is that Wyeth claimed that FDA regulations forbid the inclusion of this info, because the label had already been approved – changes were not possible. And the Bush admin is supporting this argument.

    I’d say it’s proof yet again that regulation is not in the interest of consumers but in the interest of big business.

  20. No shortage of bottom feeder attorneys to take the case right.

    http://www.anonweb.eu.tc

  21. …Here to hoping Nancy Reagan, Bill Clinton, George W Bush, and John Walters suffer painful, painful demises filled with constant nausea as a small measure of retribution for the pain they have caused others.

    I’ll second that.

  22. P Brooks writes:

    What is the point of a large and expensive “expert” bureaucracy if final policy is going to be made, on a ad hoc basis, in (or by) the courts.

    Simple. Large bureaucracy = X government jobs. Courts = Y government jobs. Large bureaucracy + courts = X+Y jobs. And that’s not even counting all the extra jobs for lawyers!

  23. I too disagree with Richard Epstein about this. I understand his trying to use a 2nd wrong to reverse a right, but I don’t go along with it. Yes, FDA and the plaintiff bar will weigh on the same side against drug makers, and tort law is really screwed up — but should we just give up on tort law or contract law and aquiesce to a regime of bureaucracy, hoping to get some approximation of liberty & justice thereby?

  24. And BTW, I feel the same way about liability exemptions for gun & cigaret makers.

  25. If it is politically too impalatable to get rid of governmental drug testing, I don’t know why we couldn’t just adopt EU stardards. As soon as a drug is adopted in Europe , we adopt it here. It would save one hell of a lot of money on FDA salaries.

  26. Seems to me this is LONG over due!

    Jess
    http://www.privacy.es.tc

  27. General statement loosely related to the thread topic!

    Jess
    http://www.privacy.es.tc

  28. Matth wrote in response to Lefiti: “Who the hell appointed you God? Where do you get off forcing me to provide for anyone but myself and my family? Fuck you.”

    While Matth wasn’t as eloquent as some might like, I agree with him. Government is the only organization in society that can legally use force. Forcing someone’s money out of their wallet is typically called theft. Why is this concept different when government engages in this activity with the altruistic motive of “helping the disadvantaged,” whoever they are?

    Regards,

    Eric

  29. Since this appears to be the weekend open thread I’ll post a link to Failblog, which many of you have probably already seen:

    Wall Fail

  30. I don’t read any comments here that begin with:
    Lefiti |

    Does anyone else read and comment on them? Do you then complain about the trolls?

    Silly rabbits.

  31. I think people find Lefiti entertaining, or they wouldn’t respond to him.

  32. So, Tom Snell, are you of the Cornwall Snells or the Amsterdam Snells?

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