TorteDeForm

Henry Greenspan

Vioxx, the FDA, and Preemption: The Power Grab

Early during my training as a psychotherapist, I was told a one-liner that has proven to be useful: "Paranoids are always right." The idea is that paranoids may lose perspective on the wider context of particular events. But, in every case, they are on to something that is genuinely true, even if they make mistakes of scale.

So allow for the possibility that what follows is a paranoid view. Some of it is true. Some of it may be out of proportion. And, of course, much of it may be dead on.

Virtually everyone agrees that Merck's recent settlement offer on Vioxx will be a victory for the company if it is approved by the requisite 85% of plaintiffs. Of course, Merck continues to face civil and criminal charges on state and federal levels. So this is not the end of the line.

Still, it is obviously a significant moment. The $4.75 billion figure is roughly what Vioxx made in two years. Given that its use should almost certainly have been strictly limited after the 2000 VIGOR study (which is what happened in Canada in, a bit later, in the states of Oregon and Washington Medicaid formularies), Merck got about two years of "freebie" blockbuster sales out of the drug even after you subtract the $5 bil. In the meantime, there were several thousand deaths and injuries that could and should have been prevented (and were largely prevented in Canada and Oregon and Washington).

(Parenthetically, the preemption gang loves to talk about an infernal "chaos" that would result from different safety drug standards co-existing with the FDA's. But I am still waiting to hear about anyone in Idaho or northern California who ever so much as sneezed as a result of the different standards set in their neighboring states.)

In any case, Merck made few attempts to use preemption to get summary judgment dismissal of Vioxx cases. I do recall New Jersey's Judge Higbee referring to the 2007 preemption preamble as a "purely political document," so there were rumblings in that direction. But it was clearly not a central strategy pursued.

In the meantime, pharma managed to get Congress to pass the FDA Amendment Act which, at core, does nothing substantial to change the FDA. PDUFA remains in place. Fines for false and misleading advertising, if they are levied at all, are pats on the wrist. Direct-to-consumer advertising remains unchanged, even during the first two years a drug is on the market (what the industry calls the "evidence-free zone"). No independent office of drug safety – which has been supported by independent reviews of the FDA for forty years – will be created. In short, despite Vioxx's taking out 50,000 people and seriously injuring twice that number – FDA reform did not happen. And all the talk by Grassley, Kennedy, Dodd, Dingell, and Waxman turned out to be that. They caved.

Still, the illusion of reform served the preemption gang well. Even before the new law was out of the oven, they enthused about how now no one can complain the FDA is "not strong enough," "needs more resources," "cannot keep us safe," yadayadayada. For them, the nothing that Congress passed became something indeed. The Emperor got clothes.

Now add a final piece. Consider the FDA preemption cases headed to the Supreme Court in a context in which the thousands of Vioxx cases are still out here. Imagine the noise it would make if, at the stroke of a pro-preemption pen, all those highly publicized Vioxx cases suddenly went up in smoke. Would that headline catch folks' attention? I've given up on predicting what catches folks' attention. But that is, indeed, a fair amount of smoke. No, not a reinstatement of racial segregation. Not a repeal of Roe. Not even Bush v. Gore. But some potentially serious business. And maybe more.

Thus, from a pro-preemption perspective, both passing sham FDA reform and getting all the Vioxx cases off the table is very convenient stuff. Very convenient indeed.

Paranoid?

A couple of years ago, I attended a Federalist Society program on FDA preemption which featured Dan Troy as the main speaker. The panel also included two other preemptors and one "moderate" to provide something resembling a difference of opinion. The "moderate" was, indeed, nuanced and careful in his comments. The whole thing came off as reasonable and decorous as such events are supposed to be.

When it was over, the "moderate" and I chatted a bit. He needed no encouragement. It was obvious he needed to spill. "Forget what I said on the panel," he almost hissed, "FDA preemption? It's just an f'ing power grab."

My professional opinion is that this guy was as sane as guys get.

Henry Greenspan: Author Bio | Other Posts
Posted at 9:39 AM, Nov 14, 2007 in Debunking Tort "Reform" | FDA | Federal Preemption | Pharmaceuticals
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Comments

"In any case, Merck made few attempts to use preemption to get summary judgment dismissal of Vioxx cases."

False, and, in fact, preemption will knock out all of the punitive damages awarded to date in New Jersey cases under the Buckman precedent that Higbee ignored.

If the plaintiffs' case against Vioxx is so strong, why are they settling for Merck's cost to prove its lack of liability?

"Vioxx’s taking out 50,000 people"

Like the rest of the post, this is a fictional figure.

Posted by: Ted | November 15, 2007 8:42 AM

The thing that I noticed about the proposed settlement was the agrement by the plaintiffs' law firms to recommend the settlement process to all their Vioxx clients. Isn't that agreement a conflict with the firm's duty to act in the best interests of their client. What does a plaintiff attorney do with a client, who he thinks is better off not going for the settlement and pursuing his claim? Not only has the attorney contractually agreed to give certain advise to his client regardless of what is best for each individual client, they also agreed to refuse to represent that client if they want to pursue the claim. Doesn't anyone else see an ethical problem with this?

Where is my professional responsibility prof. when I need her?

Posted by: Edward | November 15, 2007 1:50 PM

The thing that I noticed about the proposed settlement was the agrement by the plaintiffs' law firms to recommend the settlement process to all their Vioxx clients. Isn't that agreement a conflict with the firm's duty to act in the best interests of their client. What does a plaintiff attorney do with a client, who he thinks is better off not going for the settlement and pursuing his claim? Not only has the attorney contractually agreed to give certain advise to his client regardless of what is best for each individual client, they also agreed to refuse to represent that client if they want to pursue the claim. Doesn't anyone else see an ethical problem with this?

Where is my professional responsibility prof. when I need her?

Posted by: Edward | November 15, 2007 1:51 PM

Ted is correct on the New Jersey issue. Being in a state which has total FDA preemption, I was distracted from the New Jersey case in which punitive damages were awarded because of the jury finding Merck had committed will fraud both on the public and FDA. The latter is, indeed, the focus of Buckman, and - given the current court - Ted's prediction will probably come to pass.

"If the plaintiff's case is so strong..." As everyone knows, the problem with Vioxx cases is that MIs and strokes (unlike, say, rhabdo) are so common. Thus causality for any individual patient is particularly hard to prove. Deliberately purveying false and misleading info to physicians is much easier, and, indeed, is confirmed in two separate FDA warning letters.

The "ficitional figure." This is midway between most of the estimates that have been asserted by several sources - Graham, Nissen, Lancet, et. al.. But I realize Ted also sees these folks as literary figures.

Clearly, it's not as certain as, say, the population of New Jersey.

I would be _very_ interested to know what Ted's estimate is of the number of patients who died as a direct result of taking Vioxx. Please do share. If the epidemiological basis for that estimate can also be shared, I'd love to learn that too.

Posted by: HG | November 16, 2007 1:49 PM

As an American, I always believed if someone, even someone rich, famous and powerful, takes the life of another human being, they would be punished. We have a Constitution that protects our rights. The 14th Amendment states “no State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law." Well, this is one area in which our state government scored 100%, as they trespassed on all of the “no State shalls.” We need to know who really benefited. Surely, not the good people of Michigan. Merck has been ordered to pay $4.8 billion to their victims (or their survivors). Although Merck was found guilty, thanks to our state law, Michigan residents might not be included in the settlement. Beyond that, $4.8 billion is not nearly enough punishment for a company who knew their product was harming and killing people. Dr. David Graham, a top FDA scientist, stated in 2005, that the death count from Vioxx “is the equivalent of the Vietnam War." The New York Times reported that, “as early as 2000 (four years prior to ‘recall of Vioxx,’ Merck knew that Vioxx was killing people.”

What should the punishment be for lives lost, hearts broken, health damaged, civil rights denied, and faith and hope in medicine taken away? Like the criminals of Enron, Tyco, et al, individuals at Merck, the FDA, politicians, lobbyists, any and all who were involved in this shameful treatment of Americans and their civil liberties should be punished to the fullest extent of the law.

Posted by: Dianne Hargrove | November 20, 2007 9:39 AM