Based on off-board communications, the following needs clarification. It is a good lesson for those who have a congenital distrust for lawyer-speak. That is, it will confirm your prejudice.

Wyeth concludes its statement with the assertion: “Upholding preemption will still leave America’s courthouse doors open to injured patients. The only claims that will be decided are those where the jury’s verdict conflcits with the FDA’s considered scientific judgment. Any consumer who is injured as a result of a manufacturing defects may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA.”

Here are four non sequiturs in a row. It is certainly “crafty,” to put the best face on it.

Initially, it is written to _sound_ like a Catherine Sharkey position. FDA will have to demonstrate “considered scientific judgement” on the risk in question. That could lend itself to very narrow preemption if FDA was compelled to demonstrate its assessment process, as in Sharkey’s model. But that is not the argument here. “Considered scientific judgment” - in this statement - means anything the FDA has decided re: labeling preempts all civil claims. Period. End of story.

The “manfacturing defect” is an old canard in preemption speak. It rarely applies in the drug arena; more often in devices, but is extremely difficult to prove. So the courthourse door that is supposedly “left open” by it remains, in fact, bolted if not barred.

The reference to “strict FDA imposed penalties for concealing information’ has been exposed many times here for the farce that it is.” Such penalties are very rare, and even more rarely strict. What we’re talking about are occasional warning letters, remedial plans, occasional small fines (in the scheme of things), and in very rare cases larger fines and a misdemeanor charge. So much for policing fraud.

As I said up thread, Wyeth may have been honest about phenergan. It is not being honest about this case.

As DDL has often reiterated, the drug arena is more complicated because there is not a specific law which either grants, or denies, tort remediation over FDA approved products. So the Court must take a broad, largely conjectural reading of Congressional intent and regulation - as much in theory as in actuality. This is where ideology, and the capacity to suspend it, enters in.

I have not been convinced, however, by the arguments that, in essence, the country would have to be dismantled and begin again at Jamestown to reverse a braod preemption decision in Levine.

I do have this caveat re: Doug’s comment. I know plenty of people who work for pharma who are solidly against preemption. They recognize that, while there are certainly exploitative lawsuits, civil litigation in general is not the demon painted (any more than pharma’s own transgressions don’t represent the entire industry).

Some also believe as I do that preemption, if broad, is more likely to hurt the industry - potentially, very badly - than help it. So it is a lose, lose, lose situation - for the industry, for justice, and for everyone/everything else.

It is too bad that those who do support preemption have seemed to lose interest in engaging here. There are good middle ways - including genuine tort reform, narrower definitions, and so on. It remains possible Levine will be decided narrowly, but Wyeth’s statement makes it clear that it hopes not.

FDA preemption protects no one except pharma. Business friendly politicians on the state and federal level are trying to disguise the assault on civil rights as tort reform.

If this policy is upheld, victims injured by dangerous drugs will go uncompensated, the regulatory powers of the states will end, and the drug companies will only be answerable to the FDA. Beyond losing a precious right, the health and safety of all Americans will be at risk.

But it is also important to remember that even if we had a utopian FDA (dream on), preemption would still be irrational policy. One reason is the host of potential delinquencies that may become relevant in civil liability that are entirely _outside_ FDA’s jurisdiction. These include;

- attempts to bribe scientific researchers.
- attempts to intimidate researchers.
- deliberately mispresenting reality in medical journal articles

And so on.

Preemption Protects Everyone

– The fact is this is simply unsubstantiated and unsupported in the arguments below.–
Wyeth:
The Constitutional principle of preemption is not new. Preemption arises from the U.S. Constitution, which under the Supremacy Clause invalidates all state laws that conflict or interfere with federal law.

–The Supremacy Clause was meant for issues such as declaration of war or treaties that might be initiated by States, not in reference to public safety unless specifically stated by law initiated by Congress. Law initiated by any branch of government other than the Congress should be suspect from the start. This is the circuitous route preemption has taken.

The laws of the land, as with any governing rules, should not contradict themselves. Preemption itself causes such contradiction with the Federal Constitution. On the one hand, our Constitution states that the citizens shall have the right to be heard in a court of law when its citizens feel they have been harmed. Preemption repeals that right by absolving certain corporations from challenge in a court of law.
Furthermore States are given the responsibility, by the Federal Constitution, for the safety of its citizens. State law is one means to accomplish that. Again preemption causes conflict with this mandate.
It seems that preemption causes more conflict than it remedies. Unfortunately the harm that the conflict causes is taken from the corporation and thrust upon the backs of the public.–

Wyeth:
In Wyeth v. Levine, the Vermont’s jury verdict was in direct conflict with the FDA’s considered scientific judgment.

–This brings into question the judgment of the FDA. Two points can be made here.
1. What is the capability of the FDA’s judgment?
The FDA itself admits that its capability is such that the American public is in danger.
2. Who is the FDA is judging for. If the FDA is judging for the public, that’s fine. Is this the case? In these times, sadly this point is being debated. Does the FDA cater more to the corporation or the American citizen? The fact that there even IS a debate about this should cause one to shudder. If there is any doubt about who the FDA serves, preemption should be shelved until such time as this issue is unquestionably resolved.–

Wyeth:
Patients and physicians need to be able to rely on a single federal standard and guidelines for the risks, benefits, and use of medicines — the FDA-approved labeling.

– What patients need is a sense of confidence in their drugs, devices and doctors. The current clear lack of confidence (which is getting worse by the day) warrants an increase in protection not a decrease in recourse from harm. Preemption is calling for the public to lay down the one means of personal protection that they can grasp with their own two hands (If they still have them) and put total trust in the Pharmaceuticals companies and the FDA, both shown to be untrustworthy. –

Wyeth:
The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings — rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret.

– Please provide evidence of this.–

Wyeth:
Such a system would undermine the careful balance struck by the FDA when making approval decisions.

– This so called “careful balance” would suffer a seismic shift from the public that consumes the product in favor of the manufacturer that produces the product. This careful balance of safety would be destroyed.
Again please provide the evidence that the current system is out of “balance”? How has the past 70 year of no preemption caused such harm?–

Wyeth:
Upholding preemption will still leave America’s courthouse doors open to injured patients. The only claims that will be decided are those where the jury’s verdict conflicts with the FDA’s considered scientific judgment.

–See above comments about considered judgment.–

Wyeth:
Any consumer who is injured as a result of a manufacturing defect may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA.

–Maybe you can fool some of the people some of the time… this statement reeks of duplicity.
The evidence is – Some Pharmaceutical companies (probably more than we know about) habitually conceal information from the public and from the FDA. How would you propose that we find out about that aside for the state torte? No, preemption slams the courthouse door, locks it and throws away the keys that have for so long been the property of the American citizen.–