I understand as trial lawyers you tend to profit from successful law suits. But in this case the fault and injury was not caused by he pharmaceutical company but by the nurse/technician who administered the medication. It was labeled to be given IV but instead it was given into an artery. The complaint is that the company didn't warn that it would be idiotic to fast push into an artery.

The company also doesn't warn not to be given intra-abdominally, intra-optically, intra-articularly etc etc. So if some technician injects the medication into anyone of hundreds of unauthorized sites it will be the companies fault that it didn't warn?

If you were G-D just how would you label the product so no nurse/technician can possibly make any error? When the FDA approved the labeling it thought it had adequately covered that point but didn't account for stupidity.

Preemption is just the flip side of the corporate greed coin. They want it both ways, billions in profits so they can pay themselves millions in bonuses while claiming that without a liability free ride the public will suffer. The public up till the mortgage meltdown was easily fooled into giving corporate America a free ride. I'm sure Mr. Libertarian too believes in a right to corporate greed right up until it's his body that suffers the loss then he's in David's office whining about how the law shouldn't apply to him. Then it’s ha-wha-whaaaa. You can’t have it both ways Mr. Libertarian. Pick your poison.

One more thing Mr. Libertarian, do lawyers support the right to civil redress because they “profit” as you say, or because it’s what is right for those corporations that profit pay for the wrongs they do? Being a Libertarian shouldn’t mean being uncaring and simply motivated by profit at all costs.

Wow! I've been fighting FDA preemption for a long time - in Michigan and nationally. I've had the chance to debate the claims of Dan Troy, Michael Greve, the DDL guys, and others - people whose views are worthy of unpacking, however much I view things differently.

The Pipes piece is in a different league entirely. It is, by far, the most misinformed thing I've ever read from that side. Embarrassing, really.

The version that appeared in the Detroit Free Press has been rebutted thoroughly by several comments published there. That's probably as attention as the piece deserves.

Just a word for the Libertarian. As you no doubt know, Milton Friedman favored dismantling the FDA entirely. A key part of the "free market" that he believed would take care of us without FDA regulation was, you guessed it, the tort system.

I've always wondered (as a not-lawyer) why all the players get to be capitalists _except_ the lawyers!

That said, I do not entirely disagree with you about the Levine case. My personal hope is that SCOTUS remands it. There are much better cases through which to work through preemption.

Preemption can present many problems. When the FDA approves a new chemical they consider safety and efficacy. In theory they balance the two. IANAL. As a physician and pharmacist I know for instance that a certain medication will take 1-4 weeks to work and after that may cause problems. Once again the FDA makes the final determination.

But let me give you a hypothetical. Say, California is a safety first state and demands a label that medication A can only be used for 1-2 weeks. After that there is a very small possibility of a side effect. They know that in 1-2 weeks it will not be effective in 40% of patients but safety is their most important consideration.

Nevada on the other hand wants effectiveness. They demand a label that says before abandoning therapy try the medication for 4 weeks. They realize 5% of patients may get a side effect but it will now work on 80%. It is cost efficient to have the medication actually cure disease.

What do propose the FDA and the pharmaceutical company put on their label? In the current system the FDA is the final arbiter.

There are many problems where the states wish to have autonomy but must bow to a national standard. The Constitution grants the Federal government the final decision concerning interstate commerce. Should that be overturned?

As a Lawyer and Pharmacist, I know that the drug industry must be held accountable - that immunity will only breed an environment of dangerous and defective products entering the market place. The FDA has already acknowledged that it is not capable of performing the responsibilities asked of it. I propose that pharmaceutical companies not hold back information like Merck recently did in the Vioxx debacle due to money and greed. People died - lives were ruined without being able to make an informed decision. Why shouldn't those victims be able to hold Merck accountable?

David, you are discussing a subject totally different from preemption. If fraud was perpetrated than the victims may sue. That is not the question here. No one is arguing Wyeth was fraudulent.

Preemption asks for the states to be able to demand a totally different package label than one approved by the FDA. Wyeth and the FDA said inject IV. The administrator injected into an artery. This is not Merck hiding data.

If you want to overturn the Constitution's interstate commerce clause did you agree with Lopez and Morrison?

First of all, the Supreme Courtʼs preemption jurisprudence revolves around the supremacy clause (federal law, including the Constitution and its Amendments as well as statutes, treaties and federal rules are the supreme law of the land), not the commerce clause. My opinion on Lopez and Morrison (which dealt with Congressʼs ability to enact laws pursuant to its commerce clause powers, and nothing to do with a stateʼs right to maintain a body of law to compensate injured parties in the absence of a federal law that expressly preempts that area of law) is completely irrelevant. With respect to your hypothetical of two separate states wanting to have competing warning labels (potentially bringing forth a dormant commerce clause challenge), you answer your own question, the FDA does have the authority to create labels on new drugs, so states donʼt even bother. Instead, as former FDA Commissioners David Kessler (appointed by George H.W. Bush) and Donald Kennedy argue in their amicus brief for Respondent Levine, this isnʼt really a conflict between state law and federal law, because the FDCA and FDA procedures have always understood that ultimate responsibility for drug safety lies in the hands of the manufacturers of drugs, who are in a far superior position to learn about developing safety risks and whose reactions to failure-to-warn litigation has always been considered an instrumental step in securing consumer safety. Preemption essentially asks the federal agency, in this case the FDA, to become the sole and final authority on drug safety even though its enabling statute is silent on the matter.

Secondly, your contention about preemption leading to impossible situations for drug labeling compliance is precisely the type of argument Justice Anthony Kennedy seems unwilling to accept, and in that respect Iʼll defer to his judgment (as it is very likely heʼll be a decisive vote in this matter). He makes clear that Petitioner Wyethʼs argument about being unable to follow both federal and state law at the same time is textually, logically and semantically unsound. Wyeth was free at all times to change its warning labels, even without prior FDA approval. The trial judge in Vermont instructed the jury that the FDAʼs regulations permit drug makers to add to or strengthen a warning without prior approval and Wyeth did not object to this objection, even though they objected to other jury instructions, probably because Wyeth knows this is true. There was no evidence whatsoever that the FDA wanted to preserve IV push as a means for administering Phenegren, so the change to the label would have been a non-issue. Basically, preemption allows manufacturers to do nothing and avoid liability knowing full well that the federal agency is in an inferior position to know about developing harms in drugs.

You are correct, nobody is claiming Wyeth was acting fraudulently, only that they took no action at all even though they knew for four decades that an IV push administration of Phenegran could result in contact with an artery, resulting in necrosis, gangrene and potential amputation. Because the FDA is not in a superior position to know about subsequent dangers discovered after a warning label is initially approved, Congress clearly contemplated through its silence on an express preemption clause, that the responsibility of ensuring consumer safety still rests with the manufacturer of the drug. Your subsequent jests of "intra-abdominally, intra-optically" arenʼt actual concerns because a plaintiff would not be able to establish a duty to warn about intra-abdominal injection because (1) itʼs not foreseeable youʼd inject a nausea reducing medication in an eye, and (2) duties to warn can only be found where the defendant knew or should have known about the dangers. A reasonable jury would protect a manufacturer from liability on truly outrageous conduct on the part of a physicianʼs assistant, whereas the mistake here was IV push rather than IV drip.

Obviously both the fact patterns and the basic nature of the cases were different but it seems Riegel v. Medtronic at least superficially was about the similar preemeption concept. And that one was decided 8-1. Breyer, appointed by Clinton, was in the majority.

The importance of answering letter to the editors like this is imperative. The companies that sight this information as fact , have to be called on not only the reality but also on their true motives.

Again, for Libertarian - The Medical Device Act did, indeed, have an express preemption provision in order to prevent the situation you describe - states setting up genuinely independent "mini-FDAs" that could require different labels, withdrawing a device, requiring its remanufacture, etc..

State tort law does none of those things - those powers that remain solely in the hands of FDA, or in the hands of FDA negotiating with companies. That is why folks like Ted Kennedy, who supported the MDA, have stated repeatedly that the relevant provision was not meant to preempt state tort law.

I understand that if Vermont's verdict is upheld, it would potentially put Wyeth in a situation of liability in other states. Almost certainly, any such suits brought would play out differently in different venues. If FDA were able to document better than they now have that they thoroughly reviewed the IV push risks (the fact that there is something on the label does not, inherently, mean a risk has been thoroughly reviewed) then almost certainly such suits would not succeed. Conversely, FDA might decide the folks in Maine actually had it right, and, upon reconsideration, the phernergan label really should be changed. It would not be the first time a label change resulted from facts unearthered and reviewed in civil cases.

When former FDA Chief Counsel Porter (now famously) said that FDA regulations and state common law usually provide "two complementary systems of consumer protection," she was, indeed, making an overall risk/benefit assessment. Overall, the benefits of having both systems outweighed the risks of not having them - and thus the risks of preemption. There will be cases and instances where deference will and should be given to FDA's determinations. That has always been the case. Those states that contain "rebuttable presumption" clauses build that assumption in.

As I view it, this is all to the good. On the other hand, invoking the "nuclear option" of preemption violates my own, as well as FDA's traditional expert analysis of risks and benefits of preemption as policy.

If I am reading you correctly you seem to be defending the Supreme Court decisions in the Slaughter-House cases. Do you indeed agree with those decisions? If not how does what you write above differ?