Although state specific attempts to directly impose labeling requirements on pharma manufacturers are likely to be unsuccessful (there is no argument that FDA preempts the field here), the real world issue is that state law tort concepts have imposed an impossible burden on pharma manufacturers. Taking the Levine case as an example, the manufacturer followed FDA procedures with respect to warnings and additionally lobbied FDA for expanded warnings for its Phenergan product. FDA decided the warnings were adequate and declined the manufacturer’s request for revision. There was thus nothing more the manufacturer could do legally regading warnings on the Phenergan product. The Vermont jury, however, found that the manufacturer did not provide adequate warnings and that Mrs. Levine’s injuries were the direct result of that failure to warn. As a result, the manufacturer bears the financial brunt of an injury caused by allegedly inadequate warnings that it was constrained to maintain due to FDA fiat. This scenario is played out in courtrooms across the country as plaintiffs attempt to convince juries that, “Manufacturers selling pharmaceutical products in (fill in state) have a duty under state law to ensure that their product carries appropriate warnings to protect our citizens. It is not enough to simply have complied with FDA regulations.” The chaos that Dr. Sal references is already in play and the real world consequences are/will be reduced availability of pharmaceutical products on a state-by-state basis which has been a hotly debated issue for years.

Nurses Laurie and Lynn:
I agree that because of the age/familiarity of promethazine, most nurses are unaware of the risks of IV infusion. From the manufacturer’s perspective, however, there is an expectation that the physician requesting said administration is fully aware of a drug’s propensities. Risk-Reward is at the essence of a decision whether and how to administer a drug to a certain patient and the physician is uniquely qualified to make that determination in light of how the patient presents in his/her office. It cannot be controverted that the Risk-Reward analysis can only effectively be made when ALL of the risks have been factored. It leaves everyone empty when a physician testifies (as in this case) that he ordered IV administration because he knew it would provide immediate relief but that he had not recently read the label and did not know of the risk of extravasation. It also leaves everyone empty when the nurse administering the infusion testifies (as in this case) that she did not halt the infusion despite the patient’s cries of severe pain at the injection site in contravention of standard practice. I agree that pharma and the medical community need to write policies and procedures aimed at ensuring the safe administration of pharmaceutical products. These products are, by definition, toxic substances that can have serious unintended consequences if administered injudiciously.

However, what the preemptors did was to equate an issue like that - where there is truly an indendent “min” FDA in a state - and slid it into preemption of state tort law, which, in itself, has nothing to do with labels.

Still, there’s a great deal we’ve learned about safety issues with certain drugs (that end up in label changes or full withdrawal) through civil liability that it is unlikely we would ever have learned otherwise. See Kesselheim and Avorn, “The Role of Litigation in Drug Safety,” JAMA, January 17, 2006.

The issue in Ca. I referenced was a move to require seperate package insert/label in that state for a particular product. This is quite a different matter than a decision not to allow general coverage for a product or proceedure.

Thanks for taking my word on this matter-of-fact; I worked on many issues in my time and can only sometimes remember generalities.

- First, happy to say that I am not a lawyer. I teach about some of these issues in a policy/politics context.

- For Nathan: Yes, it is clear that the Bush administration has initiated the movement toward preemption. They make no secret of this. It was a change of policy initiated in early 2002, shortly after Dan Troy’s appointment as FDA Chief Counsel. He has been the “godfather” of the movement for several years, including since his leaving the Chief Counsel position in 2004.

Dan (we have slight acquaintance, so I guess I can use his first name) moved quickly as Chief Counsel, specifically inviting companies to bring cases to him - as FDA Chief Counsel - that FDA would then support with an amicus arguing that such cases should be rejected on the basis of FDA preemption. All of this was very out in the open. His famous line, said at a conference, was that companies should “pitch their cases to him as though they were Hollywood scripts.”

So the goal was to get us where we are - have cases work their way through the circuits - where disagreements were virtually certain - so that one or more would eventually come to the Supreme Court. That took about six years.

Once the Supreme Court rules, there is nothing a new FDA administration can do to reverse or modify it. It is now “the law of the land.” If it were to lead to demonstrably bad results, there is the possibility that Congress could pass a bill that impacted the Supreme Court’s decision. But essentially we’re in a position close to Roe v. Wade. The Supreme Court would have to reverse itself to turn back what happened yesterday. I guess that’s why we do, indeed, call it “the law of the land.”

Dr. Sal - I’ll take your word on that. There are other potentially relevant examples. The Medicaid systems in both Washington and Oregon did not support Vioxx after the 2001 FDA Advisory Committee on it. This was not based on cost but on safety (it is against the law for such formulary decisions to be based on cost in those states). So here, indeed, were cases of states making, in effect, declarations about safety that were contrary to what FDA was then saying, Merck, et. al.

Nonetheless, no chaos resulted.

Several years ago one state, I believe California, attempted to pass legislation that would have created special warning categories for some pharmaceuticals. I cannot remember the specifics (must have forgotten to take my Aricept) but I believe it had something to do with carcinogenicity. This attempt failed but it was tried. Notwithstanding this failed attempt or any other prior attempt that I am not aware of, it is very dangerous to assume that because something has not been successful in the past sociopolitical climate it would not be successful at this or some future time. I am glad “Justice” and I agree though that the standing FDA system HAS worked and prevented chaos and therefore any actions which might jeopardize this greater-good compromise through judicial activism or case law would be a bad thing.

To Justice in Michigan: True that FDA & civil litigation have coexisted up to now, but the question of where the 10th Amendment stands on the role of the state courts in litigation has not been determined. If the SC definitively decides in favor of the states, it’s entirely plausible that the chaos described by Dr. Sal would take place.