As you may have seen in the news, pharmaceutical company Wyeth was sued by Vermont resident Diana Levine over the labeling of Phenergan (now what drug class is that, nursing students?), and the case is now going to the Supremes (and I mean the ones headed by John Roberts, not the ones headed by Diana Ross).
If you check out the links at right, you will notice that just about any place in Vermont is local for me. Plus, it just so happens that one of the largest employers in the local area is... Wyeth. (Kind of ironic, no?) When I was growing up, Wyeth was called Wyeth-Ayerst Labs, and they had a research facility in nearby Chazy, NY, that employed smart people. (My coolest Boy Scout leader was an avid rock climber named Steve Bailey who was also a statistician in animal research.) The facility produced papers like this one, which was published the year I graduated from high school:
Spontaneous lymphosarcoma, likely of renal origin, was diagnosed in a naive, juvenile, male cynomolgus monkey (Macaca fascicularis). Histologically, renal architecture was effaced by dense infiltrating sheets of plump cells... Serological tests were negative for infection with Simian Immunodeficiency Virus (SIV)...Now, Wyeth has closed most of the facility and just maintains a manufacturing plant that they are planning to shut down in the near future. That will mean one more blow to the area economy and culture, which has been going downhill since the closure of Plattsburgh Air Force Base. In line with the rest of the area, the local newspaper printed an article about the case on the front page today, but had to use an AP article rather than their own reporter... stop me if I'm boring you...
Anyhow, the case went up to the higher court because Wyeth argued that federal approval of drugs and drug labeling protected pharmaceutical companies from responsibility at the state level for inadequate warnings on drug labels. I'm not a lawyer, but this seems like a pretty decent argument. Certainly not a slam-dunk case of pharmaceutical evil, like other recently uncovered nefariousness (and, by the way, the blog after the link is excellent and a great example of the usefulness of ResearchBlogging).
For those unfamiliar, the nine Supreme Court Justices are very smart and well-informed and read ahead of their cases. Probably their opinions are pretty well made up by the time the lawyers for the two opposing sides get their day in court, which is called the "oral arguments." Nevertheless, the oral argument is the sexy part, so that's when people start paying attention for realz. In Wyeth vs. Levine, the oral arguments started Monday, and you can follow them at the FDA law blog or at the Wall Street Journal law blog. Also, there is coverage the Drug and Device Law blog, including an on-the-scene report of the oral argument, which should be informative for you if you never pay attention to that stuff. In fact, here's a small sample:
JUSTICE SCALIA: Well then, gee, then all of the qualifications you were making earlier about whether it's new information or a new assessment, that's irrelevant. MR. FREDERICK: No, it's -- JUSTICE SCALIA: You're saying whenever it's unsafe, whatever the FDA has approved, you have a lawsuit. MR. FREDERICK: No. What I'm saying is that the information developed after the original label is approved, and it is not a floor and a ceiling -- JUSTICE SCALIA: There -- there was nothing about new information in what you just said. You said it's misbranded if it's not safe, new information or not. MR. FREDERICK: And that's -- JUSTICE SCALIA: Is that -- is that -- is that your position? MR. FREDERICK: Our position is that the duty is on the manufacturer to make a safe label, and if the label is -- JUSTICE SOUTER: But getting to Justice Scalia's point, as I understand your answer to an earlier question, on the day that the FDA approves the label, if there is no further information indicating danger, then any liability that is based upon what the -- the kind of information that the FDA knew would be pre-empted. The only time -- you're saying pre-emption does not occur when there is -- forget the word "new" for a moment -- when there is further information, information in addition to what the FDA was told, whether it's 1,000 years old or discovered yesterday; and if there is liability predicated on further information beyond what the FDA was told, then there is not pre-emption. Is that a fair statement of your position? MR. FREDERICK: That's fair, but let me just make clear that our test would require the FDA to consider and reject the specific basis on which the State law -- JUSTICE SCALIA: If that's a fair statement then you have to retract your -- your earlier assertion that whenever it's not safe it's misbranded. I mean -- MR. FREDERICK: I'm not going to retract that, Justice Scalia. JUSTICE SCALIA: -- which is it? Whenever it's not safe, it's misbranded, or what you just responded to Justice Souter? MR. FREDERICK: The basis -- the basis of the FDA's approval is on the basis of limitedinformation, which Congress has said for public safety reasons -- we are not doing a balancing here; we are doing this for public safety -- And if the label is not adequate for public safety it is a misbranded drug. JUSTICE SOUTER: Okay, but if -- if the so-called misbranding is determined to be misbranding, based upon information which was given to the FDA, as I understand your position, you would admit that there was pre-emption. MR. FREDERICK: I -- I think there is pre-emption, but that does not mean -- JUSTICE SOUTER: Okay. So there -- MR. FREDERICK: Maybe there is no -- JUSTICE SOUTER: In other words, there is that one exception at least to the broad statement that you gave in answer to Justice Scalia? MR. FREDERICK: Let me try to untangle it this way. The fact that there is pre-emption and you cannot bring as State law failure-to-warn claim doesn't mean that the drug isn't misbranded under the Federal standard the FDA -- JUSTICE SOUTER: But the -- but the misbranding is of no consequence to liability. MR. FREDERICK: Well, if -- JUSTICE SOUTER: In other words, I think you're saying if there -- if there would be pre-emption it may be misbranded, but there cannot be any recovery in a State tort suit. MR. FREDERICK: That's correct. The -- the point -- JUSTICE SOUTER: Okay. So misbranding under those circumstances is a purely theoretical concept. MR. FREDERICK: In that very hypothetical, yes. JUSTICE SOUTER: Okay.Scientific American points out that this case is interesting because it wouldn't normally reach the Supreme Court:
However, the court has granted review in a series of pre-emption cases, and it seems to me that the Court might be attempting to articulate a clear pre-emption doctrine. What we have, at least in the implied pre-emption context, is a lot of ambiguity.What they're saying is that the Supreme Court has agreed to make decisions on some cases it wouldn't normally hear, probably in order to set precedents.
Anyone in health care should be interested in this situation because the pre-emption issue might have big repercussions in terms of health care costs. You might think the evil conservatives on the Supreme Court are just protecting big pharma from helpless victims, but honestly, if drug labeling can't protect pharmaceutical companies from being sued, they're going to have the bejeezus sued out of them. And do you know who's going to pay for that? All of us, in the form of higher drug prices. And do you know what might happen to drug research if drugs become a huge liability? It might (a) stop or (b) move overseas. Either way, it would mean less pills for you and me. As a nurse, where do you think the greater good for patients is?
Also, you might be interested to know that the physician assistant who administered the Phenergan gave it through IV push into an artery instead of a vein. This case is separate from the settlement that Ms. Levine made with the health clinic where the PA worked.
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