Preemption, Wyeth & Bad Law: Zipursky Explains
12 CommentsBy Ed Silverman // September 29th, 2008 // 12:59 pm
On November 3, the US Supreme Court will review a case involving preemption, the legal notion that FDA approval supercedes state law claims challenging drug safety, efficacy, or labeling. Pharma and the FDA argue agency actions are the final word on safety and effectiveness. And so the court will be closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. But in a recent column, Ben Zipursky, a Fordham Law School professor, wrote that Wyeth vs. Levine may not be a good case to decide preemption (back story). We asked him to explain…
Pharmalot: Why do you call this case an unfortunate example of preemption to have the court decide?
Zipursky: The nature of Supreme Court adjudication is such that they end up deciding broad principles that have a large impact but the structure of our system is that they make those decisions by looking at a particular example before them. A risk in any form of Supreme Court adjudication is that the power of the facts will lead the court one way, even though, as a broad principle, that might really not be the best way to go. There are some cases that are hard cases that make bad law, and this may well be one of them.
Pharmalot: Why is that?
Zipursky: It’s because the very facts of the case that would have made it so appealing for a jury to come out in favor of the plaintiff and against Wyeth are facts that would typically make an appellate court think it may have to play some large-system protection role. Here’s a woman who did aboslutely nothing wrong - she had a headache and went to a clinic and because of the defendant’s drug, she had an arm amputated. And it’s a tragic case; (Diana Levine) is a guitarist. It’s just the kind of case you can imagine a jury jumping up for a plaintiff, and they did. On the other hand, apppellate courts see their role as taking a broader view and insulating large, rich defendants against verdicts they believe are precipitated by sympathy. I think, to the US Supreme Court, this is going to look exactly like that sort of case.
Pharmalot: What is about the facts here that make you say that?
Zipurksy: Wyeth was aware of the risk that its Phenergan IV drug could cause gangrene if administered improperly, and warned about this on its package insert, and explicitly cautioned against injecting the drug. But the language of Wyeth’s package insert did not prohibit the IV push method of delivery and the plaintiff argued the warning should have been even stronger.
The alleged basis for liabilty here is really just too thin to sustain a proper tort. The predicate for a liability is a failure to warn and Wyeth did warn. Failure to warn law has become quite subtle, so it is possible for a plaintiff to argue the warning was not adequate. But if you look at Wyeth’s warning, it was quite extensive - it warned of risk of gangrene and indicated that if you have the syringe go into artery by mistake, there was no reversing damage done. It was a very serious warning. And what you sometimes find is, after the fact, looking at this sort of tragedy, a jury will be persuaded that maybe an even more severe warning would have saved aplaintiff from a serious injury they incurred. That’s extraordinarily speculative. The reality is it is was the clinic’s fault, but the clinic is a much smaller financial entity and Vermont law is designed to give the plainitiff multiple options. The drug company really didn’t do anything wrong, it appears. And the previous ruling delivers the message that state judges and juries across America are hostile to big corporations. This is what the tort reform movement is saying.
Pharmalot: Why couldn’t Wyeth have stated plainly that the drug should not have been injected into the artery at all?
Zipursky: First, I think Wyeth would argue that it could not have done that without running afoul of what the FDA told it to do. But more important, I think the plaintiff’s lawyers appear to have been anxious about the risk they would face a more serious preemption argument if they phrased their argument to say it simply should have been prohibited. It was a failure to warn argument.
Pharmalot: So you’ve written that for the Supreme Court to reverse the case would make bad law. Why is that?
Zipurksy: The reasons Wyeth should win all have to do with the way Vermont law should be interpreted. But these don’t have anything to do with preemption defense. The Supreme Court has no business deciding Vermont law. The only hook for the court is federal preemption. It’s only tool for delivering Wyeth a victory here is to craft a defendent-protective rule and federal premption law and give Wyeth a vctory. And if that were done in a broad way, it could be a disaster. The world of big drug companies are hoping the court will be so tempted to find a way to make Wyeth win this case, using federal law, that it will craft federal preemption doctrine.
Pharmalot: In other words, you’re describing an overreaction. But do you think this is likely?
Zipursky: There is the possibility the court will craft a very narrow preemption idea. It could say the essence of whatever the plaintiff is arguing is this: that Wyeth needed to say you can never use this product for an IV push. And since the FDA had decided that should not be on the label, the court might decide clinics and hospitals may have that particular method available to them. And, therefore, Wyeth is put in a bind by this particular case of facts and, therefore, the claim is preempted. The court could do that and have a much narrower effect.
Nathan
Ed,
You’ve interviewed Levine and now Zipursky. Both are, obviously, anti-preemption. You’ve highlighted antipremtion briefs from various parties. Have you made any serious attempts to interview someone who is pro-preemption? Maybe someone from Wyeth or PHRMA? I’m sure there are no shortage of people who would love to give you an opinion. It seems we are all well-aware of the anti-preemption arguements. For the case to make it as far as it has, I’m sure that there are some good pro-preemption arguements out there. It would do your readers good to hear both sides of the debate (other than in the comments).
Ed Silverman
Hi Nathan,
That’s a fair question, and the short answer is yes, but first, a clarification.
Diana Levine is, of course, the central character in this drama which, to my way of thinking, puts her in a different category than a law professor with no particular skin in the game, whatever his views may be.
That said, I do have someone in mind from the ‘other side of the fence’ to discuss all this, but don’t wish to tip my hand.
By the way, I interviewed Zipursky because he got out in front of an interesting question that has been raised on this site previously - whether the Levine case is, in fact, the best choice for deciding preemption, regardless of whether one supports or opposes the broader preemption concept.
Anyway, stay tuned.
Ed
Justice in MI
Oh great….(Actually, I’m looking forward. It will be fun to respond.)
Re: Nathan’s post, I think Ed posted all the pro-Wyeth briefs as well as those against. I could be wrong.
It may also be of interest that a recent piece by co-authored by Ben Zipursky, and making much the same argument here, was cited and linked last week on Drug and Device Law - the pro-preemption website if there ever was one.
Many of us agree that Levine is the wrong case to decide preemption, and certainly not broadly. So why is it there? Ask the Court and Bush’s Solicitor General.
Nathan
Justice and Ed,
I’m not accusing Ed of bias here. I’m just pointing out that the arguements against preemption have been articulated again and again in comments and in articles. However, the arguements FOR preemption have not been so articulated. (beyond a one or two sentence reference) Maybe it’s because they don’t exist, but I doubt it…
Ed Silverman
Hi Nathan,
No offense taken. I do wish to point out that I have filed several posts - for and against preemption - whenever I learned of new briefs filed with the Supreme Court. These were beyond the interview earlier this year with Diana Levine and separate posts about other cases before different courts in which preemption was raised.
For instance, I filed posts when both Wyeth and the Solicitor General filed their briefs…
http://www.pharmalot.com/2008/09/wyeth-vs-levine-preemption-posturing-continues/
http://www.pharmalot.com/2008/06/white-house-backs-wyeth-on-preemption/
http://www.pharmalot.com/2008/05/wyeth-files-brief-for-levine-preemption-case/
http://www.pharmalot.com/2007/12/white-house-backs-preemption-in-wyeth-case/
Cheers
ed
Justice in MI
Hi Nathan,
I assume you’re being coy, but there are no shortage of sites for arguments in favor of preemption. DDL, Wall Street Journal Editorial Board, Peter Pitts’ site, AEI, WLF, ATRA, PhRMA, NAM, Chamber of Commerce, and on and on. DDL recently had a post that listed a number of the above as places corp. lawyers could go if they needed support with brief writing.
Beyond that, and whatever Ed posts, I’d say bringing those arguments here is the responsibility of participants. You have done some of that, as have Chris2, Atlex, Paul G., and others.
Nathan
Actually, I wasn’t being coy. I really don’t know anything about preemption other than what has been said on this site. I wasn’t aware that all those groups are in favor of preemption. It would be nice to hear from one of them…. Do you have links to any of their opinions?
Justice in MI
Someone posted PhRMA’s view on a recent thread in which you participated, but I don’t recall the title. All the sites I listed are linked in the sense that they work closely together on a range of projects (except the WSJ as far as I know!). A simple google search will get you there, including the pro-preemption briefs in all the relevant cases (which generally all say the same thing) and FDA’s preemption preamble itself, which can be googled. Likewise, someof Dan Troy’s papers can be googled up.
Nathan
I was the one who posted PhRMA’s view — I happened upon it one afternoon. Interestingly, almost no one in my pharma company is even aware of what preemption is…! It’s not an issue that is on the radar screen of almost any scientist in pharma.
Justice in MI
I think the vast majority of the country is watching that same radar screen….
It takes a lot, as we have learned after 13 years of preemption in Michigan. But, eventually, most people found out, and the State House voted 70-39 to repeal it. Polls show about the same - 70% of people in Michigan - are against (they can’t all be trial lawyers). But State Senate killed House bill in committee.
ol cranky
Nathan: In truth, there aren’t really arguments FOR preemption in the Levine case because it is really a medical malpractice case, not a legitimate case against a pharmaceutical company.
Justice in MI
Good to ’see’ you OC. Certainly it is a preemption case from the perspective of the briefs. As presented there, Wyeth could not possibly have added a warning about phenergan not reviewed and authorized by FDA. Thus, the view of the Vermont Sup. Ct. that they could have and should have should be preempted by this fact. That’s really the preemption issue in Levine
As we’ve often said, not as ‘juicy’ as in the various instances when it is clear FDA approval/compliance can reasonably said to coincide with fraud or negligence on the part of the company. To broadly support preemption in Levine - in a form that would cover, say, the various histories of fen-phen, Baycol, Vioxx, Paxil, Zyprexa, et. al. - would itself be a kind of fraud, in my view. But that may very well happen.