Comments on: Preemption, Wyeth & Bad Law: Zipursky Explains

By: Justice in MI

Justice in MI — Thu, 02 Oct 2008 03:13:09 +0000

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.

By: ol cranky

ol cranky — Thu, 02 Oct 2008 00:17:37 +0000

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…

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.

By: Justice in MI

Justice in MI — Tue, 30 Sep 2008 03:19:57 +0000

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.

By: Nathan

Nathan — Tue, 30 Sep 2008 01:34:21 +0000

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.

By: Justice in MI

Justice in MI — Tue, 30 Sep 2008 00:39:36 +0000

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.

By: Nathan

Nathan — Tue, 30 Sep 2008 00:30:56 +0000

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?

By: Justice in MI

Justice in MI — Mon, 29 Sep 2008 21:32:28 +0000

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.

By: Ed Silverman

Ed Silverman — Mon, 29 Sep 2008 20:15:45 +0000

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

By: Nathan

Nathan — Mon, 29 Sep 2008 20:05:16 +0000

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…

By: Justice in MI

Justice in MI — Mon, 29 Sep 2008 19:44:24 +0000

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.