March 10, 2007
Thanks, DRI Folks
I really enjoyed the DRI Toxic Torts conference. It was a terrific group of speakers; I especially enjoyed the discussion of historians as experts presented by Theodore Marmor (Yale), who was entertaining and provocative. I will hopefully be writing more about his work in the future.
As a heads-up, posting may continue to be slow for a bit. Between being (again!) a bit ill and the rather sudden death of a cousin, things are a bit chaotic. Hopefully I'll be back at normal speed soon.
March 8, 2007
Public Nuisance & Pharma
A presenter this morning mentioned this student Note [PDF] about the settlement of Oxycontin litigation in West Virginia, where, among many claims, the plaintiff asserted that improper marketing of the drug created a public nuisance. The case was settled without creating any law on the issue, apparently, but it's another step in efforts to make products liability cases into public nuisance cases.
The presenter also mentioned a Montana case, Paulsen v. Monsanto, alleging public nuisance in a PCB case, where the court denied summary judgment -- I can't find that order online,so if anyone has it, send it along. And of course the Rhode Island lead pigment case is the (largely incoherent) elephant in the corner. (I know, elephants are rarely coherent.)
In any event, the Oxycontin case made me wonder if we'll start seeing public nuisance claims for suits related to off-label marketing in, for instance, the Zyprexa and other anti-psychotic claims. Given the, shall we say, lighter standards of proof for a nuisance claim, it might well be worth a try.
Addendum: I should have mentioned -- I don't think those sort of claims should be public nuisance claims for a variety of reasons. Just observing that the trend, after a long time of failures, seems to be towards broadening the claim to capture various conduct that for a number of reasons can't be reached under traditional products liability claims.
Connecticut Mulls MySpace Rules
Connecticut is considering statutory provisions requiring MySpace and similar sites to confirm ages and to obtain parental permission for kids under 18. The AG asserts that the technology exists, but the article doesn't indicate what it is. I suppose the idea is that if you can't prove you're 18 (using technologies like those used for blocking access to adult sites), you have to provide permission from a parent, and the parent has to prove that they're 18. I doubt there's much of a way to prove the parental relationship, but a system like that would probably knock out some decent proportion of the problems.
March 7, 2007
You'll Smack Flames Out of Where?
March 6, 2007
Med Mal Compromise in the Works in Tennessee?
That's what a Nashville Post story suggests. The lede:
March may come in like a lion and out like a lamb, or vice-versa, but who would have guessed that March 2007 might be the month when the lion would lie down with the lamb?
That's what may be afoot, as a nationally unprecedented concord among medical providers and the legal profession comes together — just maybe — to bring a brand-new model of malpractice litigation reform to Tennessee.
The reforms do not include any caps on damages, instead featuring pre-filing certification, a narrowing of disclosure requirements for past suits against physicians, broader access to physicians by both sides in litigation, locality rule changes, and an extension of a data-gathering process.
March 5, 2007
Potential Bias in Outsourced Risk Assessment
The LA Times has the story of a regulatory agency tasked with evaluating human risks of various chemicals outsourcing that work to Sciences International. One potential problem: Sciences International has extensive work with industry, including entities with products regulated by the agency.
Lots of on-the-one-hand and on-the-other-hand in the story, and it's worth reading all the way through.
March 4, 2007
Zyprexa: Pennsylvania Sues and Thoughts on Sequestered Science
David Michaels (GWU) has a useful post noting the Pennsylvania suit (Bloomberg story) against Lilly and others for allegedly fraudulent marketing of Zyprexa and other anti-psychotic medications. The basis for such suits, as I understand them, is the excess payments made by states through the Medicare program for drugs that they contend ought not to have been prescribed and would not have been if not for the fraud. As is common, the suits are brought by private firms who also represent individual plaintiffs.
More interesting, Michaels also notes the possible tension between protective orders and the public health:
At [a 2004] meeting, we wrestled with the question of whether courts should allow information vital to protecting the public’s heath to be hidden from the public as part of a settlement. In many instances, attorneys representing both the plaintiffs and the defendants prefer to seal documents. The defendants may avoid public embarrassment and further suits; the plaintiffs (and their attorneys) get larger monetary awards by agreeing.
The drug maker Lilly has paid $1.2 billion to more than 28,000 individuals who claimed they developed diabetes or other diseases from taking the anti-psychotic drug Zyprexa. The attorneys on both sides, those representing Eli Lilly and those suing the drug manufacturer, agreed to seal the studies and other documents that supported these claims. Does the public’s right to this information trump the right of the parties to the litigation to secrecy?
He's got more, and it's well worth reading. It's a subject I'm working on for a new article, though I'm taking off a fairly small bite, focusing on how electronic communication and anonymizing technologies change the impact of protective orders, rather than doing big picture stuff about the propriety of protective orders in the first place.
One question to which I do not know the answer: How much would registration of clinical trials and easier access to adverse event data mitigate the concerns? Obviously that wouldn't capture everything one might want to know about off-label marketing and the like, but it seems like it should provide access to the actual data (both reliable, and in the AER context, unreliable) from which one could draw conclusions about Bad Things(tm) occurring.
I observe that Lilly has started making available clinical trial data post-2004, and AER data is nominally public (if obscure and generally useless) too. Seems likely to mitigate (but not, I assume, eliminate) the concerns, perhaps leaving much of what remains confidential either actual trade secrets or stupid bad documents that sound terrible but don't actually provide useful data on which conclusions should be based.
The role of plaintiffs' firms involved in individual personal injury suits also bringing the Medicare suits has some potential conflicts as well. As Michaels points out, the plaintiffs have some incentive to keep bad documents secret if they think they can get the defendant to globally settle cases; that secrecy provides leverage.
One point of clarification on David's post: I imagine in the settlements the parties merely agreed to maintain the documents' status under the protective order issued by the judge, not to seal the documents anew. As I've noted previously, the protective order does include a mechanism for unsealing documents that are not properly designated as confidential. I believe an effort to do that is proceeding in the Zyprexa case.
My usual disclosure: I do a small amount of work for pharmaceutical clients in the defense of tort litigation. Lilly is not and has never been a client of mine.