Sunday, March 4, 2007
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.