January 22, 2009
Egilman on Zyprexa Settlement
Dr. David Egilman has a post at the Pump Handle blog regarding the settlement of civil and criminal matters by Lilly in the Zyprexa off-label marketing case. Egilman, who acknowledged in a sworn affidavit to violating a protective order in the litigation, argues against the use of protective orders in pharmaceutical tort litigation and for delivering any sealed discovery to the FDA and DOJ.
He also contends that the criminal charges might not have proceeded if not for his leak of documents, though the criminal investigation began in 2004 (well before the protective order violation) and federal prosecutors do not lack for subpoena power. Of course, the leak may have highlighted documents that the prosecutors had not focused on, I suppose.
January 13, 2009
Wanted: Topics for Papers on Scientific Evidence
I am teaching a writing seminar this semester about experts and scientific evidence. If any readers have topics they've been thinking could use a careful look, please send them along (wchilds AT law DOT wnec DOT edu). Practitioners, academics, etc., all welcome.
September 08, 2008
Weinstein Unseals Zyprexa Documents
The NYT piece is here; the opinion (long! PDF!) is here. The vast bulk of the opinion relates to certification of a class for institutional payors and denial of a class for individual payors; only at the end are the documents noted. (The documents, of course, have been readily available online after they were released in violation of Judge Weinstein's protective order by David Egilman.)
My piece in the Review of Litigation relating to document leaks in the internet era, which includes feedback from various players in the Zyprexa litigation including Judge Weinstein himself, is available, and I have a boatload of reprints. Feel free to holler for one.
September 04, 2008
Ongoing Zyprexa Documents Fiesta
Pharmalot has details; Jim Gottstein (the Alaskan lawyer in the middle of a lot of the document hullabaloo) is seeking to unseal some of the documents as part of his renewed effort to fight Judge Weinstein's injunction, while Lilly objects.
August 25, 2008
The FDA's New CBE Rule
The FDA issued a new final rule [PDF] relating to "changes being effected" -- i.e., changes that a drug manufacturer can make to its label without advance permission. The focus of the changes is on emphasizing that it relates to new risk information, and that the CBE process isn't appropriate for tweaks to old risk information. It also reiterates the FDA's position that compliance with its regulations results in preemption of state tort claims.
The Drug & Device Law Blog has more, following up on their first look back in January. No surprise that they like the rule, but even if you disagree on the value of it, their analysis of its mechanics is worth reading.
August 11, 2008
Liptak on Partisan Experts
Here, focusing more on the criminal side, though it's certainly applicable across the board. The "hot tubbing" approach is particularly interesting.
August 07, 2008
Speaking of Funding Bias...
David Michaels of SKAPP forwarded me an interesting order I missed the first time around in the welding rod litigation in the Northern District of Ohio. In it, the judge ordered (Welding_rod_funding_order.pdf [PDF]) that both sides disclose the extent of funding provided to the authors of articles, treatises, etc., relied upon in litigation. In total, in this particular sample, the defendants' funding totaled something over $10 million, while the plaintiffs' around $500,000. A Mother Jones article describes the case more.
I'm not sure, incidentally, that the proportionate amounts spent means as much as it might -- i.e., it's not self-evident that spending 20 times more necessarily means more 20 times more wicked conduct or 20 times more intent to buy the science. I would hope that industry is spending a lot more money studying the dangers of their products than plaintiffs' lawyers are.
Now, I'd prefer it to be consistently good work (and the article notes some pretty sketchy sounding stuff), but the fact of spending money doesn't necessarily mean bad work or bad science.
In any event, the outcome of the order -- disclosure all around -- is sound.
August 06, 2008
More on the "Pharma-Free" Expert List
Shannon Brownlee has written a post for Pharmalot describing her views on the list she helped put together of (mostly) pharma-free experts (see various links in last week's roundup). Her bottom line seems fairly reasonable to me: they agree that pay for testimony can constitute a relevant bias, and that conflict is disclosed to journalists when they obtain the full list. I certainly don't dispute that industry money is relevant.
My only quibble: I'm not sure, and she doesn't explain, why they don't plan to add even a modest note on the list on HealthNewsReview.org (why not something like "Some experts may have other relevant conflicts" so that the casual reader knows?). Its absence is probably not critical -- i.e., it will only have the potential to mislead relatively few people, and not journalists using the list for sources -- but it seems like an easy thing to add without any real downside.
August 01, 2008
Personal Injury Roundup No. 1 (8/1/2008)
Welcome to the first Personal Injury Roundup (and, like Eric, I've no idea whether it should be "round up," "round-up", or "roundup," but let's go with "roundup") on TortsProf. We hope to maintain the quality of his year doing it and that of Brooks. As always, but especially for this, we'd love suggested links; e-mail addresses are off to the left.
It's getting to the end of summer, with all of us scrambling to finish various pieces, but it's still an interesting week in TortLand.
Reform, Legislation, Policy
- Public Citizen criticizes the pro-arbitration analysis performed in recent Chamber studies. [Public Citizen].
- Eric Turkewitz's op-ed published in regional NY paper; Ted Frank starts a dialogue on the statistics used within; commenters include Turkewitz and people from Public Citizen, originator of the stat in question [NY PI Law Blog, Overlawyered].
- Reforms in New Zealand [SSRN].
- Congress sends president bill banning lead, etc., in toys [AP, see also this week on TortsProf, and two-plus years ago on TortsProf].
- In a civil suit, what would have been said about this case without video? [Simple Justice]
- Six Flags discovery muddles along; 77 deps and at least 18 more months until trial on an accident that happened over a year ago [TortsProf].
- Bad documents from Zyprexa production in Alaska suggest avoidance of diabetes talk by reps [WSJ Health Blog].
Experts & Science
- Ongoing discussion of the "pharma-free expert list" prepared for journalists; most focuses on the import, or not, of it including some who have been paid litigation experts for plaintiffs [TortsProf, Beck & Herrmann, Tort Deform, Pharmalot, and HealthNewsReview.org (the list is there)].
Trials & Settlements
- An update on the Kivalina global warming litigation: Defendants have moved to dismiss arguing no cognizable tort. Hearing is scheduled for Dec. 9th. [Point of Law].
- Libya & U.S. are close to a settlement relating to 1980s terrorism [WSJ Law Blog].
- Mirapex/compulsive gambling bellwether trials start and one ends with a plaintiff's verdict [WSJ Law Blog; Pharmalot (notes $8.2 million verdict, evidently including punitives).
- $16 million verdict against Allstate upheld; could have settled the case for $50K limits [KansasCity.com].
- ScotusBlog discusses and links to Sharkey's Riegel piece and notes Levine's argument date (Nov. 3) [ScotusBlog].
- The Tennessee Supreme Court upheld a $13 million punitive damages award against Chrysler in a suit claiming that a collapsing minivan seat caused the death of a eight month old baby. [Point of Law, Overlawyered, ABA Journal]. Chrysler plans to appeal to the U.S. Supreme Court, with Ted Boutrous of Gibson Dunn at the helm. [AmLaw Daily].
- Real earthquake interrupts fake judge [YouTube].
- Ben & Jerry's marketing people are pretty sure the lawyers wouldn't like that video [Turkewitz, and read the URL, Ted].
- How I ended up in a chicken costume [Spare the Rock, Spoil the Child].
Shameless Self-Promotion (favorite posts of this week)
- Bill's: Okay, it's before this week, but hey, it's the first time we've done the round-up: And with that, a surgeon's insurer's head explodes.
- Sheila's: No Punitive Damages for NY Smokers.
Hey, that was fun. See you next week.
August 1, 2008 in Current Affairs, Damages, Experts & Science, Goofy Cases, Legislation, Reforms, & Political News, MDLs and Class Actions, Products Liability, Roundup, Scholarship | Permalink | Comments (2) | TrackBack
July 29, 2008
Updated: List of Pharma-Free Experts Published
A few months back, Shannon Brownlee and Jeanne Lenzer wrote on Slate about potential conflicts of interest, addressing doctors who had received funds from pharma talking about SSRIs on public radio. They stated that they'd created a list of pharma-free experts for journalists, but declined to share it with Ted Frank at AEI. They also declined at the time to share it with me, but noted that they intended to post it publicly at some point, and sure enough, it's now up here at their site, HealthNewsReview.org.
Glancing through, I recognize one or two names from having done work for plaintiffs (e.g., Psaty), but not as many as I would have predicted. Update: Beck & Herrmann are collecting via the comments fields who all on the list has been a paid plaintiffs' expert.
Update: Whoops! Almost forgot my own disclosure. I have done some consulting for pharma companies. I have no current pharma clients, but have in this calendar year.
July 28, 2008
Zyprexa Protective Order Piece Published
It took a bit longer than I expected, but my article, When the Bell Can't be Unrung: Document Leaks and Protective Orders in Mass Tort Litigation, is now out in The Review of Litigation (the article is not online there, but available via Lexis and Westlaw). Its citation is 27 Rev. Litig. 565. It will be reprinted later this year by the American Enterprise Institute, and we're working on a panel discussion addressing it.
June 23, 2008
"Doubt Is Their Product"
I don't think we've yet linked to David Michaels's book Doubt Is Their Product (reviews and such here, David's chat at FireDogLake here). I haven't yet read the book (coughcoughreviewcopy?coughcough), but it is on my summer list.
According to the DefendingScience.org page, "In this eye-opening exposé, David Michaels reveals how the tobacco industry's duplicitous tactics spawned a multimillion dollar industry that is dismantling public health safeguards. Product defense consultants, he argues, have increasingly skewed the scientific literature, manufactured and magnified scientific uncertainty, and influenced policy decisions to the advantage of polluters and the manufacturers of dangerous products. To keep the public confused about the hazards posed by global warming, second-hand smoke, asbestos, lead, plastics, and many other toxic materials, industry executives have hired unscrupulous scientists and lobbyists to dispute scientific evidence about health risks. In doing so, they have not only delayed action on specific hazards, but they have constructed barriers to make it harder for lawmakers, government agencies, and courts to respond to future threats."
I am curious about whether he addresses the place of litigation experts on both sides, or solely defense (it appears the latter). I'll look forward to finding out once it gets to the top of my list...
June 03, 2008
Gottstein "Wouldn't Do It Again."
James Gottstein, who was part of the conduit of documents from David Egilman to the NYT and others, did an interview with Pharmalot, and says he was just dumb (his word), not intentionally violating a protective order.
I have a nearly-final PDF of my forthcoming Review of Litigation article on the subject; feel free to get in touch if you want a copy.
April 16, 2008
Ghostwriting of Medical Studies
The New York Times examines the practice of ghost-writing medical research studies that are subsequently published in medical journals such as JAMA:
The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.
The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread. “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” Dr. Ross said, whose article, written with colleagues, was published Wednesday in JAMA, the journal of the American Medical Assocation.
Merck on Tuesday acknowledged that is sometimes hires outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article’s conclusion that the authors do little of the actual research or analysis.
And at least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was “simply false.” He said it was “egregious” that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published medical journal articles.
March 31, 2008
Chronicle of Higher Education on Peer Review Discovery
The Chronicle of Higher Education has a story (link will explode in five days), quoting me, about Pfizer's efforts to obtain discovery into the peer review process. It is a better story than most, in my view, in terms of recognizing the potentially overblown (but not baseless) predictions of doom raised by journal editors. As the story notes, but just to be sure it's clear, I have done work for pharma companies, though not Pfizer.
March 21, 2008
Peer Review & Discovery
I'm traveling (and writing this in a dark hotel room with the rest of my family asleep, so forgive incoherence), and so haven't been following it all carefully, but In The Pipeline notes, in connection with Pfizer's efforts to take discovery into the peer review process at the NEJM, some developments.
A fair amount of commentary has suggested that Pfizer is purely fishing and/or purely an attempt to scare reviewers off. Perhaps, but it's worth remembering (as I argue here (e-mail me for a final reprint)) that much of what happens in the peer review process can be quite relevant to litigation (tending to lead to admissible evidence) -- and peer reviewers, and journals, are just as much subject to discovery as, say, doctors' records.
This is all the more so if the methodology used in the article is at issue in the litigation, in which case the mere fact of peer review makes testimony based on that methodology more likely to be admitted under Daubert. All of the Daubert factors are fact issues; thus, discovery related to them is appropriate. (If the peer review is done poorly and the peer reviewers' notes indicate that, then that factor should get less weight, for instance.) After losing the first subpoena issued, Pfizer has narrowed its request in a way that suggests to me that they are in fact focused on Daubert issues, as they are just asking for peer reviewers' comments.
All that said, as again I argue, there are in some cases greater risks in connection with peer review discovery than garden-variety third party discovery, and I propose some protections. But I do not think it appropriate to treat the entire neighborhood of peer review as sacrosanct and immune from the same third-party discovery that the rest of us are subject to. The courts are looking at the requests and, probably appropriately, balancing the hassle compared to Pfizer's interests. Maybe these requests should be granted, maybe they shouldn't, but the outrage seems misplaced.
February 22, 2008
Peer Review Discovery in Bextra/Celebrex Litigation
Pharmalot has the editorial from Science. For a view on the other side (i.e., not panicked at the prospect of discovery into peer review), see my Nebraska Law Review article from last year. The SSRN draft is here; feel free to send me an e-mail to get a reprint.
January 21, 2008
Science News Online has an overview of some recent work on the subject of litigation-driven science that was presented at a 2006 Coronado Conference (presented by SKAPP at George Washington) and recently published. Many of the conclusions echo mine in this piece published in the Nebraska Law Review.
November 20, 2007
Big Win for Pfizer in Celebrex Litigation
Pharmalot has the details and the order (in Word form, with metadata indicating it originated from plaintiffs' firm Lieff Cabraser) finding no Daubert-worthy evidence of causation at the most common dose of 200 mg. You can also get the order in PDF form here: Download CelebrexDaubert.pdf.
See also the Reuters story.
(I have done some work in the Cox-2 litigation, but none in the Celebrex case and none of any sort for Pfizer.)
November 08, 2007
Litigation-Driven Science, Nth Part
Environmental Health & Perspectives has posted the current drafts of a number of articles addressing litigation-driven scholarship. If you find the pieces interesting, feel free to get in touch for a reprint of my Nebraska piece covering many of the same issues from a bit more of a litigation perspective. I end up in roughly the same place as most of the writers there seem to -- that is, there's nothing specifically about litigation-driven work that should scare us any more than other science with potential biases.