January 19, 2007
Beck & Herrmann on Bellwether Trials
Over at the Drug & Device Law Blog, defense lawyers Jim Beck and Mark Herrmann have posted Ruminations on bellwether trials, explaining why they favor bellwether trials in MDL or statewide coordinated proceedings, despite the shortcomings of bellwethers as an approach to resolving mass tort litigation.
On the one hand, they note that trying a few cases does not provide any statistically significant information, both because the sample size is too small and because individual case variations are too great, "so a few early trial results aren't particularly meaningful." Moreover, early trial results may actually hinder reaching a global settlement: "A big plaintiff's verdict may unreasonably raise the expectations of the plaintiffs' bar; a resounding defense win may make the defense too stubborn." But then -- correctly, in my view -- they turn to the other hand:
On the other hand, what's the alternative to holding bellwether trials? Discovering up 5000 cases simultaneously without trying any? That's a disaster. Discovering up 5000 cases and setting them all for trial? That's silly (and impossible). Cobbling together classwide trials in situations that don't merit them? That's both bad law and bad policy. Trying to devise a "trial by statistics" that doesn't suffer from the due process and other concerns discussed by the Fifth Circuit in Cimino v. Raymark, 151 F.3d 297 (5th Cir. 1998), and elsewhere? That's a procedural morass.
And bellwether trials do provide some information. They force plaintiffs' counsel to do the work needed to prepare their standard trial package, and the early trials give some sense of how sound that package is. The bellwether trials force the court to resolve legal questions that arise only as a trial actually approaches and witnesses begin to take the stand. And the bellwether trials test the expert witnesses and give both parties a sense of how much it costs to try a case.
Finally, for a judge who's considering certifying a class, trying one (or several) bellwether trials might be very informative. There's nothing like a real trial to help assess whether plaintiff's proposed class trial plan is workable, whether claims and defenses are in fact individualized, and to shed light on other class certification issues. In some categories of cases, one could reasonably argue that judges should be required to try a case or two before deciding to certify a class.
Bellwether trials are not the perfect way to resolve mass torts, but they're basically all that an MDL judge has to offer. Until someone suggests a viable alternative, we'll settle for the best that's available.
It was Voltaire who warned that we mustn't allow the perfect to become the enemy of the good ("Le mieux est l'ennemi du bien."). Nowhere is that advice more apt than in trying to find sensible ways to resolve mass torts. Informal bellwether trials are an imperfect, messy way of trying to move mass tort litigation forward while generating information to facilitate settlement. But aren't Beck and Herrmann exactly correct that for much mass tort litigation, bellwether trials are less imperfect than the available alternatives?
January 17, 2007
New Blog on Complex Litigation
Gregory Joseph's law firm has begun a Complex Litigation Blog which may be of interest to readers of the Mass Tort Litigation Blog. Recent posts have addressed attorney-client privilege, spoliation, expert witness discovery, electronic discovery, attorney websites, and the Class Action Fairness Act.
January 15, 2007
Tracing the Release of Eli Lilly Zyprexa Documents
An article in the New York Times -- Documents Borne by Winds of Free Speech, by Tom Zeller, Jr. -- details the release of the controversial Eli Lilly Zyprexa documents. (On the controversial documents, see our prior posts on December 16, December 18, December 19, and December 21; and see this post with links to Eli Lilly's responses.) Here's an excerpt from the article:
It all began with Dr. David Egilman of Massachusetts, who was a consulting witness in ongoing litigation against Lilly. Dr. Egilman had in his possession a trove of internal Lilly documents — not all of them flattering to the company — sealed by the court as part of that litigation.
Comes James B. Gottstein, a lawyer from Alaska, who was pursuing unrelated litigation for mentally ill patients in his state. He somehow got wind (and precisely how is the subject of separate legal jujitsu) that Dr. Egilman had some interesting documents.
Mr. Gottstein sends Dr. Egilman a subpoena for copies. Hell begins breaking loose.
In a letter dated Dec. 6, Dr. Egilman informed Lilly’s lawyers, as was required by the order sealing the documents, that he had been subpoenaed. Lilly’s lawyers expressed their deep displeasure in a Dec. 14 letter to Mr. Gottstein, and politely told him to back off. In a response a day later, Mr. Gottstein informed them, among other things, that it was too late, and that some of the material had already been produced.
It seems Mr. Gottstein was also apparently in a sharing mood, which is how hundreds of pages ended up with a Times reporter, Alex Berenson — and about a dozen or so other individuals and organizations.
This is also how copies of the documents ended up on various Web servers — and when that happened, things changed. While surely painful for Lilly, the online proliferation began flirting with some bedrock principles of free speech and press, as well as some practical realities that looked a fair bit like toothpaste out of its tube.
Nonetheless, last month, United States District Judge Jack B. Weinstein ordered Mr. Gottstein to provide a list of recipients to whom he had distributed the contraband pages, and to collect each copy back.
The New York Times article also quotes William Childs, editor of the TortsProf Blog, which is affiliated with this blog through the Law Professor Blogs Network:
On his TortsProf blog (snipurl.com/Torts), William G. Childs, an assistant professor at Western New England School of Law in Springfield, Mass., put it this way in a headline: “Judge Tries to Unring Bell Hanging Around Neck of Horse Already Out of Barn Being Carried on Ship That Has Sailed.”
A similar problem occurred in the tobacco litigation in late 1990s, when, if I recollect correctly, the judge in the Minnesota Attorney General case ruled that whole categories of types of documents were not privileged, based on a review by the special master of only a sample of the documents in each category. Disagreeing with the judge's approach to examining privilege (there is much to disagree with in such a privilege-review-by-sample approach),the tobacco defendants then continued to keep trying to claim privilege on the other documents across the country. Ultimately, I believe Congress subpoenaed the documents and put them on the internet, and plaintiffs argued against defendants' privilege assertions by saying the cat was out of the bag (add that to William Childs' animal metaphors). While at some point documents may become newsworthy and unable to be recovered (especially in the internet age), any such inappropriate and contested release of documents to the public should not be deemed to affect how courts treat the documents for litigation and trial purposes, e.g., finding implied waiver of privilege.
January 14, 2007
Questionable MDS Tests and Drug Approval Applications to FDA
Article in the Wall Street Journal -- MDS Tests Are at Center Of FDA Query, by Jennifer Corbett Dooren:
The Food and Drug Administration is asking all drug companies that have submitted drug-approval applications to the agency since 2000 to review them to see if they include questionable test results conducted by a unit of MDS Inc.
The FDA's action affects about 1,100 approved and pending drug applications for both brand-name and generic drugs. Agency officials said yesterday they aren't aware of any drug-safety problems but are taking the action as a "precautionary measure."
More FDA Fees, More Review
Article in the Wall Street Journal -- FDA Change May Begin With User Fees, by Anna Wilde Mathews:
The Food and Drug Administration's deal with the pharmaceutical industry about user fees that companies pay the agency to review their products will likely prove a starting point for broader FDA-reform efforts backed by congressional Democrats.
The pact, unveiled yesterday, allows for substantially increased payments to the FDA, with more money allotted for monitoring the safety of medicines after they go on the market and a new fee for agency reviews of consumer television ads. Most of the money for the FDA's drug-review process comes from such fees.
Congress must approve the five-year deal before it can take effect, and while the drug industry will press for a user-fee bill without major additions, lawmakers are likely to consider far bigger changes that could result in new authority and responsibilities for the FDA. The confluence of must-pass FDA legislation including the user-fee reauthorization, and the takeover of Congress by Democrats, who are more inclined to take a tough stand against the drug industry, means major adjustments to the FDA have a better shot at passing this year than anytime in at least a decade.