Tuesday, February 9, 2010

Vytorin ENHANCE Documents: 4.4 5.5 Million Pages -- In Various Congressional And Governmental Investigations

As I had earlier mentioned, with the combination of Schering-Plough and Merck now closed, the New Jersey federal District Courts have agreed that almost all of the pending ENHANCE related putative federal securities class actions, ERISA claims and shareholders' derivative cases may be coordinated -- at least for the purpose of expediting discovery, and pre-trial motion practice, as it relates to discovery of documents, testimony of common fact witnesses, and depositions of common expert witnesses.

This morning, the court conducted a telephone conference call, to assess the status, and progress on these coordinated efforts. Revealed yesterday, in the papers filed in preparation for this morning's conference call, were several fascinating facts.

Chief among these is the fact that between each of Merck and Schering-Plough, and spanning at least two Congressional investigations, a host of state-level governmental investigations, as well as a plethora of inquiries from the SEC, DoJ, FDA and FTC. . .

Approximately 4.4 million pages of documents have been made available by the two companies, related to the delay in publishing the ENHANCE study, from late 2006, through the ENHANCE study full release/publication date -- March 30, 2008.

There are apparently yet-another 1.1 million pages -- most of which at least some subsets of the various plaintiffs' lawyers have already received. [In another post, I'll lay out the coming timelines, for depositions and potential trial dates, on the federal securities, ERISA and shareholders' derivative causes of action.] In fact, by February 1, 2010, various plaintiffs' law firms may have already submitted as many as 25 formal written questions each, or 75 in total, of Merck (formally called interrogatories) -- and the answers to those 75 posers are due back in court by March 1, 2010. The call this morning should have outlined the status of those responses for the judge.

As I guessed, this development is going to allow significant cost-savings/leverage and coordination among the various plaintiffs' law firms -- and make a slow roll defense nearly impossible [to the detriment of New Merck, and its current and former officers (which term, loosely defined, still includes Hans Becherer, Fred Hassan, Carrie Smith Cox and Tom Sabatino, among others). ]

I think the overall sense of this scheduling letter (and hearing transcript) is that these several separate cases are not going to be back-burnered -- they are all moving forward, under the watchful, and (if need be) prodding, eye of the federal judiciary. So far, it seems as though the lawyers for Merck and Schering-Plough recognize that any stall-tactics, obfuscation or other delaying maneuvers will simply make their position worse, before the court -- and they seem to be producing the 4.4 million pages on a rolling basis, even as I type this.

All of the documents should be in the plaintiffs hands no later than March 15, 2010, under the court's December 22, 2009 orders (Full 24 page PDF file).

. . . .for the purpose of pre-trial discovery only. . . . these 4.4 5.5 million pages will be coordinated. . . .

Goodness. It is finally happening.


Anonymous said...

Is this volume typical? How does a legal team 'review' all of this?

Anonymous said...


Condor said...

Good questions, Number 1 -- and, wake up, Number 2 -- pay attention, here(!).

This is -- even when compared to some mass tort case settings -- an extremely large volume of responsive documents.

[Part of the reason there are so many here preserved, is likely due to the fact that so many agencies promptly began investigating -- especially Senator Grassley's office -- thus forcing almost real-time preservation of documents, from about September 2007, onward.]

But to be clear, perhaps upward of 50 percent of the pages are likely duplicates (copies of every memo, copied to every recipient, for example -- all produced separately), for that is what the rules require. Even so, there will be small differences -- someone may have scribbled in the margin of his or her copy -- so it all is provided.

As to how it is handled, surely lots of junior people will sift through them, but in a series of cases (like these) with such high stakes, the lawyers will likely scan and digitize the entire dump (via a third party service provider -- with full text recognition capability), and then have a searchable database (on CD-ROM, and maybe even on a secure internet file-server, available to all the lead plaintiffs' law-firms, and coordinating counsels) of every document that mentions (for example) both "Enrico Veltri" and "outlier data". One might also search that surname, with the phrase "f*ck off" -- Ooh wait, we already have that document. [But I digress.]

Where was I? Oh. Right. The document data-base service provider will likely be instructed to separately flag, and put in a so-called "sidecar", all the documents with hand-written notes on them.

Those, a senior lawyer with a good grasp of the claims and defenses will need to read carefully. And then, on some of them, s/he will prepare question-lines, for depositions. These documents will then be shown to subject-matter experts -- to get their opinions -- on both sides of the fence.

Hope this helps.


Pharma Conduct Guy said...

I don't recall the exact number, but I believe that the Enron situation had even more documents. There is a body of researchers who specialize in matters related to lexical text-processing algorithms that can scan this vast volume of documents and automatically generate associations between relevant documents, which can be useful for focusing a human's efforts. A few years back, The National Institute for Statistical Sciences hosted a workshop on Non-Negative Matrix Factorization, which used the Enron emails and memos to demonstrate the power of the technique for this kind of analysis.

I don't know what sorts of legal barriers exist to prevent the release of these documents to the general public before trial. However, if the documents could be released in electronic format, perhaps the collective parallel processing of many thousands of volunteers looking through them could be put to good use.

Condor said...

Thanks, Eric -- great thoughts and observations, here.

First, it is clear under the federal discovery rules that the plaintiffs in fact may not share these produced doduments, pre-trial, with anyone except retained experts, unless Merck or Schering-Plough has already made them public, or they are made public through no fault of the plaintiffs (if, for example, Senator Grassley makes them public).

I do believe the sorts of electronic algorithms you describe are pretty rountinely used by the plaintiffs' lawyers in cases of this size, these days.

Finally, I could be surprised here, but in the very first days of the Enron scandal, Arthur Andersen actively destroyed so many documents (as did various people inside Enron), that I don't think there were millions of pages left to be produced for review.

In fact, in 2002, the special committee of Enron's board reviewed "only" about 430,000 pages, in making its legally-required report (at page 39 of that 47 page PDF file):

". . .The Committee's Investigation. . . .

The Committee's counsel reviewed more than 430,000 pages of documents and interviewed more than 65 people, several more than once. Counsel interviewed nine current Enron Directors, more than 50 current and former Enron employees, and some of Enron's outside professional advisors
. . . ."

So that would be about one-tenth the number produced in these ENHANCE matters.

Namaste, and thanks for the very useful contributions!