On December 18, the FDA published its proposed rule for replacing the venerable package insert with “electronic” prescribing information. The cite is 79 Fed. Reg. 75506, and a link to it is here. We’re not regulatory lawyers, so we’ll leave any debate over whether this proposed rule is good or bad to the folks at the FDA Law Blog.

We’re product liability litigators, so when we hear about “electronic” anything, one thing we think about is ediscovery.  Currently, with paper package inserts, when we’re taking discovery, all we have is the prescriber’s say so about whether s/he reviewed the insert, and when.  Nor do we have any sure way of knowing exactly what version of drug/device labeling the prescriber reviewed.  The date of the visit that produced the prescription, when placed against the history of the relevant labeling provides a pretty good idea, but there’s always a chance that the product sat on a shelf somewhere through a label change or two.

If the FDA’s proposal to shift to electronic distribution of the prescribing information that’s now in package inserts takes effect all that could change.  The main avenue of distribution envisioned by the FDA would be a “single, comprehensive Web site” −  an online “repository” operated by the FDA itself:

The proposed rule would require manufacturers and applicants to distribute electronically prescribing information by submitting the labeling in an electronic format that FDA can process, review, and archive . . . to FDA each time the labeling content is changed.  The submitted labeling would be distributed via FDA’s labeling repository Web site (labels.fda.gov), which is a publicly available Web site.


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Walking out of the Constitutional Convention on its final day, back in 1789, Benjamin Franklin was (supposedly) asked what kind of government he had helped create for the new entity to be known as the “United States of America.”  He replied, “A republic – if you can keep it.”

We find ourselves with a similar feeling regarding the amendments to the federal discovery rules that we’ve blogged about previously.  Whatever else anyone, on either side of the “v.,” might think of last month’s election result, the Republican capture of the Senate ended the last realistic prospect of derailing those amendments – which have passed every level of the judicial committee structure unanimously and now rest with the Supreme Court.  Among other things, these amendments enshrine the requirement that discovery be “proportional to the needs of the case” squarely in Rule 26(b)(1)’s definition of the scope of discovery, intentionally emphasizing a concept previously buried deep within Rule 26.  They should be in effect by December, 2015.

The other side hates it.  They lost, badly, on these amendments, but don’t expect them to give up.  Defense counsel need to anticipate where plaintiffs will try to go next – which is to try to make the proportionality requirement so costly and impractical that everyone, judges and defendants both, gives up on proportionality as a meaningful restriction on discovery.  That approach would be a direct violation of the intent of both the purposes of the proportionality requirement itself and of Rule 1 (which is also being amended), but are you really surprised by that?


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As one of our other bloggers have recently revealed, Bexis recently went on vacation for two weeks.  He was diligent, however, and pre-wrote two posts (not time sensitive) that appeared in his absence.  As for the co-blogger’s quip about Bexis’ “active, muscular vacations” well, in this instance that’s probably right.  For most of Bexis’ two-week absence, he was rafting through the Grand Canyon.

With Bexis otherwise occupied, the blog’s other denizens did an admirable job of keeping up with current developments in case law, but nonetheless items piled up in Bexis’ inbox awaiting his return.  Most of them weren’t even judicial opinions.  It’s time to empty that inbox.

Perhaps the most important development was the approval, on May 29, by the full Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure, of the discovery-related rules changes that we’ve been covering on the blog.  Bexis has been heavily involved in this effort through the Lawyers for Civil Justice (“LCJ”), and LCJ sent him notice of the approval. We’d pass it along, except it includes internal LCJ business as well.  So we’ll just hit the highlights.

First, there were no changes to the language of the proposed amendments themselves, which we have previously discussed.  The only changes from the version published in the subcommittee’s agenda book were:  (1) a new sentence in Note for Rule 26(b)(1) encouraging computer search technology (that is to say, predictive coding), and (2) modifying the Note for Rule 37(e) concerning the role of prejudice in subsection (e)(2).  Thus, the main benefits of the amendments from our perspective remain:

  • enshrinement of proportionality in Rule 26(b)(1);
  • curtailment of the capacious “reasonably calculated” standard for the scope of discovery in the same subsection;
  • Explicit rejection of the negligence-based standard for ediscovery sanctions in Residential Funding Corp. v. DeGeorge Financial Corp., 306 F.3d 99 (2d Cir. 2002), and thus by necessary implication of other precedent in that circuit following that standard (this means you, Zubulake); and
  • Requiring a finding of specific “intent to deprive another party of the information’s use in the litigation,” under Rule 37(e)(2) before any federal jury can be instructed on evidentiary presumptions from loss of electronic information.


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The Actos litigation has a way of being topsy-turvy these days.  We discussed not too long ago the epic ediscovery fail in that litigation, whereby a defendant, because of overbroad litigation holds that it allowed to persist even after the litigation that had generated them had long since disappeared, was held to have spoliated evidence at a time when there was no Actos litigation.  Appallingly, plaintiffs were allowed to “presume” prejudice from the loss of the information – when it’s not at all clear that the missing information wasn’t, in the end, discovered either in other employee files or from third-party discovery.  In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 355995, at *26-28 (W.D. La. Jan. 30, 2014).  The missing Actos files were destroyed when people left the defendant’s employ, rather than in any extraordinary attempt to sanitize files.  Id. at *26.

The effects of this unusual ruling evidently continued at the first Actos trial.  According to a post last week on the E-Discovery Law Alert  (a blog specializing in ediscovery):

[The judge instructed the jury after closing arguments Monday that they could take [defendant’s] evidence spoliation into account.  Additionally, throughout the trial, the jurors were exposed to voluminous evidence detailing [defendant’s] conduct in destroying the relevant evidence.

As a result we ended up with a $9 billion punitive damages verdict where the plaintiff received all of $1.5 million in compensatory damages.  That’s a ratio of six thousand to one.  The Supreme Court and most state courts consider any ratio above 10:1 presumptively unconstitutional.  A ratio this large, we think, is not only unconstitutional, but is presumptively the product of what lawyers call “passion and prejudice” on the part of the jury.  A verdict based on passion and prejudice is typically thrown out in its entirety.  This one certainly should be.


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The so-called “Duke Subcommittee” today finalized and voted on its version of proposed amendments to the Federal Rules of Civil Procedure.  These amendments include those we’ve blogged about before, making alterations to the scope of discovery, the proportionality requirement, and with respect to ediscovery the availability of sanctions.  Except for the sanctions amendments (Rule 

This post discusses litigation holds.  Litigation holds aren’t sexy.  They aren’t going to take counsel to the Supreme Court.  They aren’t going to make the nightly news – at least we hope.  But you know and we know that in a mass tort between 90 and 99% of the cases generated by plaintiffs’ solicitation machines

It’s not often – like once every quarter century – that the Advisory Committee on Civil Rules (the folks who decide when the Federal Rules of Civil Procedure need to be amended, and how) decide to take on Rule 26(a) (concerning scope of discovery) and Rule 37(e) (concerning sanctions) essentially from the ground up.  That’s what’s happening now, and it’s high time that our defense-side readers put their two cents (or more) into this process.  Some very helpful changes to reduce the outrageous costs of discovery and to do away with the “gotcha game” of discovery sanctions (primarily, but not totally, concerning ediscovery) have been proposed.  You can bet your bottom dollar that when anything is proposed that is useful to us and our clients as producing parties, the other side will be out in force (see here, for example) to try to stop it in its tracks.

We need to get off our collective duffs and do something about this.  Discovery, especially ediscovery, is the biggest single cost issue in litigation, both in pharmaceutical mass torts and elsewhere.

Specifically, the committee has asked for public comment on two proposals to amend the Federal Rules, both of which are designed to reduce the costs and burdens of discovery that we as defendants and defense counsel routinely face as producers of large quantities of information, both electronically stored and otherwise.  The broadest rules change is a revision to Rule 26(b)(1), which re-defines the scope of discovery.  It would get rid of the current, and often misused (as we discussed last week) standard by which discovery is measured:  “reasonably calculated to lead to the discovery of admissible evidence.”  Instead, discovery would be permissible of “any nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case.”  Currently the proportionality concept is buried in Rule 26(b)(2)(C)(iii), where it looks more like an affirmative defense.  If the amendment is adopted, proportionality becomes part of the basic definition of scope.  Think of the difference that could make in encouraging both judges and the parties to take a pragmatic perspective on what discovery is appropriate to each particular case.


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Regular blog readers know that, for a long time, we’ve been proponents of what we call “ediscovery for defendants” – obtaining (primarily) useful admissions from a plaintiff’s social media activity.  Almost half the posts under our “E-Discovery” topic concern obtaining material from plaintiffs, and we even maintain an “E-Discovery for Defendants” cheat sheet (periodically updated) loaded with all the favorable decisions we can find.  Thus, we were very pleased when two of our regular readers, Ed Gerecke and Dave Walz of Carlton Fields agreed to grace us with a blog-friendly guest post on the topic, modeled on an article they recently put together.

As always our guest posters deserve all the credit, and any blame, for the contents of their posts.

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Not every widower mourns by partying with several young women. And most of those who soothe their pain with a couple cold ones and a few warm shoulders to cry on don’t commemorate the occasion with a Facebook photo. But a few do. Though we may disagree with how they grieve, it’s really none of our business. When they sue one of our clients for their spouse’s death, however, it definitely is our business. We have to make that photo (especially the “I ♥ hot moms” t-shirt) complicate their case just a bit. See Allied Concrete Co. v. Lester, 736 S.E.2d 699, 702-03 (Va. 2013) (noting sanctions of $542,000 against counsel, $180,000 against plaintiff, and an adverse-inference instruction, when counsel advised plaintiff to “clean up” his Facebook page, which included a photo of plaintiff drinking beer while wearing said t-shirt in the company of said presumably attractive mothers).


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Let’s see whether it works: Discovery!  Are you excited?  How about this: Technology Assisted Review!!  Nothing yet? How about: Predictive Coding!!!  We gave you three exclamation points for that one.  Are you pumped yet?

Yeah, neither are we. But we’re going to discuss these things anyway, in particular the way in which the court addressed them in a recent MDL decision in the hip implant litigation.  In re Biomet M2A Magnum Hip Implant Prods. Liab. Litig., 2013 WL 1729682 (N.D. Ind. Apr. 18, 2013).  Why?  Because it’s important for anyone whose practice involves discovery of massive amounts of electronically stored information (ESI) – and mass torts certainly qualify – to understand the potential cost savings for clients presented by technology assisted searches and the legal viability of implementing them.

We’ve blogged about predictive coding before.  Look here.  In short, predictive coding software “learns” from the user’s selections or preferences and identifies – with greater accuracy as it learns – what the user wants to find.  It’s used for many things on the Internet, and it’s now being used to identify electronic documents for production in litigation.  The process involves an initial interaction between the software and reviewing attorneys, but at some point the software should be able to take it from there alone (for the most part).  Here’s how the MDL court described the process that Biomet used to conduct it review of the 2.5 million documents it selected for review:

Under predictive coding, the software “learns” a user’s preferences or goals; as it learns, the software identifies with greater accuracy just which items the user wants, whether it be a song, a product, or a search topic.  Biomet used a predictive coding service called Axelerate and eight contract attorneys to review a sampling of the 2 .5 million documents.  After one round of “find more like this” interaction between the attorneys and the software, the contract attorneys (together with other software recommended by Biomet’s e-discovery vendor) reviewed documents for relevancy, confidentiality, and privilege.

Id. at *1. While it can reduce costs, things still aren’t cheap.  The review cost Biomet $1.07 million, and Biomet projected that its ultimate costs would total $3.25 million.  But a manual attorney review would have cost much more, and what plaintiffs were asking the court to order Biomet to do would have cost millions more.


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