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.

The last of these items, if adopted, would prevent the prejudicial jury instructions that fueled the absurd billion-dollar Actos verdict from ever happening again in that situation.  As we’ve discussed, the litigation holds in Actos were created and supposedly transgressed years before “the litigation” ever existed.

Where do things go from here?  Our understanding is the proposed rules amendments will next be considered by the full Judicial Conference in September 2014.  Further changes at that point would be unusual, but not unprecedented.  Assuming approval by the Conference, the amended rules would be considered first by the Supreme Court, and then by Congress in 2015.  With any luck, we should see the amended rules in force by the end of 2015.  They’re not perfect, but a definite improvement from the current e-discovery dismal state of affairs.

The second most important non-case development while Bexis was out was the Solicitor General’s amicus filing concerning the Medtronic v. Stengel certiorari petition in the United States Supreme Court.  Here’s a copy of that brief.  Bexis, however, (and thus Reed Smith) being part of the defense team in Stengel, cannot comment substantively on the petition.  Pending commentary from the non-RS members of the blog, we can only post copies of Medtronic’s filed briefs responding to the SG’s filing, and refer you to commentary by one of our kindred spirits.

Courtesy of Rich Samp at the Washington Legal Foundation (“WLF”), Bexis received our third item, the WLF’s recently submitted comments critiquing the FDA’s draft “Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices, 79 Fed. Reg. 11793-796 (FDA March 3, 2014) – which we previously discussed here.  In sum, WLF once again places the First Amendment implications of the FDA’s efforts to restrict truthful off-label promotion squarely at issue:

But if the Draft Guidance is to be a serious effort to distinguish constitutionally protected speech from unprotected speech − as opposed to a safe harbor standard . . . − then it is incumbent on FDA to address First Amendment issues head-on. In the absence of any mention of the First Amendment in either the 2009 Guidance or the Draft Guidance, one can only conclude that the agency’s “current thinking” includes no thoughts about the First Amendment.  WLF urges FDA to withdraw the Draft Guidance and to undertake a serious effort to harmonize its speech restrictions with First Amendment limitations.  As numerous court decisions make clear, FDA can no longer get by with its “the First Amendment does not apply to us” approach.

WLF comments at 6. The WLF comments are an instructive reminder that the First Amendment is still out there, stronger than ever, after Sorrell v. IMS Health Inc., 131 S.Ct. 2653, 2659 (2011), and United States v. Caronia, 703 F.3d 149, 169 (2d Cir. 2012), and that there are other avenues besides tort litigation
for pursuing the issue.

We’re not sure how far the WLF is going to get with this, since the FDA activity at issue is a “draft guidance,” which is hedged all around with assertions of lack of finality specifically designed to insulate the Agency from judicial review. But it’s clear to us that the FDA is on the wrong side of history here, and sooner or later its meat-axe approach to off-label promotion will fall before the Constitution’s guarantee of free speech.  Perhaps the WLF will be able to reopen its litigation from over a decade ago (see WLF comments at pp. 13-15) and be the catalyst for bringing this result about. The subject matter here – distribution of peer-reviewed scientific articles and medical textbooks – is probably the strongest set of facts for a favorable ruling.

Our fourth item comes courtesy of Vani Singhal at McAfee & Taft.  She informs us that Oklahoma has re-enacted at least part of the tort reform legislation (see here for our previous discussion), that the Oklahoma Supreme Court struck down on technical (single subject) grounds in Douglas v. Cox Retirement Properties, Inc., 302 P.3d 789 (Okla. 2013).  This new act does two things: (1) it precludes litigation against intermediate sellers unless they either took some affirmative action with respect to the product, or the manufacturer for some reason can’t be sued; and (2) it creates a compliance presumption concerning federal safety standards.  The compliance presumption is rather wimpy in that it’s rebuttable on a “preponderance of the evidence” basis with evidence that the standards were “inadequate” (among other reasons) This conjures up interesting preemption questions with respect to state juries explicitly passing on the “adequacy” of federal safety standards.  We suppose it’s better than nothing, however, since at least it shifts the burden of proof. The intermediate seller provisions should come in handy in removal/fraudulent joinder situations.

Number five.  Remember the preemption decision in Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir. 2013)?  We discussed it here.  We viewed that case as:  (1) coming from left field, since we’ve never seen a Federal Circuit case on tort preemption concerning any type of prescription medical product before, and (2) poorly reasoned, since it allowed a plaintiff asserting a state-law claim to enjoin the distribution of a product that the FDA allowed on the market essentially on the ground that the FDA followed what the plaintiff considered to be an incorrect procedure and did not impose an approval process
that the plaintiff claims should have been mandatory.  The defendant, Athena, filed a certiorari petition raising the interesting Buckman-related question:

The question presented is whether, under Buckman, the FDCA impliedly preempts a private state-law claim for unfair competition premised on a party’s purported failure to obtain FDA approval, where FDA itself has not imposed any such requirement.

Petition at i. Also of interest (at least to us) the petition cites to two of our blogposts (at pp. 26, 38).  That’s a first as far as we know.  We’ll see where
this case goes, if anywhere.

Sixth, also on the appellate front:  We’ve blogged several times about the fate of a supersized 8-figure verdict for a plaintiff who wasn’t even hurt all that much in Polett v. Public Communications, 83 A.3d 205 (Pa. Super. 2013) (en banc).  While Bexis was rafting, the Pennsylvania Supreme Court granted an appeal in Polett, on three of the four main issues:  (1) exclusion of plaintiff’s Mary-Carter-like “tolling agreement” with her treating physician; (2) flipping the burden of proof on causation; and (3) the plaintiff not identifying said treater as an expert when the expert opinion only surfaced after the treater was Mary Cartered.

Finally, Bexis discovered a few cases when he returned that for one reason or another slipped through the weekly searches.  Depuy Orthopedics, Inc. v. Brown, ___ N.E.2d ___, 2014 WL 2440375 (Ind. App. May 30, 2014), evaded the net because it concerned forum non conveniens, rather than substantive law, and thus didn’t trip any of our search terms.  It’s a significant case because it booted out litigation tourists who sued the defendant in state court in the defendant’s home state in order (we suspect) to avoid a pending federal MDL and its corresponding requirement to pay assessments to finance other plaintiffs’ litigation efforts.  This happens a lot (we saw it in Bone Screw, for example), and defendants are rarely successful in convincing courts that their own home county is an “inconvenient” forum.  Depuy pulled it off, though, because all the witnesses that really mattered to the defense – prescribers, treaters, relatives and other people with information about the plaintiffs – resided out of state and were beyond the subpoena power of the local Indiana court:

[T]he facts of this case show that many of the key witnesses, such as physicians, other medical personnel, and persons associated with the plaintiffs, are located in [plaintiff’s home states].  While there will likely be [defendant’s] employees located in Indiana who will be called as witnesses, it seems clear that the majority of the witnesses will be nonresidents.  Given the facts of this case, the inconvenience and cost [defendant] would incur securing the attendance of out of state witnesses (especially if they are uncooperative), deposing them, and conducting additional discovery is not insignificant.  As a result, this factor also supports dismissal.

2014 WL 2440375, at *4.  Choice of law issues – that Indiana law didn’t apply to the out-of-state plaintiffs’ claims – also figured.  Id. at *5-6.

It also appears that the MDL court supervising the Zoloft litigation decided to make its earlier decisions available – or Lexis went into PACER and dug them out.  Bexis came home to a couple of interesting discovery decisions dating back to October 2013 that had never surfaced before.

The first one deals with whether attachments to emails are discoverable in response to a request for the production of emails.  The court held that they were not – because discovery of emails does not automatically extend to attachments to emails.  Nor was the defendant obligated to go back and prepare a privilege log for email attachments not produced.  The attachments were withheld for relevance reasons (the attachments had nothing to do with the litigation), not privilege, and the rules only require logs for privilege, not relevance.  The court held that a producing party need not even identify documents that are not being produced on grounds of relevance.  In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 2013 WL 8445354, at *3 (E.D. Pa. Oct 31, 2013) (“there is not a requirement in the rules that a party explain how it decided that a particular document fell outside of the scope of discovery. In general, there is no basis in the rules for requiring a party to disclose its thinking about why it did not produce a particular document.”).

The other decision (which Westlaw doesn’t have yet) rejects the Zoloft plaintiffs’ attempts to avoid producing their mental health and substance abuse records. The parent plaintiffs (the litigation involves birth defects) were required to produce their mental health records broadly.  Such records (Zoloft is prescribed for depression and other mental conditions) were likely to be relevant to liability.  They would shed light on the plaintiff’s condition when the prescription at issue was written, which could affect prescriber willingness to convey various warnings.  Because medical records are often in sorry shape, more recent records would help shed light on prior conditions.  State law precedent concerning discoverability of mental health records does not control in a federal court applying federal rules.  Substance abuse records were also broadly discoverable as potentially relevant to emotional distress damages claimed both by plaintiff mothers and plaintiff children.  Such allegations were sufficient to put substance abuse at issue.  Federally funded substance abuse records are discoverable for good cause. The defendants did somewhat less well with respect to discovery of Zoloft plaintiffs’ employment records and were limited to records no older than ten years prior to the prescription over which the plaintiff was suing.  In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 2013 U.S. Dist. Lexis 187525 (E.D. Pa. Oct 22, 2013).  Overall, a useful precedent going forward.

As Bexis knows, a lot can happen in two weeks.