Defendants in prescription medical product liability litigation are at an inherent disadvantage in discovery already.  Our clients have lots and lots of electronically stored information and old-fashioned paper documents.  Plaintiffs . . . not so much.  With our opponents having many categories of information to choose from, we think that it’s not that much to ask the other side at least to provide a reasonably detailed, case-specific set of document requests – and in many cases that’s what happens.  But all too often, the same kind of sloth that leads to plaintiffs’ parking their cases by the thousands in MDLs to avoid having to do any work also shows through in discovery.

Hence, we have to deal with “cloned discovery.”  We agree with the court in Barrella v. Village of Freeport, 2012 WL 6103222, at *2 (E.D.N.Y. Dec. 8, 2012), which, when faced with the plaintiff’s demand for “all deposition transcripts and discovery produced” in prior litigation, retorted that the plaintiff “can and should conduct his own discovery” and that the federal rules “do[] not permit a party to obtain discovery obtained in a separate lawsuit . . . simply because that party maybe does not wish to spend his own time or money.”  Id. at *2.

If you’ve never heard of the term “cloned discovery” before, “[t]he name derives from the fact that the plaintiffs are attempting to clone the discovery taken by others in unrelated cases.”  Wollam v. Wright Medical Group, Inc., 2011 WL 1899774, at *1 (Mag. D. Colo. May 18, 2011).

[I]n this case the cloned discovery seeks all “documents and things produced,” “transcripts of each, any, and all depositions,” “all reports by experts by any party,” and “all other discovery responses served by any defendant” in the following:

[A]ny action from January 1, 2001, to the present, in any state or federal court in the United States, or in a foreign court or tribunal, where it was claimed or alleged that an artificial hip designed, manufactured, or distributed by a Wright entity failed in such a way that the component known as the “modular neck” corroded, fretted, or fractured, regardless of whether that exact language was used.

Id. (citation to plaintiff’s discovery requests omitted).  Not only is this kind of discovery request lazy as sin (and often an attempt to avoid limits on the number of requests for production), but it’s inherently improper, particularly after the 2014 amendments to Rule 26(b)(1), which redefined the scope of discovery to include only: “any nonprivileged matter that is relevant to any party’s claim or defense.”  By definition, “all” of the discovery from a prior case is not going to be “relevant” to a subsequent personal injury case involving different plaintiff injured at a different time and place.

Unfortunately, these considerations don’t stop lazy lawyers – even when they get pushback.  The “issue” in such cases is “whether discovery taken in other, unrelated, and as yet unidentified cases . . . is relevant to the claims of these plaintiffs.”  Id.  Wollam said, “no way”:

[A] party seeking discovery ordinarily must do their own work and request the information they seek directly and must make proper requests describing the information in which they are interested.  Direct requests allow a court to consider the relevance of the information sought to the specific claims and defenses in the pending case.  A request for all discovery in unidentified actions taken worldwide with the single similarity that those actions involve the alleged failure of [the same product] does not allow such review.  Discovery is intended to be liberal, but it is not unbounded.  The sweeping cloned discovery sought by the plaintiffs has not been shown to be sufficiently relevant to the claims and defenses in this case and simply reaches too far. . . .  It is not clear to me that any showing would be sufficient to justify an order requiring the disclosure of all discovery made or received by the . . . defendants in unknown and unspecified cases.

Id. at *2.  See Fields v. Wright Medical Technology, Inc., 2017 WL 3048867, at *3 (N.D. Ind. July 19, 2017) (“to the extent that Plaintiff is requesting that the Court compel Defendants to produce information merely because it has been produced in other cases, and she has not specifically requested the information contained in those documents in this case, that request is denied”).

Cloned discovery has attracted our attention because it reared its ugly head again recently in Costa v. Wright Medical Technology, Inc., 2019 WL 108884 (D. Mass. Jan. 4, 2019), where the plaintiff actually got some benefit from this kind of slothful request.  Costa viewed “cloned discovery” as “attractive to litigants because it can reduce the burden and expense of obtaining relevant information and help the parties narrow the issues in dispute.”  Id. at *1.  While Costa rejected the plaintiff’s request for “all documents and data” from cases involving “distinct” products and from cases that “do not involve” that particular plaintiff’s claimed failure mode, id. at *2, it did compel production of discovery from a prior case involving the same product and claimed failure mode.  Id. We wouldn’t even go that far – for the same reasons that prescription medical product liability litigation is never appropriate for class actions.  Even if the device and failure mode are the same, every product liability plaintiff has a unique injury, at a different point in time, involving different medical treatment, medical history, and treating physicians.  It may well be that a great majority of the documents are in fact discoverable in the subsequent case, but that does not excuse a plaintiff from following the rules and asking for them properly, and complying with applicable numerical limits on document requests.

Because this type of request is basically harassment – not one of the seven deadliest, but more pertinent to current litigation strategies designed to force settlement by driving up an opponent’s costs − we thought we’d collect other pertinent authorities condemning cloned discovery.  We found a number of cases refusing blanket discovery of documents produced in governmental investigations.  Midwest Gas Services Inc. v. Indiana Gas Co., 2000 WL 760700 (S.D. Ind. March 7, 2000), the primary decision cited in Wollam, was not a drug/device case, but instead involved a demand for everything an antitrust defendant had turned over to the government in response to a Civil Investigative Demand.  When the defendant refused, plaintiff unsuccessfully sought to compel:

“Cloned discovery”, requesting all documents produced or received during other litigation or investigations, is irrelevant and immaterial unless the fact that particular documents were produced or received by a party is relevant to the subject matter of the instant case. . . .  [P]laintiffs are interested in the content of documents and for that they must make proper requests describing the information in which they are interested. The plaintiffs’ counsel must do their own work and request the information they seek directly.

Id. at *1.  Similarly, in Drake v. Allergan, Inc., 2014 WL 12664971 (D. Vt. March 19, 2014), cloned discovery “which permits plaintiffs to obtain all of the materials furnished in the Department of Justice investigation” was denied because it “may result in surrender of documents that are totally irrelevant to the pending litigation.”  Id. at at *3.  “Generally, courts discourage the use of criminal discovery requests as providing the framework for civil discovery demands in unrelated litigation due to the requirement that plaintiffs make specific requests for discovery related to their individual claims.”  Id.  “The better approach to discovery here is to require Plaintiffs to make individualized demands based upon what may be relevant documents.”  Id.  Accord Pensacola Firefighters’ Relief Pension Fund v. Merrill Lynch Pierce Fenner & Smith, Inc., 265 F.R.D. 589, 597 (Mag. N.D. Fla. 2010) (“production of all of the documents produced to the SEC, without a more particularized request, could potentially allow plaintiff to bypass the limitations on the scope of discovery established by the Rules”); In re WorldCom, Inc. Securities Litigation, 2003 WL 22953645, at *7 (S.D.N.Y. Dec. 16, 2003) (“[w]hile the record generated by the Government’s work may ease the burdens of the civil litigation, the civil litigants enjoy those benefits as a matter of convenience, not as of right”); In re Milk Products Antitrust Litigation, 84 F. Supp.2d 1016, 1026 (D. Minn. 1996) (denying cloned discovery seeking documents “already compiled by Defendants in response to subpoenas from the Antitrust Division of the United States Department of Justice”); Cook v. Rockwell International Corp., 147 F.R.D. 237, 245-46 (D. Colo. 1993) (denying plaintiffs’ attempt “to piggyback on the very same discovery the grand jury conducted” in a prior criminal proceeding; “[w]hile materials relevant to Plaintiffs’ case may overlap with those subpoenaed in [the criminal case], Plaintiffs must obtain those documents because they are relevant to the claims in this case, not simply because they were provided to the grand jury in its criminal investigation”).

Concerning prior civil litigation, King County v. Merrill Lynch & Co., 2011 WL 34384913 (W.D. Wash. Aug. 5, 2011), relied on both Wollam and Midwest Gas, and explained that cloned discovery was improper because “without more, the Court cannot ascertain whether the documents requested actually relate to Plaintiffs’ claims and defenses” in the current case.  Id. at *3.  Even if “some portion of documents encompassed by Plaintiffs’ request may be relevant, the Court has no method of determining which of those documents are relevant, and which are not.”  Id.  Heck, even if “each and every document” were discoverable, “Plaintiff must make proper discovery requests, identifying the specific categories of documents sought, in order to obtain them − and each category must be relevant to its claims and defenses.’”  Id.

The first case we found that dealt with cloned discovery was Payne v. Howard, 75 F.R.D. 465 (D.D.C. 1977), which involved a blanket request for “pleadings” from a defendant’s prior litigation.  That’s less broad than the “any and all” cloning requests we tend to see these days (which usually ask for everything), but Payne refused to allow even that:

Whether pleadings in one suit are “reasonably calculated” to lead to admissible evidence in another suit is far from clear. In the Court’s view, discovery of this type of information typically will not lead to admissible evidence. . . . To date, there has been no inquiry into how let alone a showing that the pleadings sought by plaintiff are related to any of the issues raised in the instant case. Given that fact, and given also the unlikelihood that an adequate proffer could be made, the Court must conclude that the items sought are not “reasonably calculated” to lead to the discovery of admissible evidence.

Id. at 469.

Other cases denying cloned discovery requests are:  In re Volkswagen “Clean Diesel” Marketing, Sales Practices, & Products Liability Litigation, 2017 WL 4680242, at *2 (Mag. N.D. Cal. Oct. 18, 2017) (“Plaintiffs are not entitled to complete access to the MDL Production simply because there may be an overlap between their claims and those [here].  They instead must serve requests for production on [defendant] in accordance with the Federal Rules.”); Z Best Body & Paint Shops, Inc. v. Sherwin-Williams Co., 2017 WL 3730515, at *3 (Mag. C.D. Cal. Aug. 29, 2017) (“the broad request for all ‘record and documents’ produced by Defendant in [prior litigation] appears to be overbroad on its face”); Strickland v. Tristar Products, Inc., 2017 WL 2874621, at *1 (Mag. S.D. Ga. July 5, 2017) (“Plaintiffs are not entitled to ‘all documents’ and ‘all depositions’ in the 10 identified cases, regardless of the pertinence of those materials to the instant case.  They simply must identify the materials more specifically than ‘all.’”); Racing Optics v. Aevoe Corp., 2016 WL 4059358, at *1-2 (D. Nev. July 28, 2016) (“’Piggyback’ discovery requests are prohibited. . . . [plaintiff] need[s] to specify which documents it want[s] and to demonstrate its relevance”), reconsideration denied, 2016 WL 4994961 (D. Nev. Sept. 16, 2016); Caves v. Beechcraft Corp., 2016 WL 355491, at *2 (Mag. N.D. Okla. Jan. 29, 2016) (cloned discovery seeking “any and all testimony concerning any other litigation, regardless of connection to the accident or [product] at issue, is clearly objectionable”); Town of Westport v. Monsanto Co., 2015 WL 13685105, at *3 (Mag. D. Mass. Nov. 5, 2015) (cloned discovery “requests for all discovery and deposition testimony from all [prior] litigation [involving the same chemical] is overly broad”); Capital Ventures International v. J.P. Morgan Mortgage Acquisition Corp., 2014 WL 1431124, at *1-2 (D. Mass. Apr. 14, 2014) (“plaintiff indiscriminately pursues wholesale production of all testimonial materials from all employees in all [prior] cases or investigations”; “This request for ‘cloned discovery’ is, like the request for testimonial materials, overbroad and of speculative relevance.”); Burke v. Ability Insurance Co., 291 F.R.D. 343, 355 (D.S.D. 2013) (“The court will not compel defendants to produce all documents from prior litigation when [plaintiff] has not established how they will be relevant or what that prior discovery contains”); Wiand v. Wells Fargo Bank, N.A., 2013 WL 6170610, at *3 (Mag. M.D. Fla. Nov. 22, 2013) (cloned discovery held “overbroad on its face for failing to specify any subject matter of the sought-after documents.  By asking for ‘all documents produced . . .’ in the other litigation, the scope of the request is far too expansive.”); In re Cathode Ray Tube (CRT) Antitrust Litigation, 2013 WL 183944, at *1-4 (N.D. Cal. Jan. 17, 2013) (rejecting overseas litigant’s cloned subpoena to “produce all discovery related to the [prior] action” under similar analysis); Pegoraro v. Marrero, 281 F.R.D. 122, 132 (S.D.N.Y. 2012) (cloned discovery denied as “overly broad in its scope because it seeks all documents in connection with any [similar] litigation or proceeding involving the defendants, regardless of the specific nature of the proceeding and factual circumstances underlying those proceedings”); N.J. Carpenters Health Fund. v. DLJ Mortgage Capital, Inc., 2012 WL 13135408, at *1, slip op. (S.D.N.Y. March 2, 2012) (rejecting “monkey see/monkey do” discovery; plaintiffs’ “request that says ‘you gave some documents to the government concerning another investigation, so give them to me’ is DENIED”); Bean v. John Wiley & Sons, Inc., 2012 WL 129809, at *2 (D. Ariz. Jan. 17, 2012) (cloned discovery concerning “similar” but “different” prior litigation denied); Eisai Inc. v. Sanofi-Aventis U.S., LLC, 2011 WL 5416334, at *8 (Mag. D.N.J. Nov. 7, 2011); (cloned discovery held “irrelevant, unlikely to lead to the discovery of admissible evidence in this matter, and that production of same would unduly burden Defendants”); Chen v. Ampco System Parking, 2009 WL 2496729, at *2-3 (Mag. S.D. Cal. Aug. 14, 2009) (“similarities between the [prior] cases and this case . . . are not enough to require a carte blanche production of all documents from the state cases”; “Plaintiff must specifically ask for the documents he wants and be able to demonstrate that the information he seeks is relevant to his claims in this case”) (emphasis original); American Eagle Outfitters, Inc. v. Payless Shoesource, Inc., 2009 WL 152712, at *1 (Mag. E.D.N.Y. Jan. 21, 2009) (cloned discovery “seek[ing] broad categories of documents relating to every litigation in which the defendant has ever been involved where [similar] violations have been alleged” denied as “considerably overbroad”); Moore v. Morgan Stanley & Co., 2008 WL 4681942, at *5 (Mag. N.D. Ill. May 30, 2008) (“just because the information was produced in another lawsuit . . . does not mean that it should be produced in this lawsuit”); Kormos v. Sportsstuff, Inc., 2007 WL 2571969, at *3 (Mag. E.D. Mich. Sept. 4, 2007) (plaintiff’s cloned discovery demanding “copies of any and all other legal complaints filed by other plaintiffs against Defendant” held “as overly broad, unduly burdensome and not reasonably calculated to lead to the discovery of admissible evidence”); Wyeth v. Impax Laboratories, Inc., 248 F.R.D. 169, 171 (D. Del. 2006) (a “request for all documents from the [prior] Litigation is overly broad. The Court finds that [requestor] has not demonstrated why it is entitled to documents from the [prior] involving matters not at issue in this litigation”); Oklahoma v. Tyson Foods, Inc., 2006 WL 2862216, at *2 (Mag. N.D. Okla. Oct. 4, 2006) (“Plaintiffs appear to equate ‘similarity to a prior lawsuit’ to relevant to a claim or defense in the current proceeding. The Court cannot accept that this conclusion is automatic.”).

It’s bad enough for our clients to be subjected to asymmetrical discovery over and over again.  It would be worse to allow plaintiffs to recreate that asymmetry in any case they choose, merely by demanding all the discovery that took place previously in other cases.  Cloned discovery is an abusive practice that always should be resisted.

We recently gave a talk on things in MDLs that drive us crazy. Discovery is front and center. The asymmetry of discovery is a huge source of unfairness. If plaintiffs have their way, all discovery would be about company conduct, and we’d never get to find out if those 8,000 plaintiffs used the product or suffered an injury. Mere details. And don’t get us started on a plaintiffs’ insistence that we “certify” that our discovery is complete. That certification is both an insult and a departure from the Rules. Plaintiff lawyers might seek such certification in any case, but they definitely will seek it in an MDL, where discovery is most difficult, one-sided, and expensive.

Okay, now you went and got us started. Federal Rule of Civil Procedure 26(g)(1) requires that “every discovery request, response, or objection must be signed by at least one attorney of record … [to certify] that to the best of the person’s knowledge, information, and belief formed after a reasonable inquiry (A) with respect to disclosure, it is complete and correct as of the time it is made …” Although some enterprising plaintiff lawyers have argued that this language should mean parties are required to certify that discovery responses are complete, this Rule is limited to disclosures required by Rule 26(a)(1) – not discovery responses.

The comments to subsection (g)(l) tell us that Rule 26(g) “imposes an affirmative duty to engage in pretrial discovery in a responsible manner that is consistent with the spirit and the purposes of Rules 26-37.” Fed. R. Civ. P. 26(g) advisory committee’s note. Additionally, “the signature certifies that the lawyer has made a reasonable effort to assure that the client has provided all the information and documents available to him that are responsive to the discovery demand.” Id. Although there is a duty to make a reasonable inquiry to ensure that discovery responses are complete, there is no duty to certify complete discovery. United States v. Fresenius Medical Care Holdings, Inc., No. 1:10-CV-1614-AT, 2014 WL 11517841, at *5-6 (N.D. Ga. May 13, 2014). The “complete and correct” language applies only to initial disclosures required by Rule 26(a) (l). Moore v. Publicis Groupe, 287 F.R.D. 182, 188 (S.D.N.Y. 2012).

In Moore, the plaintiff relied on Rule 26(g)(l )(A) to argue that the defendant’s counsel was required to certify that the client’s document production was complete and correct at the time it was made. Id. The court disagreed, pointing out that Rule 26(g)(l)(A) specifically applies “with respect to disclosure” and that Rule 26(g)(l)(B) applies to discovery responses and does not call for certification. Id. The court acknowledged that “[i]n large-data cases … no lawyer using any search method could honestly certify that its production is ‘complete.”‘ Id. True enough.

Similarly, in Fresenius, the plaintiff argued that the defendant’s counsel was required to certify complete document production and that the court must impose sanctions under Rule 26(g)(3) for providing a certification that violates the Rule. Fresenius, 2014 WL 11517841, at *5-6. Looking at the language of Rule 26(g)(l), the court stated that there is no certification requirement for complete document production. Id. at *6.

In conclusion, while lawyers should make a reasonable effort to ensure that a client has provided all the information and documents available that are responsive to the discovery demand, there is no requirement to certify complete document production. Such certification finds no support in the law. Let’s call such certification what it truly is: a sanctions trap.

We last reviewed the case law on predictive coding (also called “technology assisted review” (“TAR”)), about 2 ½ years ago.  Back then, we concluded:

The case law has exploded.  Where only a handful of cases existed back then [2012], now we find dozens.  Substantively, we’re happy to report that courts don’t seem to have anything bad to say about using computers to undertake relevance review for documents subject to production in litigation.

How are things now?

“[I]t is ‘black letter law’ that courts will permit a producing party to utilize TAR” when “there was never an agreement to utilize a different search methodology.”  Entrata, Inc. v. Yardi Systems, Inc., 2018 WL 5470454, at *7 (D. Utah Oct. 29, 2018).  Predictive coding continues to enjoy judicial approval:

The predictive coding process required a significant amount of attorney time at the outset to devise and implement, and required the creation of an agreed to strict set of procedural and process safeguards, due to its relative novelty.  Despite the initial “front loaded” investment of time required, the predictive coding system provided a unique way to, in part, realistically manage the immense amount of information needed to be produced and reviewed in this MDL.  The predictive coding system, although not perfect or fully realized, nonetheless, provided an innovative efficiency to the discovery process when compared to the existing, prevailing methods of review.

In re Actos (Pioglitazone) Products Liability Litigation, 274 F. Supp.3d 485, 499 (W.D. La. 2017).  See Story v. Fiat Chrysler Automotive, 2018 WL 5307230, at *3 (Mag. N.D. Ind. Oct. 26, 2018) (“The Court encourages counsel . . . to consider that key word searches or technology assisted review are appropriate and useful ways to narrow the volume of an otherwise overly-broad request”); Duffy v. Lawrence Memorial Hospital, 2017 WL 1277808, at *3 (Mag. D. Kan. March 31, 2017) (“Technology-assisted review can (and does) yield more accurate results than exhaustive manual review, with much lower effort.”) (citations and quotation marks omitted); FCA US LLC v. Cummins, Inc., 2017 WL 2806896, at *1 (E.D. Mich. March 28, 2017) (“Applying TAR to the universe of electronic material before any keyword search reduces the universe of electronic material is the preferred method.”); Davine v. Golub Corp., 2017 WL 549151, at *1 (Mag. D. Mass. Feb. 8, 2017) (“Defendants are entitled to rely on their predictive coding model for purposes of identifying relevant responsive documents”); In re Bair Hugger Forced Air Warming Products Liability Litigation, 2016 WL 3702959, at *1 (D. Minn. July 8, 2016) (MDL order providing for predictive coding). Cf. Dremak v. Urban Outfitters, Inc., 2018 WL 1441834, at *8 (Cal. App. March 23, 2018) (unreported) (finding predictive coding “reasonable and necessary to the litigation” and taxing the cost to unsuccessful plaintiffs), review denied (Cal. July 11, 2018).

Another thing that appears settled is the right of the party producing electronically stored information (“ESI”) to choose the means by which it conducts electronic discovery.  Several cases have addressed this issue, with the result being that neither side can force the other to use this technology.  In a follow-up to a case mentioned in our prior post, the Tax Court in Dynamo Holdings Ltd. Partnership v. CIR, 2016 WL 4204067 (T.C. July 13, 2016), overruled an IRS objection to a taxpayer’s predictive coding-based production that amounted to the IRS seeking a redo.  In response to the IRS’s demand for a 95% recall rate (returning 95% of all relevant documents) – that had a precision rate of only 3% (97% of the total documents produced would be irrelevant) − the court chastised the IRS for perpetuating two “myths” about discovery:  First, that human review is “perfect,” or at least the “gold standard.”  Id. at*5. It isn’t:

[H]uman review is far from perfect. . . .  [I]f two sets of human reviewers review the same set of documents to identify what is responsive, research shows that those reviewers will disagree with each on more than half of the responsiveness claims.

Id. (citations omitted).  The second “myth” is that a “perfect response” to discovery is necessary.  Id.  It isn’t, nor is it even possible:

[O]ur Rules do not require a perfect response. . . .  Like the Tax Court Rules, the Federal Rule of Civil Procedure 26(g) only requires a party to make a “reasonable inquiry” when making discovery responses.  The fact that a responding party uses predictive coding to respond to a request for production does not change the standard for measuring the completeness of the response.

Id. at *5-6 (citations omitted).  Thus, predictive coding, even if imperfect for all the reasons stated by the IRS, was nonetheless proper discovery.  “Petitioners made a reasonable inquiry in responding to the Commissioner’s discovery demands when they used predictive coding to produce any documents that the algorithm determined was responsive.”  Id. at *6.

The converse was true in In re Viagra (Sildenafil Citrate) Products Liability Litigation, 2016 WL 7336411, at *1 (Mag. N.D. Cal. Oct. 14, 2016).  The MDL plaintiffs attempted to force the defendant to conduct ediscovery by predictive coding rather than the defendant’s chosen search term-based methodology. That was a no go, as the rules did not give the requesting party the right to dictate the producing party’s search methods:

[N]o court has ordered a party to engage in TAR and/or predictive coding over the objection of the party.  The few courts that have considered this issue have all declined to compel predictive coding. . . .  [T]he responding party is the one best situated to decide how to search for and produce ESI responsive to discovery requests.  The responding party can use the search method of its choice.

Id. (citations and quotation marks omitted).  Accord Rockford v. Mallinckrodt ARD, Inc., 326 F.R.D. 489, 493 (N.D. Ill. 2018) (“This Court will not micromanage the litigation and force TAR onto the parties.”); T.D.P. v. City of Oakland, 2017 WL 3026925, at *4-5 (Mag. N.D. Cal. July 17, 2017) (rejecting plaintiff’s effort to force defendant to use predictive coding); Hyles v. New York City, 2016 WL 4077114, at *2-3 (Mag. S.D.N.Y. Aug. 1, 2016) (even though “TAR is cheaper, more efficient and superior to keyword searching” “it is not up to the Court, or the requesting party . . ., to force . . . the responding party to use TAR when it prefers to use” something else).

What can happen down the road, post-production, if the requestor still thinks that the producer’s methods are inadequate?   Requestors must have “specific examples of deficiencies” before seeking discovery into an opponent’s TAR process.  Entrata, Inc. v. Yardi Systems, Inc., 2018 WL 3055755, at *3 (Mag. D. Utah June 20, 2018), objections dismissed, 2018 WL 5470454 (D. Utah Oct. 29, 2018).

One way of getting a handle on the recall rate “is to randomly sample the null set.”  Rockford, 326 F.R.D. at 493.  This so-called “null set” represents the universe of electronic documents reviewed and found non-responsive.

Conducting a random sample of the null set is a part of the TAR process.  The purpose of randomly sampling the null set after a TAR review is to validate the process and provide reasonable assurance that the production is complete.  Validation and quality assurance are fundamental principles to ESI production.  The process provides the reasonable inquiry supporting the certification under Rule 26(g) [of reasonable completeness].

Id. at 494 (citations omitted). “[A] random sample of the null set provides validation and quality assurance of the document production.”  Id.  See Winfield v. City of New York, 2017 WL 5664852, at *11 (Mag. S.D.N.Y. Nov. 27, 2017) (“Plaintiffs have presented sufficient evidence to justify their request for sample sets of non-privileged documents” even though “neither this Court nor Plaintiffs have identified anything in the TAR process itself that is inherently defective”).

Finally, for the technophobes among us, we’ll close this post with a soothing quote from one of the more recent cases:

The Court pauses here for a moment to calm down litigators less familiar with ESI. (You know who you are.) In life, there are many things to be scared of, including, but not limited to, spiders, sharks, and clowns – definitely clowns, even Fizbo.  ESI is not something to be scared of. The same is true for all the terms and jargon related to ESI. . . . The underlying principles governing discovery do not change just because ESI is involved.  So don’t freak out.

Rockford, 326 F.R.D. at 492 n.2 (citations and quotation marks omitted).

In a classic case of overreaching, plaintiffs in the In re Abilify MDL, sought sanctions against the defendant for not preserving emails dating between 2002 and 2006 – more than a decade before the start of the litigation. We have a hard time even contemplating what a duty to preserve that covered those emails would begin to look like. Fortunately, so did the court. Not for lack of argument by plaintiffs. They tried everything from industry-wide events to FDA requirements to alleged breach of a pharmacovigilance agreement between defendants. But this everything plus the kitchen sink approach couldn’t mask the lack of merit of any of their arguments.

Before 2007, defendant had a document retention policy of 60-days for emails. In re Abilify (Aripiprazole) Prods. Liab. Litig., 2018 U.S. Dist. LEXIS 172536 at *3 (N.D. Fla. Oct. 5, 2018).  Plaintiffs argued that destruction of email before that time constituted spoliation and warranted sanctions against defendant. A question that is governed by Federal Rule of Civil Procedure 37(e). Sanctions for failure to preserve electronically stored information (“ESI”) are permissible when ESI should have been preserved “in the anticipation or conduct of the litigation,” and the ESI was lost or destroyed due to the party’s failure to take reasonable steps to preserve and the ESI cannot be restored or replaced. All four of those conditions must be met. Making the only question for the court in this case – whether defendant had to duty to preserve emails from 2002-2006. It did not.

The court cites 11th Circuit precedent that the duty to preserve doesn’t arise until “litigation is pending or reasonably foreseeable.” Id. at *5. So plaintiffs’ first argument was that defendant should have reasonably anticipated the litigation long before the first lawsuit was filed in 2016. Plaintiffs’ argument was that the duty to preserve can be triggered by “industry-wide events, regardless of the status of individual litigation.” Id. at *7. But this theory is too outward focused. The industry-wide events plaintiffs rely on are scientific literature, other lawsuits, and adverse event reports. The early literature pertains to other drugs in the same class as Abilify and the question of whether that literature was sufficient to place defendant on notice of the risk of compulsive gambling is a “hotly contested issue in the case.” Id. at *10. Making it a

quantum leap to conclude that [defendant] had a duty to preserve all of its emails . . . simply because there may have been some scientific literature published in the late 1990’s and early 2000’s that addressed [the class of] drugs and a possible link to compulsive gambling.

Id. Relying on adverse events in clinical trials was similarly insufficient to place defendant on notice of possible litigation. Id. at *12. Other litigation about different drugs was also insufficient to put defendant on notice that it too would be sued a decade later.

The Court is not aware of any case law, which requires a drug manufacturer to preserve all of its documents where the manufacturer has not received any notice of the potential threat of litigation other than simply knowledge that there was other litigation involving a different drug prescribed for different conditions that may fall within the very broad category of dopaminergic drugs. Such an overly broad view of the duty of preservation would impose on every drug manufacturer a duty to preserve all of its documents, without regard to subject matter or time frame. That is at odds with the requirement that a party must preserve documents when it reasonably anticipates litigation.

Id. at *11 (“reasonable anticipation” is more than “mere possibility”).

Plaintiffs’ last industry-wide argument was that defendant should have put a legal hold in place based on a subpoena from the DOJ in an investigation concerning off-label promotion of Abilify. The court quickly pointed out that that investigation did not involve the safety or compulsive gambling information at issue in the MDL, but more importantly a demand from the DOJ at best triggers a duty to preserve that runs to the DOJ. That duty cannot be shifted to be owed to these plaintiffs in a separate action. Id. at *13-14.

Disregarding all of these external events to focus on the case specifics, plaintiffs’ counsel didn’t start advertising for plaintiffs until 2013 and didn’t threaten litigation until 2014. Id. at *8. So, in looking at the action of these plaintiffs, the earliest defendant could have anticipated litigation was 2014. Id.

We’re not done yet. Plaintiffs tried another duty-shifting argument, this time with the FDA.  Drug manufacturers are required to preserve adverse event data, including correspondence, for 10 years. Plaintiffs latched on to the “correspondence” language to argue that there must have been AE-related emails that were deleted. But even if true, “failure to comply with a regulatory obligation does not create a duty to preserve for purposes of a spoliation motion.” Id. at *15-16. The “obligation . . . runs to the FDA and not the plaintiffs in this case.” Id. at *16. The emails at issue were gone a decade before the defendant owed an obligation to the plaintiffs as opposed to the FDA.

Plaintiffs’ last attempt to find an earlier trigger was to point to the pharmacovigilance agreement between defendant and another manufacturer. The agreement required both parties to keep and make available to each other all of their adverse event information, and the language once again included correspondence. Id. at *19. There was no allegation that any manufacturer did not properly maintain their adverse event data, only that if the agreement included correspondence then there “must have been” relevant correspondence in the deleted emails. But putting aside plaintiffs’ obvious twisting of the true meaning of the agreement:

The more fundamental problem with Plaintiff’s argument is that Plaintiffs as non-parties to the Pharmacovigilance Agreement cannot enforce the obligations in the agreement to their benefit.

Id. Plaintiffs attempt to rely on state-law to make their case, but (1) Rule 37(e) prohibits reliance on state law to create a basis for discovery sanctions and (2) even under Florida law, the plaintiff has to be a party to the contract to use its breach as a basis for spoliation. Id. at *21.

Because defendant had “no inkling” in 2004 that potential claimants like plaintiffs even existed, there is no evidence that the auto-delete document policy in effect at that time was anything other than an ordinary business policy. Simply stated, defendants were not acting in bad faith. Id. at *23-24. Even more simply stated, defendants can’t be held to the standard of Carnac the Magnificent.


Just two weeks ago, we largely praised an MDL court’s handling of sanctions for a plaintiff’s stonewalling in response to discovery obligations, but thought the plaintiff got off pretty light for some really egregious conduct.  Today, we report on a circuit court’s affirmance of discovery sanctions against a plaintiff counsel’s conduct for being overly aggressive in the pursuit of discovery. In light of the holiday today, we will be extra careful in how we describe the plaintiff’s counsel’s conduct and refrain from drawing any conclusion about what the conduct here says about the counsel. We will leave to the reader to decide whether the sanction imposed here—about $25,000 in costs and fees—will have a sufficient deterrent effect and whether the cost of an appeal of a $25,000 sanction after the plaintiff lost summary judgment was worth it.

As you might expect for a case that got to an appeal on a sanction order, the history of Vallejo v. Amgen, Inc., — F.3d –, 2018 WL 4288360 (10th Cir. Sept. 10, 2018), is complicated. Our summary of the pertinent facts is just a summary, with more flavor in the actual case. The case involves an estate suing over a fatal blood cancer called myelodysplastic syndrome (“MDS”) in a patient taking a well-known biologic for psoriasis. Perhaps because of the track record of the medication and the relative novelty of the claimed injury, the court ordered that the first phase of discovery should focus on whether the medication can cause MDS. (It appears that the medication has been studied in the treatment of MDS in multiple studies among the hundreds completed over decades.) After disputes arose on the scope of such general causation discovery, the magistrate held a hearing at which plaintiff presented an expert, who claimed he needed every clinical trial on the drug and all information relating to possible effects on “red blood cells, white blood cells, platelets, or any precursor cells for these blood cell lines.” The magistrate concluded that the scope of discovery sought by plaintiff was unreasonable. Ignoring that, plaintiff served broad discovery requests and the defendant objected on scope, burden, and proportionality, offering to produce a range of documents focused on the medication and MDS. Plaintiff sought to require the defendant to search adverse events for 206 terms, but the magistrate “limited discovery to 15 search terms that provided the most specificity to MDS.”

Plaintiff also sought discovery on other medications of the same class and the defendant objected. The magistrate ordered the defendant to produce non-public studies on the possible relationship between the medication and MDS. Defendant also offered up a global safety officer for deposition and plaintiff demanded the names of everyone who ever worked on adverse event handling for the medication or who had responsibility for any evaluation of its relationship to MDS. The magistrate allowed the plaintiff to depose the safety officer to find out other witnesses as needed. Because the defendant had not submitted affidavits to prove the burden of coming up with a list of everyone who had worked on the medication over decades, the magistrate advised the parties that they would need to “quantifiably explain the burden of providing the requested information” going forward. Plaintiff sought clarification from the magistrate and appealed the discovery order to the district judge. The district judge denied the appeal, noting the role of proportionality in discovery.

Meanwhile, plaintiff noticed up the safety officer for deposition beyond what the magistrate had ruled was permissible, and the magistrate had to issue a protective order until the district court could rule. When the deposition started after the district court’s ruling, plaintiff sought to question beyond the scope of the rulings. The magistrate suspended the deposition for more briefing and to set a time to supervise the deposition when it reconvened. When that happened, plaintiff’s counsel tried to reargue prior rulings, argued with the magistrate, and “asked the witness questions which were explicitly beyond the scope of discovery as ordered by the court.” Thereafter, the magistrate denied a motion to compel additional depositions and document production, noting that plaintiff’s counsel had plenty of information on causation from what had been produced and from other sources. The magistrate also directed plaintiff to disclose the general causation experts that her counsel had claimed to have when arguing with the magistrate during the safety officer’s deposition. Plaintiff again appealed and the district court again denied it.

After all this and some more jockeying, the defendant moved for sanctions for plaintiff’s counsel’s “repeated attempts to circumvent the court’s limitations on the first stage of discovery and abused the judicial process.” Defendant sought about $141,000 in fees and costs and the magistrate awarded about $25,000 for a variety of sanctionable conduct. The district court came to the same conclusion on its de novo review after appeal. After summary judgment was granted because plaintiff failed to name a causation expert, despite the claims of her counsel that she had retained one, the appeal to the Circuit Court followed. If are not exhausted after that recap, then you have more tolerance for discovery fights than do most courts we know. You might also reflect on the question of whether the burdensome discovery plaintiff sought and the fights that she initiated on discovery issues were part of a scheme to force some kind of settlement before having to prove general causation.

In affirming, the Tenth Circuit not only reinforced the limits on what counsel can do when they keep losing discovery fights, but provided guidance on some recurring issues in discovery. We start with the final word:

Attorneys are entitled to advocate zealously for their clients, but they must do so in accordance with the law, the court rules, and the orders of the court. The district court properly exercised its inherent power to sanction Vallejo’s counsel, and we find no abuse of discretion.

Focusing on the motion to compel that plaintiff filed after the first attempt at deposing the safety officer, this was easily characterized as “relitigation of issues already decided by the court.” It did not matter whether plaintiff had a basis for the positions that it took initially. As the magistrate held—within its discretion per the Circuit Court—“absent any change in circumstances, filing additional motions raising the same arguments was harassing, caused unnecessary delay, and needlessly increased the cost of this litigation.”

On the issue of proportionality, the Circuit Court affirmed that proof of burden can be established by means other than sworn statements. While statements in a brief (signed by counsel) are not proof, a court may consider “common sense” in evaluating the burden part of proportionality. In this case, it also had plaintiff’s counsel’s demonstration of how many hits a small portion of plaintiff’s preferred search terms produced. So, plaintiff’s counsel could not excuse misconduct by claiming no limits should have been imposed in the first place.

Plaintiff’s efforts to turn the focus to alleged misrepresentations by the defendant’s counsel were similarly rejected, as the Circuit Court was “satisfied that the district court did not rely on misrepresented facts by [defendant] in issuing its discovery orders.” Nor could she shift the focus to how the magistrate conducted the discovery hearing in terms of questioning of defendant’s expert, whose core opinion was that the Biologic License Application had relevant information on causation. Among other things, the district court did not rely on the defendant’s expert in limiting the scope of discovery. Plaintiff also tried to claim that she should have had access to all the information FDA might consider in evaluating medical causation, but this was a red herring given the difference between FDA standards and court standards, the absence of any MDS signal, and the court’s discretion to limit discovery on general causation. Plaintiff’s last gasp was to claim her case was prejudiced by the sanctions against her, but it was her counsel’s decision to claim she had general causation experts and her failure to name even one when required, instead trying to get by with a designation of an unspecified employee of one of the companies involved with the medication.

In short, plaintiff’s counsel conduct was sanctionable because the court set limits on discovery within its discretion and then plaintiff’s counsel chose to relitigate them and flaunt them until plaintiff lost for the fundamental reason of having no general causation expert. The fact that plaintiff ultimately lost despite pursuing these tactics reinforces that the tactics were obstructionist rather than excusing the tactics themselves. Even on the defense side, where we have been known to litigate aggressively on issues like the scope of discovery and the sufficiency of general causation, Vallejo can be instructive on the need to respect final rulings as the law of the case.

Stop us if you have heard this before. A novel or movie depicts litigation in which a large corporate defendant is sued for causing a plaintiff or plaintiffs significant injuries through a frivolous or non-beneficial product. In defending the litigation, the corporation and its unscrupulous lawyers hide important documents from the scrappy plaintiff lawyer, who, depending on the fiction’s direction, never discovers or miraculously discovers the key evidence. Perhaps informed by this view of corporate defendants and their lawyers as less than honorable, a number of courts have imposed significant sanctions against defendants when, despite producing millions of pages of documents created well before the litigation started and gathered from around the world, fail to preserve and produce some number of documents that the plaintiffs contend should have been produced. The importance of the documents to the case and the overall merits of the case tend not matter to the award of sanctions. To the contrary, the sanctions can themselves affect the outcome of the litigation. We know you have heard about these litigations, as we have described them in a number of posts through the years.

The situation where a plaintiff is sanctioned for her refusal to disclose information and produce documents in litigation is far less common. Mind you, we do not think the conduct is less common. We think it happens all the time, but rarely goes to motion let alone a published decision about a bellwether plaintiff in a product liability MDL. In re Taxotere (Docetaxel) Prods. Liab. Litig.¸ MDL No. 2740, 2018 WL 4002624 (E.D. La. Aug. 22, 2018), presents a sanctions order that may not signal a trend toward equal treatment for plaintiffs and defendants on discovery obligations and sanctions because this plaintiff’s conduct was just so obviously bad.

The plaintiff was suing over hair loss from a chemotherapy drug for her cancer. She was also a medical doctor and bellwether plaintiff. (We pause just on these facts in case our readers want to ponder how litigation now is different than the “old days,” whenever that might have been.) The MDL had a Plaintiff Fact Sheet requirement and an order explaining discovery obligations for electronically stored information apply to them too. After bringing her suit and for over a year thereafter, the plaintiff treated with, or at least sought advice from, a physician on how to regrow her hair through an unspecified regimen.  She documented her progress with photographs and, when the treating physician asked for permission to use them to promote his treatment, squarely stated she “[w]ould rather not have the lawyers for the other side put two and two together just yet.” She failed to identify this physician on her fact sheet, provide authorizations for him, or identify the treatment she was receiving at his suggestion. When she realized that her produced emails—like we said, the court realized plaintiffs have to produce ESI too—included information about this undisclosed physician, she directed him to resist discovery: “just tell them that you weren’t really my doctor . . . you don’t have any records [and] you never saw me.” Meanwhile, plaintiff (who had a lost wages claim) directed her former employer, a particular Veterans Affairs Medical Center, to refuse to produce any employment or medical records.

The decision focused on the plaintiff’s conduct regarding her undisclosed physician. Plaintiff’s primary defense was that the doctor recommending her a treatment regimen she was utilizing and corresponding with about its progress was not really “her doctor.” She supported this argument with an affidavit from the doctor to the effect that he did not consider the plaintiff to be his patient. This argument did not hold water because the PFS required disclosure not just of treating physicians, but any healthcare provider consulted over the prior eight years, including any “hair loss specialist.” It also required disclosure of “over-the-counter medications, supplements, or cosmetic aides for your hair loss.” We assume it also required production of photographs documenting the extent of any claimed injury (i.e., hair loss over time). It was easy to find that plaintiff had failed to comply with her discovery obligations, especially because “she has encouraged at least [two] potential witness[es] to be less than forthcoming in this litigation.”

What was the sanction? She had to produce the stuff she was supposed to produce anyway, sit for further deposition on the withheld evidence, and pay the defendant’s cost for the motion for sanctions. Yawn. The order was supposed to be a warning for her or “any other plaintiff who might be considering adopting evasive tactics like those discussed in this opinion.” We think she got off light and, particularly in the context of a big MDL—this one has more than 9000 pending cases—the sanction lets plaintiffs and their lawyers make calculated decisions about whether it pays to avoid discovery obligations. We cannot see a defendant in a litigation like this getting off nearly so lightly had it done anything like what plaintiff did here.


The whole business of discovery in civil litigation is dreary and depressing.  In a mass tort, a defendant can rack up defense verdicts yet still incur discovery costs that exceed the damage amounts sustained by defendants found liable in other torts. Little wonder that the mass of defense lawyers in mass torts lead lives of quiet desperation. At least, that’s true for the poor drudges who must review documents for responsiveness and privilege.

We’ve been thinking about Henry David Thoreau.  An anniversary is almost here.  Walden was published on August 9, 1854.  Thoreau built a cabin near the shore of Walden Pond and began living in it on July 4, 1845, “alone in the woods, a mile from any neighbor.” It was a declaration of independence.  He lived there for two years, two months, and two days.  The book took eight years to write, and there is much more artifice in it than straight nature reporting.  Whatever you think about American exceptionalism, Thoreau exemplified many traits that, for better or worse, seem at the core of the American ethos:  embrace of self-reliance and ecological preservation, and stand-offishness with respect to politics and society.  We wondered whether Thoreau wrote anything about discovery.   Our well-worn volume of Walden contains an index, but we found no reference to “discovery.”  Nor was there a word about document requests.  The best we could do was the famous passage in the “What I Lived For” chapter that explains the project at hand:  “I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach, and not, when I came to die, discover that I had not lived.” There’s that word “discover,” but we suspect Henry had something else on his mind.

Thoreau never had the misfortune to encounter Federal Rules of Civil Procedure 26, etc.  Had he, he might have drafted an interrogatory about discovery:  “whether it is necessary that it be as bad as it is, whether it cannot be improved as well as not.” Most of what we do in civil litigation is discovery, and most of that is a waste of time.  Such time wasting would have mightily irked Henry:  “As if you could kill time without injuring eternity.”  From Thoreau’s revelatory prose we now turn to a judicial opinion that makes those of us who spend time opposing discovery want to retreat to the woods.

Today’s case is In re: Genentech Herceptin (Trastuzumab) Marketing and Sales Practices Litigation, 2017 WL 9939631 (N.D. Okla. May 8, 2018). The defendants wanted to argue preemption, and the plaintiffs engaged in what has become the typical response of insisting on wide-ranging discovery to test the preemption defense.  “Wide-ranging” is an understatement.  From the court’s description, it seems that the plaintiffs wanted pretty much everything.  The defendants countered with something less than everything.  And so we end up with cross discovery motions.  The plaintiffs filed a motion to compel while the defendants filed a motion for a protective order regarding all unanswered preemption discovery requested by the plaintiffs.  The court granted every one of the plaintiffs’ motions to compel discovery responses, and denied every one of the defendants’ motions for protective order.  The opinion is a sadness machine.  That machine is fueled by two all-too-common judicial impulses: (1) letting plaintiffs conduct any discovery they want, and (2) hostility to the preemption defense.  Why, it is almost as if the court was unhappy with the defendants for even raising the preemption defense.

At least the court was convinced that the preemption issue should be decided prior to class or merits discovery.  But the court entertained what it called “a more realistic view of the discovery required for resolution of the preemption motion.” “Realistic” turns out to mean exceedingly broad.  According to the court, the defendants’ preemption motion “relies upon evidence regarding its communications with FDA and its manufacturing process, both of which Plaintiffs are entitled to explore before responding to the motion.”  Consequently, the “preemption defense opened doors in discovery that may well have stayed closed if the only issue was breach of a state-law warranty.”  Open doors are bad.  They let in all sorts of unwanted things – traffic noises, heat, peddlers and, bugs, to name a few.  And bad ideas.

Here, the court opened the door very wide indeed.  For example, the plaintiffs wanted all correspondence between the manufacturer and the FDA relating to product labeling – both pre and post approval.  They also asked for all Establishment Inspection Reports, FDA Form 483s, and Warning Letters issued by the FDA relating to the labeling.  That scope might make sense if the defendants were raising Wyeth v. Levine “clear evidence” preemption.  But they weren’t.  Rather, the defendants argued that the proper inquiry is whether they could “independently do under federal law what state law requires” and whether they could, as a matter of law, “make a unilateral label change that would satisfy the state-law obligation alleged in Plaintiffs’ Complaint.”  That’s Mensing/Bartlett.  That’s different.  That’s straightforward.  That’s binary. The defendants quite logically argued that they were “not raising a Wyeth-type preemption defense and that Plaintiffs ‘have no need for discovery relating to an argument [they] will never make.’”   The defendants also argued that even under the Wyeth changes-being-effected analysis, the plaintiffs could not possibly unearth any “newly-discovered information” that would prompt a labeling change, because it was clear that the FDA knew the relevant information.  End of story.  End of inquiry.  End of discovery.

The defendants were being very Thoreauvian.  They wanted to “simplify, simplify.”  But the court, perversely, was having none of it.  Here is what the court said:  “This Court – and not Defendant – will ultimately decide how to apply Supreme Court law to the evidence presented. Plaintiffs are entitled to advocate for the Wyeth standard, and their requested discovery is relevant to the impossibility preemption analysis in Wyeth.”

And here we must digress.  We are reminded of a story about a legendary D.C. Circuit judge who had stayed on the bench a bit too long.  His practice for oral argument was to consult index cards filled with questions written up by his clerks.  By “ consult,” we mean that he would read off the questions, word for word.  At one argument, he read off a question and managed to stump a polished advocate.  Said polished advocate was stumped because the question had absolutely nothing to do with the case.  Awkward silence. Then the clerk ran up to the side of the bench and whispered frantically, “ That’s the next case, the next case.”  The elderly judge was having none of it.  He sputtered, “ We’re not getting to the next case until this lawyer answers my question!”

In the In re Herceptin case, it is as if the judge was listening to a different case – certainly a different argument.  No wonder, then, that the discovery analysis is so wrong.  Granting the discovery requests would require search of “an extensive regulatory database containing over four million documents.”  The defendants argued proportionality, but the court finds “this proportional to the needs of the case, considering the importance of the issues raised in this multi-district litigation action, the substantial amount in controversy, Defendant’s access to relevant information, Defendant’s resources, and the importance of the discovery in resolving the issues.” So now, in addition to the court’s laissez-faire (or is it les bon temps rouler?) attitude toward discovery, evident disaffection with preemption (at one point, the court bemoans how the plaintiffs “will be deprived of resolution of their state-law claims if the [preemption] defense is successful”), and misconstruction of the defense arguments, we get that other discovery bugaboo about how an MDL  can make even the most extravagant plaintiff discovery request seem proportional.  There is good authority to the contrary (see here, for example), but you won’t see it cited by this court.

Thus, the plaintiffs walk off with a clean sweep win.  They will get communications occurring prior to FDA approval relating to the “Chemistry, Manufacturing and Controls” because such information could be relevant to an obstacle preemption defense that the defendants are not raising.  The plaintiffs will get discovery on the approval process for the purpose of exploring whether FDA “weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing interests should be resolved … and implemented a conclusion via a specific mandate …”  Hmm.  That “unambiguous” bit sounds like the Third Circuit’s Fosamax analysis that is sure to be trashed by SCOTUS next year.  To be clear, it is hard to blame the plaintiffs for their approach.  They smartly asked for as much as the court would give them, which turned out to be the whole kit and caboodle.

But wait.  There’s more.  The plaintiffs will not only get everything under the sun involving the product labeling, but will also get all documents and communications touching on the mass, volume or density of the medicine available in a vial.  Naturally, inevitably, ineluctably, the court rejected the defendants’ argument that, “even if additional documents exist, they would be cumulative and would not meaningfully alter the preemption analysis.”  Why?  Here is the court’s answer:  “If one document certainly exists saying ‘ x,’ – which is relevant to overcoming a preemption defense – it is not overly speculative that other similar documents exist in Defendant’s files.” Huh?  That’s like saying that no evidence could ever be cumulative. If there is some evidence of something, we must collect all such evidence.

The defendants even lost an argument that should have been a sure winner – that discovery on “the number of rejected lots is irrelevant because these batches never reached customers.”  Nobody bought those products.  But the court wasn’t buying the argument, because the preemption defense “is not devoted to the substantive claims.”  Well, if a defense is not devoted to substantive claims, it is not really a defense, is it?

The court’s opinion in In re Herceptin leaves us dissatisfied and puzzled.  Near the end of Walden, Thoreau tells us that he “left the woods for as good a reason as I went there.  Perhaps it seemed to me that I had several more lives to live, and could not spare any more time for that one.  It is remarkable how easily and insensibly we fall into a particular route, and make a beaten track for ourselves.”  To our mind, the court’s all-in approach to discovery in Herceptin is an overly-beaten track.  It is certainly insensible.

Anyone interested in what’s wrong with mass torts in today’s litigation landscape should read the recent article in the New York Times, “How Profiteers Lure Women Into Often-Unneeded Surgery,” which ran in the paper on April 14, 2018, and is available online here.  Briefly, the article exposes litigation (and pre-litigation) conduct that amounts, at best, to unnecessary surgery, and, at worst, to certain doctors, lawyers, and litigation funders conniving to bring about harmful surgeries that caused additional injury to their own supposed clients.  Here are some excerpts from the article – there’s lots more, but we have to limit ourselves to fair use:

  • “[A] growing industry that makes money by coaxing women into having surgery − sometimes unnecessarily − so that they are more lucrative plaintiffs in lawsuits against medical device manufacturers.”
  • “Lawyers building [vaginal mesh] cases . . . turn[ing] to marketing firms to drum up clients.”
  • “Women with mesh implants . . . receiving torrents of unsolicited phone calls, some originating overseas” from telemarketers who “seemed to know their medical histories.”
  • “[M]arketers turn[ing] to finance companies to provide high-interest loans to the [women] that have to be repaid only if the [women] receive money from the case.”
  • “Those loans are then used to pay for surgery performed by doctors who are often lined up by the marketers.”
  • Promises that “all [a woman’s] expenses would be covered and that she would be set up with a lawyer to help her sue the mesh manufacturer.”
  • “[M]iddlemen” arranging for surgery in “walk-up clinics” in “shopping malls.”
  • Doctors performing “four or five removals in a day” and pocketing as much as $14,000 a day.
  • “The women generally didn’t meet the doctors who would be operating on them until shortly before the procedure.”
  • Women charged $21,000 per surgery, “at a double-digit interest rate,” to be paid for from “lawsuits brought by women against the mesh manufacturers.”
  • “[H]undreds, perhaps thousands, of women . . . sucked into this assembly-line-like system. . . .  The profits are immense.”
  • “[P]laintiffs who do collect settlements see much of the money go to the financing firms.  Another large slice goes to their lawyers.”

Other than what’s obviously disturbing about reports of such dubious goings on, the Times article leads us to two observations:

First, the conduct described in the Times article provides further support, in the form of a compelling example, for the increasing calls for some sort of mandatory disclosure of litigation financing, at least in mass torts.  The abuses described in the article show how both the integrity of the mass tort litigation process, and the reputation of litigation financing generally, can be harmed by litigation solicitation and financing arrangements not being transparent, particularly where the litigation itself is largely solicitation-driven, as in most mass torts.

As the Times article demonstrates, solicitation, while constitutional under the First Amendment, is rife with potential for abuse.  Our colleagues on the other side might counter that so is pharmaceutical detailing.  Well, precisely to prevent abuse, the sales practices of our clients are regulated in multiple ways − including disclosure of financial arrangements between them and physicians that prescribe/use their products.  Those on the P-side with nothing to hide have nothing to fear from disclosure.  Thus, if litigation financing wants to be considered as legitimate as, say, insurance, that supports the case for routine disclosure of such arrangements in the same fashion as insurance, as Wisconsin recently decided to do:

Except as otherwise stipulated or ordered by the court, a party shall, without awaiting a discovery request, provide to the other parties any agreement under which any person, other than an attorney permitted to charge a contingent fee representing a party, has a right to receive compensation that is contingent on and sourced from any proceeds of the civil action, by settlement, judgment, or otherwise.

Wis. Eng. Asbly Bill 773 §12 (new §804.01 (2)).  Whatever the merits of the Wisconsin approach, or whether it’s necessary outside of the mass tort context, that approach has the advantage of being a simple, bright line standard.

Certainly, disclosure would be a sure and quick way to expose the kind of deals described in the Times article that women have been enticed into in the Vaginal Mesh litigation.  Existence of this kind of financing would be a red flag that the injury claims in such cases required careful investigation.

Which brings us to….

Second, the Times article strongly suggests that these abuses are widespread in the Vaginal Mesh MDL litigation.  Arrangements this elaborate are not worth the trouble for only a small number of cases.  According to the Times article, “perhaps thousands” of lawsuits have been tampered with in the ways that the article describes.

Without disclosure, the kind of aggravation of damages described in the Times article – ironically, the opposite of the accepted common-law duty to mitigate − is hard to unearth.  The Times article quotes “Magistrate Judge Cheryl Eifert in West Virginia”:

“People are claiming the Fifth [Amendment privilege against self-incrimination] and so on and so forth.  They don’t have to talk about necessarily how much money they make, per se, but if someone would just give them an idea of how the arrangement works.  But nobody’s willing to do that.”

Magistrate Judge Eifert has been overseeing aspects of the Vaginal Mesh MDLs.  E.g., In re American Medical Systems, Inc. Pelvic Repair Systems Products Liability Litigation, 946 F. Supp. 2d 512 (Mag. S.D.W. Va. 2013) (opinion by Eifert).

That’s concerning because, as we pointed out a couple of months ago, discovery in the remaining 23,000 cases in the Mesh MDLs has been ordered to be completed with:  (1) extreme haste, and (2) significant limitations on the number of interrogatories that can be propounded and witnesses deposed (see paragraph 2 of the four PTOs linked to in the prior post).  Since there may well be hundreds (if not more) of those 23,000 cases involving questionable surgeries conducted under questionable circumstances, the current rush to remand – combined with the obstructive tactics described in the Times article – creates a considerable risk of miscarriage of justice.  Defendants do not appear to have been given the time or the discovery tools needed to unearth plaintiff-side shenanigans on the scale described in the Times article.  There comes a point at which the efficiency objectives of multi-district litigation have to yield to the higher objectives of justice.

In the Diet Drug litigation – a mass tort of comparable scope – all kinds of problems arose with “the District Court [being] inundated with fraudulent benefits claims.”  In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation, 573 Fed. Appx. 184, 185 (3d Cir. 2014).  Unfortunately, the widespread fraud perpetrated in Diet Drug only became apparent after settlement – as would eventually be the case here, since contingent fee surgeries will almost surely be a topic of inquiry after the Times article.  The opportunity still exists in the Pelvic Mesh MDLs for diligent discovery to ferret out the false or inflated claims, but that can only happen if adequate discovery is permitted to occur.

We are back in the trenches today after spending a wonderful day in New York with our lifelong best friend, in yet another of the blissfully endless celebrations of the milestone birthday we marked in December. We saw “The Band’s Visit,” a new musical based on a 2007 movie about eight members of an Egyptian police orchestra stranded overnight in a remote Israeli town.  The band members accept a local resident’s invitation to bunk overnight in her café, setting the stage for lovely intersections of hearts, minds, and cultures.  It is short, sweet, and very satisfying.

As is today’s case, for those of us who defend prescription drug and device manufacturers. In Kwasniewski v. Sanofi-Aventis, LLC, 2018 WL 1567851 (D. Nev. Mar. 30, 2018), the plaintiffs alleged that the defendant’s prescription sleep medication caused their decedent to commit suicide.  The opinion includes the judge’s decisions on objections to several earlier rulings by the magistrate judge and her decision on the defendant’s motion to dismiss the plaintiffs’ design defect claims.

Objections to Magistrate’s Rulings

First, the plaintiffs objected to the magistrate’s refusal to stay discovery – and relieve the plaintiffs of their obligation to respond to the defendant’s pending discovery requests – while the defendant’s Motion to Dismiss was pending. The court agreed with the magistrate, emphasizing that “[t]he Federal Rules of Civil Procedure do not provide for automatic or blanket stays of discovery when a potentially dispositive motion is pending.” Kwasniewski, 2018 WL 1567851 at *2.

Second, the plaintiffs objected to the magistrate’s application of Nevada’s learned intermediary doctrine.   In a 30(b)(6) deposition notice, the plaintiffs included topics concerning “information about direct to consumer advertising.”  Because, under the learned intermediary doctrine, the defendant had a duty to warn only “medical experts, not consumers, about the dangers of [its prescription drug],” id. at *4, the magistrate ruled that deposition testimony about direct-to-consumer advertising was irrelevant.  As such, she limited the plaintiffs’ Rule 30(b)(6) deposition topics to the defendant’s “representations to the medical community.”  The plaintiffs argued that the magistrate had “effectively decided a dispositive motion” by applying the learned intermediary doctrine, and that the doctrine was an affirmative defense that had not yet been pled.  The court again affirmed the magistrate and barred the plaintiffs from discovering information  that the defendant had disseminated directly to consumers. We like this ruling and applaud the court’s adherence to the standard imposed by Fed. R. Civ. P. 26, requiring discovery to be “relevant to [a] party’s claim or defense and proportional to the needs of the case,” and its refusal to sanction a meaningless and abusive fishing expedition.

Defendant’s Motion to Dismiss

The defendant moved to dismiss the plaintiffs’ design defect claims sounding in both strict liability and negligence, arguing that “any claim that [the defendant] should have changed the formulation of [the product] or that the product should simply not have been marketed are preempted by Federal Law.” Id. at *5.  In their response, the plaintiffs conceded that they were “not arguing that that [the defendant] should have reformulated the drug – just simply that [the defendant] should have” included adequate warnings of the drugs alleged suicidality risk. Id. As such, the court was able to grant the defendant’s motion, and foreclose the plaintiff’s from alleging a design defect claim at a later date, without addressing the preemption argument.. (Given this court’s clear-headed, correct-leaning rulings, we suspect that its preemption decision would have been fun to read.)

Kwasniewski is a tidy, no-nonsense, defense-friendly opinion.. If, on this beautiful spring day, we are confined to an office and not roaming the Great White Way, we are pleased that this case crossed our desk.

Dating back to our Bone Screw days we have mostly pleasant memories of using surveillance to catch plaintiffs making phony claims.  For a variety of reasons, a large percentage of the Bone Screw plaintiffs were workers’ compensation claimants.  A bigger collection of malingerers, Munchausens, and phony fibromyalgias we’ve never encountered, before or since.  This motley crew, particularly in those cases litigated outside the MDL, or after remand, was particularly amenable to surveillance as a means of exposing their overblown, or often just plain invented, injury claims.

One guy who supposedly couldn’t lift more than ten pounds after his back injury, we got on tape picking up the back end of his motorcycle to put it on a jack.  Another guy who claimed he could hardly walk, we caught riding a bicycle more than a mile on a Jersey Shore boardwalk.  And so on and so forth.  Sometimes their counsel were in cahoots, but most of the time their counsel (at least counsel prosecuting the Bone Screw claim) persuasively claimed to have no idea of their clients’ mendacity.  They just didn’t care to find out.  We found out.  Needless to say, our surveillance made those cases go away quickly.

That’s why we were gratified to read the Texas Supreme Court’s defense of surveillance in Diamond Offshore Services Ltd. v. Williams, ___ S.W.3d ___, 2018 WL 1122368 (Tex. March 2, 2018) (“DOS”).  DOS was – guess what – a suit over a workplace injury.  The plaintiff’s medical information “w[as] consistent with patients who are exaggerating their symptoms” and his complaints were “not consistent with what the client was able to do during” testing.  Id. at *2.  That led to surveillance.  “[T]he employer, believing the employee to be exaggerating the extent of his pain and physical limitations, hired an investigator who conducted surveillance and recorded the employee engaging in physical activities over the course of two days.”  Id. at *1.  According to the defendant, the tapes were dynamite stuff (see, id. at *2 (describing tapes)), but the trial judge, for whatever reason, refused to even look at them, let alone admit them into evidence.

The Texas Supreme Court recognized the probative value of surveillance that successfully catches plaintiffs in acts inconsistent with their injury claims:

[I]mages captured for myriad purposes, and in various forms, regularly work their way into the courtroom.  For decades, trial courts have encountered evidentiary issues related to video evidence and, as video technology continues to become more portable and affordable, will increasingly do so.

If, as it is often said, a picture is worth a thousand words, then a video is worth exponentially more.  Images have tremendous power to persuade, both in showing the truth and distorting it.  A video can be the single most compelling piece of evidence in a case, captivating the jury’s attention like no other evidence could.  Video can often convey what an oral description cannot – demeanor, personality, expressions, and motion, to name a few.

DOS, 2018 WL 1122368, at *1 (footnotes omitted).

First, we want to commend the defendant and its counsel in DOS for selectively using surveillance.  Quite apart from its cost, surveillance is a sharp, and double-edged sword.  It should only be used in cases like this one, where something in the plaintiff’s medical (or other) records provided a strong basis to believe that the plaintiff is exaggerating his/her injuries.  A smart plaintiff’s lawyer will seek discovery of surveillance material (most courts only require production after the plaintiff has been deposed), and if that discovery is allowed, will try to spin unsuccessful surveillance as confirmation of the plaintiff’s injury claims.

Now, back to DOS.  When surveillance videotapes are offered as evidence, the court has to at least look at them before deciding their admissibility.  Where, as in DOS, the trial court did not view the tapes, “the court could not have properly exercised its discretion” and “[w]e afford no deference.” Id. at *4.

Here, the trial court excluded the surveillance video despite never having viewed it.  Under these facts, that amounted to an abuse of discretion.

Id.  “[I]t is difficult for a trial judge to weigh the probative value of a video against the potentially unfair prejudice without first reviewing it.”  Id. (citation and quotation marks omitted).  “We hold that, as a general rule, a trial court should view video evidence before ruling on admissibility when the contents of the video are at issue.”  Id. at *5.  “Exceptions should be few and far between.”  Id.

Not only was the procedure an abuse of discretion, so was the exclusion itself.  “[A]ny countervailing concerns do not substantially outweigh the video’s probative value” under Rule 403.  Significantly, the court equated defense surveillance video with other types of video, such as plaintiff-side “day-in-the-life” films:

[I]t is important to note that in personal-injury cases, video footage of a plaintiff can originate not only, as here, from defense-initiated surveillance but also from plaintiff-prepared day-in-the-life videos and third-party sources like security cameras and eyewitnesses.  Many of the issues we discuss today can arise with any personal-injury plaintiff video, though each form also has its own particular concerns.  No matter the type of video, each case must be evaluated individually.

DOS, 2018 WL 1122368, at *6.  We know from personal experience that day-in-the-life videos are far more staged and edited than surveillance – since the plaintiff is intentionally performing – so any objection based on prejudicial editing should apply at least as strongly to plaintiff-offered video.  A “day-in-the-life” video depicting painful physical therapy is simply not representative where the plaintiff in fact spends most of the day parked in front of the TV in an opioid-induced haze.

Conversely, a surveillance video “can also undermine a plaintiff’s credibility if it suggests exaggeration or flat-out dishonesty regarding pain or abilities.”  Id. (footnote omitted).

The video, which depicted [plaintiff] doing physical activities he enjoys and which could have potentially been the basis for employment, on two consecutive days, is obviously probative. . . .  Moreover, [defendant] explicitly attacked [plaintiff’s] credibility, both as to the circumstances of his injury and whether he overstated the extent of his limitations and pain.  Seeing [plaintiff] on the video could have helped the jury evaluate his truthfulness.

Id. Nor could plaintiff’s concession that he “could” do the activities in the video render the evidence “cumulative.”  That ignores the power of the visual medium:

Videos, however, are qualitatively different than other types of evidence.  A video recording allows a more panoramic representation of the evidence than a document, testimony, or even a photograph.  The mere fact that [plaintiff] conceded he could [do what he was taped doing] does not automatically render a visual representation of him doing so cumulative.

Id. (footnotes omitted).

Nor is a surveillance video that damages the credibility of the plaintiff as a witness “unfairly prejudicial.”  “Mere damage to an opponent’s case does not constitute unfair prejudice.”  Id. at *7 (footnote omitted).  Showing that the plaintiff is not telling the truth is certainly “prejudicial,” but in no way is it “unfair.”

The video does not encourage the jury to decide on any improper basis, but rather on the basis that [plaintiff’s] condition is not as severe as he claims.  That is not unfair. . . .  Parties select what to record, or what part of a recording to show, to best help their case.  That is inherent in our adversarial system.  A video is not misleading just because it does not support the opponent’s view of the case.

DOS, 2018 WL 1122368, at *7 (footnote omitted).  Bias can be a problem, but bias is more of a problem in “day-in-the-life” films, where “the plaintiff is aware of being filmed, which may cause self-serving behavior, whether consciously or not.”  Id. at *8 (footnote omitted).  In DOS there was no evidence of any “improper filming,” and the private investigator “was available for deposition and at trial.”  Id.

Thus, under the probative/prejudice balance of Rule 403, “[t]he video’s probative value is significant, and concerns about cumulativeness, unfair prejudice, and misleading the jury do not substantially outweigh this value.”  Id.  Abuse of discretion on the merits, as well as the procedures.

The erroneous exclusion of the surveillance videotapes was also reversible error.  The court gave a lot of reasons in DOS for this conclusion.  See Id. at *8-9.  But for us it boils down to a jury being able to see the plaintiff for themselves “unaware of being recorded and thus with no incentive to exaggerate, [which] is qualitatively different than hearing his and his witnesses’ descriptions and would likely have had a powerful impact.”  Id. at *9.  Showing is almost always more persuasive than telling.

One of the (many) reasons that we detest aggregated litigation is that the defendant is almost always prevented by the sheer weight of numbers from giving each plaintiff’s case the work-up it deserves.  In a single plaintiff case, such as DOS, that work-up can well include surveillance.  Surveillance is a great tool for combatting malingerers trying to get something for nothing.  Every time such people get money from MDL settlements, our system of justice has failed.  Such plaintiffs getting money under false pretenses only adds to the costs of prescription medical products.