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MDL defendants in prescription medical product liability MDLs have been complaining for years about thousands of cases being brought without the slightest pre-filing vetting – “plaintiffs” who cannot establish that they ever actually used the products of the defendant(s) they have sued and/or who similarly have no proof that they suffered the injury(ies) as to which the MDL was created.  Even the lawyers on the other side concede that between 20 and 30% of the cases clogging up the usual mass-tort MDL docket are “zero value” cases of this sort.  Our side believes the percentages are much higher, because what data exists is from cases rejected after settlement, which typically happens (if at all) years after the filing of most of the lawsuits, and thus does not factor in the intervening attrition of additional zero value plaintiffs.

The ordinary rules don’t get enforced in MDLs.  Most MDL judges outright refuse to entertain the kind of individualized TwIqbal motions that put teeth in the filing requirements for one-off cases.  For a while some folks thought that “plaintiff fact sheets” would be the answer, but PFSs are different in every MDL, and take time to negotiate, so even if they wanted to, the plaintiff-side case solicitors don’t know what questions to ask – not that exposure and injury are all that hard to guess.

Instead of facilitating early vetting, PFSs have morphed into a discovery tool that largely takes the place of interrogatories.  The typical MDL PFS goes on for pages and pages, asking questions about many areas of the case, but not requiring production of the critical evidence to back up claims of product usage and injury.

That’s not early vetting, and helps neither side.  At most, it requires plaintiffs’ attorneys to ask their clients questions that they should have long before filing their lawsuits.  As a practical matter it forces defendants to subsidize the plaintiffs.  Except to avoid sanctions, the vast bulk MDL plaintiffs not selected as bellwethers have no incentive to provide any information at all.  And to seek sanctions requires the defendants to invest a great deal of time and money (not even counting PFS-related negotiations) to check PFS answers for sufficiency, notify the other side of deficiencies, wait for the other side to cure the deficiencies.  Rinse and repeat a couple of times, and then MDL defendants have to spend still more time and money to get the sanction of dismissal against unsupported cases.

And then, even when meritless cases are dismissed, they might not stay dismissed.  In Hamer v. Livanova Deutschland GMBH, 994 F.3d 173 (3d Cir. 2021), our second worst case of 2021, this process took almost a year (from entry of the relevant management order in 4/2019, to the dismissal order in 3/2020).  Id. at 176-77.  But instead of affirming the dismissal, the court decided that because the plaintiff’s case was so devoid of proof, the plaintiff should never have been in the MDL in the first place, vacated the dismissal, and remanded to allow the plaintiff to pursue an individual case.  Id. at 180.  The plaintiff in Hamer, of course, argued (until dismissal) that the case belonged in the MDL, did not seek remand promptly, but instead waited until after being sanctioned for violating the MDL order.  Id.  Thus, the plaintiff in Hamer skated despite repeated violations of the MDL order, and the defendant spent a great deal of time and effort to no effect.  Shortly after remand, that plaintiff had the nerve to seek a settlement as if still being in the MDL.  Rinse.  Repeat.

As for the plaintiff’s side, if a particular plaintiff doesn’t have evidence of exposure or injury, then completion of all the rest of these multi-page fact sheets becomes needless busy work.

Fact sheets are not the answer.

The latest alternative is the “MDL census,” or “census registry,” which typically allows would-be claimants to “register” their claim with a third-party claims administrator pursuant to an MDL-approved process, before ever filing suit, in exchange receive tolling of the statute of limitations.  The concept behind these census registries is to allow plaintiffs’ lawyers to park most of their claims there, with the parties splitting the cost – that is, defendants subsidizing half of a supposedly “producer pays” discovery system − of having a third-party vendor collect product use and injury records.  That vendor determines deficiencies and “dismissals” of claims with inadequate substantiation.

This census process is meant to carry on while, in the MDL proper, discovery proceeds in the filed lawsuits, with the MDL judge deciding key dispositive motions and issues that, in theory, will shape the census claims as much as the filed lawsuits.  However, since census registrants have never actually filed suit, their “dismissal” has no legal effect beyond the statute of limitations no longer being tolled.  “Dismissed” would-be claimants can, if they (their counsel) choose, take their chances in another court, and they will should they find the MDL is not playing out to their liking.

A “pilot” program involving these censuses (censi?) is now in place in three product liability MDLs that entirely, or largely, involve over-the-counter products:  In re 3M Combat Arms Earplug Products Liability Litigation, MDL No. 2885; In re Juul Labs, Inc., Marketing, Sales Practices, & Products Liability Litigation, MDL No. 2913; and In re Zantac (Ranitidine) Products Liability Litigation, MDL No. MDL No. 2924.  These censuses typically ask for evidence of product identification and injury.

Is this census program working to deter filing of baseless claims?

Judging purely by the current MDL statistics, we don’t think so.  The Combat Arms MDL has no fewer than 272,000 – that’s right, well over a quarter million – claimants on file as we speak.  That’s:  (1) well over half the total actions in all current MDLs taken together; (2) over a quarter of the total number of cases of all kinds pending in the entire federal court system; and (3) eight times the number of claims in the next largest pending MDL.  Indeed, the number of claimants registered in the combat-earplugs census is well over half the current size of the entire US army and almost as large as the total US casualties in World War I.  Facially, any “census,” or anything else done in that litigation, has been an abject failure in reducing the number of bogus claims.  In the Combat Arms MDL’s 2½ years of existence, a total of 272,416 of 286,978 “historical” claimants remain, for an attrition rate of barely 5%.  The Combat Arms census could have no effect on many plaintiff solicitation practices, because the order creating it was not entered until over six months after the Combat Arms MDL was created, see In re 3M Combat Arms Earplug Products Liability Litigation, 366 F. Supp.3d 1368 (J.P.M.L. 2019).  Given the “build it and they will come” nature of MDLs, the existence of a census alternative may even have encouraged more solicitation.

The Combat Arms census order, In re Combat Arms Earplug Products Liability Litigation, 2019 WL 13126350 (N.D. Fla. Oct. 22, 2019), requires all plaintiffs to submit certain data within 90 days of their cases being “filed in or transferred into MDL 2885.”  Id. at *1.  Thus, the Combat Arms census is limited to actual filed cases – of which there are (as just discussed) very many.  The census questions are “treated as interrogatories.”  Id.  Among other things, they concern product exposure and claimed injury.  Id. at Exh. A.  It includes that same MDL back-and-forth procedure about “deficiencies” that we have come to know and love in connection with PFS.  Id. at *1.

Plaintiffs are also required to produce certain documents within 45 days:  establishing their military service, any audiologic examinations either in or out of the military (which goes to injury) and any hearing-related disability records.  Id. at *2 & Exh. B.  A back-and-forth deficiency process also applies to these documents.  Id. at *2.

The Combat Arms MDL has also seen the plaintiffs attempt to use the census to restrict the defendant’s ordinary discovery.  See In re 3M Combat Arms Earplug Products Liability Litigation, 2020 U.S. Dist. Lexis 74292, at *4 (N.D. Fla. April 28, 2020).  Rebuffed, plaintiffs who were also census registrants then claimed that their census forms were worthless and superseded and should not even be admissible evidence against them in bellwether trials.  In re 3M Combat Arms Earplug Products Liability Litigation, 2020 WL 2029977, at *36-38 (N.D. Fla. March 10, 2021).  Fortunately, this gambit failed.

The newest, and according to the federal judiciary statistics, supposedly the smallest, of the three pilot project MDLs is Zantac.  The Zantac census order was entered relatively quickly, less than two months after creation of that MDL.  See In re Zantac (Ranitidine) Products Liability Litigation, 437 F. Supp.3d 1368 (J.P.M.L. 2020).  The MDL statistics state that 1,777 filed lawsuits remain of an “historical” total of 1,827 suits, for an attrition rate of under 3% in that MDL’s 21-month existence.  But in Zantac, the census registry has been conducted a bit differently than in Combat Arms.

In Zantac the “Court has created a Census Registry where tens of thousands of claimants who have not filed lawsuits have registered their claims.”  In re Zantac (Ranitidine) Products Liability Litigation, 2021 U.S. Dist. Lexis 127656, at *22 (S.D. Fla. July 8, 2021).  The order creating the registry provides:

Unfiled But Retained Clients of Leadership Applicants. Any attorney who has applied for a leadership position through appointment to the Plaintiffs’ Steering Committee (“PSC”) in accordance with Pretrial Order #1 is required to submit an ICF for his/her firm’s entire inventory of cases.

a.   Counsel must submit an ICF for all individuals who signed a retainer agreement with the leadership applicant’s firm before April 1, 2020.

b.    Counsel may voluntarily submit an ICF for individuals who retain the leadership applicant’s firm on or after April 1, 2020, but are not required to do so if it is not possible to gather the required information by the census deadline.

In re Zantac Ranitidine Products Liability Litigation, 2020 WL 1640021, at *2 (¶2) (S.D. Fla. April 2, 2020).  Claimants filing census registry forms “commit to filing any action relating to Zantac or any ranitidine products, if at all, before this Court in MDL No. 2924.”  Id. at *5 (¶6) (excluding only non-diverse actions).

As of November, 2021, “in excess of 150,000 Claimants have registered their claims.”  In re Zantac Ranitidine Products Liability Litigation, 2021 U.S. Dist. Lexis 224085, at *28 (S.D. Fla. Nov. 19, 2021).  Thus the number of putative census claimants dwarfs the number of “actions” counted in the Judicial Center’s filed-lawsuit statistics for the Zantac MDL.

What benefit comes from waiving the statute of limitations and collecting unfiled cases like that?  One main purpose of the Zantac census appears to be gathering statistical information about the pool of claimants/potential plaintiffs – not vetting.  That is, the census appears designed to generate:

information about the claims that have been filed, or that might be filed after further investigation, in this MDL, including what ranitidine product(s) an individual asserts he or she used, during what years, and for what purposes; where the individual allegedly purchased the ranitidine product(s); the type of injury the individual claims; whether the individual has documents reflecting the asserted use and/or injury; and other information that would permit the census records collection vendor, Lexitas, to obtain such documents.

In re Zantac (Ranitidine) Products Liability Litigation, 2020 U.S. Dist. Lexis 195714, at *28 (S.D. Fla. Oct. 21, 2020).  Since the Zantac registry, by its terms, expires “thirty (30) days after the Court issues a decision on Daubert motions directed to the issue of general causation,” 2020 WL 1640021, at *6 (¶8), the primary use of this information thus appears to be to establish the universe of claims for purposes of prioritizing expert admissibility rulings under F.R. Evid. 702.  That is certainly a valid use for such data, but it has no deterrent effect on lawyer solicitation – either by design or effect − and advertising for questionable claims, and defendants certainly would prefer a greater emphasis on evidence collection so that meritless claims can be discovered and dismissed earlier.

We know the least about the Juul MDL.  The Juul MDL census order was entered on October 25, 2019 − like Zantac relatively quickly (at least compared to Combat Arms) month and a half after that MDL was created.  See In re Juul Labs, Inc., 396 F. Supp.3d 1366 (J.P.M.L. 2019).  It simply ordered both sides “to confer.”  In re Juul Labs, 2019 U.S. Dist. Lexis 241364, at *53 (N.D. Cal. Oct. 25, 2019).  A minute order on the Juul docket, dated November 19, 2019, states in full:

Plaintiff leadership applicant firms must submit the initial census data to [the entity compiling census data] and any applicable certifications by December 19, 2019.  Defendants census obligations shall be completed with relevant data, documents, and certifications provided to [that entity] no later than January 20, 2020.

Nothing else in the Juul docket mentions the term “census,” so we don’t know what information is being gathered or how it is being used.

Statistically, there are currently there are 2868 Juul plaintiffs, which is 651 less than the total “historical” number of plaintiffs in that MDL, for an attrition rate of 18.5% over two years.

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From the defense perspective this pilot census project appears to have several significant drawbacks.

First, it lowers the already low barriers to entry even further, exempting these plaintiffs from their obligation under the rules even to “commence” their actions “by filing a complaint” as Fed. R. Civ. P. 3 requires.  Plaintiffs thus get the benefits of commencing an action – chiefly tolling the statute of limitations – without having to comply with the federal rules, or even to pay filing fees.

Second, to the extent that plaintiffs subject to the census have not filed any action, the census has no early vetting effect at all.  Without the filing of a lawsuit, there is nothing to dismiss as a sanction for absence of evidence of product identification or injury.  Failure to comply simply results in removal from the registry and a loss of future (but not past) tolling.  Anybody who lacks the requisite information, doesn’t file and remains unknown, or is perfectly free (subject to the statute of limitations) to try again later.

Third, having filed nothing, census-only claimants have very little to lose.  Since no complaint has been filed, there’s nothing to dismiss – even voluntarily.  If a census claimant decides, for whatever reason, that s/he would rather abandon the MDL for state court, nothing (save possibly in imminent statute of limitations problem) prevents that from happening.  This dynamic works to defendants’ disadvantage by creating implicit pressure on MDL courts not to do anything that would subject the census registry to en masse claimant departures.

Fourth, these census claimants/phantom plaintiffs mean that the Judicial Center’s statistics significantly understate the degree to which the MDL tail is no longer merely wagging the federal court dog, but is actually in the process of consuming the dog.  If census claimants were counted in the Federal Judicial Center’s statistics, the percentage of all federal cases represented by MDL cases would probably exceed 60% − adding more urgency to defense pleas to reform the MDL system.

A solution to the problem of massive number of zero value claims in MDLs remains elusive.  Because of the ubiquity of plaintiff solicitation (television commercials, internet pop-ups, cold telephone calls, and the like) in product liability MDLs, there needs to be a Federal Rule of Civil Procedure – nothing less − that everybody knows in advance would require speedy initial disclosure of exposure and injury information.  A statutory amendment allowing removal of cases with minimal diversity once an MDL is created would address the claimant flight issue, but not the overall MDL problem.

Only such a rule can create the necessary expectations when an MDL is in its initial phase.  The delay and uncertainty inherent in MDL-specific management orders means that solicitation and aggregation is not influenced by legal requirements that do not yet exist.  Nobody soliciting would-be plaintiffs is going to collect any information that s/he isn’t required to.  That costs time and money.  Nor are plaintiffs-side counsel in a position to insist on collection of information not demanded by the black letter of a generally applicable rule.  Any plaintiffs’ counsel foolish enough to try would be frozen out, since the solicitors would simply take their inventory of plaintiff names to somebody else.

The MDL system is broken, and if nothing is done, current trends indicate that within a decade or so, the entire rest of the federal judiciary system will fade into a mere adjunct to 21 U.S.C. §1407.  The only tool capable of repairing things is the Federal Rules of Civil Procedure.