Multidistrict Litigation

A lot of time is spent in litigation on discovery. As tedious and non-exciting as it often is, cases can be won or lost depending on what happens during discovery. So, it’s not to be taken lightly. When we find ourselves arguing to the court about discovery, however, it is often without being able to point to much precedential case law. That’s because many courts simply rule from the bench perhaps entering only minute orders. And if case management orders are entered they often don’t rise to the level of being published, even electronically. We are then left scouring dockets looking for rulings or calling our colleagues hoping someone has an order that is helpful. So, we really appreciate when a helpful discovery ruling grabs our attention and we can in turn alert our readers to it.

One of the reasons that more routine discovery decisions don’t generate many opinions is that the rulings frequently turn on case specifics and common sense as opposed to more traditional legal analysis. That’s true of today’s decision. A lengthy order entered in the Abilify MDL setting forth essentially a list of decisions on multiple motions made by both plaintiffs and defendants. Certainly some are more case specific and not really worth much of a mention, so what follows is a list of the more general and most helpful rulings:

  • Confidentiality: The court allowed the parties to provisionally seal documents filed with their Daubert briefing and then at the conclusion of the briefing, the party who sealed the document had to show cause why the document should remain sealed. Defendants argued to keep certain very common categories of documents confidential:
    • Clinical case reports/adverse event reports: Defendants argued that these documents contain confidential patient identifying information and personal medical information. These aren’t plaintiffs – they are people who participated in studies or for whom an AER was prepared. They absolutely have a right to an expectation of privacy, not to mention the company has an obligation to protect that privacy. The court agreed – no public interest. In re Abilify Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 161660, at *7-8 (N.D. Fla. Sep. 29, 2017).
    • Internal company documents: Defendants sought to maintain confidentiality of several categories of internal, non-public documents and the court agreed as to most. Specifically, the court found that all of the following should remain under seal: “standard operating procedures, non-public regulatory submissions, drafts of non-public regulatory submissions, or internal communications regarding the pharmacovigilance process.” Id. at *9. All things plaintiffs like to use to try the case in the media. As to SOPs, the court concluded they are proprietary and developed by the company at considerable expense. With respect to the rest, disclosure “would have a chilling effect on the pharmacovigilance process.” Id. Keeping the pharmacovigilance process confidential actually enables manufacturers to participate in the process in a “frank, open, and honest” way. Id.
    • Expert reports and testimony: Here the court was unwilling to seal expert reports and transcripts across the board. They have to be redacted to the extent they discuss any of the documents or information that the court said should remain confidential. Id. at *10-11.
  • Privilege: Plaintiffs complained that they were unable to assess defendants’ claims of privilege as to its documents because defendants were not producing privilege logs simultaneous with their document productions. Defendants correctly noted that simultaneous privilege logs would significantly slow production down – a production would have to wait the finalizing of the log before it could be produced. The court agreed.  Simultaneous production would be inefficient. Id. at *17-19.
  • Document Retention Policies: Plaintiffs want them, defendants objected. Court ruled: “in the absence of any suggestion of spoliation Defendants’ document retention policies are not relevant.” Id. at *24.
  • Other Drugs: Plaintiffs’ discovery requests included documents about other similar drugs, claiming the information would go to defendants’ knowledge. The court sustained defendants’ objection on the grounds of relevance and proportionality. Id. at *25. While other drugs in the same class may be similar, they were developed later in time, have different mechanisms, and different indications – making them marginally relevant. When you balance only marginal relevance against the issues involved in the litigation – and what we assume to be massive discovery already taking place as to the actual drug at issue — we think the court reached a sound conclusion regarding proportionality to the needs of the case.
  • Trial Pool Discovery: Plaintiffs requested many different types of information, including financial information relevant to sales representatives, physicians, and other consultants. Defendants sought to limit that discovery to just the individuals related to the cases being worked up as trial bellwethers. Again the court agreed. For example, plaintiffs’ request to know about payments and incentives to sales representatives and doctors should be narrowly tailored to those doctors who treated the bellwether plaintiffs and the sales representatives who called on those doctors. Id. at *26-27. The same applied to other categories of “liability” discovery that were more appropriately limited to the bellwether cases. “Expanding the scope to all Plaintiffs would be a Herculean task and impossible to complete in the time frame set by the Court.” Id. at *28.

All in all the rulings were very defense-friendly and provide some good cites for your next motion to compel or motion to quash.

Bexis gave a talk the other day at the Washington Legal Foundation on personal jurisdiction after last term’s United States Supreme Court decisions in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), and BNSF Railway Co. v. Tyrrell, 137 S. Ct. 1549 (2017) (“BNSF”).  One of the highlighted areas of emerging jurisdictional issues was MDL practice – specifically the MDL practice of allowing plaintiffs anywhere in the country to “direct file” actions into the MDL after it has been established – thereby bypassing the provisions of the MDL statute, 28 U.S.C. §1407(a) that “transfers shall be made by the judicial panel on multidistrict litigation.”

We thought we’d examine that a bit today.

Essentially, we don’t think that there is any jurisdictional basis for direct filing – except the defendants’ waiver of any jurisdictional challenge.  Initially, the MDL statute itself does not confer such jurisdiction.  The statute nowhere mentions direct filing, and in only one instance is an MDL judge (also called the “transferee court”) clothed with extraordinary jurisdictional powers.  That has to do with depositions.  See 28 U.S.C. §1407(b) (MDL judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions”).

Whether or not the legal maxim “expressio unius est exclusio alterius” (express mention of one item implies the exclusion of others of the same ilk) should apply here, we seriously doubt that Congress intended to hide any jurisdictional elephants in MDL statutory mouseholes.  Cf. Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 40-41 (1998) (refusing to imply MDL court jurisdiction to try transferred cases).  It “may or may not” be more efficient to allow direct filings, but the MDL statute does not so state, so “the proper venue for resolving that issue remains the floor of Congress.”  Id. at 40 (citations omitted).  We further note that the Judicial Panel on Multidistrict Litigation’s rule that has been interpreted as allowing direct filing, J.P.M.D.L.R 7.2(a), likewise does not mention jurisdiction – providing only that “[p]otential tag-along actions filed in the transferee district do not require Panel action.”

In BNSF (previously discussed here) the Supreme Court rejected an attempt to use a statute (the venue provision of the Federal Employees’ Liability Act) to create personal jurisdiction where it did not otherwise exist.  When Congress intends to expand jurisdiction (as opposed to venue) it “typical[ly]” does so by “authoriz[ing] service of process.”  137 S. Ct. at 1555 (list of examples omitted).  This statute did not expressly do so, and to the extent any prior precedent suggested otherwise, that precedent was obsolete:

[A]ll these cases . . . were decided before this Court’s transformative decision on personal jurisdiction in International Shoe Co. v. Washington, 326 U.S. 310 (1945).  See [Bauman], 134 S. Ct. [746], 761, n.18 (cautioning against reliance on cases “decided in the era dominated by” the “territorial thinking” of Pennoyer v. Neff, 95 U.S. 714 (1878)).

Id. at 1555-56 (citations modified).  We’ve already raised this cautionary note with respect to century-old precedent in jurisdiction by consent cases, but it applies more broadly.

Demise of their statutory arguments left the plaintiffs in BNSF with nothing but state law to rely on.  While the defendant “ha[d] over 2,000 miles of railroad track and more than 2,000 employees” in the state, that was insufficient to permit suit by non-resident plaintiffs under either general or specific jurisdictional principles:

[T]he business BNSF does in [the state] is sufficient to subject the railroad to specific personal jurisdiction in that State on claims related to the business it does in [the state].  But in-state business . . . does not suffice to permit the assertion of general jurisdiction over claims like [plaintiffs’] that are unrelated to any activity occurring in [the state].

Id. at 1559 (footnote omitted).

Turning to BMS, which was a mass tort worthy of a breaking news post, hundreds of plaintiffs filed in California to escape (among other things) an existing federal MDL.  Non-resident plaintiffs could not establish specific personal jurisdiction over a non-resident defendant, even though (like BNSF) resident plaintiffs could, and the non-residents might be able to sue a different defendant that was “at home” in that state.  “The primary focus of our personal jurisdiction inquiry is the defendant’s relationship to the forum State.”  137 S. Ct. at 1779.  Jurisdiction is “a consequence of the territorial limitations” on state power; therefore even a ‘convenient location for litigation’ may, as a consequence ‘of interstate federalism,’ be “divest[ed]. . . of its power to render a valid judgment.”  Id. at 1781 (quoting World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 294 (1980)).

Specific jurisdiction, as explained in BMS, requires “an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State.”  Id.  “[U]nconnected activities,” no matter how extensive, are irrelevant.  Id.  That “other,” in-state plaintiffs could bring suit was “an insufficient basis for jurisdiction,” as was the ability of the non-resident plaintiffs to sue other, in-state defendants.  Id. at 1781, 1783.  Jurisdictional requirements “must be met as to each defendant over whom a state court exercises jurisdiction.”  Id. at 1783 (citation and quotation marks omitted).  Where:

[t]he relevant plaintiffs are not [in-state] residents and do not claim to have suffered harm in that State[, and] all the conduct giving rise to the nonresidents’ claims occurred elsewhere[, i]t follows that the [state’s] courts cannot claim specific jurisdiction.

Id. at 1782 (citation omitted).  Mass tort plaintiffs have two choices after BMS:  they can all sue “in the States that have general jurisdiction” over a particular defendant, or “plaintiffs who are residents of a particular state . . . could probably sue together in their home States.”  Id. at 1873.

Returning to MDLs, as in BNSF, there is no “typical” jurisdictional provision anywhere in the MDL statute.  Unless a particular MDL happens to be located in a forum with “general jurisdiction” over a defendant, there is no constitutional basis for allowing plaintiffs anywhere in the country to file directly into the MDL and thereby bypass statutory procedures.  Further, since jurisdiction must exist “as to each defendant” individually, in MDLs with more than one major defendant (most MDLs), it is unlikely (albeit not impossible) for there to be any jurisdiction where all such defendants are “at home” so as to permit direct filing as a matter of constitutional Due Process.

Thus, the only jurisdictional basis for MDL direct filing is the acquiescence – and thus the waiver – of the defendant(s) being sued.  That is particularly dangerous in an MDL setting, as the recent decision in the Pinnacle Hip MDL litigation (discussed here) exemplifies.  See In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017).  The defendants’ agreement to a direct filing order was – wrongly, a majority of the Court of Appeals held – interpreted as a waiver of jurisdictional objections.  Id. at 351-52.  As for the propriety of direct filing, there was no majority.  The lead opinion viewed direct filed cases as being “treated ‘as if they were transferred from a judicial district sitting in the state where the case originated.’”  Id. at 348 (quoting In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 1375011, at *6 (S.D. Ill. April 12, 2011)).  The first concurrence declined to reach the issue.  Id. at 356-57.  The second, concurring and dissenting, opinion would find direct filing invalid:

But for the possibility of a “global waiver” of personal jurisdiction, the [MDL court] had no claim to personal jurisdiction over the cases:  none of the plaintiffs’ surgeries occurred in [the state]; the plaintiffs aren’t [in-state] residents; and neither general nor specific jurisdiction exists over the [defendants] for purposes of these disputes.  For that reason, the district court relied solely on the “global waiver”. . . .  Petitioners are being forced to trial over their objections to personal jurisdiction.

By comparison, a scholarly opinion . . . in an MDL case resulted in dismissal of a nonresident defendant against which there was a “direct filed” case by a nonresident plaintiff.  In re Heartland Payment Systems, Inc. Customer Data Security Breach Litigation, 2011 WL 1232352 (S.D. Tex. March 31, 2011).  The court first noted that the defendant’s agreement to transfer for purposes of pretrial proceedings was not inconsistent with and did not waive its personal jurisdiction challenge.  2011 WL 1232352 at *5–6.  Finding no waiver, the court then decided that it lacked personal jurisdiction over the non-consenting defendant based on [its] lack of minimum or relevant contacts with the [state in question]. 2011 WL 1232352 at *6–10.

Depuy Orthopaedics, 870 F.3d at 357.

This is a good place to start, so we examined the decisions cited by both sides.  Looking at Yasmin/Yaz, we were disappointed.  That decision doesn’t even discuss the jurisdictional ramifications of MDL direct filing.  Rather, as the first sentence of the opinion makes clear, “[t]his matter is before the Court for the purpose of resolving choice of law considerations.”  2011 WL 1375011, at *1.  The direct filing order at issue specified that direct filing would have no effect on choice of law.  Id. at *4 n.2, so the reference in Yasmin/Yaz to how direct filings were “treated” occurred in the context of deciding what “no effect” on choice of law meant:

As to the foreign direct filed cases, the choice of law decision is not as clear.  Foreign direct filed cases are filed in this Court pursuant to a direct filing order . . . [that] expressly provides that the parties’ direct filing agreement will not impact the choice of law that otherwise would apply to the direct filed actions.

In general, direct filing orders are beneficial to both parties because they streamline the litigation and help to eliminate the judicial inefficiency. . . .  However, direct filing orders also present difficult choice of law issues. . . .  The Court concludes that the better approach is to treat foreign direct filed cases as if they were transferred from a judicial district sitting in the state where the case originated.  For purposes of this analysis, the Court considers the originating state to be the state where the plaintiff purchased and was prescribed the subject drug.

Id. at *5-6 (citations omitted).  There is not one mention of personal jurisdiction in the entire Yasmin/Yaz opinion.

Turning instead to Heartland Payment, that case did involve a dispute over personal jurisdiction in a directly filed action.  See 2011 WL 1232352, at *4 (observing that “direct filings may present jurisdictional, venue, or related issues”).  The defendant moved to dismiss a direct filed action under Fed. R. Civ. P. 12(b)(2) on the ground that the state in which the MDL was situated had no personal jurisdiction over it.  Id. at *5.  March, 2011 was, of course, three years before Bauman was decided and even several months before the Supreme Court’s “at home” test debuted in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011).  But even under the more lax standards of that time, personal jurisdiction did not lie simply because an MDL against the defendant happened to exist in the state in question.

As in Depuy Orthopaedics, the MDL plaintiffs in Heartland Payment first attempted to use the defendant’s agreement to direct filing as a waiver of personal jurisdiction.  2011 WL 1232352, at *7.  Unlike Depuy Orthopaedics, the MDL court in Heartland Payment rejected that argument.  Id.  As for specific jurisdiction, neither the defendant’s use of an in-state processing center nor its agreements with national credit card networks sufficed.  “[M]erely contracting with a resident of the forum state is insufficient to subject the nonresident defendant to personal jurisdiction in that state.”  Id. at *8.  Plaintiff did not even try to argue that the fortuitous, after-the-fact creation of an MDL in the jurisdiction could be a “minimum contact” justifying jurisdiction.  Without a basis for jurisdiction, the directly filed case had to be either transferred or, if the parties could not agree, dismissed.  Id. at *12, 14.

On the basis of these two cases, we’d have to give the edge to the dissent on the jurisdictional issue, since Heartland Payment decided the question at issue – the jurisdictional impact of MDL direct filing – while Yasmin/Yaz did not.  But is there anything else out there, other than these two opinions, decided two weeks apart, in 2011?

We took a look, but most of what we found were either MDL orders creating negotiated direct filing regimes, or cases, like Yasmin/Yaz, that dealt with the impact of direct filing on substantive choice of law issues.  See, e.g., In re Incretin Mimetics Products Liability Litigation, 2013 WL 12171761 (S.D. Cal. Nov. 13, 2013) (an example of the former); Wahl v. General Electric Co., 786 F.3d 491, 498-99 (6th Cir. 2015) (an example of the latter).  Other than that, it appears that the two 2011 precedents are pretty much all there is.  The issue was raised in In re New England Compounding Pharmacy, Inc. Products Liability Litigation, 2015 WL 178130 (D. Mass. Jan. 13, 2015), but mooted by plaintiffs refiling in their home jurisdiction and getting a JPMDL “tag along” order before it could be decided.  Id. at *1 n.3.  The court in In re Vioxx Products Liability Litigation, 478 F. Supp.2d 897, 904 n. 2 (E.D. La. 2007), noted the possibility that “the MDL forum” might not be able to “exercise personal jurisdiction over the defendant” in discussing direct-filed complaints, but that was an aside in another choice of law decision.  A direct-filed case was dismissed for lack of subject matter jurisdiction in In re Pradaxa (Dabigatran Etexilate Products Liability Litigation, 2014 WL 7145470, at *3 (S.D. Ill. Dec. 15, 2014), where the plaintiffs were from a foreign country – but personal jurisdiction was not discussed.  Thus, it appears that Depuy Orthopaedics and Heartland Payment are the only cases actually addressing personal jurisdiction in the context of direct-filed MDL actions.

In the context of an ordinary (non-MDL) transfer, the Supreme Court has sought to “ensure that the ‘accident’ of federal diversity jurisdiction does not enable a party to utilize a transfer to achieve a result in federal court which could not have been achieved in the courts of the State where the action was filed.”  Van Dusen v. Barrack, 376 U.S. 612, 638 (1964).  We think that this principle logically extends to personal jurisdiction – and to direct filed actions.

In MDLs that rest – as product liability litigation does – on state law and diversity of citizenship, there is no jurisdictional basis for direct filing of MDL actions other than the defendant’s waiver of their rights to assert lack of personal jurisdiction.  The Supreme Court’s recent jurisdictional decisions, culminating (so far; there will be more) with BMS and BNSF, have put the other side’s mass tort business model in significant jeopardy.  Thus, we see plaintiffs making extreme and exorbitant waiver arguments based on MDL direct filing agreements, not only in Depuy Orthopaedics, but also in the earlier Heartland Payment case, which also involved an aggressive waiver claim.  Our best advice is “don’t do it anymore.”  There is no statutory basis for personal jurisdiction in a direct filed MDL case, and Lexecon indicates that the Supreme Court won’t be inclined to create one.  Except for the rare MDL located in a place where every defendant is “at home,” there is no constitutional basis for direct filing creating personal jurisdiction either.

Weighing all these considerations, and given how the jurisdictional law is evolving, it is not a good idea for a defendant to waive any personal jurisdiction defense at this time.  Thus, we believe that there is no constitutional basis for personal jurisdiction in direct-filed MDL cases, and defendants should not do plaintiffs any favors by voluntarily agreeing to such procedures.

 

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing theory of recovery.  Just last month, we noted that it looked like the issue had been largely resolved against allowing such claims or relief.  Sometimes, the issue is whether the plaintiff sufficiently pleads the elements of a medical monitoring claim in a jurisdiction that recognizes it.   Today’s case involves a different consideration of medical monitoring, looking at whether the requirements of Fed. R. Civ. 23 are met and a medical monitoring class can be certified.  There is quite a bit to Barraza v. C.R. Bard Inc., No. CV16-01374-PHX-DGC, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017), and we are only going to focus we find most interesting.

Barraza comes from an IVC Filter MDL, which has been the source of some other decisions that drew our interest, and ultimately focused on the question of whether class certification was appropriate for eleven separate classes, each for the residents of a state that has recognized medical monitoring and had a resident proposed class representative.  Each class sought medical monitoring for people with one of seven of the defendant’s IVC filter devices in-place (after being implanted at any time) who had not brought a case alleging personal injury.  In other words, these were to be classes of uninjured plaintiffs with on-going use of the allegedly defective devices.  (Note that the proposed class definition does not expressly exclude all patients claiming current complications, but the court addresses the case as though it presents a “no injury” class, so we will too.)  Keep in mind that a common reason for rejecting medical monitoring has been that the tort system is predicating on an actual injury, giving rise to accrual of claims, damages that can be determined by somewhat predictable rules, a duty to mitigate, etc., and people who have not have an actual injury do not fit well within the existing tort system.  Someone with an actual injury, however, may be entitled to compensation for on-going medical care to minimize the progression or sequelae of the injury.  With that in mind, we turn to the evaluation of whether individual considerations or common issues predominate in trying to decide the elements of medical monitoring—as identified by the plaintiffs based on an amalgam of the law of the eleven states.

We will focus on the elements that mattered to the outcome.  While plaintiffs argued that negligent design and failure to warn could be decided on common evidence, the court disagreed.  The seven devices were designed and launched over a more than ten year period and exhibited different design features, manufacturing specifications, and testing.  Similarly, the labeling for the devices differed depending on the date and product, but seemed to address the risks that plaintiffs claim required monitoring.  “Trial of a single class representative’s claim would not suffice because the representative would have received a different filter with different warnings than many members of the class.”  Similarly, the application of affirmative defenses like assumption of the risk and contributory negligence would also turn on individual evidence about what the plaintiff and her doctor knew and did.  The court noted how some of the named plaintiffs—putative class representatives—had ignored recommendations for medical follow up and removal of the device they claim subjects them to an increased risk of harm requiring monitoring.  Thus, individual considerations in evaluating liability predominated and “the classes cannot be certified simply because Plaintiffs allegedly face a common risk and need medical monitoring.”

The related issues of whether the proposed monitoring was necessary and different from the treatment the plaintiffs would otherwise receive also turned on individual considerations.

Here, the amount of monitoring a class member would require in a normal course of her treatment and illness, without the monitoring sought in this case, is an individualized inquiry into the medical needs and ongoing course of treatment for each class member.

For instance, some named plaintiffs were already undergoing monitoring of their own doctor’s devising with different levels of compliance.

Even what law would apply to classes defined by the state of residency involved individual considerations as the state where each plaintiff’s implant surgery occurred, the state where the injury occurred, and the state where the defendant designed the products and drafted labeling could affect the law that would apply.

Put it all together and plaintiff did not come particularly close to satisfying the predominance requirement and class certification under Fed. R. Civ. P. 23(a).  (The plaintiffs also tried for certification of a 23(b)(2) class, but that was pretty much a non-starter as the relief sought—paying for monitoring—is not injunctive.)  Some of the result here is likely due to the plaintiffs’ insistence on broad classes and the selection of putative class representatives with warts, but Barraza also illustrates how class treatment of medical monitoring claims should be a long shot even when state law allows monitoring for uninjured people.

As our guest post predicted in last Monday, even Hurricane Harvey could not delay the Fifth Circuit long in deciding the Pinnacle Hip MDL mandamus petition.  Its decision, denying mandamus but mostly agreeing with the defendant’s substantive position, is available hereIn re Depuy Orthopaedics, Inc., ___ F.3d ___, 2017 WL 3768923 (5th Cir. Aug. 31, 2017).  The appellate court had two issues before it:  (1) whether defendants had waived jurisdictional objections under Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), as to all 9,300 MDL cases, as the MDL judge had held, and (2) whether, if there was no waiver, mandamus would lie “to prohibit the district court from proceeding to trial” in certain bellwether cases.  Depuy, 2017 WL 3768923, at *2.

The defendant won the waiver issue.  Although mandamus was ultimately denied as to the second (bellwether trial) issue, the panel majority (different majorities decided the two issues) issued a strong shot across the MDL judge’s bow by declaring that action to be in error.

To understand our evaluation, we begin with mandamus.

Mandamus is – and is intended to be – difficult to obtain, because it upsets and short-circuits the usual process of appellate review.  2017 WL 3768923, at *3.  To obtain mandamus, a petitioner such as the MDL defendant here, must establish three things:

  • The “right to relief” – that the judicial order at issue was erroneous – must be “clear and indisputable.”  There must be a “clear” abuse of discretion that “produce[s] patently erroneous results.”
  • Mandamus must be “appropriate under the circumstances,” being “particularly appropriate” for issues extending “beyond the immediate case.”
  • The mandamus petitioner must “have no other adequate means to obtain relief.”  If ordinary appellate review will suffice, mandamus is denied.

Depuy, 2017 WL 3768923, at *4-5.

As to waiver, the majority held that no valid basis existed for the MDL court’s decision that Lexecon/personal jurisdiction objections had been waived as to all 9,300 MDL cases.  Such waivers must be “clear and unambiguous,” id. at *4, and nothing the defendant did approached that standard.

The MDL court’s notion, echoed by plaintiffs, that petitioners are trying to limit their waivers retroactively, is not borne out by the facts.  We hold that petitioners limited their venue waivers to the first two bellwether trials and that the MDL court erred by declaring that they had globally and permanently waived their objections to venue and personal jurisdiction.  That was grave error:

Id. (footnotes omitted).  Since there was no “clear and unequivocal” waiver, “the MDL court clearly abused any discretion it might have had and, in doing so, reached a ‘patently erroneous’ result.”  Id. at *5.  Since this error at least potentially infected all 9,300 cases in the MDL, that prerequisite to mandamus was also met.  Id

Although two of the three judges on the Fifth Circuit panel found “grave error” in the grounds on which the pending (and, indeed, the past) consolidated bellwether trial was predicated, and also that mandamus would be “appropriate,” mandamus was nonetheless denied.  What happened?

One of those two panelists (Judge Jerry Smith, who wrote the opinion) switched on the third element – whether an appeal, after the 10-plaintiff consolidated trial was concluded, was an “adequate” remedy.  While the MDL statute, itself, is intended to “promote the just and efficient conduct of such [MDL] actions,” 28 U.S.C. §1407(a), that is not the mandamus standard.  As far as a right to mandamus is concerned, a doomed consolidated trial, no matter how wasteful of the parties’ time and resources, is still a trial, and at the end of the whole thing (“each of the previous three bellwether trials lasted several weeks,” 2017 WL 3768923, at *5), an appeal in the normal course can be had.  Mandamus, according to this majority, isn’t available to avoid waste of time and expense:

[F]or appeal to be an inadequate remedy, there must be some obstacle to relief beyond litigation costs that renders obtaining relief not just expensive but effectively unobtainable.  Nor is . . . the risk of substantial settlement pressure [] grounds for granting a mandamus petition;

Depuy, 2017 WL 3768923, at *6 (footnotes omitted).  Thus, the defendant “met [only] two of the three” elements required for mandamus.

On this final point, Judge Edith Jones dissented, finding that, apart from time and expense, the MDL court had “plainly act[ed] in excess of its jurisdiction, [so] mandamus may issue to prevent the usurpation of power.”  Id. at *9.  The grounds for her conclusion are interesting, and have implications for future MDL practice.  She believes that “direct filed” MDL cases by plaintiffs from outside the state in which the MDL is located (including all ten of the plaintiffs in the proposed bellwether trial) lack personal jurisdiction, and therefore “but for” the “global waiver” that the panel had just found erroneous, there was “no claim to personal jurisdiction over the cases.”  Id.  Because there was no jurisdiction (and therefore, also improper venue) over the cases proposed to be tried, more than just wasted time and expense was involved, and mandamus was appropriate.  Id.

We’ve alluded to this potential jurisdictional problem with direct filed cases before, and we suspect there will soon be a lot more law on this issue.  We also believe that, in light of this jurisdictional uncertainty, and the direction in which Supreme Court’s recent jurisdictional precedents point, MDL defendants should strongly consider preserving objections to the use of direct filing.

So what now?  We doubt we have ever seen such a strong shot across the bow fired by an appellate court.  A majority of the panel – and law of the case usually applies to appellate decisions – says that the basis for the objected-to consolidated bellwether trial (and also the one just finished) was not just error but “clear” and “grave” error.  This “majority requests the district court to vacate its ruling on waiver and to withdraw its order for a trial.”   2017 WL 3768923, at *1.  Judge Jones’ dissent describes the likely result if the MDL judge disregards this signal and plows forward anyway:

If the district court lacked jurisdiction over these direct-filing plaintiffs’ cases, as our panel majority concludes, they will receive a take-nothing judgment nearly a decade after their suits were filed and will have to start all over − if they have the stomach for it.  For the remaining thousands, the goal of the bellwether process will have been perverted by unreliable judgments, delayed by the appeals, and undermined when those judgments are reversed.  Allowing the court’s conduct of trials outside its jurisdiction to spawn such unpredictability and unfairness will harm petitioners or plaintiffs and most likely both.  Such an outcome belies the goals of efficiency, economy, fairness, and predictability for which the MDL system supposedly exists.

Depuy, 2017 WL 3768923, at *10 (concurring and dissenting opinion) (citing §1407).

One possibility is for the defendant to seek en banc appellate review, since both parts of the decision – the finding of clear error, and the denial of mandamus drew dissents from different members of the panel.  That has happened before in the MDL context, although a long time ago.  See In re Exterior Siding & Aluminum Coil Antitrust Litigation, 705 F.2d 980 (8th Cir. 1983) (en banc) (vacating mandamus concerning class certification).  However, the strictures of the difficult-to-meet mandamus standard must be considered.  Plaintiffs might also seek such review, although since relief was denied, it is questionable whether they would be “aggrieved” enough to have standing.

Another possibility would be to seek relief from the Panel on MDL Litigation, since there are strong grounds (enunciated by Judge Jones) for asserting that the Pinnacle Hip MDL is no longer being conducted in accordance with the goals and purposes of the MDL statute.  Finally, it is possible, that with an appellate finding of error staring him in the face, the MDL judge, on remand, may decide that a course correction is in order.

Whatever happens, we’ll be watching with interest.

Today’s guest post is by Reed Smith Houston office associate Curtis Waldo.  Given the Noachic weather down there recently, one might ask “where’s Waldo?”  The answer is safe and sound, if not quite high and dry.  Curt is really dedicated – we offered him more time, but he said he didn’t need it.  In this post, Curt is acting the part of our on-the-scene reporter from last week’s Pinnacle Hip mandamus hearing before the Fifth Circuit.  Since things might move rather quickly (weather permitting) we wanted to bring his report to our readers ASAP.  As always our guest posters are 100% responsible for the content of their posts.  Curt deserves all the credit, and any blame, for what follows.

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First, thank you for all the support and well wishes sent to those of us in Southeast Texas riding out Hurricane Harvey.  It is a scary and challenging time, but we will recover.  Two days before Harvey’s arrival, as John Sullivan posted last week, a Fifth Circuit panel in Houston hosted a fascinating oral argument on the writ of mandamus filed by defendants in the Pinnacle hip implant litigation.  As a Reed Smith associate who works three blocks from the courthouse, I was fortunate enough to attend.

The writ has been covered by this blog here and here.  In sum, there are two issues before the court:  (1) did the district court err in holding defendants waived their personal jurisdiction rights?, and (2) if the district court did err, is it the kind of error that warrants the “extraordinary remedy” of a writ of mandamus?  The oral argument was divided about 50-50 between these two questions.  Defendants argue they did not waive their personal jurisdiction rights; plaintiffs argue they did.  Defendants argue a writ of mandamus is appropriate; plaintiffs argue it is not.  The panel was comprised of Judges Jerry Smith, Edith Jones, and Gregg Costa.

First to argue was John Beisner of Skadden Arps for defendants.  Mr. Beisner began with an analogy:  Your acquaintance invites you to dinner once.  You agree.  Your acquaintance invites you to dinner a second time.  You agree.  By agreeing to attend two dinners, have you now agreed to attend all dinners that may be called by the acquaintance in the future?

As tends to happen at oral argument, the judges wasted little time in interrupting.  Judge Smith:  Even if this was error, why a writ of mandamus?  Defendants could wait until the trial concluded and appeal the jurisdiction waiver at that time.

Mr. Beisner’s answer was twofold:  (1) why waste everyone’s time with an unnecessary trial if the appellate court can decide the issue at the outset, and (2) if plaintiff’s waiver theory is believed, defendants have waived their personal jurisdiction rights in 9,300 pending cases, which is exactly the sort of situation that is “not effectively reviewable” by a normal appeal.  As Judge Jones later pointed out, if the plaintiffs and defendants spend $50 million trying cases that are later obviated on appeal, does that $50 million not come straight from the pockets of plaintiffs and defendants, and right into the pockets of lawyers?

While this argument might make sense to anyone who is not a lawyer, Judge Costa pointed out rightly the slippery slope down which that argument might take them—should appellate courts step into district court proceedings at any stage where their input would be dispositive?  One could imagine such a system, but it is not the one we have in the federal courts.  Surely, Judge Costa asked, avoiding expense by itself is not enough to justify mandamus relief?  Mr. Beisner rightly avoided this logical sinkhole and clarified that no, it is not merely the avoidance of expense but also the likelihood of recurrence, which here is profound given the upcoming bellwether trials and thousands of other cases on the horizon where defendants have allegedly waived their constitutional rights.

Moving on to the waiver issue, Mr. Beisner framed the issue as revolving around the interpretation of a single email sent by defendants’ counsel in December 2014.  By agreeing “to allow the Court to select the next round of bellwether cases,” surely defendants were not agreeing to waive their right to object to personal jurisdiction in all 9,300 cases in the MDL and effectively agreeing that all 9,300 cases could be tried in Texas.  This, Mr. Beisner correctly emphasized, was simply not how the MDL process works.  The MDL system is for pre-trial purposes only.

Let us take a moment to consider that in a given day, we may send 100 emails or more, some of which we put more thought into than others.  I have never had one of my emails quoted at length in appellate briefs and dissected by a panel of Fifth Circuit judges, but I can’t imagine it is a good feeling.

Mr. Beisner had to explain why the email at issue referred to “bellwether cases,” and not only the bellwether case that would be tried.  He clarified that the case(s) to be tried in a single bellwether trial came from a larger pool of cases (but still not the 9,300 in the MDL), and it was this slightly larger subset that the email was referring to.  The judges appeared both intrigued and confused at the system used by the district court to select bellwether cases.  I thought Mr. Beisner made his point, but it is hard to say.  In any event, Mr. Beisner came back to his take-home message:  to waive one’s constitutional rights, surely such waiver must be clear and unambiguous, which here it was decidedly not.  Overall, the judges’ questions of Mr. Beisner on the waiver issue were not nearly as hard-hitting as the questions on the propriety of mandamus.

Next it was plaintiffs’ turn, for which plaintiffs turned to Kenneth Starr—former D.C. Circuit judge, solicitor general, law professor, Clinton investigator, and Baylor non-investigator.  Mr. Starr began his argument by quoting the All Writs Act from 1789.  Unsurprisingly, the panel did not let him finish his quote, and Judge Smith injected with the first question, which similar to his first question during Mr. Beisner’s argument cut to the chase:  Just what exactly are plaintiffs saying defendants waived?  Mr. Starr’s response was blunt:  in theory, defendants had waived their right to object to personal jurisdiction in all 9,300 MDL cases.  Mr. Starr hedged by saying this was only in theory, and plaintiffs did not plan to try 9,300 cases in Texas.  In reality, per Mr. Starr, this was only about the two bellwether trials set in the Northern District of Texas.  Despite Mr. Starr’s reassurances, his answer about the scope of the purported waiver seemed to make the panel uncomfortable.

Judge Jones took the opportunity to highlight what was really at stake—the big “M”.  While she did not say so explicitly, what is really “unreviewable” is the shift in momentum that occurs when a big verdict comes in while an appeal is pending.  Mr. Starr fought back:  This isn’t about momentum or settlement; this is about defendants trying to cut in line.  While the law may be under-developed on the issue of what contacts in a direct file case are sufficient to allow for jurisdiction, mandamus is not the proper vehicle to develop the law.  What is at stake, according to Mr. Starr, is our system of permitting trial courts to conduct trials, and leaving appeals for a later, orderly process.

Mr. Starr got out his talking points on his waiver argument, but it was hard to say he made any impact on the judges here.  Perhaps sensing that his stronger point was the impropriety of mandamus, Mr. Starr highlighted that defendants had an adequate remedy (they could appeal!), and the waiver issue was not so “clear and indistinguishable” as to justify mandamus.  Moreover, Mr. Starr brought up (for the first time by anyone) that a trial was actually set to start in September.  Lawyers and witnesses were ready to go, and his clients wanted their day in court.  Judge Jones countered that while plaintiffs may want their day in court, it would do them no good to have their verdict overturned a year later.

Ultimately it was a fascinating hour of argument—the waiver issue appears to revolve around a couple sentences in a CMO and a lawyer’s email from three years ago.  The mandamus issue cuts to the core of what role appeals courts should play in the federal system.  And overriding all of the argument was the judges’ curiosity and at times bafflement at the MDL system.  MDLs are supposed to encourage efficiency and coordination, but how do we achieve them while at the same time serving other purposes of the judiciary such as a deliberative appeals process, consistency, and finality?  What role should the court assign practical litigation considerations such as settlement momentum?  The courtroom was packed with law clerks and at least one district court judge, and the atmosphere of the courtroom had an academic and suspenseful quality.  Given the upcoming trial date, we should expect a decision soon.

 

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak.  We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle.  Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.

Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis.  First, it is a well-known issue.  Our quick PubMed searches easily got us to articles about this from the 1950s.  Second, this risk has been described in drug labels for a long time.  We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point.  Third, this risk has been seen with every anticoagulant since there have been anticoagulants.  We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA.  This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes.  These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.

We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it.  Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues.  The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention.  We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants.  Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.

Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL.  Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL.  The drug was approved in 2012 with extensive warnings about the risk of bleeding.  Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day.  These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process.  The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here.  After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice.  The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim.  That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.

As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7.  The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”:  The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8.  Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.

The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8.  This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5.  There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.

By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA.  The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug.  Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action.  In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.

Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived.  That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits.  In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.

 

This post is from the non-Reed Smith side of the blog.

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.

This post is from the non-Reed Smith side of the blog.

The plaintiff thought she had a strong summary judgment opposition. She included the deposition testimony of her prescribing doctor, who suggested that Boston Scientific’s warnings for the pelvic mesh device were inadequate. And she included her own affidavit, in which she said that she wouldn’t have agreed to let her doctor implant that device in her if she’d known that it could cause the negative life changing conditions that she allegedly later suffered. Plaintiff thought her opposition was enough to save her failure to warn claim. It wasn’t. The MDL court granted partial summary judgment. It turned out that Plaintiff’s opposition papers contained a big gap—no evidence of proximate causation. Plaintiff offered no evidence that her doctor read Boston Scientific’s Directions for Use (“DFU”). And, if her prescribing doctor didn’t read the DFU, changing it to include the allegedly proper warning wouldn’t have changed anything, particularly her doctor’s decision to prescribe.

That wasn’t the end for plaintiff, though. She had other claims that survived and that she could take to trial. That trial, however, would happen before a different court.  After its summary judgment decision and completing other pretrial matters, the MDL court transferred the case back to the original transferor court for trial.

Plaintiff saw this as an opportunity. She moved the new court to reconsider the MDL court’s summary judgment decision. Her basis was that, in fact, her prescribing doctor had read the DFU. The plaintiff had simply failed to present that portion of his deposition testimony to the MDL court. On that basis, she asked the new trial court to change the MDL court’s decision and deny summary judgment against the failure to warn claim.

No luck. She lost her reconsideration motion.

So, with no failure to warn claim, Plaintiff went to trial.

She lost there too.

Undaunted and still fighting to revive her failure to warn claim, plaintiff appealed to the Fourth Circuit. She challenged both the MDL court’s original summary judgment decision and the trial court’s denial of her motion to reconsider that decision.

And she lost again.

All of this is described in the Fourth Circuit’s recent opinion. Carlton v. Boston Scientific Corp., 2017 WL 1854278 (4th Cir. May 9, 2017). The Fourth Circuit saw plaintiff’s problems as both substantive and procedural. Substantively, a failure to warn claim cannot survive without evidence that the doctor would have read the warning. Id. at *3. Procedurally, it’s not the court’s job to find the evidence that supports proximate causation. It’s the parties’ job to present that evidence to the court: “The responsibility to comb through the record in search of facts relevant to summary judgment falls on the parties—not the court. We therefore affirm the MDL court’s partial summary judgment award.” Id.

Her procedural failings were particularly problematic on her challenge to the trial’s court’s denial of reconsideration. This wasn’t new evidence on which she was relying. It was evidence that had indisputably been available at the time the MDL court decided the summary judgment motion:

At oral argument, Appellant’s counsel asserted that in light of this late revelation, the MDL court’s summary judgment award constituted clear error causing manifest injustice. Not so. We have consistently affirmed denials of motions to reconsider summary judgment rulings where the motion is merely a vessel for the very evidence that was initially lacking in opposition to summary judgment. Significantly, the entirety of Dr. Kennelly’s deposition testimony was available well before summary judgment briefing, and the additional portions of testimony Appellant provided to the district court for “reconsideration” thus did not amount to the type of evidence constituting grounds for a valid motion for reconsideration. We therefore affirm the district court’s denial of Appellant’s motion for reconsideration.

Id. at *4.

While not for lack of fighting on plaintiff’s part, we suspect that this one is now finally over.

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York, but, as we reported here, summary judgment was granted for the defendants in all of those cases when Daubert motions disposed of the plaintiffs’ causation experts.  There is another group of Mirena plaintiffs, this time alleging that Mirena caused them to develop idiopathic intracranial hypertension (“IIH”), a serious brain disorder marked by increased pressure in the brain and central nervous system.

Exactly one published study has ever linked Mirena to IIH. The lead author was Mahyar Etminan, Pharm. D. – much more about him in a minute.  You can read the Etminan article here. The Etminan article reported the results of two analyses:  an epidemiological study and an analysis of adverse events reported in the FAERs database.  The epidemiological study – that is to say, the unbiased statistics – did not demonstrate an increased risk of IIH associated with Mirena use when compared to combined oral contraceptives.  But the article reported that the FAERs analysis demonstrated a higher-than-expected proportion of IIH reports with Mirena as compared to all other products in the FAERS database.  (We’ve devoted an entire post (and cheat sheet) to why adverse event reporting doesn’t, and can’t, demonstrate causation.)

The Etminan article was published in 2015 and included a standard “no conflict of interest” statement. In the ensuing months, Mirena IIH plaintiffs in a half-dozen district courts disclosed their experts.  Among them was none other than Mahyar Etminan, who, it turns out, had been on plaintiffs’ payroll all along in a blatant conflict of interest not disclosed in his article.  Etminan, along with three other causation experts, cherry-picked the results of the FAERs analysis to allege a causal relationship between Mirena and IIH but never dealt with the conflicting epidemiological data from the same article.

And it gets even better.   In December 2016, Etminan executed an affidavit, which you can see here.  In it, Etminan explained that the methodology of the FAERs analysis was flawed and did not support its conclusion.  Specifically, in comparing the proportion of IIH reports among Mirena users with the proportion among non-users in his FAERs analysis, Etminan failed to limit the comparator groups to women of reproductive age.  Because women of reproductive age have a higher background incidence of IIH than other age groups, failing to limit the comparator groups to these women introduced a bias against the Mirena group.  When the analysis was re-done with the correct comparator groups, the affidavit explains, the results did not support a claim that Mirena increases the risk of IIH.

And so Etminan, the source of the only published study claiming that Mirena causes IIH, publicly renounced his published conclusions. (Earlier, when the flaws in the FAERs analysis came to light, Etminan withdrew from the seven cases in which he’d been named as an expert.)  We don’t know that we have ever seen anything like this in all of our days litigating mass torts.  And we love watching the collapse of a house of cards erected on a foundation of paid (and undisclosed) advocacy.

But the story isn’t over yet. None of plaintiffs’ other causation experts – all of whom also relied on Etminan’s published FAERs analysis – has yet withdrawn.  And, just days ago, IIH cases were centralized in an MDL in the Southern District of New York.  (Plaintiffs had sought such an MDL in 2014, but the JPML rejected that request.)  Regular blog readers are familiar with our views of many MDL plaintiffs and their lawyers, spawned during countless hours fighting hordes of meritless claims that MDL judges allow to remain pending.  By rights, with no evidence of causation, plaintiffs should be out of court.  And, certainly, some threshold determination of merit should precede the formation of an MDL.  But mass torts exist for the masses, who queue up for settlement handouts that don’t depend on meritorious claims.  Can the new IIH MDL proceed very far down the litigation path when the plaintiffs’ causation claim has been debunked by its primary supporter?  Back in November, we learned never to say never.  So stay tuned.

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources.  But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else.   Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.

And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries.  The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants.  It  requires all parties to handle explanted devices in accordance with a written protocol or consistent  with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing.   All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.

In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind.  Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs.  Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted.  The sixth plaintiff had several revision surgeries.  During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head.   She explained, “I figured I paid for it.  I wanted it.”  She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition.  The devices explanted during her subsequent surgeries were not preserved.

Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices