Multidistrict Litigation

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.

As we write this, our fair city remains in a blissful haze following our Eagles’ 33-10 rout of the 49’ers to go 7-1 in the NFC East, so it might be appropriate to call today’s opinion a “touchdown.” On the other hand, the World Series approaches Game 6, following a game in which twenty-five runs were scored.  So maybe the opinion is a “home run.”  In any event, the Second Circuit’s (regrettably) unpublished affirmance in In re Mirena IUD Prods. Liab. Litig., Mirena MDL, Plaintiffs v. Bayer Healthcare Pharmaceuticals, Inc., 2017 U.S. App. LEXIS 20875 (2d. Cir. Oct. 24, 2017) is very, very good.

More than a year ago , we reported that the United States District Court for the Southern District of New York granted the defendant’s motion to exclude the plaintiffs’ general causation expert in the Mirena MDL.  In the absence of expert causation testimony, the court granted summary judgment for the defendant on all pending cases, holding that the plaintiffs could not satisfy their burden of proof without expert causation testimony.  The plaintiffs appealed to the Second Circuit.

Mirena is an implanted intrauterine birth control device. (As we have commented before, plaintiff lawyers persist in choosing contraceptive devices as their targets, despite the general absence of any basis for the plaintiffs’ claims.)  The Mirena MDL plaintiffs alleged that they were injured when their Mirena devices perforated their uteruses.  As the Court explained, “At bottom, the [Mirena] MDL is about when Mirena perforated Plaintiffs’ uteruses.  Both parties agree – and [the defendant] has warned – that Mirena can injure a woman’s uterus during insertion and afterward migrate outside the uterus (what is called “primary perforation”). Mirena, 2017 U.S. App. LEXIS 20875 at *2 (emphasis in original).  But the plaintiffs alleged that their Mirena devices perforated and migrated outside their uteruses at some later time (so-called “secondary perforation”).  The defendant did not warn of “secondary perforation,” so, the Court stated, it was “exposed to liability if secondary perforation in fact occurred.” Id.

The plaintiffs offered three general causation experts to testify that secondary perforation was possible. The District Court excluded all three pursuant to Daubert, holding that their testimony was “not reliable and, thus, not helpful to the trier of fact.”

Affirmance of Exclusion of Plaintiffs’ General Causation Experts

On review of the District Court’s Daubert decision, the Second Circuit focused on three “particularly noteworthy” problems with the opinions of the plaintiffs’ experts. Id. at *5.  First, the experts’ theories were not accepted in the relevant scientific community. “Not only [did] the experts fail to identify any authorities that directly support the existence of secondary perforation, but what scientific authority there is casts doubt on the phenomenon’s existence.” Id. Second, all of the experts developed their “secondary perforation” theories solely for purposes of the litigation and lacked in the supposed phenomenon before the litigation began.  One had no specialized expertise in Mirena or uterine perforation before being hired, one had no experience with IUDs, and the third “had not even heard of secondary perforation before consulting in the litigation.” Id. at *8.  Third, “finding no direct support in the literature for secondary perforation and having conducted no prior research on the subject, the experts all assumed the existence of the very phenomenon in dispute and then hypothesized how it could occur.” Id.

In response to the third point, the plaintiffs argued that their experts were no different than experts in Kumho Tire v. Carmichael, 526 U.S. 137 (1999), who were asked to determine the mechanism that caused the blowout of a tire.  The Court gave this argument the back of its figurative hand, emphasizing, “. . . [I]n Kumho, there was no dispute about whether the tire had blown, only how it happened. . . . Here, by contrast, the parties dispute whether the secondary perforation has ever occurred.  The experts thus begged the very question they were trying to answer.”   Id. (citations omitted).

And so the Court affirmed the exclusion of all three general causation experts.   Next, the Court considered whether the plaintiffs could escape summary judgment despite the lack of expert causation testimony.

Affirmance of Summary Judgment for Defendants

Arguing that their cases could survive the exclusion of their experts, the plaintiffs “identif[ied] dicta from several cases suggesting that party admissions can sometimes substitute for expert testimony on general causation.” Id. at *9-10.  The plaintiffs proffered four categories of such supposed admissions:

  • Three short excerpts of emails authored by the defendant’s employees that purportedly “admitted” that secondary perforation could occur. But the excerpts were from emails in which the employees “reported, without necessarily endorsing, adverse event reports,” which, as a category, are “anecdotal, and thus of very limited probative value.” Id.
  • One sentence from a PowerPoint presentation suggesting that spontaneous perforation could occur unrelated to insertion. The Court agreed with the District Court that, with no knowledge of the context in which the slide was presented or what was said at the meeting, and no details of any causes of the supposed secondary perforation, the excerpt could not substitute for expert testimony.
  • Testimony from the defendant’s Global Medical Expert that “a perforation unrelated to insertion, rare as it may be . . . could happen.” The Court held that “acknowledgment of the possibility of causation does not establish that causation is more likely than not, as the District Court correctly found.” Id. at *11.
  • In 2014, the defendant changed the Mirena label to warn that perforation “may occur most often during insertion, although the perforation may not be detected until sometime later.” The plaintiff’s argued that this was an admission that secondary perforation could occur, but the Court observed that “the grammatical structure [of the warning was] cryptic at best,” at most “suggest[ing] the hypothetical possibility of secondary perforation,” and could not substitute for expert testimony. Id. at *11-12.

And so, the Court held, “We need not reach the question of whether party admissions could ever substitute for expert testimony.   Assuming arguendo that they could, the putative admissions proffered by Plaintiffs are simply not enough to establish general causation.” Id. at *10.  Summary judgment for the defendant affirmed.

Daubert embodies real standards. And the Rules of Evidence are more than suggestions.  In this case, in the hands of a decisive District Court, both contributed to a decision that was unassailable on appeal.  We will keep you posted on similar – and hopefully published – decisions.

A talisman is something thought to protect whoever has it from evil or harm.  In the old days a talisman might be something like garlic to ward off vampires or the Seal of Solomon to keep away various evil spirits.  Nowadays, there aren’t so many – although it seems there are some people out there who appear to view Robert Mueller as something of a talisman.

How about preemption?

We noticed something recently in the course of making sure that our preemption scorecards for PMA device and generic drug preemption are current.

We don’t see many preemption cases that need to be included in either scorecard coming out of multi-district litigation.  For example, in the PMA preemption scorecard, there are exactly five cases with “In re” in their title.  The last one was In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010), which involved a pre-Riegel MDL essentially getting wiped out by a single preemption motion.  Since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), as far as we can tell from following the case law, not a single new MDL has been created involving a pre-market approved device to which extensive Riegel preemption would apply.  Sure, there has been fairly extensive post-Riegel litigation involving some PMA devices – Infuse and Essure come to mind – but no MDL where bad cases can go to hide until a single MDL judge produces enough bizarrely pro-plaintiff rulings and/or consolidated bellwether show trials to bludgeon the defendant into settling.

The same appears to be true in the generic drug area, which also enjoys broad preemption (if not for as long a time as PMA devices).  We find more “In re” captioned cases in our generic preemption scorecard, but for the most part they, as well, look like holdover MDLs involving drugs that were subject to litigation before the preemption hammer came down in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  We see some Accutane, Darvocet, Yasmin/Yaz, and Fosamax cases, all of which appear to have been in litigation – Sprint Fidelis style – since before Mensing was decided.  We also see various “In re Reglan” citations, but they are from state court.  In federal court, generic Reglan (metoclopramide) cases seem to have been brought on the same individual, if rather common, basis as Infuse or Essure in the device area.  No federal MDL.

The only possible exception to this state of affairs is In re Testosterone Replacement Therapy Products Liability Litigation, 142 F. Supp.3d 747 (N.D. Ill. 2015), which was created after Mensing.  But we don’t really see TRT as an exception, since reading the decision suggests that the litigation really targets branded manufacturers.  The generic plaintiffs who were dismissed were more or less odds and sods generated by the usual excessive solicitation followed by the even more usual inadequate vetting of actions by the other side in mass tort situations.  In any event, the generic Testosterone plaintiffs were wiped out by preemption and that was that.

So, in addition to (or perhaps because of) its other virtues, a strong preemption defense appears to be a talisman that wards off the evil of MDLs/mass torts.  Most defendants have had their fill of MDLS, and most plaintiffs don’t seem to be seeking MDLs in cases involving such products – and with good reason.  As in the aforementioned Sprint Fidelis and Testosterone decisions, a single preemption ruling wiped out all similarly situated plaintiffs in the entire MDL.  Plaintiffs do not want that efficiency like that.  If every Infuse, Essure, or Reglan case were in the same court, then one preemption ruling by a judge inclined to follow Supreme Court precedents means the litigation is over.  Not much chance for a return on all those solicitation costs.  Without MDL coordination, plaintiffs can still try to find that rogue judge here or there willing to find an off-label-promotion or duty-to-update exception to preemption in this or that case.

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.

**********

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.