Case: 1:17-md-02804-DAP Doc #: 2676 Filed: 09/26/19 1 of 14. PageID #: 417350

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
EASTERN DIVISION
IN RE: NATIONAL PRESCRIPTION
OPIATE LITIGATION

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CASE NO. 1:17-MD-2804
JUDGE POLSTER
OPINION AND ORDER

The first bellwether trial in this Opioid MDL is scheduled to begin in less than four weeks.
Of the 22 named defendants, seven have filed a Motion to Disqualify (docket no. 2603), asking me
to recuse myself from all MDL proceedings. For the reasons stated below, the motion is DENIED.

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The Opioid MDL (MDL No. 2804) was created by the Judicial Panel on Multidistrict
Litigation nearly two years ago, in December of 2017. I was honored to accept the Panel’s request
that I undertake the assignment of MDL transferee Judge. At the outset, the MDL consisted of
approximately 100 cases. It has since grown to more than 2,000 cases. The plaintiffs are primarily
governmental entities – Cities and Counties from across the country, as well as Indian Tribes.1 Just
as there are thousands of plaintiffs, there are many dozens of defendants. These defendants include
manufacturers of prescription opioids, distributors of these opioids, and pharmacies that dispense

1

Other categories of plaintiff include hospitals, third-party payors, putative classes of
individuals, and others.

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them.
The governmental-entity plaintiffs assert against the defendants: (1) various legal claims, for
which they seek damages as compensation; and (2) equitable public nuisance claims, regarding
which they seek abatement and prospective injunctive relief.
During the same time period that the number of federal cases in the Opioid MDL ballooned,
the number of cases filed in State courts also rose dramatically – there are now over 400
opioid-related cases pending in various State courts. These include at least 59 lawsuits filed by State
Attorneys General, which include similar claims and allegations against the same defendants and
seek similar monetary damages and equitable relief.
Many commentators and analysts have called the combined Opioid Litigation the most
complex and important group of cases ever filed, and I would not disagree with that characterization.
As was being reported even before the Opioid MDL was created, “more Americans died from drug
overdoses in 2016 than the number of American lives lost in the entirety of the Vietnam War, which
totaled 58,200.”2 The magnitude and significance of the “opioid crisis” and the Opioid Litigation
cannot be overstated. Ever since my appointment as transferee Judge, every type of local and
national media has reported daily, if not hourly, regarding developments in both the State and federal
opioid litigation.
Of course, I was aware from the start about the extraordinary amount of publicity this MDL
would receive. This publicity is understandable; the opioid epidemic is historic, one of the greatest
tragedies of our time. It cuts across all ages, races, religions, and socio-economic groups. The

2

See https://cbsn.ws/2yA09mq (Oct. 17, 2017) (“Drug overdoses killed more Americans
last year than the Vietnam War.”).
2

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human toll is staggering, and the continuing economic burden on government at all levels is extreme.
Publicly acknowledging this human toll does not suggest I am biased; it shows that I am human.
I was very careful in what I said during the first hearing of this MDL in January of 2018, and I have
been very careful about what I have said ever since. For example, while moving defendants claim
that the statements I made in Court at the outset (quoted at p. 2 of their memorandum) suggest bias,
I was very careful to assign responsibility (as opposed to potential legal liability) to everyone in the
case – including not only the MDL defendants and plaintiffs, but also the federal government, the
medical profession, and even individual opioid drug users. All of these groups are responsible to
some degree for having created the opioid crisis, and all who have the power to do so must now take
some responsibility for fixing it. As the MDL Judge, the latter includes me, and I said so.
Acknowledging the immense scope of the opioid crisis, and calling on all entities who have the
power to ameliorate it to join me in doing so without delay, does not reflect any bias or prejudice
toward any party to the litigation; and no reasonable observer would so conclude.
Since that time, I have pursued simultaneously and vigorously both a “settlement track” and
a “litigation track.”3 I have utilized the assistance of three very experienced and talented Special
Masters to assist me in simultaneously managing both tracks. Of course, neither plaintiffs nor
defendants can credibly express surprise or dismay that I addressed the prospect of settlement from
the very start. Addressing settlement early and often is my standard operating procedure, and I

3

See Manual for Complex Litigation Fourth §13.11 at 168 (“Settlement [and] . . . the
pretrial process both can and should operate effectively on parallel tracks.”).
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believe this is partly why the MDL Panel chose me as transferee Judge.4 Nor can plaintiffs or
defendants credibly complain of my public observations that any settlement will unquestionably
require the defendants to pay money to the plaintiffs. This is simply a fact of litigation, not an
expression of bias or prejudice or prejudgment against any defendant. Each defendant has a choice
to litigate or settle; if it wants to settle, it will have to pay money to plaintiffs. My statements that
early settlements are preferable to settlements only after protracted litigation do not carry any
negative implication, and the seven moving defendants’ drawing of a negative inference is not
accurate.
During the course of the last twenty months, I have worked ceaselessly with the parties and
also my three Special Masters on both the settlement track and the litigation track. These efforts
have begun to bear fruit, as evidenced by the following:
•

After having been postponed twice by party request, the first bellwether MDL trial is
scheduled to begin in less than a month, on October 21, 2019, with jury selection starting on
October 16. At this juncture, there are two governmental-entity plaintiffs and seven
defendants, which reflects a substantial whittling-down from the beginning of the case, when
there were dozens of plaintiffs and over 20 defendants.5

•

With the Court’s help, the bellwether plaintiffs have reached multi-million dollar settlements

4

The Manual for Complex Litigation suggests early discussion of settlement should be
standard operating procedure. See id. at 167 (“The judge can encourage the settlement process by
asking [about it] at the first pretrial conference . . . .”); see also id. §11.214 at 40 (“At each
conference, the judge should explore the settlement posture of the parties and the techniques,
methods, and mechanisms that may help resolve the litigation short of trial.”) (emphasis added).
5

The current plaintiffs are Cuyahoga County and Summit County, Ohio, which encompass
the cities of Cleveland and Akron, respectively. Initially there were also dozens of city-plaintiffs
within the two counties, but all of these cities have been dismissed or severed. Similarly, the
complaints and amended complaints named a total of 22 opioid manufacturers, distributors, and
pharmacies, but the majority have either settled or been severed, leaving only seven defendants for
trial (or fewer, if there are additional settlements).
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with three manufacturing defendants – Endo, Allergan, and Mallinckrodt. The Court
continues to assist the parties with ongoing, serious negotiations, which may lead to
additional bellwether case settlements before trial.
•

In addition to addressing claims made in the bellwether cases, the Court has also assisted and
overseen negotiations directed at achieving “global resolution” of all opioid litigation against
the defendants, in both State and federal courts. These efforts led directly to the proposed
multi-billion dollar agreed bankruptcy settlement with Purdue and the Sackler family.
The Court’s settlement efforts have included countless meetings not only with all of the

many parties’ outside litigation counsel, but also their highest-ranking decision-makers, including
General Counsel, Chief Financial Officers, and Chief Executive Officers, as well as their hired
experts (e.g. outside accountants, financial advisors, and bankruptcy attorneys).
At the same time, the Court’s litigation efforts (during only the 20 months since this MDL
was formed) have so far included: (i) oversight of discovery involving over 450 depositions and over
160 million pages of documents; (ii) rulings on innumerable discovery motions, ranging from the
trivial to motions to compel production of documents from the United States Drug Enforcement
Agency; (iii) rulings on dozens of dispositive and Daubert motions; and (iv) deep preparation for
the imminent bellwether trial, up to and including sending out jury questionnaires, review of
potential jury instructions, and so on. My Special Masters have also coordinated the voluminous
State court litigation with the federal court litigation.
Certain defendants6 now point to a few discrete settlement and litigation events as a basis for

6

Of the seven defendants remaining in the bellwether trial, five joined the Motion to
Disqualify (AmerisourceBergen, Cardinal, McKesson, Walgreens, and Schein) and two did not
(Teva and J&J). Three other MDL defendants who are no longer a part of the bellwether trial also
joined the motion (CVS, Rite Aid, and Walmart), while many others did not (e.g. Purdue, Endo,
Allergan, Mallinckrodt, Anda, DDM, HBC Giant Eagle, HD Smith, Kroger, Noramco, and
Prescription Supply).
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my recusal. Specifically, on September 14, 2019 – only 32 days before jury selection in the first
MDL bellwether trial – a few of the distributor and pharmacy defendants (but none of the
manufacturer defendants) filed this Motion to Disqualify. Their 36-page memorandum alleges that
statements I have made in open court and to the media, beginning in January of 2018, create a
reasonable question about my impartiality. Most of the statements concern the devastating impact
of the opioid crisis, the urgent need to address it, and the benefit to everyone of settlement. The
moving defendants allege these statements create the impression that I am biased against them and
could not fairly preside over the upcoming October trial. On September 16, 2019, plaintiffs filed
a Response (docket no. 2607), and the moving defendants filed a Reply on September 17, 2019
(docket no. 2616).
Plaintiffs’ opposition memorandum succinctly refutes the arguments that allegedly support
the moving defendants’ Motion to Disqualify, and demonstrates that nothing I have said in or out
of Court remotely suggests I could not fairly and impartially preside over the October trial; and also
that no reasonable observer would question my impartiality. I will not repeat the plaintiffs’ points
here. It suffices to say that the burden to sustain a motion to disqualify a judge is exceedingly high,
and the moving defendants have not met it. There are just a few points that need to be made.
To explain why they did not file their Motion to Disqualify earlier, the moving defendants
advance the rationale that it was only recently, after two events occurred, that the need to seek
recusal became clear. See Reply at 1 (docket no. 2616) (the “decision to file this motion . . . was
based on an accumulation of statements made and actions taken by the Court over time, including
the Court’s recent decisions [1] to certify a novel ‘negotiation class’ and [2] to take on the role of
finder of fact in any remedial phase of the nuisance case”). But neither of these two decisions show

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any bias and neither provide “new” grounds for a motion to disqualify.
Regarding my certification of the Negotiation Class, it is true that this procedural mechanism
is novel and also true that I issued the order very recently, on September 11, 2019 (docket no. 2591).
But this matter has been under active consideration for months: the initial motion for approval was
filed on June 14, 2019 (docket no. 1683), and I held a lengthy hearing on the certification motion
on August 6, 2019 (tr. available at docket no. 2147). More important, as I have repeatedly made
clear, the Negotiation Class mechanism is entirely optional. No defendant has to use it, and no
defendant suffers any negative impact whatsoever if it decides not to. The Negotiation Class
mechanism is simply another, as-yet-untested approach that a defendant may use to settle with
plaintiffs. I have also repeatedly stated I have no preference for that settlement mechanism over any
other that a defendant may choose.
Indeed, the entire motivation for creation of the Negotiation Class mechanism was the
insistence of defendants that they would not seriously consider resolution unless there was a global
mechanism to bind all Cities and Counties that filed lawsuits in the MDL, and also the 20,000 other
Cities and Counties that potentially could file lawsuits. Defendants have repeatedly expressed
frustration on this front, and the Negotiation Class simply provides a voluntary approach that may

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help.7
I stated clearly at the hearing that the Negotiation Class under consideration need not be the
exclusive vehicle for resolution, that nobody would ever be required to use it, and I encouraged
alternative settlement concepts. See, e.g., Hrg. Tr. at 55:7-8, 74:8-9 (docket no. 2147). The fact that
some Attorneys General do not like the Negotiation Class mechanism because they believe only
States, and not Cities and Counties, have authority to settle the opioid lawsuits, does not support the
argument that “reasonable observers” now question my impartiality. It is also fair to state that the
plaintiffs’ work in creating the Negotiation Class mechanism, with my Special Masters’ assistance,
yielded increased agreement amongst Cities and Counties. I believe that without the cohesiveness
that now exists among the 2,000 litigating Cities and Counties, the proposed multi-billion dollar
bankruptcy settlement with Purdue and the Sackler family would not have occurred.
The second “recent event” that the moving defendants point to is my supposedly new

7

The moving defendants argue that my Order certifying the Negotiation Class displayed
bias when I stated certification would “remove ‘an obstacle to settlement’” and “expedite relief to
communities so they can better address this devastating national health crisis.” Reply at 5 (docket
no. 2616); see also Motion at 5, 12, and 18 (docket no. 2603-1).
When I addressed plaintiffs’ motion for class certification, Rule 23(b)(3) required me to
ascertain whether class certification was “superior to other available methods for fairly and
efficiently adjudicating the controversy.” Addressing that prong, the defendants explained that this
question “can be answered in the affirmative only if certification of this class would actually help
to facilitate the settlement of a substantial proportion of the pending litigation.” Opposition to
motion for class certification at 41 (docket no. 1949) (emphasis added). The defendants’ own
arguments on superiority therefore demanded that I address whether settlement would be advanced
through certification of a Negotiation Class. Moreover, as to the value of settlement, the defendants
stated they were “acutely aware of the benefits that could accrue if a legally supportable mechanism
were available to permit global settlements in this litigation.” Id. at 1 (emphasis added).
In other words, defendants made clear to the Court that settlement is important and the Court
must decide whether certification of a Negotiation Class furthers that goal; but the moving
defendants now insist the Court must disqualify itself for stating that settlement is important and
certification of a Negotiation Class furthers that goal.
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“decision to take on the role of finder of fact in any remedial phase of the nuisance case.” Reply at
1 (docket no. 2616). But it is settled law that, if a defendant is found liable for creating a public
nuisance, the decision of whether to impose an abatement remedy (and if so, what that remedy
should be) is one that must be decided by the Court, not the jury. The Court stated this clearly
weeks ago. See Order Denying Defendants’ Motion to Exclude Abatement Experts at 3 (docket no.
2519) (August 26, 2019) (“In Ohio, ‘[w]hen a nuisance is established, the form and extent of the
relief designed to abate the nuisance is within the discretion of the court.’”) (citing 72 Ohio Jur. 3rd
Nuisances §49). Moreover, everyone in this case has understood this from the start, as confirmed
by recent submissions from the parties. See Certain Defendants’ Position Paper at 6 n.7 (Sept. 13,
2019) (docket no. 2599) (conceding that “truly equitable relief . . . is for the Court to decide”).
Defendants did recently raise the question of whether the Court or the jury would determine
whether a public nuisance caused by any defendant exists (e.g., liability). After reviewing the
parties’ submissions and consulting with counsel on a September 16, 2019 telephone conference,
I determined the best course of action is to let the jury decide public nuisance liability, while the
question of abatement remains for the Court. It was defendants who argued for this conclusion, not
plaintiffs.8 The Court agreed with defendants because there is substantial overlap in the evidence
going to the plaintiffs’ nuisance claim and plaintiffs’ other claims, and case-law supports allowing

8

See docket no. 2599 at 1-2 (six trial defendants stating they “have a right to trial by jury
of Ohio public nuisance claims with respect to the issues of liability and any legal damages . . . [but]
the trial should be bifurcated, and any evidence or arguments relating to Plaintiffs’ proposed
remedies should not be presented to the jury” and instead decided by the Court); docket no. 2602
at 1 (defendant Teva stating it has “a right to trial by jury of Ohio public nuisance claims with
respect to issues of liability, but a court should decide Plaintiffs’ proposed “equitable abatement”
remedy for the public nuisance claims”); compare docket no. 2601 at 1-2 (plaintiffs asserting “there
is no right to a jury trial on [any aspect of] a public nuisance claim for abatement”).
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the jury to make the threshold liability determination.9 None of this remotely supports the moving
defendants’ claim that I am biased or appear biased against them, or that the grounds for claiming
bias arose only recently.
This leaves, as grounds for the moving defendants’ Motion to Disqualify, the comments I
have made in Court or to the press. I have addressed this above, but add these thoughts. The opioid
crisis is a topic of everyday conversation. There are few if any Ohioans who don’t have a family
member, a friend, a parent of a friend, or a child of a friend who has not been impacted. I have made
this observation several times, partly to underscore how important resolution of this litigation is to
all of our citizens (not just the parties themselves), and partly to reflect how hard it may be to pick
a jury. These comments do not show bias, nor do they provide grounds for a reasonable person to
question my impartiality. Nor does my speaking to the press show anything other than a desire to
manage the MDL appropriately. See Civil Litigation Management Manual Second at 131 (F.J.C.
2010) (“At the outset of a high-visibility case, you will want to take steps to gain the media’s
cooperation and goodwill.”). The moving defendants’ citation of cases where other judges made
comments to the media are distinguishable because those judges made explicit statements about the

9

I initially stated orally during a teleconference my intention to allow a jury to determine
public nuisance liability, while I would decide abatement if necessary; shortly thereafter, the moving
defendants filed their Motion to Disqualify. More recently, I entered an Order reaffirming and
explaining my decisions. See docket no. 2629. I have structured the October trial so that the jury,
and not the Court, will be the trier of the facts. The jury will decide whether any of the defendants
is liable under any of the theories advanced by plaintiffs, and if so, what, if any, damages should be
awarded. Because the law is clear that, should the jury find a defendant liable for causing a public
nuisance, any abatement remedy is a matter of equity for the Court to decide, I will need to hold a
separate, post-trial evidentiary proceeding on remedy should the jury find public nuisance liability.
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merits of the claims in litigation.10 I have not done this.
I freely admit I have been very active from the outset of this MDL in encouraging all sides
to consider settlement. It goes without saying that if even a small fraction of the 2,000 cases in the
MDL requires a months-long trial, the federal judiciary will be overwhelmed and most of the
defendants would be forced into bankruptcy, simply because of litigation costs. (Two manufacturer
defendants – Insys and Purdue – have filed for bankruptcy this year.) Ordinarily, the resolution of
a social epidemic should be the responsibility of our other two branches of government, but these
are not ordinary times. I feel it is important for our citizens to know what I am doing and to have
confidence that the judicial branch is up to the task – I have said so publicly. The moving
defendants complain that I have had a “personal mission” from the start of the case. That is true,
but it does not suggest any bias or partiality. Prescription opioids are “controlled substances” under
federal law. Current levels of opioid overdoses make it painfully obvious that our system of
“controls,” which depend jointly upon all levels of government, the pharmaceutical industry, and
the medical profession, has not performed the way it should. The result one way or another of a

10

The cases cited by the moving defendants, where courts held judges should have recused,
are materially different on the facts. See, e.g., Ligon v. City of New York, 736 F.3d 118, 125-26 (2nd
Cir. 2013), vacated in part, 743 F.3d 362 (2nd Cir. 2014) (“the judge . . . urged a party to file a new
lawsuit to assert [a new] claim, suggested that such a claim could be viable and would likely entitle
the plaintiffs to documents they sought, and advised the party to designate it as a related case so that
the case would be assigned to her”) (emphasis added); United States v. Cooley, 1 F.3d 985, 990 (10th
Cir. 1993) (before presiding over a criminal case against the defendants, the judge stated on national
television that “these people are breaking the law”); In re Boston’s Children First, 244 F.3d 164,
171, 167 (1st Cir. 2001) (in “a highly idiosyncratic case,” the judge “arguably suggested that the
petitioner’s claims for certification and temporary injunctive relief were less than meritorious”).
It is simply not true, as the moving defendants assert, that I have intimated my view on the
merits of any of the claims or defenses asserted in this litigation. And it is not reasonable to insist
that my devoted efforts toward settlement have somehow suggested to a reasonable observer that
I harbor some bias or prejudice.
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single bellwether trial, or even of 2,000 trials, cannot bring about systemic change. This is why I
have tried to engage everyone, including even non-parties to this litigation (such as State Attorneys
General and the DEA), to look at ways to improve the system. Defendants have willingly
participated in these discussions for many months, at the same time they have vigorously defended
themselves against the allegations in the lawsuits; and as a result, there have already been some
positive voluntary changes. For example, a motion for injunction against three Pharmacy Benefit
Manager (“PBM”) defendants was mooted after my settlement discussions led to voluntary adoption
of changes to the PBMs’ drug formularies, including limitations on the maximum number of opioid
pills per prescription and number of opioid pills allowed to minors. I have requested and received
the assistance of the State Attorneys General in the settlement track, because each defendant has
made clear that a prerequisite to considering settlement is the development of a structure that would
permit global resolution of both the State and federal litigation. Toward that end, my Special
Masters have spent more than a year working intensively to develop such a structure, and I approved
the creation of a Negotiation Class two weeks ago. At the same time, I encouraged defendants to
develop any alternative structure if they felt one was better, and my Special Masters have long been
working with the parties on those alternatives, as well.
It must be noted that any involvement in settlement by me and my Special Masters has been
with the approval of any involved defendant. At no time before filing of the recent Motion to
Disqualify has any defendant filed any objection suggesting in any way that my involvement in
settlement discussions might compromise my ability to be fair and impartial in conducting a trial.
To the contrary, in many instances defendants have reached out and requested my assistance, or the
assistance of my Special Masters, in exploring settlement. Through these efforts, several defendants

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have reached settlements and others are in active discussion. I do not believe that any of the
settlements that have so far been achieved would have happened without my active participation and
the work of my Special Masters.
The law is very clear that a party who feels a judge has said or done anything meriting the
drastic remedy of disqualification must file a motion promptly. The seven moving defendants have
long ago waived any objection to the conduct cited in their motion.11 The moving defendants waited
more than 18 months to complain about anything I have said in Court, or in public, or my
involvement in settlement discussions. Tellingly, they have not cited a single instance in all of the
myriad rulings I have made leading up to trial that would suggest to anyone bias or partiality.
Indeed, the only time I have been reversed in this case is when I sided with the defendants and ruled
that the DEA’s ARCOS data should not be made public. Instead, the moving defendants filed their
disqualification motion following months of settlement negotiations with the Court; after the Court
issued opinions resolving dozens of Daubert and summary judgment motions; and close to the eve
of trial. A party cannot sit on a disqualification issue and then deploy it only when it might be
strategically beneficial.
And finally, it is appropriate to consider the impact of the remedy sought by the moving
defendants, which they make explicit in their Reply: my removal not only from the upcoming
October 21 bellwether trial, but from the entire MDL. This would require the Judicial Panel on
Multidistrict Litigation to identify another judge who could abandon everything on his/her docket

11

The grounds for recusal that defendants assert in their motion do not pertain only to the
first bellwether trial. Just as defendants make clear they actually seek my recusal from the entire
MDL, the question of waiver is applicable to the entire MDL. See Manual for Complex Litigation
Fourth §13.11 at 168 (“Occasionally, the parties request that the assigned judge participate in
settlement discussions, waiving the right to seek recusal.”).
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to try to learn and understand in less than four weeks what has taken me nearly two years, to come
to Cleveland for two months to try this case, and then to undertake continued management of this
MDL. Without this replacement judge, the first Opioid MDL bellwether trial will be postponed for
some indefinite period of time and the Opioid MDL will quickly degenerate. The focus of opioid
litigation will shift more heavily to State courts; the advantages to all parties of central, federal
discovery and motion practice will wither; and the likelihood of nationwide, global resolution will
wane. Such a result would starkly undermine the main point of my public comments: that the
federal judicial branch is up to the task of addressing the opioid crisis, using all the tools it has,
including both fairly-negotiated settlements and fairly-fought litigation.
The undersigned is confident that the imminent trial of the first bellwether case, along with
the parties’ ongoing settlement negotiations – addressing not only the bellwether trial, but also
global resolution – will continue to bear fruit. And the undersigned is confident that no reasonable
person can legitimately question my impartiality.
Accordingly, the moving defendants’ Motion to Disqualify is DENIED.

/s/ Dan Aaron Polster
DAN AARON POLSTER
UNITED STATES DISTRICT JUDGE
Dated: September 26, 2019

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