City of Charleston West Virginia et al v. The Joint Commission et al
Filing
53
MEMORANDUM OPINION AND ORDER The 50 Motion for Leave to File a Sur-Reply is GRANTED and the sur-reply is deemed filed; the 43 Motion for Leave to File an Amended Complaint is DENIED; and the 44 Motion to Vacate the Judgment is DENIED, as more fully set forth herein. Signed by Senior Judge John T. Copenhaver, Jr. on 9/20/2021. (cc: counsel of record; any unrepresented parties) (kew)
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UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
CITY OF CHARLESTON, WEST VIRGINIA,
CITY OF HUNTINGTON, WEST VIRGINIA,
CITY OF KENOVA, WEST VIRGINIA, and
TOWN OF CEREDO, WEST VIRGINIA,
municipal corporations, and other municipal
corporations similarly situated,
Plaintiffs,
v.
Civil Action No. 2:17-cv-04267
THE JOINT COMMISSION f/k/a
THE JOINT COMMISSION ON ACCREDITATION OF HEALTH
CARE ORGANIZATIONS, a not-forprofit organization, and its wholly-owned
affiliate, JOINT COMMISSION
RESOURCES, INC. d/b/a JOINT
COMMISSION INTERNATIONAL, a
not-for-profit organization,
Defendants.
MEMORANDUM OPINION AND ORDER
Pending are the plaintiffs’ motion for leave to amend
the complaint [ECF No. 43] and motion to vacate the judgment
[ECF No. 44], each filed August 17, 2020.
Additionally pending
is the defendants’ motion for leave to file a sur-reply [ECF No.
50], filed September 15, 2020, which motion is granted and the
sur-reply attached thereto is deemed filed.
Case 2:17-cv-04267 Document 53 Filed 09/20/21 Page 2 of 32 PageID #: 600
I.
This action, filed November 2, 2017, involved
allegations against defendants The Joint Commission (“Joint
Commission”) and its wholly-owned subsidiary Joint Commission
Resources, Inc. (“Joint Commission Resources”) pertaining to
their roles in the promulgation of Pain Management Standards
(sometimes “PM Standards”) used in accrediting health care
organizations and other health care educational materials that
purportedly led to the over-prescription of opioids to the
detriment of the plaintiffs.
See ECF No. 1 (Complaint).
The
plaintiffs, four West Virginia municipalities, brought three
claims on behalf of themselves and others similarly situated,
against the defendants: Count I, “Negligence, Gross Negligence
and Willful Conduct”; Count II, “Unjust Enrichment”; and Count
III, “Declaratory Judgment.” 1
Id. at ¶¶ 143-59.
The defendants moved to dismiss the complaint pursuant
to Federal Rule of Civil Procedure 12(b)(6) on January 29, 2018.
ECF No. 19 (Joint Commission’s Motion to Dismiss, or in the
Alternative, Strike Class Action Allegations); ECF No. 21 (Joint
Commission Resources’ Motion to Dismiss).
On July 20, 2020, the
The court notes, as it did in its July 20, 2020 memorandum
opinion and order, that Count III requested injunctive, as well
as declaratory, relief. See ECF No. 41, at 76-78 (Memorandum
Opinion and Order on the Motion to Dismiss).
1
2
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court granted these motions by memorandum opinion and order and
dismissed the complaint by judgment order.
42 (Judgment Order).
ECF No. 41; ECF No.
The seventy-nine-page memorandum opinion
and order, found at ECF No. 41, offers a comprehensive
discussion of the reasons for dismissing each claim, of which a
brief summary is in order.
The court determined that Count I failed for several
reasons relating to existence of a duty of care.
33-62.
ECF No. 41, at
Specifically, the court found that the economic loss
doctrine applied to bar Count I inasmuch as the plaintiffs
claimed economic losses and did not allege a “special
relationship” or “privity of contract” with the defendants that
might otherwise establish a duty of care.
ECF No. 41, at 33-45.
The court also concluded that, notwithstanding the
application of the economic loss doctrine, the plaintiffs failed
to plead facts that could establish a duty of care inasmuch as
they did not “plausibly show that defendants could reasonably
foresee the harms described in the complaint.”
Id. at 45-53.
In doing so, the court: observed that the defendants did not
control the manufacture, distribution, or prescription of
opioids; noted that the Pain Management Standards promulgated by
the Joint Commission did not mention opioids or mandate their
prescription; and found persuasive the defendants’ argument that
3
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“independent standards organizations like themselves do not
generally owe a duty to the intended recipients of those
standards, let alone third parties.”
Id. at 49-53.
The court
determined that additional policy considerations weighed against
finding a duty of care inasmuch as, inter alia, doing so would
expose the defendants to “a liability to the public at large
with no manageable limits” and, relatedly, the learned
intermediary doctrine counseled against finding such a duty.
Id. at 53-60.
Regarding the gross negligence and reckless and
willful conduct allegations found in Count I, the court
concluded that “[t]he lack of foreseeability or duty of care
precludes any showing that defendants were grossly negligent or
conscious that the injury to plaintiffs was the likely or
probable result of their conduct.”
Id. at 62.
The court also determined that the complaint did not
adequately plead proximate cause, a necessary element of the
Count I claims and the Count II unjust enrichment claim.
62-76.
Id. at
In so holding, the court summarized the chain of events
that allegedly led to the plaintiffs’ injuries alleged in the
complaint:
4
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(i) After defendants promoted incorrect claims about
the safety of opioids in promulgating the PM Standards
and providing consulting services and accreditation to
HCOs, (ii) HCOs [Health Care Organizations] adopted
pain management protocols to ensure compliance with
the PM Standards, (iii) licensed independent
practitioners prescribed opioid medication based on
these protocols and their own judgment, (iv) which led
to a flood of opioid medication as well as a black
market for addicts, and (v) this crisis forced
plaintiffs to expend far greater resources and
expenditures to combat addiction, respond to crime,
and to support the numerous other costs alleged in the
complaint.
Id. at 73-74.
The court observed that the “[p]laintiffs’ claims
rely on various criminal actions of third parties, such as
‘illegal drug trafficking,’ ‘criminal vagrancy,’ ‘stolen
merchandise,’ and ‘property crimes,’ as triggering a need for
increased governmental services and remediation” and that the
plaintiffs’ claims are also dependent on the decisions of
licensed independent medical professionals to overprescribe
opioids to patients.
Id. at 75.
“[G]iven the numerous
intervening events and parties standing between [the plaintiffs
and the defendants],” the court concluded that the complaint,
“failed to plead that the pain management strategies promoted by
defendants proximately caused the widespread societal ills and
costs suffered by plaintiffs.”
Id. at 74.
The court dismissed Count III, which sought
declaratory and injunctive relief, inasmuch as this count did
not assert an independent cause of action but simply sought
5
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relief based on the underlying claims asserted in Counts I and
II that were dismissed.
Id. at 76-78.
The plaintiffs contemporaneously filed their two
pending motions on August 17, 2020.
ECF No. 43 (Motion for
Leave to Amend the Complaint); ECF No. 44 (Motion to Vacate the
Judgment).
The motion to vacate the judgment states, in full:
The plaintiffs respectfully move to vacate the
judgment under Rule 59(e) or 60(b) so that the Court
may consider the motion for leave to amend filed
earlier today. The plaintiffs are seeking this relief
only if the Court decides to grant the pending motion
for leave to amend. If the Court denies our motion for
leave to amend, then it should deny this motion as
well.
ECF No. 44.
Attached to the motion for leave to amend is a copy of
the plaintiffs’ proposed amended complaint with three exhibits. 2
ECF No. 43-1 (Proposed Amended Complaint with Three Exhibits).
One of these exhibits, Exhibit 3, is an April 13, 2016
letter from Physicians for Responsible Opioid Prescribing to Dr.
Mark Chassin, the president and CEO of the Joint Commission,
relaying concerns about the Pain Management Standards’ effect on
opioid prescription and abuse. ECF No. 43-1, at 68-71 (April
13, 2016 letter from Physicians for Responsible Opioid
Prescribing to Dr. Mark Chasson). The body of this letter was
quoted in the original complaint, ECF No. 1, at ¶ 82.a-d, and
referenced by the court in its July 20, 2020 memorandum opinion
and order, ECF No. 41, at 15, 27-28, 48, 58, 59.
Thus, although the letter itself was not attached as an
exhibit to the original complaint, its inclusion as an exhibit
to the proposed amended complaint does not substantively present
new allegations. Exhibits 1 and 2 present new materials and are
discussed herein.
2
6
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The motion first contends that the proposed amendments avoid the
economic loss doctrine defects of the original complaint
identified by the court inasmuch as the proposed amended
pleading now alleges physical harm to the plaintiffs’ property.
ECF No. 43, at 2-3.
According to the plaintiffs, several
proposed amendments address this issue: (1) an allegation that
“[m]unicipalities bear the cost of removing [opioid-addicted]
residents, repairing or bulldozing the[ir abandoned] houses, and
remediating the environmental pollutants that affect not only
the lots on which the abandoned houses sit but also public
property owned by the plaintiffs,” ECF No. 43-1, at ¶ 143; (2)
an allegation that “pollution associated with the opioid crisis
also takes place in public streets, parks, and parking lots
owned by the Municipalities, which have been damaged by human
waste, used needles, and trash discarded by people who have
entered the Municipalities to obtain drugs, and which the
Municipalities bear the cost of cleaning up,” id. at ¶ 144; an
allegation of “deterioration in environmental quality,” namely,
that “Water supplies are harmed by the flushing of over-supplied
opioids down toilets and drains, human waste, and trash”; and an
allegation that physical damage associated with opioid-related
pollution has “significantly reduced the aesthetic beauty of the
municipalities and their surrounding environments,” id. at ¶
146.
7
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The plaintiffs further contend, “The amended complaint
also reiterates and clarifies the non-economic losses that the
plaintiffs have suffered on account of the defendants’ behavior,
such as aesthetic harms and environmental pollution.”
ECF No.
43, at 3; see also ECF No. 49, at 2 (Reply in Support of Motion
for Leave to Amend the Complaint).
They cite one proposed
amendment in support of this claim, an allegation that “they
have suffered non-economic loss, including but not limited to
disruptions to quality of life, losses of recreational
opportunities, and significant community blight.
In addition,
plaintiffs allege devaluation of property, environmental
pollution, and the elevation in the spread of infectious
diseases.” 3
ECF No. 43-1, at ¶ 41.
The plaintiffs also assert that the proposed amended
complaint avoids the economic loss doctrine inasmuch as they now
plead a “special relationship” with the defendants.
at 4.
ECF No. 43,
The proposed amended complaint alleges that since the
Joint Commission has “sought to enact through state
Like the original complaint, the proposed amended complaint
continues to allege the following damages characterized as
“economic damages”: “increased health care costs, insurance and
self-insurance costs, health services costs, costs related to
responding to and dealing with opioid-related crimes and
emergencies, additional first responders, first responder and
building department overtime, remediation of dilapidated and
fire-damaged properties,[] criminal vagrancy, and other
significant public safety costs.” ECF No. 43-1, at ¶ 41.
3
8
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legislatures” certain “statutory provisions” pertaining to
health care accreditation,
Plaintiffs and other governmental entities rely upon
JCAHO to enact responsible standards and to enforce
those standards in a responsible manner, including but
not limited to standards related to pain management
and opioid prescribing. Plaintiffs and other
governmental entities further rely on JCAHO and JCR to
adequately investigate the basis for any standards as
well as any information JCAHO and JCR provide to
health care organizations or physicians, or that JCAHO
and JCR suggest or require that health care
professionals provide to patients.
ECF No. 43-1, at ¶ 21.
It further alleges:
Plaintiffs did not see the need to impose or enforce
their own standards on health care organizations and
providers concerning the minutiae of pain management
or opioid prescribing practices. As a consequence,
Plaintiffs quite reasonably focused their regulatory
and enforcement efforts on the unlicensed transfer of
drugs, and rely on JCAHO to enforce its own standards
concerning pain management.
Id. at ¶ 22.
As a result of this “sacred trust” placed in the
defendants, the proposed amended complaint alleges that “the
public record reveals no local ordinances designed to regulate
opioid prescriptions at those health care organizations.”
at ¶ 23.
Id.
These amended allegations, in the plaintiffs’
estimation, establish a special relationship between them and
the defendants.
ECF No. 43, at 4.
The plaintiffs further posit that the proposed
amendments, and attached exhibits, resolve the deficiencies
identified by the court that relate to foreseeability as it
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pertains to the existence of a duty of care.
Id. at 4-5.
On
this point, the proposed amended complaint adds the following
allegations:
85. In September 2006, Dr. Andrew Kolodny then the
Vice Chair for Clinical Psychiatry in the Department
of Psychiatry at Maimonides Medical Center, spoke at
length with Kelly Podgorny, project director in
JCAHO’s Division of Standards and Survey Methods and
the subject matter liaison for the Medication
Management Standards, about the unintended
consequences of broad based (rather than targeted)
pain assessments as required by the JCAHO standard
PC.8.10 “pain is assessed in all patients”. Dr.
Kolodny expressed his concerns about widespread
addition [sic], including by those individuals who
were not directly prescribed opioids under JCAHO
standards. Dr. Kolodny also provided Ms. Podgorny
with Exhibits 1 and 2 on September 20, 2006.
86. Dr. Kolodny explained to Ms. Podgorny that Exhibit
1 “documents a new epidemic of narcotic analgesic
overdose deaths. [Exhibit 1] demonstrates that the
overdose death rate increase has occurred in
conjunction with a national trend toward more
aggressive pain management.”
87. Dr. Kolodny explained to Ms. Podgorny that Exhibit
2 “documents a new epidemic of narcotic analgesic
abuse. Narcotic analgesics are now the second most
commonly abused class of drugs in the United States.
Like overdose deaths, the increase in abuse of
narcotic analgesics also corresponds with the trend
toward more aggressive management of pain that has
occurred over the past decade.”
ECF No. 43, at ¶¶ 85-87.
Exhibit 1 referenced therein is a
report entitled “Increasing deaths from opioid analgesics in the
United States,” published in 15 Pharmacoepidemiology and Drug
Safety 618-27 (2006).
ECF No. 43-1, at 55-64 (Exhibit 1 to
Proposed Amended Complaint).
Exhibit 2 referenced therein is a
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May 21, 2004 article published in The NSDUH (National Survey on
Drug Use and Health) Report, “an annual survey sponsored by the
Substance Abuse and Mental Health Services Administration
(SAMHSA)” of the United States Department of Health and Human
Resources, entitled “Nonmedical Use of Prescription Pain
Relievers.”
Id. at 65-67 (Exhibit 2 to Proposed Amended
Complaint).
The plaintiffs further contend that they have “add[ed]
allegations involving historical, empirical, and observational
evidence that widespread opiate use leads to the very harms the
plaintiffs allege in their complaint, and that as health care
professionals, the defendants knew or should have known of this
historical, empirical, and observational evidence.”
at 5.
ECF No. 43,
These added allegations that purportedly support
foreseeability are as follows:
42. In promulgating, enforcing, and educating about
the Pain Management Standards, Defendants, along with
manufacturers and industry front groups, sought to
overturn years of proven medical treatment practices
dating to at least the start of the 20th Century,
based on hard-learned lessons in China and the United
States demonstrating that opiates are highly addictive
and that their widespread use empirically and
historically leads to a dizzying array of widespread
damages to municipalities.
43. China, in 1839, was so distressed by Britain’s
importing of opium and the widespread damages
associated with large-scale addiction that it went to
war with Britain to prevent future imports. The
damages inflicted on Chinese municipalities by
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Britain’s opium importing and promotion were similar
to the damages suffered by Plaintiffs. Defendants, as
health care experts, knew or should have known that
widespread use of opiates leads to widespread impacts
on municipalities.
44. After the Civil War, doctors in the United States
increased their prescribing of opium, causing
widespread harm to municipalities similar to that
suffered by Plaintiffs today. Defendants, as health
care experts, knew or should have known that
widespread use of opiates leads to widespread impacts
on municipalities.
45. As a result of this history, and the experience of
health care professionals with those who are addicted
to opiates, physicians were reluctant to prescribe
opioids for fear of patient dependency and the broader
consequences of widespread addiction. Thus, the
damages Plaintiffs experienced were not only
foreseeable, they were foreseen by those who had
learned from history and experience. This was the
prevailing wisdom throughout the medical profession
prior to Defendants’ efforts, in conjunction with
pharmaceutical companies and others, to reverse nearly
a century of medical knowledge and practice.
46. According to the Smithsonian magazine’s review of
the post-Civil War opium crisis: Educating doctors was
key to fighting the epidemic. Medical instructors and
textbooks from the 1890s regularly delivered strong
warnings against overusing opium. “By the late 19th
century, [if] you pick up a medical journal about
morphine addiction,” says Courtwright, “you’ll very
commonly encounter a sentence like this: ‘Doctors who
resort too quickly to the needle are lazy, they’re
incompetent, they’re poorly trained, they’re behind
the times.’” Defendants therefore knew or should have
known as health care experts that this type of
messaging is particularly effective in getting health
care professionals to change the way patients are
treated, and this is precisely the type of messaging
Defendants used as part of their means of interfering
with the treatment of pain.
ECF No. 43-1, at ¶¶ 42-46 (alteration in Proposed Amended
Complaint); see also id. at ¶ 176 (“Furthermore, Defendants
12
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decided to reverse nearly a century of medical knowledge and
practice.
Defendants did so based on little or no research.”).
Finally, the plaintiffs argue that the proposed
amended complaint pleads additional facts to establish proximate
cause and “rebut any assumption that physicians who prescribed
the opioids relied on their ‘independent medical judgment.’”
ECF No. 43, at 6.
On this point, the proposed amended complaint
emphasizes the Joint Commission’s “power and influence over
medical practices.”
ECF No. 43-1, at ¶ 26.
The plaintiffs
allege that according to the Joint Commission itself, as
admitted in an amicus brief in a case before the Supreme Court
of the United States, “the Medicare Act of 1965, 42 U.S.C. §
1395bb, specifically provides that hospitals accredited by The
Joint Commission, subject to certain limited exceptions, are
deemed to be eligible to participate in the Medicare program.”
Id. at ¶ 24 (quoting a brief filed in Christie v. Adkins, No.
07-538, 2007 WL 4178499, at *2 (U.S. Nov. 21, 2007)).
The plaintiffs also quote a Karen Sibert, M.D., who
wrote in 2014: 4
The Joint Commission has the power to decide whether
the hospital deserves reaccreditation.
Administrators, doctors, nurses, technicians, clerks,
and janitors will be obsessed with the fear that the
The plaintiffs give no context for this quotation other
than that it was written by Sibert in 2014.
4
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reviewers will see them doing something that the Joint
Commission doesn’t consider a “best practice”, and
that they’ll catch hell from their superiors. For you
as a patient, any idea that your clinical care and
your medical records are private becomes a delusion
when the Joint Commission is on site. Their reviewers
are given complete access to all your medical records,
and they may even come into the operating room while
you’re having surgery without informing you ahead of
time or asking your permission.
[. . .]
A few competitors, such as the international firm DNV
GL, have started to make inroads in the lucrative
business of accrediting hospitals, but for the time
being the Joint Commission holds a virtual monopoly in
the U.S.
[. . .]
. . . when the Joint Commission declares that evidence
supports one treatment or medication as a standard of
quality in healthcare, it forces clinicians to follow
that recipe. If they don’t, the hospital will score
poorly on its next review.
[. . .]
Meanwhile, at my hospital, the level of tension is
rising as we anticipate Joint Commission review within
the next few weeks. Experienced nurses are pulled
away from patient care to make mock review rounds.
Department chairs circulate memos about minute details
that could trip us up. One chairman concluded
succinctly, “These people are not your friends.”
Id. at ¶ 25 (alterations and emphasis in Proposed Amended
Complaint).
On a similar note, the plaintiffs allege, without
citing to a particular instance, that “Defendants threatened
physicians with potential malpractice liability if opioids were
underprescribed and ridiculed physicians who believed opioids
were addictive.”
Id. at ¶ 4.
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Additionally, the plaintiffs claim that the proposed
amended complaint alleges proximate cause inasmuch as it
outlines the Joint Commission’s enforcement of its Pain
Management Standards.
ECF No. 43, at 6.
The proposed amended
complaint describes the Joint Commission’s surveys of health
care facilities, which occur at least once every thirty-nine
months and which health care professionals allegedly claim to
cause “great anxiety.”
ECF No. 43-1, at ¶ 100.
The proposed
amended complaint alleges that Joint Commission surveyors
“review patient charts to determine compliance with JCAHO
standards, including the Pain Management Standards.
Pain
assessment and reassessment is reviewed, as well as how the
health care provider responded to the pain assessment.”
¶ 101.
Id. at
The plaintiffs further claim that Joint Commission
surveyors interview healthcare professionals to “review the
informational material provided to patients, expecting to see
material similar to that produced or distributed by JCR and
endorsed by JCAHO . . . .”
Id. at ¶ 101.
It is also alleged that:
[h]ealth care organizations risk their accreditation
if their charts and staff interviews do not echo the
JCR materials in terms of opioid treatment practices,
e.g., prescribing or providing opioids with little
concern that they are addictive, administering opioids
in doses designed to make the patient free of pain,
and providing patients materials like Health Facts for
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You that grossly misinform patients about the risks of
opioids.
Id. at ¶ 102.
According to the plaintiffs, “In areas where the
health care provider fails to meet the JCAHO surveyor’s view of
how the pain management standard should be implemented, the
health care organization is given ‘requirements for improvement’
and is expected to follow them in order to remain accredited.”
Id. at ¶ 103.
The proposed amended complaint includes the following
quotation alleged to be found on the Joint Commission’s website:
JCAHO’s influence extends well beyond the survey,
however, as JCAHO describes on its website: Joint
Commission accreditation does not begin and end with
the on-site survey. It is a continuous process. Every
time a nurse double-checks a patient’s identification
before administering a medication, every time a
surgical team calls a “time out” to verify they agree
they’re about to perform the correct procedure, at the
correct site, on the correct patient, they live and
breathe the accreditation process. Every three
months, hospitals submit data to the Joint Commission
on how they treat conditions such as heart attack care
and pneumonia – data that is available to the public
and updated quarterly on qualitycheck.org. Throughout
the accreditation cycle, organizations are provided
with a self-assessment scoring tool to help monitor
their ongoing standards compliance. Joint Commission
accreditation is woven into the fabric of a health
care organization’s operations.
Id. at ¶ 105 (emphasis in Proposed Amended Complaint).
proposed amended complaint also states, without
particularization, as follows:
16
The
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JCAHO surveyors began faulting health care providers
for not addressing pain quickly enough through
opioids, even though providing opioids in this manner
was totally irresponsible. Because JCAHO and JCR also
falsely claimed that opioids were essentially
risk-free, JCAHO and JCR made what health care
professionals previously believed was totally
irresponsible seem like the responsible path.
Id. at ¶ 106.
The plaintiffs assert that there was no undue delay in
seeking to amend the complaint after a ruling on the motions to
dismiss inasmuch as they had no indication how the court would
rule prior to the entry of the memorandum opinion and order on
July 20, 2020, and they “reasonably believed the facts the
defendants claimed in their reply were not in the complaint were
fair inferences from what was alleged.”
ECF No. 49, at 4-5.
Moreover, they assert that delay alone is insufficient reason to
deny a motion to amend absent prejudice to opposing parties,
which, they claim, does not exist under the present
circumstances.
Id. at 5.
The defendants argue that amendment is futile and
should be denied inasmuch as the proposed amended complaint
“fails to satisfy the requirements of the federal rules,”
namely, Federal Rule of Civil Procedure 12(b)(6).
ECF No. 48,
at 7 (Response to Motion for Leave to Amend the Complaint)
(quoting Friend v. Remac America, Inc., 924 F. Supp. 2d 692, 696
(N.D. W. Va. 2013)).
Specifically, the defendants argue that
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the plaintiffs cannot overcome the economic loss doctrine
inasmuch as the new allegations pertaining thereto are merely
repackaged iterations of their prior “community blight” and
“disruptions to quality of life” allegations and the plaintiffs
offer no caselaw in support of their position that such
allegations are non-economic losses.
Id. at 8.
They further
contend that the harm to water supplies allegation is not a
well-pled fact entitled to an assumption of truth and that,
notwithstanding this point, it contrasts with their theory of
recovery, which is based on overconsumption of opioids, inasmuch
as it alleges that residents have been flushing over-supplied
opioids.
Id. at 9, 9 n. 2.
And insofar as the plaintiffs now
allege harm to streets, sidewalks, and common areas, the
defendants assert that such allegations are speculative and
conclusory.
Id.
The defendants argue that the new allegations do not
establish a “special relationship” such that the economic loss
problem may be overcome inasmuch as the defendants’ alleged
conduct has not affected the plaintiffs differently from society
in general.
Id. at 10.
The defendants also posit that a
special relationship must be narrowly defined and the new
“special relationship” alleged in the proposed amended
complaint, which pertains to nationwide governmental reliance on
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the Joint Commission’s standards and enforcement of such
standards, cannot be narrowly defined if it is as widespread as
claimed.
Id. at 11.
As to foreseeability, the defendants note the
allegations relating to Kolodny’s 2006 communications with the
Joint Commission as well as the allegations pertaining to
historical damages to municipalities in the United States and
China.
Id.
They assert, however, that such allegations “miss
the mark” on foreseeability inasmuch as they do not show that
the plaintiffs were invited to rely upon the Joint Commission’s
Pain Management Standards.
Id. at 12.
Additionally, the
defendants contend:
no additional allegations (and certainly not those in
the Proposed Amendment) can change the nature of the
parties’ relationship – that of two independent
standards organizations and third-party government
entities. As this Court previously held, independent
standards organizations do not owe a duty to intended
recipients of their standards, let alone third parties
like Plaintiffs.
Id.
The defendants further contest the sufficiency of the
proposed amended complaint’s new allegations pertaining to
proximate cause.
Id. at 12-14.
Insofar as the plaintiffs have
attempted to allege that prescribing physicians did not exercise
independent judgment, the defendants claim, “None of the new
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allegations explains how Defendants ‘overcame’ physicians’
independent medical judgment.”
Id. at 13.
Assuming this were
the case, however, the defendants assert that numerous other
intervening factors, including unnecessary over-prescription of
opioids, drug trafficking, criminal vagrancy, and property
crimes, contributed to the injuries alleged by the plaintiffs,
precluding proximate cause.
Id. at 13-14.
The defendants additionally contend that amendment
should be denied inasmuch as the plaintiffs were dilatory in
their efforts to seek amendment and amendment would prejudice
them.
Id. at 14-17.
They contend that the plaintiffs were
dilatory inasmuch as they should have moved for leave to amend
the complaint rather than oppose the motions to dismiss during
the two-and-a-half-year window the motions were pending.
15.
Id. at
They also observe that such action would have been possible
since the new facts contained in the proposed amended complaint
were available to the plaintiffs at the outset of the
litigation.
Id. at 16.
The defendants further contend that
“[a]llowing Plaintiffs leave to amend under these circumstances
would both delay final justice and significantly prejudice
Defendants by forcing them to re-start their legal defense
nearly three years after suit was first filed.”
20
Id. at 4.
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II.
Federal Rule of Civil Procedure 15(a)(1) allows a
party to amend a pleading once as a matter of course “within 21
days after serving it,” or, “if the pleading is one to which a
responsive pleading is required, 21 days after service of a
responsive pleading or 21 days after service of a motion under
Rule 12(b), (e), or (f), whichever is earlier.”
Rule 15(a)(2)
provides that “[i]n all other cases, a party may amend its
pleading only with the opposing party’s written consent or the
court’s leave.
The court should freely give leave when justice
so requires.”
The Fourth Circuit has “interpreted Rule 15(a) to
provide that ‘leave to amend a pleading should be denied only
when the amendment would be prejudicial to the opposing party,
there has been bad faith on the part of the moving party, or the
amendment would have been futile.’”
Laber v. Harvey, 438 F.3d
404, 426 (4th Cir. 2006) (en banc) (quoting Johnson v. Oroweat
Foods Co., 785 F.2d 503, 509 (4th Cir. 1986)).
“Futility is
apparent if the proposed amended complaint fails to state a
claim under the applicable rules and accompanying standards . .
. .”
Katyle v. Penn Nat’l Gaming, Inc., 637 F.3d 462, 471 (4th
Cir. 2011).
21
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“[A] post-judgment motion to amend is evaluated under
the same legal standard as a similar motion filed before
judgment was entered — for prejudice, bad faith, or futility.”
Laber, 438 F.3d at 427 (citing Foman v. Davis, 371 U.S. 178, 182
(1962); Johnson, 785 F.2d at 509-10).
Although a post-judgment
motion to amend may not be granted unless it is appropriate to
vacate the judgment under Rule 59(e) or Rule 60(b), the court
“need only ask whether the amendment should be granted, just as
it would on a prejudgment motion to amend pursuant to Fed. R.
Civ. P. 15(a).”
Katyle, 637 F.3d at 471.
III.
The July 20, 2020 memorandum opinion and order
identified four independent reasons that the negligence claim
asserted in Count I should be dismissed for failure to state a
claim, three of which (the economic loss doctrine,
foreseeability, and policy considerations) pertained to the
existence of a duty of care and one of which pertained to
proximate cause.
The memorandum opinion and order likewise
found that the gross negligence and reckless and willful conduct
claims contained in Count I should be dismissed inasmuch as the
complaint did not adequately plead a duty of care generally or
foreseeability.
Additionally, the court found that the unjust
enrichment claim alleged in Count II failed for lack of
22
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proximate cause.
Finally, the court found that dismissal of
Count III was warranted inasmuch as dismissal of Counts I and II
was appropriate.
At bottom, the question of whether the plaintiffs
should be granted leave to amend their complaint centers on
whether the proposed amended complaint adequately addresses each
independent deficiency warranting dismissal of Count I and Count
II.
The proposed amended complaint does not accomplish this
task for several reasons.
First, the proposed amended complaint does not
adequately address foreseeability as it pertains to the
existence of a duty of care.
On foreseeability, the plaintiffs
bring new allegations describing Kolodny’s 2006 communications
with the Joint Commission and historical examples.
None of
these allegations address the foreseeability problems identified
in the court’s analysis.
They do not address the court’s
finding that “[u]nlike the manufacturer and distributor
defendants in Summit County, defendants here had no control or
responsibility over the manufacturing or distributing of
opioids.
Although the 2001 NPC Monograph and 2001 TJC Monograph
refer to opioids, the PM Standards themselves did not even
mention opioids or mandate opioid prescriptions.”
at 49.
ECF No. 41,
Indeed, the plaintiffs acknowledge as much by the
23
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allegation in its complaint at paragraph 56 which is set forth
in its proposed amended complaint at paragraph 72: ”JCAHO’s Pain
Management Standards never overtly required opioid treatments.”
An exception to the absence of mention of opioids in the PM
Standards applies in that, as alleged in the complaint at
paragraph 86, “In 2016, JCAHO . . . reexamined the Pain
Management Standards and in July 2017 issued new Standards to
take effect in January of 2018,” as a result of which Standard
LD.04.03.13 prescribed as follows:
Standard LD.04.03.13
Pain assessment and pain management, including safe
opioid prescribing is identified as an organizational
priority for the hospital.
R3 Report, The Joint Comm’n (Aug. 29, 2017).
As the defendants correctly note, the proposed
amendments do not address the foreseeability analysis’ emphasis
on caselaw indicating that independent standards organizations
like the defendants do not generally owe a duty of care to the
intended recipients of those standards, i.e., the health care
organizations in this action, let alone third parties like the
municipality plaintiffs.
Id. at 49-53 (citing In re Welding
Fume Prod. Liab. Litig., 526 F. Supp. 2d 775, 799, 800 n.114
(N.D. Ohio 2007); Evenson v. Osmose Wood Preserving, Inc., 760
F. Supp. 1345, 1349 (S.D. Ind. 1990); Gunsalus v. Celotex Corp.,
674 F. Supp. 1149, 1157 (E.D. Pa. 1987); Klein v. Council of
24
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Chem. Ass’ns, 587 F. Supp. 213, 225 (E.D. Pa. 1984); Meyers v.
Donnatacci, 531 A.2d 398, 403 (N.J. Super. Ct. 1987); Bailey v.
Edward Hines Lumber Co., 719 N.E.2d 50, 178 (Ill. App. Ct.
1999)).
Additionally, the court observes that the July 20,
2020 memorandum opinion and order quoted Syllabus Point 3 of
Sewell v. Gregory, 371 S.E.2d 82, 83 (W. Va. 1988), in which the
Supreme Court of Appeals of West Virginia held:
The ultimate test of the existence of a duty to use
care is found in the foreseeability that harm may
result if it is not exercised. The test is, would the
ordinary man in the defendant’s position, knowing what
he knew or should have known, anticipate that harm of
the general nature of that suffered was likely to
result?
The court likewise quoted Robertson v. LeMaster, 301 S.E.2d 563,
568 (W. Va. 1983), for the proposition that “[d]ue care is a
relative term and depends on time, place, and other
circumstances.
It should be in proportion to the danger
apparent and within reasonable anticipation.”
These quotations
make clear that foreseeability does not gauge whether the
defendants could foresee any harm resulting from their conduct,
but rather involves an inquiry of whether the defendants could
foresee a harm similar to that actually suffered.
Neither the Kolodny nor the historical allegations of
the proposed amended complaint remotely relate to the physical
25
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harms now alleged by the plaintiffs.
There is no allegation
that Kolodny told the Joint Commission about public property
damage and pollution that could conceivably impact
municipalities.
And there is no allegation that municipalities
in China and the United States experienced physical harms, such
as water pollution due to opioids flushed down toilets or other
opioid-related pollution on publicly owned streets and
sidewalks, after a rise in opium consumption and addiction
during the Nineteenth Century – there are only vague allusions
by plaintiffs to that which they call “a dizzying array of
widespread damages to municipalities,” “damages . . . similar to
the damages suffered by Plaintiffs,” and “widespread harm to
municipalities.”
ECF No. 43-1, at ¶¶ 43-44.
And to the extent the economic damages, “community
blight,” “disruptions to quality of life,” “losses of
recreational opportunities,” aesthetic harms, and related
injuries alleged, id. at ¶¶ 41, 146, are not barred by the
economic loss doctrine since obscure physical harms to the
plaintiffs’ properties are also alleged, 5 the Kolodny and
historical allegations still fail to relate to these harms.
The
The court need not decide whether the proposed amended
complaint cures all economic loss doctrine problems identified
in the July 20, 2020 memorandum opinion and order, see ECF No.
41, at 33-45, inasmuch as it is clear that Count I remains
deficient for the other reasons discussed herein.
5
26
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Kolodny-related allegations have nothing to do with harms to
municipalities, and the historical harm examples are so vague
that they do not even allege that Chinese and American
municipalities suffered “harm of the general nature of that
suffered” by the plaintiffs according to the proposed amended
complaint.
Syl. Pt. 3, Sewell, 371 S.E.2d at 83.
Second, the proposed amended complaint does not
adequately address the policy considerations discussed in the
July 20, 2020 memorandum opinion and order.
In the memorandum
opinion and order, the court quoted Robertson, 301 S.E.2d at
568, for the proposition, “Beyond the question of
foreseeability, the existence of duty also involves policy
considerations underlying the core issue of the scope of the
legal system’s protection.”
ECF No. 41, at 53.
“These policy
factors ‘include the likelihood of injury, the magnitude of the
burden of guarding against it, and the consequences of placing
that burden on the defendant.’”
Id. (quoting Robertson, 301
S.E.2d at 568).
With regard to the latter two factors, the court found
as follows:
[T]he consequences of imposing this duty on defendants
would expose them to a liability to the public at
large with no manageable limits. Aikens noted that
“[e]ach segment of society will suffer injustice,
whether situated as plaintiff or defendant, if there
27
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are no finite boundaries to liability.” 541 S.E.2d at
592. The “[c]ourt’s obligation is to draw a line
beyond which the law will not extend its protection in
tort, and to declare, as a matter of law, that no duty
exists beyond that court-created line.” Id. Several
intermediaries stand in between plaintiffs and
defendants, including the HCOs responsible for issuing
their own pain management protocols, the medical
practitioners responsible for issuing opioid
treatments, as well the pharmaceutical manufacturers,
distributors, and retailers who bring the opioids to
market in the first place.
Id. at 55 (second alteration in the July 20, 2020 memorandum
opinion and order).
The court similarly found that the learned
intermediary doctrine, which restricts the liability of
prescription drug and medical device manufacturers to patients
if they warn practitioners of the dangers associated with their
products, weighed against finding a duty, “where the independent
medical practitioners [in this case] assumed ultimate
responsibility for advising patients about opioid risks and,
compared to the opioid manufacturers themselves, defendants are
at least one step further removed from the individual patients.”
Id. at 57.
Indeed, the court found the plaintiffs’
acknowledgement that “[h]ealth care professionals are capable of
using their clinical judgment to determine when to assess
patients for pain” to be indicative of a “corollary principle
that physicians exercise their independent clinical judgment in
patient evaluations, including when deciding whether to
28
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prescribe opioid treatments.”
Id. at 59 (alteration in the July
20, 2020 memorandum opinion and order).
These points formed the basis of the court’s
conclusion that “[t]he enormous scale of the opioid crisis has
reached almost every corner of society, but the court must draw
a line somewhere.
It cannot extend a duty to the full
constellation of individuals and communities who have suffered
in the wake of the opioid crisis without running afoul of
Aikens.”
Id. at 60.
Nothing offered in the proposed amendments
refutes this conclusion.
As the defendants argue, the new
allegations pertaining to the Joint Commission’s efforts to
enforce their standards through surveys and otherwise do not
demonstrate that practitioners at accredited health care
organizations had their independent medical judgments overcome
by those of the Joint Commission.
Indeed, the plaintiffs
effectively allege, through the citation to Exhibit 3 in
paragraph 108.b, that “[h]ealth care professionals are capable
of using their clinical judgment to determine when to assess
patients for pain.”
ECF No. 43-1, at ¶ 108.b.
And the court’s general policy reasoning relating to
intermediaries remains unchanged.
This case does not involve
claims alleged by a plaintiff against a prescribing physician or
drug manufacturer defendant.
Between the plaintiffs and the
29
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defendants stand the opioid manufacturers, opioid distributors,
accredited health care organizations, opioid prescribers who
possess independent medical judgment, and patients and other
third-parties who must commit additional acts, such as
polluting, to cause the harms alleged by the plaintiffs.
Courts
have an obligation to draw lines beyond which no duty of care
exists.
Aikens, 541 S.E.2d at 592.
From a policy standpoint,
the proposed amended complaint continues to assert a duty of
care that falls beyond such a line.
Third and similarly, the proposed amended complaint
fails to adequately plead proximate cause.
The new allegations
concerning the power of the Joint Commission over practitioners
at accredited health care organizations and the enforcement of
standards through surveys and related activities could not, if
true, establish that the independent medical judgment of
prescribing practitioners was overborne by the defendants.
And
even if they could establish this, there remains an exceedingly
long chain of independent actions between the defendants’
conduct and the harms alleged by the plaintiffs, which includes,
inter alia, opioid manufacture and distribution, the
acquiescence of health care organizations to a course of conduct
that transcends the PM Standards promulgated by the defendants,
the over-prescription of opioids by prescribing health care
30
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professionals, the rise of a black market for opioids, and harms
such as pollution, vagrancy, and community blight resulting from
the use of opioids unnecessarily prescribed or obtained through
illegal means.
Simply put, the proposed amended complaint does
not, and cannot, adequately plead proximate cause due to the
plethora of independent actions that lie between the alleged
conduct of the defendants and the injuries allegedly suffered by
the plaintiffs.
Inasmuch as foreseeability, policy considerations, and
proximate cause problems remain outstanding despite the new
allegations raised in the proposed amended complaint, amendment
of Count I would be futile.
And inasmuch as the unjust
enrichment claim found in Count II also requires a showing of
proximate cause, amendment thereof would also be futile.
Since
amendment of the two substantive counts would be futile, the
court finds that the July 20, 2020 memorandum opinion and
order’s rationale for dismissing Count III’s requests for
declaratory and injunctive relief stands.
Inasmuch as it is clear that amendment would be futile
for the foregoing reasons, the court need not address the undue
delay and prejudice arguments of the defendants.
31
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IV.
Accordingly, it is ORDERED that:
1.
The defendants’ motion for leave to file a
sur-reply (ECF No. 50) be, and it hereby is, GRANTED and the
sur-reply attached thereto is deemed filed.
2.
The plaintiffs’ motion for leave to file an
amended complaint (ECF No. 43) be, and it hereby is, DENIED.
3.
The plaintiffs’ motion to vacate the judgment
(ECF No. 44) be, and it hereby is, DENIED.
The Clerk is directed to transmit copies of this
memorandum opinion and order to all counsel of record and any
unrepresented parties.
ENTER: September 20, 2021
32
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